http://www.clinicaltrials.gov/ct/show/NCT00091689?order=1

3M Pharmaceuticals

Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest tolerated dose of an immune response modifier cream directly applied to advanced, inoperable, melanoma skin lesions. The study will also measure blood levels of the drug and examine the potential anti-tumor activity of the cream.

Melanoma

Drug:852A

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Study start:September 2004

http://www.clinicaltrials.gov/ct/show/NCT00095160?order=2

3M Pharmaceuticals

Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment.

Neoplasms

Drug:852A

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Primary Outcomes:Safety and PharmacokineticsSecondary Outcomes:Tumor Response

http://www.clinicaltrials.gov/ct/show/NCT00077779?order=1

Abbott Laboratories

The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)

Crohn's Disease

Drug:Adalimumab

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control

Official Title:A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Crohns Disease

http://www.clinicaltrials.gov/ct/show/NCT00062699?order=2

Abbott Laboratories

To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to death.

End-Stage Kidney Disease

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

Official Title:A Phase IV, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study to Evaluate the Survival Benefits of Zemplar Relative to Calcijex in Subjects with Stage V Chronic Kidney Disease on Hemodialysis

http://www.clinicaltrials.gov/ct/show/NCT00048425?order=3

Abbott Laboratories

The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.

Heart Failure, Congestive

Drug:Levosimendan

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00085644?order=4

Abbott Laboratories

The objective of this study is to evaluate the safety and efficacy of adalimumab 40mg every other week (eow) compared to placebo in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAID) and who may have additionally failed one or more disease-modifying anti-rheumatic drug (DMARD) therapy.

Ankylosing Spondylitis

Drug:Adalimumab (D2E7)

Phase III

Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study

Official Title:A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Ankylosing Spondylitis

http://www.clinicaltrials.gov/ct/show/NCT00093301?order=5

Wentworth Area Health Services

The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Cardiogenic ShockSeptic Shock

Drug:LevosimendanDrug:Dobutamine

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Efficacy Study

Official Title:Efficacy of Levosimendan in the Critically Ill Patients with Unstable Hemodynamics (the LICI study) - A Double Blind Randomized Pilot Study

http://www.clinicaltrials.gov/ct/show/NCT00048542?order=6

Abbott Laboratories

This is a multicenter, Phase III randomized, placebo-controlled study in which polyarticular JRA subjects who are either MTX treated or non-MTX treated will initially receive Adalimumab by subcutaneous injection every other week for a four-month open-label lead-in period. Subjects who respond to the open-label therapy will then be rolled over into the double-blind portion of the study and will be randomized to receive either adalimumab or placebo for an additional 32 weeks or until flare of disease, whichever is earlier. Subjects who experience disease flare during the double-blind portion of the study or subjects who complete 48 weeks of the study will be given the option to receive open-label treatment with adalimumab for an additional 44 weeks.

Arthritis, Juvenile Rheumatoid

Drug:Adalimumab/anti-TNF alfa

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00067262?order=7

Abbott Laboratories

The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

Bipolar Disorder

Drug:Divalproex Sodium Extended-Release Tablets

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00061672?order=8

Abbott Laboratories

The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with refractory lymphoma.

Lymphoma, Non-HodgkinHodgkin's Lymphoma

Drug:ABT-510 - Thrombospondin-1 Mimetic

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00086671?order=9

Abbott Laboratories

The objective of the trial is to study the safety and effectiveness of ABT-874 administered weekly or every other week in patients with relapsing remitting and secondary progressive multiple sclerosis as compared to placebo. Effectiveness will be measured based on MRI scans done periodically thoughout the study.

Multiple SclerosisMultiple Sclerosis, Relapsing RemittingMultiple Sclerosis, Secondary Progressive

Drug:ABT-874/Human monoclonal antibody against IL-12

Phase II

Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study

Study start:May 2004

http://www.clinicaltrials.gov/ct/show/NCT00073138?order=10

Abbott Laboratories

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with colorectal cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Colorectal Cancer

Drug:ABT-751

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00073151?order=11

Abbott Laboratories

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with non-small cell lung cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Non-small cell lung cancer

Drug:ABT-751

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00063102?order=12

Abbott Laboratories

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Breast Cancer

Drug:ABT-751

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00091481?order=13

Abbott Laboratories

To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).

Kidney Failure, Chronic

Drug:Zemplar

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control

Official Title:A Randomized, Active-Controlled, Double-Blind Multi-center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

http://www.clinicaltrials.gov/ct/show/NCT00073710?order=14

Abbott Laboratories

A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects

HypoparathyroidismHypercalcemiaChronic Kidney Disease

Study Type:ObservationalStudy Design:Natural History

Official Title:A Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium

http://www.clinicaltrials.gov/ct/show/NCT00053378?order=15

Abbott Laboratories

A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients

Hypocalcemia

Drug:paricalcitol injection (Zemplar)Behavior:Effects on calcium regulationBehavior:Administration of elemental Ca during hypocalcemic ICU pts.

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety/Efficacy Study

Official Title:A Placebo-Controlled, Double-Blind Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

http://www.clinicaltrials.gov/ct/show/NCT00091975?order=16

Abbott Laboratories

The objective of this study is to determine the safety and efficacy of Zemplar Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis, while using the revised dose titration scheme.

Kidney Disease

Drug:Zemplar Capsule

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control

Official Title:A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis

http://www.clinicaltrials.gov/ct/show/NCT00061867?order=1

Celsion

adenocarcinoma of the prostatestage III prostate cancerstage IV prostate cancer

Drug:doxorubicin HCl liposomeProcedure:chemotherapyProcedure:hyperthermia

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I Study of Doxorubicin HCl Liposome and Thermal Therapy in Patients With Adenocarcinoma of the Prostate

http://www.clinicaltrials.gov/ct/show/NCT00073372?order=1

Centocor

Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled trial to evaluate efficacy and safety of Abciximab in Acute Ischemic Stroke onset within 6 hour time window and subjects who wake from sleep with stroke symptoms, and in whom the planned treatment initiation is within 3 hours of awakening

Stroke

Drug:Abciximab

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Abciximab(ReoPro) in Acute Ischemic Stroke: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial

http://www.clinicaltrials.gov/ct/show/NCT00073437?order=2

Centocor

Subjects eligible for this study will have a diagnosis of sarcoidosis for a least one year prior to screening and have evidence of disease on chest X-ray. Sarcoidosis must also have been proven by biopsy. Subjects must be taking a minimum of 10 mg prednisone (or equivalent dose of steroid) per day or one or more immunosuppressants (methotrexate, azathioprine, etc.) for at least the three month period immediately prior to screening.

Sarcoidosis

Drug:Infliximab

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Infliximab (Remicade) in Subjects with Chronic Sarcoidosis with Pulmonary Involvement

http://www.clinicaltrials.gov/ct/show/NCT00076726?order=3

Centocor

Phase II clinical trial looking for newly diagnosed subjects with giant cell arteritis (GCA) or temporal arteritis. Standard Infliximab care. Subjects may also have polymyalgia rheumatica (PMR).

Giant Cell ArteritisGranulomatous Arteritis

Drug:biologic therapy

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00046228?order=4

Centocor

The purpose of this medical research study is to determine whether the administration of abciximab and reteplase before patients have a coronary intervention, is safe and effective in the treatment of acute myocardial infarction compared to only abciximab given during coronary intervention.

Myocardial Infarction

Drug:abciximabDrug:reteplase

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study

Official Title:A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Reteplase and Abciximab with Abciximab Alone Administered Early or Just Prior to Primary Percutaneous Coronary Intervention (PCI) for Acute Myocardial Infarction

http://www.clinicaltrials.gov/ct/show/NCT00094458?order=5

Centocor

The purpose of this medical research study is to compare the efficacy of infliximab and infliximab plus azathioprine to azathioprine treatment of patients with moderate to severe Crohns Disease.

Crohns Disease

Drug:InfliximabDrug:Azathioprine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study

Official Title:Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing Remicade (infliximab) and Remicade plus Azathioprine to Azathioprine in the Treatment of Patients with Crohns Disease Nave to both Immunomodulators and Biologic Therapy

http://www.clinicaltrials.gov/ct/show/NCT00060502?order=6

Centocor

Pancreatic NeoplasmsCachexia

Drug:Infliximab

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00078312?order=1

Cephalon

The primary objective of this study is to evaluate the safety and tolerability of CEP-10953 administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD). Safety and tolerability will be evaluated throughout the study through adverse event data, clinical laboratory test evaluations, vital sign measurements, electrocardiography, and physical examination findings.

NarcolepsySleep Apnea, ObstructiveSleep Apnea SyndromesShift-Work Sleep Disorder

Drug:CEP-10953

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study

Official Title:A 12-Month, Open Label, Flexible-Dosage Study of the Safety/Efficacy of CEP 10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

http://www.clinicaltrials.gov/ct/show/NCT00078325?order=2

Cephalon

The primary objective of this study is to determine whether treatment with CEP 10953 is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Drug:CEP-10953

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A 12 Week, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy/Safety of CEP 10953 as Treatment for Adults With Residual Excessive Sleepiness Associated With OSA/H Syndrome

http://www.clinicaltrials.gov/ct/show/NCT00079677?order=3

Cephalon

The primary objective of this study is to determine whether treatment with CEP-10953 is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

Obstructive Sleep ApneaSleep Hypopnea

Drug:CEP-10953

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A 12 Week, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy/Safety of CEP 10953 Treatment for Adults With Residual Excessive Sleepiness Associated With OSA/H Syndrome

http://www.clinicaltrials.gov/ct/show/NCT00078377?order=4

Cephalon

The primary objective of this study is to determine whether treatment with CEP-10953 is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbasline visit)

Narcolepsy

Drug:CEP-10953

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 and 250 mg/day) as Treatment for Adults with Excessive Daytime Sleepiness Associated with Narcolepsy

http://www.clinicaltrials.gov/ct/show/NCT00080288?order=5

Cephalon

The primary objective of this study is to determine whether treatment with CEP 10953 is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) and by Clinical Global Impression of Change (CGI C) ratings (for sleepiness during night shifts including the commute to and from work) at week 12 (or last postbaseline visit).

Excessive SleepinessShift Work Sleep Disorder

Drug:CEP-10953

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 as Treatment for Adults With Excessive Sleepiness Associated With Chronic SWSD

http://www.clinicaltrials.gov/ct/show/NCT00079482?order=6

Cephalon

The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).

Acute Myeloid Leukemia

Drug:lestaurtinib

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations

http://www.clinicaltrials.gov/ct/show/NCT00081601?order=7

Cephalon

The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.

Prostate Cancer

Drug:CEP-701

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:An Open-Label Phase 2 Study of Oral CEP-701 in Patients With Asymptomatic Hormone-Refractory Cancer With Rising Prostate specific Antigen

http://www.clinicaltrials.gov/ct/show/NCT00087789?order=1

Ceregene

This is a Phase I clinical study to assess the safety, tolerability and biologic activity of in vivo AAV-mediated delivery of CERE-110. Six subjects will receive CERE-110 in dose-escalating fashion. All subjects will receive bilateral, stereotactic injections of CERE-110 for a total of four injections to target the basal forebrain region of the brain containing the nucleus basalis of Meynert (NBM). Two doses will be administered to each of three subjects in an open-label manner. A four-week observation period will be implemented after each subject within a cohort is dosed. Three months from the time that the last subject in the first dose cohort has been dosed, escalation to the next dose will proceed if CERE-110 has been shown to be safe. All study participants will be observed for a 24-month period and then followed annually.

Alzheimer's Disease

Gene Transfer:CERE-110: adeno-associated virus delivery of NGF

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Phase I, Dose-Escalating Study to Assess the Safety and Tolerability of CERE-110 [Adeno-Associated Virus (AAV)-Based Vector-Mediated Delivery of Beta-Nerve Growth Factor (NGF)] in Subjects with Mild to Moderate Alzheimer's Disease

http://www.clinicaltrials.gov/ct/show/NCT00030355?order=1

ChemGenex Therapeutics

recurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiaadult acute promyelocytic leukemia (M3)childhood acute promyelocytic leukemia (M3)adult acute myeloid leukemia with t(15;17)(q22;q12)

Drug:homoharringtonineProcedure:chemotherapy

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I/II Study of Salvage Therapy Comprising Homoharringtonine in Patients With Refractory Acute Promyelocytic Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00006441?order=1

The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV). After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies.

HIV Infections

Drug:Lamivudine/ZidovudineDrug:Nelfinavir mesylateDrug:Aldesleukin

Study Type:InterventionalStudy Design:Treatment,Open Label,Efficacy Study

Official Title:A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons with Primary or Early HIV Infection

http://www.clinicaltrials.gov/ct/show/NCT00051688?order=2

Chiron Corporation

The primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs.

Colorectal Neoplasms

Drug:tezacitabineDrug:oxaliplatin

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00054873?order=3

Chiron Corporation

The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma

Drug:tezacitabineDrug:5-fluorouracil

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00084071?order=4

Chiron Corporation

The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.

Pneumonia

Drug:Tifacogin

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Tifacogin (recombinant tissue factor pathway inhibitor) for the Treatment of Patients with Severe Community-Acquired Pneumonia

http://www.clinicaltrials.gov/ct/show/NCT00080470?order=1

Advanced Bionics

Urinary Incontinence

Device:battery powered bion microstimulator

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind,Placebo Control,Crossover Assignment,Safety/Efficacy Study

Official Title:Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

http://www.clinicaltrials.gov/ct/show/NCT00043368?order=1

Coley Pharmaceutical Group

Neoplasm Metastasis

Drug:CpG 7909

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00070642?order=2

Coley Pharmaceutical Group

Melanoma

Drug:CPG 7909Drug:DTIC Chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:CPG 7909 Injection with or without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study

http://www.clinicaltrials.gov/ct/show/NCT00043420?order=3

Coley Pharmaceutical Group

Lymphoma, T-Cell, Cutaneous

Drug:CpG 7909

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase I/II Multi-Center, Open Label Study of CpG 7909 in Patients with Cutaneous T-Cell Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00043407?order=4

Coley Pharmaceutical Group

Renal Cell CancerPost Nephrectomy

Drug:CpG 7909

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer

http://www.clinicaltrials.gov/ct/show/NCT00086177?order=1

Columbia Laboratories

This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication). Neither the investigators nor the patients in the trial will know which treatment has been assigned. All study medications will be given vaginally once a day. Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy week 36.

Pregnancy

Drug:8% progesterone vaginal gel

Phase IV

Study Type:InterventionalStudy Design:Diagnostic,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy, Safety, and Tolerability of 8% Progesterone Vaginal Gel in Preventing Preterm Delivery in Pregnant Women at Increased-Risk for Preterm Delivery

http://www.clinicaltrials.gov/ct/show/NCT00037115?order=1

MidAmerica Neuroscience Institute

The participant will receive weekly intramuscular treatment with AVONEX (interferon beta 1-a) and a one-time high dose intravenous methotrexate with Leucovorin rescue, along with the standard solumedrol treatment before beginning AVONEX treatment.

Demyelinating DisordersMultiple SclerosisOptic NeuritisMyelitisNeuritis

Drug:interferon beta 1aDrug:methotrexateDrug:methylprednisolone

Phase IV

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study

Official Title:An Open Label Pilot Study of Induction Therapy with a Single High Dose Bolus of Intravenous Methotrexate with Leucovorin Rescue, Prior to Initiation of AVONEX Treatment, in Patients Presenting with a First Acute Demyelinating Event: Comparison with CHAMPS results.

http://www.clinicaltrials.gov/ct/show/NCT00091741?order=1

Georgetown University

The purpose of conducting this already-FDA approved Phase I clinical trial is to evaluate the safety and efficacy of etanercept (Enbrel) on the response rate in HIV-infected subjects who have failed to respond to conventional antiretroviral (HAART) therapy and for whom no alternative therapy exists. The greatest challenge faced by HIV-treating clinicians today is the management of virologic failure and metabolic complications of anti-HIV treatment. Treatment failure can occur because of non-compliance, drug discontinuation, lack of drug potency, inadequate drug plasma concentration or drug resistance. Of these, drug resistance remains the single most important reason for virological failure and rapidly limits treatment options.

HIV Infection

Drug:Etanercept (Enbrel)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase I Pilot Study to Evaluate Safety and Efficacy of Etanercept (Enbrel) on the Response Rate of HIV-infected Subjects Who are in Virologic Failure and Who Have Failed to Respond to Standard Antiretroviral Therapy

http://www.clinicaltrials.gov/ct/show/NCT00090714?order=1

Corautus Genetics

The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto) system needed to benefit patients with severe Angina Pectoris.

Angina Pectoris

Gene Transfer:pVGI.1(VEGF2)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00086164?order=1

Corgentech

The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed for hemodialysis at 6 months after enrollment.

HyperplasiaChronic Renal Failure

Drug:edifoligide (E2F Decoy)

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety Study

Official Title:A Phase 1/2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial to Assess the Effect of Treatment of the Recipient Vein of a Polytetrafluoroethylene (PTFE) Vascular Access Graft with Two Concentrations of E2F Decoy as Compared to Placebo on Neointimal Hyperplasia and the Preservation of Graft Function in Patients with Chronic Renal Failure Requiring Hemodialysis

http://www.clinicaltrials.gov/ct/show/NCT00078676?order=1

Corixa Corporation

The primary purpose of this trial is to compare safety and efficacy between Bexxar and Zevalin.

Follicular LymphomaDiffuse Large Cell Lymphoma

Drug:Bexxar - Iodine I 131 Tositumomab Therapeutic RegimenDrug:Zevalin - Ibritumomab Tiuxetan Therapeutic Regimen

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multi-Center, Randomized, Phase III Study of Iodine I 131 Tositumomab Therapeutic Regimen versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients with Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00062894?order=2

Corixa Corporation

The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab.

Non-Hodgkin's Lymphoma

Drug:Iodine I 131 Tositumomab

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Pharmacokinetics Study

Official Title:A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients with Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00022945?order=3

Corixa Corporation

The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody followed by CHOP and to see what effects it has on patients with previously untreated mantel cell lymphoma.

Mantle Cell Lymphoma

Drug:Iodine-131 Anti-B1 AntibodyDrug:Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00062907?order=4

Corixa Corporation

The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.

Non-small cell lung cancer

Vaccine:Recombinant DNA- pVAX/L523SVaccine:Recombinant adenovirus- Ad/L523S

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00078598?order=5

Corixa Corporation

A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe. Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada Rituxan; EU - Mabthera), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the dosimetric dose, patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patients weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the therapeutic dose, patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131conjugated Tositumomab (35 mg). Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10.

Non-Hodgkin's Lymphoma

Drug:Rituximab or Iodine I 131 Tositumomab Therapy

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multi-Center, Randomized, Phase III Study of Rituximab versus Iodine I 131 Tositumomab Therapy for Patients with Relapsed Follicular Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00054730?order=1

Cortex Pharmaceuticals

Fragile X SyndromeAutism

Drug:CX516 (Ampalex)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Effects of Ampakine CX516 (Ampalex) on Functioning in Fragile X Syndrome and Autism

http://www.clinicaltrials.gov/ct/show/NCT00061035?order=1

Cosmo Bioscience

Dr. Frederick Millard, MD, Associate Clinical Professor at the UCSD Cancer Center, will be conducting a 12-week study in advanced prostate cancer patients. The study will be held at the UCSD Medical Center and will test an experimental investigational gene therapy vaccine designed to make the patient's immune system react against telomerase, an enzyme expressed in prostate cancer cells.

Prostatic Neoplasms

Vaccine:Transgenic Lymphocyte Immunization Vaccine (TLI)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00086463?order=1

CoTherix

The purpose of this study is to determine the safety and efficacy of Iloprost is safe and effective in subjects that have 'Pulmonary Arterial Hypertension' and are concurrently taking bosentan (Tracleer TM).

Pulmonary Arterial HypertensionPAHPulmonary Hypertension

Drug:Iloprost or placebo

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00098358?order=1

Critical Therapeutics

Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.

Acne Vulgaris

Drug:Zileuton

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Clinical Proof of Concept Study of Zileuton IR in Patients with Moderate to Severe Facial Acne Vulgaris

http://www.clinicaltrials.gov/ct/show/NCT00038766?order=1

Cytokine PharmaSciences

The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohns Disease.

Crohn Disease

Drug:CNI-1493

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-controlled study of CNI-1493 for Treatment of Moderate to Severe Crohns Disease

http://www.clinicaltrials.gov/ct/show/NCT00017511?order=1

Daiichi Pharmaceuticals

Hypopharyngeal CancerLaryngeal Cancerlip and oral cavity cancermetastatic squamous neck cancer with occult primaryNasopharyngeal Canceroral complications of cancer and cancer therapyOropharyngeal Cancerparanasal sinus and nasal cavity cancerradiation toxicitySalivary Gland Cancer

Drug:cevimelineProcedure:complications of therapy assessment/managementProcedure:radioprotectionProcedure:supportive care/therapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Cevimeline in Patients With Xerostomia Secondary to Radiotherapy for Cancer in the Head and Neck Region

http://www.clinicaltrials.gov/ct/show/NCT00077077?order=2

Daiichi Pharmaceuticals

unspecified adult solid tumor, protocol specific

Drug:DJ-927Drug:capecitabineProcedure:chemotherapy

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I Study of DJ-927 and Capecitabine in Patients With Locally Advanced or Metastatic Solid Tumors

http://www.clinicaltrials.gov/ct/show/NCT00080834?order=3

Daiichi Pharmaceuticals

Colon CancerRectal Cancer

Drug:DJ-927Procedure:chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of DJ-927 as Second-Line Treatment in Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma

http://www.clinicaltrials.gov/ct/show/NCT00072228?order=4

Daiichi Pharmaceuticals

unspecified adult solid tumor, protocol specific

Drug:gemcitabineDrug:soblidotinProcedure:chemotherapy

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors

http://www.clinicaltrials.gov/ct/show/NCT00064220?order=5

Daiichi Pharmaceuticals

adult soft tissue sarcoma

Drug:soblidotinProcedure:chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Soblidotin in Patients With Advanced or Metastatic Soft Tissue Sarcoma Previously Treated With Anthracycline-Based Chemotherapy

http://www.clinicaltrials.gov/ct/show/NCT00060892?order=6

AnGes

The primary purpose of this study is to assess the overall safety of different dose regimens of AMG0001 as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study will also evaluate the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.

Arterial Occlusive DiseasePeripheral Vascular DiseaseIschemia

Gene Transfer:HGF transferred via plasmid vector

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia

http://www.clinicaltrials.gov/ct/show/NCT00065442?order=1

Dendreon

Prostate Cancer

Vaccine:Provenge

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

Official Title:A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy with PA2024-loaded Autologous APCs (Provenge, APC8015) in Asymptomatic Patients with Gleason Sum less than or equal to 7, Metastatic, AIPC

http://www.clinicaltrials.gov/ct/show/NCT00058981?order=1

DeveloGen Israel, Ltd.

Randomized, double-blind, parallel-group study to evaluate DiaPep0277 or placebo at baseline. Study medication will be administered at time 0, 1 and 3 months, and then every 3 months for a total of 8 administrations. The total duration of the trial is 24 months (treatment for 18 months and follow-up for an additional 6 months). Patients will be male or female between the ages of 30 and 55 years, inclusive, within 2 to 60 months of the diagnosis of diabetes mellitus. Subjects must be positive for glutamic acid decarboxylate (GAD) autoantibodies. At the Screen Visit (Visit 2), all subjects will be asked to discontinue their use of all oral antidiabetic medications with the exception of metformin. The subjects will be placed on a stable regimen of insulin and diet (plus metformin if needed). Prior to the Baseline Visit (Visit 3), diabetic control must be achieved by diet and insulin (plus metformin if needed).

Diabetes, Autoimmune

Drug:DiaPep277

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Tolerability as Well as the Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in LADA Subjects

http://www.clinicaltrials.gov/ct/show/NCT00064649?order=1

The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.

Benign Prostatic Hyperplasia

Device:Transurethral Microwave Thermotherapy (TUMT)Device:Transurethral Needle Ablation (TUNA) TherapyDrug:Finasteride and Alfuzosin

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study

Official Title:Minimally Invasive Surgical Therapy for BPH

http://www.clinicaltrials.gov/ct/show/NCT00095368?order=1

Advancis Pharmaceutical Corporation

The purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).

PharyngitisTonsillitis

Drug:Amoxicillin Pulsatile Release Multiparticulate Tablet (drug)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 days vs Penicillin VK 250 mg QID for 10 days in Patients with Streptococcus pyogenes

http://www.clinicaltrials.gov/ct/show/NCT00004500?order=1

Meconium Aspiration

Drug:Lucinactant

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Active Control,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00007657?order=1

PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the combined endpoint of all-cause mortality or nonfatal MI.

Myocardial Ischemia

Procedure:Intensive medical therapyProcedure:Percutaneous Coronary Intervention

Phase III

Study Type:InterventionalStudy Design:Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study

Official Title:Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

http://www.clinicaltrials.gov/ct/show/NCT00057525?order=1

DynPort Vaccine Company

This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 ?g to 100 ?g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.

Anthrax

Vaccine:Vaccine

Phase I

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety Study

Official Title:A Phase 1 Study of Safety and Immunogenicity of E. coli-Derived Recombinant Protective Antigen (rPA), a New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults

http://www.clinicaltrials.gov/ct/show/NCT00097396?order=2

DynPort Vaccine Company

The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels.

Pneumonic PlaguePreventive therapy

Vaccine:rF1V vaccine

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant Plague Vaccine rF1V in Healthy Volunteers

http://www.clinicaltrials.gov/ct/show/NCT00098098?order=3

DynPort Vaccine Company

The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein dosage level.

Recombinant Botulinum Vaccine a/B

Vaccine:rBV A/B

Phase I

Study Type:InterventionalStudy Design:Prevention,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Phase 1, Open-Label, Dose-Escalating Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults

http://www.clinicaltrials.gov/ct/show/NCT00078637?order=1

Eisai Medical Research Inc

The purpose of this study is to determine the appropriate dose of E7820 and to evaluate its safety.

NeoplasmsLymphoma, Malignant

Drug:E7820

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:Phase I and Pharmacokinetic Study of E7820 after Oral Administration to Patients with Malignancy

http://www.clinicaltrials.gov/ct/show/NCT00096473?order=2

Eisai Medical Research Inc

Alzheimer's DiseaseDementia

Drug:Donepezil hydrochloride

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients with Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period

http://www.clinicaltrials.gov/ct/show/NCT00060567?order=3

Eisai Medical Research Inc

The purpose of this study is to find a safe and effective dose of E7070 when used in combination with irinotecan hydrochloride (CPT-11, Camptosar) in patients with cancer of the GI tract or lungs.

Colorectal CancerColorectal CarcinomaColorectal TumorsPulmonary NeoplasmsPulmonary Cancer

Drug:E7070Drug:irinotecan hydrochloride

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00046072?order=4

Eisai Medical Research Inc

SepsisShock, SepticSepsis SyndromeSepticemiaInfection

Drug:lipid A antagonist lyophilized powder

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study

Official Title:A Double-Blind, Placebo-Controlled Study of E5564, A Lipid A Antagonist, Administered by Twice Daily Infusions in Patients with Severe Sepsis

http://www.clinicaltrials.gov/ct/show/NCT00069277?order=5

Eisai Medical Research Inc

To determine the maximum tolerated dose of E7389 when administered on Day 1 of a 21-day cycle to patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.

Advanced Solid Tumors

Drug:E7389 BOLD

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) Administered Once Every Three Weeks In Patients With Advanced Solid Tumors

http://www.clinicaltrials.gov/ct/show/NCT00069264?order=6

Eisai Medical Research Inc

To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.

Advanced Solid Tumors

Drug:E7389

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients with Advanced Solid Tumors

http://www.clinicaltrials.gov/ct/show/NCT00080197?order=7

Eisai Medical Research Inc

The purpose of this study is to determine if E7070 is an efficacious, safe, and tolerable treatment for patients with metastatic breast cancer who have failed, or could not tolerate, prior treatments with an anthracycline, a taxane, and capecitabine.

Breast NeoplasmsMetastases

Drug:E7070

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:An Open-label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated with an Anthracycline, a Taxane, and Capecitabine

http://www.clinicaltrials.gov/ct/show/NCT00097721?order=8

Eisai Medical Research Inc

The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.

Breast Neoplasms

Drug:E7389

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase II Open Label Study of E7389 (Halichondrin B Analog) in Patients with Advanced/Metastatic Breast Cancer Previously Treated with Chemotherapy Including An Anthracycline and A Taxane

http://www.clinicaltrials.gov/ct/show/NCT00078611?order=1

Elan Pharmaceuticals

The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohns Disease.

Crohn's Disease

Drug:Antegren(TM) (natalizumab)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (natalizumab) in Subjects with Moderately to Severely Active Crohns Disease With Elevated C-Reactive Protein

http://www.clinicaltrials.gov/ct/show/NCT00083759?order=2

Elan Pharmaceuticals

The purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells are thought to cause damage in the joints leading to the symptoms of RA.

Rheumatoid Arthritis

Drug:Natalizumab

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase II, Multicenter, Double-blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (natalizumab 300 mg) in Subjects with Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment with Methotrexate (MTX)

http://www.clinicaltrials.gov/ct/show/NCT00076544?order=3

Elan Pharmaceuticals

The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.

Pain

Drug:Ziconotide

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Expanded Access Assignment,Safety Study

Official Title:An Open-Label, Long-Term, Multi-Center, Intrathecal Ziconotide (PRIALT) Effectiveness and Safety Trial (ZEST) in Patients with Chronic Severe Pain

http://www.clinicaltrials.gov/ct/show/NCT00074737?order=1

Eleos, Inc.

Acute Myelogenous Leukemia

Drug:EL625Drug:IdarubicinDrug:Ara-C

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

Official Title:Open Label, Phase II Dosing Study of Ara-C Chemotherapy in Combination with EL625 and Idarubicin in Refractory and Relapsed Acute Myelogenous Leukemia (AML)

http://www.clinicaltrials.gov/ct/show/NCT00073372?order=1

Centocor

Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled trial to evaluate efficacy and safety of Abciximab in Acute Ischemic Stroke onset within 6 hour time window and subjects who wake from sleep with stroke symptoms, and in whom the planned treatment initiation is within 3 hours of awakening

Stroke

Drug:Abciximab

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Abciximab(ReoPro) in Acute Ischemic Stroke: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial

http://www.clinicaltrials.gov/ct/show/NCT00087711?order=2

Eli Lilly and Company

This study is a randomized Phase 3 study comparing ALIMTA and cisplatin combination to GEMZAR and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). GEMZAR plus cisplatin is currently the standard of care for NSCLC. It is thought that ALIMTA plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Non Small Cell Lung Carcinoma

Drug:Alimta and CisplatinDrug:Gemzar and Cisplatin

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized

Official Title:A Randomized Phase 3 Trial of Alimta (pemetrexed) and Cisplatin versus Gemzar (gemcitabine) and Cisplatin in Patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00071136?order=3

Eli Lilly and Company

Phase 1/2 Dose-Escalating Study of Biweekly ALIMTA and Gemcitabine in Patients with Advanced Cancer.

Neoplasms

Drug:AlimtaDrug:Gemzar

Phase I

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00078260?order=4

Eli Lilly and Company

Non-Small-Cell Lung Carcinoma

Drug:pemetrexed

Phase III

Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00087698?order=5

Eli Lilly and Company

This study aims to determine how successful the chemotherapy regimen of Alimta(pemetrexed) plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.

Pleural Neoplasms

Drug:Alimta (pemetrexed) and cisplatin

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00061451?order=6

Eli Lilly and Company

The purposes of this study are to determine: 1) The safety of ALIMTA plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2) Whether ALIMTA plus Gemcitabine can help patients with non-small cell lung cancer live longer. 3) Whether ALIMTA plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4) To see if patients feel better while taking ALIMTA plus Gemcitabine.

Carcinoma, Non-Small-Cell Lung

Drug:ALIMTA Plus Gemcitabine

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00061477?order=7

Eli Lilly and Company

The purposes of this study are to determine: 1) The safety of ALIMTA plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2) Whether ALIMTA plus Gemcitabine can help patients with mesothelioma live longer. 3) Whether ALIMTA plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4) To see if patients feel better while taking ALIMTA plus Gemcitabine.

Mesothelioma

Drug:ALIMTA Plus Gemcitabine

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00063570?order=8

Eli Lilly and Company

The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both Alimta and Gemzar in patients with advanced breast cancer.

Breast Cancer

Drug:Pemetrexed (Alimta)-Investigational drugDrug:Gemcitabine (Gemzar)

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00089869?order=9

Eli Lilly and Company

Study of a medication for the treatment of Schizophrenia in patients who are already taking Abilify, Risperdol, Seroquel, Zyprexia

Schizophrenia

Drug:Add on therapy

Phase I

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00090012?order=10

Eli Lilly and Company

Schizophrenia

Drug:OlanzapineDrug:Quetiapine

Phase IV

Study Type:InterventionalStudy Design:Treatment

Official Title:The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients with Schizophrenia and Schizoaffective Disorder

http://www.clinicaltrials.gov/ct/show/NCT00097591?order=11

Eli Lilly and Company

The sponsors of this investigational drug are developing prasugrel as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel will be compared with clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.

Coronary Arteriosclerosis

Drug:Prasugrel

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00088491?order=12

Eli Lilly and Company

Schizophrenic Disorders

Drug:Intramuscular Olanzapine Depot

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:A Double-Blind, Randomized Study Comparing Instramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in the Maintenance Therapy of Patients With Schizophrenia

http://www.clinicaltrials.gov/ct/show/NCT00088478?order=13

Eli Lilly and Company

Schizophrenia

Drug:Intramuscular Olanzapine Depot

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot with Placebo in the Treatment of Patients with Schizophrenia

http://www.clinicaltrials.gov/ct/show/NCT00051558?order=14

Eli Lilly and Company

Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (a type of cortisone such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study will be comparing the effects of the study drug to an available drug called alendronate on glucocorticoid-induced osteoporosis.

Osteoporosis

Drug:Study drug or Alendronate Sodium

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Study start:November 2002; Expected completion:July 2003

http://www.clinicaltrials.gov/ct/show/NCT00071708?order=15

Eli Lilly and Company

The primary objective of this study is to provide duloxetine to investigators for the treatment of patients who have previously participated in neuroscience duloxetine clinical trials and for whom effective alternative therapy is not available.

Major Depressive Disorder

Drug:Duloxetine Hydrochloride

Phase III

Study Type:InterventionalStudy Design:Treatment,Open Label

Official Title:Open Label Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

http://www.clinicaltrials.gov/ct/show/NCT00088010?order=16

Eli Lilly and Company

Osteoporosis, Postmenopausal

Drug:Arzoxifene

Phase III

Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00085956?order=17

Eli Lilly and Company

Postmenopausal Bone Loss

Drug:Arzoxifene

Phase III

Study Type:InterventionalStudy Design:Prevention,Randomized

http://www.clinicaltrials.gov/ct/show/NCT00097500?order=18

Amylin Pharmaceuticals

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus injection) on beta-cell function in subjects with type 2 diabetes mellitus who have not achieved target HbA1c (<=7.0%) using metformin. Subjects will be randomly assigned to add exenatide or insulin glargine to their current antidiabetic treatment regimen for 52 weeks.

Type 2 diabetes mellitus

Drug:exenatideDrug:Insulin glargine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase 3, Randomized, Open Label, Comparator Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects with Type 2 Diabetes Treated with Metformin who have not Achieved Target HbA1c (<=7.0%)

http://www.clinicaltrials.gov/ct/show/NCT00079924?order=19

Eli Lilly and Company

The purpose of this study is to compare treatment of postmenopausal women having osteoporosis with teriparatide alone or with teriparatide plus an antiresorptive.

Postmenopausal Osteoporosis

Drug:teriparatide (FORTEO)

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00051909?order=20

Eli Lilly and Company

Study of an investigational medication for the treatment of Alzheimer's Disease in patients who are not taking Aricept, Reminyl, Exelon.

Alzheimer's Disease

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00088036?order=21

Eli Lilly and Company

The purpose of the protocol is to evaluate the efficacy and safety of olanzapine compared with placebo in patients with Borderline Personality Disorder (BPD).

Borderline Personality Disorder

Drug:Olanzapine and Placebo

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study

Official Title:Efficacy and Safety of Olanzapine in Patients with Borderline Personality Disorder: A Randomized Double-Blind Comparison with Placebo

http://www.clinicaltrials.gov/ct/show/NCT00089817?order=22

Eli Lilly and Company

Patients will be randomly assigned to one of two groups. Patients in group one will receive a 1-hour infusion of cisplatin on day 1, dexamethasone by infusion or by mouth on days 1-4, and an infusion of gemcitabine on days 1 and 8. Patients in group two will receive a 24-hour continuous infusion of cisplatin on day 1, dexamethasone as in group one, and a 3-hour infusion of cytarabine twice on day 2. Treatment in both groups may be repeated every 3 weeks for up to three courses. Some patients may then have stem cells collected and will undergo autologous stem cell transplantation. They may then be randomly assigned to one of two groups. Beginning 4 weeks after transplantation, patients in group one will receive an infusion of rituximab every 2 months for up to 1 year. Patients in group two will undergo observation. Quality of life will be assessed periodically. Patients will be evaluated every 1-6 months for approximately 2 years and once a year thereafter.

Lymphoma

Drug:dexamethasone and cisplatin with gemcitabineDrug:dexamethasone and cisplatin with cytarabine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized

Official Title:Phase III Randomized Study of Gemcitabine, Dexamethasone and Cisplatin Versus Dexamethasone, Cytarabine, Cisplatin as salvage chemotherapy before Autologous Stem Cell Transplantation, with or Without Maintenance Rituximab in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00088465?order=23

Eli Lilly and Company

This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment, Determine the blood levels of IM olanzapine depot in patients during long-term treatment

Schizophrenic Disorders

Drug:Intramuscular Olanzapine Depot

Phase III

Study Type:InterventionalStudy Design:Treatment,Open Label

Official Title:An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

http://www.clinicaltrials.gov/ct/show/NCT00049764?order=24

Eli Lilly and Company

Sepsis

Drug:Drotrecogin alfa (activated)(recombinant human Activated Protein C)

Phase III

Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00074828?order=25

Eli Lilly and Company

LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from forming in the legs and may prevent those blood clots from traveling to the lungs. Leg and lung blood clots occur commonly after patients have surgery to replace a hip or knee joint. These clots often occur while patients are in bed in the hospital after hip or knee joint surgery. The purpose of this study is to test if different dose strengths (amount of drug in the capsules) of LY517717 can prevent blood clots from forming and to determine if LY517717 is safe. This study will compare LY517717 to enoxaparin, another blood thinner. Enoxaparin is one of the standard medications given after hip or knee joint surgery.

Total Knee ReplacementTotal Hip Replacement

Drug:LY517717

Phase II

Study Type:InterventionalStudy Design:Prevention

Official Title:Comparison of a New Oral Anticoagulant Therapy to a Marketed Injectable Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery

http://www.clinicaltrials.gov/ct/show/NCT00094549?order=26

Eli Lilly and Company

The goals of this study are: A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania. B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine. C. To assess how olanzapine compares to divalproex.

Bipolar Disorder

Drug:OlanzapineDrug:Divalproex

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00091650?order=27

Eli Lilly and Company

The goals of this study are to determine: the safety of olanzapine and any side effects that might be associated with it, how olanzapine compares to placebo, whether olanzapine can help patients with symptoms of Borderline Personality Disorder (BPD), and how much olanzapine should be given to patients.

Borderline Personality Disorder

Drug:Olanzapine and Placebo

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study

Official Title:Efficacy and Safety of Olanzapine in Patients with Borderline Personality Disorder: A Randomized Flexible Dose Double-Blind Comparison with Placebo

http://www.clinicaltrials.gov/ct/show/NCT00088205?order=28

Eli Lilly and Company

The purposes of this study are to determine the safety of oral enzastaurin HCl and any side effects that might be associated with it and whether enzastaurin HCl can help patients with Mantle Cell Lymphoma.

Mantle-Cell Lymphoma

Drug:Enzastaurin HCl

Phase II

Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study

Official Title:A Phase 2 Study of Oral Enzastaurin HCl in Patients with Relapsed Mantle Cell Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00094640?order=29

Eli Lilly and Company

The goals of this study are to: Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these levels to the amount of olanzapine in the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).

SchizophreniaSchizoaffective Disorder

Drug:Intramuscular Olanzapine Depot

Phase I

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00049777?order=30

Eli Lilly and Company

The purpose of this study is to evaluate the relative efficacy and safety of prophylactic heparin co-administration during Xigris infusion in the treatment of severe sepsis in the adult.

Sepsis

Drug:Drotrecogin Alfa (Activated)Drug:Unfractionated heparinDrug:Low molecular weight heparin

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00090519?order=31

Eli Lilly and Company

The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.

Diabetic Retinopathy

Drug:Ruboxistaurin

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00097383?order=32

Eli Lilly and Company

This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.

Breast Cancer

Drug:ALIMTA plus Epirubicin

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized

Official Title:A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients with Locally Advanced or Metastatic Breast Cancer

http://www.clinicaltrials.gov/ct/show/NCT00035321?order=33

Eli Lilly and Company

Depressive Disorders

Drug:OlanzapineDrug:Fluoxetine

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00088049?order=34

Eli Lilly and Company

The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.

Schizophrenia

Drug:OlanzapineDrug:Aripiprazole

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00042666?order=35

Eli Lilly and Company

This study will measure the effectiveness and any side effects of LY317615 in patients with Diffuse large B-cell lymphoma ( a sub-type of Non-Hodgkins Lymphoma).

Non-Hodgkin's Lymphoma

Drug:LY317615

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00055250?order=36

Eli Lilly and Company

The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine (Gemzar) in patients with pancreatic cancer.

Pancreatic Cancer

Drug:GemzarDrug:LY293111

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00079872?order=37

Eli Lilly and Company

Colorectal Cancer

Drug:PemetrexedDrug:IrinotecanDrug:LeucovorinDrug:5-Fluorouracil

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized

Official Title:A Randomized Phase 2 Trial for First-Line Treatment of Colorectal Cancer

http://www.clinicaltrials.gov/ct/show/NCT00081627?order=1

Adventrx Pharmaceuticals

Colon CancerRectal Cancer

Drug:CoFactor and 5FU

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study

Official Title:COFU:A Multi-Center Phase II Clinical Trial to Evaluate the Safety and Efficacy of Weekly Treatment with CoFactor and 5-Fluorouracil in Patients with Metastatic Colorectal Carcinoma

http://www.clinicaltrials.gov/ct/show/NCT00093964?order=1

EMD Pharmaceuticals

Glioblastoma Multiforme

Drug:EMD 121974

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Multicenter, Open-label, Randomized, Uncontrolled, Phase IIa Trial in Subjects with Recurrent Glioblastoma Multiforme to Investigate the Clinical Activity, Safety, and Tolerability of EMD 121974 Administered as a Single Agent in Doses of 500 mg and 2000 mg

http://www.clinicaltrials.gov/ct/show/NCT00073541?order=2

EMD Pharmaceuticals

EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.

Ovarian Cancer

Drug:EMD 72000

Phase II

Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study

Official Title:An Open-Label Phase II Study in Subjects with Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent

http://www.clinicaltrials.gov/ct/show/NCT00039858?order=1

GlaxoSmithKline

The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.

ThrombocytopeniaThrombosis

Drug:Argatroban

Phase IV

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00053716?order=1

Endovasc

This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease.

Peripheral Vascular Disease

Drug:Liprostin [liposomal Prostaglandin E1]

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Expanded Access Assignment,Safety/Efficacy Study

Official Title:Phase II, Single Center, Non-Controlled, Open-Label Study of Liposomal Prostaglandin E1 (Liprostin) as Adjunct Therapy with Lower Limb Angioplasty in Patients with Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease

http://www.clinicaltrials.gov/ct/show/NCT00049790?order=1

EntreMed

The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.

Carcinoma, Non-Small-Cell Lung

Drug:recombinant human Angiostatin proteinDrug:paclitaxelDrug:carboplatin

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00080002?order=1

Enzon

The purpose of this study is to evaluate the safety and efficacy of pegamotecan (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen.

Cancer of StomachGastroesophageal Cancer

Drug:Pegamotecan

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Effectiveness and Safety Study of Pegamotecan (PEG-Camptothecin) in Patients with Locally Advanced or Metastatic Cancer of the Stomach or Gastroesophageal Junction Who Have Relapsed or Progressed Following a Previous Chemotherapy Treatment

http://www.clinicaltrials.gov/ct/show/NCT00035919?order=1

Gordon, Erlinda, M.D.

This is a Phase I safety study of a gene transfer drug for colorectal cancer that has spread to the liver. The main purpose of this study is to determine if it is safe to give this new intervention to persons with cancer, but we will also look for indications that the drug is effective. Although the findings in animals that have cancer are encouraging, this is the first time humans will receive this experimental gene transfer drug. A gene called cyclin G1 has been shown to play a very important part in cancer growth. In animal experiments, a genetically modified virus (or vector)carrying a modified cyclin G1 gene caused the cancerous tumors to grow much slower or even die. In this safety study, the drug will be injected through the liver artery to get it near the cancer that has spread to the liver. The way the gene gets into the cancer cells is by using a targeted vector that concentrates in the area of the cancer to improve the delivery of the killing gene into cancer cells. The vector we are using is a virus that has been changed so that the infectious genes have been removed and instead carries the modified cyclin G1 gene.

Colorectal Neoplasms

Gene Transfer:Mx-dnG1 Retroviral Vector

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Tumor Site Specific Phase I Evaluation of Safety of Hepatic Arterial Infusion of a Matrix-Targeted Retroviral Vector Bearing a Dominant Negative Cyclin G1 Construct as Intervention for Colorectal Carcinoma Metastatic to Liver

http://www.clinicaltrials.gov/ct/show/NCT00086528?order=1

Exelixis

Cancer

Drug:XL647

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects with Solid Tumors

http://www.clinicaltrials.gov/ct/show/NCT00090025?order=2

Exelixis

The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.

Biliary Tract Cancer

Drug:XL119Drug:5-Fluorouracil and Leucovorin

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind,Active Control,Parallel Assignment,Efficacy Study

Official Title:A Phase 3 Multicenter, Single-Blind, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) plus Leucovorin (LV) in Subjects with Advanced Biliary Tumors Not Amenable to Conventional Surgery

http://www.clinicaltrials.gov/ct/show/NCT00085852?order=1

Aeris Therapeutics

The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

Pulmonary Emphysema

Procedure:Aeris BLVR TreatmentDrug:Aeris BLVR TreatmentDevice:Aeris BLVR Treatment

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Single-center, Non-blinded, Non-randomized, Non-controlled Phase 1 Trial Assessing the Safety of the Aeris Therapeutics Bronchoscopic Lung Volume Reduction (BLVR) System in Patients with Advanced Heterogeneous Emphysema

http://www.clinicaltrials.gov/ct/show/NCT00012324?order=1

Eximias Pharmaceutical

localized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver canceradult primary hepatocellular carcinoma

Drug:doxorubicinDrug:nolatrexed dihydrochlorideProcedure:chemotherapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Nolatrexed Dihydrochloride Versus Doxorubicin in Patients With Unresectable or Recurrent Hepatocellular Carcinoma

http://www.clinicaltrials.gov/ct/show/NCT00088192?order=1

Eyetech Pharmaceuticals

To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsors other clinical studies with this drug for AMD, until such time as the patients lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.

Macular Degeneration

Drug:pegaptanib sodium

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:An Open Label, Non-Comparative Protocol for use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients with Exudative Age-Related Macular Degeneration (AMD)

http://www.clinicaltrials.gov/ct/show/NCT00088283?order=2

Eyetech Pharmaceuticals

Macular Degeneration

Drug:pegaptanib sodium

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase II Randomized, Dose-ranging, Double-masked, Multi-center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 weeks in Patients with Recent Vision Loss due to Macular Edema Secondary to CRVO

http://www.clinicaltrials.gov/ct/show/NCT00087763?order=3

Eyetech Pharmaceuticals

The purpose of this study is to determine if Macugen reduces foveal thickness and improves vision in patients with wet AMD.

Macular Degeneration

Drug:Macugen (pegaptanib sodium injection)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Safety/Efficacy Study

Official Title:A Phase II Prospective, Randomized, Double-masked, Sham-controlled, Dose-ranging, Multi-center Trial to Assess the Effect of Pegaptanib Sodium on Foveal Thickening in Patients with Exudative Subfoveal Age-related Macular Degeneration (AMD)

http://www.clinicaltrials.gov/ct/show/NCT00053001?order=1

Fallon Clinic

de novo myelodysplastic syndromessecondary myelodysplastic syndromespreviously treated myelodysplastic syndromesAnemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiable

Drug:epoetin alfaDrug:thalidomideProcedure:anti-cytokine therapyProcedure:antiangiogenesis therapyProcedure:biological response modifier therapyProcedure:growth factor antagonist therapyProcedure:hematologic toxicity attenuationProcedure:non-specific immune-modulator therapyProcedure:supportive care/therapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Thalidomide and Epoetin alfa for the Treatment of Anemia in Patients With Low- or Intermediate-Risk Myelodysplastic Syndromes

http://www.clinicaltrials.gov/ct/show/NCT00089115?order=1

Favrille

grade 1 follicular lymphomagrade 2 follicular lymphomagrade 3 follicular lymphoma

Drug:autologous immunoglobulin idiotype-KLH conjugate vaccineDrug:rituximabDrug:sargramostimProcedure:antibody therapyProcedure:biological response modifier therapyProcedure:colony-stimulating factor therapyProcedure:cytokine therapyProcedure:monoclonal antibody therapyProcedure:tumor cell derivative vaccineProcedure:vaccine therapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Idiotype-KLH Conjugate Vaccine and Sargramostim (GM-CSF) Versus Placebo and Sargramostim (GM-CSF) Following Treatment with Rituximab in Patients with Grade 1, 2, or 3 Follicular B-Cell Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00030277?order=1

Focus Surgery

stage I prostate cancerstage II prostate cancerrecurrent prostate cancer

Procedure:hyperthermiaProcedure:thermal ablation therapy

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I Study of High-Intensity Focused Ultrasound Using the Sonablate System in Patients With Locally Recurrent Prostate Cancer

http://www.clinicaltrials.gov/ct/show/NCT00097942?order=1

Forest Laboratories

Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.

Schizophrenia

Drug:memantine HCl

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients with Persistent Residual Symptoms

http://www.clinicaltrials.gov/ct/show/NCT00097916?order=2

Forest Laboratories

About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.

Alzheimer's Disease

Drug:memantine HCl

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients with Moderate to Severe Alzheimer's Disease

http://www.clinicaltrials.gov/ct/show/NCT00090116?order=3

Forest Laboratories

Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (NMDA receptor antagonist).

Alzheimer's Disease

Drug:Neramexane

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind,Placebo-Controlled Evaluation of the Safety and Efficacy of Neramexane Monotherapy in Patients with Moderate to Severe Dementia of the Alzheimer's Type

http://www.clinicaltrials.gov/ct/show/NCT00098124?order=4

Forest Laboratories

Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.

Fibromyalgia

Drug:milnacipran hydrochloride

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia

http://www.clinicaltrials.gov/ct/show/NCT00087724?order=1

Fujisawa Healthcare, Inc.

The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.

Alzheimer's Disease

Drug:FK962

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects with Mild to Moderate Alzheimer's Disease

http://www.clinicaltrials.gov/ct/show/NCT00087724?order=1

Fujisawa Healthcare, Inc.

The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.

Alzheimer's Disease

Drug:FK962

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects with Mild to Moderate Alzheimer's Disease

http://www.clinicaltrials.gov/ct/show/NCT00094120?order=1

Genaera Corporation

Age-Related Macular Degeneration (AMD) is a degenerative disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine when administered with verteporfin therapy in patients with "wet" AMD.

Macular Degeneration

Drug:MSI-1256F (Squalamine Lactate)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Safety and Efficacy of MSI-1256F (Squalamine Lactate) in Combination with Verteporfin in Patients with "Wet" Age-Related Macular Degeneration (AMD)

http://www.clinicaltrials.gov/ct/show/NCT00089830?order=2

Genaera Corporation

Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.

Macular Degeneration

Drug:MSI-1256F (Squalamine Lactate)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00082511?order=1

Genelabs Technologies

Open label safety and efficacy follow-up.

Systemic Lupus Erythematosus

Drug:Prasterone (GL701)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment with GL701 (Prestara) in Women with Systemic Lupus Erythematosus Receiving Treatment with Glucocorticoids

http://www.clinicaltrials.gov/ct/show/NCT00097526?order=1

Genentech

This study is a multicenter, open-label, postmarketing surveillance study. The substudy will collect information on BMD in adolescents and young adults with GHD or Turner syndrome who are completing growth hormone (GH) treatment for statural indications.

Dwarfism, PituitaryTurner Syndrome

Drug:Nutropin [somatropin (rDNA origin) for injection]Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Protropin [somatrem for injection]

Phase IV

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

Official Title:Bone Mineral Density in Adolescent Subjects with Growth Hormone Deficiency Who Are Completing Treatment with Nutropin AQ, Nutropin, or Protropin in the National Cooperative Growth Study (NCGS)

http://www.clinicaltrials.gov/ct/show/NCT00038402?order=2

M.D. Anderson Cancer Center

The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1)to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, 4) evaluate significance of HER2 expression by two different methods, and 5) determine correlation of cardiac blood tests with echocardiogram results in the detection of cardiac muscle damage.

Breast Cancer

Drug:HerceptinDrug:TaxolDrug:FluorouracilDrug:CytoxanDrug:Epirubicin

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00097578?order=3

Genentech

This is an observational study designed to follow patients with metastatic colorectal cancer who are receiving Avastin in combination with first-line chemotherapy regimens and whose cancer has been either previously untreated or treated less than or equal to 3 months prior to enrollment.

Colorectal NeoplasmsMetastases

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

Official Title:An Observational Study of Avastin (Bevacizumab) in Combination with Chemotherapy for First-Line Treatment of Metastatic Colorectal Adenocarcinoma

http://www.clinicaltrials.gov/ct/show/NCT00097240?order=4

Genentech

The Raptiva Pregnancy Registry is a prospective observational study established to obtain data on pregnancy outcomes of women who are exposed to Raptiva.

PsoriasisPregnancy

Study Type:ObservationalStudy Design:Natural History,Prospective Study

Official Title:The Raptiva Pregnancy Registry: An Observational Study of the Use and Safety of Raptiva (Efalizumab) during Pregnancy

http://www.clinicaltrials.gov/ct/show/NCT00097565?order=5

Genentech

This is a prospective, observational, longitudinal, multicenter study of patients with newly diagnosed follicular Non-Hodgkin's Lymphoma (NHL) designed to delineate differences in clinical outcome by comparing the effectiveness and safety of common treatment regimens.

Lymphoma, Non-Hodgkin

Drug:Rituxan (rituximab)

Phase IV

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

Official Title:The National Lymphocare Study: An Observational Study of Treatment, Outcomes, and Prognosis in Patients with Follicular Non-Hodgkins Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00097539?order=6

Genentech

This study is a multicenter, open label, observational, postmarketing surveillance study of Nutropin AQ, Nutropin, and Protropin in the United States and Canada. This study (and subsequent substudies) were developed to investigate specific aspects of growth hormone (GH) treatment.

Growth Disorders

Drug:Nutropin [somatropin (rDNA origin) for injection]Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Protropin [somatrem for injection]

Phase IV

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

Official Title:Genentech National Cooperative Growth Study (NCGS) Postmarketing Surveillance Program for Nutropin AQ [Somatropin (rDNA Origin) Injection], Nutropin [Somatropin (rDNA Origin) for Injection], and Protropin [Somatrem for Injection]

http://www.clinicaltrials.gov/ct/show/NCT00069446?order=7

Genentech

The purpose of this study is to assess the safety of telbermin applied topically to chronic, diabetic foot ulcers and to explore the possible effectiveness of this treatment to induce healing of diabetic foot ulcers.

Diabetic Foot

Drug:Vascular endothelial growth factor (VEGF, Telbermin)

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:An Exploratory, Double-blind, Randomized, Placebo-controlled Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers

http://www.clinicaltrials.gov/ct/show/NCT00090051?order=8

Biogen Idec

The purpose of this study is to provide treatment for patients who have CLL, and to compare the use of rituximab added to FC with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

Chronic Lymphocytic Leukemia

Drug:Rituxan

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab/fludarabine/cyclophosphamide (FCR) vs. fludarabine/cyclophosphamide (FC) alone in previously treated patients with CD20 positive B-cell CLL

http://www.clinicaltrials.gov/ct/show/NCT00086606?order=9

Genentech

Allergy

Drug:Xolair (omalizumab)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment

Official Title:A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Oral Food Challenge trial of Xolair (Omalizumab) in Peanut Allergy

http://www.clinicaltrials.gov/ct/show/NCT00077870?order=10

Genentech

The purpose of this study is to determine the safe dose of PRO70769 for subjects with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate.

Rheumatoid Arthritis

Drug:PRO70769

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00081614?order=11

Genentech

The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.

Renal Cell CarcinomaMetastases

Drug:Avastin (bevacizumab)Drug:Tarceva (erlotinib HCl)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination with Avastin (Bevacizumab) versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma

http://www.clinicaltrials.gov/ct/show/NCT00097617?order=12

Genentech

This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with CRI in the United States.

Chronic Renal InsufficiencyEnd-Stage Renal Disease

Drug:Nutropin [somatropin (rDNA origin) for injection]Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Protropin [somatrem for injection]

Phase IV

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

Official Title:National Cooperative Growth Study (NCGS) of Nutropin AQ, Nutropin, and Protropin in Children with Growth Failure due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

http://www.clinicaltrials.gov/ct/show/NCT00097019?order=13

Genentech

This is an open-label, single-arm, two-stage, multicenter Phase II study evaluating the efficacy and safety of bevacizumab in women with platinum resistant, advanced (Stage III or IV) epithelial ovarian cancer (EOC) or primary peritoneal carcinoma (PPC) for whom subsequent Doxil or topotecan therapy also has failed.

Ovarian Cancer

Drug:Avastin (bevacizumab)

Phase II

Study Type:InterventionalStudy Design:Treatment,Open Label,Single Group Assignment

Official Title:A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects with Platinum-Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for Whom Subsequent Doxil or Topotecan Therapy Has Failed

http://www.clinicaltrials.gov/ct/show/NCT00090623?order=14

Genentech

This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Macular Degeneration

Drug:rhuFab V2 (ranibizumab)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study

Official Title:A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovascularization (CNV) with or without Classic CNV Secondary to Age Related Macular Degeneration

http://www.clinicaltrials.gov/ct/show/NCT00097201?order=15

Genentech

This is a research sample collection substudy of Study U2787g, a phase II, randomized, double-blind, parallel-group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in adults with Relapsing-Remitting Multiple Sclerosis (RRMS).

Multiple Sclerosis

Drug:Rituxan (rituximab)

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Research Studies to Characterize the Immunologic and Pharmacodynamic Effects of Rituximab in Patients with Relapsing-Remitting MS (RRMS)

http://www.clinicaltrials.gov/ct/show/NCT00061594?order=16

Genentech

This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.

Macular Degeneration

Drug:rhuFab V2 (ranibizumab)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Safety/Efficacy Study

Official Title:A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared with Verteporfin (Visudyne) Photodynamic Therapy in Subjects with Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration

http://www.clinicaltrials.gov/ct/show/NCT00095225?order=17

Genentech

This phase II, multicenter, randomized trial is designed to make preliminary evaluations of the efficacy of combining Avastin with docetaxel or Tarceva relative to docetaxel monotherapy in patients with previously treated advanced Non-Small Cell Lung Cancer (NSCLC).

Carcinoma, Non-Small-Cell LungLung NeoplasmsAdenocarcinomaCarcinoma, Large Cell

Drug:Avastin (bevacizumab)Drug:Tarceva (erlotinib HCl)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Safety/Efficacy Study

Official Title:A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Avastin (Bevacizumab) in Combination with Docetaxel or Tarceva (Erlotinib Hydrochloride) Compared with Docetaxel Alone for Treatment of Recurrent or Refractory NonSmall Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00079742?order=18

Genentech

The purpose of this study is to evaluate the safety and efficacy of Nutropin AQ in treating growth restriction and increase lean body mass in children with Cystic Fibrosis (CF) and growth restriction.

Cystic Fibrosis

Drug:Nutropin AQ [somatropin (DNA origin) injection]

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study

Official Title:A Phase II, Multicenter, Randomized, Controlled, Open-label Study of the Safety and Efficacy of Nutropin AQ [somatropin (DNA origin) injection] for the Treatment of Growth Restriction in Children with Cystic Fibrosis

http://www.clinicaltrials.gov/ct/show/NCT00097513?order=19

Genentech

This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat GH-deficient subjects with optimal GH dosing during puberty.

Dwarfism, Pituitary

Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Nutropin [somatropin (rDNA origin) for injection]

Phase IV

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

Official Title:National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects

http://www.clinicaltrials.gov/ct/show/NCT00096928?order=20

Genentech

This study is a multicenter, prospective, 5-year, surveillance study of approximately 5000 Raptiva-treated patients and approximately 2500 comparison patients (not treated with Raptiva) with chronic moderate to severe plaque psoriasis who are candidates for treatment with Raptiva.

Psoriasis

Drug:Raptiva (efalizumab)

Phase IV

Study Type:ObservationalStudy Design:Natural History

Official Title:Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients with Chronic Moderate to Severe Plaque Psoriasis (Response)

http://www.clinicaltrials.gov/ct/show/NCT00096993?order=21

Genentech

This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.

Ovarian CancerPeritoneal Cancer

Drug:rhuMAb 2C4 (pertuzumab)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control

Official Title:A Phase II, Randomized, Placebo Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination with Gemcitabine and the Effect of Tumor-Based HER2 Activation in Subjects with Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

http://www.clinicaltrials.gov/ct/show/NCT00097188?order=22

Genentech

This is a phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with Relapsing-Remitting Multiple Sclerosis (RRMS).

Multiple Sclerosis

Drug:Rituxan (rituximab)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase II, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults with Relapsing Remitting Multiple Sclerosis

http://www.clinicaltrials.gov/ct/show/NCT00096941?order=23

Genentech

This is a multicenter, open-label extension study. Subjects who have completed 17 cycles (approximately 1 year) of treatment with single-agent pertuzumab in a Genentech-sponsored Phase II cancer study and have shown no signs of unacceptable toxicity are eligible for inclusion in this trial.

Cancer

Drug:rhuMAb 2C4 (pertuzumab)

Phase III

Study Type:InterventionalStudy Design:Treatment,Open Label

Official Title:An Open-Label, Multicenter Extension Study of Pertuzumab (rhuMAb 2C4) in Subjects Treated with Pertuzumab in a Previous Genentech-Sponsored Phase II Cancer Study

http://www.clinicaltrials.gov/ct/show/NCT00097552?order=24

Genentech

This study is a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the United States and Canada.

Turner Syndrome

Drug:Nutropin [somatropin (rDNA origin) for injection]Drug:Nutropin AQ [somatropin (rDNA origin) injection]Drug:Protropin [somatrem for injection]

Phase IV

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

Official Title:Characterization of subjects with Turner Syndrome treated with growth hormone in the national cooperative growth study (NCGS)

http://www.clinicaltrials.gov/ct/show/NCT00096954?order=25

Genentech

This is a multicenter, parallel group, double-blind, randomized, placebo controlled study to evaluate the efficacy of Xolair in atopic asthmatics with good lung capacity who remain difficult to treat.

Asthma

Drug:Xolair (omalizumab)

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

Official Title:A Prospective, Randomized, Double-Blind Study of the Efficacy of Xolair in Atopic Asthmatics with Good Lung Capacity Who Remain Difficult to Treat (Exact)

http://www.clinicaltrials.gov/ct/show/NCT00063154?order=26

Genentech

The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced lung cancer that has recurred following prior chemotherapy.

Non-small cell lung cancer

Drug:Pertuzumab (rhuMAb 2C4)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A phase II, open-label, multicenter study to evaluate the effect of tumor-based HER2 activation on the efficacy of rhuMAb 2C4 (pertuzumab) in subjects with recurrent nonsmall cell lung cancer

http://www.clinicaltrials.gov/ct/show/NCT00087529?order=27

Genentech

This is a phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with primary progressive multiple sclerosis (PPMS).

Primary Progressive Multiple Sclerosis

Drug:Rituxan (rituximab)

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:A Phase II/III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults with Primary Progressive Multiple Sclerosis

http://www.clinicaltrials.gov/ct/show/NCT00095706?order=28

Translational Oncology Research International

The purpose of this study is to evaluate the safety and effectiveness of combined treatment with trastuzumab (Herceptin) and bevacizumab (anti-VEGF antibody) in patients with HER2-positive metastatic breast cancer.

Breast Cancer

Drug:Bevacizumab (drug), Herceptin (drug)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase I/II Combined Biological Therapy of Breast Cancer Using Monoclonal Antibodies Directed Against HER2/neu Proto-Oncogene and Vascular Endothelial Growth Factor

http://www.clinicaltrials.gov/ct/show/NCT00097747?order=1

Affymax

The purpose of this study is to evaluate the safety, PK, and minimum pharmacologically active dose of Hematide in Healthy Volunteers.

Renal Failure, ChronicCancer

Drug:Hematide

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study

Official Title:A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmcokinetics of Single Intravenous Doses of Hematide in Healthy Volunteers

http://www.clinicaltrials.gov/ct/show/NCT00071955?order=1

Genitope

grade 1 follicular lymphomagrade 2 follicular lymphomagrade 3 follicular lymphoma

Drug:autologous immunoglobulin idiotype-KLH conjugate vaccineDrug:sargramostimProcedure:biological response modifier therapyProcedure:colony-stimulating factor therapyProcedure:cytokine therapyProcedure:tumor cell derivative vaccineProcedure:vaccine therapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Immediate or Delayed Autologous Immunoglobulin Idiotype-KLH Conjugate Vaccine and Sargramostim After Rituximab in Patients With Refractory or Progressive Follicular Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00093314?order=1

Genmab

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.

Chronic Lymphocytic Leukemia

Drug:HuMax-CD20

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:An Open-labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00093041?order=2

Genmab

The purpose of this trial is to determine the safety of HuMax-EGFr as a treatment for head and neck cancer.

Head and Neck Neoplasms

Drug:HuMax-EGFr

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety Study

Official Title:An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (HuMax-EGFr) in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

http://www.clinicaltrials.gov/ct/show/NCT00092274?order=3

Genmab

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).

Lymphoma, Follicular

Drug:HuMax-CD20

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients with Relapsed or Refractory Follicular Lymphoma Grade I-II

http://www.clinicaltrials.gov/ct/show/NCT00078234?order=1

Genta

The treatment combination of Rituxan (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. GenasenseTM (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense may also directly kill CLL cells. This study will test whether treating subjects with Genasense, fludarabine and rituximab is safe and effective.

Chronic Lymphocytic Leukemia

Drug:Oblimerson sodium, G3139Drug:FludarabineDrug:Rituximab

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Pilot Study of Genasense (Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated and Untreated Subjects with Chronic Lymphocytic Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00021749?order=2

Genta

This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

Chronic Lymphocytic LeukemiaCLL

Drug:Oblimerson, G3139

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase I-II Multicenter Study of Genasense? (Bcl-2 Antisense Oligonucleotide) in Patients with Advanced Chronic Lymphocytic Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00074919?order=1

Genzyme

Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this protocol is to provide enzyme replacement therapy with rhGAA on an expanded access basis, to severely affected patients with infantile-onset Pompe disease for whom there is no alternative treatment and who do not meet the clinical characteristics described in the inclusion criteria for participation in other Genzyme Corporation-sponsored study currently enrolling patients with infantile-onset Pompe disease.

Glycogen Storage Disease Type IIGlycogenosis 2

Drug:alglucosidase alfa

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Study start:December 2003

http://www.clinicaltrials.gov/ct/show/NCT00069862?order=2

Genzyme

A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and GT56-252, an experimental oral iron chelator.

beta-Thalassemia

Drug:GT56-252Drug:desferoxamine (DFO)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Crossover Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00081900?order=3

Genzyme

Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM at approximately 5 centers in the United States. First, we will be trying to determine the highest dose that can be given safely and is well tolerated (this is called the maximally tolerated dose, or the MTD, for short). Once that is established, we will enroll additional patients to learn more about potential side effects and to see whether DENSPM can slow the growth of HCC tumors. We also want to learn about the safety of DENSPM. Many medications used to treat cancer cause side effects (discomforts or illness). In this study, we want to understand what side effects occur in patients with HCC who are treated with DENSPM.

Carcinoma, Hepatocellular

Drug:DENSPM (N1, N11-diethylnorspermine) (drug)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase 1/2 Study of DENSPM (N1, N11-diethylnorspermine) in Patients with Unresectable Hepatocellular Carcinoma

http://www.clinicaltrials.gov/ct/show/NCT00089947?order=4

Genzyme

Renal TransplantationGraft Rejection

Drug:Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Randomized, Prospective, Phase 2 Study Comparing Thymoglobulin in a Rapid Discontinuation of Corticosteroids Protocol with Standard Corticosteroid Therapy in Living Donor Renal Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy

http://www.clinicaltrials.gov/ct/show/NCT00088543?order=5

Genzyme

Acute myelogenous leukemia (AML)Acute lymphocytic leukemia (ALL)Graft vs. Host Disease (GvHD)

Drug:Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:Pilot Trial of Two Dose Levels of Thymoglobulin as Part of a Myeloablative-Conditioning for a Human Leukocyte Antigen (HLA) Identical Matched Related Donor (MRD) Stem Cell Transplant (SCT) with Cyclosporine (CSa) as Post-transplant Graft vs. Host Disease (GvHD) Prophylaxis

http://www.clinicaltrials.gov/ct/show/NCT00052468?order=1

AGO Ovarian Cancer Study Group

stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerFallopian Tube Cancer

Drug:carboplatinDrug:gemcitabineDrug:paclitaxelProcedure:adjuvant therapyProcedure:chemotherapyProcedure:conventional surgeryProcedure:surgery

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Adjuvant Study of Carboplatin and Paclitaxel With or Without Gemcitabine in Patients With Stage I-IV Ovarian Epithelial or Fallopian Tube Cancer

http://www.clinicaltrials.gov/ct/show/NCT00072553?order=2

GERCOR

Stage IV rectal cancerstage IV colon canceradenocarcinoma of the colonadenocarcinoma of the rectumrecurrent rectal cancerrecurrent colon cancer

Drug:celecoxibDrug:fluorouracilDrug:leucovorin calciumDrug:oxaliplatinProcedure:adjuvant therapyProcedure:anti-cytokine therapyProcedure:antiangiogenesis therapyProcedure:biological response modifier therapyProcedure:chemotherapyProcedure:conventional surgeryProcedure:enzyme inhibitor therapyProcedure:growth factor antagonist therapyProcedure:neoadjuvant therapyProcedure:surgery

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Celecoxib, Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Patients With Metastatic Colorectal Cancer

http://www.clinicaltrials.gov/ct/show/NCT00075465?order=3

GERCOR

adenocarcinoma of the stomachstage III gastric cancerstage IV gastric cancer

Drug:docetaxelDrug:epirubicinProcedure:chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Docetaxel and Epirubicin as First-Line Therapy in Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach

http://www.clinicaltrials.gov/ct/show/NCT00075543?order=4

GERCOR

recurrent ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancer

Drug:docetaxelDrug:oxaliplatinProcedure:chemotherapy

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I/II Study of Docetaxel and Oxaliplatin in Patients With Stage III or IV Ovarian Epithelial Cancer

http://www.clinicaltrials.gov/ct/show/NCT00075738?order=5

GERCOR

stage IV esophageal cancerrecurrent esophageal cancer

Drug:cisplatinDrug:fluorouracilDrug:irinotecanDrug:leucovorin calciumProcedure:chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Fluorouracil, Irinotecan, Leucovorin Calcium, and Cisplatin as First-Line Therapy in Patients With Metastatic Esophageal Cancer

http://www.clinicaltrials.gov/ct/show/NCT00075595?order=6

GERCOR

stage IV colon cancerStage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Drug:fluorouracilDrug:irinotecanDrug:leucovorin calciumProcedure:chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Fluorouracil, Leucovorin Calcium, and Irinotecan in Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

http://www.clinicaltrials.gov/ct/show/NCT00075517?order=7

GERCOR

stage IIIB non-small cell lung cancerstage IV non-small cell lung cancerAdenocarcinoma of the Lunglarge cell lung cancerSquamous Cell Lung Cancer

Drug:docetaxelDrug:gemcitabineProcedure:chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Gemcitabine and Docetaxel in Patients With Inoperable Stage IIIB or IV Non-Small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00075452?order=8

GERCOR

adenocarcinoma of the pancreasstage II pancreatic cancerstage III pancreatic cancerstage IVA pancreatic cancerstage IVB pancreatic cancer

Drug:gemcitabineDrug:oxaliplatinProcedure:chemotherapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Gemcitabine With or Without Oxaliplatin in Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

http://www.clinicaltrials.gov/ct/show/NCT00075556?order=9

GERCOR

stage III colon cancerstage IV colon cancerstage III rectal cancerStage IV rectal canceradenocarcinoma of the rectumadenocarcinoma of the colon

Drug:capecitabineProcedure:chemotherapyProcedure:conventional surgeryProcedure:neoadjuvant therapyProcedure:radiation therapyProcedure:surgery

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Neoadjuvant Radiotherapy and Capecitabine in Patients With Stage III or IV Colorectal Adenocarcinoma

http://www.clinicaltrials.gov/ct/show/NCT00077220?order=10

GERCOR

stage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Drug:carboplatinDrug:paclitaxelProcedure:adjuvant therapyProcedure:chemotherapyProcedure:radiation therapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Paclitaxel, Carboplatin, and Radiotherapy With or Without Adjuvant Paclitaxel and Carboplatin in Patients With Stage II or III Unresectable Non-Small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00047112?order=11

Federation Francophone de Cancerologie Digestive

Adenocarcinoma of the Esophagussquamous cell carcinoma of the esophagusstage I esophageal cancerstage II esophageal cancer

Drug:cisplatinDrug:fluorouracilProcedure:chemotherapyProcedure:conventional surgeryProcedure:neoadjuvant therapyProcedure:radiation therapyProcedure:surgery

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Neoadjuvant Radio-Chemotherapy and Surgery Versus Surgery Alone in Patients With Resectable Thoracic Esophageal Cancer

http://www.clinicaltrials.gov/ct/show/NCT00071201?order=1

Gilead Sciences

This is a multi-center phase 3, open-label, parallel-group study designed to evaluate the efficacy, safety and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and varying degrees of renal impairment.

Chronic Hepatitis B

Drug:Adefovir Dipivoxil for oral suspension, 2 mg/mL

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multi-Center Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Adefovir Dipivoxil Liquid Suspension in Patients with Chronic Hepatitis B and Varying Degrees of Renal Impairment

http://www.clinicaltrials.gov/ct/show/NCT00042393?order=2

Gilead Sciences

The purpose of this early access protocol is to provide access to adefovir dipivoxil prior to its commercial availability to people with lamivudine-resistant chronic hepatitis B who have limited treatment options.

Chronic Hepatitis B

Drug:Adefovir Dipivoxil

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Expanded Access Assignment,Safety Study

Official Title:A Phase 3b, Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B Who Have Limited Treatment Options

http://www.clinicaltrials.gov/ct/show/NCT00095121?order=3

Gilead Sciences

The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18) compared to placebo following 48 weeks of treatment.

Chronic Hepatitis B

Drug:Adefovir Dipivoxil, 10 mg tablet or oral suspension, 2 mg/mL

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to less than 18) with Chronic Hepatitis B

http://www.clinicaltrials.gov/ct/show/NCT00006441?order=1

The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV). After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies.

HIV Infections

Drug:Lamivudine/ZidovudineDrug:Nelfinavir mesylateDrug:Aldesleukin

Study Type:InterventionalStudy Design:Treatment,Open Label,Efficacy Study

Official Title:A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons with Primary or Early HIV Infection

http://www.clinicaltrials.gov/ct/show/NCT00056407?order=1

GlaxoSmithKline

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

Prostate Cancer

Drug:Oral investigational prostate cancer risk reduction drug

Phase III

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00089583?order=2

GlaxoSmithKline

This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .

HIV Infections

Drug:Lexiva (GW433908)Drug:Ritonavir

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00085813?order=3

GlaxoSmithKline

Purpose of study is to determine how effective and safe a new investigational drug is in treating locally advanced or metastatic Non-small Cell Lung cancer in patients who have received a platinum-based chemotherapy and whose disease continues to progress. Treatment involves a 1-hr treatment given intravenously (IV), repeated once every 21 days. A patient may continue treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over 24 hr period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.

Non-small cell lung cancer

Drug:Investigational Cancer Drug

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00090103?order=4

GlaxoSmithKline

This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) are done annually.

Benign Prostatic Hyperplasia

Drug:AvodartDrug:Tamsulosin

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00056277?order=5

GlaxoSmithKline

A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder

Bipolar Disorder

Drug:Investigational Bipolar Disorder Drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00078572?order=6

GlaxoSmithKline

The purpose of this study is to compare the efficacy and safety of an oral dual tyrosine kinase inhibitor in combination with capecitabine versus capecitabine alone in women with locally advanced or metastatic breast cancer that has not responded to previous therapy.

Metastatic breast cancer

Drug:XelodaDrug:Lapatinib (GW572016)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00082394?order=7

GlaxoSmithKline

This clinical research study evaluates the safety and effectiveness of marketed HIV drugs in investigational combinations given to HIV-infected patients who have not received prior therapy. All subjects will be screened and monitored at 12 scheduled clinic visits over a 48-week period and will have a follow up visit or telephone call 4 weeks after the last study visit. Abnormal laboratory values or certain side effects may require additional clinic visits over the course of the study.

HIV Infections

Drug:Investigational HIV Drugs

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00071747?order=8

GlaxoSmithKline

The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.

Schizophrenia

Drug:Investigational Schizophrenia Drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00065182?order=9

GlaxoSmithKline

The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in patients with advanced non-small cell lung cancer who have received one previous chemotherapy.

Non-small cell lung cancer

Drug:Two FDA approved chemotherapy drugs

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00076882?order=10

GlaxoSmithKline

This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.

Bipolar Disorder

Drug:Investigational Bipolar Disorder Drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00085904?order=11

GlaxoSmithKline

SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Safety evaluations, including blood sampling for various laboratory tests, will be conducted. Additional blood samples will also be taken to measure the amount of drug in the body at specific times.

CancerLymphoma

Drug:SB-485232

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00085878?order=12

GlaxoSmithKline

This is a Phase I, open-label, dose-escalation study of SB-485232. Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested. An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing.

Solid Tumors

Drug:SB-485232

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00058526?order=13

GlaxoSmithKline

Breast Cancer

Vaccine:Investigational Cancer Vaccine

Phase I

Study Type:InterventionalStudy Design:Prevention,Non-Randomized,Single Blind,Dose Comparison,Single Group Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00062790?order=14

GlaxoSmithKline

This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride. Male patients at least 50 years old will take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.

Benign Prostatic Hyperplasia

Drug:Dutasteride

Phase IV

Study Type:InterventionalStudy Design:Diagnostic,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Pharmacokinetics/Dynamics Study

http://www.clinicaltrials.gov/ct/show/NCT00094523?order=15

GlaxoSmithKline

HIV Infections

Drug:fosamprenavir (Lexiva)

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00039858?order=16

GlaxoSmithKline

The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.

ThrombocytopeniaThrombosis

Drug:Argatroban

Phase IV

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00089986?order=17

GlaxoSmithKline

The primary objective of this study is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

SepsisSeptic Shock

Drug:Intravenous GR270773- Phospholipid Emulsion

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00044330?order=18

GlaxoSmithKline

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

Metastatic breast cancer

Drug:GW572016

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00085943?order=19

GlaxoSmithKline

This randomized, multicenter study will compare the safety and efficacy of Lexiva plus ritonavir versus Kaletra (Lopinavir/ritonavir) over 48 weeks in ART (anti-retroviral therapy)-naive HIV-1 infected subjects while utilizing the Abacavir/lamivudine (ABC/3TC) FDC (fixed-dose combination tablet) as a NRTI (nucleoside reverse transcriptase inhibitor) backbone. This clinical research study evaluates the safety and efficacy (how well it works) of marketed HIV drugs [PI (protease inhibitor) plus NRTIs] given to HIV-infected patients who have not received prior therapy. All subjects will be screened and monitored at 12 scheduled clinic visits over a 48-week period. Abnormal laboratory values or certain side effects may require additional clinic visits over the course of the study.

HIV Infections

Drug:Lexiva (GW433908)Drug:RitonavirDrug:KaletraDrug:EpivirDrug:Ziagen

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00086658?order=20

GlaxoSmithKline

Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia. HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications. Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.

Hypereosinophilic SyndromeHypereosinophilia

Drug:mepolizumab

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00089999?order=21

GlaxoSmithKline

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

Breast CancerMetastases

Drug:Lapatinib

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00093288?order=22

GlaxoSmithKline

Placebo Controlled Study Evaluating the Effectiveness of Medication in Elderly Subjects with Major Depressive Disorder (MDD)

Major Depressive Disorder

Drug:Investigational Major Depression Disorder drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00090077?order=23

GlaxoSmithKline

To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients

HIV Infections

Drug:Investigational HIV drug

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00041470?order=24

Gralow, Julie, M.D.

Breast Cancer

Drug:PaclitaxelDrug:VinorelbineDrug:TrastuzumabDrug:Filgrastim

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00097370?order=25

GlaxoSmithKline

This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.

Hypereosinophilic SyndromeHypereosinophilia

Drug:mepolizumab

Phase III

Study Type:InterventionalStudy Design:Treatment,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00075270?order=26

GlaxoSmithKline

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Metastatic breast cancer

Drug:PaclitaxelDrug:GW572016

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00044278?order=27

GlaxoSmithKline

This study will evaluate the safety of an investigational medication to treat pediatric patients 1-24 months old with uncontrolled partial seizures.

Epilepsy

Drug:Investigational Epilepsy Drug

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00065065?order=28

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12.

Ulcerative ColitisInflammatory Bowel Disease

Drug:rosiglitazone (Avandia)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Efficacy Study

Official Title:A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis

http://www.clinicaltrials.gov/ct/show/NCT00075049?order=29

Walter Reed Army Institute of Research (WRAIR)

This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.

Malaria

Vaccine:RTS,S with AS02A/AS01B adjuvant

Phase I

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00097409?order=30

GlaxoSmithKline

The purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinum/taxane based chemotherapy and whose disease continues to progress. The treatment involves a 1-hour treatment given intravenously (IV), repeated once every 21 days. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times over a 24-hour period to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for routine lab tests, such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment.

Ovarian Cancer

Drug:SB-715992

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00094367?order=31

GlaxoSmithKline

The purpose of this study is to test the short-term safety of a new once-daily fixed-dose combination tablet containing two drugs for treatment of HIV.

HIV Infections

Drug:Investigational HIV drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00073528?order=32

GlaxoSmithKline

This study will compare the efficacy and tolerability of GW572016 administered in combination with letrozole, versus letrozole and placebo, as treatment for hormone receptor-positive advanced or metastatic breast cancer.

Breast CancerMetastases

Drug:Lapatinib (GW572016)Drug:Letrozole

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00067457?order=33

GlaxoSmithKline

The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Irritable Bowel Syndrome

Drug:Investigational IBS Drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00086593?order=34

GlaxoSmithKline

This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples.

Schizophrenia

Drug:Lamictal

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00071760?order=35

GlaxoSmithKline

This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old.

HIV Infections

Drug:Investigational HIV Drugs

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00073008?order=36

GlaxoSmithKline

The purpose of this study is to evaluate and compare the efficacy of two dose schedules of an oral investigational drug for the treatment of advanced or metastatic non-small cell lung cancer

Non-small cell lung cancer

Drug:GW572016

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00089973?order=37

GlaxoSmithKline

The purpose of this research study is to find how breast cancer responds to the investigational drug, SB-715992. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions: 1. Does breast cancer respond to SB-715992? 2. What are the side effects of SB-715992? 3. How much SB-715992 is in the blood at specific times after it is taken?

Breast Cancer

Drug:SB715992

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Uncontrolled,Single Group Assignment,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00067561?order=38

GlaxoSmithKline

The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Irritable Bowel Syndrome

Drug:Investigational IBS Drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00097331?order=39

GlaxoSmithKline

The study will evaluate the effectiveness and safety of the investigational drug SB683699 in treating patients with relapsing multiple sclerosis, using data from magnetic resonance imaging (MRI) scans as the main measure.

Multiple Sclerosis

Drug:SB683699

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00095186?order=1

Agennix

The purpose of this study is to determine if orally-administered recombinant human lactoferrin is effective in the treatment of advanced renal cell carcinoma (RCC) in patients who have failed at least one prior systemic therapy for RCC.

Carcinoma, Renal Cell

Drug:Recombinant Human Lactoferrin

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Multi-Center, Phase 2, Open Label Study of Safety and Efficacy of Oral Recombinant Human Lactoferrin (rhLF) Monotherapy in Patients with Advanced Renal Cell Carcinoma (RCC), Who Have Failed at Least One Regimen of Systemic Therapy for RCC

http://www.clinicaltrials.gov/ct/show/NCT00093132?order=1

GPC Biotech

Carcinoma, Non-Small Cell LungLung Cancer

Drug:SatraplatinDrug:Docetaxel

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Safety/Efficacy Study

Official Title:A Phase 1/2 Study with Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00069745?order=2

GPC Biotech

Prostate CancerHormone Refractory Prostate CancerOne Prior Cytotoxic Chemotherapy Regimen

Drug:SatraplatinDrug:Prednisone

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients with Hormone Refractory Prostate Cancer Previously Treated with One Cytotoxic Chemotherapy Regimen

http://www.clinicaltrials.gov/ct/show/NCT00090376?order=1

Guilford Pharmaceuticals

ImpotenceProstate Cancer

Drug:GPI 1485

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 3 Arm, 12-Month Study to Evaluate the Effects of GPI 1485 on Erectile Function in Patients Undergoing Bilateral Nerve-Sparing Radical Retropubic Prostatectomy for Prostatic Carcinoma

http://www.clinicaltrials.gov/ct/show/NCT00096408?order=1

Queensland Centre for Gynaecological Cancer

The purpose of this study is to determine whether women with Stage I endometrial cancer have the same or better Quality of Life and disease-free survival when treated with Total Laparoscopic Hysterectomy compared to Total Abdominal Hysterectomy.

Endometrial Cancer

Procedure:Total Laparascopic Hysterectomy

Phase III

Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study

Official Title:Total Laparoscopic Hysterectomy for the Treatment of Endometrial Cancer Quality of Life: A Multicentre, Randomised Phase 3 Clinical Trial.

http://www.clinicaltrials.gov/ct/show/NCT00073554?order=1

Nuvelo

This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).

Arterial Occlusive DiseasesPeripheral Vascular DiseasesThrombosis

Drug:Alfimeprase

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients with Acute Peripheral Arterial Occlusion

http://www.clinicaltrials.gov/ct/show/NCT00035893?order=1

Hemispherx Biopharma

This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.

HIV SeropositivityHIV Infection

Drug:(Ampligen) polyI-polyC12U

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment,Safety/Efficacy Study

Official Title:The Role of Ampligen in Strategic Therapeutic Intervention (STI) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval.

http://www.clinicaltrials.gov/ct/show/NCT00035581?order=2

Hemispherx Biopharma

This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).

HIV SeropositivityHIV Infection

Drug:(Ampligen) polyI-polyC12U

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00006441?order=1

The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV). After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies.

HIV Infections

Drug:Lamivudine/ZidovudineDrug:Nelfinavir mesylateDrug:Aldesleukin

Study Type:InterventionalStudy Design:Treatment,Open Label,Efficacy Study

Official Title:A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons with Primary or Early HIV Infection

http://www.clinicaltrials.gov/ct/show/NCT00090636?order=1

Hoffmann-La Roche

Myasthenia gravis is a rare, debilitating neurological autoimmune disease. Mycophenolate mofetil (MMF) modulates autoimmune responses through a unique mode of action which may be relevant for autoimmune disease patients. This study will test the safety and efficacy of adjunct MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis.

Myasthenia Gravis

Drug:mycophenolate mofetil

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Prospective, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, 36-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control with Reduced Corticosteroids in Subjects with Myasthenia Gravis

http://www.clinicaltrials.gov/ct/show/NCT00022672?order=2

Hoffmann-La Roche

stage IV breast cancerrecurrent breast cancer

Drug:anastrozoleDrug:trastuzumabProcedure:antibody therapyProcedure:aromatase inhibitionProcedure:biological response modifier therapyProcedure:endocrine therapyProcedure:hormone therapyProcedure:monoclonal antibody therapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II/III Randomized Study of Anastrozole With or Without Trastuzumab (Herceptin) in Postmenopausal Women With Hormone-Receptor Positive HER2-Overexpressing Metastatic Breast Cancer

http://www.clinicaltrials.gov/ct/show/NCT00022698?order=3

Hoffmann-La Roche

Colon CancerRectal Cancer

Drug:capecitabineDrug:irinotecanProcedure:chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Capecitabine and Irinotecan in Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer

http://www.clinicaltrials.gov/ct/show/NCT00069108?order=4

Hoffmann-La Roche

The primary purpose of the study is to show that the combination of capecitabine plus oxaliplatin (XELOX) is at least as effective as the combination of fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX4) in terms of time to tumor progression or death in patients with metastatic colorectal cancer, who have received previous treatment with CPT-11 in combination with fluorouracil/leucovorin as first line therapy.

Metastatic Colorectal Cancer

Drug:Capecitabine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label

Official Title:Open-label randomized phase 3 study of capecitabine in combo w/ XELOX vs fluorouracil/leucovorin w/ oxaliplatin (FOLFOX4) as treatment for pts w/ metastatic colorectal cancer, who have received prior treatment w/ CPT-11 in combo w/ fluorouracil/leucovorin

http://www.clinicaltrials.gov/ct/show/NCT00081653?order=5

Hoffmann-La Roche

The purposes of this study are to study the effect of long-term treatment with monthly oral ibandronate 100 mg and 150 mg, given as a single tablet, on the lumbar spine and hip BMD and bone turnover, and to assess the overall long-term tolerability and safety of the treatment regimens.

Osteoporosis

Drug:BM 21.0955 Na?H2O Oral (USAN:ibandronate sodium, INN:iband acid)

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00087568?order=6

Hoffmann-La Roche

The objective of this study is to investigate if patients with Chronic Hepatitis C virus who were unable to tolerate or did not respond to 12 weeks of PEG-Intron plus Rebetol/Ribavirin therapy can be safely initiated on Pegasys plus Copegus therapy and tolerate and complete a full course (36 to 60 weeks) of treatment.

Hepatitis C

Drug:Pegylated Interferon alfa-2a in combination with Ribavirin

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00050167?order=7

M.D. Anderson Cancer Center

The purpose of this study is to evaluate two taxane regimens (weekly paclitaxel or docetaxel + capecitabine) given in addition to anthracycline based therapy in patients with newly diagnosed breast cancer as adjuvant or neoadjuvant therapy. The objectives of the study are: 1) to evaluate the ability of these two treatments to prevent recurrence and impact survival, 2) to evaluate the ability of the taxane regimens to reduce the tumor size and 3) increase the possibility of breast conservative surgery when given in the neoadjuvant setting.

Breast Cancer

Drug:PaclitaxelDrug:DocetaxelDrug:CapecitabineDrug:5-fluorouracilDrug:EpirubicinDrug:Cyclophosphamide

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00087646?order=8

Hoffmann-La Roche

The objective of this study is to compare the efficacy of the combination of standard dose Pegasys and Copegus given for 72 weeks (including a 12-week high dose induction) versus the standard doses of Pegasys and Copegus given for 48 weeks in patients that did not respond to previous treatment with PEG-Intron in combination with Rebetol/Ribavirin.

Hepatitis

Drug:Pegylated Interferon alfa-2a in combination with Ribavirin

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00087581?order=9

Hoffmann-La Roche

renal transplant

Drug:mycophenolate mofetil

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00077857?order=10

Hoffmann-La Roche

The primary purpose of this study is to demonstrate that the combination of capecitabine (950 mg/m2 twice daily d1-14) and docetaxel (75 mg/m2) d1 Q3W is at least equivalent to the combination of capecitabine (1250 mg/m2 twice daily d1-14 ) and docetaxel (75 mg/m2) d1 Q3W in terms of time to disease progression or death due to any cause.

Breast (combo) and Colon Cancer (monotherapy)

Drug:Capecitabine

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00090753?order=11

Hoffmann-La Roche

The purpose of this study is to document that RO0503821 administered for prolonged periods (104 weeks) is efficacious, safe, and well tolerated in patients treated for chronic renal anemia.

Renal Anemia

Drug:RO0503821

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00087620?order=12

Hoffmann-La Roche

To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W)

Breast Cancer

Drug:capecitabine

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00077597?order=13

Hoffmann-La Roche

The primary purpose of this study is to demonstrate the efficacy of RO0503821 administered intravenously for the treatment of anemia in patients with chronic kidney disease who are on dialysis. The secondary purpose is to assess the safety and tolerability of multiple doses of RO0503821 during the correction and the extension periods in this patient population.

Renal Anemia

Drug:RO0503821

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00077610?order=14

Hoffmann-La Roche

The primary purpose of this study is to demonstrate that RO0503821 administered intravenously maintains hemoglobin concentrations in dialysis patients on prior intravenous epoetin maintenance treatment of chronic renal anemia. The secondary purpose is to assess the safety and tolerability of intravenous administration of RO0503821 in this patient patient population.

Renal Anemia

Drug:RO0503821

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00081484?order=15

Hoffmann-La Roche

The primary purpose of this study is to demonstrate that RO0503821 administered with pre-filled syringes maintains hemoglobin concentrations in dialysis patients on prior intravenous or subcutaneous epoetin maintenance treatment of chronic renal anemia.

Renal Anemia

Drug:RO0503821

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00090051?order=16

Biogen Idec

The purpose of this study is to provide treatment for patients who have CLL, and to compare the use of rituximab added to FC with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

Chronic Lymphocytic Leukemia

Drug:Rituxan

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab/fludarabine/cyclophosphamide (FCR) vs. fludarabine/cyclophosphamide (FC) alone in previously treated patients with CD20 positive B-cell CLL

http://www.clinicaltrials.gov/ct/show/NCT00081471?order=17

Hoffmann-La Roche

The primary purpose of this study is to demonstrate the efficacy of RO0503821 treatment administered subcutaneously once every two weeks for correction of anemia in chronic kidney disease patients who are not on dialysis and are not treated with epoetin.

Renal Anemia

Drug:RO0503821

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Open-label, randomized, parallel-group, comparative, active-controlled, multi-center study w/ 1 dosing interval during the correction and evaluation periods, and 2 dosing intervals during the extension period

http://www.clinicaltrials.gov/ct/show/NCT00087633?order=18

Hoffmann-La Roche

The objective of this study is to study the impact of prophylactic administration of antiviral therapy (Prophylaxis Arm) as compared to initiation of antiviral therapy at the time of clinical recurrence of Hepatitis C infection (Observation Arm). Another primary objective is to compare the efficacy, tolerability and safety of antiviral therapy in posttransplant patients in the two arms.

Hepatitis C

Drug:Pegylated Interferon alfa-2a in combination with Ribavirin

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00087594?order=19

Hoffmann-La Roche

The objective of this study is to investigate if patients with Chronic Hepatitis C virus Genotype 1 who are previous intravenous drug users and enrolled in a physician supervised methadone maintenance treatment program can safely tolerate Chronic Hepatitis C treatment consisting of Pegasys plus Copegus.

Hepatitis C

Drug:Pegylated Interferon alfa-2a in combination with Ribavirin

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00089492?order=20

Hoffmann-La Roche

The purpose of this study is to evaluate the antiviral activity of Fuzeon (enfuvirtide) 180 mg administered once daily in combination with an Optimized Background (OB) regimen (consisting of 3 to 5 antiretroviral drugs individualized by the physician and the patient based on the patient?s prior treatment history), compared to the currently recommended dosing of Fuzeon 90 mg administered twice daily in combination with an Optimized Background regimen for 48 weeks of treatment.

HIV Infections

Drug:enfuvirtide

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control

Official Title:A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Fuzeon (enfuvirtide) Dosing versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment Experienced Patients

http://www.clinicaltrials.gov/ct/show/NCT00069095?order=21

Hoffmann-La Roche

There are two primary purposes of the study. One is to show that the combination of capecitabine plus oxaliplatin (XELOX) with or without bevacizumab is at least as effective as the combination of fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX-4) with or without bevacizumab in terms of time to tumor progression or death in patients with metastatic colorectal cancer, who have not received previous treatment for metastatic disease. The other is to show that bevacizumab in combination with chemotherapy (XELOX or FOLFOX-4) is better than chemotherapy alone in the same patient population.

Metastatic Colorectal Cancer

Drug:Capecitabine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized

Official Title:A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or w/out bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or w/out bevacizumab as first-line treatment for pts w/ metastatic colorectal cancer

http://www.clinicaltrials.gov/ct/show/NCT00089479?order=22

Hoffmann-La Roche

The purpose of this study is to compare the disease-free survival distributions obtained with 2 different regimens of adjuvant chemotherapy for patients with high-risk breast cancer.

Breast Cancer

Drug:capecitabine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label

Official Title:A Randomized, Open-Label, Multicenter, Phase III Trial Comparing Regimens of Adriamycin plus Cytoxan Followed by Either Taxotere or Taxotere plus Xeloda as Adjuvant Therapy for Female Patients with High-Risk Breast Cancer

http://www.clinicaltrials.gov/ct/show/NCT00090766?order=23

Hoffmann-La Roche

The purposes of this study are to describe the safety and tolerability profile of valganciclovir syrup and tablets in pediatric solid organ transplant recipients, to determine the pharmacokinetics (the body's absorption, distribution, metabolism, and excretion) of ganciclovir following oral administration of valganciclovir syrup and tablets in pediatric solid organ transplant recipients, and to describe the incidence of CMV disease.

Cytomegalovirus Infections

Drug:valganciclovir hydrochloride

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients

http://www.clinicaltrials.gov/ct/show/NCT00095251?order=1

Vanderbilt University

Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).

Delirium

Drug:Dexmedetomidine

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-blind Trial in Ventilated ICU Patients Comparing Treatment with an Alpha2 Agonist versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status

http://www.clinicaltrials.gov/ct/show/NCT00088023?order=1

Hudson Health Sciences

The purpose of this study is to determine the safety of a short intravenous infusion of PT523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist.

Neoplasms

Drug:PT523 for Injection

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase I Study of PT523 in Patients with Solid Tumors

http://www.clinicaltrials.gov/ct/show/NCT00097435?order=1

Human Genome Sciences

This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.

Hepatitis C

Drug:Albuferon plus ribavirin

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination with Ribavirin in Interferon Treatment Experienced Subjects with Chronic Hepatitis C

http://www.clinicaltrials.gov/ct/show/NCT00094848?order=2

Human Genome Sciences

The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).

Lymphoma, Non-Hodgkin

Drug:TRAIL-R1 mAb (TRM-1; HGS-ETR1)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Multi-Center, Open-Label, Dose-Escalation Study to Evaluate the Safety, Efficacy, and Exposure to TRM-1 (Fully Human Monoclonal Antibody to the TRAIL-R1) in Subjects with Relapsed or Refractory Non-Hodgkins Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00092924?order=3

Human Genome Sciences

The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer.

Carcinoma, Non-Small-Cell Lung

Drug:TRAIL-R1 mAb (TRM-1;HGS-ETR1)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase 2, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of TRM-1 (Fully Human Monoclonal Antibody To TRAIL-R1) in Subjects with Relapsed or Refractory Non-Small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00057265?order=1

Idenix Pharmaceuticals

Idenix Pharmaceuticals, Inc is conducting this research study to see if the investigational medication, LdT (Telbivudine), is safe and effective (that is, how well it works by decreasing the level of hepatitis B virus in your blood and improving the condition of your liver) in the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine, which is a drug currently approved by the Food and Drug Adminstration (FDA) for the treatment of hepatitis B infection.

Chronic Hepatitis B

Drug:telbivudine or lamivudine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00076336?order=2

Idenix Pharmaceuticals

Idenix Pharmaceuticals, Inc is conducting this research study to see if the investigational medication, LdT (Telbivudine), is safe and effective (that is, how well it works by decreasing the level of hepatitis B virus in your blood and improving the condition of your liver) in the treatment of decompensated hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine, which is a drug currently approved by the Food and Drug Adminstration (FDA) for the treatment of hepatitis B infection.

HepatitisHepatitis B, ChronicCirrhosis

Drug:Telbivudine (LdT) versus Lamivudine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:Randomized, Double-Blind Trial of Telbivudine versus Lamivudine in Adults with Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

http://www.clinicaltrials.gov/ct/show/NCT00088140?order=1

Idun Pharmaceuticals

The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.

Hepatitis C, Chronic

Drug:IDN-6556

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients

http://www.clinicaltrials.gov/ct/show/NCT00080236?order=2

Idun Pharmaceuticals

The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.

Liver TransplantationHepatitisCholestasisCarcinoma, Hepatocellular

Drug:IDN-6556

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)

http://www.clinicaltrials.gov/ct/show/NCT00071396?order=1

M.D. Anderson Cancer Center

The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.

Chronic Lymphocytic Leukemia

Drug:Campath-1HDrug:Rituximab

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

Official Title:Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders

http://www.clinicaltrials.gov/ct/show/NCT00067028?order=2

M.D. Anderson Cancer Center

The goal of this clinical research study is to find the best safe dose for 2 different drug combinations. For this purpose, participants will either receive the combination of clofarabine plus idarubicin or clofarabine plus idarubicin and ara-C. Once the best safe dose for these drug combinations are found, the next goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with acute myeloid leukemia (AML), high-grade myelodysplastic syndrome (MDS), or myeloid blast phase of chronic myeloid leukemia (CML) who have relapsed following their initial therapy. The safety of these treatments will also be studied.

Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myeloid Leukemia

Drug:clofarabineDrug:IdarubicinDrug:Ara-C

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Prospective Randomized Phase I/II Study of Clofarabine and Ara-C vs Clofarabine and Idarubicin vs Clofarabine plus Idarubicin and Ara-C in Patients with First Relapse or First Salvage of Primary Refractory acute myeloid leukemia (AML); and High-Grade Myelodysplastic Syndrome (MDS) (>/= 10% Blasts); or with Chronic Myeloid Leukemia (CML) in Myeloid Blasts Phase as Front Line Therapy or in First Salvage Chromosome Positive Chronic Myeloid Leukemia)

http://www.clinicaltrials.gov/ct/show/NCT00081887?order=3

M.D. Anderson Cancer Center

The goal of this clinical research study is to find the highest safe dose of clofarabine that can be given on a weekly schedule for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL). The effectiveness of this treatment will also be studied.

Chronic Lymphocytic Leukemia

Drug:clofarabineDrug:Ara-C

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase I Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00088218?order=1

M.D. Anderson Cancer Center

Clofarabine is a chemotherapy drug that is designed to interfere with the growth and development of cancer cells. Ara-C is a chemotherapy drug which is approved for the treatment of AML and MDS. Although there is experience with the combination of both drugs, there have not been any phase 1 trials that explored the particular doses and schedule of clofarabine plus ara-C that a patient may receive.

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Drug:ClofarabineDrug:Ara-C

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Historical Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Randomized Phase II Study of Clofarabine alone versus Clofarabine in Combination with Low-Dose Cytarabine (ara-C) in Previously Untreated Patients >= 60 Years with Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

http://www.clinicaltrials.gov/ct/show/NCT00086580?order=2

ILEX Pharmaceuticals

This is a Phase III, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of Fludara plus alemtuzumab versus Fludara alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.

B-Cell Lymphocytic Leukemia

Drug:Alemtuzumab (Campath, MabCampath)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Safety/Efficacy Study

Official Title:Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy with Fludara plus Alemtuzumab (Campath, MabCampath) versus Fludara Alone in Patients with B-Cell Chronic Lymphocytic Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00051701?order=3

ILEX Pharmaceuticals

The purpose of this study is to determine the optimal dose of Campath for patients with relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also evaluate the safety of the drug and whether it is effective in treating these patients.

Non-Hodgkins Lymphoma

Drug:alemtuzumab

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00077961?order=4

ILEX Pharmaceuticals

The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response.

Non-Hodgkin's Lymphoma

Drug:CAMPATH (alemtuzumab)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase I/II Study of Rituximab plus CAMPATH in Patients with Previously Treated Relapsed or Refractory Low-Grade or Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00078026?order=1

ILEX Products

Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.

Osteoporosis

Drug:Apomine

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase I/II Randomized Study of the Short-Term Effects of APOMINE vs Placebo in Postmenopausal women with Osteoporosis or Low Bone Mass

http://www.clinicaltrials.gov/ct/show/NCT00081822?order=2

University of Alabama

The purpose of this study is to determine the recommended phase II dose of clofarabine when administered in combination with standard dose Ara-C to older (>=60 years of age) patients with newly diagnosed acute myeloid leukemia (AML).

Acute Myeloid Leukemia

Drug:clofarabineDrug:cytosine arabinoside

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase I/II Study of Clofarabine & Cytosine Arabinoside Therapy for Older Adults with Acute Myeloid Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00082134?order=3

ILEX Products

This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.

Hormone-Refractory Prostate Cancer

Drug:ILX651

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients with Hormone-Refractory Prostate Cancer Previously Treated with Docetaxel

http://www.clinicaltrials.gov/ct/show/NCT00068211?order=4

ILEX Products

This is a Phase II, non-randomized, open label study of ILX651 in patients with inoperable locally advanced or metastatic melanoma. Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate for all patients who are treated with ILX651. The secondary objectives are to determine the progression free survival at 18 weeks, duration of response, time to tumor progression, survival, safety/tolerability of ILX651 and to evaluate the pharmacokinetic profile.

Melanoma

Drug:ILX651

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients with Inoperable Locally Advanced or Metastatic Melanoma.

http://www.clinicaltrials.gov/ct/show/NCT00078455?order=5

ILEX Products

This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate. The secondary objectives are to determine the progression free survival, duration of response, time to tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic profile.

Non-Small-Cell Lung Carcinoma

Drug:ILX651

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

http://www.clinicaltrials.gov/ct/show/NCT00046696?order=6

ILEX Products

A study for patients who have failed standard therapy. If there is no dose limiting toxicities the patients will receive further cycles of therapy if there is no evidence of disease progression.

Neoplasms

Drug:NM-3

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Safety/Efficacy Study

Official Title:A Phase I and Pharmacokinetic Study of NM-3 Administered Orally once or twice Daily on Five Consecutive Days and Repeated Weekly for Six Weeks Every Eight Weeks in Patients with Advanced Solid Tumors.

http://www.clinicaltrials.gov/ct/show/NCT00097214?order=1

ImClone Systems

This is a phase II study in previously untreated subjects with histologically or cytologically proven stage IIIB/IV NSCLC designed to determine the efficacy of first line treatment with carboplatin and cetuximab.

Non-small cell lung cancer

Drug:CetuximabDrug:Carboplatin

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIb/IV Non-Small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00095199?order=2

ImClone Systems

This trial is a multicenter, open-label, randomized, phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will be randomized to one of the following 4 treatment arms: Cetuximab plus Docetaxel, Cetuximab plus Pemetrexed, Docetaxel alone, or Pemetrexed alone.

Non-Small-Cell Lung Cancer

Drug:DocetaxelDrug:PemetrexedDrug:Cetuximab

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Randomized Phase III Study of Docetaxel or Pemetrexed with or without Cetuximab in Patients with Recurrent or Progressive Non-Small Cell Lung Cancer after Platinum-Based Therapy

http://www.clinicaltrials.gov/ct/show/NCT00063401?order=3

Bristol-Myers Squibb

To determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer

Ovarian CancerPeritoneal NeoplasmsFallopian Tube Neoplasms

Drug:Cetuximab

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

http://www.clinicaltrials.gov/ct/show/NCT00061815?order=4

ImClone Systems

The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with Oxaliplatin, 5-Fluorouracil and Leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.

Colorectal Cancer

Drug:cetuximab

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00063141?order=5

ImClone Systems

The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, EGFR-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

Colorectal Cancer

Drug:cetuximab

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00082212?order=6

Bristol-Myers Squibb

The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma.

Ovarian Cancer

Drug:Cetuximab

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients with Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

http://www.clinicaltrials.gov/ct/show/NCT00083720?order=7

ImClone Systems

Colorectal NeoplasmsMetastasesNeoplasm

Drug:Erbitux tm (cetuximab)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase II Multicenter Study of Erbitux (cetuximab) in Patients with Refractory, EGFR-Negative Metastatic Colorectal Carcinoma

http://www.clinicaltrials.gov/ct/show/NCT00034554?order=8

ImClone Systems

Up to 24 patients with stage III or stage IV melanoma will be enrolled. Patients who are currently disease-free but at high risk for relapse are also eligible. Patients will receive vaccinations of gp75 at assigned dose levels. Patients who exhibit serologic and stable/clinical response are eligible to receive booster vaccinations. Patients will be evaluated for safety and efficacy throughout the duration of the study. In this study, the optimal biologically effective dose is defined as the lowest dose of gp75 that results in the production of anti-gp75 antibodies.

Malignant Melanoma

Vaccine:gp75 DNA vaccine

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase I Study of gp75 DNA Vaccine in Patients With AJCC Stage III and IV Melanoma

http://www.clinicaltrials.gov/ct/show/NCT00097227?order=9

ImClone Systems

The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated.

Non-small cell lung cancer

Drug:CetuximabDrug:CarboplatinDrug:Paclitaxel

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00051194?order=1

Alcon Research

To compare the intraocular pressure(IOP)-lowering efficacy of morning or evening instillations of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

Glaucoma, Open-AngleOcular Hypertension

Drug:Combination IOP Lowering Therapy

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A 6-week safety and efficacy study of combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

http://www.clinicaltrials.gov/ct/show/NCT00051155?order=2

Alcon Research

To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with open-angle glaucoma or ocular hypertension.

Glaucoma, Open-AngleOcular Hypertension

Drug:Travoprost (0.004%)Drug:Latanoprost (0.005%)/Timolol (0.5%)

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A 6-week safety and efficacy study of TRAVATAN compared to XALCOM in subjects with open-angle glaucoma or ocular hypertension.

http://www.clinicaltrials.gov/ct/show/NCT00058994?order=3

Alcon Research

To demonstrate that anecortave acetate is superior to placebo in maintenance of visual acuity at the 12- and 24-month visits.

Macular DegenerationMaculopathy, Age-Related

Drug:anecortave acetate

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:An evaluation of safety and efficacy of Anecortave Acetate versus placebo in patients with subfoveal choroidal neovascularization due to exudative age-related macular degeneration.

http://www.clinicaltrials.gov/ct/show/NCT00051129?order=4

Alcon Research

To demonstrate that anecortave acetate is superior to placebo in maintenance of visual acuity at the 12- and 24-month visits.

Macular DegenerationMaculopathy, Age-RelatedAge-Related MaculopathiesAge-Related MaculopathyMaculopathies, Age-Related

Drug:anecortave acetate

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:An evaluation of safety and efficacy of Anecortave Acetate versus placebo in patients with subfoveal choroidal neovascularization due to exudative age-related macular degeneration.

http://www.clinicaltrials.gov/ct/show/NCT00051168?order=5

Alcon Research

Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.

Glaucoma, Open-AngleOcular Hypertension

Drug:Travoprost (0.004%)

Phase IV

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00061503?order=6

Alcon Research

The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

GlaucomaOcular Hypertension

Drug:Travoprost

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Double-Masked, Placebo-Controlled, Paired Comparison Study of the Mechanism of Action of TRAVATAN 0.004% in Subjects with Glaucoma or Ocular Hypertension

http://www.clinicaltrials.gov/ct/show/NCT00065728?order=7

Alcon Research

A 24 month study of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.

Macular Degeneration

Drug:Anecortave Acetate

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients with Subfoveal Exudative Age-Related Macular Degeneration (AMD) Who Were Enrolled in Alcon Study C-98-03.

http://www.clinicaltrials.gov/ct/show/NCT00047515?order=8

Alcon Research

To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.

Open-Angle GlaucomaOcular Hypertension

Drug:Alcon Investigational Agent

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Phase III safety and efficacy study to evaluate combination IOP lowering therapy in open angle glaucoma and ocular hypertensive patients C-01-69.

http://www.clinicaltrials.gov/ct/show/NCT00047541?order=9

Alcon Research

To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.

Open-Angle GlaucomaOcular Hypertension

Drug:Alcon Investigational Agent

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Phase III safety and efficacy study to evaluate combination IOP lowering therapy in open angle glaucoma and ocular hypertensive patients C-01-70.

http://www.clinicaltrials.gov/ct/show/NCT00047528?order=10

Alcon Research

To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.

Open-Angle GlaucomaOcular Hypertension

Drug:Alcon Investigational Agent

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Phase III safety and efficacy study to evaluate combination IOP lowering therapy in open angle glaucoma and ocular hypertensive patients (C-02-41).

http://www.clinicaltrials.gov/ct/show/NCT00047606?order=11

Alcon Research

The purpose of this study is to evaluate safety and efficacy of two different IOP lowering medications after six weeks of treatment in Caucasian and Japanese subjects.

Open-Angle GlaucomaOcular Hypertension

Drug:IOP Lowering Medications

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Phase 4 study to compare two different IOP lowering medications for the treatment of Open Angle Glaucoma or Ocular Hypertension in Caucasian and Japanese Subjects C-02-32.

http://www.clinicaltrials.gov/ct/show/NCT00069706?order=12

Alcon Research

The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Open-Angle GlaucomaOcular Hypertension

Drug:Glaucoma therapy

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00047554?order=13

Alcon Research

To monitor iris pigmentation changes over a five year period in subjects with open-angle glaucoma or ocular hypertension who have experienced an iris pigmentation change while dosing with TRAVATAN.

Open-Angle GlaucomaOcular Hypertension

Drug:TRAVATAN (travoprost ophthalmic solution) 0.004%

Phase IV

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Phase IV safety study of TRAVATAN 0.004% in subjects with TRAVATAN induced iris pigmentation changes C-01-79.

http://www.clinicaltrials.gov/ct/show/NCT00061516?order=14

Alcon Research

To evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.

GlaucomaOcular Hypertension

Drug:BETAXON (levobetaxolol HCl)Drug:AZOPT (brinzolamide)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Study start:January 2003

http://www.clinicaltrials.gov/ct/show/NCT00061542?order=15

Alcon Research

To evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.

GlaucomaOcular Hypertension

Drug:BETOPTIC S (betaxolol HCl)Drug:Timolol Gel-forming Solution (timolol maleate)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Study start:January 2003

http://www.clinicaltrials.gov/ct/show/NCT00051181?order=16

Alcon Research

To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma.

Glaucoma, Angle-ClosureOcular Hypertension

Drug:Travoprost (0.004%)Drug:Latanoprost (0.005%)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A safety and efficacy study of Travoprost 0.004% compared to Latanoprost 0.005% in patients with chronic angle-closure glaucoma.

http://www.clinicaltrials.gov/ct/show/NCT00051142?order=17

Alcon Research

To evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.

Glaucoma, Open-AngleOcular Hypertension

Drug:TravoprostDrug:Latanoprost

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A safety and efficacy study of Travoprost 0.004% compared to Latanoprost 0.005% in patients with open-angle glaucoma or ocular hypertension.

http://www.clinicaltrials.gov/ct/show/NCT00083538?order=1

University of Arkansas

The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.

Multiple Myeloma

Drug:DexamethasoneDrug:ThalidomideDrug:CisplatinumDrug:AdriamycinDrug:CyclophosphamideDrug:Etoposide

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients

http://www.clinicaltrials.gov/ct/show/NCT00054834?order=1

Immunomedics, Inc.

The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma.

Non-Hodgkins Lymphoma

Drug:hLL2 (epratuzumab)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study

Official Title:A Phase I Clinical Trial of Radiolabeled Immunotherapy with Humanized LL2 in Patients with Refractory or Recurrent Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00067392?order=1

The purpose of this study is to determine the difference in success when placing implants immediately into an extraction site compared to delaying the implant placement until the extraction site has healed. In addition, the level of bone around the implants will be compared to determine if one method leads to better results over time.

Dental Caries

Procedure:Dental Implant

Phase III

Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Single Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Prospective Evaluation of Immediate Temporized Implants

http://www.clinicaltrials.gov/ct/show/NCT00041574?order=1

INO Therapeutics

The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.

Pulmonary HypertensionLung DiseaseSickle Cell DiseaseCardiac transplantLung transplant

Drug:INOmax (nitric oxide for inhalation)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00041561?order=2

INO Therapeutics

The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.

Respiratory InsufficiencyAnoxemia

Drug:INOmax (nitric oxide for inhalation)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00060840?order=3

INO Therapeutics

Congestive Heart Failure

Drug:INOmax (nitric oxide) for inhalation

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00041548?order=4

INO Therapeutics

The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.

Lung DiseaseHypoxemiaRespiratory Acidosis

Drug:INOmax (nitric oxide for inhalation)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Crossover Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00060450?order=5

INO Therapeutics

The purpose of this study is to evaluate the effects of inhaled nitric oxide on both short-term physiology as well as on the development of ischemia-reperfusion lung injury (IRLI) in the immediate post transplant period. The specific hypothesis is that inhaled NO post lung transplantation will improve gas exchange/hemodynamic and thus reduce the development of post transplant IRLI.

Ischemia-Reperfusion Injury

Drug:INOmax (nitric oxide for inhalation)

Phase III

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Crossover Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00008437?order=1

InSightec-TxSonics

stage I breast cancerstage II breast cancerstage IIIA breast cancer

Procedure:MRI-guided focused ultrasound ablation

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Pilot Study of MRI-Guided Focused Ultrasound Ablation in Women With Stage I-IIIA Breast Cancer

http://www.clinicaltrials.gov/ct/show/NCT00091637?order=1

Procter & Gamble Pharmaceuticals

In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 90 days.

Acute Myocardial Infarction

Drug:PexelizumabProcedure:Angioplasty

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:APEX-AMI

http://www.clinicaltrials.gov/ct/show/NCT00088179?order=2

Alexion Pharmaceuticals

During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.

Coronary Artery Disease

Drug:pexelizumab in conjunction with CABG

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting with Cardiopulmonary Bypass (PRIMO-CABG II)

http://www.clinicaltrials.gov/ct/show/NCT00083967?order=1

Inspire Pharmaceuticals

The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery.

Retinal Detachment

Drug:denufosol tetrasodium (INS37217)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Masked, Placebo Controlled, Parallel Group, Multi-Center, Dose-Ranging Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects with Rhegmatogenous Retinal Detachment

http://www.clinicaltrials.gov/ct/show/NCT00097344?order=1

Intarcia Therapeutics

The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston), is more effective than another approved drug, letrozole (Femara), in delaying the growth of breast cancer, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.

Breast NeoplasmsNeoplasms, Hormone-Dependent

Drug:AtamestaneDrug:ToremifeneDrug:LetrozoleDrug:Aromatase inhibitionDrug:Estrogen receptor blockerProcedure:Hormone therapyProcedure:Endocrine therapyProcedure:Antiestrogen therapy

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Phase 3 Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer

http://www.clinicaltrials.gov/ct/show/NCT00097045?order=2

Intarcia Therapeutics

This study is designed to compare the safety, tolerability and antiviral effects of omega interferon administered alone to omega interferon administered with ribavirin in the treatment of subjects with chronic Hepatitis C virus (HCV) infection.

Hepatitis C

Drug:omega interferonDrug:Ribavirin

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Phase 2 Study of Omega Interferon Alone or in Combination with Ribavirin in Subjects with Hepatitis C

http://www.clinicaltrials.gov/ct/show/NCT00084279?order=1

InterMune

To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.

Chronic Hepatitis C

Drug:Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety Study

Official Title:Safety and Tolerability of Consensus Interferon-Alpha (CIFN) plus Interferon Gamma-1b (IFN-? 1b) with or without Ribavirin (RBV) in the Treatment of Patients with Chronic Hepatitis C who are Non-responders to PEG-IFN-a (2a or 2b) plus RBV

http://www.clinicaltrials.gov/ct/show/NCT00086541?order=2

InterMune

The purpose of this study is to evaluate the safety and efficacy of two different dose levels of Interferon Alfacon-1 with Ribavirin administered daily in Hepatitis C infected patients who are nonresponders to previous pegylated Interferon Alfa plus Ribavirin therapy.

Chronic Hepatitis C

Drug:Interferon Alfacon-1, Ribavirin

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:Phase 3 Safety and Efficacy Study of Two Dose Levels of Interferon Alfacon-1 plus Ribavirin Daily for 48 Weeks vs No-treatment in Hepatitis C Infected Patients (Nonresponders to Previous Pegylated Interferon Alfa plus Ribavirin)

http://www.clinicaltrials.gov/ct/show/NCT00075998?order=3

InterMune

Idiopathic Pulmonary FibrosisLung DiseasePulmonary Fibrosis

Drug:Interferon gamma-1b ("Actimmune")

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon gamma-1b in Patients with Idiopathic Pulmonary Fibrosis (The INSPIRE Trial)

http://www.clinicaltrials.gov/ct/show/NCT00080223?order=4

InterMune

Idiopathic Pulmonary FibrosisPulmonary Fibrosis

Drug:Pirfenidone

Phase II

Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study

Official Title:An Open-Label, Phase 2 Study of the Safety and Efficacy of Oral Pirfenidone in Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

http://www.clinicaltrials.gov/ct/show/NCT00063583?order=5

Sharma, Kumar, M.D.

The purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. Our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.

Diabetes MellitusDiabetic Nephropathy

Drug:Pirfenidone

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Factorial Assignment,Efficacy Study

Official Title:Pirfenidone: A Novel Anti-Scarring Therapy for Diabetic Nephropathy

http://www.clinicaltrials.gov/ct/show/NCT00040716?order=1

Introgen Therapeutics

Head and Neck Cancer

Drug:Ad5CMV-p53 geneDrug:cisplatinDrug:docetaxelDrug:fluorouracilProcedure:chemotherapyProcedure:gene therapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Cisplatin and Fluorouracil With Versus Without Ad5CMV-p53 Gene Therapy (INGN 201) in Patients With Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck (T302)

http://www.clinicaltrials.gov/ct/show/NCT00040703?order=2

Introgen Therapeutics

Head and Neck Cancer

Drug:Ad5CMV-p53 geneDrug:methotrexateProcedure:chemotherapyProcedure:gene therapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Ad5CMV-p53 Gene Therapy (INGN 201) Versus Methotrexate in Patients With Refractory Squamous Cell Carcinoma of the Head and Neck (T301)

http://www.clinicaltrials.gov/ct/show/NCT00041626?order=3

Introgen Therapeutics

There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy.

Carcinoma, Squamous Cell

Gene Transfer:INGN 201

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00041613?order=4

Introgen Therapeutics

There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) will be compared to methotrexate in patients who have failed surgery, radiotherapy and chemotherapy with platinum or taxanes.

Carcinoma, Squamous Cell

Gene Transfer:INGN 201

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00071552?order=1

IVAX Research

The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.

Asthma

Drug:Beclomethasone dipropionate HFA

Phase IV

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00094016?order=2

IVAX Research

The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in 1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal awakening and utilization of rescue medication per day also will be evaluated. In addition, an exploratory evaluation will assess the comparability of the two devices (i.e., QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.

Asthma

Drug:beclomethasone dipropionate

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Parallel Assignment,Safety/Efficacy Study

Official Title:Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate Asthmatic Children

http://www.clinicaltrials.gov/ct/show/NCT00034814?order=3

IVAX Research

This study is to see if talampanel helps and is safe to use on adults with partial seizures.

Epilepsy

Drug:Talampanel

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00062504?order=4

IVAX Research

Approximately 91 patients with high grade gliomas will be evaluated. The primary objective is to determine if Talampanel can significant delay progression in patient by measuring the number of patient who are progression free at 6 months after dosing.

Glioblastoma MultiformeAnaplastic AstrocytomaAnaplastic OligodendrogliomaAnaplastic Mixed Oligoastrocytoma

Drug:Talampanel

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00071539?order=5

IVAX Research

Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma.

Recurrent Glioblastoma Multiforme

Drug:TP-38

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00003034?order=1

Alfacell

localized malignant mesotheliomaadvanced malignant mesotheliomarecurrent malignant mesothelioma

Drug:doxorubicinDrug:ranpirnaseProcedure:chemotherapy

Phase III

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00006195?order=1

The overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. Undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment.

Schizophrenia

Drug:risperidoneDrug:olanzapine

Study Type:InterventionalStudy Design:Treatment,Open Label

http://www.clinicaltrials.gov/ct/show/NCT00082602?order=2

Janssen Pharmaceutica

The purpose of this study is to evaluate the safety and tolerability of an extended release formulation of the drug galantamine using a rapid dose escalation regimen.

Alzheimer's Disease

Drug:galantamine ER

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety Study

Official Title:Galantamine ER Open Label Rapid Dose Escalation Trial in Alzheimers Disease

http://www.clinicaltrials.gov/ct/show/NCT00086112?order=3

Janssen Pharmaceutica

This is a medical research study using a drug called Risperdal (risperidone) in subjects with Generalized Anxiety Disorder.

Anxiety Disorders

Drug:Risperidone

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind

Official Title:A Double-Blind Study Comparing Adjunctive Risperidone versus Placebo in Generalized Anxiety Disorder that Is Not Responding to Standard Therapy

http://www.clinicaltrials.gov/ct/show/NCT00095134?order=4

Janssen Pharmaceutica

The purpose of this trial is to evaluate the efficacy and safety of risperidone versus placebo in subjects with Major Depressive Disorder with sub-optimal response to antidepressant therapy.

Major Depressive Disorder

Drug:risperidone

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Double-Blind Study Comparing Adjunctive Risperidone versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy

http://www.clinicaltrials.gov/ct/show/NCT00097032?order=5

Janssen Pharmaceutica

The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.

Bipolar Disorder

Drug:risperidoneDrug:quetiapine

Phase IV

Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Double-Blind,Active Control,Crossover Assignment,Safety Study

Official Title:Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients

http://www.clinicaltrials.gov/ct/show/NCT00097708?order=1

Jazz Pharmaceuticals

The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Anxiety Disorder

Drug:experimental anti-anxiety drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder

http://www.clinicaltrials.gov/ct/show/NCT00097695?order=1

Jerini AG

The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).

Angioedema

Drug:Icatibant

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema

http://www.clinicaltrials.gov/ct/show/NCT00078039?order=1

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

The primary objective of the double blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of extended release (ER) OROS paliperidone (6, 9, and 12 mg/day) compared with placebo in subjects with schizophrenia. The efficacy response will be measured by the change in the Positive and Negative Syndrome Scale (PANSS) total score from start of treatment to the end of double blind phase.

Schizophrenia

Drug:Paliperidone

Phase III

Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-blind, Placebo- and Active-controlled Parallel Group Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS Paliperidone (6, 9, and 12mg/day) and Olanzapine (10mg/day) with Open-label Extension in the Treatment of Subjects with Schizophrenia

http://www.clinicaltrials.gov/ct/show/NCT00094926?order=2

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

This is a prospective double-blind, multi-center trial designed to evaluate the efficacy of Risperdal CONSTA as augmentation therapy of treatment-as-usual in adult subjects with frequently relapsing bipolar disorder.

Bipolar Disorder

Drug:Addition of Risperidal CONSTA to treatment-as-usual

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Prospective, Randomized, Double-blind, Placebo-controlled Study of the Effectiveness and Safety of Risperidal CONSTA Augmentation in Adult Patients with Frequently-relapsing Bipolar Disorder

http://www.clinicaltrials.gov/ct/show/NCT00034749?order=3

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Schizophrenia

Drug:Risperidone

Phase III

Study Type:InterventionalStudy Design:Treatment

Study start:April 2001

http://www.clinicaltrials.gov/ct/show/NCT00086684?order=4

ALZA

The purpose of this research study is to test two doses of a drug called ELMIRON (pentosan polysulfate sodium). ELMIRON has been approved by the U.S. FDA for the relief of bladder pain or discomfort associated with interstitial cystitis (IC). You may not be on other medications that could affect your IC symptoms such as antihistamines, antidepressants, anticholingergics, or antispasmodics.

Interstitial Cystitis

Drug:ELMIRONDrug:Placebo

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

Official Title:Multi-center, Randomized, Double-blind, PBO-controlled Parallel Evaluation of the Efficacy and Tolerability of ELMIRON

http://www.clinicaltrials.gov/ct/show/NCT00072670?order=5

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

This is a study to test the safety and effectiveness of an investigational chemotherapy agent in men with advanced prostate cancer. After a subject meets all entry criteria and signs informed consent he will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have PSA levels measured multiple times throughout the study. A detailed explanation can be provided by the investigator conducting this study.

Prostate Cancer

Drug:ET-743 (YONDELIS)

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00083668?order=6

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of ER OROS paliperidone(3, 9, and 15mg/day) compared with placebo in subjects with schizophrenia. The efficacy response will be measured by the change in the Positive and Negative Syndrome Scale (PANSS) total score from start of treatment to the end of the double-blind phase.

Schizophrenia

Drug:Paliperidone

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS Paliperidone (3, 9 and 15 mg/day) and Olanzapine (10mg/day), with Open-Label Extension, in the Treatment of Subjects with Schizophrenia

http://www.clinicaltrials.gov/ct/show/NCT00088075?order=7

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

This clinical study is to evaluate the efficacy, safety and tolerability of 2 doses range of Risperidone (1-3 mg/day, and 4-6 mg/day) versus placebo (an inactive substance like a sugar pill) in adolescents (age 13-17) with Schizophrenia (i.e. abnormal behavior and thoughts). The trial is about 6-7 weeks.

Schizophrenia

Drug:Risperidone

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Risperidone for the Treatment of Schizophrenia in Adolescents

http://www.clinicaltrials.gov/ct/show/NCT00051753?order=8

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media.

Otitis Media

Drug:LevofloxacinDrug:Augmentin ES-600

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study

Official Title:A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have Recurrent and/or Persistent Acute Otitis Media

http://www.clinicaltrials.gov/ct/show/NCT00091910?order=9

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

A randomized trial to determine whether giving epoetin alfa to treat anemia in critically ill patients admitted to ICUs, results in fewer blood transfusions given. A subject's participation in the study will last about 5 months. Subjects will receive up to 3 weekly doses of epoetin alfa or placebo while they are in the hospital. Once discharged from the hospital, subjects will be seen periodically for blood tests and a physical exam.

Anemia

Drug:epoetin alfa

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00085748?order=10

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study. The study consists of a screening phase, a double-blind treatment phase, and an optional open-label treatment phase. For administrative purposes, the screening and the double-blind treatment phases together are named R076477-SCH-302 and the open-label treatment phase is named R076477-SCH-702. The primary objective of the study is to evaluate the safety and tolerability of flexible dosages of Extended Release (ER) OROS paliperidone as compared with placebo in subjects with schizophrenia who are 65 years of age or older. The primary objective of the open-label extension is the long-term assessment of safety and tolerability of ER OROS paliperidone in subjects diagnosed with schizophrenia.

Schizophrenia

Drug:paliperidone

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00091442?order=11

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

This study will evaluate the safety and effectiveness of a combination of doxorubicin HCl liposome injection (DOXIL/CAELYX) and docetaxel in women with recurrent advanced breast cancer who received anthracycline in the adjuvant or neoadjuvant setting. The safety and effectiveness of the combination will be compared to treatment with docetaxel alone (monotherapy). The purpose of this research study is to determine if overall survival for the docetaxel and DOXIL/CAELYX treated group is longer than that for the group treated with docetaxel alone. Additional comparisons between the two treatment groups include: response rate (how much your tumor shrinks in response to the drug), time to progression, safety, and quality of life.

Cancer of Breast

Drug:DOXIL/CAELYXDrug:Docetaxel

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment

Official Title:A Randomized Controlled Study of Docetaxel Monotherapy or DOXIL/CAELYX and Docetaxel for the Treatment of Advanced Breast Cancer

http://www.clinicaltrials.gov/ct/show/NCT00060944?order=12

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

This is a study to test the safety and effectiveness of an investigational chemotherapy agent in subjects with advanced liposarcoma or leiomyosarcoma. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the investigator conducting the study

LiposarcomaLeiomyosarcoma

Drug:ET743 I.V. administration

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Multicenter,Open-label Study of YONDELIS, ET-743 (ecteinascidin) Administered by Two Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment with an Anthracycline and Ifosfamide

http://www.clinicaltrials.gov/ct/show/NCT00086320?order=13

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

The purpose of this study is to determine the efficacy and safety of OROS paliperidone compared with placebo in the prevention of recurrence of symptoms of schizophrenia.

Schizophrenia

Drug:ER OROS Paliperidone

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With An Open-Label Extension Evaluating Extended Release OROS Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia

http://www.clinicaltrials.gov/ct/show/NCT00077727?order=14

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

This is an exploratory study which will evaluate Galantamine in cognitive deficits (learning) in patients with schizophrenia. The trial will last for 8 weeks. Efficacy and safety will be studied. The patients must be on a stable dose of an antipsychotic and smoke cigarettes.

Schizophrenia

Drug:Galantamine ER

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Primary Outcomes:Computerized Cognitve test battery

http://www.clinicaltrials.gov/ct/show/NCT00076115?order=15

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

The purpose of this study is to determine the safety and effectiveness of Risperidone compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

Bipolar Disorder

Drug:Risperidone

Phase III

Study Type:InterventionalStudy Design:Treatment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00093990?order=16

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

This study tests the effectiveness of tipifarnib in older patients with acute myeloid leukemia. In this study, half the patients will receive tipifarnib and the other half of the patients will receive the standard treatment of the hospital.

Myeloid LeukemiaAcute Disease

Procedure:Bone marrow aspirateDrug:Tipifarnib

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:A Randomized Study of Tipifarnib Versus Best Supportive Care (Including Hydroxyurea) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) in Subjects 70 Years or Older (Farnesyl transferase Inhibition Global Human Trials AML 301 [F.I.G.H.T. AML 301])

http://www.clinicaltrials.gov/ct/show/NCT00074997?order=17

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Phase II trial to determine safety and efficacy of an anti-HIV-1 gene transfer product.

HIV Infections

Gene Transfer:OZ1 (anti-HIV-1 gene)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized Phase II, Double-blind, Controlled Trial to Evaluate the Safety and Efficacy of Autologous CD34+ Hematopoietic Progenitor Cells Transduced with Placebo or an Anti-HIV-1 Ribozyme (OZ1) in Patients with HIV-1 Infection

http://www.clinicaltrials.gov/ct/show/NCT00093197?order=1

KAI Pharmaceuticals

Restoring blood flow to coronary arteries as quickly as possible is the best way to reduce the damage to the muscle that occurs with a heart attack. However, up to 25-50% of patients who have angioplasty may have ongoing damage to the heart muscle when the blockage is opened and blood flow is restored. Complications which may result from this ongoing damage include a larger area of damaged muscle in the heart, enlargement of the heart, an increased risk of death, and an increased risk of heart failure. Some of the ongoing damage may involve increased levels of the protein kinase C (PKC) enzyme. KAI-9803 is a selective inhibitor of delta PKC. In this study, delta PKC is used with angioplasty and other standard procedures to restore blood flow after a heart attack. This study is designed to evaluate safety of different amounts of KAI-9803 when used in treating heart attack patients undergoing angioplasty. We will also try to evaluate whether KAI-9803 can reduce the amount of heart muscle damage and the complications that may occur in these patients.

Myocardial Infarction

Drug:KAI-9803 for Injection

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study

Official Title:Intracoronary KAI-9803 for Injection as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Elevation Myocardial Infarction

http://www.clinicaltrials.gov/ct/show/NCT00079638?order=1

Kos Pharmaceuticals

The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.

DyslipidemiaCoronary Heart DiseaseAtherosclerosisStrokeDiabetes

Drug:NiacinDrug:AtorvastatinDrug:SimvastatinDrug:EzetimibeDrug:Rosuvastatin

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:Comparative Efficacy Evaluation of Lipid Levels when Treated with Niaspan and Statin or Other Lipid-Modifying Therapies

http://www.clinicaltrials.gov/ct/show/NCT00071266?order=2

Kos Pharmaceuticals

Intermittent ClaudicationPeripheral Vascular Disease

Drug:Niacin Extended Release and Lovastatin Tablets

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients with Intermittent Claudication a Matrix Design

http://www.clinicaltrials.gov/ct/show/NCT00062556?order=3

Kos Pharmaceuticals

Intermittent ClaudicationPeripheral Vascular Disease

Drug:Niacin Extended Release and Lovastatin Tablets

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:Effect of Niacin ER/Lovastatin on Peak Walking Time in Patients with Intermittent Claudication

http://www.clinicaltrials.gov/ct/show/NCT00080275?order=4

Kos Pharmaceuticals

Coronary Heart DiseaseDyslipidemiaAtherosclerosisHypercholesterolemiaStroke

Drug:Niacin Extended-Release and simvastatinDrug:Zocor (simvastatin)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia (OCEANS)

http://www.clinicaltrials.gov/ct/show/NCT00082251?order=5

Kos Pharmaceuticals

Dyslipidemia

Drug:Niacin extended release and simvastatin

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:The Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study

http://www.clinicaltrials.gov/ct/show/NCT00089804?order=1

La Jolla Pharmaceutical Company

The primary purpose of this study is to determine whether LJP 394 is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.

Lupus Erythematosus, SystemicLupus Nephritis

Drug:abetimus sodium (LJP 394)

Phase IV

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg and 300 mg of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease

http://www.clinicaltrials.gov/ct/show/NCT00070421?order=1

Leap of Faith Technologies

childhood Hodgkin's lymphomachildhood non-Hodgkin's lymphomachildhood solid tumorLeukemiapsychosocial effects and treatment

Procedure:cancer prevention interventionProcedure:complementary and alternative therapyProcedure:complications of therapy assessment/managementProcedure:psychosocial assessment/careProcedure:supportive care/therapy

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I/II Study of @neWorld: A Virtual Community for Pediatric Patients With Cancer

http://www.clinicaltrials.gov/ct/show/NCT00051532?order=1

LEO Pharma

The purpose of the study is to determine whether Seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma).

Liver Neoplasms

Drug:Seocalcitol

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Expanded Access Assignment,Efficacy Study

Official Title:Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients with Hepatocellular Carcinoma not Amenable to Curative Treatment.

http://www.clinicaltrials.gov/ct/show/NCT00051545?order=2

LEO Pharma

To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma.

Liver Neoplasms

Drug:Seocalcitol

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Expanded Access Assignment,Efficacy Study

Official Title:Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5 ug) or Placebo in Prolonging Time to Relapse Following Intended Curative Resection or Percutaneous Ablative Treatment for Hepatocellular Carcinoma.

http://www.clinicaltrials.gov/ct/show/NCT00063076?order=1

M.D. Anderson Cancer Center

The rationale for the use of bexarotene in alopecia areata comes from the drugs' immunomodulatory effects. It has been shown to be effective in inflammatory dermatoses, many of which are known to have T-cell mediated mechanisms. Alopecia areata is an organ-specific autoimmune reaction mediated by perifollicular T lymphocytes that clear upon resolution of disease. Therefore, since bexarotene is able to reduce or clear T-cell from the skin in CTCL lesions, we hypothesize that it may be effective in alopecia areata in eliminating the T-cells around the hair follicles.

Alopecia Areata

Drug:Targretin Gel 1%

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00051025?order=2

Ligand Pharmaceuticals

The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.

Non-Hodgkin's LymphomaLymphoma, B-CellLymphoma, Low-Grade

Drug:ONTAK

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Multicenter, Phase II Evaluation of ONTAK (Denileukin Diftitox) in Patients with Previously Treated, Indolent, B-Cell, Non-Hodgkin's Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00050999?order=3

Ligand Pharmaceuticals

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.

Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Drug:ONTAK

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multicenter Phase III Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 mcg/kg/day) in Cutaneous T-Cell Lymphoma (CTCL) Patients with Stage Ia-III Disease who, following less than or equal to 3 Previous Therapies, have Recurrent or Persistent Disease that has been Biopsy-documented to Express CD25

http://www.clinicaltrials.gov/ct/show/NCT00051012?order=4

Ligand Pharmaceuticals

The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.

Lymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Drug:ONTAK

Phase IV

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Multicenter Open-label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-cell Lymphoma (CTCL) Patients following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or who meet the Requirements for Protocol 93-04-11 except have Biopsy-documented CTCL that does not Express CD25

http://www.clinicaltrials.gov/ct/show/NCT00055146?order=5

Ligand Pharmaceuticals

The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)

Leukemia, Lymphocytic, Chronic

Drug:ONTAK

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients with Previously-Treated Chronic Lymphocytic Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00076687?order=1

Allergan

Stroke

Drug:BOTOX (Botulinum Toxin Type A)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study

Official Title:A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Safety Study of Pulmonary Function in Patients with Reduced Lung Function Treated with BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex for Focal Upper Limb Poststroke Spasticity

http://www.clinicaltrials.gov/ct/show/NCT00025818?order=2

Allergan

A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.

Keratoconjunctivitis SiccaSjogren's SyndromeLupus Erythematosus, SystemicArthritis, RheumatoidScleroderma, Systemic

Drug:Ophthalmic Emulsion

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00068068?order=1

Light Sciences Corporation

The purpose of this study is to determine whether the Litx platform is safe and effective in the treatment of liver metastasis arising from colorectal cancer. Litx is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.

Liver MetastasisColorectal NeoplasmsLiver NeoplasmsNeoplasm Metastasis

Drug:Talaporfin sodium (LS11)Device:LED-based light infusion deviceDevice:Light emitting diodes (LED)Procedure:Photodynamic therapyProcedure:PhototherapyProcedure:Chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Safety and efficacy of treating refractory cancers with the Litx system: Phase II safety and efficacy study in patients with liver metastases from colorectal cancer that have failed chemotherapy

http://www.clinicaltrials.gov/ct/show/NCT00083785?order=2

Light Sciences Corporation

The purpose of this study is to determine whether the Litx system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Litx is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.

Liver MetastasisColorectal NeoplasmsLiver NeoplasmsNeoplasm Metastasis

Drug:Talaporfin sodium (LS11)Device:LED-based light infusion deviceDevice:Light emitting diodes (LED)Procedure:Photodynamic therapyProcedure:PhototherapyProcedure:Chemotherapy

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Safety and effectiveness of treating cancers with the Litx system and chemotherapy. Section A: phase II safety and effectiveness study in patients with liver metastases from colorectal cancer

http://www.clinicaltrials.gov/ct/show/NCT00084331?order=1

Lorus Therapeutics

Stage IV Renal Cell Cancerrecurrent renal cell cancer

Drug:GTI-2040Drug:capecitabineProcedure:antisense therapyProcedure:chemotherapy

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I/II Study of GTI-2040 and Capecitabine in Patients With Advanced or Metastatic Renal Cell Cancer

http://www.clinicaltrials.gov/ct/show/NCT00056173?order=2

Lorus Therapeutics

This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell carcinoma.

Carcinoma, Renal CellMetastases, Neoplasm

Drug:GTI-2040

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)

http://www.clinicaltrials.gov/ct/show/NCT00087776?order=1

Luitpold Pharmaceuticals

The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treament failure will be measured. Toxicity will be evaluated and compared between the two groups.

Malignant Melanoma

Drug:Chemotherapy

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00091377?order=1

Marshall Edwards, Inc

recurrent ovarian epithelial cancerFallopian Tube Cancerperitoneal cavity cancer

Drug:cisplatinDrug:paclitaxelDrug:phenoxodiolProcedure:chemosensitization/potentiationProcedure:chemotherapyProcedure:enzyme inhibitor therapyProcedure:protein tyrosine kinase inhibitor therapy

Phase I

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase I/II Randomized Study of Phenoxodiol Chemosensitization With Cisplatin or Paclitaxel in Patients With Recurrent Late-Stage Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer That is Refractory or Resistant to Platinum and/or Taxane Drugs

http://www.clinicaltrials.gov/ct/show/NCT00080769?order=1

McNeil Consumer & Specialty Pharmaceuticals

lip and oral cavity cancerNasopharyngeal Canceroral complications of chemotherapy and head and neck radiationOropharyngeal Cancer

Drug:benzydamine hydrochlorideProcedure:complications of therapy assessment/managementProcedure:radioprotectionProcedure:supportive care/therapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Benzydamine Hydrochloride for the Treatment of Radiation-Induced Oral Mucositis in Patients With Cancer of the Oral Cavity, Oropharynx, and/or Nasopharynx Undergoing Radiotherapy

http://www.clinicaltrials.gov/ct/show/NCT00051441?order=2

McNeil Consumer & Specialty Pharmaceuticals

Mouth Neoplasms

Drug:Benzydamine Hydrochloride Oral Rinse

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Double-Blind, Randomized, Vehicle-Controlled Study Comparing the Safety and Efficacy of Benzydamine HCl 0.15% Oral Rinse Including a Separate Open-Label Standard of Care Arm in Subjects with Radiation-Induced Mucositis.

http://www.clinicaltrials.gov/ct/show/NCT00083304?order=1

Allos Therapeutics

Breast CancerMetastases

Procedure:Whole brain radiation therapy with supplemental oxygenDrug:RSR13

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase 3, Randomized, Open-label, Comparative Study of Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer

http://www.clinicaltrials.gov/ct/show/NCT00094653?order=1

Medarex

The purpose of this study is to determine the safety and efficacy of MDX-010 (anti-CTLA4) in combination with MDX-1379 in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing IL-2, dacarbazine, and/or temozolamide, have 1) relapsed following an objective response (PR/CR); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

MelanomaMetastases

Drug:MDX-010 (anti-CTLA4) monoclonal antibodyVaccine:MDX-1379 Melanoma Peptide Vaccine

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination with a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients with Previously Treated Unresectable Stage III or IV Melanoma

http://www.clinicaltrials.gov/ct/show/NCT00079859?order=1

Medical Research Laboratories International

The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).

Familial Hypercholesterolemia

Drug:Implitapide

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study

Official Title:Safety and Efficacy Study of Implitapide Compared with Placebo in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy

http://www.clinicaltrials.gov/ct/show/NCT00079846?order=2

Medical Research Laboratories International

The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Familial Hypercholesterolemia

Drug:Implitapide

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study

Official Title:Safety and Efficacy Study of Implitapide Compared with Placebo in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy

http://www.clinicaltrials.gov/ct/show/NCT00080132?order=3

Medical Research Laboratories International

The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.

Hypertriglyceridemia

Drug:implitapide

Phase II

Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study

Official Title:An Open-label, Dose-escalating Efficacy and Safety Study of Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy

http://www.clinicaltrials.gov/ct/show/NCT00079508?order=1

The Medicines Company

The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary bypass (CPB), Angiomax is a safe and effective anticoagulant.

Cardiovascular DiseaseCoronary Artery Bypass Surgery

Drug:Angiomax (bivalirudin)

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase III Study of Angiomax (bivalirudin) in Patients with HIT/HITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)

http://www.clinicaltrials.gov/ct/show/NCT00073580?order=2

The Medicines Company

The purpose of this study is to examine the safety and efficacy of Angiomax as an anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass (OPCAB) surgery.

ThrombocytopeniaThrombosisCardiac DiseaseCoronary Artery Bypass Surgery

Drug:Angiomax (bivalirudin) anticoagulant

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

Official Title:Angiomax in Patients with HIT/HITTS Type II Undergoing Off-PUMP CABG

http://www.clinicaltrials.gov/ct/show/NCT00093184?order=3

The Medicines Company

The purpose of this study is to demonstrate the benefit of bivalirudin in combination with clopidogrel with provisional GPIIb/IIIa inhibitor use, in reducing the bleeding complications associated with early invasive management of patients presenting with an ST Elevation Myocardial Infarction (STEMI) and undergoing primary PCI, while providing similar rates of ischemic events when compared to published results of relevant trials.

Myocardial Infarction

Drug:Angiomax (bivalirudin) anticoagulant

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Study Evaluating the Safety and Efficacy of Bivalirudin in the Management of Patients with ST-Segment Elevation Acute Myocardial Infarction Undergoing Primary PCI (BIAMI)

http://www.clinicaltrials.gov/ct/show/NCT00093912?order=4

The Medicines Company

The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension.

Hypertension

Drug:Clevelox (clevidipine)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study

Official Title:Evaluation of Clevelox in the Perioperative Treatment of Hypertension Assessing Safety Events (with Sodium Nitroprusside as Active Comparator) (ECLISPE-SNP)

http://www.clinicaltrials.gov/ct/show/NCT00093925?order=5

The Medicines Company

The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension.

Hypertension

Drug:Clevelox (clevidipine)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study

Official Title:Evaluation of Clevelox in the Postoperative Treatment of Hypertension Assessing Safety Events (with nicardipine as Active comparator) (ECLIPSE-NIC)

http://www.clinicaltrials.gov/ct/show/NCT00093886?order=6

The Medicines Company

The purpose of this study is to establish the safety of clevidipine in the treatment of preoperative hypertension.

Hypertension

Drug:Clevelox (clevidipine)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety Study

Official Title:Evaluation of Clevelox in the Preoperative Treatment of Hypertension Assessing Safety Events (with Nitroglycerin as Active Comparator) (ECLIPSE-NTG)

http://www.clinicaltrials.gov/ct/show/NCT00079586?order=7

The Medicines Company

The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.

Cardiovascular DiseaseCoronary Artery Bypass Surgery

Drug:Angiomax (bivalirudin)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Study Comparing Angiomax (bivalirudin) to Heparin with Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)

http://www.clinicaltrials.gov/ct/show/NCT00093158?order=8

The Medicines Company

Unstable AnginaMyocardial InfarctionAcute Disease

Drug:Angiomax (bivalirudin) anticoagulant

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:The ACUITY Trial: A Randomized Comparison of Angiomax (bivalirudin) versus Heparin (unfractionated heparin or enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary Syndromes without ST-Segment Elevation

http://www.clinicaltrials.gov/ct/show/NCT00043277?order=9

The Medicines Company

Thrombosis

Drug:Angiomax (bivalirudin)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

Official Title:Pilot Dose Finding And Efficacy Study Of Angiomax (bivalirudin) As Primary Anticoagulation In Infants Under Six Months With Thrombosis

http://www.clinicaltrials.gov/ct/show/NCT00093262?order=10

The Medicines Company

The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating postoperative hypertension.

Hypertension

Drug:Clevelox (clevidipine)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

Official Title:Efficacy Study of Clevidipine (Clevelox) Assessing its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

http://www.clinicaltrials.gov/ct/show/NCT00093249?order=11

The Medicines Company

The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension.

Hypertension

Drug:Clevelox (clevidipine)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

Official Title:Efficacy Study of Clevidipine (Clevelox) Assessing its Preoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-1)

http://www.clinicaltrials.gov/ct/show/NCT00072930?order=1

MedImmune, Inc.

Prostate Cancer

Drug:MEDI-522Drug:DocetaxelDrug:PrednisoneDrug:Zoledronic acid

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label

Official Title:Phase II, Randomized, Open-Label, Two-Arm, Multicenter Study of MEDI-522, a HuMA Directed Against the Human Alpha V Beta 3 Integrin, in Combination with Docetaxel, Prednisone, and Zoledronic Acid in the Treatment of Patients with Metastatic Androgen-Independent Prostate Cancer

http://www.clinicaltrials.gov/ct/show/NCT00086099?order=2

MedImmune, Inc.

LeukemiaAcute Myeloid Leukemia

Drug:Ethyol

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label

Official Title:A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol) will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination with Cytosine Arabinoside in Older Patients with Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00081315?order=3

MedImmune, Inc.

The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy.

EsophagitisPneumonitisNon-small cell lung cancer

Drug:Amifostine

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind

Official Title:Phase II, Randomized, Double-Blind, Multicenter Trial of Subcutaneous Amifostine (Ethyol) versus Placebo in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients with Unresectable Non-Small Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00064649?order=1

The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.

Benign Prostatic Hyperplasia

Device:Transurethral Microwave Thermotherapy (TUMT)Device:Transurethral Needle Ablation (TUNA) TherapyDrug:Finasteride and Alfuzosin

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study

Official Title:Minimally Invasive Surgical Therapy for BPH

http://www.clinicaltrials.gov/ct/show/NCT00095095?order=1

Medtronic Bakken Research Center

Lumbar spinal fusion is commonly performed as a last resort in patients with chronic low back pain caused by degenerative changes and instability of the spine. The aim of this study is to compare two fusion devices, which are used in spinal surgery in order to promote the fusion of two lumbar vertebrae.

Low Back PainSpondylolisthesisSpinal StenosisIntervertebral Disc Displacement

Device:Posterior Lumber Interbody Fusion

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Single Blind,Uncontrolled,Parallel Assignment,Safety/Efficacy Study

Official Title:Lumbar Interbody Fusion Using The Telamon Peek Versus The Telamon Hydrosorb Fusion Device - A Prospective, Randomized Controlled Trial To Assess Surgical And Clinical Outcomes

http://www.clinicaltrials.gov/ct/show/NCT00090246?order=1

Merck

The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

Postoperative Nausea and Vomiting

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, to Examine the Safety, Tolerability, and Efficacy of 2 doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting

http://www.clinicaltrials.gov/ct/show/NCT00094627?order=2

Merck

The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.

Primary Insomnia

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment

http://www.clinicaltrials.gov/ct/show/NCT00083343?order=3

Merck

Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.

Candidiasis

Drug:Caspofungin

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00090168?order=4

Merck

A 6-week treatment study to compare the reduction in cholesterol of two investigational drugs for high cholesterol, in patients with hypercholesterolemia and atherosclerotic or coronary vascular disease.

HypercholesterolemiaAtherosclerotic DiseaseCoronary Disease

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multicenter Study to Assess the Cholesterol Lowering Level of Switching to an Investigational Drug Compared to Doubling the Dose of an Investigational Drug in Patients with Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease

http://www.clinicaltrials.gov/ct/show/NCT00082524?order=5

Merck

This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 2-17 years).

AspergillosisCandidiasis

Phase II

Study Type:InterventionalStudy Design:Treatment,Open Label,Uncontrolled,Single Group Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00095069?order=6

Merck

The purpose of this trial is to study the safety and effectiveness of an investigational medication for adults with insomnia.

Insomnia

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Research Study to Evaluate the Efficacy and Safety of an Investigational Drug for Insomnia in Adults

http://www.clinicaltrials.gov/ct/show/NCT00094666?order=7

Merck

The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.

Primary Insomnia

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment

http://www.clinicaltrials.gov/ct/show/NCT00080444?order=8

Merck

The purpose of this study is to demonstrate that this investigational drug prevents nausea and vomiting caused by cisplatin cancer chemotherapy in adolescent patients.

Vomiting

Phase IV

Study Type:InterventionalStudy Design:Prevention,Randomized,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00095056?order=9

Merck

The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).

Diabetes Mellitus, Type 2Chronic Renal Insufficiency

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized

Official Title:A Study with an Investigational Drug in Patients with Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

http://www.clinicaltrials.gov/ct/show/NCT00093106?order=10

Merck

The purpose of this study is to evaluate the cholesterol lowering efficacy of an investigational drug in patients with Type II diabetes (high blood sugar).

HypercholesterolemiaDiabetes Mellitus, Type II

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00094757?order=11

Merck

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes).

Diabetes Mellitus, Type 2

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00094770?order=12

Merck

The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

Diabetes Mellitus, Type 2

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00092898?order=13

Merck

This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.

Lipid Metabolism, Inborn ErrorsHeart Disease

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment

http://www.clinicaltrials.gov/ct/show/NCT00076973?order=14

Merck

The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.

Bronchiolitis

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00097929?order=15

Merck

A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.

B-Cell Lymphoma

Drug:Suberoylanilide Hydroxamic Acid (SAHA)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00082537?order=16

Merck

This study is a double-blind, randomized study of the investigational agent versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

NeutropeniaFever

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Single Group Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00095576?order=17

Merck

This study will test the safety and efficacy of an investigational HIV vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.

AIDSHIV Infections

Vaccine:Investigational vaccine

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00092989?order=18

Merck

The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug in addition to approved standard treatment.

Asthma

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00090285?order=19

Merck

Condylomata Acuminata

Vaccine:investigational vaccine

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

Official Title:A Study to Evaluate the Efficacy of an Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

http://www.clinicaltrials.gov/ct/show/NCT00064649?order=20

The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.

Benign Prostatic Hyperplasia

Device:Transurethral Microwave Thermotherapy (TUMT)Device:Transurethral Needle Ablation (TUNA) TherapyDrug:Finasteride and Alfuzosin

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Safety/Efficacy Study

Official Title:Minimally Invasive Surgical Therapy for BPH

http://www.clinicaltrials.gov/ct/show/NCT00087516?order=21

Merck

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Diabetes Mellitus, Type 2

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00090259?order=22

Merck

A multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.

Heart Failure

Phase IV

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00091559?order=23

Merck

A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.

Cutaneous T-Cell LymphomaSezary SyndromeMycosis Fungoides

Drug:Suberoylanilide Hydroxamic Acid (SAHA)

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00080171?order=24

Knee osteoarthritis (OA) is the most common cause of disability in adults. The "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA.

OsteoarthritisKnee Osteoarthritis

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

http://www.clinicaltrials.gov/ct/show/NCT00007657?order=25

PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the combined endpoint of all-cause mortality or nonfatal MI.

Myocardial Ischemia

Procedure:Intensive medical therapyProcedure:Percutaneous Coronary Intervention

Phase III

Study Type:InterventionalStudy Design:Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study

Official Title:Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

http://www.clinicaltrials.gov/ct/show/NCT00086502?order=26

Merck

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Diabetes Mellitus, Type 2

Phase II

Study Type:InterventionalStudy Design:Treatment

http://www.clinicaltrials.gov/ct/show/NCT00095017?order=27

Merck

The purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study.

Bone Neoplasms

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Study to Assess the Safety and Efficacy of an Investigational Drug versus Placebo in the Treatment of Cancer Pain

http://www.clinicaltrials.gov/ct/show/NCT00095043?order=28

Merck

The purpose of this trial is to study the safety of an investigational drug on insomnia in the elderly.

Insomnia

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Research Study to Evaluate the Safety of an Investigational Study Drug for Insomnia in the Elderly

http://www.clinicaltrials.gov/ct/show/NCT00090272?order=29

Merck

The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.

Colorectal Surgery

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection following Colorectal Surgery as Compared to a Marketed Drug Approved for this Indication

http://www.clinicaltrials.gov/ct/show/NCT00092053?order=30

Merck

The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis.

Postmenopausal Osteoporosis

Phase II

Study Type:InterventionalStudy Design:Randomized,Double-Blind,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00093899?order=31

Merck

The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

HyperlipidemiaHypercholesterolemiaHypertriglyceridemia

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00090220?order=32

Merck

This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus infection and disease (external genital warts and vulvar, vaginal, and cervical cancer) in women.

Healthy

Vaccine:Investigational Vaccine

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00095004?order=33

Merck

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.

Migraine

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00097838?order=1

Alphavax

The purpose of this study is to evaluate the safety of and immune response to an alphavirus replicon, HIV-1 subtype C gag vaccine, AVX101, in HIV uninfected adults in the United States, South Africa, and Botswana.

HIV Infections

Vaccine:AVX101

Phase I

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study

Official Title:A Phase I, Dose Escalation, Safety, and Immunogenicity Trial of an Alphavirus Replicon HIV-1 Subtype C gag Vaccine (AVX101) in Healthy HIV-1 Uninfected Adult Participants

http://www.clinicaltrials.gov/ct/show/NCT00093964?order=1

EMD Pharmaceuticals

Glioblastoma Multiforme

Drug:EMD 121974

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Multicenter, Open-label, Randomized, Uncontrolled, Phase IIa Trial in Subjects with Recurrent Glioblastoma Multiforme to Investigate the Clinical Activity, Safety, and Tolerability of EMD 121974 Administered as a Single Agent in Doses of 500 mg and 2000 mg

http://www.clinicaltrials.gov/ct/show/NCT00073541?order=2

EMD Pharmaceuticals

EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.

Ovarian Cancer

Drug:EMD 72000

Phase II

Study Type:InterventionalStudy Design:Treatment,Open Label,Safety/Efficacy Study

Official Title:An Open-Label Phase II Study in Subjects with Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent

http://www.clinicaltrials.gov/ct/show/NCT00073736?order=1

Metabasis Therapeutics

Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for this study is to determine the safety and tolerability of MB07133.

Hepatocellular Carcinoma

Drug:MB07133

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:A Phase 1/2 Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MB07133 in Subjects with Unresectable Hepatocellular Carcinoma and Child-Pugh Class A Liver Function

http://www.clinicaltrials.gov/ct/show/NCT00073177?order=1

Pfizer

This study is to evaluate the efficacy and safety of an oral investigational drug in patients with stable asthma. Patient will be withdrawn from their current controller medication and enter a run-in phase. Throughout the study patients will have supplies of rescue medication (inhaled albuterol/salbutamol). After completion of the run-in phase, patients will be re-evaluated and those who meet all entry criteria will be randomized at a 1:1:1 ratio to receive either, the investigational drug at 250 mcg, 500 mcg or placebo daily. During the 24-week double-blind treatment period patients will be evaluated in the morning at the investigators clinic at weeks 2, 4, 8, 12, 18, and 24. At each clinic visit, patients will complete relevant questionnaires, undergo spirometry, review of electronic diaries, and complete laboratory procedures.

Asthma

Drug:Investigational New Drug

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00076076?order=2

ALTANA Pharma

The purpose of this study is to determine whether roflumilast is effective in the treatment of asthma.

Asthma

Drug:Roflumilast

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:FLASH Study: A 24 week randomized, controlled study of roflumilast versus placebo in patients with asthma

http://www.clinicaltrials.gov/ct/show/NCT00076089?order=3

ALTANA Pharma

The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Chronic Obstructive Pulmonary Disease

Drug:Roflumilast

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00074906?order=4

ALTANA Pharma

Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment

Pneumonia

Drug:lusupultide

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

Official Title:Venticute in Patients with Pneumonia or Aspiration of Gastric Contents Leading to Intubation, Ventilation, and Severe Oxygenation Impairment: A randomized, multinational, multicenter, parallel group, double blind, control group study

http://www.clinicaltrials.gov/ct/show/NCT00044226?order=1

Milkhaus Laboratory

Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH. Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study.

Prostatic Hyperplasia

Drug:ML-04A

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical trial to Evaluate the Efficacy and Safety of Two Dosing Regimens of ML-04A in Subjects with Symptomatic Benign Prostatic Hyperplasia

http://www.clinicaltrials.gov/ct/show/NCT00084851?order=1

Millennium Pharmaceuticals

recurrent mantle cell lymphoma

Drug:bortezomibProcedure:enzyme inhibitor therapy

Phase II

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase II Study of Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00089895?order=2

Millennium Pharmaceuticals

The purpose of this study is to see if early INTEGRILIN (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention compared to placebo.

Myocardial Ischemia

Drug:eptifibatide

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Early Glycoprotein IIb/IIIa Inhibition : A Randomized, Placebo-Controlled Trial Evaluating the Clinical Benefits of Early Front-loaded Eptifibatide in the Treatment of Patients with Non-ST-segment Elevation Acute Coronary Syndrome

http://www.clinicaltrials.gov/ct/show/NCT00070837?order=3

Millennium Pharmaceuticals

The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up, broken down and eliminated by the body.

Prostatic Neoplasms

Drug:MLN2704 (DM1 conjugated monoclonal antibody MLN591)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 (DM1 conjugated monoclonal antibody MLN591) in Subjects with Metastatic Androgen-Independent Prostate Cancer

http://www.clinicaltrials.gov/ct/show/NCT00052000?order=4

Millennium Pharmaceuticals

This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis.

Prostate Cancer

Drug:MLN2704 (DM1 conjugated monoclonal antibody MLN591)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase 1 Single Ascending Dose Trial of MLN2704 (DM1 conjugated monoclonal antibody MLN591) in Subjects with Metastatic Androgen Independent Prostate Cancer

http://www.clinicaltrials.gov/ct/show/NCT00059618?order=5

M.D. Anderson Cancer Center

The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.

Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer

Drug:PS-341 and Carboplatin

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Expanded Access Assignment,Safety/Efficacy Study

Official Title:A Phase I Study Evaluating the Safety and Tolerability of PS-341 and Carboplatin in Patients with Platinum- and Taxane-Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer

http://www.clinicaltrials.gov/ct/show/NCT00080405?order=6

Millennium Pharmaceuticals

The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to participate in the pharmacogenetic portion of the study, an additional blood sample will be collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug metabolizing enzymes.

Multiple Myeloma

Drug:Bortezomib

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Single Group Assignment,Pharmacokinetics/Dynamics Study

http://www.clinicaltrials.gov/ct/show/NCT00064584?order=7

Millennium Pharmaceuticals

This is the first study of the drug CT53518 when given to humans. The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug. The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body. Additionally, the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood, known as a blast.

Acute Myelogenous LeukemiaMyelodysplastic Syndrome

Drug:CT53518

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety Study

Official Title:Tolerability and PK/PD of Multiple Oral Doses of CT53518 in Patients with Acute Myelogenous Leukemia

http://www.clinicaltrials.gov/ct/show/NCT00083460?order=8

University of Arkansas

The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination.

Multiple Myeloma

Drug:PS-341Drug:ThalidomideDrug:Dexamethasone

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma

http://www.clinicaltrials.gov/ct/show/NCT00063726?order=9

Millennium Pharmaceuticals

The purpose of this study is to allow patients to receive VELCADE (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.

Multiple Myeloma

Drug:bortezomib

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Single Group Assignment,Safety/Efficacy Study

Official Title:An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039

http://www.clinicaltrials.gov/ct/show/NCT00081939?order=10

University of Arkansas

Multiple Myeloma

Drug:VelcadeDrug:Thalidomide

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Efficacy Study

Official Title:A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) Co-Targeting Bortezomib into Tandem Melphalan-Based Autotransplants with DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance

http://www.clinicaltrials.gov/ct/show/NCT00063713?order=11

Millennium Pharmaceuticals

The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.

Mantle Cell Lymphoma

Drug:VELCADE TM (bortezomib) for Injection

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase 2 Study of VELCADE in Subjects with Relapsed or Refractory Mantle Cell Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00085696?order=12

Millennium Pharmaceuticals

The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.

B-Cell LymphomaFollicular LymphomaMarginal Lymphoma

Drug:VELCADE and rituximab

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase 2 Study of VELCADE (bortezomib) with Rituximab in Subjects with Relapsed or Refractory Indolent B-Cell Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00059657?order=1

Mitsubishi Pharma Corporation

Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease(PAD);This trial is designed to assess the efficacy and safety of the drug in the treatment of CLI.

Critical Limb Ischemia due to peripheral arterial disease

Drug:Ecraprost in lipid emulsion

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A double-blind, randomized, placebo-controlled study to assess the efficacy and safety of CirculaseTM in conjunction with peripheral revascularization for the treatment of critical leg ischemia

http://www.clinicaltrials.gov/ct/show/NCT00078013?order=2

Mitsubishi Pharma Corporation

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary objectives of this study are to examine the safety, tolerability, and efficacy of intravenous MCC-135 in limiting final infarct size, as measured by single photon emission computed tomography (SPECT), in patients who require percutaneous coronary intervention (PCI) for a first-documented ST-segment elevation acute myocardial infarction (AMI).

Myocardial Infarction

Drug:MCC-135

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Examine the Safety and Efficacy of Intravenous MCC-135 as an Adjunct to Standard Therapy with Primary PCI in Patients Diagnosed as Having an ST Elevation Acute Myocardial Infarction

http://www.clinicaltrials.gov/ct/show/NCT00091598?order=1

Myogen

The primary objective is to determine the effect of ambrisentan on exercise capacity in subjects with PAH.

Pulmonary Hypertension

Drug:Ambrisentan

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Dose Comparison,Parallel Assignment,Safety/Efficacy Study

Official Title:ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension

http://www.clinicaltrials.gov/ct/show/NCT00077948?order=2

Myogen

Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.

Heart Failure, Congestive

Drug:enoximone plus metoprolol succinateDrug:metoprolol succinate alone

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase III, Randomized, Double-Blind, Double Placebo-Controlled, Multicenter, Three Parallel Group Study of Enoximone Plus Extended-Release Metoprolol Succinate in Advanced CHF Subjects Previously Intolerant to Beta-Blocker Treatment

http://www.clinicaltrials.gov/ct/show/NCT00063089?order=1

Nabi Biopharmaceuticals

Altastaph has been developed to help the removal of S. aureus from the bloodstream. The main objective of this study will be to test the safety and behavior of Altastaph in patients with S.aureus bacteremia and continuing fever

Staphylococcal Infections

Drug:S. aureus Immune Globulin Intravenous (Human) 5%

Phase I

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study

Official Title:Initial Safety and Pharmacokinetics trial of Immune Globulin to Staphylococcus aureus Capsule Polysaccharide (Altastaph) in subjects with S. aureus Bacteremia and Persistent Fever

http://www.clinicaltrials.gov/ct/show/NCT00066989?order=2

Nabi Biopharmaceuticals

The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.

Staphylococcal Infections

Drug:Staphylococcus aureus Immune Globulin (Human) 5%

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety Study

Official Title:A Double Blind, Randomized, Multicenter Stratified Study to Assess the Safety of an Intravenous Staphylococcus aureus Immune Globulin (Human) [Altastaph] in Low-Birth-Weight-Neonates

http://www.clinicaltrials.gov/ct/show/NCT00071214?order=3

Nabi Biopharmaceuticals

Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus

Staphylococcal InfectionsKidney Failure, Chronic

Vaccine:S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine

Phase III

Study Type:InterventionalStudy Design:Prevention,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Efficacy Study

Official Title:A phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus aureus Glycoconjugate Vaccine in Adults on Hemodialysis

http://www.clinicaltrials.gov/ct/show/NCT00089427?order=1

Neopharm

This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery (CED) to the area around the tumor site after the tumor is surgically removed (resection). In addition, the patient will receive radiation therapy and may or may not be treated with oral temozolomide.

Glioblastoma MultiformeAnaplastic AstrocytomaOligoastrocytoma

Drug:IL13-PE38QQRProcedure:Surgery for placementProcedure:Radiation therapyDrug:Temozolomide with radiation therapy

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study

Official Title:Phase I Study of Convection Enhanced Delivery (CED) of IL13-PE38QQR Infusion After Resection Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma

http://www.clinicaltrials.gov/ct/show/NCT00046540?order=2

Neopharm

Neoplasms

Drug:Liposome-encapsulated SN38

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

http://www.clinicaltrials.gov/ct/show/NCT00080418?order=3

Neopharm

The purpose of this study is to determine the highest dose of Liposome Entrapped Paclitaxel Easy to Use formulation (LEP-ETU) that can be safely administered by an intravenous infusion to patients with advanced cancer.

Neoplasm

Drug:Liposome Entrapped Paclitaxel Easy to Use

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety Study

Official Title:Phase I Study of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) Formulation in Patients with Advanced Cancer

http://www.clinicaltrials.gov/ct/show/NCT00076986?order=4

Neopharm

The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme.

Glioblastoma Multiforme

Drug:IL13-PE38QQRProcedure:surgery and catheter placement (2 procedures)Drug:prolifespan 20 with carmustine implant (GLIADEL Wafer)Procedure:surgery and wafer placement (1 procedure)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study

Official Title:PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL Wafer with Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence

http://www.clinicaltrials.gov/ct/show/NCT00087542?order=1

ACADIA Pharmaceuticals Inc.

The primary objective is to demonstrate that the investigational new drug, ACP-103, is well tolerated by, and will not worsen parkinsonism in, patients with Parkinson's disease and psychosis. The secondary objectives are to determine whether ACP-103 will ameliorate psychosis in patients with Parkinson's disease and whether ACP-103 is safe in Parkinson's disease patients taking multiple anti-parkinsonian medications.

HallucinationsPsychosesParkinson's Disease

Drug:ACP-103

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00083564?order=1

NeoRx Corporation

The phase III study of STR (Skeletal Targeted Radiotherapy) is a multi-center, randomized, controlled study, designed to evaluate the safety and efficacy of STR in patients with primary refractory multiple myeloma. These are patients who have failed to achieve at least a partial response to conventional therapy and have been undergoing treatment for less than 18 months. The trial is expected to enroll approximately 240 evaluable patients, half on the experimental arm and half on the control arm. Patients on the experimental arm will receive STR at a dose of 750 mCi/m2 plus the chemotherapy drug melphalan at 200 mg/m2, followed by autologous (self-donor) stem cell transplantation. Patients on the control arm will receive melphalan only, followed by transplantation. Patients on both study arms will be evaluated for response to treatment six months after transplantation, using an immunofixation assay to detect myeloma protein in patient samples. Analysis of patient samples will be conducted at a central laboratory, and blinded results will be reviewed by an independent panel of experts. The studys primary endpoint is complete response, as determined by the complete disappearance of myeloma protein at six months post-transplant.

Multiple Myeloma

Drug:STR(TM) (Skeletal Targeted Radiotherapy, Holmium-166-DOTMP)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized Multicenter Study to Compare the Safety and Efficacy of 166Ho-DOTMP plus Melphalan to Melphalan Alone as Conditioning for Autologous Peripheral Blood Stem Cell Transplant in Subjects with Primary Refractory Multiple Myeloma

http://www.clinicaltrials.gov/ct/show/NCT00041795?order=1

NeoTherapeutics

This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.

Peripheral Nervous System DiseasesChemotherapy-Induced Peripheral Neuropathy

Drug:leteprinim potassium (Neotrofin)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients with Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer

http://www.clinicaltrials.gov/ct/show/NCT00088166?order=1

Neurobiological Technologies

Brain EdemaBrain Tumor

Drug:XERECEPT (corticorelin acetate)

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study

Official Title:A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated with Peritumoral Brain Edema in Patients with Malignant Brain Tumor who Require Chronic Administration of High-Dose Dexamethasone

http://www.clinicaltrials.gov/ct/show/NCT00091013?order=2

Neurobiological Technologies

adult brain tumorbrain metastasesCerebral Edema

Drug:dexamethasoneDrug:human corticotropin-releasing factorProcedure:cerebral edema managementProcedure:endocrine therapyProcedure:hormone therapyProcedure:steroid therapyProcedure:supportive care/therapy

Phase III

Study Type:InterventionalStudy Design:Treatment

Official Title:Phase III Randomized Study of Human Corticotropin-Releasing Factor to Control Symptoms Associated With Peritumoral Edema in Patients With Malignant Brain Tumors Requiring Chronic Administration of High-Dose Dexamethasone

http://www.clinicaltrials.gov/ct/show/NCT00088673?order=1

Neurochem Inc.

The purpose of this Phase III study is to evaluate the efficacy and safety of Alzhemed compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimers disease.

Alzheimer Disease

Drug:Alzhemed

Phase III

Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase III Study of the Efficacy and Safety of Alzhemed in Patients with Mild to Moderate Alzheimers Disease

http://www.clinicaltrials.gov/ct/show/NCT00079495?order=1

Neurocrine Biosciences

Multiple Sclerosis

Drug:NBI-5788

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients with Relapsing Multiple Sclerosis

http://www.clinicaltrials.gov/ct/show/NCT00085761?order=1

NeurogesX

The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.

HIV InfectionsPeripheral Nervous System DiseasesPain

Drug:Capsaicin Dermal Patch

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Safety/Efficacy Study

Official Title:An International, Multicenter, Randomized, Double-blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy

http://www.clinicaltrials.gov/ct/show/NCT00079781?order=1

NeuroPace

The purpose of the Responsive Neurostimulator (RNS) system feasibility clinical investigation is to demonstrate safety, and to provide evidence of efficacy of the NeuroPace RNS system in reducing the number of seizures in patients having medically refractory epilepsy.

Epilepsy

Device:Responsive Neurostimulator

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Responsive Neurostimulator (RNS) System Feasibility Clinical Investigation

http://www.clinicaltrials.gov/ct/show/NCT00090480?order=1

NewLink Genetics Corporation

Breast Cancer

Vaccine:HyperAcute - Breast cancer vaccine

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase I/II Study of an Antitumor Vaccination Using alpha(1,3)Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients with Relapsed or Refractory Breast Cancer

http://www.clinicaltrials.gov/ct/show/NCT00089713?order=1

Alteon Inc.

This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).

Hypertension

Drug:alagebrium chloride (ALT-711)

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Effect of ALT-711 in Combination With Fixed-Dose Hydrochlorothiazide Therapy on Systolic Blood Pressure in Hypertensive Patients

http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1

Northfield Laboratories

This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.

Hemorrhagic Shock

Drug:Poly SFH-P Injection

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Parallel Assignment,Safety/Efficacy Study

Official Title:A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception from Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting

http://www.clinicaltrials.gov/ct/show/NCT00090727?order=1

Novacea

Solid MalignanciesNon-Hodgkin's Lymphoma

Drug:AQ4N

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Parallel Assignment,Safety Study

Official Title:A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients with Advanced Malignancies

http://www.clinicaltrials.gov/ct/show/NCT00066885?order=2

Novacea

This Phase 1/2 clinical trial is a multi-center, open-label study with two main objectives. The first is to determine the maximum-tolerated dose of DN-101 when administered in combination with Taxotere (docetaxel) every three weeks. The second is to evaluate the safety and objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose level each 21 days until disease progression or unacceptable toxicity.

Carcinoma, Non-Small-Cell Lung

Drug:calcitriol + docetaxel

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Dose Comparison,Single Group Assignment,Safety/Efficacy Study

Official Title:A Phase 1/2 Multicenter, Open Label, Dose Ranging Study of DN-101 and Taxotere in Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) who Have Failed Previous Therapy with Platinum-Based Chemotherapy

http://www.clinicaltrials.gov/ct/show/NCT00097864?order=1

Novartis Pharmaceuticals

A study of two drugs, Lotrel (amlodipine/benazepril) and benazepril/HCTZ, for effectiveness in reducing heart disease and deaths from heart attacks.

Heart Disease

Drug:Lotrel (benazepril/amlodipine)Drug:benazepril plus hydrochlorothiazide

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Comparison of the Safety and Effectiveness of Lotrel and Benazapril+HCTZ in Reducing Heart Disease and Heart Attacks

http://www.clinicaltrials.gov/ct/show/NCT00063479?order=2

Novartis Pharmaceuticals

The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

Osteogenesis Imperfecta

Drug:Zoledronic Acid

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00098735?order=3

Novartis Pharmaceuticals

In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.

Kidney Transplantation

Drug:FTY720

Phase III

Study Type:InterventionalStudy Design:Diagnostic,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Primary Outcomes:To compare efficacy of FTY720 in combination with two other drugs vs. a marketed drug to prevent rejection.

http://www.clinicaltrials.gov/ct/show/NCT00079937?order=4

Novartis Pharmaceuticals

This study will look at data collected over 1 year to determine the effectiveness of omalizumab (Xolair) in controlling moderate-to-severe allergic asthma in children 6 to 12 years of age whose asthma is persistent and not well controlled. This study will also evaluate the safety of this treatment in terms of side effects and other clinical and laboratory measures.

Asthma

Drug:Omalizumab

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00097825?order=5

Novartis Pharmaceuticals

The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.

Osteoporosis

Drug:Zoledronic Acid

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

Primary Outcomes:Change in Bone Mineral Density

http://www.clinicaltrials.gov/ct/show/NCT00088127?order=6

Novartis Pharmaceuticals

This study will investigate the effect of EPO906 given once every 3 weeks to patients with advanced non-small cell lung cancer.

Non-small cell lung cancerNSCLC

Drug:CEPO906A

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

Official Title:An Open Label, Phase I/II Dose Escalating Study Evaluating the Safety and Efficacy of EPO906 q3w in Patients with Non-Small-Cell Lung Cancer

http://www.clinicaltrials.gov/ct/show/NCT00098046?order=7

Novartis Pharmaceuticals

Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of Famvir in children 1-12 years of age.

ChickenpoxHerpes Zoster

Drug:famciclovir (Famvir)

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:Pharmacokinetics and Safety of Famciclovir (Famvir) Oral Pediatric Formulation in Children 1-12 Years of Age with Varicella Zoster Infection

http://www.clinicaltrials.gov/ct/show/NCT00098059?order=8

Novartis Pharmaceuticals

Herpes simplex virus causes cold sores (fever blisters) and can lead to painful lesions in the mouth in healthy children. Children with impaired immune systems might develop severe complications. Famvir (famciclovir) is a drug approved to treat herpes simplex and varicella zoster infection in adults. This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age.

Herpes Simplex

Drug:Famvir (famciclovir)

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety Study

Official Title:Pharmacokinetics and Safety of Famvir (famciclovir) Pediatric Formulation in Children 1-12 Years of Age with Herpes Simplex Infection

http://www.clinicaltrials.gov/ct/show/NCT00081926?order=9

Novartis Pharmaceuticals

This study will evaluate the molecular response to high dose Gleevec in newly diagnosed patients with Chronic myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate the ability of Gleevec to reduce the amount of abnormal protein that occurs in patients with CML. Patients who are eligible to participate will be treated for 18 months. This trial will include male or female patients 18 years or older who are newly diagnosed (within 6 months) with CML.

Chronic Myelogenous Leukemia

Drug:Gleevec

Phase IV

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Historical Control,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00051636?order=10

Novartis Pharmaceuticals

HORIZON TOP will study the effect of zoledronic acid given once as an iv infusion compared to 60 days of oral risedronate in patients with Pagets disease of bone. The effect will be demonstrated in the reduction of serum alkaline phosphatase (SAP).

Paget's Disease of Bone

Drug:Zoledronic Acid

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00051649?order=11

Novartis Pharmaceuticals

HORIZON TOP will study the effect of zoledronic acid given once as an iv infusion compared to 60 days of oral risedronate in patients with Pagets disease of bone. The effect will be demonstrated in the reduction of serum alkaline phosphatase (SAP).

Paget's Disease of Bone

Drug:Zoledronic Acid

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00086268?order=12

Novartis Pharmaceuticals

This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.

Non Small Cell Lung Carcinoma

Drug:zoledronic acidDrug:TaxotereDrug:Carboplatin

Phase II

Study Type:InterventionalStudy Design:Prevention,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study

Primary Outcomes:Proportion of patients without disease progressionSecondary Outcomes:Time to disease progression; Response rate; Time to progression in bone; Overall survival; Safety

http://www.clinicaltrials.gov/ct/show/NCT00080171?order=13

Knee osteoarthritis (OA) is the most common cause of disability in adults. The "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA.

OsteoarthritisKnee Osteoarthritis

Study Type:ObservationalStudy Design:Natural History,Longitudinal,Defined Population,Prospective Study

http://www.clinicaltrials.gov/ct/show/NCT00076362?order=14

Novartis Pharmaceuticals

Obesity

Drug:Sandostatin LAR

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Double-Blind,Placebo Control,Single Group Assignment,Safety/Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00087659?order=15

Novartis Pharmaceuticals

This study is being conducted to compare the effect of an investigational drug versus placebo on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). The study drug or placebo will be administered every three months of four treatments in one year. In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers.

Prostate Cancer

Drug:Zometa

Phase III

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Placebo Control,Single Group Assignment,Efficacy Study

http://www.clinicaltrials.gov/ct/show/NCT00088231?order=16

M.D. Anderson Cancer Center

The goal of this clinical research study is to find the highest safe doses of PTK 787 (vatalanib) and Gleevec (imatinib mesylate) that can be given to treat Chronic Myelogenous Leukemia-Blastic Phase (CML-BP), Refractory Acute Myelogenous Leukemia (AML), or Agnogenic Myeloid Metaplasia (AMM). Another goal is to see how effective this combination treatment is.

Acute Myelogenous LeukemiaAgnogenic Myeloid MetaplasiaChronic Myelogenous Leukemia

Drug:imatinib mesylate (Gleevec)Drug:PTK 787 (vatalanib)

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Ph I/II Study of PTK 787 (vatalanib) and Gleevec (imatinib) in Patients with Refractory Acute Myelogenous Leukemia (AML), Agnogenic Myeloid Metaplasia (AMM), and Chronic Myelogenous Leukemia- blastic phase (CML-BP)

http://www.clinicaltrials.gov/ct/show/NCT00087685?order=17

M.D. Anderson Cancer Center

Endometrial Cancer

Drug:RAD001

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Efficacy Study

Official Title:A Phase II Study of RAD001 in Patients with Recurrent Endometrial Cancer

http://www.clinicaltrials.gov/ct/show/NCT00081874?order=18

M.D. Anderson Cancer Center

The goal of this clinical research study is to find the highest safe dose of RAD001 that can be given as a treatment for leukemia, mantle cell lymphoma, or myelofibrosis. Another goal is to learn how effective the dose that is found is as a treatment. RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer.

LeukemiaMantle Cell LymphomaMyelofibrosis

Drug:RAD001

Phase I

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Phase I/II Study of RAD001 in Patients with Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia in Blastic-Phase, Agnogenic Myeloid Metaplasia, Chronic Lymphocytic Leukemia, T-Cell Leukemia, or Mantle Cell Lymphoma

http://www.clinicaltrials.gov/ct/show/NCT00098241?order=19

Novartis Pharmaceuticals

The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.

Kidney Transplantation

Drug:Certican

Phase III

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de novo Renal Transplant Patients

http://www.clinicaltrials.gov/ct/show/NCT00097955?order=20

Novartis Pharmaceuticals

Study of the efficacy and safety of aliskiren when used for patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.

Diabetic Nephropathy

Drug:aliskiren

Phase II

Study Type:InterventionalStudy Design:Educational/Counseling/Training,Randomized,Double-Blind,Placebo Control,Parallel Assignment,Safety/Efficacy Study

Official Title:Safety and Efficacy of the Antihypertensive Drug Aliskiren in Patients with Hypertension, Type 2 Diabetes and Proteinuria

http://www.clinicaltrials.gov/ct/show/NCT00097968?order=21

Novartis Pharmaceuticals

Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.

Graft Rejection

Drug:everolimus

Phase III

Study Type:InterventionalStudy Design:Prevention,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral in Cardiac Transplant Recipients with Established Allograft Vasculopathy

http://www.clinicaltrials.gov/ct/show/NCT00088582?order=22

Novartis Pharmaceuticals

5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.

Acromegaly

Drug:SOM230 s.c.Drug:Sandostatin s.c.

Phase II

Study Type:InterventionalStudy Design:Treatment,Randomized,Open Label,Active Control,Crossover Assignment,Safety/Efficacy Study

Official Title:A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients

http://www.clinicaltrials.gov/ct/show/NCT00088595?order=23

Novartis Pharmaceuticals

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Carcinoid Tumors

Drug:Sandostatin LARDrug:SOM230

Phase II

Study Type:InterventionalStudy Design:Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study

Official Title:An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients with Metastatic Carcinoid Tumors

http://www.clinicaltrials.gov/ct/show/NCT00098007?order=24

Novartis Pharmaceuticals

The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy. This objective will be assessed by comparing renal function post-transplant between 2 groups of patients.

Heart transplantation

Drug:Everolimus (Certican)

Phase III

Study Type:InterventionalStudy Design:Treatment,Ran