ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01023620
Conditions: HIV Infections
Keywords: HIV Lipodystrophy Lipoatrophy Lipohypertrophy Human Immunodeficiency Virus
Sponsor: University of Texas Southwestern Medical Center
Start date: 2009-10-01; Completion date: 2010-05-31
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to better understand why people with HIV who have taken drugs for HIV begin to show abnormal changes in fat loss or fat gain in their bodies. This condition is called lipodystrophy.

Patients who take medicine for HIV and who have lipodystrophy report loss of subcutaneous (sc) fat from the arms, legs, and face and excess fat gain in the neck and truncal region. They also more likely to have problems with insulin in the body, high fat levels in the blood and diabetes. The reason that lipodystrophy develops is not fully understood although some HIV drugs have are very likely the cause. The complications pose an increased risk of fat blockage forming in the arteries making you more at risk for heart problems in the future. Changes in body fat can cause physical discomfort and psychological distress. Management of these problems can be a challenge for the patient's doctor.

The investigators propose data collection to determine if there is more than one reason why this might happen in some people and not in others. Laboratory samples being collected: 1) special imaging of the liver; 2) fat collected by needle from the mid thigh and mid-shoulder areas; 3) blood samples to measure the virus, t-cells, fats, and other markers of how the patient's body is handling the virus.

This study is being done because science does not fully understand why some patients with HIV who take medicines for the virus have abnormal fat loss or gain and some do not. This research study is intended to help us better understand why and how this happens.

Detailed description:

Arms: arm 1: 10 male patients with lipodystrophy taking daily Pioglitazone 45 mg arm 2: 10 male patients with lipodystrophy not taking daily Pioglitazone
Interventions: intervention 1: Pioglitazone intervention 2: Observation
Intervention descriptions: intervention 1: Participants will take oral Pioglitazone 45 mg daily for 16 weeks. intervention 2: Participants will be observed for 16 weeks but will not receive drug

Protocol documents:
Clinical trial NCT00343252
Conditions: Osteoporosis, Postmenopausal Back Pain Spinal Fracture
Sponsor: Eli Lilly and Company
Start date: 2006-06-01; Completion date: 2010-06-01
Enrollment: 712 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

Detailed description:

Arms: arm 1: Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo arm 2: Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Interventions: intervention 1: teriparatide intervention 2: risedronate intervention 3: placebo intervention 4: placebo
Intervention descriptions: intervention 1: 20 ug/day, subcutaneous, 18 months intervention 2: 35 mg/once weekly, oral, 18 months intervention 3: once weekly, oral, 18 months intervention 4: daily, subcutaneous, 18 months

Protocol documents:
Clinical trial NCT00426660
Conditions: HIV Infections
Keywords: HIV Infections
Sponsor: ViiV Healthcare
Start date: 2007-02-01; Completion date: 2010-06-01
Enrollment: 1047 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: maraviroc
Intervention descriptions: intervention 1: The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Protocol documents:
Clinical trial NCT00486278
Conditions: Congenital Bleeding Disorder Haemophilia A Haemophilia B
Sponsor: Novo Nordisk A/S
Start date: 2007-06-01; Completion date: 2010-06-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.

The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: eptacog alfa (activated) intervention 2: vatreptacog alfa (activated) intervention 3: vatreptacog alfa (activated) intervention 4: vatreptacog alfa (activated) intervention 5: vatreptacog alfa (activated) intervention 6: vatreptacog alfa (activated)
Intervention descriptions: intervention 1: 90 mcg/kg, injected i.v. intervention 2: 5 mcg/kg, injected i.v. intervention 3: 10 mcg/kg, injected i.v. intervention 4: 20 mcg/kg, injected i.v. intervention 5: 40 mcg/kg, injected i.v. intervention 6: 80 mcg/kg, injected i.v.

Protocol documents:
Clinical trial NCT00666224
Conditions: Multiple Sclerosis
Keywords: Clinically Definite Multiple Sclerosis Clinically Isolated Syndrome Multiple Sclerosis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2004-01-01; Completion date: 2010-06-01
Enrollment: 481 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during the double-blind period. The secondary objective is to assess, within the time frame of the up to 3-year double-blind, placebo-controlled study period, the effect of GA on clinical and Magnetic Resonance Imaging (MRI) parameters. The long-term objectives of the study (exploratory in nature) are to assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed treatment with GA as reflected by clinical and MRI parameters measuring the accumulated irreversible brain tissue damage.

A pre-planned interim analysis was performed on all efficacy and safety data accumulated in the database up to October 14, 2007, i.e. when 81% of exposure to treatment in the double-blind, placebo-controlled period had been collected. Upon review of the interim analysis results, the Data Monitoring Committee (DMC) recommended that the double-blind portion of the study be stopped and that subjects be switched to the 2-year Open-label period, during which time they would have the option of receiving GA therapy. The sponsor (Teva) adopted the DMC recommendations and took the necessary action towards its implementation.

Detailed description:

Arms: arm 1: Glatiramer acetate 20 mg once daily by subcutaneous injection is administered in both the double-blind and open label periods. arm 2: Placebo matching glatiramer acetate once daily by subcutaneous injection during the double-blind period (DB). Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection during the open-label period (OL).
Interventions: intervention 1: Glatiramer Acetate (DB) intervention 2: Placebo intervention 3: Glatiramer Acetate (OL)
Intervention descriptions: intervention 1: Double blind period (DB): glatiramer acetate (GA) by subcutaneous injection, 20mg, once daily, for up to 36 months or until conversion to clinically definite multiple sclerosis (CDMS). intervention 2: Double blind period (DB): subcutaneous injection of placebo, once daily, for up to 36 months or until conversion to CDMS intervention 3: Open label period (OL): glatiramer acetate (GA), 20 mg, subcutaneous injection, once daily, given for up to an additional 24 months.

Protocol documents:
Clinical trial NCT00742209
Conditions: Migraine Disorders Migraine
Keywords: migraine prophylaxis prevention
Sponsor: XenoPort, Inc.
Start date: 2008-08-01; Completion date: 2010-06-01
Enrollment: 526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose of the study is to evaluate dose response relationship, efficacy, safety and tolerability of target doses of GSK1838262 compared to placebo in the prophylactic treatment of migraine headache. Once subjects complete the baseline and meet the randomization criteria, they will complete a 5-wk flexible titration period and then enter the 12 week maintenance period.

Detailed description:
MPX111381 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, flexible-dose evaluation of GSK1838262 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day compared with placebo in the prophylactic treatment of migraine headache.

Subjects 18 years of age must have experienced at least three migraine headache attacks (with or without aura according to 2004 International Headache Society \[IHS\] criteria 1.1 and 1.2.1) per month during the 3 months prior to screening and at least four migraine headache days but less than 15 total headache days (migraine or non-migraine) per month during the 3 months prior to screening and must maintain this requirement throughout the last 4 weeks of the baseline period. Approximately 528 subjects from approximately 53 centers in North America will be randomized in a 2:1:2:2:1 ratio to the following treatment groups: placebo, GSK1838262 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day. Investigational product will be administered twice daily (morning and evening) with food (e.g., meal or snack).

The study will consist of six study periods for a total study duration of up to 30 weeks: Screening (2 weeks), baseline (including randomization, 6 weeks), flexible titration (5 weeks), maintenance (12 weeks), taper (3 weeks) and post-treatment (2 weeks). The flexible titration administration of investigational product is designed to allow subjects to reach the target dose for maintenance treatment or, if unable to reach this target dose, to achieve a maximum tolerated dose for maintenance treatment. Subjects will have the opportunity to undergo a single dose (600 mg/day) downward adjustment during the flexible titration period if intolerability at the current dose occurs. Subsequently, if a single dose downward adjustment has occurred, no further dose adjustments in the study (upward or downward) will be permitted.

Arms: arm 1: PBO arm 2: 600 or 1200 mg/day arm 3: 600 or 1200 or 1800 mg/day arm 4: 600 or 1200 or 1800 or 2400 mg/day arm 5: 600 or 1200 or 1800 or 2400 or 3000 mg/day
Interventions: intervention 1: GSK1838262 intervention 2: Placebo
Intervention descriptions: intervention 1: Flexible dosing: 1200 mg/day, 1800 mg/day, 2400 mg/day and 3000 mg/day intervention 2: Placebo-control

Protocol documents:
Clinical trial NCT00829829
Conditions: Intercritical Gout
Keywords: Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout
Sponsor: Regeneron Pharmaceuticals
Start date: 2009-02-01; Completion date: 2010-06-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15. arm 3: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
Interventions: intervention 1: Placebo intervention 2: Rilonacept 80 mg intervention 3: Rilonacept 160 mg
Intervention descriptions: intervention 1: Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks. intervention 2: Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks. intervention 3: Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.

Protocol documents:
Clinical trial NCT00830960
Conditions: Acute Coronary Syndrome
Sponsor: Eli Lilly and Company
Start date: 2009-02-01; Completion date: 2010-06-01
Enrollment: 720 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.

Detailed description:

Arms: arm 1: Loading dose 60 mg followed by maintenance dose 10 mg/day arm 2: Loading dose 30 mg followed by maintenance dose 7.5 mg/day arm 3: Loading dose 30 mg followed by maintenance dose 5 mg/day arm 4: Loading dose 300 mg followed by maintenance dose 75 mg/day arm 5: Loading dose 30 mg followed by maintenance dose 5 mg/day arm 6: Loading dose 300 mg followed by maintenance dose 75 mg/day
Interventions: intervention 1: Prasugrel intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Oral, daily, 90 days intervention 2: Oral, daily, 90 days

Protocol documents:
Clinical trial NCT01041404
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-09-01; Completion date: 2010-06-01
Enrollment: 584 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.

Detailed description:

Arms: arm 1: Participants received an initial loading dose of 8 milligrams per kilogram (mg/kg) trastuzumab i.v. on Day 1 of cycle, followed by 6 mg/kg i.v. every 3 weeks until disease progression; 800 mg/m2 fluorouracil i.v. on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles. arm 2: Participants received 800 milligrams per square meter (mg/m2) fluorouracil intravenous (i.v.) on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine orally (p.o.) twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
Interventions: intervention 1: Trastuzumab intervention 2: Fluorouracil intervention 3: Cisplatin intervention 4: Capecitabine
Intervention descriptions: intervention 1: Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression intervention 2: 800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles intervention 3: 80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles intervention 4: 1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles

Protocol documents:
Clinical trial NCT00037830
Conditions: Parkinson Disease
Keywords: Parkinson's disease PD GM1 Ganglioside Sygen
Sponsor: Thomas Jefferson University
Start date: 1999-11-01; Completion date: 2010-06-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to examine the short term effects (24 Weeks) of GM1 on Parkinson's disease (PD) symptoms, as well as the effects of long-term treatment (120 Weeks) with GM1 on disease progression, and to examine the extent to which GM1 treatment influences the underlying disease process in PD.

Detailed description:
The study is designed to further examine the extent to which GM1 ganglioside can improve symptoms, delay disease progression, and, perhaps, partially restore damaged brain cells in PD patients. GM1 ganglioside is a chemical that is normally found in the brain and is a normal part of the outer covering or membrane of nerve cells. This study will compare the effectiveness of GM1 to standard PD treatment. In addition to studying clinical measures of motor and cognitive functioning, the investigators will use PET (positron emission tomography) scanning to image the brain and the dopamine nerve endings in a subgroup of patients. Patients with mild to moderate idiopathic PD will be divided into 2 groups. One group will receive GM1 for 24 weeks and the other will receive placebo. At the end of this 24 week period, all patients will enter into a 96 week treatment period in which all patients will receive GM1.

In parallel, a group of standard-of-care patients with mild to moderate PD will be monitored over a 1 to 2 year period to assess the natural progression of PD. These patients will receive the same clinical evaluations as the treatment group subjects but they will not receive the experimental medication.

Arms: arm 1: Subjects were randomized to receive GM1 ganglioside for 24 weeks. arm 2: Subjects were randomized to receive placebo for 24 weeks. arm 3: A separate group of Parkinson's disease patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This comparison group was not compared statistically to the treatment groups since they were not randomized.
Interventions: intervention 1: GM1 ganglioside intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg twice per day by subcutaneous injection intervention 2: Twice per day subcutaneous injection, equal volume as active drug

Protocol documents:
Clinical trial NCT00056862
Conditions: Hepatitis C
Keywords: Hepatitis C Virus Antiviral Agents Hemolysis Neutropenia Cirrhosis Hemolytic Anemia Viral Hepatitis Ribavirin Alfa Interferon Pegylated Interferon Hepatitis C HCV
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2003-03-01; Completion date: 2010-06-01
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that, in some patients, can progress to cirrhosis of the liver, liver cancer, and liver failure.

Detailed description:
Sixty patients with chronic hepatitis C infected with HCV genotype 2 or 3 will be treated using the combination of either low- or standard dose peginterferon and ribavirin for 24 weeks, with re-treatment using the standard doses and a longer duration (48 weeks) for those who do not respond to or relapse after initial low dose therapy.

Adult patients with chronic hepatitis C who have HCV genotype 2 or 3 and previously have not received anti-viral treatment will be given peginterferon alfa-2a (90 or 180 micrograms weekly by injection) and ribavirin (800 mg daily by mouth). Patients will be monitored at 2- to 4-week intervals for side effects, compliance, complete blood counts, liver biochemical tests and HCV RNA. Patients becoming HCV RNA negative by week 12 will be considered on-treatment responders, continue therapy to week 24, and be monitored thereafter for another 24 weeks. Patients who do not become HCV RNA negative by week 12 as well as patients who relapse after therapy will be retreated with 180 micrograms of peginterferon weekly and 800 mg of ribavirin for another 48 weeks.

The primary outcome will be sustained loss of HCV RNA at 24 weeks after low- or standard-dose combination therapy. Secondary outcomes include viral kinetics and side effects. Because of preliminary results in the initial 31 patients enrolled in this study, the dose of peginterferon was changed from 90 to 180 micrograms weekly for the remaining 29 patients to be enrolled, allowing for a direct comparison of efficacy, viral kinetics and side effects of standard- vs low-dose peginterferon therapy.

This study will evaluate the relative efficacy and safety of the standard versus lower doses of peginterferon with ribavirin in patients with chronic hepatitis C and HCV genotype 2 or 3.

Arms: arm 1: Patients receive a lower dose of peginterferon alfa-2a (90 mcg per week) and standard dose of ribavirin (800 mg/d) for chronic hepatitis C, genotype 2/3, for 24 weeks. arm 2: Patients receive the standard, recommended doses of peginterferon alfa-2a (180 mcg per week) and ribavirin (800 mg/d) for chronic hepatitis c, genotype 2/3, for 24 weeks.
Interventions: intervention 1: Peginterferon alfa-2a intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: Peginterferon alfa-2a 90 mcg/week intervention 2: 180 mcg/week intervention 3: 800 mg/day

Protocol documents:
Clinical trial NCT00076999
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2003-11-01; Completion date: 2010-06-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule.

The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.

Detailed description:

Arms: arm 1: TPV and RTV oral solution low dose arm 2: TPV and RTV oral solution high dose
Interventions: intervention 1: TPV oral solution intervention 2: TPV oral solution intervention 3: RTV oral solution intervention 4: RTV oral solution
Intervention descriptions: intervention 1: Tipranavir oral solution intervention 2: Tipranavir oral solution intervention 3: Ritonavir oral solution intervention 4: Ritonavir oral solution

Protocol documents: