ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00265382
Conditions: Schizophrenia
Keywords: Adolescent Subjects
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-06-01; Completion date: 2009-06-01
Enrollment: 221 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.

Detailed description:
On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.

Arms: arm 1: None
Interventions: intervention 1: Ziprasidone oral capsules
Intervention descriptions: intervention 1: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.

Protocol documents:
Clinical trial NCT00272337
Conditions: Cardiovascular Diseases Atherosclerosis Myocardial Infarction
Keywords: Cardiovascular diseases Aspirin Atherosclerosis Myocardial Infarction
Sponsor: Florida Atlantic University
Start date: 2006-10-01; Completion date: 2009-06-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients who have had a heart attack.

Detailed description:
Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack.

Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.

Arms: arm 1: 81 mg Aspirin arm 2: 162 mg Aspirin arm 3: 325 mg Aspirin arm 4: 650 mg Aspirin arm 5: 1300 mg Aspirin
Interventions: intervention 1: Aspirin
Intervention descriptions: intervention 1: Dosage

Protocol documents:
Clinical trial NCT00282048
Conditions: Kidney Neoplasms Carcinoma, Renal Cell
Sponsor: Pfizer
Start date: 2006-03-01; Completion date: 2009-06-01
Enrollment: 62 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).

Detailed description:

Arms: arm 1: AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity
Interventions: intervention 1: AG-013736 (axitinib)
Intervention descriptions: intervention 1: AG-013736 5 mg twice daily \[bid\] continuous dosing in 28 day cycles.

Protocol documents:
Clinical trial NCT00296400
Conditions: Hyperlipidemia
Keywords: Hyperlipidemia Proteinuria Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2006-02-01; Completion date: 2009-06-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate proteinuria and hypercholesterolaemia.

Detailed description:

Interventions: intervention 1: Rosuvastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00308087
Conditions: Lymphoma, Follicular
Keywords: Sargramostim Leukine NHL
Sponsor: Genzyme, a Sanofi Company
Start date: 2006-05-01; Completion date: 2009-06-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.

Detailed description:
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

The study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sargramostim (Leukine) intervention 2: Rituximab
Intervention descriptions: intervention 1: Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab intervention 2: Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks

Protocol documents:
Clinical trial NCT00308620
Conditions: HIV Infections
Keywords: HIV chloroquine disease progression inflammation treatment naive
Sponsor: University of Minnesota
Start date: 2006-03-01; Completion date: 2009-06-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful.

This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.

Detailed description:
Summary:

A phase I randomized, double-blind, placebo controlled trial to investigate the efficacy of chloroquine to decrease T-cell activation and decrease viral load in early HIV.

Scientific Rationale:

Chloroquine has in vivo direct anti-HIV effects and an anti-inflammatory effect. These properties may be beneficial in reducing viral burden and immune activation therefore delaying HIV disease progression.

Sample Size: 25

Length of Study: 8 weeks, \[enrollment + 2 follow up visits\].

Intervention:

* Arm 1a: Chloroquine 250mg orally once daily for 8 weeks.
* Arm 1b: Chloroquine 500mg orally once daily for 8 weeks.
* Arm 2: Placebo once daily for 8 weeks.

Measurements:

* Blood draws at weeks: 0, 4, and 8 weeks.
* CD4, viral load measurements will be communicated to the referring provider (with subject consent).

Arms: arm 1: Chloroquine 205mg or 500mg orally once daily (Results pooled) arm 2: Placebo once daily for 8 weeks
Interventions: intervention 1: chloroquine phosphate intervention 2: Placebo
Intervention descriptions: intervention 1: 250mg or 500mg PO (by mouth) QDay intervention 2: Placebo once daily for 8 weeks

Protocol documents:
Clinical trial NCT00312728
Conditions: Non-Small Cell Lung Cancer Brain Neoplasms
Keywords: Brain Cancer Brain Metastases Avastin NSCLC Lung Cancer PASSPORT
Sponsor: Genentech, Inc.
Start date: 2006-03-01; Completion date: 2009-06-01
Enrollment: 115 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab intervention 2: First-Line Chemotherapy Agents intervention 3: Second-Line Chemotherapy Agents
Intervention descriptions: intervention 1: 15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be \< 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity. intervention 2: Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily.

All agents were dosed and administered per institutional standards using the respective package insert as a guideline. intervention 3: Erlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued.

All agents were dosed and administered per institutional standards using the respective package insert as a guideline.

Protocol documents:
Clinical trial NCT00324350
Conditions: Atherosclerosis Cardiovascular Diseases Hypercholesterolemia Hypertension Diabetes Mellitus Coronary Disease
Keywords: Diabetes Mellitus Fracture Falls Height Loss
Sponsor: University of California, San Francisco
Start date: 2003-10-01; Completion date: 2009-06-01
Enrollment: 7287 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic control for type 2 diabetes (in ACCORD participants) on factors related to bone health, including, fractures, falls, and bone mineral density.

Detailed description:
Recent studies have established that type 2 diabetes is a risk factor for fractures, particularly of the hip, shoulder and foot. Additionally, type 2 diabetes is associated with a 50-60% increase in the risk of falling. The higher risk of fracture associated with type 2 diabetes is an important health burden for these patients. More frequent falls and perhaps reduced bone strength in those with diabetes are thought to be key contributing factors. The best approach to preventing fractures in type 2 diabetes is not yet understood. There is observational evidence to support our hypothesis that better glycemic control will preserve bone and reduce falls and fractures. The ACCORD-BONE study provides a unique opportunity to determine whether intensive glycemic control will prevent fractures, falls, and bone loss in older diabetic adults, which may lead to improved treatment and prevention in the future.

Arms: arm 1: intensive glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level below 6.0%) arm 2: standard glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of 7 to 7.9%)
Interventions: intervention 1: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents
Intervention descriptions: intervention 1: type 2 diabetes treatments, per standard of care

Protocol documents:
Clinical trial NCT00340704
Conditions: Bladder, Neurogenic
Keywords: tamsulosin pediatric neurogenic bladder
Sponsor: Boehringer Ingelheim
Start date: 2006-04-01; Completion date: 2009-06-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: tamsulosin hydrochloride
Intervention descriptions: intervention 1: oral

Protocol documents:
Clinical trial NCT00347022
Conditions: Diagnostic Imaging
Keywords: Multislice computed tomography (MSCT)indications
Sponsor: Guerbet
Start date: 2006-05-01; Completion date: 2009-06-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.

Detailed description:

Arms: arm 1: The patient receive one injection of Xenetix 300 (300 mg of iodine/ml) arm 2: The patient receive one injection of Visipaque 270 (270 mg of iodine/ml)
Interventions: intervention 1: Xenetix intervention 2: Visipaque
Intervention descriptions: intervention 1: 300 mg of iodine/ml intervention 2: 270 mg of iodine/ml

Protocol documents:
Clinical trial NCT00351377
Conditions: Autoimmune Disease
Keywords: Autoimmune disease, mycophenolate, GI problems
Sponsor: Novartis Pharmaceuticals
Start date: 2006-06-01; Completion date: 2009-06-01
Enrollment: 111 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will 1) determine the proportion of patients with autoimmune diseases who are experiencing any GI complaints under MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes.

Detailed description:

Arms: arm 1: Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Interventions: intervention 1: Enteric-coated Mycophenolate Sodium
Intervention descriptions: intervention 1: Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.

Protocol documents:
Clinical trial NCT00365859
Conditions: Autistic Disorder Behavioral Symptoms
Keywords: Serious behavioral problems in children and adolescents with AD behavioral problems
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2006-09-01; Completion date: 2009-06-01
Enrollment: 330 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).

Detailed description:

Arms: arm 1: De novo participants (those who did not participate in protocol (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. arm 2: Participants who completed participation in protocol (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose. arm 3: Participants who completed participation in protocol CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks

Protocol documents:
Clinical trial NCT00383149
Conditions: Metastatic Pancreatic Cancer
Sponsor: R-Pharm
Start date: 2007-01-01; Completion date: 2009-06-01
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied.

Detailed description:

Arms: arm 1: All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour).
Interventions: intervention 1: Ixabepilone intervention 2: Cetuximab
Intervention descriptions: intervention 1: Intravenous Infusion (IV), 32 mg/m\^2 every 21 days. intervention 2: Initial dose of 400 mg/m\^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m\^2 IV over 1 hour.

Protocol documents:
Clinical trial NCT00385216
Conditions: Dental Crowding
Keywords: Third Molar Pain
Sponsor: Columbia University
Start date: 2004-07-01; Completion date: 2009-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determine whether nicotine affects pain or inflammation.

Detailed description:
This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients.

Arms: arm 1: In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application. arm 2: In one sitting the subject will receive a placebo nasal spray (0 mg), one application.
Interventions: intervention 1: Nicotine intervention 2: Placebo
Intervention descriptions: intervention 1: Nicotine nasal spray 3mg x 1 before surgery intervention 2: Placebo nasal spray 0mg x 1 before surgery

Protocol documents:
Clinical trial NCT00403403
Conditions: Small Cell Lung Cancer
Keywords: SCLC SALUTE Lung Cancer Avastin
Sponsor: Genentech, Inc.
Start date: 2007-03-01; Completion date: 2009-06-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).

Detailed description:

Arms: arm 1: Chemotherapy = cisplatin (or carboplatin) + etoposide arm 2: Chemotherapy = cisplatin (or carboplatin) + etoposide
Interventions: intervention 1: Bevacizumab intervention 2: Chemotherapy intervention 3: Placebo
Intervention descriptions: intervention 1: Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. intervention 2: Chemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. intervention 3: Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.

Protocol documents: