ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00828711
Conditions: Cervical Ripening Induction of Labor
Keywords: Misoprostol vaginal insert Induction of labor Cervical ripening Rate of cesarean section
Sponsor: Ferring Pharmaceuticals
Start date: 2009-04-01; Completion date: 2009-12-01
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.

Detailed description:

Arms: arm 1: MVI 100 mcg vaginal insert arm 2: MVI 150 mcg vaginal insert arm 3: MVI 200 mcg vaginal insert
Interventions: intervention 1: MVI 100 intervention 2: MVI 150 intervention 3: MVI 200
Intervention descriptions: intervention 1: Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. intervention 2: Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. intervention 3: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.

Protocol documents:
Clinical trial NCT00832650
Conditions: Healthy
Keywords: Healthy; Fesoterodine; Solifenacin
Sponsor: Pfizer
Start date: 2009-04-01; Completion date: 2009-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.

Detailed description:

Arms: arm 1: Tablets arm 2: Tablets arm 3: Tablets
Interventions: intervention 1: fesoterodine fumarate intervention 2: placebo intervention 3: solifenacin
Intervention descriptions: intervention 1: 8 mg OD for 14 days intervention 2: OD for 14 days intervention 3: 10 mg OD for 14 days

Protocol documents:
Clinical trial NCT00842075
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes adolescents post prandial glucose
Sponsor: University of Colorado, Denver
Start date: 2006-12-01; Completion date: 2009-12-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes.

This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).

Detailed description:
Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are:

* HbA1c level between 7.5 and 10% inclusive
* Currently using carbohydrate to insulin ratio
* Acceptable form of birth control

Exclusion factors:

* Oral hyperglycemic agents or medications which might affect blood sugar levels
* Recurrent severe hypoglycemia requiring assistance in previous 6 months
* Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility
* Previous use of pramlintide

The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. Meals will be controlled for carbohydrate, fat and protein content. Meals will be identical at each CTRC visit.

After a baseline visit for all participants, randomization will occur to either Treatment or Control.Bolus insulin will be adjusted for participants when beginning pramlintide and will likely remain at a reduced rate throughout the trial. All participants will have access to staff to assist with insulin dosing. There will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study.

Insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final visit of the study. Hypoglycemic events will be tracked, as well as any other adverse events.

Arms: arm 1: Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin arm 2: Usual bolus insulin dose at each meal
Interventions: intervention 1: pramlintide
Intervention descriptions: intervention 1: subcutaneous injection (15 mcg initial dose)prior to meals

Protocol documents:
Clinical trial NCT00848081
Conditions: Benign Prostatic Hyperplasia
Keywords: Prostate BPH Benign Prostatic Hyperplasia BPH-LUTS LUTS Phosphodiesterase Inhibitors tadalafil alpha blockers
Sponsor: Eli Lilly and Company
Start date: 2009-03-01; Completion date: 2009-12-01
Enrollment: 318 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg taken by mouth once daily for 12 weeks intervention 2: By mouth once daily for 12 weeks

Protocol documents:
Clinical trial NCT00855062
Conditions: HIV-associated Cognitive Impairment HIV Infections
Keywords: Human immunodeficiency virus (HIV) HIV associated cognitive impairment HIV dementia Uganda Acquired immune deficiency syndrome (AIDS) Treatment Naive
Sponsor: Johns Hopkins University
Start date: 2008-04-01; Completion date: 2009-12-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive impairment in Uganda.

Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 (CD4) Count in the 251-350 Range

* Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)
* Arm 2: Matching placebo orally every 12 hours (50 subjects)

Primary Objective:

· To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline

Secondary Objectives:

* To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
* To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
* To examine whether minocycline treatment for 24 weeks improves functional impairment

Detailed description:

Arms: arm 1: Minocycline 100 mg orally every 12 hours arm 2: Placebo minocycline capsules every 12 hours
Interventions: intervention 1: minocycline intervention 2: minocycline placebo capsule
Intervention descriptions: intervention 1: 100 mg capsule every 12 hours by mouth intervention 2: 1 capsule every 12 hours by mouth

Protocol documents:
Clinical trial NCT00858962
Conditions: HIV Infection HIV Infections
Keywords: HIV Pharmacokinetics Pharmacodynamics Buprenorphine Raltegravir HIV seronegativity Interaction
Sponsor: Yale University
Start date: 2009-03-01; Completion date: 2009-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this protocol is to study the effect of an HIV medication known as Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine for at least 3 weeks before study entry. This will be determined by giving Raltegravir along with Buprenorphine and by measuring the amount of Raltegravir and Buprenorphine in the blood. The investigators will also learn about the effects of Buprenorphine on Raltegravir and about the safety of taking these two medications together.

Detailed description:
A large number of people who are infected with HIV have acquired it through injection drug use. Some of these people are currently being treated with Buprenorphine for their addiction and with medications for HIV infection. Raltegravir is a medication that was approved by the Food and Drug Administration (FDA) for the treatment of HIV infection. Raltegravir acts by making it more difficult for the virus that causes AIDS to multiply and cause more damage to the immune system in someone who is HIV infected.

Earlier studies looking at the effect of Buprenorphine and HIV medications have shown that Buprenorphine and some HIV medications act differently when taken together. It is important to learn if taking Buprenorphine and HIV medications together results in changes in the blood level of either medication. If the HIV medication affects the level of Buprenorphine in the blood, an individual taking Buprenorphine and HIV medications may experience symptoms of withdrawal, even while taking their usual dose of Buprenorphine. On the other hand, if Buprenorphine decreases the amount of HIV medication in the blood, then the HIV medication may be less effective in controlling HIV infection. It is therefore important to learn if Raltegravir and Buprenorphine will affect each other when taken together.

In order to learn about the effects of Buprenorphine and Raltegravir, we will need to measure the amount of Buprenorphine in your blood for 24 hours before you have taken Raltegravir and then compare that to the amount of Buprenorphine in your blood after you have taken Buprenorphine and Raltegravir together .

Arms: arm 1: Buprenorphine and Raltegravir co-administration
Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: 400 mg of raltegravir orally twice daily together with normally prescribed stable dose of buprenorphine for a minimum of 4 days and up to 14 days.

Protocol documents:
Clinical trial NCT00860262
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2009-03-01; Completion date: 2009-12-01
Enrollment: 858 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Detailed description:

Arms: arm 1: telmisartan and amlodipine used in combination vs amlodipine or telmisartan arm 2: telmisartan and amlodipine used in combination vs amlodipine or telmisartan arm 3: telmisartan and amlodipine used in combination vs amlodipine or telmisartan
Interventions: intervention 1: amlodipine intervention 2: telmisartan intervention 3: telmisartan and amlodipine
Intervention descriptions: intervention 1: amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w intervention 2: telmisartan 80mg for the 8w, no titration required intervention 3: telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w

Protocol documents:
Clinical trial NCT00863707
Conditions: Kidney Diseases Coronary Artery Disease
Keywords: regadenoson chronic kidney disease stage III chronic kidney disease stage IV renal impairment coronary artery disease
Sponsor: Astellas Pharma Inc
Start date: 2009-04-01; Completion date: 2009-12-01
Enrollment: 511 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.

Detailed description:

Arms: arm 1: Matching intravenous (IV) bolus injection arm 2: 0.4 mg/5 mL intravenous bolus injection
Interventions: intervention 1: Regadenoson intervention 2: Placebo
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol documents:
Clinical trial NCT00865904
Conditions: Cystic Fibrosis
Keywords: ∆F508 F508del Cystic Fibrosis Transmembrane Conductance Regulator CFTR Pancreatic diseases Lung diseases Genetic disease, inborn Infant, newborn, diseases
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2009-03-01; Completion date: 2009-12-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Detailed description:
This was a Phase 2, randomized, double-blind, placebo-controlled, multiple-dose study of orally-administered VX-809 in participants with CF who are homozygous for the specific CFTR mutation known as ∆F508 or F508del. Enrollment was planned for 90 participants at approximately 20 centers. Participants were planned to be randomized in a 4:1 ratio to receive 1 of 4 doses of VX-809 or placebo once a day for 28 days in a parallel design. Participants were outpatients during the study, except for overnight stays on Day 1 and 28.

Arms: arm 1: Placebo matched to VX-809 capsule orally once daily for 28 days. arm 2: VX-809, 25 milligram (mg) capsule orally once daily for 28 days. arm 3: VX-809, 50 mg capsule orally once daily for 28 days. arm 4: VX-809, 100 mg capsule orally once daily for 28 days. arm 5: VX-809, 200 mg capsule orally once daily for 28 days.
Interventions: intervention 1: VX-809 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules intervention 2: Placebo matched to VX-809 capsules.

Protocol documents:
Clinical trial NCT00866320
Conditions: Kidney Cancer
Keywords: clear cell renal cell carcinoma recurrent renal cell cancer stage IV renal cell cancer
Sponsor: Case Comprehensive Cancer Center
Start date: 2006-02-01; Completion date: 2009-12-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.

Detailed description:
OBJECTIVES:

Primary

* To determine the tumor burden reduction rate in patients with sunitinib malate- or bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with sorafenib tosylate.

Secondary

* To determine the safety of sorafenib tosylate in these patients.
* To record the duration of tumor reduction, time to disease progression, and overall survival of patients treated with sorafenib tosylate.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).
Interventions: intervention 1: sorafenib tosylate
Intervention descriptions: intervention 1: Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor targeting both tumor cells and the tumor vasculature. Patients with metastatic RCC meeting eligibility criteria will receive 400 mg BID of sorafenib in a single-arm phase II study. Treatment will be administered on an outpatient basis.

Protocol documents:
Clinical trial NCT00868439
Conditions: Hyperkalemia Heart Failure
Keywords: HF Heart failure hyperkalemia chronic kidney disease prevention of hyperkalemia in heart failure participants
Sponsor: Relypsa, Inc.
Start date: 2009-04-01; Completion date: 2009-12-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.

Detailed description:
This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of the study, Part 2 was not conducted.

Participants were randomly assigned to and received patiromer (30 g/day) or placebo for up to 28 days. All participants also received spironolactone; the initial spironolactone dose was 25 mg daily and was increased to 50 mg daily for participants who had a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits occurred on treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact was made 7 days after administration of last dose of study drug.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: patiromer intervention 2: placebo
Intervention descriptions: intervention 1: Active investigational drug intervention 2: placebo

Protocol documents:
Clinical trial NCT00871728
Conditions: Onychomycosis, Toe
Keywords: Onychomycosis, Toe Itraconazole Sporanox
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2007-01-01; Completion date: 2009-12-01
Enrollment: 132 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial identification test after administration of itraconazole (ICZ) capsule, to identify the change in Scoring Clinical Index for Onychomycosis (SCIO) score and to determine the relationship between the change of SCIO score and mycological cure rate and clinical improvement.

Detailed description:
This is an open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) study of ICZ in participants with onychomycosis. The present study consists of 2 periods: Screening period (up to Week minus 2) and Treatment period (up to Week 49). The ICZ will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally, twice daily, continuously for 1 week. Total duration of treatment will be of 49 weeks. Efficacy will primarily be evaluated by percentage of participants showing 10 percent or higher response in SCIO Score. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Itraconazole
Intervention descriptions: intervention 1: Itraconazole (ICZ) capsule will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment will be 49 weeks.

Protocol documents:
Clinical trial NCT00881868
Conditions: Scalp Psoriasis
Sponsor: Galderma R&D
Start date: 2009-04-01; Completion date: 2009-12-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: clobetasol propionate spray 0.05% intervention 2: Vehicle spray
Intervention descriptions: intervention 1: Apply enough product to cover affected areas topically twice daily at least 8 hours apart intervention 2: Apply enough product to cover affected areas topically twice daily at least 8 hours apart

Protocol documents:
Clinical trial NCT00907335
Conditions: Acne Vulgaris
Keywords: acne irritation objective sensory methods
Sponsor: Bausch Health Americas, Inc.
Start date: 2009-02-01; Completion date: 2009-12-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.

Detailed description:
Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled in this randomized, double blind, multi-center study.

Following satisfaction of entry criteria and screening procedures, subjects will receive either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the 12-week treatment period. Subjects will be monitored for safety throughout the study and for signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at study completion, week 12.

Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment of Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be taken at Baseline and weeks 2, 4, 8 and 12.

Arms: arm 1: Retin-A Micro 0.04% facial acne treatment used once daily arm 2: Color matched facial gel vehicle control used once daily
Interventions: intervention 1: Retin-A Micro 0.04% facial acne treatment intervention 2: Vehicle control
Intervention descriptions: intervention 1: Retin-A Micro 0.04% facial acne treatment used once daily intervention 2: Color-matched facial gel vehicle control used once daily

Protocol documents:
Clinical trial NCT00909064
Conditions: Total Knee Replacement
Sponsor: Paul Di Cesare,MD
Start date: 2009-06-01; Completion date: 2009-12-01
Enrollment: 114 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators hypothesize that Arixtra patients will be less likely to experience wound infection than patients who have received low-molecular weight heparin, coumadin or aspirin with mechanical compression.

Detailed description:

Arms: arm 1: Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement
Interventions: intervention 1: Fondaparinux Sodium (Arixtra)
Intervention descriptions: intervention 1: 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.

Protocol documents: