ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00792103
Conditions: Migraine Disorders
Sponsor: NuPathe Inc.
Start date: 2009-01-01; Completion date: 2010-09-01
Enrollment: 198 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by:

* Subject self-examination skin irritation scores
* Adverse events
* Changes in vital signs and ECG parameters

The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:

* Headache pain free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Headache pain relief at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Nausea free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Phonophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Photophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
* Migraine free at two hours after patch activation for all initial acute migraine attacks treated with NP101

This study will use an open-label design to assess the long term safety of NP101 (sumatriptan iontophoretic transdermal patch).

Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not contraindicated) and received treatment (patch activation) with the study patch for a qualifying migraine under study NP101-007 will be considered eligible for enrollment into the open-label study. Subjects will be expected to remain in the study for up to 12 months.

Detailed description:

Arms: arm 1: sumatriptan iontophoretic transdermal patch
Interventions: intervention 1: NP101
Intervention descriptions: intervention 1: NP101 study patch 4 hour application

Protocol documents:
Clinical trial NCT00798434
Conditions: Urinary Bladder, Overactive
Keywords: Overactive bladder syndrome fesoterodine elderly flexible dose regimen urgency frequency urge urinary incontinence anticholinergic antimuscarinic
Sponsor: Pfizer
Start date: 2008-06-01; Completion date: 2010-09-01
Enrollment: 794 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged \> 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.

Detailed description:

Arms: arm 1: Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated. arm 2: Flexible dose regimen of fesoterodine fumarate 4mg once daily. The dose can be increased to 8mg once daily after 4 weeks if clinically indicated. Subsequently the dose can be reduced to 4mg if clinically indicated.
Interventions: intervention 1: Placebo intervention 2: Fesoterodine fumarate
Intervention descriptions: intervention 1: placebo administered orally in the morning or evening. intervention 2: Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.

Protocol documents:
Clinical trial NCT00805480
Conditions: Chronic Plaque Psoriasis
Keywords: Plaque psoriasis inflammatory skin disease skin condition, thickening flaking scaly patches skin disease
Sponsor: Novartis Pharmaceuticals
Start date: 2008-12-01; Completion date: 2010-09-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.

Detailed description:

Arms: arm 1: Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29. arm 2: Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29. arm 3: Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29. arm 4: Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: AIN457 was administered intravenously. intervention 2: Matching placebo to AIN457 was administered intravenously.

Protocol documents:
Clinical trial NCT00805792
Conditions: Ischemic Stroke
Keywords: Ischemic stroke treatment recovery donepezil Aricept
Sponsor: Mayo Clinic
Start date: 2008-11-01; Completion date: 2010-09-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study involves treating patients that have suffered an acute ischemic stroke with the medication donepezil (Aricept ®). The hypothesis is that taking donepezil (FDA-approved for the treatment of Alzheimer's Disease) for the first 90 days following a stroke enhances recovery.

Detailed description:
We hypothesize that donepezil (5 mg per day, titrated up to 10 mg per day as tolerated) will enhance recovery following stroke by improving attention, learning and memory thereby enhancing rehabilitation. The null hypothesis is that the probability of a favorable outcome among post-stroke donepezil users is equal to that observed among similar participants in an existing National Institutes of Neurological Disorders and Stroke (NINDS) resource, the Phase III clinical trial of Tissue Plasminogen Activator (tPA) for acute ischemic stroke. The NINDS tPA stroke trial has been used as historical control data in pilot trials of reperfusion and neuroprotection.

The MASTER trial will be a multicenter, single-arm NINDS Recominant tPA trial-controlled, modified 2-stage adaptive clinical trial set in 2 tertiary care hospitals in the United States. Participants will be men and women with acute (\< 24 hours of onset of symptoms) ischemic stroke. A favorable outcome will be defined as National Institutes of Health Stroke Scale (NIHSS) values of 0 or 1 at 90 days post-stroke.

Arms: arm 1: Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
Interventions: intervention 1: Donepezil
Intervention descriptions: intervention 1: Study participants will be treated with donepezil orally at an initial dose of 5 mg daily for the first 4 weeks, then increased at their 30-day visit by 5 mg to a maximum dose of 10 mg daily, if tolerated. If the participant does not tolerate the 10 mg dose, they will remain on 5 mg through the course of the study.

Protocol documents:
Clinical trial NCT00811174
Conditions: Immunologic Deficiency Syndromes
Sponsor: Octapharma
Start date: 2009-01-01; Completion date: 2010-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.

Detailed description:
The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used Octagam 5%.

The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.

Arms: arm 1: None
Interventions: intervention 1: Octagam 10%
Intervention descriptions: intervention 1: 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)

Protocol documents:
Clinical trial NCT00812565
Conditions: Alzheimer's Disease
Sponsor: Octapharma
Start date: 2009-02-01; Completion date: 2010-09-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the effect of 6 or 12 infusions of different doses of octagam (intravenous immunoglobulin \[IVIG\]) 10% on the reduction of amyloid beta peptide (Aβ) in cerebral spinal fluid (CSF) and on the increase of Aβ in blood plasma in patients with mild to moderate Alzheimer's disease.

Detailed description:
Participants received 12 infusions of 0.1 g/kg, 0.25 g/kg, or 0.4 g/kg body weight octagam 10% at 2-week intervals (±3 days) or 6 infusions of 0.2 g/kg, 0.5 g/kg, or 0.8 g/kg body weight octagam 10% at 4-week intervals (±5 days). The effect of the infusions on the reduction of Aβ peptide in CSF and the increase of Aβ peptide in blood plasma was evaluated.

Arms: arm 1: Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions). arm 2: Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions). arm 3: Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). arm 4: Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions). arm 5: Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions). arm 6: Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions). arm 7: Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions). arm 8: Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
Interventions: intervention 1: Placebo intervention 2: octagam 10%
Intervention descriptions: intervention 1: Commercially available 0.9% isotonic sodium chloride solution. intervention 2: octagam 10% was supplied as ready-to-use solutions of human immunoglobulin.

Protocol documents:
Clinical trial NCT00812968
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndromes Lenalidomide
Sponsor: Celgene
Start date: 2007-09-01; Completion date: 2010-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body \[pharmacokinetics\]) in Japanese subjects with low- or intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33) abnormality and symptomatic anemia.

Detailed description:

Arms: arm 1: Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).

Protocol documents:
Clinical trial NCT00817843
Conditions: Metabolic Syndrome
Keywords: Postprandial hypertriglyceridemia Metabolic syndrome Endothelial function Flow mediated dilatation EndoPAT Simvastatin Ezetimibe
Sponsor: dr.Frank L.J. Visseren
Start date: 2009-04-01; Completion date: 2010-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate whether low-dose simvastatin in combination with ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the function of the endothelium after an oral fat load in patients with metabolic syndrome.

Detailed description:
Metabolic syndrome is defined as a group of cardiovascular risk factors and is mainly driven by the epidemic of obesity. High blood lipid levels after a meal may be an important risk factor for cardiovascular disease. In this study we will investigate whether simvastatin in combination with ezetimibe vs. simvastatin alone, has a beneficial effect on the lipid levels after a meal, but more importantly, whether we can measure a difference in function of the endothelium. In a small pilot study we already found that the combination had a beneficial effect in comparison with simvastatin alone. Now we want to solidify these findings in a larger study.

Arms: arm 1: First 6 weeks of Simvastatin 80mg, then 6 weeks of Simvastatin/Ezetimibe 10/10mg after 6 weeks of placebo washout arm 2: First 6 weeks of Simvastatin/Ezetimibe 10/10mg, then 6 weeks of Simvastatin 80mg after 6 weeks of placebo washout
Interventions: intervention 1: Simvastatin intervention 2: Simvastatin/Ezetimibe
Intervention descriptions: intervention 1: 6 weeks of treatment with simvastatin 80 mg intervention 2: 6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination

Protocol documents:
Clinical trial NCT00825812
Conditions: Anesthesia, General Neuromuscular Blockade
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-01-01; Completion date: 2010-09-01
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.

Detailed description:

Arms: arm 1: At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. arm 2: At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. arm 3: At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. arm 4: At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Interventions: intervention 1: Sugammadex intervention 2: neostigmine
Intervention descriptions: intervention 1: After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered. intervention 2: After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.

Protocol documents:
Clinical trial NCT00827775
Conditions: Intradialytic Hypertension
Keywords: Hypertension Hemodialysis
Sponsor: University of Texas Southwestern Medical Center
Start date: 2009-06-01; Completion date: 2010-09-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel mechanistic markers in the causal pathway for detrimental cardiovascular outcomes; and
2. To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood pressure elevations with hemodialysis can improve endothelial cell dysfunction as a surrogate mechanistic marker for improving cardiovascular outcomes.

Detailed description:

Arms: arm 1: Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions arm 2: Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the last dialysis treatment sessions
Interventions: intervention 1: Carvedilol
Intervention descriptions: intervention 1: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid

Protocol documents:
Clinical trial NCT00830388
Conditions: Tinea Versicolor
Keywords: tinea versicolor ketoconazole
Sponsor: Boni Elewski, MD
Start date: 2008-11-01; Completion date: 2010-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.

Detailed description:
Objectives

1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor
2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.
3. To assess treatment satisfaction as rated by patients

Study Design:

This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4 scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified and mycological and clinical assessments will be performed at this site as well as a global assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2 weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for calcofluor/potassium hydroxide (KOH) assessment and photographs of target lesions will be performed at baseline, week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH is positive). Body surface area estimation of disease will also be performed at each visit. Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit using the same 4 point scale. Patient questionnaires will be administered at baseline and week 2 to assess symptoms and satisfaction with study medication.

Arms: arm 1: Open-label study
Interventions: intervention 1: Ketoconazole 2% Foam
Intervention descriptions: intervention 1: Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.

Protocol documents:
Clinical trial NCT00830804
Conditions: HIV-1 Infections
Keywords: Treatment Naive
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2009-04-01; Completion date: 2010-09-01
Enrollment: 113 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.

Detailed description:
Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose of this study is to estimate the cumulative proportion of ART-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).

The study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial.

After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry.

RAL and DRV were provided by the study. RTV was not provided by the study.

Arms: arm 1: Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
Interventions: intervention 1: Raltegravir intervention 2: Darunavir/Ritonavir
Intervention descriptions: intervention 1: 400 mg tablet taken orally twice daily intervention 2: 800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily

Protocol documents:
Clinical trial NCT00846547
Conditions: Autism Spectrum Disorders
Keywords: Autism Autism Spectrum Disorders irritability aberrant behavior
Sponsor: Seaside Therapeutics, Inc.
Start date: 2009-02-01; Completion date: 2010-09-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study objective is to explore the safety and tolerability of STX209 in subjects with Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in treating irritability. We hypothesize that STX209 will be safe and well-tolerated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Arbaclofen
Intervention descriptions: intervention 1: variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period

Protocol documents: