ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01026454
Conditions: HSV Infection HIV Infection
Keywords: HSV HIV
Sponsor: University of Washington
Start date: 2010-02-01; Completion date: 2010-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether treating HSV-2 with either valacyclovir or acyclovir is more effective in suppressing HIV-1 virus levels in people co-infected with HIV-1 and HSV-2.

Detailed description:
Sexual transmission is responsible for the vast majority of HIV-1 infections among adults worldwide. In sub-Saharan Africa, the region hardest hit by the HIV-1 epidemic, HSV-2 prevalences of 30-50% have been seen in the general population with prevalence up to 90% in infected with HIV-1. HSV-2 is common in those with, or at risk for, HIV-1 infection, and HSV-2 reactivation increases HIV-1 acquisition and infectiousness. Recent studies have shown that suppression of HSV-2 has a sustained effect on lowering HIV-1 levels in blood plasma. New data have raised the question whether higher doses of HSV-2 suppressive therapy might be more effective at suppressing HIV-1 levels. Acyclovir and valacyclovir, chosen for use in this study, are safe and effective treatments for decreasing the frequency of HSV-2 reactivation and shedding. The standard dose of acyclovir is 400 mg twice a day. Valacyclovir, a drug that converts to acyclovir after absorption, delivers higher concentrations of acyclovir. 1.5 grams of valacyclovir, will be used to provide a higher dose of acyclovir, and will be compared with the standard dose of 400 mg twice a day of acyclovir.

Arms: arm 1: acyclovir 400 mg orally twice daily arm 2: valacyclovir 1.5 g orally twice daily
Interventions: intervention 1: acyclovir intervention 2: valacyclovir
Intervention descriptions: intervention 1: acyclovir 400 mg orally, twice daily for 12 weeks intervention 2: valacyclovir 1.5 g orally, twice daily, for 12 weeks

Protocol documents:
Clinical trial NCT01032889
Conditions: Moderate or Severe Submental Fullness
Sponsor: Kythera Biopharmaceuticals
Start date: 2009-12-01; Completion date: 2010-12-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Detailed description:

Arms: arm 1: Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. arm 2: Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. arm 3: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Interventions: intervention 1: Deoxycholic acid injection intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Phosphate buffered saline placebo for injection

Protocol documents:
Clinical trial NCT01037816
Conditions: Ankle Sprain
Keywords: Ankle Sprain
Sponsor: Hisamitsu Pharmaceutical Co., Inc.
Start date: 2009-12-01; Completion date: 2010-12-01
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).

Detailed description:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

Arms: arm 1: One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) arm 2: One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Interventions: intervention 1: FS-67 Patch intervention 2: Placebo Patch
Intervention descriptions: intervention 1: One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) intervention 2: One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Protocol documents:
Clinical trial NCT01043094
Conditions: Severe Renal Impairment
Sponsor: Kowa Research Institute, Inc.
Start date: 2009-12-01; Completion date: 2010-12-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):

The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.

Detailed description:

Arms: arm 1: Subjects with severe renal impairment (glomerular filtration rate \[GFR\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis arm 2: Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Interventions: intervention 1: Pitavastatin 4mg
Intervention descriptions: intervention 1: Pitavastatin 4mg single dose

Protocol documents:
Clinical trial NCT01048697
Conditions: Obesity Tuberculosis
Keywords: Obesity Pharmacokinetics Pharmacodynamics Dose individualization Tuberculosis
Sponsor: Texas Tech University Health Sciences Center
Start date: 2010-01-01; Completion date: 2010-12-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner volunteers, and those with a BMI \> 40 kg/m2 will have even greater clearance than those who are leaner.

Detailed description:

Arms: arm 1: All volunteers in each category will receive a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines.1 We will not use any doses higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):

40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) \> 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)
Interventions: intervention 1: Ethambutol
Intervention descriptions: intervention 1: All volunteers in each category will receive a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines.1 We will not use any doses higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):

40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) \> 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)

Protocol documents:
Clinical trial NCT01056380
Conditions: Influenza
Keywords: influenza influenza like illness
Sponsor: Romark Laboratories L.C.
Start date: 2010-01-01; Completion date: 2010-12-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, we hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities, and viral shedding.

Detailed description:
The study is conducted at approximately 25 sites in the United States. Subjects selected based on symptoms will be randomized to receive oral nitazoxanide or placebo twice daily for 5 days. Subjects will be monitored by daily by telephone or home visit to monitor symptoms and complications of influenza for safety and will be referred for medical care as required. Subjects will complete a diary twice daily to record the presence and severity of symptoms, ability to perform normal daily activities and time lost from work. Complications of influenza (including sinusitis, otitis, bronchitis, pneumonia, central nervous system disease) and other adverse events will be reported. Nasopharyngeal swabs will be collected at Baseline (Day 0) and Day 7 for all patients and on Days 1 through 4 for a subset of patients to test for influenza A (including novel H1N1), influenza B and 17 other respiratory viruses by RT-PCR and culture and to evaluate quantitative viral shedding. The primary analysis will be for patients with confirmed influenza, and secondary analyses will be conducted for subjects with any respiratory virus and for all treated subjects.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nitazoxanide intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, 500 mg with food twice daily for 5 days intervention 2: Tablet, twice daily with food for 5 days

Protocol documents:
Clinical trial NCT01057433
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Sponsor: Kowa Research Institute, Inc.
Start date: 2010-01-01; Completion date: 2010-12-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Detailed description:
This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be one treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through 24. Pitavastatin will be administered under fasting conditions in the morning and lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.

Arms: arm 1: Healthy adult subjects
Interventions: intervention 1: Pitavastatin (NK-104) intervention 2: Lopinavir/ritonavir
Intervention descriptions: intervention 1: pitavastatin (NK-104) 4 mg once daily (QD) intervention 2: lopinavir/ritonavir 800 mg/200 mg

Protocol documents:
Clinical trial NCT01058642
Conditions: Postherpetic Neuralgia
Keywords: pain delta opioid receptor agonist
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2010-01-01; Completion date: 2010-12-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN). The secondary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of ADL5747.

Detailed description:

Arms: arm 1: ADL5747 150 milligrams (mg) administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods. arm 2: Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.

Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. arm 3: Pregabalin administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
Interventions: intervention 1: ADL5747 intervention 2: Placebo intervention 3: Pregabalin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01062165
Conditions: Obesity Fungal Infection
Keywords: Echinocandin Obesity Pharmacokinetics Pharmacodynamics Fungal infection
Sponsor: Texas Tech University Health Sciences Center
Start date: 2010-02-01; Completion date: 2010-12-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.

Detailed description:

Arms: arm 1: Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.
Interventions: intervention 1: Caspofungin
Intervention descriptions: intervention 1: Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)

Protocol documents:
Clinical trial NCT01068873
Conditions: HIV Infections
Keywords: HIV Protease Inhibitor CCR5 Co-receptor Antagonist treatment naive
Sponsor: Temple University
Start date: 2010-04-01; Completion date: 2010-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty patients will be enrolled and studied for 48 weeks.

Detailed description:
As patients with HIV are living longer it is important to explore antiretroviral treatments which may reduce the development of long term complications while preserving future HIV treatment options. This trial explores an antiretroviral treatment regimen which does not include the nucleoside reverse transcriptase inhibitor class which is thought to have long-term toxicity. This is a non-randomized, open label trial in participants meeting entry requirements.

Participants will be evaluated at screening, baseline,and weeks 4, 8, 12, 24, 36, and 48 to include clinical assessments as well as laboratory assessments.

An interim analysis will be performed when all patients have reached the week 24 visit.

Arms: arm 1: Drug: lopinavir/ritonavir plus maraviroc
Interventions: intervention 1: lopinavir/ritonavir plus maraviroc
Intervention descriptions: intervention 1: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.

Protocol documents:
Clinical trial NCT01076647
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-03-01; Completion date: 2010-12-01
Enrollment: 467 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial was conducted in Europe and North America. The aim of this clinical trial was to compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine
Intervention descriptions: intervention 1: Will be injected subcutaneously (under the skin) once daily three times weekly. intervention 2: Will be injected subcutaneously (under the skin) once daily administered at the same time each day.

Protocol documents:
Clinical trial NCT01100606
Conditions: Cystic Fibrosis Exocrine Pancreatic Insufficiency
Keywords: Exocrine Pancreatic Insufficiency Infants with CF
Sponsor: Forest Laboratories
Start date: 2010-06-01; Completion date: 2010-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma (formerly Eurand).

Detailed description:
This is a multicenter, randomized, open-label, crossover study in pediatric participants with EPI due to CF. The study will be carried out in infants between 1 and 12 months of age.

The study comprises of a screening period (up to 10 days) followed by 2 treatment periods (10 days each). During the screening period, all participants will be administered Zenpep® 5,000 (pancrelipase) mixed with a small amount of apple sauce. Once determined eligible for participation, participants will be randomized into 1 of 2 treatment sequences. Each sequence corresponds to taking one treatment in the first period and the other treatment in the second period, and were administered EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) 3,000 lipase units capsule either mixed with apple juice using a syringe nurser or apple sauce using a spoon.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: EUR-1008 (APT-1008) intervention 2: EUR-1008 (APT-1008)
Intervention descriptions: intervention 1: EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple juice, will be given orally daily using a syringe nurser at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day. intervention 2: EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) from open capsule, mixed with a small amount of apple sauce, will be given orally daily using a spoon at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total dose will not exceed 10,000 lipase units per kg of body weight per day.

Protocol documents:
Clinical trial NCT01104701
Conditions: Type 2 Diabetes
Keywords: Exenatide Amylin Lilly Byetta Exenatide Once Weekly
Sponsor: AstraZeneca
Start date: 2010-05-01; Completion date: 2010-12-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.

Detailed description:

Arms: arm 1: 2 mg exenatide once weekly subcutaneous (SC). This arm is used as a reference arm in the study. arm 2: Low dose 5 mg exenatide once monthly suspension SC. arm 3: Medium dose 8 mg exenatide once monthly suspension SC. arm 4: High dose 11 mg exenatide once monthly suspension SC.
Interventions: intervention 1: exenatide once weekly intervention 2: exenatide once monthly suspension intervention 3: exenatide once monthly suspension intervention 4: exenatide once monthly suspension
Intervention descriptions: intervention 1: subcutaneous injection, 2 mg, once a week intervention 2: subcutaneous injection, low dose, once a month intervention 3: subcutaneous injection, medium dose, once a month intervention 4: subcutaneous injection, high dose, once a month

Protocol documents:
Clinical trial NCT01107899
Conditions: Acute Coronary Syndromes
Keywords: Acute Coronary Syndromes Angina Platelet Function Coronary Angiography Clinical Symptoms of Angina Positive Stress Test
Sponsor: Eli Lilly and Company
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate how platelets recover to normal function in subjects who have symptoms of a heart attack or unstable angina and who get a loading dose of prasugrel or clopidogrel for planned coronary angiography.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: clopidogrel intervention 2: prasugrel
Intervention descriptions: intervention 1: taken orally, day one, single dose intervention 2: taken orally, day one, single dose

Protocol documents:
Clinical trial NCT01119950
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2010-04-01; Completion date: 2010-12-01
Enrollment: 388 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: NVA237 12.5 µg once daily arm 2: NVA237 25.0 µg once daily arm 3: NVA237 12.5 µg twice daily arm 4: NVA237 50.0 µg once daily arm 5: NVA237 25.0 µg twice daily arm 6: NVA237 100.0 µg once daily arm 7: NVA237 50.0 µg twice daily arm 8: Placebo to NVA237 once daily
Interventions: intervention 1: NVA237 12.5 µg once daily intervention 2: NVA237 25.0 µg once daily intervention 3: NVA237 12.5 µg twice daily intervention 4: NVA237 50.0 µg once daily intervention 5: NVA237 25.0 µg twice daily intervention 6: NVA237 100.0 µg once daily intervention 7: NVA237 50.0 µg twice daily intervention 8: Placebo to NVA237 once daily
Intervention descriptions: intervention 1: NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 2: NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 3: NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. intervention 4: NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 5: NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. intervention 6: NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2. intervention 7: NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2. intervention 8: Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

Protocol documents: