ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01316341
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2011-03-01; Completion date: 2012-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
the pharmacokinetics, pharmacodynamics and safety and tolerability of single and multiple oral doses of BI 10773 at low dose once daily (q.d.) and high dose q.d. administered to Chinese female and male patients with type 2 diabetes will be investigated.

Detailed description:

Arms: arm 1: patient to receive a tablet containing low dose BI10773 Per Os(p.o.) plus one placebo arm 2: patient to receive two placebos arm 3: patient to receive a tablet containing high dose BI10773 Per Os(p.o.) plus one placebo
Interventions: intervention 1: BI10773 intervention 2: Placebo intervention 3: Placebo intervention 4: Placebo intervention 5: BI10773
Intervention descriptions: intervention 1: patient to receive a tablet containing high dose BI10773 p.o. plus one placebo intervention 2: patient to receive two placebos intervention 3: patient to receive two placebos intervention 4: patient to receive two placebos intervention 5: patient to receive a tablet containing low dose BI10773 p.o. plus one placebo

Protocol documents:
Clinical trial NCT01324310
Conditions: Hematologic Malignancy Malignant Lymphoma
Keywords: ROMI-001 romi Romidepsin Istodax advanced malignancy PK pharmacokinetics
Sponsor: Celgene
Start date: 2011-04-01; Completion date: 2012-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect and safety of multiple doses of ketoconazole on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.

Detailed description:

Arms: arm 1: Romidepsin 8 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8.

Ketoconazole 400 mg oral once daily on Days 4-8
Interventions: intervention 1: Romidepsin intervention 2: Ketoconazole
Intervention descriptions: intervention 1: Romidepsin 8 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8. intervention 2: Ketoconazole 400 mg oral once daily on Days 4-8

Protocol documents:
Clinical trial NCT01335997
Conditions: Primary Hypercholesterolemia Mixed Dyslipidemia
Keywords: Low-density lipoprotein LDL High-density lipoprotein HDL Niacin Lipid modifying therapy Cholesterol High cholesterol Triglycerides
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-05-01; Completion date: 2012-01-01
Enrollment: 1139 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g /20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing low-density lipoprotein cholestrol (LDL-C).

Detailed description:

Arms: arm 1: Weeks 0-4 (Period 1): Participants will take ERN/LRPT/SIM 1 g/10 mg and SIM-matching placebo tablets daily; Weeks 5-12 (Period 2): Participants will be advanced to ERN/LRPT/SIM 2 g/20 mg and SIM-matching placebo tablets daily; Weeks 13-20 (Period III): Participants will crossover to ERN/LRPT 2 g + SIM 20 mg coadministration treatment. arm 2: Weeks 0-4 (Period I): Participants will take ERN/LRPT co-administered with SIM (ERN/LRPT 1g + SIM 10 mg tablets) daily; Weeks 5-12 (Period II): Participants will be advanced to ERN/LRPT 2 g + SIM 20 mg daily; Weeks 13-20 (Period III): Participants will crossover to the ERN/LRPT/SIM 2 g/20 mg combination treatment and SIM-matching placebo tablets.
Interventions: intervention 1: ER niacin/laropiprant (ERN/LRPT) intervention 2: ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM) intervention 3: Simvastatin (SIM) intervention 4: Placebo Run-In intervention 5: SIM-matching placebo
Intervention descriptions: intervention 1: ER niacin 1 g/laropiprant 20 mg oral tablet taken once daily intervention 2: ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet taken once daily intervention 3: Simvastatin 10 mg oral tablet taken once daily intervention 4: Placebo matches both ER niacin 1 g/laropiprant 20 mg oral tablet and ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet; placebo is taken once daily intervention 5: Placebo for simvastatin 10 mg oral tablet taken once daily

Protocol documents:
Clinical trial NCT01341405
Conditions: Osteoarthritis
Keywords: COX-1 COX-2 carbonic anhydrase anti-inflammatory Cyclooxygenase Inhibitors Polmacoxib
Sponsor: CrystalGenomics, Inc.
Start date: 2011-04-01; Completion date: 2012-01-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind, randomized, multicenter, phase 2b, noninferiority comparison of two active dose levels of CG100649 vs. a standard anti-arthritic dose of celecoxib (Celebrex).

Detailed description:
This is a double-blind, randomized, multicenter, noninferiority, phase 2 study. Subjects will discontinue current medications (NSAID or COX-2 inhibitor) 5-14 days prior to randomization. Paracetamol (acetaminophen; ≤2 gm/day) may be used for breakthrough pain. Other NSAIDs, COX-2 inhibitors, opioids, and corticosteroids may not be used at any time during this study. Only subjects recording average WOMAC pain score of 4 to 8 on a 0-10 numerical rating scale during the washout period and meeting all other inclusion criteria will be randomized into the study.

Male and female adults, ages 20 and older, with a history of osteoarthritis (OA) of the knee or hip diagnosed by radiograph obtained within the past 20 years and with pain at least 3 months from OA can participate in this study. OA must be confirmed by radiographs and diagnosed according to American College of Rheumatology (ACR) guidelines. Subjects must qualify as ACR global functional status I, II, or III (excluding IV) and Kellgren-Lawrence grade 1, 2 or 3 (excluding grade 4).

Subjects meeting screening criteria will be randomized to receive 28 days dosing of an active dose of CG100649 or comparator (celecoxib).

Antiarthritic efficacy will be evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) OA index completed on Day 1 (Baseline) and on Days 14, 28 and 42. The WOMAC pain subscale will be evaluated at screening and on Days 1, 7, 14, 21, 28, 35 and 42.

All doses will be administered orally once daily in the morning. There are 3 planned treatment arms (2 with active compound + one comparator (celecoxib) group) with n=44 per treatment arm. Total number of subjects will be 132.

Treatment A: CG100649: 2 mg/day (Days 1-28); Treatment B: CG100649: 4 mg/day (Days 1-28); Treatment C: celecoxib: 200 mg/day (Days 1-28); Active and comparator medications will have identical appearance.

Arms: arm 1: capsule, once daily for 28 days arm 2: capsule, once daily for 28 days arm 3: capsule, once daily for 28 days
Interventions: intervention 1: CG100649 intervention 2: Celecoxib
Intervention descriptions: intervention 1: once daily for 28 days intervention 2: capsule, celecoxib 200 mg, once daily for 28 days

Protocol documents:
Clinical trial NCT01349114
Conditions: Diabetes Pre-hypertension Hypertension
Keywords: aliskiren endothelial function hypertension
Sponsor: University of Alabama at Birmingham
Start date: 2011-06-01; Completion date: 2012-01-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.

Detailed description:
Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.

Arms: arm 1: aliskiren 300 mg daily arm 2: Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo
Interventions: intervention 1: aliskiren 300 mg once daily intervention 2: Placebo/sugar pill
Intervention descriptions: intervention 1: aliskiren 300 mg daily intervention 2: Sugar pill/placebo

Protocol documents:
Clinical trial NCT01355471
Conditions: Rosacea
Keywords: rosacea
Sponsor: Galderma R&D
Start date: 2011-05-01; Completion date: 2012-01-01
Enrollment: 293 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CD07805/47 Gel intervention 2: Placebo
Intervention descriptions: intervention 1: applied topically once daily intervention 2: applied topically once daily

Protocol documents:
Clinical trial NCT01364428
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-06-01; Completion date: 2012-01-01
Enrollment: 373 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin degludec
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.

Dose was individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.

Dose was individually adjusted.

Protocol documents:
Clinical trial NCT01370564
Conditions: Heart Failure
Keywords: Heart failure Cardiac filling pressure
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Start date: 2011-06-01; Completion date: 2012-01-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This chronic, prospective, non-randomized feasibility study is designed to evaluate the Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers Management to Patients with Advanced Signs \& Symptoms of Heart Failure (COMPASS-HF) Extension Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling pressures from the Chronicle device to provide timely medication adjustments (diuretics) to subjects.

Detailed description:
Subjects will be asked to transmit to the CareLink Network daily. Data specific to this study (subject's daily estimated Pulmonary Arterial Diastolic (ePAD) pressure values) will be extracted from the CareLink database and transferred to the IPC clinician website.

As each subject is enrolled, clinicians at each participating site will determine the appropriate target pressure range for each subject based on a review of the subject's pressure data. Each day after enrollment, the subject's current pressure data will be compared to a target pressure range that the clinician sets for that subject.

The patient instruction set (PtIS) is limited to a daily diuretic prescription and associated supplements, per physician discretion. The PtIS should not include adjustments of non-heart failure medications and should not include heart failure medications that are not indicated for day-to-day adjustments (e.g. ACE-Inhibitors, Angiotensin Receptor Blockers (ARBs), and Beta-Blockers). The PtIS will be sent from the IPC clinician website to the subject through a Patient Home Monitor.

Arms: arm 1: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Interventions: intervention 1: Diuretics
Intervention descriptions: intervention 1: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.

Protocol documents:
Clinical trial NCT01396226
Conditions: Arrhythmia
Keywords: Atrial refractoriness cardiac electrophysiology IKACh
Sponsor: AstraZeneca
Start date: 2011-09-01; Completion date: 2012-01-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Medical Products Agency

Detailed description:
* A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure.
* The study has an adaptive design. In the 1st dose group the planned number of randomised patients is 24. The tentative number of randomised patients in the optional 2nd dose group is 12, 24 or 36 and thus a total maximum of 60 patients will be randomised in the study.

Arms: arm 1: A single dose of AZD2927 administered as an iv infusion arm 2: A single dose of placebo administered as an iv infusion
Interventions: intervention 1: AZD2927 intervention 2: Placebo
Intervention descriptions: intervention 1: A single dose of AZD2927 administered as an iv infusion intervention 2: A single dose of placebo administered as an iv infusion

Protocol documents:
Clinical trial NCT01397084
Conditions: Gastroesophageal Reflux Disease GERD Reflux Esophagitis
Keywords: esomeprazole 20mg heartburn rabeprazole 10mg reflux esophagitis Phase IV
Sponsor: AstraZeneca
Start date: 2011-08-01; Completion date: 2012-01-01
Enrollment: 107 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.

Detailed description:

Arms: arm 1: esomeprazole 20 mg
Interventions: intervention 1: esomeprazole 20 mg
Intervention descriptions: intervention 1: esomeprazole 20 mg once daily for 8 weeks

Protocol documents:
Clinical trial NCT01403376
Conditions: Multiple Sclerosis
Sponsor: Sanofi
Start date: 2011-09-01; Completion date: 2012-01-01
Enrollment: 128 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population.

Secondary Objectives:

* Assess the effect of teriflunomide on immunoglobulin levels;
* Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide.

The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.

Detailed description:
The maximum duration of the study period for a participant was approximatively 49 days broken down as follows:

* Screening period of up to 21 days;
* Influenza vaccination at Day 1;
* Follow-up period of 28 days (±2 days).

MS treatment (Teriflunomide or interferon-β-1) was to be continued during the course of the study.

Arms: arm 1: Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months arm 2: Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months arm 3: Influenza vaccine in participants treated with a stable dose of Interferon-β-1 (IFN-β-1) for at least 6 months
Interventions: intervention 1: teriflunomide intervention 2: Interferon-β-1 intervention 3: Influenza vaccine
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection intervention 3: Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

Protocol documents:
Clinical trial NCT01417195
Conditions: Infertility
Keywords: Assisted Reproductive Technology
Sponsor: Ferring Pharmaceuticals
Start date: 2011-07-01; Completion date: 2012-01-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART). Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.

Detailed description:

Arms: arm 1: The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20. arm 2: The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
Interventions: intervention 1: Bravelle intervention 2: Menopur
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01426347
Conditions: Rheumatoid Arthritis Vitamin D Deficiency
Keywords: Rheumatoid Arthritis Vitamin D deficiency Disability
Sponsor: Johns Hopkins University
Start date: 2009-01-01; Completion date: 2012-01-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effect of vitamin D repletion on disease activity and disability in patients with rheumatoid arthritis.

The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D deficiency have greater disease activity and disability, compared to RA patients with normal vitamin D levels. The investigators also hypothesize that vitamin D treatment in these deficient patients will result in a decrease in RA disease activity and disability.

Detailed description:

Arms: arm 1: RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.

Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm. arm 2: Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
Interventions: intervention 1: Placebo sugar pill intervention 2: Ergocalciferol
Intervention descriptions: intervention 1: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule. intervention 2: Ergocalciferol 50,000 IU per week for 16 weeks

Protocol documents:
Clinical trial NCT01428076
Conditions: Varicose Veins
Keywords: Varicose Veins SFJ Reflux
Sponsor: Boston Scientific Corporation
Start date: 2011-08-01; Completion date: 2012-01-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the pharmacokinetic profile of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an investigational treatment for varicose veins.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Polidocanol Endovenous Microfoam (PEM)
Intervention descriptions: intervention 1: Pharmacokinetic comparison of different doses of drug

Protocol documents:
Clinical trial NCT01437501
Conditions: Environmental Carcinogenesis
Keywords: glucoraphanin sulforaphane pharmacokinetics pharmacodynamics broccoli sprout carcinogens, environment
Sponsor: Johns Hopkins Bloomberg School of Public Health
Start date: 2011-10-01; Completion date: 2012-01-01
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships will be screened and three hundred eligible individuals will be enrolled in the study. Participants will be randomized into two treatment groups: one will receive a juice beverage containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice, lime juice, and water and the other will receive a placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide biweekly urine samples and monthly blood samples. The principal endpoints of this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this population.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Broccoli Sprout Extract Beverage intervention 2: placebo beverage
Intervention descriptions: intervention 1: Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days. intervention 2: 100 mL of dilute pineapple and lime juice daily for 84 days.

Protocol documents:
Clinical trial NCT01437943
Conditions: Kidney Disease Kidney Failure, Chronic
Keywords: Transplant Failure Kidney
Sponsor: Brigham and Women's Hospital
Start date: 2010-04-01; Completion date: 2012-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of a short-term aliskiren treatment on kidney metabolism in patients at high risk for developing kidney dysfunction (i.e. kidney transplanted patients). The study is aimed at evaluating if any effect on kidney metabolism \[using proton MR Spectroscopy(1H-MRS)\] can be detected following a 6 months treatment with aliskiren regardless of its anti-hypertensive role. 1H-MRS can record a larger number of chemical species (up to 40) in the kidney, and monitor changes according to the pathologic state and health of the transplanted kidney.

Detailed description:

Arms: arm 1: Aliskiren 150 mg daily for 180 days arm 2: Placebo identical to Aliskiren drug daily for 180 days
Interventions: intervention 1: Aliskiren intervention 2: Placebo
Intervention descriptions: intervention 1: Take 1 tablet (150 mg) by mouth daily for 180 days intervention 2: Take 1 tablet (0 mg) daily for 180 days.

Protocol documents: