ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00999687
Conditions: Nail Psoriasis
Keywords: Nail psoriasis Indigo naturalis
Sponsor: Chang Gung Memorial Hospital
Start date: 2009-09-01; Completion date: 2010-09-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.

Detailed description:
Nail psoriasis treatment is notoriously difficult. While indigo naturalis has been demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis remains unverified.

Arms: arm 1: Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks. arm 2: Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.
Interventions: intervention 1: Indigo Naturalis Extract in Oil intervention 2: Olive Oil
Intervention descriptions: intervention 1: Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks intervention 2: Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.

Protocol documents:
Clinical trial NCT01006291
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-11-01; Completion date: 2010-09-01
Enrollment: 687 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: insulin degludec intervention 2: insulin degludec intervention 3: insulin glargine
Intervention descriptions: intervention 1: Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted. intervention 2: Injected s.c. (under the skin) once daily. Dose was individually adjusted. intervention 3: Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT01012037
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-11-01; Completion date: 2010-09-01
Enrollment: 491 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Detailed description:

Arms: arm 1: linagliptin low dose twice daily arm 2: placebo matching linagliptin arm 3: linagliptin medium dose once daily
Interventions: intervention 1: linagliptin low dose intervention 2: placebo intervention 3: linagliptin medium dose
Intervention descriptions: intervention 1: patient to receive tablets containing low dose linagliptin twice daily intervention 2: patient to receive placebo tablet(s) matching linagliptin intervention 3: patient to receive a tablet containing medium dose linagliptin once daily

Protocol documents:
Clinical trial NCT01016912
Conditions: Hepatitis C Infection
Sponsor: Bristol-Myers Squibb
Start date: 2009-12-01; Completion date: 2010-09-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

Detailed description:

Arms: arm 1: Treatment Naive arm 2: Treatment Naive arm 3: Treatment Naive arm 4: Non-Responder arm 5: Non-Responder
Interventions: intervention 1: BMS-790052 intervention 2: BMS-790052 intervention 3: Placebo intervention 4: Peginterferon alfa-2b intervention 5: Ribavirin
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, daily, 24-48 weeks intervention 2: Tablets, Oral, 60 mg, daily, 24-48 weeks intervention 3: Tablets, Oral, 0 mg, daily, 48 weeks intervention 4: Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks intervention 5: Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Protocol documents:
Clinical trial NCT01022112
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284 JNJ-28431754 Canagliflozin Type 2 diabetes mellitus Sodium Glucose Co-transporter (SGLT2 inhibitor)
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-11-01; Completion date: 2010-09-01
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

Detailed description:
Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of T2DM and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, placebo-controlled, parallel-group study to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with T2DM, who are not optimally controlled on diet and exercise. The primary study hypothesis is that the study drug will be superior to placebo as assessed by the change in HbA1c from baseline. The patients will receive tablets of TA-7284, or placebo, once daily for 12 weeks.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: TA-7284-Low intervention 2: TA-7284-Low-middle intervention 3: TA-7284-High-middle intervention 4: TA-7284-High intervention 5: Placebo
Intervention descriptions: intervention 1: TA-7284-Low intervention 2: TA-7284-Low-middle intervention 3: TA-7284-High-middle intervention 4: TA-7284-High intervention 5: Placebo

Protocol documents:
Clinical trial NCT01037192
Conditions: Skin and Soft Tissue Infections
Keywords: outpatient skin and soft tissue infections vancomycin intravenous
Sponsor: Fraser Health
Start date: 2010-03-01; Completion date: 2010-09-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.

Detailed description:

Arms: arm 1: Subject receives vancomycin 30 mg/kg dose arm 2: Subject receives vancomycin 15 mg/kg twice daily
Interventions: intervention 1: vancomycin intervention 2: vancomycin
Intervention descriptions: intervention 1: vancomycin 30 mg/kg intravenous administered once daily intervention 2: vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)

Protocol documents:
Clinical trial NCT01068964
Conditions: Open-angle Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2010-02-01; Completion date: 2010-09-01
Enrollment: 235 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension

Detailed description:

Arms: arm 1: Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution arm 2: Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
Interventions: intervention 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution intervention 2: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
Intervention descriptions: intervention 1: One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution intervention 2: One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Protocol documents:
Clinical trial NCT01070043
Conditions: Hypertension High Blood Pressure
Keywords: Hypertension valsartan amlodipine high blood pressure
Sponsor: Novartis
Start date: 2009-06-01; Completion date: 2010-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.

Detailed description:

Arms: arm 1: During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks. arm 2: In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks. arm 3: During run-in period, oral valsartan 80 mg once daily for 4 weeks.
Interventions: intervention 1: Amlodipine 5mg/Valsartan 80 mg intervention 2: Valsartan
Intervention descriptions: intervention 1: Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks. intervention 2: For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks.

Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks

Protocol documents:
Clinical trial NCT01078623
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Bronchitis Chronic Emphysema
Sponsor: AstraZeneca
Start date: 2010-02-01; Completion date: 2010-09-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.

Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.

Detailed description:

Arms: arm 1: Formoterol fumarate 12 μg twice daily arm 2: Placebo twice daily arm 3: Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily arm 4: Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily arm 5: Aclidinium bromide 200 μg twice daily
Interventions: intervention 1: Aclidinium 200 μg / formoterol 12 μg intervention 2: Placebo intervention 3: Formoterol 12 μg intervention 4: Aclidinium 200 μg intervention 5: Aclidinium 200 μg / Formoterol 6 μg
Intervention descriptions: intervention 1: Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily intervention 2: Placebo control twice daily intervention 3: Formoterol fumarate 12 μg twice daily intervention 4: Aclidinium bromide 200 μg twice daily intervention 5: Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily

Protocol documents:
Clinical trial NCT01078753
Conditions: Nocturnal Enuresis
Sponsor: Ferring Pharmaceuticals
Start date: 2010-01-01; Completion date: 2010-09-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."

Detailed description:

Arms: arm 1: During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of \<75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II. arm 2: Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
Interventions: intervention 1: Desmopressin intervention 2: Placebo
Intervention descriptions: intervention 1: Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime. intervention 2: Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.

Protocol documents:
Clinical trial NCT01085006
Conditions: Hemorrhage
Keywords: cesarean delivery Tranexamic acid hemorrhage Spinal analgesia 1-the amount of hemorrhage during cesarean delivery 2-the amount of hemorrhage in the first 2 hours of cesarean delivery 3-the amount of hemorrhage in the first 24 hour after cesarean delivery
Sponsor: Tehran University of Medical Sciences
Start date: 2009-09-01; Completion date: 2010-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tranexamic acid intervention 2: Normal saline
Intervention descriptions: intervention 1: Tranexamic acid in cases, normal saline in controls intervention 2: Tranexamic acid in cases, normal saline in controls

Protocol documents:
Clinical trial NCT01086410
Conditions: Asthma
Keywords: HPA axis
Sponsor: GlaxoSmithKline
Start date: 2010-03-01; Completion date: 2010-09-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system

Detailed description:

Arms: arm 1: Fluticasone furoate/GW642444 Dose B inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study arm 2: Fluticasone furoate/GW642444 Dose A inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study arm 3: Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study arm 4: Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral prednisolone 10mg capsule each day on the last 7 days of the study
Interventions: intervention 1: Placebo Inhalation Powder intervention 2: Fluticasone Furoate/GW642444 Inhalation Powder intervention 3: Fluticasone Furoate/GW642444 Inhalation Powder intervention 4: Placebo Oral Capsule intervention 5: Prednisolone Oral Capsule
Intervention descriptions: intervention 1: Placebo Inhalation powder inhaled once daily for 6 weeks' treatment intervention 2: Dose B inhaled once daily for 6 weeks' treatment intervention 3: Dose A inhaled once daily for 6 weeks' treatment intervention 4: One placebo capsule taken each day on the last 7 days of the study intervention 5: Prednisolone 10mg oral capsule taken each day on the last 7 days of the study

Protocol documents:
Clinical trial NCT01104246
Conditions: Hypogonadism
Keywords: Hypogonadism Testosterone Hormone replacement therapy
Sponsor: Watson Pharmaceuticals
Start date: 2010-04-01; Completion date: 2010-09-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Detailed description:
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.

Arms: arm 1: Testosterone
Interventions: intervention 1: Testerone Transdermal System
Intervention descriptions: intervention 1: Transdermal testosterone applied daily for 4 weeks

Protocol documents:
Clinical trial NCT01106248
Conditions: Advanced Solid Tumor
Keywords: tumor
Sponsor: Eisai Limited
Start date: 2009-03-01; Completion date: 2010-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis.

Detailed description:
This is an open-label, multicenter, single arm QT Interval prolongation study of eribulin mesylate (E7389) in patients with advanced solid tumors.

Arms: arm 1: None
Interventions: intervention 1: Eribulin Mesylate
Intervention descriptions: intervention 1: 1.4 mg/m\^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.

Protocol documents:
Clinical trial NCT01106859
Conditions: Insomnia
Keywords: insomnia
Sponsor: Transcept Pharmaceuticals
Start date: 2010-06-01; Completion date: 2010-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The next morning driving performance will be measured by taking a standardized driving test.

Detailed description:

Arms: arm 1: Zopiclone is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet. arm 2: A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving. arm 3: A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 4 hours prior to driving. arm 4: A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Interventions: intervention 1: zopiclone intervention 2: zolpidem tartrate sublingual tablet intervention 3: Placebo (sublingual tablet) intervention 4: Placebo
Intervention descriptions: intervention 1: 7.5 mg tablet by mouth. Zopiclone is a commonly used hypnotic in Europe that is known to impair driving in the morning 9 hours after dosing. intervention 2: 3.5 mg zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 3: Placebo matching zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 4: Placebo matching zopiclone

Protocol documents:
Clinical trial NCT01119287
Conditions: Allergic Conjunctivitis
Keywords: Conjunctivitis ocular allergy
Sponsor: Alcon Research
Start date: 2010-03-01; Completion date: 2010-09-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).

Detailed description:
This study consisted of 6 visits. Visit 1 was the Medical Screening Visit (skin prick test). Visit 2 and Visit 3 consisted of 2 consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the Clinic, 10 hours total, each visit) followed by 7 days of wash-out. Visit 2 and Visit 3 occurred prior to dispense and the measures obtained during these visits were used as baseline. At Visit 4 patients were randomized and dispensed the assigned study medication for 7 days of at-home dosing. Visit 5 (Day 8 of treatment) and Visit 6 (Day 9 of treatment) consisted of 2 additional consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the clinic, 10 hours total, each visit). During each EEC visit, patients were exposed to either ragweed or cat allergen, depending on their skin prick test results. Of the 180 participants enrolled, 170 received at least one dose of study treatment and were randomized to one of the three study treatments.

Arms: arm 1: Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] arm 2: Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] arm 3: Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
Interventions: intervention 1: Dexamethasone 0.1% ophthalmic suspension intervention 2: Olopatadine hydrochloride 0.1% ophthalmic solution intervention 3: Inactive ingredients, used as placebo
Intervention descriptions: intervention 1: Maxidex intervention 2: Patanol intervention 3: Tears Naturale II

Protocol documents: