ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01626118
Conditions: Other Acute Postoperative Pain
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2012-05-01; Completion date: 2012-08-01
Enrollment: 373 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Indomethacin intervention 2: Indomethacin intervention 3: Indomethacin intervention 4: Placebo
Intervention descriptions: intervention 1: capsules, 40 mg, TID intervention 2: capsules, 40 mg, BID intervention 3: capsules, 20 mg, TID intervention 4: capsules

Protocol documents:
Clinical trial NCT01630135
Conditions: Rhinitis, Allergic, Perennial
Sponsor: GlaxoSmithKline
Start date: 2012-06-01; Completion date: 2012-08-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to \< 15 years with perennial allergic rhinitis will be evaluated compared with placebo.

Detailed description:

Arms: arm 1: GW685698X 55mcg/day arm 2: Placebo
Interventions: intervention 1: Fluticasone furoate intervention 2: Placebo
Intervention descriptions: intervention 1: 55 mcg/day, intranasal, 2 weeks intervention 2: Placebo, intranasal, 2 weeks

Protocol documents:
Clinical trial NCT01634100
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-06-01; Completion date: 2012-08-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.

Detailed description:

Arms: arm 1: Empagliflozin (BI 10773), Film-coated tablet, single dose arm 2: Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose arm 3: Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily
Interventions: intervention 1: Probenecid intervention 2: Rifampicin intervention 3: Empagliflozin intervention 4: Empagliflozin intervention 5: Rifampicin intervention 6: Probenecid intervention 7: Empagliflozin (BI 10773)
Intervention descriptions: intervention 1: Probenecid intervention 2: Rifampicin intervention 3: BI Drug intervention 4: BI Drug intervention 5: Rifampicin intervention 6: Probenecid intervention 7: BI Drug

Protocol documents:
Clinical trial NCT01639222
Conditions: Calcium Deficiency Vitamin D Deficiency
Keywords: Drug therapy Increase in calcium urinary excretion and PTH decrease in serum
Sponsor: Takeda
Start date: 2012-07-01; Completion date: 2012-08-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to baseline.

Detailed description:
The drug being tested in this study is called Calcichew. This study will look at calcium absorption in healthy postmenopausal women and healthy men.

The study will enroll approximately 55 healthy adults. All participants will receive Calcichew.

All participants will be asked to take one chewable tablet at the same time each day for three days in period 2 of the trial.

This trial will be conducted at one clinical site in Germany. The overall time to participate in this study is 4 weeks. Participants will make 9 visits to the clinic, and will be contacted by telephone 7days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Period 1: Low calcium meals for up to 3 days.

Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals.
Interventions: intervention 1: Calcium 500 mg and Vitamin D3 800 IU intervention 2: Low calcium meals
Intervention descriptions: intervention 1: Calcium 500 mg and Vitamin D3 800 IU chewable tablets intervention 2: A normal Western European diet with reduced calcium content (400 mg per day).

Protocol documents:
Clinical trial NCT01648790
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-07-01; Completion date: 2012-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.

Detailed description:
The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).

Arms: arm 1: 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state. arm 2: 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state. arm 3: 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state. arm 4: 5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast. arm 5: 2 mg Prasugrel as ODT2 formulation administered once in the fasted state.
Interventions: intervention 1: Prasugrel ODT1 - Tablet intervention 2: Prasugrel ODT2 - Tablet intervention 3: Prasugrel ODT2 - Suspension
Intervention descriptions: intervention 1: Administered orally as tablet. intervention 2: Administered orally as tablet. intervention 3: Administered orally as suspension.

Protocol documents:
Clinical trial NCT01665170
Conditions: Healthy Stress
Keywords: Pascoflair tsst passiflora incarnata non smoking male and female volunteers
Sponsor: Pascoe Pharmazeutische Praeparate GmbH
Start date: 2012-05-01; Completion date: 2012-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation

Detailed description:
Randomized, double-blind, placebo-controlled, single-center study During Visit 1 study information and an informed consent form are handed out. After study inclusion on Visit 2, participants are assigned to one of two groups at random and receive the test products (either Pascoflair® or placebo tablets). The 3rd visit includes the completion of questionnaires regarding wellbeing and the Trier Social Stress Test.

Arms: arm 1: Placebo arm arm 2: Verum arm - Pascoflair 425mg
Interventions: intervention 1: Passiflora incarnata intervention 2: Placebo
Intervention descriptions: intervention 1: 3 x 1 tablet per day for 3 days intervention 2: 3 x 1 ablet per day for 3 days

Protocol documents:
Clinical trial NCT01669122
Conditions: Smoking Cessation
Sponsor: GlaxoSmithKline
Start date: 2012-06-01; Completion date: 2012-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.

Detailed description:

Arms: arm 1: 4mg nicotine lozenge administered orally as a single dose treatment per subject arm 2: 4mg nicotine lozenge administered orally as a single dose treatment per subject arm 3: 4mg nicotine lozenge administered orally as a single dose treatment per subject arm 4: 4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject.
Interventions: intervention 1: nicotine
Intervention descriptions: intervention 1: 4 mg nicotine lozenge experimental

Protocol documents:
Clinical trial NCT01672827
Conditions: Alzheimer's Disease Mild Cognitive Impairment
Keywords: Alzheimer's Disease Mild Cognitive Impairment Positron Emission Tomography (PET) PET Images
Sponsor: GE Healthcare
Start date: 2012-07-01; Completion date: 2012-08-01
Enrollment: 276 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting \[18F\]flutemetamol Positron Emission Tomography (PET) Images.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: [18F]Flutemetamol
Intervention descriptions: intervention 1: No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.

Protocol documents:
Clinical trial NCT01672996
Conditions: Healthy
Keywords: Use in Abdominal Contrast Enhanced Computed Tomography Optimize concentration dosage of Ioforminol Injection
Sponsor: GE Healthcare
Start date: 2012-07-01; Completion date: 2012-08-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.

Detailed description:

Arms: arm 1: Single administration of Ioforminol 160mgI/mL given to the subject. arm 2: Given as a single administration to the subject arm 3: Given as a single administration to the subject
Interventions: intervention 1: Ioforminol 160 mgI/mL intervention 2: Ioforminol 200 mgI/mL intervention 3: Iopamidol 300 mgI/mL
Intervention descriptions: intervention 1: Given as s single administration to the subject intervention 2: Given as a single administration to the subject intervention 3: Given as a single administration to the subject

Protocol documents:
Clinical trial NCT01673009
Conditions: Neurofibromatosis
Keywords: Gleevec
Sponsor: Indiana University
Start date: 2006-05-01; Completion date: 2012-08-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients with plexiform neurofibromas

Detailed description:
This is an open-label Phase II Study to determine the efficacy of Gleevec® in neurofibromatosis (NF1) patients with plexiform neurofibromas with the secondary goals of determining the toxicity, and tumor markers in this genetically defined population. The rationale for this study arises from the response of human and murine NF1 cells to Gleevec® in vitro and the response of a single NF1 patient treated with Gleevec® for airway compression by a plexiform neurofibroma with a dramatic response not previously seen in NF1 therapy. The plan of therapy will include oral dosing of Gleevec® at 440 mg/m\^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients. (with 25% dose reduction for significant toxicity). Treatment will continue for 6 months with an option to continue as long as the patient remains on study provided the patient shows benefit from treatments with Gleevec® and there are no safety concerns.

Arms: arm 1: Gleevec® will be dosed orally 440 mg/m\^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
Interventions: intervention 1: Gleevec
Intervention descriptions: intervention 1: Gleevec® will be dosed orally 440 mg/m\^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.

Protocol documents:
Clinical trial NCT01798589
Conditions: Allergic Contact Dermatitis
Keywords: ethylenediamine dihydrochloride
Sponsor: Allerderm
Start date: 2012-07-01; Completion date: 2012-08-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.

Detailed description:
We propose an open, prospective, single-site study to evaluate the bioequivalence of ethylenediamine dihydrochloride in methylcellulose (MC)and polyvinylpyrrolidone (PVP) formulations. Bioequivalence will be determined in minimum of 15 adult subjects, with a clinical history of contact dermatitis and a positive patch test (current or previous) to ethylenediamine ("sensitives").

Arms: arm 1: Ethylenediamine dihydrochloride in methylcellulose 50 mcg/cm2 Ethylenediamine dihydrochloride in polyvinylpyrrolidone 50 mcg/cm2 Methylcellulose (negative control 1) Polyvinylpyrrolidone (negative control 2)
Interventions: intervention 1: Ethylenediamine dihydrochloride allergen patch
Intervention descriptions: intervention 1: 1 allergen panel containing 2 allergen and 2 control patches

Protocol documents:
Clinical trial NCT01859702
Conditions: Cataract
Keywords: Aqueous Humor Moxifloxacin Vigadexa
Sponsor: Alcon Research
Start date: 2012-04-01; Completion date: 2012-08-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.

Detailed description:

Arms: arm 1: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
Interventions: intervention 1: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00325468
Conditions: Low Bone Mineral Density
Keywords: bone loss osteoporosis
Sponsor: Amgen
Start date: 2006-05-01; Completion date: 2012-08-02
Enrollment: 200 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Detailed description:

Arms: arm 1: AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
Interventions: intervention 1: AMG 162
Intervention descriptions: intervention 1: AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42

Protocol documents:
Clinical trial NCT01445301
Conditions: Acne Vulgaris
Keywords: twice daily once daily CLDM 1%-BPO 3% gel Clindamycin (CLDM) benzoyl peroxide (BPO) inflammatory lesion non-inflammatory lesion acne vulgaris
Sponsor: GlaxoSmithKline
Start date: 2011-09-27; Completion date: 2012-08-02
Enrollment: 800 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin \[CLDM\] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide \[BPO\] 3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.

Detailed description:
Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions (open and closed comedones), including nasal lesions. The primary objectives are to demonstrate the superiority of GSK2585823 twice daily to CLDM twice daily in total lesion counts, and to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in total lesion counts. The secondary objectives are to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in inflammatory lesion counts, and to evaluate the efficacy of GSK2585823 once or twice daily compared with CLDM twice daily at each visit. A total of 800 subjects will be enrolled and randomly assigned to one of the groups.

Arms: arm 1: Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. arm 2: Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime. arm 3: Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime.
Interventions: intervention 1: GSK2585823(CLDM 1%-BPO 3% gel) intervention 2: CLDM 1% gel twice daily
Intervention descriptions: intervention 1: Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg intervention 2: Topical gel containing clindamycin 10 mg/1 g gel

Protocol documents:
Clinical trial NCT01138007
Conditions: Depressive Disorder, Major
Keywords: Bupropion 323U66 Sustained Release (SR) MDD (Major Depressive Disorder) IVRS HAM-D IDS-SR MADRS
Sponsor: GlaxoSmithKline
Start date: 2010-06-17; Completion date: 2012-08-07
Enrollment: 572 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total score, and to evaluate the safety based on adverse events, clinical laboratory tests and vital signs.

Detailed description:

Arms: arm 1: 323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening throughout the treatment phase. arm 2: 323U66 SR 150 mg tablet is orally administered once in the morning and 323U66 SR 150 mg placebo tablet is orally administered once in the evening during the first week of the treatment phase. At the second week, 323U66 SR 300mg cohort is up-titrated to a daily dose of 323U66 SR 300 mg, administered as 323U66 SR 150 mg tablet twice daily in the morning and in the evening, and the same daily dose is maintained to administer until the end of the treatment phase. arm 3: 323U66 SR placebo tablet is orally administered twice daily throughout the treatment phase.
Interventions: intervention 1: 323U66 SR 150 mg tablet intervention 2: 323U66 SR 150 mg placebo tablet
Intervention descriptions: intervention 1: 323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase. intervention 2: 323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase.

Protocol documents:
Clinical trial NCT01463098
Conditions: Insomnia
Sponsor: Eisai Inc.
Start date: 2011-10-05; Completion date: 2012-08-11
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects.

Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None arm 11: None arm 12: None arm 13: None arm 14: None
Interventions: intervention 1: E2006 1.0 mg intervention 2: E2006 2.5 mg intervention 3: E2006 5.0 mg intervention 4: E2006 10.0 mg intervention 5: E2006 25.0 mg intervention 6: E2006 50.0 mg intervention 7: E2006 100 mg intervention 8: E2006 200 mg intervention 9: Zolpidem 10 mg intervention 10: E2006 Matched Placebo or Zolpidem Matched Placebo intervention 11: E2006 Matched Placebo
Intervention descriptions: intervention 1: E2006 1.0 mg capsule. intervention 2: E2006 2.5 mg capsule. intervention 3: E2006 5.0 mg (2 capsules of 2.5 mg each). intervention 4: E2006 10.0 mg capsule. intervention 5: E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each). intervention 6: E2006 50.0 mg capsule. intervention 7: E2006 100 mg (2 capsules of 50 mg each). intervention 8: E2006 200 mg (4 capsules of 50 mg each). intervention 9: Zolpidem 10 mg immediate release tablet. intervention 10: E2006-matched placebo capsules or zolpidem-matched placebo tablets. intervention 11: E2006-matched placebo capsule.

Protocol documents:
Clinical trial NCT01117051
Conditions: Non-cancer Pain Opioid Induced Constipation
Keywords: Opioid induced constipation/prucalopride chronic non-cancer pain Subjects with chronic non-cancer pain suffering from OIC
Sponsor: Shire
Start date: 2010-05-19; Completion date: 2012-08-13
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.

Detailed description:

Arms: arm 1: placebo arm 2: prucalopride
Interventions: intervention 1: placebo intervention 2: prucalopride
Intervention descriptions: intervention 1: placebo intervention 2: 1 or 2 mg prucalopride once daily before breakfast

Protocol documents:
Clinical trial NCT00756938
Conditions: Hypertension
Sponsor: Organon and Co
Start date: 2009-03-01; Completion date: 2012-08-14
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.

Detailed description:

Arms: arm 1: Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved arm 2: Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved arm 3: Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Interventions: intervention 1: losartan potassium
Intervention descriptions: intervention 1: losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.

Protocol documents: