ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00830791
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-01-01; Completion date: 2009-09-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.

Detailed description:

Arms: arm 1: MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes. arm 2: MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes. arm 3: MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes. arm 4: MK-0941 20 mg administered to age-, gender-, race-, body mass index (BMI)-, and hemoglobin A1C (HbAIc)-matched control subjects with normal renal function and type 2 diabetes. arm 5: MK-0941 5 mg administered to age-, gender-, race-, body mass index (BMI)-, and HbAIc-matched control subjects with normal renal function and type 2 diabetes.
Interventions: intervention 1: MK-0941 20 mg intervention 2: MK-0941 5 mg
Intervention descriptions: intervention 1: Two 10-mg tablets of MK-0941 administered as a single oral dose. intervention 2: MK-0941 administered as one single 5-mg tablet.

Protocol documents:
Clinical trial NCT00834210
Conditions: Acne Vulgaris
Sponsor: Allergan
Start date: 2008-12-01; Completion date: 2009-09-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris

Detailed description:

Arms: arm 1: Dapsone Gel 5% and Tazarotene Cream 0.1% arm 2: Tazarotene Cream 0.1%
Interventions: intervention 1: Dapsone intervention 2: Tazarotene
Intervention descriptions: intervention 1: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks intervention 2: Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks

Protocol documents:
Clinical trial NCT00841672
Conditions: Moderate to Severe Hypertension
Keywords: Hypertension systolic blood pressure cardiovascular disease aliskiren amlodipine
Sponsor: Novartis
Start date: 2009-01-01; Completion date: 2009-09-01
Enrollment: 485 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.

Detailed description:

Arms: arm 1: Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. arm 2: Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
Interventions: intervention 1: Aliskiren/amlodipine 300/10 mg tablet intervention 2: Amlodipine 10 mg capsule
Intervention descriptions: intervention 1: Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study. intervention 2: Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Protocol documents:
Clinical trial NCT00847197
Conditions: Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-06-01; Completion date: 2009-09-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.

Detailed description:

Arms: arm 1: MK1903 arm 2: Placebo to MK1903
Interventions: intervention 1: MK1903 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period. intervention 2: Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.

Protocol documents:
Clinical trial NCT00847210
Conditions: Gastroesophageal Reflux
Keywords: Esophageal Reflux Gastro-Esophageal Reflux Gastroesophageal Reflux Disease GERD Regurgitation, Gastric Heartburn Drug Therapy Adolescent
Sponsor: Takeda
Start date: 2009-05-01; Completion date: 2009-09-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.

Detailed description:
Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the reflux of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of Gastroesophageal reflux disease in the pediatric population is becoming increasingly recognized and documented. It is a chronic disease that can persist through adulthood with symptoms in older children and adolescents being similar to those seen in adults. The prevalence of gastroesophageal reflux disease increases with age, from 2.5% of children between the ages of 3 and 9 years, to 8.5% of those between the ages of 10 and 17 years.

Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type gastroesophageal reflux disease symptoms of heartburn and regurgitation. Treatment for gastroesophageal reflux disease is aimed at alleviating symptoms and healing the esophageal inflammation.

This study evaluated the pharmacokinetics and safety of dexlansoprazole MR in the pediatric population (ages 12-17) and determined if the pharmacokinetic profile is similar to that in adults given the same dose.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dexlansoprazole MR intervention 2: Dexlansoprazole MR
Intervention descriptions: intervention 1: Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days. intervention 2: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.

Protocol documents:
Clinical trial NCT00852241
Conditions: Infraorbital Hollows
Sponsor: The Cleveland Clinic
Start date: 2009-02-01; Completion date: 2009-09-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the efficacy and longevity of the use of Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment

Detailed description:
This study will examine the effectiveness of using Restylane® and Perlane® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). Restylane® and Perlane® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.

Arms: arm 1: One syringe of Perlane® (1.0cc) and one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.
Interventions: intervention 1: Restalyne intervention 2: Perlane
Intervention descriptions: intervention 1: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas. intervention 2: One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.

Protocol documents:
Clinical trial NCT00859053
Conditions: Hepatic Insufficiency
Sponsor: Bristol-Myers Squibb
Start date: 2009-03-01; Completion date: 2009-09-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: BMS-790052
Intervention descriptions: intervention 1: Capsules, Oral, 30 mg, single dose, one day

Protocol documents:
Clinical trial NCT00862992
Conditions: Schizophrenia
Keywords: schizophrenia antipsychotics dopamine D3/D2 antagonist
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-04-01; Completion date: 2009-09-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cariprazine 3 mg intervention 2: Cariprazine 6 mg intervention 3: Cariprazine 12.5 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00867100
Conditions: Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2007-12-01; Completion date: 2009-09-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.

Detailed description:
This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

Arms: arm 1: Placebo treatment arm 2: 140 mg SC PsO arm 3: 350 mg SC PsO arm 4: 700 mg IV PsO
Interventions: intervention 1: 700 mg IV intervention 2: 350 mg SC intervention 3: Placebo intervention 4: 140 mg SC
Intervention descriptions: intervention 1: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). intervention 2: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). intervention 3: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B). intervention 4: single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

Protocol documents:
Clinical trial NCT00869440
Conditions: Procedural Sedation Endoscopy
Keywords: CNS 7056 Procedural Sedation Sedation Endoscopy
Sponsor: Paion UK Ltd.
Start date: 2009-03-01; Completion date: 2009-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.

Detailed description:
This was a randomized, double-blind, parallel-group, dose-finding study assessing the safety and efficacy of three dose levels of CNS 7056 compared with midazolam in patients undergoing diagnostic upper GI endoscopy.

Patients who met all study entry criteria and completed screening procedures were randomly assigned to 1 of 4 treatment groups: CNS 7056 0.10 mg/kg,0.15 mg/kg, or 0.20 mg/kg; or midazolam 0.075 mg/kg. Patients received their assigned treatment administered as a single intravenous injection by a syringe driver over 1 minute. The endoscopy started when a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤3 has been reached, but no earlier than 90 seconds after Time 0 (the start of study drug injection). Rescue with sedative medication (midazolam 1-2 mg) was be permitted at the discretion of the administering physician.

Efficacy assessments consisted of the MOAA/S scores, Aldrete scores, and drowsiness measures using a Visual Analogue Scale (VAS). Cognitive function was assessed by the Hopkins Verbal Learning Test-Revised™ (HVLT-R™) and memory for the procedure by the Brice Questionnaire.

Safety assessments included adverse events, physical examinations, vital signs, ECGs, pulse oximetry measurements, clinical laboratory tests, and pain on injection using a VAS.

Arms: arm 1: Remimazolam (CNS 7056) 0.10 mg/kg iv arm 2: Remimazolam (CNS 7056) 0.15 mg/kg iv arm 3: Remimazolam (CNS 7056) 0.20 mg/kg iv arm 4: Midazolam 0.075 mg/kg iv
Interventions: intervention 1: CNS 7056 intervention 2: Midazolam
Intervention descriptions: intervention 1: Administered as a single intravenous injection by a syringe driver over 1 minute intervention 2: Administered as a single intravenous injection by a syringe driver over 1 minute

Protocol documents:
Clinical trial NCT00879775
Conditions: Cancer Pain
Keywords: Pain Cancer patients Caffeine Adjuvant analgesics Sedation Confusion Quality of life Fatigue
Sponsor: Korea Research Foundation
Start date: 2009-04-01; Completion date: 2009-09-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pain is a most common symptom and it has a high impact on quality of life in cancer patients. Many cancer patients have received opioid therapy, but also many of them have suffered from side effects of opioids. Drowsiness and confusion are common side effects of opioids. Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the investigators aimed to prove the efficacy of intravenous caffeine administration as an adjuvant analgesics to opioids. At the same time, the investigators tried to find that the side effects of opioids could be ameliorated by caffeine.

Detailed description:
Previous studies on cancer pain lacked assessment of quality of life. And most of previous studies on cancer pain did not give attention to symptoms accompanied with pain. We include such variables as outcome measures, and aimed to evaluate the efficacy and the safety of intravenous caffeine in advanced cancer inpatients.

Arms: arm 1: Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour arm 2: Intravenous injections of 100ml of normal saline over 1 hour
Interventions: intervention 1: Caffeine intervention 2: Normal saline
Intervention descriptions: intervention 1: Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days. intervention 2: Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days

Protocol documents:
Clinical trial NCT00883233
Conditions: Acne
Keywords: Acne
Sponsor: Galderma R&D
Start date: 2009-04-01; Completion date: 2009-09-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.

Detailed description:

Arms: arm 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks arm 2: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks arm 3: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks arm 4: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Interventions: intervention 1: Adapalene BPO Gel standard daily overnight application intervention 2: Adapalene-BPO 3-hour daily application before bedtime intervention 3: Adapalene-BPO Gel every other day application intervention 4: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Intervention descriptions: intervention 1: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week intervention 2: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks intervention 3: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks intervention 4: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks

Protocol documents:
Clinical trial NCT00894699
Conditions: Sedation Anxiety Pain
Keywords: procedural sedation
Sponsor: Talphera, Inc
Start date: 2009-06-01; Completion date: 2009-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).

Detailed description:

Arms: arm 1: single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ arm 2: single dose of sublingual Placebo NanoTab™
Interventions: intervention 1: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) intervention 2: Placebo NanoTab™
Intervention descriptions: intervention 1: Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ intervention 2: Single dose of sublingual placebo NanoTab™

Protocol documents:
Clinical trial NCT00905580
Conditions: Pain, Postoperative
Keywords: thyroidectomy pain, postoperative pregabalin
Sponsor: Severance Hospital
Start date: 2009-05-01; Completion date: 2009-09-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.

Detailed description:

Arms: arm 1: Patients receive oral Placebo 150 mg 1 hour prior to surgery, and 12 hours later arm 2: Patients receive oral pregabalin 150 mg 1 hour prior to surgery, and 12 hours later
Interventions: intervention 1: Pregabalin intervention 2: Vitamin Complex (placebo)
Intervention descriptions: intervention 1: Pregabalin 150 mg orally intervention 2: Vitamin Complex 150 mg orally

Protocol documents:
Clinical trial NCT00907257
Conditions: Acne Vulgaris
Keywords: acne irritation objective sensory methods
Sponsor: Bausch Health Americas, Inc.
Start date: 2009-02-01; Completion date: 2009-09-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.

Detailed description:
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.

Arms: arm 1: 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day arm 2: 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Interventions: intervention 1: benzoyl peroxide wash intervention 2: Tretinoin gel
Intervention descriptions: intervention 1: 5% benzoyl peroxide wash intervention 2: 0.04% tretinoin gel

Protocol documents:
Clinical trial NCT00915551
Conditions: Actinic Keratosis
Keywords: Peplin Actinic keratosis PEP005
Sponsor: Peplin
Start date: 2009-06-01; Completion date: 2009-09-01
Enrollment: 278 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PEP005 (Ingenol Mebutate) gel, 0.015% intervention 2: Vehicle Gel
Intervention descriptions: intervention 1: once daily for 3 consecutive days intervention 2: once daily for 3 consecutive days

Protocol documents:
Clinical trial NCT00916006
Conditions: Actinic Keratosis
Keywords: Peplin Actinic keratosis PEP005
Sponsor: Peplin
Start date: 2009-06-01; Completion date: 2009-09-01
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Detailed description:

Arms: arm 1: PEP005 gel, 0.015% applied once daily for three consecutive days arm 2: Vehicle gel applied once daily for three consecutive days
Interventions: intervention 1: PEP005 Gel intervention 2: Vehicle gel
Intervention descriptions: intervention 1: 0.015%, three day treatment intervention 2: Vehicle gel, three day treatment

Protocol documents: