ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00942604
Conditions: Actinic Keratoses
Keywords: Peplin Actinic keratosis PEP005
Sponsor: Peplin
Start date: 2009-07-01; Completion date: 2009-10-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Detailed description:

Arms: arm 1: PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days arm 2: Vehicle gel once daily for 2 consecutive days
Interventions: intervention 1: PEP005 (ingenol mebutate) Gel intervention 2: Vehicle gel
Intervention descriptions: intervention 1: two day treatment intervention 2: two day treatment

Protocol documents:
Clinical trial NCT00947791
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder Depression Treatment-Resistant ketamine antidepressant glutamate
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2009-07-01; Completion date: 2009-10-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.

Detailed description:
Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with this devastating condition. Despite the high degree of morbidity and mortality associated with bipolar depression, currently available treatments are few and often inadequate. Recently, a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine has demonstrated rapid antidepressant effects in severe unipolar depression. Therefore, the objective of the current study is to investigate the safety and efficacy of a single IV dose of ketamine in treatment-resistant bipolar depression (TRBD).

Arms: arm 1: Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to ketamine-midazolam. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart. arm 2: Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to midazolam-ketamine. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart.
Interventions: intervention 1: ketamine intervention 2: midazolam
Intervention descriptions: intervention 1: a single IV infusion of ketamine, IV 0.5 mg/kg intervention 2: a single IV infusion of midazolam, 0.045 mg/kg

Protocol documents:
Clinical trial NCT00952523
Conditions: Acne Vulgaris
Keywords: acne irritation objective sensory methods
Sponsor: Bausch Health Americas, Inc.
Start date: 2009-07-01; Completion date: 2009-10-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.

Detailed description:
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.

Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.

Arms: arm 1: Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
Interventions: intervention 1: Tretinoin Facial Gel intervention 2: Adapalene/Benzoyl Peroxide Facial Gel
Intervention descriptions: intervention 1: A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks. intervention 2: A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks

Protocol documents:
Clinical trial NCT00964548
Conditions: Cerebral Vasospasm After Subarachnoid Hemorrhage
Keywords: vasospasm subarachnoid hemorrhage neurocritical care dantrolene vasorelaxation
Sponsor: University of Massachusetts, Worcester
Start date: 2007-07-01; Completion date: 2009-10-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP.

Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with dantrolene in patients with cVSP after SAH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with Dantrolene can improve the outcome of patients with cVSP after SAH.

Detailed description:
Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of dantrolene, by determining the treatment related adverse events, in participants with cVSP after SAH; and 2) to determine the maximal tolerated dose to be adopted in subsequent studies and 3) to determine efficacy trends of dantrolene on brain vessels as assessed by ultrasound of brain vessels (transcranial Doppler).

We hypothesize that dantrolene is well-tolerated and has minimal serious adverse effects in patients with cVSP after SAH. The results can potentially bring a new treatment to patients with SAH. cVPS after SAH is a frequent cause of disability and death. A successful study demonstrating the safety of dantrolene in would be of considerable public health significance.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dantrolene intervention 2: Dantrolene
Intervention descriptions: intervention 1: 1.25 mg/kg IV once over 60 min intervention 2: 2.5 mg/kg IV once over 60 min

Protocol documents:
Clinical trial NCT00966641
Conditions: Healthy Volunteers
Sponsor: PLx Pharma
Start date: 2009-08-01; Completion date: 2009-10-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.

Detailed description:

Arms: arm 1: Active experimental drug arm 2: Active comparator
Interventions: intervention 1: Naproxen intervention 2: PL 3100
Intervention descriptions: intervention 1: Single orally administered dose of 500 mg naproxen intervention 2: Single orally administered dose of PL 3100 (500 mg naproxen)

Protocol documents:
Clinical trial NCT00989235
Conditions: Rheumatoid Arthritis
Keywords: NOS
Sponsor: Bristol-Myers Squibb
Start date: 2007-04-01; Completion date: 2009-10-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 \[DAS 28\]-erythrocyte sedimentation rate \[ESR\] \< 2.6) at Day 701 of study IM101023.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Abatacept intervention 2: Abatacept
Intervention descriptions: intervention 1: IV solution, IV, 10 mg/Kg, Once monthly, 1 year intervention 2: IV solution, IV, 5 mg/Kg, Once monthly, 1 year

Protocol documents:
Clinical trial NCT00997321
Conditions: Sedation
Keywords: ketamine propofol procedural sedation moderate procedural sedation in the ED
Sponsor: Hennepin Healthcare Research Institute
Start date: 2007-07-01; Completion date: 2009-10-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.

Detailed description:

Arms: arm 1: propofol 1 milligram per kilogram intravenous bolus followed by 0.5 millligrams per kilogram as needed for mooderate procedural sedation arm 2: ketamine 1 milligram per kilogram followed by 0.5 millgram per kilogram as needed for moderate procedural sedation
Interventions: intervention 1: propofol intervention 2: Ketamine
Intervention descriptions: intervention 1: propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation intervention 2: ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation

Protocol documents:
Clinical trial NCT01001052
Conditions: Healthy
Keywords: Healthy bioavailability
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2009-10-01; Completion date: 2009-10-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast.

Detailed description:
The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young, healthy subjects 18-30 years of age compared to a group of older, generally healthy subjects 60 years of age or older following an overnight fast. On study Day 1 following an overnight fast, twenty healthy, non-smoking, non-obese male and female subjects between the ages of 18 and 30 and twenty generally healthy, non-smoking, non-obese male and female subjects over 60 years of age will be administered one single dose of Colcrys™ (1 x 0.6 mg tablet). Fasting will continue for 4 hours after the dose. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Colcrys. Blood sampling will continue on a non-confined basis at 36, 48, 60 and 72 hours post-dose. Subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures. Vitals signs (temperature, respiratory rate, pulse rate and blood pressure) will be measured in the sitting position prior to dosing. Seated blood pressure and pulse will be measured at approximately 1, 3, 6 and 12 hours after dosing and prior to release from the facility. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Arms: arm 1: One single dose of Colcrys™ 0.6mg taken by mouth on day 1 arm 2: One single dose of Colcrys™ 0.6mg taken by mouth on day 1
Interventions: intervention 1: Colcrys™ (colchicine)
Intervention descriptions: intervention 1: 0.6 mg taken by mouth on day 1

Protocol documents:
Clinical trial NCT01015534
Conditions: Brain Neoplasms
Keywords: Brain metastases Temozolomide Whole-brain radiotherapy Phase II trial
Sponsor: Instituto Nacional de Cancerologia de Mexico
Start date: 2006-01-01; Completion date: 2009-10-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE

* Fractionated radiotherapy uses high-energy photons to kill, or damage tumor cells. High daily dose temozolomide combined with fractionated radiotherapy may make tumor cells more sensible to treatment.

PURPOSE

* This randomized phase II trial, assess in patients with brain metastases from solid tumors, whether the whole brain radiotherapy (WBRT) plus temozolomide is able to improve the results obtained with WBRT.

Detailed description:
Primary Outcome Measures

* Objective Response Rates

Secondary Outcome Measures

* Survival Free of Brain Metastases progression
* Overall Survival
* Systemic Side effects

Objectives

Primary

* Compare objective response rates in both arms of treatment

Secondary

* Compare survival free of progression in both arms of treatment
* Compare Overall Survival in both arms of treatment
* Compare side effects

Arms: arm 1: Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide. arm 2: Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks
Interventions: intervention 1: Temozolomide intervention 2: Whole brain irradiation
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01047189
Conditions: Acne Vulgaris
Keywords: Mild to moderate acne vulgaris
Sponsor: Wake Forest University
Start date: 2009-03-01; Completion date: 2009-10-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.

Detailed description:

Arms: arm 1: Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks arm 2: Generic clindamycin 1% gel plus tretinoin 0.025% cream
Interventions: intervention 1: clindamycin phosphate 1.2% and tretinoin 0.025% intervention 2: clindamycin 1% gel intervention 3: tretinoin 0.025% cream
Intervention descriptions: intervention 1: applied once daily for 12 weeks intervention 2: Topical clindamycin applied each morning for 12 weeks intervention 3: Tretinoin 0.025% cream each evening for 12 weeks

Protocol documents:
Clinical trial NCT01049243
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis Open-Label Topical Cream Eczema Vanos
Sponsor: Wake Forest University Health Sciences
Start date: 2009-03-01; Completion date: 2009-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.

Detailed description:
This is a single center study. This is an open label study of fluocinonide cream 0.1% (Vanos™) for subjects with mild to severe atopic dermatitis with an assessment of 2 to 4 on the Investigator Global Assessment scale (Appendix B). Up to 20 subjects age 12 and above will be enrolled after providing informed consent. All subjects will receive the study medication, fluocinonide cream 0.1% (Vanos™). Each subject will be instructed to use fluocinonide cream 0.1% (Vanos™) twice daily for three consecutive days (for a total of 6 doses). The study period will last for approximately 2 weeks. Subjects will be evaluated at baseline and Day 2 or 3 (as needed to achieve 6 doses), day 7 and day 14 (or end of study). Subjects will not apply any study drug after the 6 doses.

Arms: arm 1: Fluocinonide Cream 0.1% open label
Interventions: intervention 1: Fluocinonide Cream 0.1%
Intervention descriptions: intervention 1: 0.1% Cream, One Application, Twice Daily, 14 Days

Protocol documents:
Clinical trial NCT01115452
Conditions: Dentine Hypersensitivity
Keywords: potassium nitrate tooth sensitivity dentin sensitivity
Sponsor: GlaxoSmithKline
Start date: 2009-09-01; Completion date: 2009-10-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.

Detailed description:

Arms: arm 1: Participants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. arm 2: Participants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. arm 3: Participants to apply sterile water to a single sensitive tooth for two minutes, in each of the five day treatment period.
Interventions: intervention 1: 5% Potassium nitrate intervention 2: 2.5% Potassium nitrate intervention 3: Sterile water
Intervention descriptions: intervention 1: 5% potassium nitrate solution intervention 2: 2.5% potassium nitrate solution intervention 3: Sterile water

Protocol documents:
Clinical trial NCT01128972
Conditions: Tooth Erosion
Keywords: enamel erosion tooth remineralization tooth erosion
Sponsor: GlaxoSmithKline
Start date: 2009-08-01; Completion date: 2009-10-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

Detailed description:

Arms: arm 1: Test fluoride dentifrice and test fluoride MR arm 2: Test fluoride dentifrice and sterile water rinse arm 3: Placebo dentifrice and test fluoride rinse arm 4: Marketed fluoride dentifrice with sterile water rinse arm 5: Placebo dentifrice and sterile water rinse
Interventions: intervention 1: Sodium fluoride intervention 2: Sodium monoflurophosphate intervention 3: Sterile water
Intervention descriptions: intervention 1: Test fluoride toothpaste and test fluoride mouth rinse intervention 2: United Kingdom marketed fluoride toothpaste intervention 3: Sterile water rinse

Protocol documents:
Clinical trial NCT02449044
Conditions: Hyponatremia
Keywords: Hyponatremia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2004-05-01; Completion date: 2009-10-01
Enrollment: 111 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states.

Detailed description:

Arms: arm 1: Enrolled subjects began treatment with 15 mg tolvaptan QD. A titration between target doses of 15 mg, 30 mg, or 60 mg of trial medication was based on the subject's change in serum sodium concentration and clinical tolerance of the trial medication.
Interventions: intervention 1: Tolvaptan
Intervention descriptions: intervention 1: Once Daily

Protocol documents:
Clinical trial NCT03091751
Conditions: Hemophilia B
Keywords: Factor IX (FIX)
Sponsor: Grifols Biologicals, LLC
Start date: 2005-08-01; Completion date: 2009-10-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this non-randomized, multi-center study in subjects with severe hereditary haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.

Detailed description:
Two pharmacokinetic assessments (studies) were carried out in the same subjects during a previous clinical trial. The first pharmacokinetic study (PK1) was performed after a single dose of AlphaNine. The second pharmacokinetic study (PK2) was performed following 26 Weeks of AlphaNine treatment after PK1. To compare AlphaNine with BeneFIX, a third pharmacokinetic study (PK3) (current study) was performed after a single dose of BeneFIX administered following a 7- to 15-day wash-out period.

The main objective of the PK3 study was to assess the pharmacokinetic profile of BeneFIX and compare to the pharmacokinetic profile of AlphaNine from the PK2 study.

Arms: arm 1: BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection.
Interventions: intervention 1: BeneFIX
Intervention descriptions: intervention 1: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg.

Protocol documents:
Clinical trial NCT00667719
Conditions: Essential Hypertension
Keywords: Essential hypertension High blood pressure
Sponsor: Novartis
Start date: 2008-06-05; Completion date: 2009-10-05
Enrollment: 564 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.

Detailed description:

Arms: arm 1: Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
Interventions: intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: 300 mg tablet intervention 2: 5 mg tablet intervention 3: 12.5 mg and 25 mg capsule

Protocol documents: