ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00705003
Conditions: Major Depressive Disorder
Keywords: depression
Sponsor: Massachusetts General Hospital
Start date: 2008-05-01; Completion date: 2008-12-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing symptoms of depression in patients with Major Depressive Disorder.

The safety and tolerability of the combination product will also be evaluated as measured by adverse events and vital signs.

Detailed description:
Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.

Arms: arm 1: BCI-024: over-encapsulated Buspirone tablet 15 mg at bedtime(QD) and BCI-049: over-encapsulated Melatonin tablet 3 mg QD arm 2: BCI-024: over-encapsulated Buspirone 15 mg QD arm 3: Placebo: 1 capsule QD
Interventions: intervention 1: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD intervention 2: BCI-024 (Buspirone) intervention 3: Matching placebo
Intervention descriptions: intervention 1: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and Drug BCI-049: over-encapsulated Melatonin tablet 3 mg QD taken in combination for 6 weeks intervention 2: Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks. intervention 3: Placebo comparator once a day at bedtime for 6 weeks.

Protocol documents:
Clinical trial NCT00706628
Conditions: Prostatic Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2006-03-01; Completion date: 2008-12-01
Enrollment: 87 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to estimate and compare the 12-week progression-free rate of BIBF 1120, BIBW 2992 or sequential administration of BIBF 1120 and BIBW 2992 in patients with HRPC as determined by radiographic, bone and PSA criteria.

Detailed description:

Interventions: intervention 1: BIBF 1120 intervention 2: BIBW 2992 intervention 3: Sequential BIBF 1120 + BIBW 2992
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00706836
Conditions: Anxiety Disorders
Keywords: anxiety functional magnetic resonance imaging fMRI pregabalin Lyrica
Sponsor: University of California, San Diego
Start date: 2008-06-01; Completion date: 2008-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function. In this case, the medication pregabalin will be used. The investigators hypothesize that pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.

Detailed description:
Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, pregabalin. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

Arms: arm 1: Pregabalin oral tablets (50 mg) arm 2: Pregabalin oral tablets (200 mg) arm 3: Placebo
Interventions: intervention 1: Pregabalin 50mg intervention 2: Pregabalin 200 MG intervention 3: placebo
Intervention descriptions: intervention 1: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan intervention 2: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan intervention 3: One dose of matched oral placebo to be administered one hour prior to fMRI scan

Protocol documents:
Clinical trial NCT00716963
Conditions: Mild Intermittent Asthma
Keywords: late allergic response fluticasone propionate
Sponsor: Hamilton Health Sciences Corporation
Start date: 2008-07-01; Completion date: 2008-12-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded, randomized, crossover study in which single doses of placebo, will be compared to Fluticasone propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from post-allergen peak)

Detailed description:
The aim of this pilot study is to evaluate whether fluticasone propionate affects the late allergic reaction after a single dose post-allergen challenge administered following cessation of the early allergic reaction.

Six subjects with mild asthma will be asked to volunteer for the study.The diagnosis of asthma will be and includes the presence of variable airflow limitation and AHR (PC20 methacholine \< 16 mg/mL). Subjects will be asked to participate if they demonstrate an allergen-induced early and late asthmatic response of at least 20% and 15% reduction in FEV1, respectively.

The study will consist of 4 periods, composed of a screening allergen period with 3 subsequent allergen challenge/treatment periods. Each period will be separated with a washout of at least 2 weeks. Subjects who demonstrate a dual asthmatic response in the screening period will be selected for randomization to treatment.

Arms: arm 1: Fluticasone propionate (Flovent Diskus) 250 mcg arm 2: budesonide 400mcg arm 3: placebo
Interventions: intervention 1: Fluticasone propionate (Flovent Diskus) 250 mcg intervention 2: budesonide 400 mcg intervention 3: Placebo
Intervention descriptions: intervention 1: Flovent Diskus 250 mcg intervention 2: budesonide 400 mcg intervention 3: Placebo

Protocol documents:
Clinical trial NCT00725491
Conditions: Controlled Ovarian Stimulation
Keywords: Reproductive techniques assisted
Sponsor: Organon and Co
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 259 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).

Detailed description:

Arms: arm 1: ganirelix arm 2: triptorelin
Interventions: intervention 1: ganirelix intervention 2: triptorelin
Intervention descriptions: intervention 1: On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration. intervention 2: a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 \<= 50 pg/ml (\<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.

Protocol documents:
Clinical trial NCT00730912
Conditions: Perennial Allergic Rhinitis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-06-01; Completion date: 2008-12-01
Enrollment: 261 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine.

Detailed description:

Arms: arm 1: Pediatrics 3 to 6 years arm 2: Pediatrics 7 to 15 years arm 3: Adults 16 to 64 years
Interventions: intervention 1: loratadine intervention 2: loratadine intervention 3: loratadine
Intervention descriptions: intervention 1: Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks intervention 2: loratadine 10 mg tablet once daily for 4 weeks intervention 3: loratadine 10 mg tablet once daily for 4 weeks

Protocol documents:
Clinical trial NCT00736489
Conditions: Asthma Airway Obstruction
Keywords: Asthma airway obstruction beta2-agonist efficacy inhalation
Sponsor: AstraZeneca
Start date: 2008-08-01; Completion date: 2008-12-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.

Detailed description:

Arms: arm 1: AZD3199 120 microgram arm 2: AZD3199 480 microgram arm 3: AZD3199 1920 microgram arm 4: Placebo arm 5: Formoterol 9 microgram arm 6: Formoterol 36 microgram
Interventions: intervention 1: AZD3199 intervention 2: Formoterol intervention 3: Placebo
Intervention descriptions: intervention 1: Dry powder for inhalation, single dose intervention 2: Dry powder for inhalation, single dose intervention 3: Dry powder for inhalation, single dose

Protocol documents:
Clinical trial NCT00739297
Conditions: Chronic Asthma
Keywords: Chronic asthma
Sponsor: Organon and Co
Start date: 2008-07-01; Completion date: 2008-12-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

Detailed description:

Arms: arm 1: montelukast Placebo arm 2: montelukast arm 3: montelukast arm 4: montelukast
Interventions: intervention 1: Comparator: montelukast intervention 2: Comparator: placebo
Intervention descriptions: intervention 1: 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo. intervention 2: 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.

Protocol documents:
Clinical trial NCT00739960
Conditions: Sarcoidosis
Sponsor: University of Chicago
Start date: 2008-08-01; Completion date: 2008-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Abatacept
Intervention descriptions: intervention 1: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.

Protocol documents:
Clinical trial NCT00754013
Conditions: Down Syndrome Cognitive Dysfunction
Keywords: pediatric Down syndrome cognitive dysfunction Downs Aricept children with Down syndrome
Sponsor: Eisai Inc.
Start date: 2008-09-01; Completion date: 2008-12-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.

Detailed description:
This is a multinational study with sites in the US, India, Singapore, South Korea, Mexico and Chile. There will be 210 subjects (male or female) enrolled that are residing in community or facilities with a reliable caregiver that have been clinically diagnosed with Down syndrome. The assessments performed during this study will be used to evaluate skills. The study duration will be 10 weeks of double blind treatment with a total of 6 visits; 4 in office visit and 2 phone visits.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aricept (Donepezil hydrochloride) intervention 2: Placebo
Intervention descriptions: intervention 1: All subjects will start with a dose of 1.25 mg/day (1.25 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil.

All doses will be administered orally. intervention 2: All subjects will start with a dose of 1.25 mg/day (1.25 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) placebo.

All doses will be administered orally.

Protocol documents:
Clinical trial NCT00754052
Conditions: Down Syndrome Cognitive Dysfunction
Keywords: Pediatric Down syndrome Downs Cognitive Dysfunction of Down syndrome
Sponsor: Eisai Inc.
Start date: 2008-09-01; Completion date: 2008-12-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, aged 11 to 17.

Detailed description:
The study will be conducted in approximately 75 sites in the US, India, Singapore, South Korea, Mexico and Chile and will include 210 participants to be enrolled.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Aricept (donepezil hydrochloride) intervention 2: Aricept (donepezil hydrochloride) intervention 3: Placebo
Intervention descriptions: intervention 1: All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalation will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil. All doses will be administered orally. intervention 2: All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) donepezil. All doses will be administered orally. intervention 3: All participants will start with a dose of 2.5 mg/day (2.5 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) placebo. All doses will be administered orally.

Protocol documents:
Clinical trial NCT00755196
Conditions: Psoriasis
Keywords: Plaque Type Psoriasis Topical
Sponsor: Pfizer
Start date: 2008-09-01; Completion date: 2008-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis

Detailed description:
This is a single center, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily for 12 weeks. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.

Arms: arm 1: AN2728 Ointment, 5% arm 2: AN2728 Ointment vehicle
Interventions: intervention 1: AN2728 intervention 2: Ointment vehicle
Intervention descriptions: intervention 1: AN2728 Ointment, 5%, twice daily for 12 weeks intervention 2: Ointment vehicle, twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00757627
Conditions: Pain
Sponsor: Organon and Co
Start date: 2007-12-01; Completion date: 2008-12-01
Enrollment: 500 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.

Detailed description:

Arms: arm 1: Etoricoxib
Interventions: intervention 1: etoricoxib
Intervention descriptions: intervention 1: etoricoxib 60 mg QD for 4 weeks.

Protocol documents:
Clinical trial NCT00762762
Conditions: Periodontitis
Sponsor: Colgate Palmolive
Start date: 2006-03-01; Completion date: 2008-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.

Detailed description:

Arms: arm 1: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. arm 2: Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.
Interventions: intervention 1: Triclosan/copolymer/fluoride intervention 2: Fluoride
Intervention descriptions: intervention 1: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses. intervention 2: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

Protocol documents:
Clinical trial NCT00763269
Conditions: Dentin Hypersensitivity
Sponsor: Colgate Palmolive
Start date: 2008-09-01; Completion date: 2008-12-01
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypersensitivity

Detailed description:

Arms: arm 1: sensitive toothpaste arm 2: Triclosan control toothpaste
Interventions: intervention 1: Triclosan, Silicon dioxide, fluoride intervention 2: Triclosan, fluoride
Intervention descriptions: intervention 1: Brush twice daily intervention 2: Brush twice daily

Protocol documents:
Clinical trial NCT00765375
Conditions: Acne Vulgaris
Keywords: acne Botox cosmetic treatments
Sponsor: DeNova Research
Start date: 2008-09-01; Completion date: 2008-12-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
• To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)

Detailed description:
• 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Patient will complete a subject evaluation at each visit. Follow-up visits occur at Day 3, 7, 14, 30 and 90.

Arms: arm 1: Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)
Interventions: intervention 1: Botulinum Neurotoxin Type A intervention 2: Bacteriostatic saline
Intervention descriptions: intervention 1: 1.5-3 units of Botox/lesion intervention 2: .1 cc bacteriostatic saline/lesion

Protocol documents:
Clinical trial NCT00770991
Conditions: Familial Adenomatous Polyposis
Keywords: Polyp, Familial Adenomatous Polyposis, Prevention
Sponsor: The Cleveland Clinic
Start date: 2005-12-01; Completion date: 2008-12-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.

Detailed description:

Arms: arm 1: 20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS arm 2: 20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
Interventions: intervention 1: Black raspberry (BRB) Slurry intervention 2: Black Raspberry (BRB) Suppositories intervention 3: Black Raspberry (BRB) Placebo Slurry
Intervention descriptions: intervention 1: 20 grams BRB Slurry intervention 2: Two, 730 mg BRB suppositories QHS intervention 3: 20 grams BRB placebo slurry

Protocol documents:
Clinical trial NCT00776009
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords: ADHD, children, subjects, laboratory classroom
Sponsor: Novartis Pharmaceuticals
Start date: 2008-10-01; Completion date: 2008-12-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.

Detailed description:

Arms: arm 1: Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days. arm 2: Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days. arm 3: Two Capsules taken orally once a day for 7 days
Interventions: intervention 1: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg and/or 20 mg capsules intervention 2: Placebo Comparator

Protocol documents: