ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01135134
Conditions: Rhinitis, Allergic, Perennial
Sponsor: Organon and Co
Start date: 2010-06-01; Completion date: 2010-10-01
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.

Detailed description:

Arms: arm 1: The dose will be as follows:

* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks arm 2: Administration will be as follows:

* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks
Interventions: intervention 1: Mometasone furoate intervention 2: Placebo
Intervention descriptions: intervention 1: The study drug is MFNS (50 μg spray device) and the dose will be:

* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks intervention 2: MF Placebo nasal spray and administration will be as follows:

* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks

Protocol documents:
Clinical trial NCT01138514
Conditions: Acne Vulgaris
Sponsor: Padagis LLC
Start date: 2009-10-01; Completion date: 2010-10-01
Enrollment: 1555 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) intervention 2: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) intervention 3: Placebo
Intervention descriptions: intervention 1: Applied to the entire face twice daily for 10 weeks intervention 2: Applied to the entire face twice daily for 10 weeks intervention 3: Placebo

Protocol documents:
Clinical trial NCT01145222
Conditions: Sedation
Keywords: CNS 7056 Procedural Sedation Colonoscopy
Sponsor: Paion UK Ltd.
Start date: 2010-05-01; Completion date: 2010-10-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

Detailed description:
This is a double-blind, randomized, parallel group, dose-response study to assess the safety and efficacy of three dose levels of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.

Safety assessment will include physical examinations, vital signs, ECGs, pulse oximetry measurements, capnography, clinical chemistry and hematology laboratory tests, routine drug and ethanol screening, urinalysis, pregnancy test, pain on injection using a verbal scale, and monitoring of adverse events.

Arms: arm 1: Initial 8 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. arm 2: Initial 7 mg iv for sedation induction, and 2 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. arm 3: Initial 5 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. arm 4: Initial 2.5 mg iv for sedation induction, and 1 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses
Interventions: intervention 1: A. CNS 7056 intervention 2: B. CNS 7056 intervention 3: C. CNS 7056 intervention 4: D. Midazolam
Intervention descriptions: intervention 1: Initial low dose plus supplemental doses as necessary. intervention 2: Initial intermediate dose plus supplemental doses as necessary. intervention 3: Initial high dose plus supplemental doses as necessary. intervention 4: Initial standardized dose plus supplemental doses as necessary.

Protocol documents:
Clinical trial NCT01147055
Conditions: Healthy
Keywords: crizotinib healthy volunteers rifampin pharmacokinetics single dose
Sponsor: Pfizer
Start date: 2010-07-01; Completion date: 2010-10-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to estimate the effect of multiple doses of Rifampin on the single dose pharmacokinetics of Crizotinib in healthy volunteers.

Detailed description:

Arms: arm 1: There should be at least 14-day washout period between treatment A and B.
Interventions: intervention 1: crizotinib intervention 2: rifampin intervention 3: crizotinib
Intervention descriptions: intervention 1: Treatment A: a single 250-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets. intervention 2: Treatment B: 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 1 to Day 14. intervention 3: Treatment B: A single 250-mg dose of crizotinib will be administered in the fasted state on Day 9 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets.

Protocol documents:
Clinical trial NCT01148771
Conditions: Healthy
Keywords: Pharmacokinetics Safety
Sponsor: Hartford Hospital
Start date: 2010-08-01; Completion date: 2010-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.

Detailed description:

Arms: arm 1: Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 5 minute IV bolus. arm 2: Participants received ertapenem 1 gram every 24 hours for 3 doses with each dose infused as a 30 minute infusion (i.e., the standard dose).
Interventions: intervention 1: ertapenem intervention 2: ertapenem
Intervention descriptions: intervention 1: 1 gram IV bolus every 24 hours (q24h) for 3 days intervention 2: 1 gram 30 minute infusion q24h for 3 days

Protocol documents:
Clinical trial NCT01158534
Conditions: Renal Cell Cancer Stage IV Renal Cell Cancer
Keywords: recurrent renal cell cancer
Sponsor: Case Comprehensive Cancer Center
Start date: 2006-03-01; Completion date: 2010-10-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Recombinant interferon alfa-2b may interfere with the growth of cancer cells and slow the growth of kidney cancer. Giving celecoxib together with recombinant interferon alpha-2b may kill more tumor cells and be an effective treatment for metastatic kidney cancer.

PURPOSE: This phase II trial is studying how well giving celecoxib together with recombinant interferon alfa-2b works in treating patients with metastatic kidney cancer who have undergone surgery.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the objective response rate of interferon alpha plus celecoxib in metastatic RCC patients with 3+ COX-2 tumor immunostaining.

SECONDARY OBJECTIVES:

I. To compare cellular immune parameters in metastatic RCC patients with 3+ COX-2 tumor immunostaining to patients with \< 1+ tumor immunostaining.

II. To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters in metastatic RCC patients with 3+ COX-2 tumor immunostaining.

OUTLINE:

Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: celecoxib intervention 2: recombinant interferon alfa-2b intervention 3: polymerase chain reaction intervention 4: laboratory biomarker analysis intervention 5: reverse transcriptase-polymerase chain reaction intervention 6: immunologic technique intervention 7: immunohistochemistry staining method intervention 8: flow cytometry
Intervention descriptions: intervention 1: Given orally intervention 2: Given subcutaneously intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Correlative studies intervention 8: Correlative studies

Protocol documents:
Clinical trial NCT01159015
Conditions: Allergic Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-07-01; Completion date: 2010-10-01
Enrollment: 534 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.

Detailed description:

Arms: arm 1: KetoNaph Ophthalmic Solution arm 2: Vehicle of KetoNaph Ophthalmic Solution
Interventions: intervention 1: KetoNaph intervention 2: Vehicle
Intervention descriptions: intervention 1: Ophthalmic Solution administered BID for 6 weeks intervention 2: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks

Protocol documents:
Clinical trial NCT01170364
Conditions: Obesity
Keywords: Obesity sibutramine eating behavior
Sponsor: New York State Psychiatric Institute
Start date: 2009-02-01; Completion date: 2010-10-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Obesity is a major public health concern, and the search for useful pharmacologic interventions is ongoing. This study aims to develop a comprehensive series of assessments to directly assess eating behavior, cognitive functioning, and psychological functioning under sibutramine and placebo conditions.

Detailed description:
We will recruit 48 moderately obese men and women seeking weight-loss treatment to participate in a 3-week, randomized, double-blind, cross-over trial of sibutramine 15mg or placebo daily. At the end of weeks 1 and 3, subjects will be asked to participate in a two-day/three-night stay in the Residential Laboratory or Biological Studies Unit of the New York State Psychiatric Institute for comprehensive assessments. The major outcome variable will be the difference in total daily caloric intake between sibutramine and placebo.

Assessments will concentrate on three main components of eating behavior: eating patterns, psychological processing, and neurocognitive function. Eating behavior studies will examine objective variables such as meal size, meal frequency, and subjective aspects of eating such as hunger and fullness. Psychological studies will measure hedonics, including craving, behavioral restraint, and impulsivity. Neurocognitive function assessment will gather information about decision-making, such as the effects of distractors (food and non-food) on task performance. Additionally, drawing from the field of behavioral neuroeconomics, tasks that assess decision-making and the influence of irrational factors on decisions will be assessed. Neuroimaging (fMRI) procedures will also be conducted, and will augment the psychological and neurocognitive assessments by providing a window into the underlying neural circuitry involved.

Following the double-blind phase, participants will be offered open treatment with sibutramine for weight loss.

Arms: arm 1: Participants in this arm receive sibutramine 15mg for one week followed by two weeks of placebo. arm 2: Participants are prescribed two weeks of placebo, followed by one week of 15mg sibutramine.
Interventions: intervention 1: Sibutramine intervention 2: Placebo
Intervention descriptions: intervention 1: 1 week of active sibutramine (15mg) intervention 2: 2 weeks of placebo

Protocol documents:
Clinical trial NCT01177943
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2010-08-01; Completion date: 2010-10-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4 milligrams per milliliter \[mg/mL\]) compared with 2 capsules of atomoxetine (25 mg per capsule) in healthy adult male Japanese subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: Administered orally, once.

Protocol documents:
Clinical trial NCT01178528
Conditions: Heart Failure
Keywords: heart failure heart rate ivabradine carvedilol
Sponsor: IRCCS San Raffaele
Start date: 2009-09-01; Completion date: 2010-10-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left ventricular dysfunction and heart rate \> 70 bpm. The association of ivabradine and atenolol has been proven effective in increasing exercise tolerance in patients with ischemic heart disease. Aim of the present study is to evaluate the effect of heart rate reduction with ivabradine, carvedilol or their combination in patients with heart failure of ischemic origin.

Detailed description:
Patients with chronic heart failure of ischemic origin (120) Stable coronary artery disease Acute coronary syndromes \> 3 months Revascularization procedures \> 3 months Naive on heart rate reducing agents New York Heart Association (NYHA) Class II III 6 minute walking test (6MW) tolerance between 200 and 400 m Stable medications for the past 3 months

Treatment Ivabradine up to 7.5 mg b.i.d. Carvedilol up to 25 mg b.i.d. Carvedilol and Ivabradine up to 12.5/5 mg b.i.d.

Efficacy measure Intention to treat Exercise tolerance Quality of life

Arms: arm 1: 7.5 mg bd arm 2: up to 25 mg bd arm 3: up to 12.5/5 mg bd
Interventions: intervention 1: ivabradine intervention 2: "Drug:Carvedilol" and "Drug:Ivabradine" intervention 3: Carvedilol
Intervention descriptions: intervention 1: 7.5 mg bd intervention 2: up to 12.5/5 mg bd intervention 3: 25 mg bd

Protocol documents:
Clinical trial NCT01188603
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2010-07-01; Completion date: 2010-10-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial examines the way flibanserin is metabolized in postmenopausal women with Hypoactive Sexual Desire Disorder.

Detailed description:

Arms: arm 1: flibanserin 100 mg dose every evening
Interventions: intervention 1: flibanserin 100 mg dose every evening
Intervention descriptions: intervention 1: all subjects receive flibanserin

Protocol documents:
Clinical trial NCT01188668
Conditions: Pharmacokinetics Cytochrome P-450 CYP2D6 CYP3A4 Protein, Human
Keywords: Pharmacokinetic safety and tolerability genetic testing CYP 2D6 and CYP 3A4
Sponsor: Pfizer
Start date: 2010-08-01; Completion date: 2010-10-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Aripiprazole when coadministered to healthy adult subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole intervention 2: Aripiprazole + desvenlafaxine succinate sustained release
Intervention descriptions: intervention 1: Period 1-Aripiprazole 5mg on study day 1. intervention 2: Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.

Protocol documents:
Clinical trial NCT01189500
Conditions: Pharmacokinetics
Keywords: Pharmacokinetic safety and tolerability genetic testing CYP 2D6
Sponsor: Pfizer
Start date: 2010-08-01; Completion date: 2010-10-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tamoxifen intervention 2: Tamoxifen and Desvenlafaxine Succinate Sustained Release
Intervention descriptions: intervention 1: Period 1-Tamoxifen 40mg on study day 1. intervention 2: Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.

Protocol documents:
Clinical trial NCT01196377
Conditions: Acute Asthma
Keywords: Asthma Acute asthma Pediatrics
Sponsor: Vanderbilt University Medical Center
Start date: 2010-09-01; Completion date: 2010-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

Detailed description:
The objective of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Participants are randomized in randomly permuted blocks of four. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.

Arms: arm 1: Active control arm, 10mg/hr continuous. arm 2: Experimental 10mg/hr pulsed albuterol regimen. arm 3: Experimental 25mg/hr continuous albuterol. arm 4: Experimental 25mg/hr pulsed albuterol
Interventions: intervention 1: Albuterol
Intervention descriptions: intervention 1: Nebulized albuterol

Protocol documents:
Clinical trial NCT01229423
Conditions: Eyelash Hypotrichosis
Sponsor: Allergan
Start date: 2009-11-01; Completion date: 2010-10-01
Enrollment: 62 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of LATISSE® (bimatoprost 0.03%) in the augmentation of eyelashes in Korean women.

Detailed description:

Arms: arm 1: bimatoprost 0.03% (LATISSE®)
Interventions: intervention 1: bimatoprost 0.03%
Intervention descriptions: intervention 1: One drop of bimatoprost 0.03% (LATISSE®) applied evenly to each upper eyelid in the evening. Treatment is once daily for up to 40 weeks.

Protocol documents:
Clinical trial NCT01243450
Conditions: Acne
Sponsor: Spear Pharmaceuticals
Start date: 2009-10-01; Completion date: 2010-10-01
Enrollment: 958 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Detailed description:
Acne study

Arms: arm 1: Treatment of acne for 12 weeks with generic tretinoin arm 2: Treatment of acne for 12 weeks with Placebo arm 3: Treatment of acne over 12 weeks with tretinoin Brand
Interventions: intervention 1: Tretinoin intervention 2: placebo
Intervention descriptions: intervention 1: Treatment of acne intervention 2: treatment of acne

Protocol documents:
Clinical trial NCT01309581
Conditions: Major Depression Bipolar Depression
Keywords: depression electroconvulsive therapy ketamine antidepressant
Sponsor: James Murrough
Start date: 2010-04-01; Completion date: 2010-10-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects.

Detailed description:
Electroconvulsive therapy (ECT) is one of the most robust antidepressant treatments available. However, there is the potential for significant acute and longer term adverse cognitive effects with ECT and the antidepressant response requires multiple treatment sessions, increasing risk of adverse effects. Further, antidepressant response to ECT is often less than maximal and relapse is common. Growing preclinical and clinical evidence of the rapid-acting antidepressant properties of the anesthetic agent ketamine suggests the use of ketamine anesthesia as a strategy to increase rate of response and shorten treatment course in the administration of ECT. In addition, preclinical and clinical evidence suggests the potential of ketamine to decrease the adverse cognitive effects associated with ECT.

The investigators propose a pilot study to measure both acute therapeutic efficacy and cognitive side effects of ECT using ketamine compared to methohexital in depressed patients. The investigators will also explore other parameters of ECT such as seizure duration and morphology, as well as hemodynamic and behavioral changes.

Arms: arm 1: Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic). arm 2: Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
Interventions: intervention 1: Ketamine intervention 2: Methohexital
Intervention descriptions: intervention 1: Ketamine 1-2 mg/kg IV as indicated for ECT intervention 2: Methohexital 1 mg/kg IV as indicated for ECT

Protocol documents: