ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00673881
Conditions: Dyslipidemia
Sponsor: Radiant Research
Start date: 2008-03-01; Completion date: 2009-05-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objectives of the study are:

1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT (reverse cholesterol transport) in men and post-menopausal women diagnosed with dyslipidemia (i.e., low high-density lipoprotein \[HDL\] cholesterol levels and elevated triglyceride \[TG\] concentrations).
2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL.
3. To obtain pilot data for power calculations for subsequent comparative study.

Detailed description:
This trial assesses the effects of ABT-335 on RCT as measured by cholesterol efflux or rate of appearance of cholesterol (Ra in mg/kg/hr), cholesterol excretion (%/day), RCT efflux (mg/kg/day) and de novo cholesterol synthesis (%) during a baseline period (7 days) and during a treatment period (94 days).

The goal of using RCT to reverse atherosclerosis is to increase the rate of cholesterol export or "efflux" from the tissues and plaques. An increase in this cholesterol efflux rate should shrink arterial plaques by decreasing their static accumulation of cholesterol. While some currently marketed drugs have a positive impact on RCT by increasing the rate of cholesterol excretion from the body, no drug has yet been approved to increase the rate of cholesterol efflux from the tissues

Arms: arm 1: ABT-335 (choline fenofibrate)
Interventions: intervention 1: choline fenofibrate
Intervention descriptions: intervention 1: 135 mg choline fenofibrate daily(oral, capsule)

Protocol documents:
Clinical trial NCT00678041
Conditions: Urinary Tract Infections
Keywords: urinary catheterization urinary tract infection urinary incontinence pelvic floor prolapse antibiotics
Sponsor: University of Pittsburgh
Start date: 2008-05-01; Completion date: 2009-05-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects.

This study will not require any additional visits or blood draws. You will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a UTI to your doctor.

Detailed description:
Abstract:

Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (CISC) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo.

Study Design: Randomized double-blind placebo-controlled trial.

Methods: Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC and for three subsequent days after stopping CISC. Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis. Symptomatic UTI will be defined using strict culture-based definitions. We anticipate that the study will end within 6 weeks of starting CISC.

Data Analysis: Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test.

Sample Size: Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 33% to 10%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 108 patients.

Arms: arm 1: extended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC arm 2: identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC
Interventions: intervention 1: Nitrofurantoin intervention 2: Placebo
Intervention descriptions: intervention 1: nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC intervention 2: Placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC

Protocol documents:
Clinical trial NCT00680316
Conditions: Cystic Fibrosis
Keywords: Pulmozyme CF
Sponsor: Genentech, Inc.
Start date: 2008-06-01; Completion date: 2009-05-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF). Approximately 40 patients were planned to be enrolled in this study. However, only 3 patients were eligible for random allocation and received treatment: 1 patient in the Pulmozyme group and 2 patients in the placebo group. All 3 patients completed the study assessments but did not have usable pulmonary function test (PFT) data.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dornase alfa intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days intervention 2: 2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days

Protocol documents:
Clinical trial NCT00689117
Conditions: Acne Vulgaris Acne
Keywords: Acne Vulgaris Acne
Sponsor: Stiefel, a GSK Company
Start date: 2008-04-01; Completion date: 2009-05-01
Enrollment: 1649 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Detailed description:
CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Arms: arm 1: CT Gel arm 2: Clindamycin Gel (clindamycin) arm 3: Tretinoin Gel (tretinoin) arm 4: Vehicle Gel
Interventions: intervention 1: CT Gel intervention 2: Clindamycin Gel (clindamycin ) intervention 3: Tretinoin Gel (tretinoin) intervention 4: Vehicle Gel
Intervention descriptions: intervention 1: Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks intervention 2: Clindamycin 1% gel applied topically once daily in the evening for 12 weeks intervention 3: Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks intervention 4: Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

Protocol documents:
Clinical trial NCT00690794
Conditions: Open-angle Glaucoma Ocular Hypertension
Sponsor: Alcon Research
Start date: 2008-07-01; Completion date: 2009-05-01
Enrollment: 726 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: One drop self-administered in the study eye(s) once daily for 90 days arm 2: One drop self-administered in the study eye(s) once daily for 90 days
Interventions: intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention descriptions: intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanprost.

Protocol documents:
Clinical trial NCT00699192
Conditions: Hypertension
Keywords: Blood pressure hypertension elderly
Sponsor: Novartis Pharmaceuticals
Start date: 2008-05-01; Completion date: 2009-05-01
Enrollment: 965 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.

Detailed description:

Arms: arm 1: 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily arm 2: 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily arm 3: 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
Interventions: intervention 1: Amlodipine 5 mg intervention 2: Valsartan 80 mg intervention 3: Valsartan 40 mg intervention 4: Placebo
Intervention descriptions: intervention 1: 1 capsule amlodipine 5 mg orally once daily intervention 2: 1 capsule valsartan 80 mg orally once daily intervention 3: 1 capsule valsartan 40 mg orally once daily intervention 4: 1 capsule placebo to match valsartan orally once daily

Protocol documents:
Clinical trial NCT00715559
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder, depression neurotrophic brain-derived neurotrophic factor antidepressant cysteamine
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2008-07-01; Completion date: 2009-05-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether cysteamine bitartrate, an FDA-approved drug for a non-psychiatric condition, is safe and effective for the treatment of major depression.

Detailed description:
Major depressive disorder (MDD) is a chronic, disabling illness affecting about 17% of the general population. Despite advances in treatment, about two-thirds of patients fail to respond to an initial trial of pharmacotherapy. Brain-derived neurotrophic factor (BDNF) is a neural growth-promoting polypeptide found in the central nervous system, and has been implicated in the pathophysiology and potential treatment of MDD. A multitude of studies have shown low levels of BDNF in subjects with MDD, which have normalized after treatment with an antidepressant. Traditional antidepressants such as serotonin reuptake inhibitors may increase BDNF via an indirect intracellular pathway. The current study drug, cysteamine bitartrate (Cystagon), is FDA approved for the treatment nephropathic cystinosis and has been shown to increase BNDF in neuronal tissue, and to stimulate cell growth. Cysteamine has already been investigated in humans as a potential treatment for Huntington's Disease. Given the evidence of decreased levels in major depression, and subsequent increase post-treatment with antidepressants, BDNF may play a key role in developing novel treatments for patients who have failed conventional agents. Therefore, drugs that can demonstrably increase central BDNF, such as cysteamine, may have significant potential as novel antidepressant medications.

Arms: arm 1: Participants received cysteamine bitartrate by mouth up to 300 mg three times daily.
Interventions: intervention 1: cysteamine bitartrate
Intervention descriptions: intervention 1: All enrolled participants will begin open treatment with cysteamine on the first visit of the experimental period (after screening, medical clearance and medication washout period if necessary). The dosing schedule is a flexible regimen starting at 150 mg PO three times daily. After one week, patients without intolerable side effects will increase the dose to 300 mg three times daily. The titration schedule will continue up to a maximum of 1800 mg a day. In case of adverse events, the investigator may decrease the dose by 150 mg daily.

Protocol documents:
Clinical trial NCT00725270
Conditions: Psychotic Disorders Depressive Disorder, Major Depressive Disorder
Sponsor: Stanford University
Start date: 1998-04-01; Completion date: 2009-05-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

Detailed description:
You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown. Current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). While these therapies are often effective, they can take several weeks or longer to work. We hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.

Arms: arm 1: Patients will be randomized to placebo arm 2: Patients will be randomized to mifepristone
Interventions: intervention 1: Mifepristone intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: 600 mg of mifepristone intervention 2: Placebo comparator

Protocol documents:
Clinical trial NCT00726999
Conditions: Postoperative Pain
Keywords: Gabapentin Pediatric Spinal Fusion Narcotic Use
Sponsor: Medical College of Wisconsin
Start date: 2006-06-01; Completion date: 2009-05-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).

Detailed description:
Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.

Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine

No remifentanil, clonidine, ketamine

N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08

Arms: arm 1: Gabapentin arm 2: Placebo Comparator -- pill matched in appearance to gabapentin
Interventions: intervention 1: Gabapentin intervention 2: Placebo intervention 3: Morphine
Intervention descriptions: intervention 1: oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge intervention 2: None intervention 3: Administered as needed

Protocol documents:
Clinical trial NCT00734617
Conditions: Cigarette Smoking
Keywords: Cigarette Nicotine
Sponsor: Duke University
Start date: 2007-08-01; Completion date: 2009-05-01
Enrollment: 479 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent \& 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nicotine Patch
Intervention descriptions: intervention 1: Groups 1 \& 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day

Groups 2 \& 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day

Protocol documents:
Clinical trial NCT00739999
Conditions: Pediatric Heterozygous Hypercholesterolemia
Keywords: heterozygous familial hypercholesterolemia (HeFH); atorvastatin; pediatric
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-12-01; Completion date: 2009-05-01
Enrollment: 39 participants; Allocation: NA; Intervention model: PARALLEL

Brief summary:
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia

Detailed description:

Arms: arm 1: 6-10 years will be administered with atorvastatin tablet formulation with initial doses based on age cohort. arm 2: 10-17 years will be administered 10-mg daily dose of atorvastatin tablet formulation.
Interventions: intervention 1: Atorvastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (\<3.35 mmol/L) after 4-week treatment. intervention 2: 10-17 years Tanner Stage 2 will be administered 10-mg daily dose of atorvastatin tablet formulation. Dose may be doubled if subjects have not attained target LDL (\<3.35 mmol/L) after 4-week treatment.

Protocol documents:
Clinical trial NCT00750308
Conditions: Metabolic Syndrome
Sponsor: Vanderbilt University
Start date: 2006-12-01; Completion date: 2009-05-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will measure the effect of the agent tadalafil on glucose and insulin homeostasis in people with metabolic syndrome in the presence and absence of an ACE inhibitor.

Detailed description:

Arms: arm 1: placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril + tadalafil, washout, placebo+placebo for three weeks arm 2: placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks arm 3: ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks arm 4: placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks arm 5: placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks arm 6: placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo for three weeks arm 7: ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks arm 8: placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks arm 9: placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks arm 10: placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks arm 11: ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks arm 12: placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks
Interventions: intervention 1: Ramipril intervention 2: Tadalafil intervention 3: placebo intervention 4: placebo
Intervention descriptions: intervention 1: Ramipril 10 mg per day for three weeks intervention 2: tadalafil 10 mg every other day for three weeks intervention 3: placebo matching ramipril intervention 4: placebo matching tadalafil

Protocol documents: