ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01149655
Conditions: Schizophrenia
Keywords: Adolescent Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-07-01; Completion date: 2013-12-01
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a follow up period.

Subjects may be either outpatients or inpatients between screening and through the time they reach stabilization at the end of Phase 2; hospitalization is not a study requirement. However, eligible subjects must be outpatients at the beginning of Phase 3.

Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and 3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any tolerability issues. The investigator will also have the option to phone the subjects and their guardian(s) at any time to ensure clinical stability.

A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing the interim analysis. One interim analysis is planned after 75% of the total expected number of impending relapse events (28 events) are achieved and will be conducted by an independent data analysis center. The DMC will make a recommendation about stopping or continuing the study based on safety and efficacy reviews. The results of the interim analysis and individual subject data will remain blinded to the sponsor during the course of the study until the DMC determines that the study will conclude based on the results of the interim analysis, or the study is completed after 37 endpoint events.

Detailed description:

Arms: arm 1: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) arm 2: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) arm 3: Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg) or placebo
Interventions: intervention 1: Aripiprazole intervention 2: Aripiprazole
Intervention descriptions: intervention 1: Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) intervention 2: Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Protocol documents:
Clinical trial NCT01151813
Conditions: Alcohol Dependence Cocaine Dependence
Sponsor: University of Pennsylvania
Start date: 2010-07-01; Completion date: 2013-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase II within-subjects double-blind placebo-controlled human laboratory study. The purpose of the study is to determine the efficacy of varenicline (Chantix) for reducing cue-induced cocaine and alcohol craving.

Detailed description:

Arms: arm 1: Varenicline, oral administration for 1 week arm 2: Placebo, oral administration for 1 week
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Varenicline, oral target dose of 1.0 mg BID, one week titration. intervention 2: Placebo

Protocol documents:
Clinical trial NCT01155518
Conditions: Hypogonadotropic Hypogonadism Type 2 Diabetes
Keywords: hypogonadism diabetes spermatogenesis insulin resistance
Sponsor: State University of New York at Buffalo
Start date: 2010-06-01; Completion date: 2013-12-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.

Detailed description:
This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.

Arms: arm 1: intramuscular injections every 2 weeks arm 2: oral drug thrice a week arm 3: placebo for testosterone arm arm 4: oral placebo for clomiphene arm arm 5: obese men with normal testosterone level arm 6: healthy lean men (control)
Interventions: intervention 1: testosterone intervention 2: clomiphene intervention 3: placebo intervention 4: placebo
Intervention descriptions: intervention 1: intramuscular every 2 weeks intervention 2: thrice a week intervention 3: intramuscular saline injections every 2 weeks intervention 4: oral

Protocol documents:
Clinical trial NCT01162473
Conditions: Milk Hypersensitivity
Keywords: Food hypersensitivity Milk hypersensitivity Milk allergy Food allergy
Sponsor: Children's Hospital of Philadelphia
Start date: 2010-06-01; Completion date: 2013-12-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background and Rationale

For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy.

Main Objective

The primary objective is to study the efficacy of milk oral immunotherapy.

Target Population

Children aged six to 17 years with a history of cow's milk allergy will be recruited from The Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.

Detailed description:
Primary Study Interventions

Prior to and after the desensitization, we will conduct double-blind placebo controlled food challenges to cow's milk protein. During the desensitization phase, we will give increasing doses of cow's milk protein by mouth on a weekly basis, as tolerated. The desensitization protocol starts with dilutional doses of milk and build up to a goal of 8 ounces of cow's milk.

Main Study Outcome Measure

The percentage of children completing the desensitization protocol in each study group will be the primary outcome measure.

Arms: arm 1: All subjects will undergo a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 16 and continue thru Week 50. Total active participation will last 51 weeks. arm 2: All subjects will undergo a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 3 and continue thru Week 35. Total active participation will last 38 weeks.
Interventions: intervention 1: Milk Oral Immunotherapy intervention 2: Milk Protein Powder intervention 3: Food Challenge
Intervention descriptions: intervention 1: Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks. intervention 2: Milk protein powder will be administered in incremental doses during the desensitization protocol. intervention 3: None

Protocol documents:
Clinical trial NCT01166594
Conditions: Glaucoma Optic Neuropathy Fibrosis
Keywords: Glaucoma Elevated Intraocular Pressure (IOP) Optic Neuropathy Bleb Failure Avastin (Bevacizumab)
Sponsor: Sunnybrook Health Sciences Centre
Start date: 2010-06-01; Completion date: 2013-12-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
When a patient with glaucoma who has a pressure that is too high and causing damage to their vision, despite receiving the maximum amount of medication that can be tolerated, the decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in the eye and partially covered with a flap of tissue. This new opening allows fluid to drain out of the eye bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and lowers eye pressure.

However, many people need another trabeculectomy or other glaucoma surgery because the surgery may fail either early or much later because the body closes the drain created by the surgeon. The surgery is also less likely to work in patients with darker pigmentation, children who have congenital glaucoma, people with difficult to control glaucoma with new blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result, the investigators need to find ways to improve the longterm survival of trabeculectomy surgery in all patients.

Detailed description:
The usual treatment is to not have an injection of Bevacizumab on the third through fifth day after trabeculectomy surgery. Topical anaesthetic drops to numb the eye will be given, prior to being given the tested medicine. Once the eye has been anaesthetized, the medication will be injected into the potential space created during the glaucoma surgery, also called a bleb, using a standard small syringe. The patient will receive an injection of either 1.25mg (0.05ml) of Bevacizumab or Balanced Salt Solution (BSS) into the trabeculectomy bleb that had been created in the surgery. Participants will be randomly (by chance) placed in one of the 2 study groups. There will be a 50% chance of being placed in either group. There will be 60 people who will participate in this study at 2 centres throughout the Toronto region. The length of this study for participants is 12 months, and the entire study is expected to take about 18 months to complete.

Arms: arm 1: Tested Drug arm 2: Control - BSS
Interventions: intervention 1: Bevacizumab intervention 2: Control
Intervention descriptions: intervention 1: Intrableb injection intervention 2: intrableb BSS injection

Protocol documents:
Clinical trial NCT01171690
Conditions: Hypoparathyroidism Post-surgical
Keywords: Hypoparathyroidism
Sponsor: Mayo Clinic
Start date: 2010-11-01; Completion date: 2013-12-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism.

Detailed description:
Transient hypoparathyroidism with hypocalcemia occurs in up to 20 % of patients after surgery for thyroid cancer, multinodular goiter or Graves' disease and is severe in around 3 to 18% of cases. Severe hypocalcemia significantly lengthens their hospital stay. This study will evaluate the effects of teriparatide (synthetic parathyroid hormone, brand name Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone.

This was a feasibility open-label, single-arm trial with historical matched controls with a planned enrollment of 15 patients with severe, symptomatic hypocalcemia that would be treated with teriparatide for a maximum duration of 3 weeks and compared the active subjects with 30 gender and age matched controls.

Therapy for hypocalcemia continued in accordance with current practice. The decision for discharge, as far as calcium is concerned, was to be reached when calcium level was \> 7.5 mg/dL and increased x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for IV calcium in the last 24 hours. Subjects were followed by phone and with blood tests 2 days after discharge and 9, 17 and 25 days after initiation of teriparatide. They were off teriparatide for 24 hours prior to testing on days 9, 17 and 25.

If hypocalcemia recurred after 2nd week, teriparatide was continued for a 3rd week and then discontinued. If hypocalcemia recurred again current standard therapy for hypoparathyroidism was continued off teriparatide.

Arms: arm 1: The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
Interventions: intervention 1: Teriparatide
Intervention descriptions: intervention 1: The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.

Protocol documents:
Clinical trial NCT01176591
Conditions: Cocaine Dependence Alcohol Dependence
Keywords: Cocaine and alcohol dependence (CAD)
Sponsor: University of Pennsylvania
Start date: 2010-09-01; Completion date: 2013-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed research will focus on investigating the determinants and consequences of CAD via measurement of physiological, behavioral and subjective effects of physiologic and psychologic stress cues in CAD volunteers in the laboratory, and through examination of the effects of the effects of Aprepitant, an NK1 antagonist, on the above effects. This study will examine the effects of the above stress cues on cocaine and alcohol craving under acute Aprepitant dosing, and under placebo conditions. The study is a within-subjects crossover design using 24 subjects.

Detailed description:
Non treatment seeking subjects with DSM IV cocaine and alcohol dependence were included. Subjects received double-blind acute dosing of 80 mg of aprepitant (Emend) at session start, or matched placebo. During each session subjects were exposed to one of two types of stressors, one stressor per session, presented in counterbalanced order across participants. The Physiologic stress was the cold-pressor task. Subjects immersed their hand in cold water for up to 3 minutes. The psychological stress was the Trier Social Stress Test it was completed in 25 minutes: 5 min audio taped instructions, 10 min to mentally prepare for their performance tasks, 5 min to complete a public speaking task and 5 min to complete a mental arithmetic task. Outcome measures included: Alcohol Craving measured by visual analog scale, cocaine craving measured by visual analog scale and The Multiple Choice Procedure. Each assessment was done during study screening, and then at multiple times during each study session.

Arms: arm 1: Participants receive placebo in session 1 and Aprepitant in session 2 of a psychological stressor presentation and receive placebo in session 1 and Aprepitant in session 2 of a physiological stressor presentation. Participants take Aprepitant (80 mg) or placebo tablets for 7 days prior to each session. arm 2: Participants receive placebo in session 1 and placebo in session 2 of a psychological stressor presentation and receive placebo in session 1 and placebo in session 2 of a physiological stressor presentation. Participants take placebo tablets for 7 days prior to each session. The placebo group is used for analysis purposes in order to control for any order effects found in the Experimental group.
Interventions: intervention 1: Placebo session 1, Aprepitant session 2 intervention 2: Placebo session 1, Placebo session 2
Intervention descriptions: intervention 1: placebo in session 1, Aprepitant 80 mg in session 2, oral administration. intervention 2: Placebo, one per session, oral administration

Protocol documents:
Clinical trial NCT01186250
Conditions: Cardiac Allograft Vasculopathy
Keywords: cardiac allograft vasculopathy pioglitazone insulin resistance heart transplant
Sponsor: Stanford University
Start date: 2010-07-01; Completion date: 2013-12-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the benefit of using the FDA-approved insulin-sensitizing agent, Pioglitazone, on human heart transplant recipients. The objectives of this project are to (1) determine if pioglitazone effectively treats insulin resistance in heart transplant recipients, and (2) to determine whether pioglitazone therapy after heart transplantation impacts the development or progression of cardiac allograft vasculopathy (CAV), a form of chronic rejection after heart transplantation.

Detailed description:
CAV, a rapidly progressive obliterative disease involving the graft coronary arteries, is the leading cause of morbidity and mortality beyond the first year after heart transplantation. This common complication occurs in almost half of recipients within 3 years after heart transplantation, and is associated with high rates of graft failure and mortality. Clinical care of heart transplant recipients in the current era is greatly limited by the lack of effective treatment options to prevent or retard the progression of CAV. CAV appears to be strongly associated with the state of insulin resistance, which is present in over half of heart transplant recipients and is characterized by metabolic abnormalities including glucose intolerance, dyslipidemia, endothelial dysfunction, and high levels of circulating inflammatory markers. Insulin resistance can be effectively treated with pioglitazone, a TZD compound which directly affects tissue insulin sensitivity. In this study, we will enroll 32 insulin-resistant heart transplant recipients and will randomize them to pioglitazone or placebo for a one-year period. We will determine the efficacy of pioglitazone for the treatment of insulin resistance and prevention of the development and progression of CAV after heart transplantation. The data generated from this study will provide important preliminary data for future, larger-scale clinical investigations.

Arms: arm 1: Pioglitazone arm 2: Placebo
Interventions: intervention 1: Pioglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months intervention 2: placebo taken daily for one year

Protocol documents:
Clinical trial NCT01199783
Conditions: Diabetic Foot
Keywords: Diabetic Foot,MRSA, Complicated skin and skin structure infections Antimicrobial therapy Daptomycin
Sponsor: Ruhr University of Bochum
Start date: 2011-07-01; Completion date: 2013-12-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment with Vancomycin (effective blood-plasma concentration of 15 mg/l). In case of microbiologically confirmed gram-negative co-infection effective antibiotic treatment according to microbiologic analysis will be administered upon medical decision in both therapy groups. The study will be carried out as a randomized, open label study.

Detailed description:

Arms: arm 1: Infusion of Daptomycin (6 mg/kg bodyweight) once daily arm 2: Vancomycin once daily (effective blood-plasma concentration of 15 mg/l)
Interventions: intervention 1: Daptomycin intervention 2: Vancomycin
Intervention descriptions: intervention 1: Infusion (6 mg/kg/bodyweight) once daily intervention 2: vancomycin once daily (effective blood-plasma concentration of 15 mg/L)

Protocol documents:
Clinical trial NCT01206452
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation; Ablation
Sponsor: Dhanunjaya Lakkireddy, MD, FACC
Start date: 2010-09-01; Completion date: 2013-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.

Detailed description:
The purpose of this study is:

1. To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.
2. To measure the inflammatory cytokine (TNF-α, IL-1, IL-6, IL-8) response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment.

Arms: arm 1: Participants undergo ablation procedure and receive predinisone at protocol determined times. arm 2: Participants undergo ablation procedure and receive placebo at protocol determined times.
Interventions: intervention 1: Prednisone intervention 2: Placebo intervention 3: Ablation Procedure
Intervention descriptions: intervention 1: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure intervention 2: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure intervention 3: Atrial Fibrillation (AF) ablation

Protocol documents:
Clinical trial NCT01208233
Conditions: Ischemic Stroke
Keywords: Phase 2 Ischemic stroke Safety and efficacy
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2013-12-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.

Detailed description:
The interim analysis for the POC study A9541004 demonstrated futility, and the study was stopped on the 6th of November 2013. There were no signals of serious safety concern.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PF-03049423 intervention 2: PF-03049423 intervention 3: PF-03049423 intervention 4: Placebo
Intervention descriptions: intervention 1: 1 mg of PF-03049423 daily for 90 days intervention 2: 3 mg of PF-03049423 daily for 90 days intervention 3: 6 mg of PF-03049423 daily for 90 days intervention 4: Placebo of PF-03049423 daily for 90 days

Protocol documents: