ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01668836
Conditions: Vascular System Injuries Lipid Metabolism Disorders Endothelial Disfunction
Keywords: sirtuin atherosclerosis longevity calorie restriction resveratrol vascular reactivity
Sponsor: InCor Heart Institute
Start date: 2012-08-01; Completion date: 2014-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Women have a natural protection that gives them greater longevity. One hypothesis most commonly used is the estrogen protection in the premenopausal period. However many studies of various forms of hormone replacement therapy proved ineffective in promoting additional protection for women. Thus, it is discussed other ways of protection associated with longevity in women. Of these, the sirtuin system was found in several animal studies to be associated with longevity. This system also showed, through the involvement of several metabolic pathways, an important protection against the process of atherosclerosis. But the activity of this system in humans is unknown and if it is more active in women than in men. The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55 to 65 years, and their influence on the main metabolic pathways related to longevity and the process of atherosclerosis. The research protocol includes analysis of the influence of sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of inflammation and homeostasis, before and after the interventions with caloric restriction or resveratrol administration. It is expected of this study mechanistic conclusion for longevity and possible clinical applications in the mechanism of atherosclerosis prevention.

Detailed description:
After a washout period of 15 days without medication, men and women will be randomized to the group of calorie restriction or resveratrol so that in 24 individuals (12 women and 12 men) will be given a hypocaloric diet (1000 calories per day) and the remaining 24 individuals (12 women and 12 men), a daily pill of 500mg of resveratrol. In the two moments, after the washout period and before the intervention (baseline) and after 30 days of intervention (final) will evaluate the clinical, laboratory and vascular reactivity of all subjects.

Arms: arm 1: 12 men will receive a pill with 500mg of resveratrol daily for 30 days arm 2: 12 women will receive a pill with 500mg of resveratrol daily for 30 days arm 3: 12 men will follow a 1000 calories per day diet for 30 days arm 4: 12 women will follow a 1000 calories per day diet for 30 days
Interventions: intervention 1: Resveratrol intervention 2: Caloric restriction
Intervention descriptions: intervention 1: 1 pill daily containing 500 mg/d of resveratrol for 30 days intervention 2: Diet of 1000kcal per day for 30 days

Protocol documents:
Clinical trial NCT01669174
Conditions: Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
Keywords: Chronic Obstructive Pulmonary Disease COPD; cachexia; muscle wasting
Sponsor: Novartis Pharmaceuticals
Start date: 2012-09-01; Completion date: 2014-12-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: BYM338
Intervention descriptions: intervention 1: None intervention 2: BYM338

Protocol documents:
Clinical trial NCT01673191
Conditions: Macular Edema Diabetes Mellitus
Sponsor: Retinal Consultants of Arizona
Start date: 2012-11-01; Completion date: 2014-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

Detailed description:
The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery

Arms: arm 1: OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg arm 2: NSAID eye drop: Acular LS Steriod eye drop: Pred Forte
Interventions: intervention 1: Dexamethasone intravitreal implant intervention 2: Steroid plus NSAID eye drop combination therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01680991
Conditions: Lymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2012-09-01; Completion date: 2014-12-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+) malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: Participants with chronic lymphocytic leukemia (CLL) will receive 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. The first infusion on Cycle 1 Day 1 will be given over two days: Day 1 and Day 2. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15. arm 2: Participants with diffuse large B-cell lymphoma (DLBCL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15. arm 3: Participants with follicular lymphoma (FL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.
Interventions: intervention 1: Obinutuzumab
Intervention descriptions: intervention 1: Multiple doses of obinutuzumab.

Protocol documents:
Clinical trial NCT01689207
Conditions: Complicated Infection Bacterial Infections
Keywords: Phase I, Safety, tolerability, healthy.
Sponsor: Pfizer
Start date: 2012-09-01; Completion date: 2014-12-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single administration, and following multiple administrations of ATM-AVI in healthy male and female (females of nonchildbearing potential) volunteers both young and elderly.

Detailed description:
A Phase I, Randomised, Double-blind, 3-Part Study in Healthy Young and Elderly Subjects to Assess the Safety and Tolerability, and Investigate the Pharmacokinetics of Aztreonam and Avibactam given Alone and in Combination (ATM-AVI)

Arms: arm 1: Avibactam (AVI) arm 2: Aztreonam (ATM) arm 3: combination of Aztreonam-Avibactam (ATM-AVI) arm 4: Matching Placebo
Interventions: intervention 1: Avibactam (AVI) intervention 2: Aztreonam (ATM) intervention 3: combination of Aztreonam - Avibactam (ATM-AVI) intervention 4: Placebo
Intervention descriptions: intervention 1: PART A: AVI IV infusion intervention 2: PART A: ATM IV infusion intervention 3: PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions. intervention 4: PART A, PART B, PART C: matching placebo IV infusions

Protocol documents:
Clinical trial NCT01691079
Conditions: Bronchospasm, Exercise-Induced
Sponsor: University of California, San Francisco
Start date: 2012-12-01; Completion date: 2014-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug.

Detailed description:
Exercise-induced asthma (EIA) is common and often unrecognized among endurance athletes. The mechanisms of asthma appear to be different between athletes and non-athletes, in that the occurrence of asthma is higher among endurance athletes and seems to be promoted by training. This suggests that factors inherent to athleticism, such as the parasympathetic nervous system, which has been shown to change with endurance training and is known to lead to narrowing of the airways, may be involved with the development of asthma in athletes. Although asthma mechanisms and treatments have been extensively studied in classic asthmatics, there is very limited data in athletes.

This will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug.

If ipratropium bromide proves to prevent EIA in athletes, this drug may be appropriate and effective to target EIA in this population. The results of this study may lead to improved clinical management of athletes with asthma.

Arms: arm 1: placebo 2 puffs prior to exercise challenge arm 2: ipratropium bromide HFA 2 puffs prior to exercise challenge
Interventions: intervention 1: ipratropium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Inhaled ipratropium bromide administered before exercise. intervention 2: Inhaled placebo administered before exercise.

Protocol documents:
Clinical trial NCT01702896
Conditions: Melanoma Metastatic
Keywords: Metastatic Melanoma
Sponsor: Western Regional Medical Center
Start date: 2012-09-01; Completion date: 2014-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage

Detailed description:
In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (\> 1440 million IU/m2/year).

Arms: arm 1: Interleukin-2 will be used in this group
Interventions: intervention 1: Interleukin-2
Intervention descriptions: intervention 1: Interleukin-2

Protocol documents:
Clinical trial NCT01702909
Conditions: Renal Cell Cancer Metastatic Kidney Cancer Metastatic
Keywords: Metastatic Renal Cell Metastatic Kidney Cancer
Sponsor: Western Regional Medical Center
Start date: 2012-09-01; Completion date: 2014-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used in this study will help increase tumor shrinkage.

Detailed description:
In this phase II study, the IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a cohort of kidney cancer patients to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (\> 1440 million IU/m2/year).

Arms: arm 1: Interleukin-2
Interventions: intervention 1: Interleukin-2
Intervention descriptions: intervention 1: Interleukin-2

Protocol documents:
Clinical trial NCT01704196
Conditions: Cocaine Dependence
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2013-04-01; Completion date: 2014-12-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.

Detailed description:

Arms: arm 1: Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks arm 2: Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Interventions: intervention 1: Nepicastat intervention 2: Placebo
Intervention descriptions: intervention 1: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks. intervention 2: None

Protocol documents:
Clinical trial NCT01726049
Conditions: Heart Failure, Diastolic Pulmonary Hypertension
Keywords: HFpEF PH
Sponsor: University Medical Center Groningen
Start date: 2011-10-01; Completion date: 2014-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aim of the study is to investigate whether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output (CO) and in improvement of exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF) with pulmonary hypertension ( PH).

Detailed description:
Rationale: Treatment of diastolic left heart failure is a challenging task. Compared to systolic left heart failure the level of evidence for known medical treatment regiments is low. Sildenafil, a phosphodiesterase 5 (PDE 5) inhibitor and effective therapy for pulmonary arterial hypertension acts as a selective pulmonary vasodilator by inhibiting the impaired nitric oxide (NO) pathway. Reducing the pulmonary vascular resistance would be the primary target by treatment of diastolic left heart failure with PH. But clinical and hemodynamical studies to evaluate the role of Sildenafil in diastolic heart failure, also called heart failure with preserved ejection fraction (HFpEF) with secondary pulmonary hypertension are lacking. Our hypothesis is that Sildenafil decreases pulmonary artery pressure in patients with HFpEF and pulmonary hypertension.

Objective: To investigate whether Sildenafil treatment results in a hemodynamic improvement and in an improvement of exercise capacity in these patients.

Study design: single-center, prospective, randomized, placebo controlled study. Study population: 52 patients with HFpEF and PH Intervention : One group receives three times daily 20 mg Sildenafil for 2 weeks followed by three times daily 60 mg Sildenafil for 10 weeks. The other group receives three times daily 20 mg of Placebo, followed by 3 times daily 60 mg placebo.

Main study parameters/endpoints:

Primary objectives

1\. To investigate whether Sildenafil treatment results in a reduction of pulmonary artery pressure (PAP) in HFpEF patients with PH (investigated invasively by right heart catheterization) .

Secondary objectives

1. To investigate whether Sildenafil treatment results in an reduction of wedge pressure in HFpEF patients.
2. To investigate whether Sildenafil treatment results in an improvenemt of cardiac output (CO) in HFpEF patients.
3. To investigate whether Sildenafil treatment results in improvement of exercise capacity in these patients ( defined as change in VO2max)

Arms: arm 1: Sildenafil orally 3 times 20mg for 2 weeks , followed by 3 times 60 mg for 10 weeks arm 2: placebo orally 3 times 20mg tablets, followed by 3 times 60 mg for 10 weeks
Interventions: intervention 1: Sildenafil intervention 2: Placebo
Intervention descriptions: intervention 1: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks intervention 2: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks

Protocol documents:
Clinical trial NCT01734551
Conditions: Neonatal Abstinence Syndrome
Keywords: Prenatal opiate exposure neonatal withdrawal Pharmacologic treatment
Sponsor: Henrietta Bada
Start date: 2011-09-01; Completion date: 2014-12-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.

Detailed description:
Withdrawal from drugs, called Neonatal abstinence syndrome (NAS), is a group of symptoms that occurs to babies whose mother took or used drugs (prescription, addicting, illegal, pain pills, or drugs for addiction treatment) during pregnancy. Medicines the mother takes while pregnant, the baby also takes. Babies may experience withdrawal after delivery, and may need treatment. There are different ways to treat babies with withdrawal - about 50% of doctors use morphine, an opiate, to treat these babies, the rest uses other drugs, like clonidine and phenobarbitol.

Arms: arm 1: Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months. arm 2: Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.
Interventions: intervention 1: Morphine intervention 2: Clonidine
Intervention descriptions: intervention 1: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.

Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is \<0.1mg/kg/day, may discontinue. intervention 2: Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.

Protocol documents:
Clinical trial NCT01740401
Conditions: Melanoma
Keywords: Melanoma Advanced Malignant Melanoma Anti CTLA4 Blockade Progression Free Survival Interventional Therapy Phase II Clinical Trial Immunotherapy T Cell Activation
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2012-10-01; Completion date: 2014-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see whether the combination of low-dose Cyclophosphamide and Anti-CTLA4 (Ipilimumab) will stop tumor growth in patients with advanced skin cancer. The investigators expect to see an increase in response rate of the combination over Anti-CTLA-4 alone and estimate a response rate of approximately 20 % in the proposed population.

Detailed description:
The transient removal of CTLA-4-mediated inhibition (CTLA-4 blockade) can induce effective anti-tumor immunity. Efficacy of CTLA-4 blockade as a single agent has been shown in melanoma 53. It has been hypothesized that anti-CTLA-4 antibody might deplete Treg cells 54, inducing autoimmunity. However, patients receiving Ipilimumab have not shown a decrease in Treg number or function in peripheral blood 55.

This trial will answer the question if the combination of Anti-CTLA 4 (following a well established regimen of Ipilimumab) and Cyclophosphamide (given at immunomodulatory doses) will result in antitumor activity in patients with metastatic melanoma due to synergistic immunomodulating effects by overcoming tolerance.

Arms: arm 1: Treatment:

Cyclophosphamide 300 mg/m2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)

Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv
Interventions: intervention 1: Cyclophosphamide
Intervention descriptions: intervention 1: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study

Protocol documents:
Clinical trial NCT01751802
Conditions: Lesch-Nyhan Disease Self-injurious Behavior
Keywords: Lesch Nyhan Disease Self-Injury
Sponsor: Emalex Biosciences Inc.
Start date: 2012-12-01; Completion date: 2014-12-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to gather scientific information about the effectiveness and safety of the study drug, Ecopipam (PSYRX 101), for the treatment of self-injurious behaviors when compared with the effectiveness and safety of placebo (inactive substance) in subjects with Lesch-Nyhan Disease.

Detailed description:
This study will be done in approximately 6 centers in approximately 4 countries, and approximately 24 subjects will be included. This study is divided into two parts. The first is a double-blinded portion lasting up to 18 weeks in total. The second portion is an optional open-label extension and lasts up to 54 weeks total. The total duration of the study, if you choose to participate in both portions, is anticipated to be up to approximately 78 weeks.

The first portion of this study is double-blind and assignment to a treatment group is done randomly. In this study, there are two treatment groups. One group will receive Ecopipam for one 6-week period and placebo for two 6-week periods, and the other group will receive Ecopipam for two 6-week periods and placebo for one 6-week period.

Subjects who did not experience any clinically significant side effects during the blinded portion of the study may be eligible to participate in an open-label extension that may last up to 54 weeks.

Arms: arm 1: Active substance being tested, orally once a day at bedtime arm 2: Inactive substance being tested, orally once a day at bedtime
Interventions: intervention 1: Ecopipam intervention 2: Placebo
Intervention descriptions: intervention 1: Antagonist of the dopamine D1 receptor intervention 2: Placebo for Ecopipam

Protocol documents: