ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01278745
Conditions: Cardiac Allograft Vasculopathy Heart Transplant Recipients
Keywords: cardiac allograft vasculopathy (CAV) prevention cardiac transplantation rituximab
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2011-09-01; Completion date: 2015-10-01
Enrollment: 362 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function. People who develop antibodies after transplant have a higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the risk of developing CAV. People who develop CAV usually have to receive another transplant.

Detailed description:
The purpose of this research study is to see if a study drug called rituximab (Rituxan®) prevents CAV. Rituximab destroys certain types of white blood cells called B cells. B cells are important cells in the immune system that help the body fight infection by producing substances called antibodies. B cells and the antibodies they produce are also involved in some kinds of rejection after organ transplantation. Rituximab decreases the number of B cells in the blood and other tissues. The goal of this study is to determine if decreasing B cells with Rituximab can prevent injury to the transplanted heart.

Arms: arm 1: Rituximab induction/conventional immunosuppression arm 2: Rituximab Placebo / conventional immunosuppression
Interventions: intervention 1: Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper) intervention 2: Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01295112
Conditions: Non-Ischemic Central Retinal Vein Occlusion
Sponsor: Texas Retina Associates
Start date: 2011-05-01; Completion date: 2015-10-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study designed to determine if the addition of Ozurdex® to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Detailed description:
This is a multicenter clinical study designed to determine if the addition of Ozurdex® injection to bevacizumab (Avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Arms: arm 1: Active bevacizumab (Avastin®) and Sham Ozurdex® arm 2: Active bevacizumab (Avastin®) and Active Ozurdex®
Interventions: intervention 1: Active bevacizumab and Sham dexamethasone intervention 2: Active bevacizumab and Active dexamethasone
Intervention descriptions: intervention 1: Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe intervention 2: Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose

Protocol documents:
Clinical trial NCT01332019
Conditions: Relapsing Multiple Sclerosis
Keywords: Subcutaneous Extension Interferon MS PEGylated Injectable SC PEG peginterferon beta-1a Relapsing
Sponsor: Biogen
Start date: 2011-04-01; Completion date: 2015-10-01
Enrollment: 1077 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.

Detailed description:

Arms: arm 1: 125 µg peginterferon beta-1a administered by subcutaneous (SC) injection every 4 weeks (Q4W) for at least 2 years and up to 4 years. arm 2: 125 μg peginterferon beta-1a administered by SC injection every 2 weeks (Q2W) for at least 2 years and up to 4 years.
Interventions: intervention 1: peginterferon beta-1a
Intervention descriptions: intervention 1: Administered as specified in the treatment arm

Protocol documents:
Clinical trial NCT01367236
Conditions: HIV Impaired Cognition
Keywords: HIV
Sponsor: Imperial College London
Start date: 2013-01-01; Completion date: 2015-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.

The study will compare anti-HIV therapy combinations which are currently in use.

The patients will not have had any previous treatment for their HIV infection.

Detailed description:
Impairment in neurocognitive(NC) function in HIV-infected subjects in the current anti-retroviraltreatment (cART) era has been associated with poor compliance with cART, reduced quality-of-life and increased mortality. Reported factors associated with the development of NC function impairment in HIV disease and risks associated with progression of such impairment include degree of immune suppression related to HIV infection, other chronic viral infections (such as chronic hepatitis C co-infection), age and central nervous system (CNS) antiretroviral drug exposure.

One modifiable factor which may be associated with the evolution of NC function impairment is the direct effect of cART on the central-nervous-system (CNS). Certain antiretroviral drugs such as zidovudine, lamivudine, abacavir, nevirapine, efavirenz and indinavir are known to achieve optimal exposure in the cerebro-spinal-fluid (CSF) whereas other drugs, such as the majority of the HIV-1 protease inhibitors penetrate less effectively. Studies to date suggest different cART regimens may have differing effects on NC performance. In the EuroSIDA study, the use of nucleoside-reverse-transcriptase inhibitors was found to specifically protect against the development of HIV related brain disease. More recently, in a small prospective study, ALTAIR, different effect on cerebral function was reported in subjects randomised to commence three different cART regimens.

The investigators propose, in a prospective, randomised study to assess the effects of two different antiretroviral regimens on NC function in HIV infected subjects commencing antiretroviral therapy for the first time.

Arms: arm 1: treatment with:

* atazanavir 300 mg daily
* ritonavir 100 mg daily
* tenofovir 245 mg daily\*
* emtricitabine 200 mg daily\* \* as the fixed dose combination Truvada™ arm 2: * darunavir 800 mg daily
* ritonavir 100 mg daily
* lamivudine 300 mg daily\*\*
* abacavir 600 mg daily\*\*
* maraviroc 150 mg once daily \*\* as the fixed dose combination Kivexa ™
Interventions: intervention 1: standard care intervention 2: novel treatment
Intervention descriptions: intervention 1: * atazanavir 300 mg daily
* ritonavir 100 mg daily
* tenofovir 245 mg daily\*
* emtricitabine 200 mg daily\* intervention 2: * darunavir 800 mg daily
* ritonavir 100 mg daily
* lamivudine 300 mg daily\*\* and abacavir 600mgs daily\*\*
* maraviroc 150 mg once daily

Protocol documents:
Clinical trial NCT01394939
Conditions: Colorectal Carcinoma CRC
Keywords: Vaccinia Vaccinia Virus JX-594 Jennerex Colorectal Carcinoma Colorectal cancer Colon Cancer Rectal Cancer oncolytic virus viral therapy RAS mutant Erbitux failure Oxaliplatin failure FOLFOX failure FOLFIRI failure Irinotecan failure Pexa-Vec
Sponsor: Jennerex Biotherapeutics
Start date: 2012-01-01; Completion date: 2015-10-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.

Detailed description:
This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)

Arms: arm 1: JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10\^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29 arm 2: JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29 arm 3: JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.

JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. arm 4: JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.

JX-594: RAC VAC GM-CSF JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
Interventions: intervention 1: JX-594 intervention 2: Irinotecan
Intervention descriptions: intervention 1: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) intervention 2: 180 mg/m2 IV every 2 weeks.

Protocol documents:
Clinical trial NCT01417156
Conditions: Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Start date: 2011-09-01; Completion date: 2015-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31).

Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Nintedanib intervention 2: Pirfenidoneone
Intervention descriptions: intervention 1: 150 mg bid intervention 2: Existing treatment

Protocol documents:
Clinical trial NCT01422161
Conditions: Stroke With Hemiparesis
Keywords: Rehabilitation Fingers Grasp Hand Strength Brain Infraction Pathology Physiopathology Functional Laterality Neuronal Plasticity Psychomotor Performance Biomechanics Touch Weight-Bearing
Sponsor: NYU Langone Health
Start date: 2010-04-01; Completion date: 2015-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the study drug but contains no active study medication).

Detailed description:
Hemiparesis is the most common motor impairment after stroke that frequently leads to persistent deficits in hand function. This study investigates whether the application of botulinum toxin to a set of synergistically-acting hand muscles, in conjunction with task-specific therapy, will lead to reorganization and improved motor function in the stroke-involved hand. The investigators will use objective psychophysical measures of hand function and hand function rating scales to investigate if Botox in conjunction with task-specific therapy will lead to:

* improved motor execution,
* improved motor planning during a psychophysical two-finger grasping and lifting task with varying object weight, and
* increased hand function as assessed by the time taken to complete fine motor tasks.

Arms: arm 1: Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received. arm 2: Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.
Interventions: intervention 1: Botulinum Toxin commonly known as BOTOX® intervention 2: Placebo
Intervention descriptions: intervention 1: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.

There will be 1 treatment cycle during the 9 week study. intervention 2: The control group will receive a placebo injection.

Protocol documents:
Clinical trial NCT01422408
Conditions: Breast Carcinoma
Sponsor: OHSU Knight Cancer Institute
Start date: 2011-09-01; Completion date: 2015-10-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients undergoing hormone therapy.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.

SECONDARY OBJECTIVES:

I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.

II. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application.

III. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream.

IV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream.

OUTLINE:

Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.

Arms: arm 1: Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.
Interventions: intervention 1: Fluocinonide Cream intervention 2: Management of Therapy Complications intervention 3: Questionnaire Administration
Intervention descriptions: intervention 1: Given topically intervention 2: Receive fluocinonide cream intervention 3: Ancillary studies

Protocol documents:
Clinical trial NCT01437995
Conditions: Asthma
Keywords: Asthma Step down therapy Inhaled corticosteroids Long-acting beta agonists Fluticasone Salmeterol
Sponsor: Johns Hopkins University
Start date: 2012-03-01; Completion date: 2015-10-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group comparative effectiveness study of approaches to stepping down therapy for patients with well-controlled asthma treated with combination ICS and LABA.

Detailed description:
Current asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months. For patients treated with inhaled corticosteroids (ICS) alone, a dose reduction of 25-50% to a minimal dose that controls disease is recommended. The optimal approach to reducing treatment in patients with asthma treated with combination inhaled corticosteroids and long-acting beta agonists (ICS/LABA) is not clear. The American Lung Association Asthma Clinical Research Center (ALAACRC) is a network of 18 asthma research centers with the goal of performing clinical trials directly relevant to clinical practice. The question of the optimal way to de-escalate therapy in patients with asthma that is well controlled on fixed dose combination ICS/LABA is a key question for practitioners caring for patients with moderate to severe persistent asthma. We propose a 56 week multi-center, prospective, randomized, three-arm parallel group comparative effectiveness study comparing three approaches to care of patients with asthma well-controlled for three months on combination ICS/LABA: reduction of ICS dose and maintenance of LABA, initial discontinuation of LABA with continuation of ICS, and continuation of stable dose ICS/LABA. Our primary goal is to perform a pragmatic study that resembles clinical practice and determine the optimal treatment strategy that results in the lowest rate of treatment failure over 48 weeks of follow-up. Additional exploratory analyses include assessing risk factors for step-down failure, and to assess the duration of time that asthma control is maintained when therapy is de-escalated.

Arms: arm 1: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily arm 2: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily arm 3: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Interventions: intervention 1: Fluticasone/Salmeterol Diskus intervention 2: Fluticasone/Salmeterol Diskus intervention 3: Fluticasone Diskus
Intervention descriptions: intervention 1: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily intervention 2: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily intervention 3: Fluticasone Diskus alone 250 ug twice daily without Salmeterol

Protocol documents:
Clinical trial NCT01440569
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment Naïve Treatment Experienced
Sponsor: Gilead Sciences
Start date: 2011-09-01; Completion date: 2015-10-01
Enrollment: 314 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations.

After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.

Detailed description:

Arms: arm 1: Participants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase.
Interventions: intervention 1: COBI intervention 2: DRV intervention 3: NRTIs
Intervention descriptions: intervention 1: 150 mg tablet administered orally with food once daily intervention 2: 800 mg (2 x 400 mg tablets) administered orally with food once daily intervention 3: Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.

Protocol documents:
Clinical trial NCT01444430
Conditions: Asthma
Keywords: Symbicort pMDI Asthma safety budesonide
Sponsor: AstraZeneca
Start date: 2011-12-01; Completion date: 2015-10-01
Enrollment: 12460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

Detailed description:
A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.

Arms: arm 1: Symbicort arm 2: budesonide
Interventions: intervention 1: Symbicort pMDI intervention 2: budesonide pMDI
Intervention descriptions: intervention 1: Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation. intervention 2: Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.

Protocol documents:
Clinical trial NCT01483183
Conditions: Atrial Fibrillation Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation
Keywords: Atrial fibrillation Paroxysmal Atrial fibrillation Persistent Atrial fibrillation A-fib
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-11-01; Completion date: 2015-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).

The purpose of Part 2 of this study is to determine potential efficacy of dose(s) of OPC-108459 for the treatment of paroxysmal and persistent atrial fibrillation.

Detailed description:
This trial will test the pharmacokinetic and pharmacodynamic characteristics of ascending doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects.

The trial will consist of two parts. Each part will evaluate two populations of subjects presenting for cardioversion in a hospital setting.

Cohorts of paroxysmal and persistent subjects may have their dose increased independently.

Arms: arm 1: To safely meet each of the following Cmax targets: 1.0-10.0 µg/mL. There will be 9 cohorts in all: 1.0, 1.6, 2.4, 3.6, 5.4, 7.0, 8.0, 9.0, and 10.0. arm 2: None arm 3: Single dose to safely meet target concentration from Part 1, if subject fails to convert to sinus rhythm within 10 minutes, second dose will be administered to achieve 25% increase when compared to first infusion arm 4: None
Interventions: intervention 1: OPC-108459 intervention 2: Placebo
Intervention descriptions: intervention 1: Part 1: single dose OPC-108459, 10-minute constant rate IV infusion to achieve specified Cmax target

Part 2: single dose OPC-108459, 10-minute constant rate IV infusion to achieve Cmax target concentration from Part 1; if failure to convert to sinus rhythm, second dose OPC-108459 administered, 10-minute constant rate IV infusion to achieve target concentration from Part 1 intervention 2: Placebo dose, 10-minute constant rate IV infusion

Protocol documents: