ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00895414
Conditions: Breast Cancer
Keywords: stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2009-04-01; Completion date: 2015-10-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Enalapril maleate may help protect heart cells from the side effects of chemotherapy. It is not yet known whether giving enalapril maleate before or after doxorubicin hydrochloride is more effective in treating women with breast cancer.

PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with doxorubicin hydrochloride to see how well it works in treating women with breast cancer.

Detailed description:
This study is a drug interaction study designed to study the effects of enalapril on doxorubicin metabolism. Women with breast cancer for whom at least two cycles every 14 day doxorubicin is planned will be considered for enrollment. Study participation will be for 2 treatment cycles of doxorubicin or approximately 4 weeks. Patients will receive a 14 day course of daily enalapril in association with one cycle of doxorubicin and receive no study agent during the other cycle allowing patients to act as their own control. The sequence of enalapril dosing will be assigned by randomization at study enrollment. Blood samples for pharmacokinetics will be drawn before and at 7 time points after each of the two doses of doxorubicin. For each patient, serum doxorubicin and doxorubicinol concentrations both on and off of enalapril will be compared.

Arms: arm 1: Patients receive doxorubicin hydrochloride IV over 5-10 minutes on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 week before course 2, patients also receive oral enalapril maleate once daily until day 8 of course 2. arm 2: Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 week before course 1, patients receive oral enalapril maleate once daily until day 8 of course 1.
Interventions: intervention 1: doxorubicin hydrochloride intervention 2: enalapril maleate
Intervention descriptions: intervention 1: Given IV 5-10 minutes on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. intervention 2: Given orally - Beginning 1 week before course 2, patients also receive oral enalapril maleate once daily until day 8 of course 2. OR Beginning 1 week before course 1, patients receive oral enalapril maleate once daily until day 8 of course 1.

Protocol documents:
Clinical trial NCT00957671
Conditions: Growth Hormone Deficiency Traumatic Brain Injury
Keywords: TBI Traumatic Brain injury Growth hormone deficiency Anterior pituitary hormone Recombinant human growth Hormone Genotropin
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2003-11-01; Completion date: 2015-10-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

Detailed description:
This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Growth hormone deficiency will be replaced for a period of one year. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.

Arms: arm 1: recombinant human growth hormone (rhGH) self administered daily for one year
Interventions: intervention 1: Recombinant human growth hormone
Intervention descriptions: intervention 1: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)

Protocol documents:
Clinical trial NCT00999713
Conditions: Acute Lung Injury
Keywords: Acute Lung Injury Cancer Pediatrics
Sponsor: Milton S. Hershey Medical Center
Start date: 2010-06-01; Completion date: 2015-10-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these children represent a relatively small and unique patient population, they account for the largest proportion of deaths of all pediatric diseases. The long-term goal of this project is to improve outcomes among these patients. Recently, the intratracheal administration of calfactant has resulted in decreased mortality among children with ALI including promising results among children with cancer and following HSCT. Consequently, the primary specific aim of this study is to assess the effect of calfactant on intensive care (PICU) survival among pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung injury in the overall pediatric population by improving oxygenation and decreasing mortality. These findings, in conjunction with recent subgroup analysis in which calfactant therapy appeared to improve outcomes in immunocompromised children provide the rationale for assessing calfactant therapy in this patient population.

Funding Source - FDA Office of Orphan Products Development (OOPD)

Detailed description:

Arms: arm 1: Endotracheal calfactant administration arm 2: Endotracheal air administration
Interventions: intervention 1: Calfactant intervention 2: Air placebo
Intervention descriptions: intervention 1: Endotracheal calfactant, up to 3 doses if subject qualifies intervention 2: Endotracheal air administration

Protocol documents:
Clinical trial NCT01054339
Conditions: Alpha-1 Antitrypsin Deficiency
Keywords: Alpha-1 antitrypsin deficiency Adeno-associated virus vector AAV Gene therapy Human gene transfer
Sponsor: Beacon Therapeutics
Start date: 2010-06-01; Completion date: 2015-10-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Assessment of the safety and efficacy of intramuscular (IM) administration of a recombinant adenoassociated virus (rAAV) alpha-1 antitrypsin (AAT) vector (rAAV1-CB-hAAT) in AAT-deficient adults at three dosage levels \[6.0 × 10e11, 1.9 × 10e12 and 6.0 × 10e12 vector genome particles (vg) per kg body weight\].

Funding Sources - The FDA Office of Orphan Products Development and NIH National Heart, Lung, and Blood Institute

Detailed description:
The study is a non-randomized, open-label, multi-center, sequential, three-arm, Phase 2 clinical trial evaluating the safety and efficacy of administration of a rAAV1-CB-hAAT vector administered by IM injection. Each participant will receive rAAV1-CB-hAAT on a single occasion. Three groups of three subjects each will receive rAAV1-CB-hAAT at dosage levels of 6 x 10e11 vg/kg, 1.9 x 10e12 vg/kg or 6 x 10e12 vg/kg by IM injection. Subjects in group 1 will receive a total of 10 IM injections distributed across a single muscle site, subjects in group 2 will receive a total of 32 IM injections distributed across three muscle sites, and subjects in group 3 will receive 100 IM injections distributed across 10 muscle sites. Each injection will be given in a volume of 1.35 mL, at the appropriate vector concentration to achieve the desired total vector dose.

The three groups were enrolled sequentially, with review of safety data by a Data and Safety Monitoring Board before enrollment of each higher dosage level group.

Safety was monitored by evaluation of adverse events, hematology and clinical chemistry parameters, histological examination of muscle biopsies, and measurement of serum antibodies to AAT. Efficacy was measured by evaluation of serum concentrations of M-specific AAT and total AAT, and serum AAT phenotype determined on isoelectric focusing gels. Additional information collected included presence of the vector in blood or semen, changes in serum anti-AAV antibody titers, and changes in T cell responses to AAV and AAT.

Arms: arm 1: rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg arm 2: rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg arm 3: rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg
Interventions: intervention 1: rAAV1-CB-hAAT
Intervention descriptions: intervention 1: Recombinant adeno-associated virus vector expressing human alpha-1 antitrypsin

Protocol documents:
Clinical trial NCT01074944
Conditions: Gaucher Disease
Keywords: Gaucher disease Genz-112638 beta-glucosidase acid β-glucosidase glucocerebrosidase glucosylceramide D-glucosyl-N-acylsphingosine glucohydrolase substrate reduction therapy
Sponsor: Genzyme, a Sanofi Company
Start date: 2010-06-01; Completion date: 2015-10-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective was to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) was administered QD and BID in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638).

Detailed description:
NOTE: Other Phase 3 studies being conducted with eliglustat tartrate (Genz-112638) are GZGD02507 (ENGAGE): NCT00891202 and GZGD02607 (ENCORE): NCT00943111

Arms: arm 1: Patients will receive either 50 mg BID or 100 mg BID arm 2: Patients will receive either 100 mg QD or 200 mg QD
Interventions: intervention 1: Eliglustat tartrate
Intervention descriptions: intervention 1: Oral Capsule in 50 mg or 100 mg dosages

Protocol documents:
Clinical trial NCT01086150
Conditions: Diabetic Peripheral Neuropathy
Sponsor: Albany Medical College
Start date: 2009-10-01; Completion date: 2015-10-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.

Detailed description:

Arms: arm 1: Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. arm 2: 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. arm 3: 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.
Interventions: intervention 1: Skin biopsy intervention 2: Lidocaine 5% patches
Intervention descriptions: intervention 1: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. intervention 2: Subject will apply patches to affected area QD for 12 hours then remove.

Protocol documents:
Clinical trial NCT01108003
Conditions: Recurrent Bladder Cancer Stage 0 Bladder Cancer Stage I Bladder Cancer Stage II Bladder Cancer Transitional Cell Carcinoma of the Bladder
Sponsor: Roswell Park Cancer Institute
Start date: 2010-04-01; Completion date: 2015-10-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.

Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.

Detailed description:
Primary Objectives:

I. To determine the tolerability and toxicity of a broccoli sprout extract (providing 200 micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo definitive bladder resection for bladder cancer.

Secondary Objectives:

I. Establish the safety of administration of the broccoli extract on the bladder surgery specifically.

II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign urothelium and bladder cancer tissue.

III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by measuring angiogenesis, cell proliferation and apoptosis.

IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per dose per day of broccoli sprout extract in future therapeutic and prevention clinical trials.

Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks.

Arms: arm 1: Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive mango juice alone.
Interventions: intervention 1: broccoli sprout extract intervention 2: laboratory biomarker analysis intervention 3: Mango Juice
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: given orally

Protocol documents:
Clinical trial NCT01111461
Conditions: Endometrial Cancer
Keywords: Advanced Endometrial Cancer
Sponsor: Eisai Inc.
Start date: 2010-03-01; Completion date: 2015-10-01
Enrollment: 133 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the objective response rate (ORR: complete response + partial response \[CR+ PR\]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. .

Detailed description:

Arms: arm 1: Participants with advanced endometrial cancer and disease progression following platinum-based, first line chemotherapy.
Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: Lenvatinib 24 mg administered orally, once daily continuously in 28-day cycles to participants with advanced endometrial cancer and disease progression following first-line chemotherapy. Participants continued to receive study drug until disease progression, development of unacceptable toxicity or withdrawal of consent. 'Treatment interruption and subsequent dose reduction' was allowed for participants who experienced lenvatinib-related toxicity.

Protocol documents:
Clinical trial NCT01142336
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease Prevention Spinal Fluid Biomarkers Simvastatin
Sponsor: University of Washington
Start date: 2010-06-01; Completion date: 2015-10-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's disease.

Detailed description:
The purpose of this study is to see if a drug called simvastatin (brand name Zocor) beneficially affects the level of certain molecules (such as proteins) in the spinal fluid of people. The molecules the investigators are measuring are thought to be important in the development of Alzheimer's disease (AD), and the investigators are testing whether simvastatin can change proteins to a level that is associated with a reduced risk for AD.

Simvastatin has been approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol and to reduce the risk of coronary artery disease. It is an investigational drug in this study.

Participants will be randomly assigned to Placebo or Simvastatin. The investigators and the participant will be blinded. Randomization will be stratified by age and gender.

This study is being funded by the National Institute on Aging. The investigators will take part in this study at the VA Puget Sound Health Care System.

This study will last up to 1 year. Participants will be asked to come to the VA in Seattle a total of 9 times, 2 of those times will be for lumbar punctures (also known as a spinal tap).

The investigators would also like to ask a person who knows the participant well (such as a spouse, child, sibling, or good friend) some questions about the participant's health, memory, mood and behavior, and abilities to do daily tasks at the beginning and the end of the study.

Participants must be cognitively normal, healthy, willing to have a lumbar puncture, and not need or take any medications to control cholesterol.

Arms: arm 1: Simvastatin 40mg qHS for 1 year arm 2: Placebo 1 tablet qHS for 1 year
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Simvastatin 40mg qHS for 1 year intervention 2: Placebo 1 tablet qHS for 1 year

Protocol documents:
Clinical trial NCT01217307
Conditions: ST Elevation Myocardial Infarction (STEMI) Coronary Artery Disease Heart Failure Diabetes
Keywords: Metformin ST elevation myocardial infarction (STEMI) Coronary artery disease Heart failure Diabetes
Sponsor: University Medical Center Groningen
Start date: 2011-01-01; Completion date: 2015-10-01
Enrollment: 380 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will evaluate the effect of metformin therapy during 4 months in non-diabetic patients following ST-elevation myocardial infarction on left ventricular ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.

Detailed description:
In this trial, the investigators will evaluate the effect of metformin therapy following ST-elevation myocardial infarction (STEMI) in a total of 380 non-diabetic patients. This trial is a randomized, double blind, controlled trial. The intervention, which consist of metformin 500mg twice daily or placebo twice daily, will commence within three hours after the percutaneous coronary intervention, and will be continued for 4 months. The primary endpoint is the difference between the two intervention groups (metformin vs placebo) in left ventricular ejection fraction, as measured with magnetic resonance imaging after 4 months. The investigators hypothesize that metformin therapy results in a significantly higher ejection fraction in this population.

Arms: arm 1: metformin 500mg twice daily during 4 months arm 2: Placebo twice daily during 4 months
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: Metformin 500mg twice daily during 4 months intervention 2: Placebo twice daily during 4 months

Protocol documents:
Clinical trial NCT01248949
Conditions: Advanced Solid Tumors Advanced Recurrent Ovarian Tumors
Keywords: Advanced solid tumors Advanced recurrent ovarian tumors MEDI3617 Ang2 Ovarian cancer Malignant glioma
Sponsor: MedImmune LLC
Start date: 2010-10-01; Completion date: 2015-10-01
Enrollment: 162 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.

Detailed description:

Arms: arm 1: Participants will receive MEDI3617 via intravenous (IV) infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days. arm 2: Participants will receive MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days. arm 3: Participants will receive MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days. arm 4: Participants will receive MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days. arm 5: Participants will receive MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
Interventions: intervention 1: MEDI3617 intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. intervention 2: Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. intervention 3: Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. intervention 4: Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.

Protocol documents: