ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00478244
Conditions: Epidermolysis Bullosa
Keywords: epidermolysis bullosa dystrophic epidermolysis bullosa
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2007-04-01; Completion date: 2011-08-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: In animal models, stem cells have been shown to home to the skin and repair the biochemical and structural abnormalities associated with recessive dystrophic epidermolysis bullosa (RDEB) (collagen 7 deficiency).

PURPOSE: To determine the safety and effectiveness of stem cell infusion in the treatment of RDEB.

Detailed description:
OBJECTIVES:

Primary

* Estimate the incidence of detectable donor-derived collagen type VII at day 100 in patients with epidermolysis bullosa by donor.

Secondary

* Determine the incidence of transplant-related mortality at day 180
* Determine the incidence of blood chimerism at days 21, 100, 180, 365, and 730
* Determine the incidence of neutrophil recovery at day 42 and platelet recovery at day 180
* Determine the incidence of acute graft-versus-host disease (GVHD) grade II-IV and grade III-IV at day 100
* Determine the incidence of chronic GVHD at 1 year
* Determine the probability of survival at 1 and 2 years
* Determine the incidence of donor derived cells in the skin
* Determine resistance to blister formation OUTLINE: This is an open-label, pilot study.
* Conditioning regimen: Busulfan intravenously (IV) over 2 hours every 6 hours on days -9 to -4, fludarabine phosphate IV over 1 hour on days -5 to -3, and high-dose cyclophosphamide IV over 1 hour on days -5 to -2.
* Stem cell transplantation on day 0.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: 30 patients

Arms: arm 1: Epidermolysis bullosa patients treated per study regimen with chemotherapy and stem cell transplant.
Interventions: intervention 1: busulfan intervention 2: cyclophosphamide intervention 3: fludarabine phosphate intervention 4: hematopoietic bone marrow transplantation
Intervention descriptions: intervention 1: Day -9 through Day -6: 1.1 mg/kg if \< 12 kg IV every 6 hours; 0.8 mg/kg if \> 12 kg. intervention 2: Day -5 through Day -2: 50 mg/kg IV over 120 min. intervention 3: Day -5 through Day -3: 25 mg/m2 IV over 60 min. intervention 4: allogeneic bone marrow, peripheral stem cell or umbilical cord blood transplantation

Protocol documents:
Clinical trial NCT00526591
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer
Sponsor: Jorge A. Garcia, MD
Start date: 2007-09-01; Completion date: 2011-08-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus works in treating patients with newly diagnosed localized prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the clinical effects of everolimus, in terms of pathologic response (i.e., histologic P0, margin status, or capsular penetration) and surgical outcome, in patients with newly diagnosed localized prostate cancer treated with two different doses of everolimus prior to radical prostatectomy.
* To evaluate the safety and tolerability of this drug in these patients.

Secondary

* To determine the effect of this drug on prostate-specific antigen (PSA) levels in these patients.
* To determine the effect of this drug on levels of expression of PTEN, Akt, phospho-mTOR (i.e., Se2448), phospho-p70 S6 kinase (i.e., Thre389), phospho-Smad3 (i.e., Ser433/435), phospho-Smads 1/5 (i.e., Ser463/465), AR, and TUNEL in these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive low-dose oral everolimus once daily for up to 8 weeks in the absence of unacceptable toxicity.
* Arm II: Patients receive high-dose oral everolimus once daily for up to 8 weeks in the absence of unacceptable toxicity.

Within 7 days after the last dose of everolimus, all patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy.

Tumor biopsy specimens acquired prior to treatment and prostate tumor tissue acquired at the time of radical prostatectomy are evaluated for biomarker correlative studies. Tissue samples are assessed by immunohistochemistry (IHC) and tissue microarray analysis for expression of cellular and molecular biomarkers (i.e., p-S6, p-4E-BP1, and p-Akt) that correlate with response. Prostatectomy specimens are also assessed by pathologic analysis for histopathologic response (i.e., pathologic stage, Gleason score, margin status, and tumor size).

After completion of study therapy, patients are followed at 6 weeks.

Arms: arm 1: 5mg Everolimus daily continuously for 8 weeks and conventional surgery arm 2: 10mg Everolimus daily continuously for 8 weeks and conventional surgery
Interventions: intervention 1: Everolimus intervention 2: conventional surgery
Intervention descriptions: intervention 1: Patients will receive arm-specific dosage of Everolimus daily continuously for 8 week intervention 2: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).

Protocol documents:
Clinical trial NCT00529568
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C ribavirin Hepatitis C-related thrombocytopenia thrombopoietin peginterferon alfa-2b platelets
Sponsor: GlaxoSmithKline
Start date: 2007-10-01; Completion date: 2011-08-01
Enrollment: 759 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

Detailed description:

Arms: arm 1: active treatment arm arm 2: placebo control arm
Interventions: intervention 1: eltrombopag intervention 2: placebo
Intervention descriptions: intervention 1: double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg intervention 2: double-blind matched placebo control daily oral administration

Protocol documents:
Clinical trial NCT00542308
Conditions: Head and Neck Cancer Squamous Cell Cancer
Sponsor: Genmab
Start date: 2008-01-01; Completion date: 2011-08-01
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Detailed description:

Arms: arm 1: Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Interventions: intervention 1: Zalutumumab
Intervention descriptions: intervention 1: Individual dose titration weekly i.v. doses

Protocol documents:
Clinical trial NCT00554229
Conditions: Prostate Cancer
Keywords: Hormone Resistant Prostate Cancer Endothelin A Receptor Antagonist Endothelin A Endothelin A antagonist
Sponsor: AstraZeneca
Start date: 2007-11-01; Completion date: 2011-08-01
Enrollment: 896 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

* This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
* ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
* All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
* Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
* No patients will be deprived of standard prostate cancer therapy.

Detailed description:

Arms: arm 1: ZD4054 10 mg oral tablet once daily arm 2: Matching Placebo, oral tablets once daily
Interventions: intervention 1: ZD4054 intervention 2: Placebo
Intervention descriptions: intervention 1: ZD4054 10 mg oral tablet once daily intervention 2: Matching placebo oral tablet once daily

Protocol documents:
Clinical trial NCT00577031
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-02-01; Completion date: 2011-08-01
Enrollment: 205 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: Oxaliplatin intervention 3: Xeloda
Intervention descriptions: intervention 1: 7.5mg iv on day 1 of each 3 week cycle intervention 2: 130mg/m2 iv on day 1 of each 3 week cycle intervention 3: 1000mg/m2 po bid on days 1-14 of each 3 week cycle

Protocol documents:
Clinical trial NCT00617201
Conditions: Substance Abuse
Keywords: cocaine dependence stimulants
Sponsor: Sharon Walsh
Start date: 2007-07-01; Completion date: 2011-08-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.

Detailed description:

Arms: arm 1: Atomoxetine arm 2: Matched Placebo
Interventions: intervention 1: atomoxetine intervention 2: placebo
Intervention descriptions: intervention 1: Once daily oral dosing intervention 2: Once daily oral dosing - matched placebo

Protocol documents:
Clinical trial NCT00630955
Conditions: Alcohol Drinking
Keywords: Alcohol Drinking Memantine
Sponsor: Yale University
Start date: 2006-06-01; Completion date: 2011-08-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of the study medication, memantine (placebo, 20 mg or 40 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. We hypothesize that memantine will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period. We will also evaluate the influence of family history of alcoholism on the efficacy of memantine in reducing alcohol drinking behavior.

Detailed description:

Arms: arm 1: 20 mg memantine arm 2: 40 mg memantine arm 3: None
Interventions: intervention 1: memantine intervention 2: Memantine intervention 3: Placebo
Intervention descriptions: intervention 1: Memantine 20 mg once per day for 7 days intervention 2: Memantine 40 mg once per day for 7 days intervention 3: Placebo once per day for 7 days

Protocol documents:
Clinical trial NCT00637377
Conditions: Macular Degeneration
Keywords: Eye diseases Vision Impairment and Blindness Eyes and Vision Seniors Neovascular Age-Related Macular Degeneration (AMD) Retinal Disease
Sponsor: Bayer
Start date: 2008-04-01; Completion date: 2011-08-01
Enrollment: 1240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.

Detailed description:
Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.

Arms: arm 1: Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. arm 2: Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. arm 3: Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. arm 4: Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Interventions: intervention 1: Ranibizumab intervention 2: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) intervention 3: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) intervention 4: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Intervention descriptions: intervention 1: Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. intervention 2: Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. intervention 3: Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. intervention 4: Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Protocol documents:
Clinical trial NCT00650845
Conditions: Renal Insufficiency
Keywords: contrast-induced nephropathy, creatinemia
Sponsor: Guerbet
Start date: 2008-01-01; Completion date: 2011-08-01
Enrollment: 135 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

Detailed description:
Patients with renal insufficiency not requiring hemodialysis and scheduled to undergo a contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis, were selected for inclusion. Two groups of patients were defined on the basis of the planned imaging procedure selected to obtain a diagnosis: those undergoing a Dotarem®-enhanced MRI and those undergoing an unenhanced MRI.

A clinically significant increase in serum creatinine levels after the contrast-enhanced MRI exam was used as an indication of contrast induced nephrotoxicity. A blood test was performed 24h before the MRI in order to evaluate baseline creatinine values. 72h after the exam, a second blood test was performed. An increase in creatinemia above 25% from baseline levels was defined as a contrast-induced nephrotoxic reaction. The primary endpoint of the study assessed the percentage of patients presenting a contrast-induced nephrotoxic reaction in order to show a non inferiority of enhanced as compared to non-enhanced MRI exams.

Arms: arm 1: Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes arm 2: Patients undergoing non-enhanced MRI for diagnostic purposes
Interventions: intervention 1: Dotarem®-enhanced MRI intervention 2: non-enhanced MRI
Intervention descriptions: intervention 1: Single IV administration before MRI exam intervention 2: non injected MRI

Protocol documents:
Clinical trial NCT00655681
Conditions: Osteoporosis Cerebral Palsy Spina Bifida Osteopenia Osteogenesis Imperfecta
Keywords: pediatric osteoporosis pediatric osteopenia pamidronate post operative osteopenia
Sponsor: University of New Mexico
Start date: 2007-09-01; Completion date: 2011-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density

Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.

Detailed description:
Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora

Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D

Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose) v placebo group

Repeat DXA scan after end of immobilization or non-weightbearing

Arms: arm 1: Receives pamidronate 1mg/kg once arm 2: receives saline injection 10 cc/kg over 4 hours once post operatively
Interventions: intervention 1: pamidronate intervention 2: saline
Intervention descriptions: intervention 1: The pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children \< 8 kg (80cc infusion), the rate would be 20 cc/hr and the duration would be determined by the volume. intervention 2: receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids

Protocol documents:
Clinical trial NCT00668265
Conditions: Generalized Anxiety Disorder Comorbid Opiate Dependence in Remission Status Post Methadone-Maintenance Treatment
Keywords: Generalized Anxiety Disorder Opiate Dependence Methadone-Maintenance Drug Addiction Treatment
Sponsor: Beth Israel Medical Center
Start date: 2008-01-01; Completion date: 2011-08-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 16 week study of the efficacy of quetiapine in treating symptoms of generalized anxiety disorder (GAD) in subjects with comorbid opiate dependence. The study will be conducted in a prospective, randomized, double-blind, and placebo-controlled fashion. Study subjects will be inpatients at a residential drug-treatment facility, enrolled in a 1 year methadone-to-abstinence treatment plan. Subjects will be randomized to receive either quetiapine or placebo in addition to ongoing drug addiction treatment. Subjects will be followed for 16 weeks and a variety of psychometric assessments will be made.

Hypothesis One: Compared to placebo, Quetiapine will demonstrate a greater reduction in symptoms of anxiety in subjects with GAD and remitted comorbid opiate abuse.

Exploratory Hypotheses: Compared to placebo, Quetiapine will demonstrate a greater improvement in psychosocial functioning and compliance with community norms in subjects enrolled in a residential drug addiction treatment facility.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Quetiapine
Intervention descriptions: intervention 1: Dosage is 50 - 300 mg, once daily, at bedtime.

Protocol documents: