ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00276614
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer recurrent renal cell cancer papillary renal cell carcinoma
Sponsor: Jonsson Comprehensive Cancer Center
Start date: 2006-04-01; Completion date: 2009-07-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine, preliminarily, the efficacy of bortezomib in patients with metastatic non-clear cell renal cell carcinoma in terms of objective response rate after a minimum of 2 courses of treatment.

Secondary

* Correlate clinical response in these patients with baseline von Hippel-Lindau expression and nuclear factor-KB activity.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month and then periodically for 2 years.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Arms: arm 1: Velcade IV twice a week for two weeks on Days 1, 4, 8 and 11 of each cycle. A 10 day-rest period (Days 12-21) with no Velcade will follow the 2 weeks of treatment in each cycle. one cycle = 21 days
Interventions: intervention 1: bortezomib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00282282
Conditions: Graft Versus Host Disease GVHD
Keywords: non-myeloablative peripheral blood stem cell PBSCT tacrolimus sirolimus
Sponsor: Dana-Farber Cancer Institute
Start date: 2006-01-01; Completion date: 2009-07-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how effective it is in preventing graft versus host disease (GVHD)in patients that have received non-myeloablative peripheral blood stem cell transplantation.

Detailed description:
* After the screening procedures confirm that the patient is eligible to participate in the research study, they will be admitted to the hospital to receive chemotherapy and stem cell transplantation (SCT). The duration of the hospitalization for the procedure is approximately 8 days.
* Patients will receive fludarabine once daily over 30 minutes intravenously for 4 days and busulfex once daily over 3 hours intravenously each day for the same 4 days.
* Just prior to the transplant and following the transplant the patient will receive sirolimus and tacrolimus to help prevent Graft versus Host Disease (GvHD). Both medications are taken orally.
* Patients will also take medications to help prevent possible infections (e.g. acyclovir). Filgrastim, a white blood cell growth factor, will be given daily in an injection under the skin, starting the day after the stem cell transplant and until the patients blood counts have recovered.
* After the stem cell infusion, the patient will be examined and have blood tests weekly for 1 month. At about the 1-month visit, a bone marrow biopsy and/or blood tests will be performed to determine the percentage of donor's cells in the blood or bone marrow. These tests will be repeated at 3-4 months after transplant.
* At 3-4 months after the transplant, patients will also have tests to reassess the response of your disease to transplant. This may involve a bone marrow biopsy, blood tests, and/or radiology studies depending upon the type of cancer.
* Follow-up will continue for the remainder of the patients life.

Interventions: intervention 1: tacrolimus intervention 2: sirolimus intervention 3: fludarabine intervention 4: busulfex
Intervention descriptions: intervention 1: Given orally just prior to and following stem cell transplant intervention 2: Given orally just prior to and following stem cell transplant intervention 3: Given once daily over 30 minutes for 4 days intervention 4: Given intravenously over 3 hours for 4 days

Protocol documents:
Clinical trial NCT00289653
Conditions: Nicotine Dependence
Keywords: nicotine dependence, transdermal nicotine patch, smoking while receiving nicotine replacement, comorbidities
Sponsor: Centre for Addiction and Mental Health
Start date: 2005-09-01; Completion date: 2009-07-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes.

Detailed description:
Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes.

Arms: arm 1: Adult smokers willing to quit were treated with escalating doses of transdermal nicotine patch (Nicoderm) and brief counselling if they continued to smoke over a 9-week treatment period.
Interventions: intervention 1: Nicoderm
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00290758
Conditions: Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-01-01; Completion date: 2009-07-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well genistein works in preventing breast cancer in women at high risk for breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of genistein may prevent breast cancer in women at high risk for breast cancer.

Detailed description:
PRIMARY OBJECTIVE:

I. Determine the effect of genistein on the proliferation of breast epithelial cells obtained by fine needle aspiration (FNA), as measured by Ki-67 labeling index, in women who are at high risk for breast cancer.

SECONDARY OBJECTIVE:

I. Determine the effect of this drug on cellular and molecular parameters using epithelial cells obtained by FNA, nipple aspirate fluid, and blood from these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal) and history of breast cancer (no history of breast cancer vs history of estrogen receptor \[ER\] positive breast cancer vs history of ER negative breast cancer). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral genistein once daily.

ARM II: Patients receive oral placebo once daily.

In both arms, treatment continues for up to 6 months in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed at 30-37 days.

Arms: arm 1: Patients receive oral genistein once daily for up to 6 months. arm 2: Patients receive oral placebo once daily for up to 6 months.
Interventions: intervention 1: placebo intervention 2: genistein intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00291226
Conditions: Schizophrenia Prodrome
Keywords: schizophrenia prodrome
Sponsor: Yale University
Start date: 2006-03-01; Completion date: 2009-07-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo.

Detailed description:
A pilot clinical trial comparing glycine to placebo in patients with the schizophrenia prodrome.

Arms: arm 1: Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing \> 100 kg were limited to a total daily dose of 80 g daily. Glycine was dispensed under IND 33,515 (DCJ). arm 2: Placebo was dispensed as a proprietary formulations developed by Glytech, Inc, consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech placebo formulation, consisting of proprietary pre-flavored sugar powders to be dissolved in 8 ounces of water.
Interventions: intervention 1: Glycine intervention 2: Placebo
Intervention descriptions: intervention 1: Glycine 0.4 g/kg bid intervention 2: Placebo

Protocol documents:
Clinical trial NCT00292162
Conditions: Chronic Heart Failure Atrial Fibrillation
Keywords: Chronic Heart Failure Atrial Fibrillation Radiofrequency Ablation
Sponsor: NHS Greater Glasgow and Clyde
Start date: 2007-01-01; Completion date: 2009-07-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Heart failure is a condition that occurs when the heart muscle weakens and no longer contracts normally. Half of these patients have an irregularity of heart rhythm called atrial fibrillation (AF). Patients with both heart failure and AF spend more time in hospital, and die earlier than those with heart failure alone. AF is difficult to treat with conventional methods in patients with heart failure. Radiofrequency ablation is a new technique used to cure AF. The investigators aim to establish if radiofrequency ablation for atrial fibrillation in patients with advanced heart failure can result in marked improvement in the function of the heart.

Detailed description:

Arms: arm 1: Standard therapy for heart failure with angiotensin converting enzyme inhibitors(ACE) - (Ramipril, enalapril, lisinopril, captopril, perindopril), beta-blocker (BB) - (carvedilol, bisoprolol, metoprolol), Aldosterone antagonists (spironolactone) +/- diuretics and digoxin arm 2: Isolation of the pulmonary veins using radiofrequency ablation
Interventions: intervention 1: radiofrequency ablation intervention 2: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril intervention 3: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol intervention 4: Aldosterone Antagonists - spironolactone
Intervention descriptions: intervention 1: isolation of the pulmonary veins with radiofrequency ablation (RFA) intervention 2: Evidence based treatment for heart failure. Dose and type will depend on patient tolerability. intervention 3: Evidence based treatment for heart failure. Dose and type will depend on patient tolerance. intervention 4: Evidence based treatment for heart failure. Dose and type will depend on patient to treatment.

Protocol documents:
Clinical trial NCT00309140
Conditions: Neoplasms Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-03-01; Completion date: 2009-07-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public.

The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: enzastaurin
Intervention descriptions: intervention 1: 500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity

Protocol documents:
Clinical trial NCT00318136
Conditions: Non-small Cell Lung Cancer
Keywords: BRIDGE NSCLC Lung Cancer Avastin
Sponsor: Genentech, Inc.
Start date: 2005-09-01; Completion date: 2009-07-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: 15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3 intervention 2: Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles intervention 3: Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles

Protocol documents:
Clinical trial NCT00336232
Conditions: Aging Osteoporosis
Keywords: Vitamin K metabolism Bone health Metabolism
Sponsor: Tufts University
Start date: 2006-05-01; Completion date: 2009-07-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body stores of vitamin K.

Detailed description:
Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K supplementation and bone health of women in a narrow age group. This study is the first to assess the role of dietary and other factors that influence the response to vitamin K status and bone turnover to vitamin K depletion and repletion in adults. This study also compares the absorption efficiency and body retention of vitamin K relative to current vitamin K status. Men and women \[21 younger (18-40y) and 21 older (55+y)\] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K supplementation period (500 ug/d). Coagulation times will be monitored during the dietary restriction period. Serial measurements of vitamin K status markers and of bone turnover markers will show the response of vitamin K to dietary manipulation for both age groups under identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore, measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin K. The findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin K may have in chronic disease prevention.

Arms: arm 1: 28 day diet low vitamin K, 28 day diet high vitamin K
Interventions: intervention 1: Vitamin K
Intervention descriptions: intervention 1: phylloquinone (vitamin K1) 500 mcg daily in third month

Protocol documents:
Clinical trial NCT00387036
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-01; Completion date: 2009-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: Arm 1: drug, crossing over to Pbo comparator arm 2: Arm 2: Pbo comparator, crossing over to drug
Interventions: intervention 1: Fluticasone intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment. intervention 2: Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.

Protocol documents:
Clinical trial NCT00391430
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD Trauma Sexual Abuse Sexual Assault
Sponsor: NYU Langone Health
Start date: 2005-05-01; Completion date: 2009-07-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder.

Detailed description:
Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a traumatic event. PTSD symptoms may include emotional numbness, loss of interest in activities that were once enjoyable, irritability, and sleep problems. Medication therapy, behavioral therapy, and a combination of both therapies are among the available treatment options for people with PTSD. Cognitive behavioral therapy (CBT), a type of talking therapy that has been shown to be effective in treating PTSD, teaches patients how to alter their thinking to, in turn, improve how they feel. A selective serotonin reuptake inhibitor (SSRI) is a type of medication that has also been effective in treating PTSD. Information about the comparative physiological effects of each of these treatments on people with PTSD is needed. This study will evaluate which parts of the brain are affected by CBT treatment versus SSRI treatment in people with PTSD.

Participants with and without PTSD will be enrolled in this 12-week, open label study. Following a screening visit to determine eligibility, participants with PTSD will be offered a choice of either CBT or SSRI treatment. Those participants who choose CBT will attend 16 therapy sessions. The first phase of therapy will focus on the development of emotional and interpersonal regulation skills. The second phase will use a modified form of prolonged exposure therapy, which has been effective in reducing symptoms of PTSD. Participants who elect to receive medication will take sertraline, an SSRI that has been safe and effective in treating PTSD. These participants will attend 12 treatment sessions. Pre- and post-treatment fear response will be assessed in all participants using fMRI scans to measure brain responses and using saliva samples to test cortisol levels. All participants will also self-administer saliva samples at various points during the 3 days prior to fMRI scanning. Other outcomes will be assessed throughout the study using questionnaires.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00648375

Arms: arm 1: Participants assigned to the control condition will receive no treatment arm 2: Participants will receive treatment with sertraline arm 3: Participants will receive cognitive behavioral therapy
Interventions: intervention 1: Sertraline intervention 2: Cognitive behavioral therapy (CBT)
Intervention descriptions: intervention 1: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks intervention 2: CBT consists of sixteen 1-hour sessions during a period of 12 weeks.

Protocol documents:
Clinical trial NCT00406367
Conditions: Blepharospasm
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2006-10-01; Completion date: 2009-07-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.

Detailed description:

Arms: arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to 50 Units per eye; Open-Label Extension Period: up to 5 injections, up to 50 Units per eye per injection session; Mode of administration: intramuscular injection arm 2: Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection
Interventions: intervention 1: incobotulinumtoxinA (Xeomin) intervention 2: Placebo
Intervention descriptions: intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection intervention 2: Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection

Protocol documents:
Clinical trial NCT00415168
Conditions: Gastric Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-12-01; Completion date: 2009-07-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not amenable to curative surgery, or recurrence after prior surgery, who have had no prior chemotherapy. It was planned to enroll approximately 50 patients who qualified for tumor response population.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pemetrexed intervention 2: cisplatin
Intervention descriptions: intervention 1: 700 milligrams/meters squared (mg/m2), intravenous (IV), every 21 days x 6 cycles intervention 2: 75 mg/m2, IV, every 21 days x 6 cycles

Protocol documents:
Clinical trial NCT00417885
Conditions: Breast Neoplasms
Sponsor: Pfizer
Start date: 2007-06-01; Completion date: 2009-07-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

Detailed description:
The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.

Arms: arm 1: sunitinib + exemestane
Interventions: intervention 1: exemestane intervention 2: sunitinib malate
Intervention descriptions: intervention 1: 25 mg, oral, daily dosing intervention 2: 37.5 mg, oral, continuous dosing, daily

Protocol documents: