ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00782509
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2009-02-01; Completion date: 2010-09-01
Enrollment: 644 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler arm 3: High dose inhaled orally once daily from the Respimat inhaler
Interventions: intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Placebo
Intervention descriptions: intervention 1: Comparison of low and high doses on efficacy and safety in COPD patients intervention 2: Comparison of low and high doses on efficacy and safety in COPD patients intervention 3: Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler

Protocol documents:
Clinical trial NCT00857649
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Sponsor: H. Lundbeck A/S
Start date: 2003-12-01; Completion date: 2010-09-01
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.

Detailed description:
Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline.

This 24-week randomised, double-blind, placebo-controlled, multicentre study examines the effect of memantine 20 mg, administered once daily, on cognitive and behavioural symptoms in outpatients diagnosed with moderate to severe AD and significant psychopathology.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Memantine intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg Oral Tablets Once Daily intervention 2: Oral Tablets Once Daily

Protocol documents:
Clinical trial NCT00006170
Conditions: Tobacco Use Disorder
Keywords: smoking cessation Women bupropion weight concerns weight
Sponsor: University of Pittsburgh
Start date: 2000-09-01; Completion date: 2010-09-01
Enrollment: 349 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.

Detailed description:
Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women, which is associated with poorer cessation outcome. We previously documented that cognitive behavior therapy to minimize weight concerns (CBT) was effective in promoting cessation and controlling weight gain among weight concerned women smokers. The current study is a randomized, double-blind, controlled trial to determine whether the addition of bupropion (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term abstinence. Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation, attenuates cessation-related weight gain (particularly in women), and relieves negative mood, which appears more common in weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions. In addition, we will determine the effects of these treatments on tobacco withdrawal, mood, and weight. Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population.

Arms: arm 1: Bupropion SR and a weight concerns psychosocial intervention arm 2: A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion arm 3: Bupropion SR and a time and attention controlled smoking cessation intervention arm 4: A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention
Interventions: intervention 1: Bupropion intervention 2: Placebo intervention 3: weight concerns intervention intervention 4: smoking cessation intervention
Intervention descriptions: intervention 1: smoking cessation medication aid intervention 2: A matched placebo pill intervention 3: cognitive behavioral treatment to address weight concners intervention 4: Cognitive behavioral intervention for smoking cessation

Protocol documents:
Clinical trial NCT00064025
Conditions: Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation Recurrent Uterine Corpus Carcinoma Stage I Uterine Corpus Cancer Stage II Uterine Corpus Cancer Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer
Sponsor: Gynecologic Oncology Group
Start date: 2004-04-01; Completion date: 2010-09-01
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Compare the efficacy of medroxyprogesterone, in terms of induction of histologic response, in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus.

II. Determine the early and late changes in gene expression at 72 hours and 21 days in patients treated with this drug.

III. Examine the mechanisms surrounding the dynamic changes in endometrial tumor cells by determining possible correlations among histologic response, steroid receptor status, immunohistochemical measures of growth and apoptosis, and gene expression profiles in patients treated with this drug.

OUTLINE: This is a pilot, multicenter study.

Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.

A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Arms: arm 1: Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.

A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Medroxyprogesterone intervention 3: Therapeutic Conventional Surgery
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given IM intervention 3: Undergo surgical hysterectomy

Protocol documents:
Clinical trial NCT00080483
Conditions: Hypopituitarism Hypogonadism Growth Hormone Deficiency
Sponsor: University of Pennsylvania
Start date: 2004-03-01; Completion date: 2010-09-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Deficiency of testosterone, growth hormone, or both hormones can result in osteoporosis. If either hormone is replaced, the condition of the bones improves. The purpose of this study is to determine if dual hormone treatment for men deficient in testosterone and growth hormone improves bone structure more than testosterone treatment alone.

Detailed description:
Replacement of testosterone or growth hormone in patients who are deficient improves osteoporosis associated with these deficiencies. In some tissues, such as muscle, the effects of testosterone and growth hormone are additive, but it is not known if the effects are additive in bone as well. This study will compare the effects of testosterone alone with testosterone plus growth hormone in improving bone structure in men with total pituitary hormone deficiency.

Participants in this study will be men who have pituitary or hypothalamic disease and have deficiencies of all pituitary hormones, but who have not been treated with either testosterone or growth hormone. The men will be randomly assigned to receive either testosterone alone or testosterone plus growth hormone for two years. Testosterone in a gel form will be applied daily to the skin. Growth hormone will be self-administered by daily subcutaneous injection. Blood concentrations of both hormones will be monitored with blood tests every 3 months during the 2-year study. Doses of the hormones will be adjusted to keep blood concentrations of the hormones within the normal range. Changes in bone structure will be assessed noninvasively before treatment and after one year and two years of treatment by magnetic resonance microimaging (µMRI) and dual energy X-ray absorptiometry (DEXA).

Arms: arm 1: Testosterone transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day arm 2: AndroGel transdermally 5 g a day for two years
Interventions: intervention 1: Testosterone plus somatropin intervention 2: testosterone
Intervention descriptions: intervention 1: AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years intervention 2: AndroGel transdermally 5 g a day for two years

Protocol documents:
Clinical trial NCT00096954
Conditions: Asthma
Keywords: Omalizumab (Xolair) Atopic Asthma
Sponsor: Genentech, Inc.
Start date: 2006-02-01; Completion date: 2010-09-01
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists \[LABAs\], leukotriene receptor antagonist \[LTRA\], or immunotherapy).

Detailed description:

Arms: arm 1: Omalizumab (Xolair) administered in this study was either a minimum of 0.008 mg/kg/IgE \[IU/mL\] every 2 weeks or a minimum of 0.016 mg/kg/IgE \[IU/mL\] every 4 weeks. arm 2: Placebo administered in this study was either a minimum of 0.008 mg/kg/IgE \[IU/mL\] every 2 weeks or a minimum of 0.016 mg/kg/IgE \[IU/mL\] every 4 weeks.
Interventions: intervention 1: omalizumab (Xolair) intervention 2: placebo
Intervention descriptions: intervention 1: Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of \> 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site. intervention 2: The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.

Protocol documents:
Clinical trial NCT00130689
Conditions: Esophageal Cancer Gastric Cancer Neoplasm Metastasis
Keywords: Esophageal Cancer Gastric Cancer Metastatic Esophageal Cancer Metastatic Gastric Cancer Cetuximab Metastatic Esophageal and Gastric Cancer
Sponsor: Dana-Farber Cancer Institute
Start date: 2005-07-01; Completion date: 2010-09-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Purpose: There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased EGFR expression in a significant proportion of both esophageal and gastric carcinomas. Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted in inhibition of tumor growth. Agents designed to block the EGFR pathway have demonstrated disease control among previously treated patients with metastatic esophageal and gastric cancer. The proposed mechanism of action for cetuximab is its ability to effectively disrupt EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle progression, induces apoptosis, and also inhibits processes important for tumor growth, such as cell invasion and angiogenesis.

Detailed description:
OBJECTIVES:

Primary - To assess the response rate of single-agent cetuximab in patients with advanced esophageal or gastric cancer who have failed 1-2 prior chemotherapy regimens given in the metastatic setting.

Secondary

* To evaluate the duration of response, progression-free survival and overall survival.
* To assess the safety of cetuximab.

Exploratory

\- To assess whether levels of EGFR expression and/or EGFR mutation status correlates with response and toxicity of cetuximab.

STATISTICAL DESIGN:

This study used a two-stage design to evaluate efficacy of cetuximab based on overall response (OR) defined as complete response (CR) or partial response (PR). The null and alternative OR rate were 5% and 15%. If one or more patients enrolled in the stage one cohort (n=20 patients) achieved PR or better than accrual would proceed to stage two (n=16 patients). There was 36% probability of stopping the trial at stage one if the true OR rate was 5%. The probability that the regimen would be considered promising if the true OR rate was 5% was 10% and 80% if the true OR rate was 15%.

Arms: arm 1: Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
Interventions: intervention 1: Cetuximab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00144300
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2005-01-01; Completion date: 2010-09-01
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.

Detailed description:

Arms: arm 1: Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines arm 2: Requip tablets three times daily (TID) dosing according to manufacturer's guidelines
Interventions: intervention 1: Mirapex intervention 2: Requip
Intervention descriptions: intervention 1: Standard marketed product dispensed according to manufacturer's guidelines intervention 2: Standard marketed product dispensed according to manufacturer's guidelines

Protocol documents:
Clinical trial NCT00182637
Conditions: Lymphoma
Keywords: recurrent mycosis fungoides/Sezary syndrome stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma
Sponsor: Jonsson Comprehensive Cancer Center
Start date: 2004-07-01; Completion date: 2010-09-01
Enrollment: 5 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.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with relapsed or refractory cutaneous T-cell lymphoma.

Detailed description:
OBJECTIVES:

* Determine the response rates (complete response and partial response) and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib.
* Determine the safety and tolerability of this drug in these patients.

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 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month and then at least every 3 months for 2 years or until disease progression.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: bortezomib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00237718
Conditions: End-stage Renal Disease
Sponsor: Vanderbilt University
Start date: 2006-04-01; Completion date: 2010-09-01
Enrollment: 385 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.

Detailed description:
Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress while improving the erythropoietic response in hemodialysis patients.

Arms: arm 1: 600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months arm 2: placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
Interventions: intervention 1: Alpha, gamma, beta, and delta (mixed) tocopherols intervention 2: Alpha lipoic acid intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: approximately 666 IU daily (1 pill) for 6 months intervention 2: 600 mg daily (2 pills 300 mg each) for 6 months intervention 3: placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months intervention 4: placebo for alpha lipoic acid; 2 pills daily for 6 months

Protocol documents:
Clinical trial NCT00253370
Conditions: Adenocarcinoma of the Gastroesophageal Junction Metastatic Gastric Cancer Advanced Unresectable Gastric Cancer
Keywords: Sorafenib Docetaxel Cisplatin gastric cancer gastroesophageal junction adenocarcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-10-01; Completion date: 2010-09-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by surgery. Sorafenib 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. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel and cisplatin may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response rate (complete response and partial response) of the combination of BAY 43-9006 with docetaxel and cisplatin or oxaliplatin in patients with gastric and GEJ adenocarcinoma.

II. To evaluate the progression-free survival (PFS) and overall survival.

III. To evaluate the toxicities of BAY 43-9006 in patients with advanced and metastatic gastric or GEJ adenocarcinoma combined with docetaxel/cisplatin or docetaxel/oxaliplatin.

IV. To evaluate Raf status in the tumor and to correlate response and PFS to the presence or absence of an activating mutation in B-Raf.

V. To analyze the pharmacokinetic and pharmacogenetic properties of BAY 43-9006 including angiogenesis, monooxygenases, polymorphisms and multidrug-resistance (MDR). This study will be conducted via the E1Y03 mechanism.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to Siewert's tumor location (I vs II vs III) and extent of disease (locally advanced unresectable vs distant metastases).

Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

An addition of an arm containing oxaliplatin was proposed after meeting the accrual goal but did not move forward and the study was closed to accrual in July, 2007 with a final accrual of 44 patients.

Arms: arm 1: Patients receive oral BAY 43-9006 400mg twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: BAY 43-9006 intervention 2: docetaxel intervention 3: cisplatin
Intervention descriptions: intervention 1: Given orally intervention 2: Given IV intervention 3: Given IV

Protocol documents: