ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00460993
Conditions: Poor Quality Sleep
Keywords: Aging Sleep Nursing Home Sleep in nursing homes
Sponsor: Emory University
Start date: 2005-06-01; Completion date: 2010-12-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone), on older adults who reside in a nursing home and have poor sleep as determined by wrist actigraphy.

Detailed description:
Older people living in nursing homes do not sleep very well for many reasons including pain, sleep disorders like sleep apnea (when someone briefly stops breathing during sleep) and night time urination, as well as the environmental disturbances caused by living in the nursing home, such as noise and disruptive care routines. Previous studies' attempts to improve sleep by modifying the nighttime nursing home environment have shown limited improvements in sleep.

This study will evaluate how well eszopiclone (Lunesta) works to improve sleep in nursing home residents with poor sleep. Eszopiclone is FDA approved and has been tested on older adults living in the community, but not on older adults living in nursing homes. We expect sleep to improve on the study drug, in comparison to the placebo. Based on adverse events reported in previous samples of older subjects, we expect the study drug to cause very few side effects.

We will evaluate how well eszopiclone works by measuring sleep at night and during the day. After consenting and final determination of eligibility, participants will complete a baseline phase to assess typical sleep, as well as daytime alertness and activity, thinking, memory and mood. Sleep at night and during the day will be objectively assessed with wrist actigraphs for all subjects. Approximately half will also receive polysomnographic studies to assess nighttime sleep. Subjects who sleep more than 75% of the time they are in bed will not continue in the study. Subjects will be randomized to one of two treatment groups-one will receive the active drug and then a placebo and the other will receive the placebo first and then the active drug. Following randomization, subjects will complete a brief run-in phase and then enter the treatment phase. Assessment of sleep and other measures will be repeated.

Arms: arm 1: Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration. arm 2: Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.

Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve.
Interventions: intervention 1: Lunesta
Intervention descriptions: intervention 1: Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4.

Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4.

Protocol documents:
Clinical trial NCT00464204
Conditions: Sepsis
Sponsor: Fresenius Kabi
Start date: 2007-07-01; Completion date: 2010-12-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. Vascular filling may also have an impact on tolerability of enteral nutrition. The earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. This study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. A Data Monitoring Committee will review regularly safety data of the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®" intervention 2: 0.9 % NaCl
Intervention descriptions: intervention 1: Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs. intervention 2: NaCl 0.9 % was administered intravenously. NaCl 0.9% rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day, according to patient needs.

Protocol documents:
Clinical trial NCT00467818
Conditions: Autism
Keywords: Aggression Irritability Global severity
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2007-01-01; Completion date: 2010-12-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in Clinical Global Impression Scale, Young Mania Rating Scale, and HAM-D scores. The following are the hypotheses:

* Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.
* Omega 3 fatty acids will be superior to placebo in improving aggression and irritability associated with autism.
* Omega 3 fatty acids will be superior to placebo in improving functional ability.

Detailed description:
This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. The data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial.

Arms: arm 1: Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. arm 2: The placebo will be dispensed to subjects in the control group
Interventions: intervention 1: Omega 3 fatty acids intervention 2: Placebo
Intervention descriptions: intervention 1: The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly. intervention 2: Same dosage as that of omega 3 fatty acids

Protocol documents:
Clinical trial NCT00474175
Conditions: Toothache
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-05-01; Completion date: 2010-12-01
Enrollment: 577 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache and to assess the subject's compliance with proposed label directions.

Detailed description:

Arms: arm 1: Placebo control arm 2: 10% benzocaine gel formulation arm 3: 20% benzocaine gel formulation
Interventions: intervention 1: Placebo gel intervention 2: benzocaine intervention 3: benzocaine
Intervention descriptions: intervention 1: single dose (less than 1g) of a matching placebo gel intervention 2: single dose (less than 1g) of 10% benzocaine gel formulation intervention 3: single dose (less than 1g) of 20% benzocaine gel formulation

Protocol documents:
Clinical trial NCT00477464
Conditions: Metastatic Breast Cancer Neoplasms, Breast
Keywords: dual kinase inhibitor, EGFR/ErbB1, ErbB2-overexpressing, GW572016, advanced/metastatic breast cancer, Lapatinib, HER-2/new, pharmacokinetics
Sponsor: GlaxoSmithKline
Start date: 2007-06-01; Completion date: 2010-12-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study will move into the second phase (Part 2) to further evaluate the safety and clinical activity.

Detailed description:

Arms: arm 1: Lapatinib 1250mg once daily +capecitabine 2000mg/m\^2 twice daily (14 days out of 21 days)
Interventions: intervention 1: Lapatinib intervention 2: capecitabine
Intervention descriptions: intervention 1: 1250mg once daily intervention 2: 2000mg/m\^2 twice daily (14 days out of 21 days)

Protocol documents:
Clinical trial NCT00483405
Conditions: Liver Cancer
Keywords: advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2006-10-01; Completion date: 2010-12-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with cetuximab works in treating patients with advanced liver cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with advanced hepatocellular carcinoma and hepatic dysfunction treated with oxaliplatin, capecitabine, and cetuximab.

Secondary

* Determine the safety of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.
* Determine the time to tumor progression in patients treated with this regimen.

OUTLINE: This is an open label, nonrandomized study.

Patients receive oral capecitabine twice daily on days 1-14, cetuximab IV over 60-120 minutes on days 1, 8, and 15, and oxaliplatin IV over 120 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-4 weeks and then every 3 months thereafter.

Arms: arm 1: Single Arm Trial
Interventions: intervention 1: cetuximab intervention 2: capecitabine intervention 3: oxaliplatin
Intervention descriptions: intervention 1: 250 mg/m2, intravenously, once per week intervention 2: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle. intervention 3: 130 mg/m2, intravenously on Day 1 of each 21 day cycle

Protocol documents:
Clinical trial NCT00484289
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2006-12-01; Completion date: 2010-12-01
Enrollment: 217 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Abatacept
Intervention descriptions: intervention 1: Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.

Protocol documents:
Clinical trial NCT00495625
Conditions: Liver Cancer
Keywords: Hepatocellular cancer (HCC) Sunitinib malate Vascular endothelial growth factor (VEGF) Platelet-derived growth factor (PDGF) Tyrosine kinases Liver
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2006-10-01; Completion date: 2010-12-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open label multi-site phase II clinical trial of dose escalated sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

Detailed description:
An open label multi-site phase II clinical trial of sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Sunitinib malate will be dispensed as capsules at the beginning of each treatment cycle. The dose may be escalated at the investigator's discretion. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

A follow up visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel (including liver function tests) and alpha-feto protein (when indicated) will be obtained at every scheduled follow up visit.

Arms: arm 1: None
Interventions: intervention 1: Sunitinib Malate
Intervention descriptions: intervention 1: Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5 mg daily for 28 days, every 42 days. Dose may be escalated to 50 mg daily for 28 days at the treating investigator's discretion.

Protocol documents:
Clinical trial NCT00516919
Conditions: Obesity Binge Eating
Keywords: Obesity Binge Eating Monolingual Hispanic Persons Orlistat Behavioral Weight Loss Treatment
Sponsor: Yale University
Start date: 2007-08-01; Completion date: 2010-12-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese monolingual (Spanish-speaking only) men and women.

Detailed description:

Arms: arm 1: Xenical + behavioral intervention arm 2: Placebo + behavioral intervention
Interventions: intervention 1: Xenical + behavioral intervention intervention 2: Behavioral intervention + placebo
Intervention descriptions: intervention 1: 120 mg TID; Behavioral weight loss in Spanish intervention 2: Behavioral weight loss treatment in Spanish Placebo TID

Protocol documents:
Clinical trial NCT00521001
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2008-01-01; Completion date: 2010-12-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Giving everolimus together with temozolomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving everolimus together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery

Detailed description:
OBJECTIVES:

Primary

* Estimate the 9-week progression-free survival rate for patients with stage IV malignant melanoma treated with everolimus and temozolomide.

Secondary

* Evaluate overall survival time.
* Evaluate time to disease progression.
* Evaluate confirmed response rate.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and oral temozolomide once a day on days 8-12 for course 1 only. For course 2 and all subsequent courses, patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, and 22-26 and oral temozolomide once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

All patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for relative numbers of T, B, and NK cells via flow cytometry, quantitative immunoglobulin levels (IgG, IgM, and IgA), Tetramer/ELISPOT CTL frequencies to CMV/EBV immunodominant antigens, V beta T cell spectratyping, and VEGF levels via ELISA.

After completion of study treatment, patients are followed every 8 weeks.

Arms: arm 1: Patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and oral temozolomide once a day on days 8-12 for course 1 only. For course 2 and all subsequent courses, patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, and 22-26 and oral temozolomide once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

All patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for relative numbers of T, B, and NK cells via flow cytometry, quantitative immunoglobulin levels (IgG, IgM, and IgA), Tetramer/ELISPOT CTL frequencies to CMV/EBV immunodominant antigens, V beta T cell spectratyping, and VEGF levels via ELISA.

After completion of study treatment, patients are followed every 8 weeks.
Interventions: intervention 1: everolimus intervention 2: temozolomide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00523237
Conditions: HIV Infections
Sponsor: Stanford University
Start date: 2007-10-01; Completion date: 2010-12-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to:

* Provide raltegravir to subjects with HIV and an undetectable viral load who are experiencing injection site reactions (ISR) to Enfuvirtide,
* Monitor the safety and efficacy of raltegravir, and
* Assess the change in quality of life in patients who have switched from Enfuvirtide to raltegravir

Detailed description:
We enrolled virologically suppressed HIV-1 infected patients with injection site reactions for a switch from enfuvirtide to raltegravir. At baseline, enfuvirtide was switched to raltegravir without additional changes to the antiretroviral regimen allowed. Viral load, T-cells, and toxicity were evaluated at baseline, 2, 4, 12 and 24 weeks. Adherence and injection site reactions were evaluated at baseline, 4, 12 and 24 weeks. The single-copy assay was used to measure HIV RNA levels at screening, baseline and at 12 and 24 weeks.

Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: 400 mg Twice daily for 24 weeks

Protocol documents:
Clinical trial NCT00524342
Conditions: Von Willebrand Disease
Keywords: IL-11 von Willebrand disease von Willebrand factor VWFmRNA menorrhagia
Sponsor: Margaret Ragni
Start date: 2008-01-01; Completion date: 2010-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy and safety of rhIL-11, when given subcutaneously for six consecutive months, in reducing menstrual blood loss in women with type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.

Detailed description:
This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in women with type 1 VWD and menorrhagia refractory to estrogen, hormones, or hemostatic agents. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete this study. All aspects of this study, including the rhIL-11 injections and the screening, hemostatic and safety monitoring, and coagulation testing, are considered experimental. The specific objectives are to determine the efficacy and safety of rhIL-11 in reducing menstrual blood loss in adult women with type 1 VWD during six consecutive menstrual cycles, and to determine the mechanism of the hemostatic response of rhIL-11.

Arms: arm 1: 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
Interventions: intervention 1: Oprelvekin, Interleukin 11, IL-11
Intervention descriptions: intervention 1: 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles

Protocol documents:
Clinical trial NCT00525590
Conditions: Metastatic Brain Cancer
Keywords: Gliadel
Sponsor: Eisai Inc.
Start date: 2007-12-12; Completion date: 2010-12-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: GLIADEL
Intervention descriptions: intervention 1: Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible). Slight overlapping of wafer edges is permitted. The number of wafers will be determined by the size of the tumor resection cavity. Each GLIADEL wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted. The GLIADEL wafer is a round white to yellow disk with flat surfaces.

Protocol documents: