ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00504257
Conditions: Fallopian Tube Cancer Ovarian Cancer Malignant Tumor of Peritoneum
Keywords: recurrent ovarian epithelial cancer recurrent primary peritoneal cavity cancer recurrent fallopian tube cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2007-03-01; Completion date: 2012-10-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of the combination of Avastin and Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian cancer within 12 months of platinum chemotherapy.

Detailed description:

Arms: arm 1: Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m\^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
Interventions: intervention 1: Avastin intervention 2: Docetaxel
Intervention descriptions: intervention 1: Day 1, every 21 day cycle intervention 2: Day 1, 8, every 21 day cycle

Protocol documents:
Clinical trial NCT00511238
Conditions: Multiple Myeloma
Keywords: Onyx PR171 carfilzomib multiple myeloma relapsed refractory
Sponsor: Amgen
Start date: 2007-08-01; Completion date: 2012-10-01
Enrollment: 312 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma.

Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: carfilzomib intervention 2: carfilzomib
Intervention descriptions: intervention 1: Subjects will receive carfilzomib 20 mg/m2 as an intravenous bolus over 2 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. A maximum of 12 cycles will be administered. intervention 2: Subjects will receive carfilzomib intravenously over up to 10 minutes on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles. In cycle 1, the dose is 20 mg/m2. If all doses are administered and well-tolerated over Cycle 1, beginning with Cycle 2 the dose will escalate to 27 mg/m2 cycle. A maximum of 12 cycles will be administered.

Protocol documents:
Clinical trial NCT00523848
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
Sponsor: Roswell Park Cancer Institute
Start date: 2006-06-01; Completion date: 2012-10-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and thalidomide works as first-line therapy in treating patients with previously untreated multiple myeloma.

Detailed description:
OBJECTIVES:

Primary

* To determine the overall response rate (complete response and partial response) in patients previously untreated stage I, II, or III multiple myeloma.

Secondary

* To evaluate the complete response rate in patients treated with this regimen.
* To determine the time to disease progression from the start of this therapy in patients treated with this regimen.

OUTLINE: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease who continue to show response after completion of 6 courses may receive 2 additional courses for a total of 8 courses.

After completion of study treatment, patients are followed every 3 months.

Arms: arm 1: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Interventions: intervention 1: bortezomib intervention 2: pegylated liposomal doxorubicin hydrochloride intervention 3: thalidomide
Intervention descriptions: intervention 1: IV intervention 2: IV intervention 3: Oral

Protocol documents:
Clinical trial NCT00537810
Conditions: Obesity Binge Eating
Keywords: Obesity Binge eating Sibutramine Self-help Primary care
Sponsor: Yale University
Start date: 2007-09-01; Completion date: 2012-10-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.

Detailed description:

Arms: arm 1: Sibutramine 15 mg daily arm 2: Placebo Daily arm 3: Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating arm 4: Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Interventions: intervention 1: Sibutramine intervention 2: Placebo intervention 3: Self-help CBT + Sibutramine intervention 4: Self-help CBT + Placebo
Intervention descriptions: intervention 1: 15 mg daily intervention 2: Daily intervention 3: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily intervention 4: Cognitive behavioral treatment manual for binge eating Placebo daily

Protocol documents:
Clinical trial NCT00544908
Conditions: Pancreatic Cancer
Keywords: stage IV pancreatic cancer
Sponsor: City of Hope Medical Center
Start date: 2007-09-01; Completion date: 2012-10-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Dasatinib 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 dasatinib works in treating patients with stage IV pancreatic cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the 4-month progression-free survival (PFS) rate in patients with stage IV pancreatic cancer treated with dasatinib.

Secondary

* To evaluate the response rate (complete and partial response) in patients treated with this drug.
* To evaluate the median PFS and overall survival of patients treated with this drug.
* To study the toxicities and tolerability of this drug in these patients.
* To evaluate the impact of this drug on quality of life measures.
* To evaluate the impact of this drug on Src and FAK in peripheral blood mononuclear cells prior to and during treatment.
* To study the pre-treatment expression of various signaling molecules in the Src and STAT3 pathways and attempt to identify a relationship between these findings and the aggressiveness of the tumor or its response to treatment with dasatinib.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative and biological studies. Blood samples are analyzed for phosphorylation levels of proteins, including phospho-Src, phospho-Fak, and other relevant biomarkers, by western blotting. Tumor tissue samples are analyzed for biomarkers by immunohistochemistry.

Quality of life is assessed at baseline, after every other course during treatment, and then at 1 year after treatment using the FACT-HEP questionnaire.

After completion of study treatment, patients are followed every 2 months.

Arms: arm 1: Dasatinib 70 mg po bid (1 cycle=28 days)
Interventions: intervention 1: dasatinib intervention 2: immunoenzyme technique intervention 3: immunohistochemistry staining method intervention 4: laboratory biomarker analysis intervention 5: quality-of-life assessment
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00560235
Conditions: Ewing's Sarcoma Family of Tumors
Sponsor: Pfizer
Start date: 2008-03-01; Completion date: 2012-10-01
Enrollment: 138 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: CP-751,871
Intervention descriptions: intervention 1: Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity

Protocol documents:
Clinical trial NCT00582010
Conditions: Reperfusion Injury Liver Injury
Keywords: ischemia-reperfusion nitric oxide inflammation cell-death Liver-function post transplantation
Sponsor: University of Alabama at Birmingham
Start date: 2008-04-01; Completion date: 2012-10-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This blinded, placebo-controlled study will administer inhaled nitric oxide to patients undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide prevents liver injury associated with the restoration of blood flow. The premise of the current study is provided by previous studies which document a protective effect of inhaled nitric oxide in this clinical setting.

Detailed description:
Specifically, presenting ischemia-reperfusion injury to transplanted livers remains a therapeutic goal in improving liver function and potentially expanding the number of transplantable livers. This study aims to assess the efficacy of inhaled nitric oxide to limit ischemia-reperfusion injury in transplanted livers and by doing so improve liver function post transplantation and decrease patient hospital length of stays.

Arms: arm 1: iNO administration arm 2: Placebo (nitrogen)
Interventions: intervention 1: inhaled nitric oxide intervention 2: nitrogen gas
Intervention descriptions: intervention 1: inhaled 80ppm for duration of surgery. intervention 2: inhaled

Protocol documents:
Clinical trial NCT00600821
Conditions: Non-Small-Cell Lung Carcinoma Adenocarcinoma
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2012-10-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.

Detailed description:

Arms: arm 1: Bevacizumab will be administered in combination with carboplatin and paclitaxel. arm 2: AG-013736 will be administered in combination with carboplatin and paclitaxel.
Interventions: intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: AG-013736 (axitinib) intervention 5: Carboplatin intervention 6: Paclitaxel
Intervention descriptions: intervention 1: Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks. intervention 2: Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks. intervention 3: Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks intervention 4: AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID- intervention 5: Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks. intervention 6: Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks

Protocol documents:
Clinical trial NCT00611130
Conditions: Cocaine Dependence
Keywords: Cocaine Addiction Dependence Treatment
Sponsor: Catalyst Pharmaceuticals, Inc.
Start date: 2008-01-01; Completion date: 2012-10-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment.

Detailed description:
Cocaine addiction, a serious public health concern associated with significant medical, social, and economic consequences, is difficult to treat using traditional psychosocial and behavioral therapies. Despite testing of a number of different agents for cocaine dependency, there remains no proven pharmacologic treatment for cocaine addiction.

The addictive properties of cocaine have been associated with its actions on mesotelencephalic dopamine reward pathways in the central nervous system (CNS). Cocaine administration increases the levels of dopamine, a neurotransmitter associated with sensations of pleasure and reward. Therefore, blocking cocaine-induced increases in dopamine levels represents a valid pharmaceutical approach to the treatment of cocaine addiction.

Another neurotransmitter, gamma-aminobutyric acid (GABA), suppresses striatal dopamine release, and attenuates cocaine-induced increases in extracellular and synaptic dopamine levels in the striatum and nucleus accumbens in animal models of drug dependence. Significant elevation of brain GABA levels may reduce cocaine-stimulated dopamine release and dampen the sensations of pleasure and reward. Thus, drugs that potentiate or enhance GABA-ergic transmission are candidates for the treatment of cocaine addiction.

Arms: arm 1: 3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks arm 2: 3 Placebo Tablets, bid, for 9 weeks
Interventions: intervention 1: vigabatrin intervention 2: placebo
Intervention descriptions: intervention 1: Tablets twice a day for 9 weeks intervention 2: tablets twice daily for 9 weeks

Protocol documents:
Clinical trial NCT00617240
Conditions: Weight Gain
Keywords: antipsychotic metformin children adolescents
Sponsor: University of North Carolina, Chapel Hill
Start date: 2007-01-01; Completion date: 2012-10-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to determine whether starting metformin in conjunction with a second-generation antipsychotic (SGA) and providing information about healthy eating and activity will prevent or reduce the amount of weight gain and the metabolic changes in adolescent youth typically seen with second-generation antipsychotic medication.

Detailed description:
This is a 24 week, placebo-controlled, random assignment pilot study in which participants will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin for 6 months as well as a newly initiated second generation antipsychotic medication or to receive placebo and the newly initiated antipsychotic medication. All subjects will also be provided healthy lifestyle instruction. The study involves monthly visits for the duration of the study. Participants may be treated as inpatients or outpatients throughout the course of the study. Participants will receive a psychiatric evaluation, physical exam, lab work, ECG, medication treatment, and psychiatric care.

The goal is to evaluate the safety and efficacy of means to prevent and treat weight gain and the associated endocrine, metabolic, and inflammatory changes caused by antipsychotic medications. Behavioral treatments to reduce weight gain and metabolic problems after weight gain has occurred have had little impact. Such interventions must be intensive and sustained over months, if not years to be effective. Although basic lifestyle instruction (diet and physical activity) should be the standard of care for all children and adolescents at risk for becoming overweight, pharmacologic interventions may be the best option for substantially augmenting behavioral approaches to weight management.

Arms: arm 1: metformin in doses from 250mg to 2000mg/day for 26 weeks arm 2: Matched placebo to metformin, doses between 250/0mg and 2000/0mg per day
Interventions: intervention 1: metformin intervention 2: placebo
Intervention descriptions: intervention 1: 500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks intervention 2: 500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks

Protocol documents:
Clinical trial NCT00624338
Conditions: Lupus Erythematosus, Systemic
Keywords: Atacicept 75 and 150 mg Placebo
Sponsor: EMD Serono
Start date: 2008-01-01; Completion date: 2012-10-01
Enrollment: 461 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Atacicept 75 mg intervention 2: Atacicept 150 mg intervention 3: Placebo Comparator
Intervention descriptions: intervention 1: 75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks. intervention 2: 150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks. intervention 3: Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Protocol documents:
Clinical trial NCT00626210
Conditions: Insomnia Sleep Initiation and Maintenance Disorders Alzheimer Disease
Keywords: Mild Cognitive Impairment (MCI) Sleep Fatigue Memory
Sponsor: VA Palo Alto Health Care System
Start date: 2008-02-01; Completion date: 2012-10-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: modafinil
Intervention descriptions: intervention 1: 100-400 mg daily for 4 weeks

Protocol documents:
Clinical trial NCT00629343
Conditions: Soft Tissue Sarcoma Mesothelioma
Keywords: Soft Tissue Sarcoma Mesothelioma Azacitidine Temozolomide Temodar
Sponsor: Columbia University
Start date: 2007-10-01; Completion date: 2012-10-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with complete history and physical as well as laboratory studies (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all sites of measurable disease. This study will be conducted over the course of 3 years.

Detailed description:
The primary objective of the study is to determine the clinical and laboratory toxicities as well as acceptability/tolerance of this dose schedule of combined drug treatment with temozolomide and azacitidine.

Secondary objectives include determination of biochemical response to azacitidine as defined as change in methylation status. The investigators will specifically be looking at changes in genome wide methylation patterns as determined by two high-throughput platforms:

1. A single nucleotide polymorphism chip-based method (MSNP) for genome wide epigenetic profiling
2. CpG island promoter arrays will be performed to focus on promoter methylation status.

The investigators will also monitor clinical response, time to progression and overall survival.

Arms: arm 1: Subjects will receive azacitidine in combination with temozolomide
Interventions: intervention 1: Azacitidine intervention 2: Temozolomide
Intervention descriptions: intervention 1: Azacitidine will be delivered sub-cutaneously for 5 days intervention 2: Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days

Protocol documents: