ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01667731
Conditions: Hepatitis C Human Immunodeficiency Virus
Keywords: Hepatitis C Chronic HCV HIV Human Immunodeficiency Virus Co-Infected
Sponsor: Gilead Sciences
Start date: 2012-07-01; Completion date: 2014-02-01
Enrollment: 224 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.

Detailed description:

Arms: arm 1: Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks. arm 2: Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks. arm 3: Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks.
Interventions: intervention 1: SOF intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT00201864
Conditions: Breast Cancer
Keywords: Postmenopausal Women
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2005-09-01; Completion date: 2014-02-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.

Detailed description:

Arms: arm 1: Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Interventions: intervention 1: Exemestane intervention 2: Fulvestrant
Intervention descriptions: intervention 1: 25 mg orally per day intervention 2: 250 mg IM starting on Day 8 and then every 28 days.

Protocol documents:
Clinical trial NCT00297258
Conditions: Sarcoma, Soft Tissue
Keywords: Sarcoma Synovial sarcoma Pazopanib(GW786034) Adipocytic tumors Leiomyosarcoma Phase II
Sponsor: GlaxoSmithKline
Start date: 2005-11-01; Completion date: 2014-02-01
Enrollment: 148 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the activity and tolerability of pazopanib in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of pazopanib in this subject population.

Detailed description:

Interventions: intervention 1: pazopanib
Intervention descriptions: intervention 1: oral tablet

Protocol documents:
Clinical trial NCT00474812
Conditions: Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-05-01; Completion date: 2014-02-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with metastatic pancreatic cancer.

Detailed description:
PRIMARY OBJECTIVE:

I. Determine the overall survival, including median survival, of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib.

SECONDARY OBJECTIVES:

I. Determine the effects of this drug on quantities of circulating tumor cells in these patients.

II. Determine the time to progression in patients treated with this drug. III. Determine pre- and post-drug fat-free mass and gait speed in patients treated with this drug.

IV. Evaluate the toxicity of this drug in these patients. V. Evaluate objective response rate in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

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

Patients undergo blood collection at baseline and during days 25-31. Samples are analyzed for quantification of circulating tumor cells. Patients also undergo analysis of fat-free mass and gait speed at baseline and at 1, 2, and 6 months.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Patients receive oral dasatinib twice daily on days 1-28.
Interventions: intervention 1: dasatinib intervention 2: laboratory biomarker analysis intervention 3: physiologic testing
Intervention descriptions: intervention 1: None intervention 2: Correlative study intervention 3: Correlative study

Protocol documents:
Clinical trial NCT00533897
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis (RA)
Sponsor: Bristol-Myers Squibb
Start date: 2007-11-01; Completion date: 2014-02-01
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Abatacept intervention 2: Placebo
Intervention descriptions: intervention 1: Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term) intervention 2: Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)

Protocol documents:
Clinical trial NCT00547521
Conditions: Rheumatoid Arthritis (RA)
Sponsor: Bristol-Myers Squibb
Start date: 2007-12-01; Completion date: 2014-02-01
Enrollment: 119 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept

Detailed description:

Arms: arm 1: In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. arm 2: In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
Interventions: intervention 1: abatacept intervention 2: Methotrexate (MTX)
Intervention descriptions: intervention 1: solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open intervention 2: Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks

Protocol documents:
Clinical trial NCT00558012
Conditions: Osteoporosis Bone Loss Fragility Fractures
Keywords: Osteoporosis Bone loss Frail Geriatric Women Nursing Home Patients Fragility Fractures
Sponsor: University of Pittsburgh
Start date: 2007-12-01; Completion date: 2014-02-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will examine the safety, efficacy and feasibility of a single dose of intravenous zoledronic acid in the maintenance of skeletal integrity for frail, institutionalized women, who are most at risk for the deleterious outcomes of osteoporosis. The investigators will test the hypothesis that in institutionalized elderly women a single dose of intravenous zoledronic acid therapy will: (1) be efficacious as demonstrated by stability or improvement in bone mass measurements and reductions in bone turnover; (2) be safe and feasible; and (3) provide estimates for vertebral and nonvertebral fracture reduction in this cohort for use in planning a future study.

Detailed description:
This is a 2-year, randomized, double-blind, calcium/vitamin D-controlled clinical trial of a single dose of therapy with at least 12 months follow-up. All participants will receive calcium and vitamin D throughout the trial. At baseline, 190 women will be randomized in a 1:1 allocation to zoledronic acid (group 1) or zoledronic acid placebo (group 2). At the end of 24 months, women will be followed to gather data on longer term fragility fracture rates and survival until all participants have completed 24 months of follow-up.

Arms: arm 1: One-time dose: Intravenous Zoledronic Acid 5.0 mg; Vitamin D (800 IU/daily); Calcium 1200 mg/daily (supplement plus diet) arm 2: One-time dose: intravenous saline; Vitamin D (800 IU/daily); 1200 mg calcium (supplement plus diet)
Interventions: intervention 1: Intravenous zoledronic acid intervention 2: Vitamin D 800 IU/daily intervention 3: Calcium 1200 mg/daily
Intervention descriptions: intervention 1: Intravenous zoledronic acid 5.0 mg once intervention 2: Daily divided dose intervention 3: supplement plus diet

Protocol documents:
Clinical trial NCT00583349
Conditions: Bladder Cancer
Keywords: Bladder Cancer Chemotherapy Bladder Neoplasms
Sponsor: Columbia University
Start date: 2008-12-01; Completion date: 2014-02-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
Phase I:

To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose.

To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67.

Phase II:

To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory non-muscle invasive and a subset of T2 TCC of the bladder as measured by response rate (defined as negative cytology and bladder biopsy).

To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.

Detailed description:
In 2006, it is estimated that 61,420 cases of bladder cancer will be diagnosed in the United States and 13,060 people will die from the disease. This makes bladder cancer the fourth leading cause of cancer in men and the ninth leading cause of cancer in women in the United States. Non-muscle invasive bladder cancer accounts for 70 to 80 percent of these cases and the natural history can vary widely with recurrence being common. In individual cases with high-risk clinical and pathological features (Ta, Tis, and T1) the use of intravesical therapy following complete transurethral resection of the tumor has become the standard of care. However up to 50 percent of patients treated with intravesical therapy for high-risk non-muscle invasive bladder cancer will recur. Response rates to second-line intravesical therapy are 20 percent or less in this population. Innovations in the efficacy of intravesical agents also have applications within a subset of patients with muscle-invasive disease who are undergoing complete transurethral resection in conjunction with local chemotherapy.

Arms: arm 1: Phase I and Phase II: Patients will receive intravesical Abraxane by sterile urethral catheterization once weekly for six weeks.

Phase II: If a complete response after six weekly installations is achieved, patients will receive additional monthly maintenance instillations until there is a positive cystoscopic biopsy or until a maximum of six additional instillations have been administered.
Interventions: intervention 1: Abraxane
Intervention descriptions: intervention 1: Abraxane is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug.

Intravesically administered, dose escalation, 6 weekly instillations

Protocol documents:
Clinical trial NCT00618826
Conditions: Metastatic Breast Cancer
Keywords: Breast cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2006-11-01; Completion date: 2014-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at a new chemotherapy schedule in metastatic breast cancer.

Detailed description:
The purpose of this study is to determine whether a new chemotherapy schedule using biweekly combination of paclitaxel (Taxol®), gemcitabine (Gemzar®) and Avastin would help to lessen in-between-cycle growth of resistant cells and to evaluate the toxicity of this therapy.

Taxol is approved by the Food and Drug Administration (FDA) for use in metastatic breast and metastatic ovarian cancer but its use in this study is investigational. Gemzar is FDA approved for the use in breast, lung and pancreatic cancer but its use in this study is investigational.

The Avastin being given in this study is commercially available, however, it has not been approved by FDA for use in metastatic breast cancer.

Arms: arm 1: Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
Interventions: intervention 1: Paclitaxel intervention 2: Gemcitabine intervention 3: Avastin
Intervention descriptions: intervention 1: Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins. intervention 2: Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel. intervention 3: 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.

Protocol documents:
Clinical trial NCT00621049
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer Resected Carboplatin Docetaxel Bevacizumab Erlotinib
Sponsor: SCRI Development Innovations, LLC
Start date: 2007-12-01; Completion date: 2014-02-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Docetaxel/Carboplatin/Bevacizumab/Erlotinib intervention 2: Docetaxel/Carboplatin
Intervention descriptions: intervention 1: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1

Docetaxel should be administered before carboplatin.

After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:

Maintenance Treatment for patients in Cohort A:

Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily

Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. intervention 2: Adjuvant Treatment Cohort B:

Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1

Docetaxel should be administered before carboplatin.

Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.

Protocol documents:
Clinical trial NCT00816348
Conditions: Cholestasis Total Parenteral Nutrition-induced Cholestasis
Keywords: Cholestasis Parenteral Nutrition Associated Liver Disease
Sponsor: Cindy Haller
Start date: 2008-12-01; Completion date: 2014-02-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).

Detailed description:
Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. However, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to PN associated liver disease.

It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of PN-associated cholestasis may be prevented or reversed.

Arms: arm 1: All subjects will receive Omegaven
Interventions: intervention 1: Omegaven
Intervention descriptions: intervention 1: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day.

Protocol documents:
Clinical trial NCT00826540
Conditions: Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2009-09-01; Completion date: 2014-02-01
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, 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. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate proportion of patients who are progression-free at 3 months (in historic comparison with results for single-agent bevacizumab in ECOG 3200).

SECONDARY OBJECTIVES:

I. Response rate (RR) II. Overall survival (OS) III. Safety IV. Feasibility

OUTLINE: This is a multicenter study.

Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies.

After completion of study treatment, patients are followed periodically for up to 2 years.

Arms: arm 1: Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies
Interventions: intervention 1: sorafenib tosylate intervention 2: bevacizumab
Intervention descriptions: intervention 1: Given orally intervention 2: Given IV

Protocol documents:
Clinical trial NCT00843713
Conditions: HIV Infection Inflammation Cardiovascular Disease HIV Infections
Keywords: HIV endothelium inflammation Treatment Experienced
Sponsor: University of California, San Francisco
Start date: 2009-01-01; Completion date: 2014-02-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recent studies suggest that HIV patients are at increased risk for cardiovascular events; however, the mechanisms underlying this increased risk remain unclear. Our group was one of the first to demonstrate that HIV infection is independently associated with accelerated atherosclerosis, as measured by carotid artery-intima media thickness (IMT), and that HIV-associated inflammation may be driving this accelerated atherosclerosis. The mechanism by which HIV disease independent of any drug-specific toxicity increases the risk of cardiovascular disease during HAART is not known. We hypothesize that even well controlled HIV infection is independently associated with cardiovascular risk and that further decreasing HIV-associated inflammation adding newer antiretroviral agents will also decrease cardiovascular risk.

We will perform a small clinical trial of approximately 50 HIV-infected patients each to study the relationship between HIV infection, inflammation, thrombosis, atherogenic lipoproteins, and measures of atherosclerosis. We propose the following specific aims: Aim 1: To determine the influence of traditional and novel markers of inflammation on endothelial function and IMT progression; Aim 2: To determine if "intensification" with raltegravir in subjects on long-term antiretroviral therapy with clinically undetectable HIV RNA levels will improve endothelial function, and to determine if this effect is mediated by alterations in inflammatory markers, lipoproteins and/or thrombotic factors. For Aim 2, subjects from 2 randomized, double-blind, placebo-controlled raltegravir intensification studies will be asked to co-enroll in this cardiovascular study.

Detailed description:

Arms: arm 1: For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication arm 2: For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication
Interventions: intervention 1: raltegravir intervention 2: Placebo
Intervention descriptions: intervention 1: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication intervention 2: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication

Protocol documents: