ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00294671
Conditions: Familial Amyloid Polyneuropathy Familial Amyloidosis
Keywords: familial amyloid polyneuropathy familial amyloidosis diflunisal amyloidosis transthyretin peripheral neuropathy autonomic neuropathy amyloid cardiomyopathy
Sponsor: Boston University
Start date: 2006-02-01; Completion date: 2012-12-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if diflunisal can prevent progressive lower leg nerve damage in patients with familial amyloidosis polyneuropathy.

Funding Source - FDA Office of Orphan Products Development (OOPD); National Institute of Neurological Disorders and Stroke (NINDS)

Detailed description:
Familial amyloidosis polyneuropathy (FAP) is a rare, lethal, autosomal dominant, neurodegenerative disease characterized by misfolding of variant transthyretin tetramer (TTR) - a transport protein produced by the liver. The disease causes TTR to become unstable, triggering amyloid fibrils to form and leading to peripheral and autonomic nerve dysfunction.

Currently, the only treatment for FAP is a liver transplant, which is expensive and risk-filled. Medicines are needed to treat this disease. Previous in vitro (in a test tube) studies have shown that a common anti-inflammatory drug called diflunisal stabilizes TTR, preventing the formation of amyloid fibrils.

The goal of this 2-year randomized, double-blind, placebo-controlled research study is to establish whether diflunisal can stop the nerve damage, or peripheral neuropathy, resulting from amyloid production in patients with FAP. Scientists already know that diflunisal prevents formation of amyloid in the test tube. This study will determine if the drug can block amyloid production in FAP patients.

Participants will be randomly chosen to receive either diflunisal or an inactive (placebo) pill twice daily for 24 months. Participants will be carefully monitored through 7 follow-up visits, either at the study center or with individual primary care physicians. Participating in the study does not preclude patients from being listed for liver transplantation.

Arms: arm 1: Diflunisal 250 mg po bid arm 2: Placebo 1 po bid
Interventions: intervention 1: diflunisal intervention 2: placebo
Intervention descriptions: intervention 1: given twice daily for 24 months intervention 2: an inactive substance given twice daily for 24 months

Protocol documents:
Clinical trial NCT00301756
Conditions: Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor Recurrent Ovarian Carcinoma Stage III Borderline Ovarian Surface Epithelial-Stromal Tumor Stage III Ovarian Cancer Stage IV Borderline Ovarian Surface Epithelial-Stromal Tumor Stage IV Ovarian Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-09-01; Completion date: 2012-12-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well belinostat works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that have spread to other places in the body or ovarian low malignant potential tumors. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the antitumor activity of PXD 101 as a single agent in the following patient population using objective response rates (complete and partial): a) Platinum resistant ovarian carcinoma (progression within 6 months of platinum based therapy); b) Micropapillary / borderline (Low Malignant potential) ovarian carcinoma.

SECONDARY OBJECTIVES:

I. To determine the antitumor activity of PXD 101 with regards to stable disease rates, duration of response, progression- free, median and overall survival rates as well as determine the safety and tolerability this drug.

TERTIARY OBJECTIVES:

I. To determine the relationship between clinical and pharmacodynamic effects of PXD101 in patients with platinum resistant and micropapillary tumors undergoing treatment with this drug.

OUTLINE:

Patients receive belinostat intravenously (IV) over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

Arms: arm 1: Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Belinostat intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00313612
Conditions: Recurrent Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-01-01; Completion date: 2012-12-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with oxaliplatin and topotecan.

II. Determine the toxic effects in patients treated with this regimen.

SECONDARY OBJECTIVES:

I. Estimate the time to progression and overall clinical response duration in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to response to prior platinum therapy (resistant vs sensitive).

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.
Interventions: intervention 1: oxaliplatin intervention 2: topotecan
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00321828
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon stage IV colon cancer
Sponsor: NSABP Foundation Inc
Start date: 2006-03-01; Completion date: 2012-12-01
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, 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 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. Bevacizumab may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Determine the rate of major morbidity in patients with unresectable stage IV colon cancer and a synchronous asymptomatic primary tumor treated with fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX6) in combination with bevacizumab without resection of the primary tumor.

Secondary

* Determine the rate of specific events related to the intact primary tumor requiring hospitalization or a major intervention but not requiring surgery.
* Determine the rate of ≥ grade 3 toxicity as defined by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) that is related to study therapy prior to disease progression.
* Determine overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV given concurrently with leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years after study entry.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Arms: arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Interventions: intervention 1: bevacizumab intervention 2: fluorouracil intervention 3: leucovorin intervention 4: oxaliplatin
Intervention descriptions: intervention 1: bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression intervention 2: 5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression intervention 3: leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression intervention 4: Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression

Protocol documents:
Clinical trial NCT00343382
Conditions: Breast Cancer Vaginal Dryness
Keywords: sexuality and reproductive issues sexual dysfunction recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2006-12-01; Completion date: 2012-12-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients with breast cancer It is not yet known whether pilocarpine is more effective than a placebo in treating vaginal dryness in patients with breast cancer.

PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works compared to a placebo in treating vaginal dryness in patients with breast cancer.

Detailed description:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18 to 45 vs 46 to 55 vs 56 to 65 vs \> 65), concurrent tamoxifen therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), concurrent aromatase inhibitor therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), and perception of severity of vaginal symptoms at baseline (mild vs moderate vs severe). Patients are randomized to 1 of 4 treatment arms. The primary and secondary objectives of the study are described below.

OBJECTIVES:

Primary

* Determine the effectiveness of pilocarpine hydrochloride for alleviation of vaginal dryness in patients with breast cancer.

Secondary

* Evaluate any toxicities arising from pilocarpine hydrochloride in these patients.
* Evaluate quality of life of these patients treated with pilocarpine hydrochloride.

Quality of life was assessed at baseline and then weekly for 6 weeks.

Arms: arm 1: Patients receive oral pilocarpine hydrochloride once a day for 3 days, twice a day for 3 days, three times a day for 3 days, and then 4 times a day for up to 6 weeks in the absence of unacceptable toxicity. arm 2: Patients receive oral pilocarpine hydrochloride once a day for 3 days and then twice a day for up to 6 weeks in the absence of unacceptable toxicity. arm 3: Patients receive oral placebo once a day for 3 days, twice a day for 3 days, three times a day for 3 days, and then 4 times a day for up to 6 weeks in the absence of unacceptable toxicity. arm 4: Patients receive oral placebo once a day for 3 days and then twice a day for up to 6 weeks in the absence of unacceptable toxicity.
Interventions: intervention 1: pilocarpine hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT00393796
Conditions: Bladder Cancer
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2006-05-01; Completion date: 2012-12-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.

Detailed description:

Arms: arm 1: Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. arm 2: Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
Interventions: intervention 1: SUTENT intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248. intervention 2: None

Protocol documents:
Clinical trial NCT00435994
Conditions: Bronchiolitis Respiratory Syncytial Virus Infections
Keywords: Infant Respiratory Syncytial Virus Bronchiolitis
Sponsor: Indiana University School of Medicine
Start date: 2003-12-01; Completion date: 2012-12-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.

Detailed description:
We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.

Arms: arm 1: Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants arm 2: Healthy infants between the ages of 2-24 month arm 3: Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only
Interventions: intervention 1: Inhaled primatene will be given as a breathing treatment intervention 2: Nasal Washing
Intervention descriptions: intervention 1: While the research subject is sedated an inhaled mist of primatene mist will be given to the patient. intervention 2: 1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence

Protocol documents:
Clinical trial NCT00459186
Conditions: Metastatic, Androgen Independent Prostate Cancer Prostate Cancer
Keywords: prostate cancer RAD001 mTOR inhibition docetaxel
Sponsor: Dana-Farber Cancer Institute
Start date: 2005-11-01; Completion date: 2012-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).

Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (Phase II).

Detailed description:
* Patients will be designated into one of two groups based upon the results of a FDG-PET scan.
* A patient with a baseline positive scan will have serum drawn for baseline serum proteomics assessment then be treated with RAD001 daily for two weeks. On day 10-14, another FDG-PET scan and serum assessment will be performed. An optional bone marrow biopsy may also be done. On day 15, patients will enter the Phase I portion of the trial at the current enrolling dosage or if Phase I is completed patients will enter Phase II.
* A patient that does not have a positive scan will enter directly into the Phase I trial or Phase II depending on which trial is currently enrolling.
* Phase I trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks.
* Phase II trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks.
* The maximum duration of the trial is one year of therapy.

Arms: arm 1: RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
Interventions: intervention 1: RAD001 intervention 2: Docetaxel intervention 3: Prednisone
Intervention descriptions: intervention 1: Daily for two weeks intervention 2: Infusion once per cycle intervention 3: Prednisone 5 mg by mouth twice daily

Protocol documents:
Clinical trial NCT00473746
Conditions: Prostate Neoplasms
Keywords: Prostate neoplasms Hormone refractory prostate cancer Abiraterone acetate CB7630
Sponsor: Janssen Research & Development, LLC
Start date: 2006-06-01; Completion date: 2012-12-01
Enrollment: 66 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of abiraterone acetate (also referred to as CB7630) in patients with hormone refractory prostate cancer (HRPC).

Detailed description:
This is an open-label (identity of assigned study drug will be known) study to evaluate the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug does to the body), and anti-tumor activities of abiraterone acetate (also known as CB7630) in patients with HRPC. The study will be conducted in 2 phases (Phase 1 and Phase 2). In the first part of the study (Phase 1), the maximum tolerated dose (MTD) of abiraterone acetate will be determined for use in the second part of the study (Phase 2) where the number of patients who achieve at least a 50% decrease in prostate specific antigen (PSA) during treatment with abiraterone acetate will be assessed (MTD from Phase 1). Abiraterone acetate will be taken orally (by mouth) in fed and fasted patients once daily. Doses of abiraterone acetate (starting at 250 mg up to a maximum of 2000 mg) will be taken for 28-day treatment periods to determine the MTD. Patients will take MTD of abiraterone acetate for up to twelve 28 day cycles (12 months; patients will be given the option of staying on abiraterone acetate treatment if they are deriving benefit). In Phase 2, prednisone or dexamethasone will be administered concurrently with abiraterone acetate. Serial pharmacokinetic and pharmacodynamic samples will be collected and safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Abiraterone acetate intervention 2: Abiraterone acetate intervention 3: prednisone/prednisolone or dexamethasone
Intervention descriptions: intervention 1: The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000mg/day until Maximum Tolerated Dose (MTD) and a recommended Phase II dose was established. intervention 2: Abiraterone acetate 1000 mg daily under fasted conditions upto 10 cycles of therapy. intervention 3: prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) concurrent with abiraterone acetate

Protocol documents: