ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00265200
Conditions: Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Metastases
Keywords: Zometa bone metastasis lung cancer non-small cell lung cancer small cell lung cancer bone metabolic markers tartrate resistant acid phosphatase
Sponsor: University of Louisville
Start date: 2005-02-01; Completion date: 2010-12-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.

Detailed description:
The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.

Arms: arm 1: 3.0-4.0 mg by IV (in the vein), once a month for 6 months
Interventions: intervention 1: zoledronic acid
Intervention descriptions: intervention 1: 3.0-4.0 mg by IV (in the vein), once a month for 6 months

Protocol documents:
Clinical trial NCT00274287
Conditions: Prostate Cancer
Sponsor: Oncology Specialists, S.C.
Start date: 2006-01-01; Completion date: 2010-12-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance program in patients with androgen-independent prostate cancer (AIPC) who have achieved a maximal response on a taxotere or other chemotherapy schedule.

Detailed description:
Patients will be treated on this single arm, open label trial until primary end point is met, patient's withdrawal, or investigator's discretion. After achieving a maximal response on taxotere or other chemo schedule they were eligible to enroll in this trial and begin treatment with maintenance GMCSF for 2 weeks followed by 2 weeks of rest. Once progression was documented the patients were taken off study.

Arms: arm 1: Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol
Interventions: intervention 1: GM CSF
Intervention descriptions: intervention 1: 250 ug/m2 daily for 2 weeks followed by 2 weeks of rest

Protocol documents:
Clinical trial NCT00275002
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent childhood brain stem glioma recurrent childhood brain tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2006-02-01; Completion date: 2010-12-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving O6-benzylguanine together with temozolomide works in treating young patients with recurrent or progressive gliomas or brain stem tumors. Drugs used in chemotherapy, such as O6-benzylguanine and temozolomide , work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the sustained objective response rate to the combination of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas and brain stem tumors.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (high-grade gliomas vs brain stem tumors).

Patients receive O6-benzylguanine IV over 1 hour followed by oral temozolomide on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed to the earliest of 30 days following discontinuation of therapy or the initiation of additional anti-cancer therapy or death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Arms: arm 1: O6-benzylguanine (O6-BG) and temozolomide (TMZ)
Interventions: intervention 1: O6-benzylguanine intervention 2: temozolomide
Intervention descriptions: intervention 1: Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. O6-Benzylguanine, 120 mg/m\^2, will be administered as a one-hour intravenous (IV) infusion, daily for 5 days. Four consecutive weeks will constitute one course. Courses will be repeated every 4 weeks for up to 12 courses of therapy. intervention 2: Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. Temozolomide, 75 mg/m\^2 (rounded to the nearest 5 mg, the size of the smallest capsule) will be given orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course. Courses will be repeated every 4 weeks for up to 12 courses.

Protocol documents:
Clinical trial NCT00281021
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: non-small cell lung cancer Erlotinib Digoxin
Sponsor: University of Louisville
Start date: 2006-02-01; Completion date: 2010-12-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the potential benefit of adding Digoxin to erlotinib (Tarceva) treatment for patients with non-small cell lung cancer.

Detailed description:
Non-small cell lung cancer (NSCLC) accounts for 80% of all lung cancer cases. The majority of NSCLC patients have advanced disease at the time of diagnosis, which usually requires treatment beyond standard first-line chemotherapy. Until recently, patients were limited in the number of options available for second-line treatment of NSCLC. In 2004, erlotinib was approved by the FDA for second and third-line treatment of NSCLC. Erlotinib is a cancer chemotherapy medication that slows the growth and spread of cancer cells in the body.

Recent research suggests that a medication called Digoxin can sensitize cancer cells to respond better to chemotherapy. Digoxin is normally used to treat certain heart conditions by helping the heart beat more strongly and regularly and is not approved by the FDA for the treatment of NSCLC. Investigators hope that subject response rates to standard erlotinib therapy will be significantly improved by the addition of Digoxin.

The purpose of this study is to determine the tumor response rate and overall survival of patients with non-small cell lung cancer treated with a daily regimen of erlotinib (Tarceva) plus Digoxin.

Arms: arm 1: Erlotinib plus Digoxin
Interventions: intervention 1: Erlotinib plus Digoxin
Intervention descriptions: intervention 1: Each subject will receive erlotinib and digoxin daily until progression.

Protocol documents:
Clinical trial NCT00285857
Conditions: Breast Cancer
Keywords: duct cytology
Sponsor: Stanford University
Start date: 2005-11-01; Completion date: 2010-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study evaluates if a 6-month course of oral lovastatin at 80 mg/day would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk.

Detailed description:
The study evaluates if a 6-month course of oral lovastatin at 80 mg/day (as 40 mg twice-a-day) would decrease abnormal breast duct cytology in women with a high inherited breast cancer risk. Breast duct cytology was assessed as hyperplasia or hyperplasia with atypia, as measured by random periareolar fine needle aspiration (rpFNA), of breast duct cells.

A stratified analysis of this objective will be performed according to BRCA mutation status (absence or presence of an inherited deleterious BRCA1 or BRCA2 mutation).

Additional objectives of the study are to:

* Assess change in mammographic density, which is known to associate with breast cancer risk, before and after treatment with lovastatin
* Asess incidence of breast cancers and new high-risk breast lesions, including atypical hyperplasia, ductal or lobular carcinoma in situ, or radial scar.
* Assess change in other breast cancer risk-associated biomarkers in rpFNA specimens, including:

  * Ki-67 (a marker of cell proliferation)
  * Estrogen receptor (ER)
  * Progesterone receptor (PR)
  * HER/2-neu over-expression
  * Susceptibility to DNA damage

Arms: arm 1: Lovastatin 80 mg/day as 40 mg orally twice daily, for 6 months.
Interventions: intervention 1: Lovastatin
Intervention descriptions: intervention 1: Lovastatin 80 mg/day as 40 mg orally twice daily.

Lovastatin is approved by FDA as a cholesterol-lowering agent.

Protocol documents:
Clinical trial NCT00296647
Conditions: Tobacco Dependence
Sponsor: University of Wisconsin, Madison
Start date: 2004-09-01; Completion date: 2010-12-01
Enrollment: 1346 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.

Detailed description:
Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. In the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line. Assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from Project 1: Efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. The cost of incorporating tobacco dependence treatment into primary care will also be estimated.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: nicotine patch intervention 2: nicotine patch intervention 3: nicotine lozenge intervention 4: bupropion intervention 5: patch + lozenge intervention 6: bupropion + lozenge
Intervention descriptions: intervention 1: Decreasing dosages from 21 to 7 mg over 12 week period intervention 2: Decreasing dosage from 21 to 7 mg over 12 weeks intervention 3: 4 mg nicotine lozenge: dosage according to package directions for 16 weeks intervention 4: dosage according to prescription directions: 12 weeks intervention 5: dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge) intervention 6: dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)

Protocol documents:
Clinical trial NCT00324675
Conditions: Type 2 Diabetes Overt Diabetic Nephropathy
Keywords: type 2 diabetes, glomerular filtration rate, renal plasma flow, endothelial dysfunction, proteinuria, diabetic nephropathy
Sponsor: Technische Universität Dresden
Start date: 2006-08-01; Completion date: 2010-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective:

To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.

Background:

Diabetic nephropathy is a world wide public health concern of increasing proportions. It has become the most common single cause of end-stage renal disease in the United States and in Europe. Previous studies have already found agents modifying the renin-angiotensin-system (ACE inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. These agents are likely to exert multiple effects in the kidney. One of them appear to be their known ability to improve endothelial function and to change renal glomerular hemodynamics.

In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2 diabetic patients without end organ damage after treatment with rosiglitazone. In that study, rosiglitazone significantly reduced glomerular hyperfiltration. This was associated with a reduction of urinary albumin excretion. The observed effects are potentially important in the context of renal protection, provided that a similar beneficial effect of rosiglitazone is demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria).

Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in patients with chronic renal insufficiency due to overt diabetic nephropathy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rosiglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: 4 mg tablets, bid, 12 months intervention 2: 2 tablets per day

Protocol documents:
Clinical trial NCT00325442
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension
Sponsor: United Therapeutics
Start date: 2006-10-01; Completion date: 2010-12-01
Enrollment: 354 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Detailed description:

Arms: arm 1: Subjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets. arm 2: Subjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets.
Interventions: intervention 1: Oral treprostinil (UT-15C) sustained release tablets intervention 2: Placebo
Intervention descriptions: intervention 1: UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours intervention 2: Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours

Protocol documents:
Clinical trial NCT00344968
Conditions: Diabetic Macular Edema
Sponsor: Alimera Sciences
Start date: 2007-09-01; Completion date: 2010-12-01
Enrollment: 956 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: fluocinolone acetonide intervention 2: Fluocinolone Acetonide intervention 3: Standard of care laser photocoagulation
Intervention descriptions: intervention 1: 0.5 mg fluocinolone acetonide intravitreal insert intervention 2: 0.2 mg fluocinolone acetonide intravitreal insert intervention 3: Laser photocoagulation

Protocol documents:
Clinical trial NCT00350363
Conditions: Ophthalmic Surgery
Sponsor: Stanford University
Start date: 2007-01-01; Completion date: 2010-12-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Comparison of 1 day versus 1 hour application of topical Zymar.

Detailed description:

Arms: arm 1: presence of conjunctival bacteria 1 hour after administration of topical gatifloxacin
Interventions: intervention 1: Zymar
Intervention descriptions: intervention 1: zymar qid

Protocol documents:
Clinical trial NCT00350870
Conditions: Cocaine Abuse
Keywords: disulfiram cognitive behavioral therapy contingency management drug abuse therapy educational/resource design/development
Sponsor: Yale University
Start date: 2005-04-01; Completion date: 2010-12-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).

Detailed description:
This study will compare four types of treatment involving skills training and incentives for attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to alcohol use. In addition to weekly cognitive behavioral therapy (CBT), participants will be assigned to one of the following treatments:

1. placebo
2. disulfiram
3. placebo plus incentives for cocaine abstinence and medication compliance (prize CM)
4. disulfiram plus incentives for cocaine abstinence and medication compliance

Arms: arm 1: Placebo (plus Cognitive Behavioral Therapy- CBT) arm 2: Disulfiram (plus CBT) arm 3: Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). arm 4: Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).
Interventions: intervention 1: disulfiram intervention 2: Placebo intervention 3: Placebo plus Contingency Management intervention 4: Disulfiram plus Contingency Management
Intervention descriptions: intervention 1: 250mg per day of Disulfiram plus CBT intervention 2: Placebo plus CBT intervention 3: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT intervention 4: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.

Protocol documents:
Clinical trial NCT00357162
Conditions: de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes
Sponsor: National Cancer Institute (NCI)
Start date: 2006-05-01; Completion date: 2010-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well belinostat works in treating patients with myelodysplastic syndromes. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Detailed description:
OBJECTIVES:

I. Establish the efficacy and safety of PXD101 (belinostat) in patients with myelodysplastic syndromes that progressed after or is ineligible for azacitidine treatment.

II. Assess the biological activity of PXD101 in these patients via assays of histone acetylation, gene expression profiling, and DNA methylation.

OUTLINE: This is a multicenter study.

Patients receive belinostat intravenously (IV) over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response, partial response, or hematologic improvement after 4 courses receive 4 additional courses of therapy. After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

Arms: arm 1: Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: belinostat
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00363883
Conditions: Localized Transitional Cell Cancer of the Renal Pelvis and Ureter Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Regional Transitional Cell Cancer of the Renal Pelvis and Ureter Transitional Cell Carcinoma of the Bladder
Sponsor: National Cancer Institute (NCI)
Start date: 2006-06-01; Completion date: 2010-12-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Vorinostat 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 vorinostat works in treating patients with locally recurrent or metastatic cancer of the urothelium.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine response rate measured by RECIST criteria for SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium.

SECONDARY OBJECTIVES:

I. To determine the time to progression and overall survival for SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium.

II. To provide data on safety and toxicity of SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium.

III. To obtain preliminary data on molecular correlates in tissue, oral mucosa and blood to determine feasibility and clinical efficacy.

OUTLINE: This is a multicenter study.

Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and buccal mucosa collection and tumor biopsies (if accessible) at baseline and periodically during study for correlative studies. Samples are examined by gene expression profiling and immunohistochemistry.

After completion of study treatment, patients are followed for up to 26 weeks.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Arms: arm 1: Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: vorinostat intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00367432
Conditions: Epilepsies Partial
Keywords: Epilepsies Partial Keppra levetiracetam
Sponsor: UCB Japan Co. Ltd.
Start date: 2006-07-01; Completion date: 2010-12-01
Enrollment: 398 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 \[NCT00160165\] or N01221 \[NCT00280696\].

Detailed description:

Arms: arm 1: Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

Protocol documents: