ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00457392
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: Non-small cell lung cancer sunitinib erlotinib Phase 3
Sponsor: Pfizer
Start date: 2007-07-01; Completion date: 2012-12-01
Enrollment: 960 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: erlotinib intervention 2: sunitinib intervention 3: erlotinib intervention 4: placebo
Intervention descriptions: intervention 1: plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity intervention 2: Sunitinib 37.5 mg daily by oral capsules in a continuous regimen intervention 3: plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity intervention 4: Placebo daily by oral capsules in a continuous regimen

Protocol documents:
Clinical trial NCT01156571
Conditions: Atherosclerosis Percutaneous Coronary Intervention Acute Coronary Syndrome
Sponsor: The Medicines Company
Start date: 2010-09-01; Completion date: 2012-12-01
Enrollment: 11145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).

Detailed description:

Arms: arm 1: Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.

Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered. arm 2: Clopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion.

During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm.
Interventions: intervention 1: cangrelor P2Y12 (platelet) inhibitor intervention 2: Clopidogrel - 300 or 600 mg (study arm) intervention 3: Clopidogrel 600 mg post cangrelor
Intervention descriptions: intervention 1: None intervention 2: Over encapsulated tablets. intervention 3: over-encapsulated clopidogrel (600 mg)

Protocol documents:
Clinical trial NCT01336205
Conditions: Opioid-Induced Constipation (OIC)
Keywords: Non-Cancer-Related Pain Opioid-Induced Constipation
Sponsor: AstraZeneca
Start date: 2011-04-01; Completion date: 2012-12-01
Enrollment: 844 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.

Detailed description:

Arms: arm 1: Oral Treatment arm 2: Oral treatment
Interventions: intervention 1: NKTR-118 intervention 2: Usual care
Intervention descriptions: intervention 1: 25 mg oral tablet once daily intervention 2: As prescribed by the investigator

Protocol documents:
Clinical trial NCT02435836
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 1998-04-01; Completion date: 2012-12-01
Enrollment: 631 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to determine the safety of aripiprazole administered long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects with chronic or first episode of schizophrenia. Information on the continued efficacy of aripiprazole was also gathered in this long-term trial (until 31 Dec 2012 or until aripiprazole was otherwise available through marketed means and/or reimbursed).

Detailed description:

Arms: arm 1: All subjects began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a subject stabilized at the 30 mg per day dose, the investigator could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage AEs.
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00006101
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
Sponsor: Thomas E. Ahlering
Start date: 1998-10-01; Completion date: 2012-12-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of eflornithine (DMFO) may be an effective way to prevent the development of prostate cancer.

PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease.

Detailed description:
OBJECTIVES:

* Compare the levels of polyamines (putrescine, spermidine, and spermine) and progression-related genes in the prostate tissue of patients at high genetic risk for prostate cancer treated with eflornithine (DFMO) vs placebo.
* Determine the side effects of DFMO and compare them with the biological effect on the prostate gland in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (35 to 60 vs 61 to 70) and presence of localized cancer (yes vs no).

All patients receive oral placebo daily for 4 weeks. Patients who are compliant and take the placebo 5-7 days each week are randomized to one of two arms.

* Arm I: Patients receive oral placebo daily.
* Arm II: Patients receive high-dose oral eflornithine (DFMO) daily. Treatment continues for 1 year in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 3 years.

Arms: arm 1: 500mg/d for 12 months arm 2: placebo for 12 months
Interventions: intervention 1: eflornithine intervention 2: Placebo
Intervention descriptions: intervention 1: Take 500mg of DFMO per day for 12 months intervention 2: Take placebo per day for 12 months

Protocol documents:
Clinical trial NCT00009945
Conditions: Breast Cancer
Keywords: stage I breast cancer stage II breast cancer
Sponsor: NSABP Foundation Inc
Start date: 2001-01-01; Completion date: 2012-12-01
Enrollment: 3323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body. It is not yet known whether clodronate is more effective alone or combined with chemotherapy and /or hormonal therapy in preventing metastatic breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of clodronate with or without chemotherapy and /or hormonal therapy in preventing metastases in women who have stage I or stage II breast cancer.

Detailed description:
OBJECTIVES:

* Determine whether clodronate administered alone or in addition to adjuvant chemotherapy and/or hormonal therapy improves disease-free survival in women with early stage breast cancer.
* Determine whether clodronate reduces the incidence of skeletal metastases and non-skeletal metastases in these patients.
* Determine whether clodronate improves overall and relapse-free survival in these patients.
* Determine whether clodronate reduces the incidence of skeletal morbidity (e.g., skeletal fractures, hypercalcemia, skeletal pain, need for radiotherapy, spinal cord compression) in these patients.
* Investigate the relevance of serum markers of bone turnover as a prognostic factor for the development of bone metastasis in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified by age (under 50 vs 50 and over), number of positive lymph nodes (0 vs 1-3 vs 4 or more), and hormone receptor status (estrogen receptor \[ER\] and progesterone receptor \[PR\] negative vs ER and/or PR positive). Patients are randomized to one of two treatment arms.

Patients in both arms commence treatment within 2 weeks of randomization and continue treatment for 3 years in the absence of bone metastasis or unacceptable toxicity. Study medication must be continued in the case of documented visceral or soft tissue metastasis or other event without skeletal metastasis.

Patients in both arms may also receive adjuvant chemotherapy and/or tamoxifen at the discretion of the protocol investigator. Patients receiving hormonal therapy begin hormonal therapy within 3-12 weeks after the last dose of chemotherapy and continue for a minimum of 5 years.

Patients who have undergone a prior lumpectomy receive adjuvant whole breast radiotherapy. Patients who have undergone a prior mastectomy may receive radiotherapy at the investigator's discretion.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 3,323 patients will be accrued for this study within 3.5 years.

Arms: arm 1: Patient receives 2 tablets once daily for 3 years. arm 2: Patient receives 2 tablets once daily for 3 years.
Interventions: intervention 1: clodronate intervention 2: placebo
Intervention descriptions: intervention 1: 1600 mg PO daily intervention 2: 2 pills PO daily

Protocol documents:
Clinical trial NCT00108485
Conditions: Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia
Keywords: Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia Randomized Controlled Trials
Sponsor: University of Miami
Start date: 2005-04-01; Completion date: 2012-12-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to test the effectiveness and tolerability of Niaspan® to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.

Detailed description:
Diabetic nephropathy is the leading cause of end stage kidney disease in the United States. Patients with chronic kidney disease have a markedly increased risk of death from cardiovascular disease, and traditional risk factors such as hyperlipidemia have been shown to be of critical importance. Almost 90% of patients with diabetes and chronic kidney disease have lipid abnormalities. Here, we investigate whether Niaspan, taken in addition to lipid-lowering drugs referred to as "statins", will decrease LDL cholesterol and increase LDL particle size, increase HDL, reduce proteinuria, and reduce the speed of loss of renal function.

Arms: arm 1: Extended release niacin 1500-2000 mg daily versus placebo comparator arm 2: Placebo tablets
Interventions: intervention 1: Extended release niacin intervention 2: Placebo
Intervention descriptions: intervention 1: Extended release niacin 1500-2000mg once daily intervention 2: Placebo tablets

Protocol documents:
Clinical trial NCT00123955
Conditions: Diastolic Heart Failure Heart Failure, Congestive
Sponsor: Wake Forest University
Start date: 2005-04-01; Completion date: 2012-12-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).

Detailed description:
Exercise intolerance due to HFPEF is a major cause of disability among older Americans. Several lines of evidence suggest that aldosterone antagonism may improve exercise tolerance in HFPEF. Therefore, the primary aim of this study is to test the hypothesis that spironolactone will improve exercise tolerance and quality of life in elderly patients with isolated HFPEF. A total of 72 participants aged 60 or older will be randomized to receive either spironolactone 25mg daily or a placebo.

Arms: arm 1: Spironolactone arm 2: Placebo
Interventions: intervention 1: Spironolactone intervention 2: Placebo
Intervention descriptions: intervention 1: 25mg tablet daily for 9 months intervention 2: Placebo tablet daily for 9 months

Protocol documents:
Clinical trial NCT00129311
Conditions: Tobacco Use Cessation
Keywords: Tobacco
Sponsor: Yale University
Start date: 2004-07-01; Completion date: 2012-12-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Despite the widespread use of nicotine replacement therapies for the treatment of nicotine dependence, many smokers are still unable to quit smoking. The purpose of this study is to determine the safety and effectiveness of selegiline as an aid to help smokers quit smoking.

Detailed description:
Despite the availability of nicotine replacement therapies and sustained-relapse bupropion for the treatment of nicotine dependence, there is still a significant proportion of cigarette smokers who are unable to quit smoking. Therefore, new and effective pharmacotherapies for smoking cessation are needed. The primary aim of this study is to determine the safety and efficacy of selegiline as an aid to smoking cessation.

In this study, 200 nicotine-dependent cigarette smokers will participate in an 8-week, double-blind, placebo-controlled trial and then will be followed over 4 years. Participants will be randomly assigned to receive either selegiline or placebo. Selegiline doses of 5 mg will be taken once a day during the first week. This will be increased to 5 mg twice daily for the remaining 7 weeks. The target smoking "quit date" will be Day 15. All smokers will receive brief weekly manualized smoking cessation counseling from the Mayo Clinic's "Smoke Free and Livin' It" program. The primary smoking cessation outcome measure will be 7-day point prevalence smoking abstinence at the 6-month follow-up. Secondary cessation outcome measures will include continuous smoking abstinence during the last four weeks of the trial (Days 29-56) and 7-day point prevalence abstinence at the end of the 8-week trial (Days 49-56).

Arms: arm 1: Selegiline arm 2: Placebo
Interventions: intervention 1: Selegiline intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks. intervention 2: None

Protocol documents:
Clinical trial NCT00159874
Conditions: Pulmonary Arterial Hypertension
Keywords: children
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2004-01-01; Completion date: 2012-12-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Active treatment, dose-blinded extension study evaluating the safety and long term efficacy of sildenafil citrate in children with PAH.

Detailed description:

Arms: arm 1: As per Protocol Amendment 8 (Aug 2011), all doses in the high dose treatment group were discontinued. Subjects who were receiving these doses and continued in the study were requested to down titrate. arm 2: None arm 3: As per Protocol Amendment 8 (August 2011), the dose 40 mg TID in the medium dose treatment group was discontinued. Subjects who were receiving this dose and continued in the study were requested to down titrate.
Interventions: intervention 1: Sildenafil citrate intervention 2: Sildenafil citrate intervention 3: Sildenafil citrate
Intervention descriptions: intervention 1: Oral, subjects with body weight ≥8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight \>20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight \>45 kg: 80 mg 3 times a day (tid) intervention 2: Oral,10 mg 3 times a day (tid), only subjects with body weight \>20 kg intervention 3: Oral, subjects with body weight ≥8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight \>20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight \>45 kg: 40 mg 3 times a day (tid)

Protocol documents:
Clinical trial NCT00244985
Conditions: Lymphoma
Keywords: recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent small lymphocytic lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma
Sponsor: Roswell Park Cancer Institute
Start date: 2005-09-01; Completion date: 2012-12-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the safety, including qualitative and quantitative toxic effects and their duration and reversibility, of rituximab and doxorubicin HCl liposome in patients with relapsed or refractory, indolent or aggressive CD20-positive B-cell non-Hodgkin's lymphoma.

Secondary

* Determine the efficacy, including overall response rate and durability of objective response, of this regimen in these patients.
* Correlate pretreatment functional, phenotypic, and genotypic characteristics of host immune effector cells with response in patients treated with this regimen.

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

Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 4 years.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Arms: arm 1: Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
Interventions: intervention 1: rituximab intervention 2: pegylated liposomal doxorubicin hydrochloride
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol documents:
Clinical trial NCT00266864
Conditions: Spinal Cord Injury Hypogonadism
Keywords: Spinal Cord Injury Testosterone Replacement Therapy Dual Energy X ray Absorptiometry Lean Tissue Mass
Sponsor: VA Office of Research and Development
Start date: 2003-08-01; Completion date: 2012-12-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on:

body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment

Detailed description:
This study is 24 months in duration. Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid cream will be provided to the subjects should any skin irritations occur. If the patch causes persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be used. Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject.

Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate as a control subject for the full 24-month period of the study. These subjects visit the lab at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.

Arms: arm 1: Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch) arm 2: Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
Interventions: intervention 1: Testosterone Transdermal System (Androderm 5 mg patch)
Intervention descriptions: intervention 1: Testosterone Transdermal System (Androderm 5 mg patch)

Protocol documents: