ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00466167
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2007-04-01; Completion date: 2008-11-01
Enrollment: 517 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations.

In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done.

The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Pramipexol Extended Release intervention 2: Pramipexol Immediate Release intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00598832
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris Adapalene
Sponsor: Galderma R&D
Start date: 2007-11-01; Completion date: 2008-11-01
Enrollment: 1075 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Detailed description:
This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Adapalene lotion 0.1% intervention 2: Adapalene Lotion Vehicle
Intervention descriptions: intervention 1: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks intervention 2: Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks

Protocol documents:
Clinical trial NCT00626522
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Bronchitis Chronic Emphysema Smokers or ex-Smokers
Sponsor: AstraZeneca
Start date: 2008-02-01; Completion date: 2008-11-01
Enrollment: 808 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials

Detailed description:
Dose-finding clinical trial, to assess the efficacy, safety and pharmacokinetics of three different doses of formoterol combined with the inhaled anticholinergic aclidinium bromide, aclidinium bromide monotherapy and formoterol monotherapy

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Aclidinium bromide and formoterol intervention 2: Aclidinium bromide and formoterol placebo
Intervention descriptions: intervention 1: once daily intervention 2: once daily

Protocol documents:
Clinical trial NCT00672958
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Drug Therapy Major Depressive Episode
Sponsor: Takeda
Start date: 2008-04-01; Completion date: 2008-11-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults with major depressive disorder.

Detailed description:
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took vortioxetine.

The study enrolled 600 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 5 mg
* Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in the United States. The overall time to participate in this study was approximately 94 days. Participants made 8 visits to the clinic, and were contacted by telephone 1 week, 2 weeks, and 4 weeks after the last dose of study drug for a follow-up assessment.

Arms: arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablet, orally, once daily for up to 6 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated immediate-release tablets. intervention 2: Vortioxetine placebo-matching capsules.

Protocol documents:
Clinical trial NCT00010439
Conditions: Osteoporosis
Keywords: arthritis & connective tissue diseases idiopathic juvenile osteoporosis rare disease
Sponsor: Medical University of South Carolina
Start date: 2000-09-01; Completion date: 2008-11-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
OBJECTIVES:

I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.

Detailed description:
PROTOCOL OUTLINE:

Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
Interventions: intervention 1: Alendronate
Intervention descriptions: intervention 1: Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.

Protocol documents:
Clinical trial NCT00058188
Conditions: Osteoporosis Prostate Cancer
Keywords: osteoporosis stage III prostate cancer stage IV prostate cancer
Sponsor: Northwestern University
Start date: 2003-03-01; Completion date: 2008-11-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss.

PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.

Detailed description:
OBJECTIVES:

* Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate.
* Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens.
* Compare markers of bone formation and resorption in patients treated with these regimens.
* Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated with these regimens.
* Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens.
* Compare the survival rate of patients treated with these regimens.

OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
* Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study.

Arms: arm 1: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity. arm 2: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
Interventions: intervention 1: cholecalciferol intervention 2: calcium gluconate intervention 3: zoledronic acid
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Given IV

Protocol documents:
Clinical trial NCT00072566
Conditions: Primary Peritoneal Carcinoma Recurrent Ovarian Carcinoma Stage IV Ovarian Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-12-01; Completion date: 2008-11-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works in treating patients with ovarian epithelial or primary peritoneal cancer that has come back or spread to other parts of the body. Monoclonal antibodies, such as bevacizumab, 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 deliver cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide may kill more tumor cells.

Detailed description:
OBJECTIVES: Primary I. Determine the time to progression in patients with recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab and low-dose cyclophosphamide.

Secondary I. Determine the response rate in patients treated with this regimen. II. Determine the toxicity of this regimen in these patients. III. Determine molecular correlates for response and outcomes in patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 1-2 years.

Arms: arm 1: Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bevacizumab intervention 2: Cyclophosphamide intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00076024
Conditions: Breast Neoplasms
Keywords: metastatic breast cancer
Sponsor: Pfizer
Start date: 2004-02-01; Completion date: 2008-11-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.

Detailed description:

Arms: arm 1: Docetaxel + Placebo arm 2: Docetaxel + AG-013736
Interventions: intervention 1: Placebo intervention 2: Docetaxel intervention 3: AG-013736 (axitinib) intervention 4: Docetaxel
Intervention descriptions: intervention 1: 5 mg twice daily \[bid\] continuous dosing intervention 2: Standard of care drug administration intervention 3: 5mg twice daily \[bid\] continuous dosing intervention 4: Standard of care drug administration

Protocol documents:
Clinical trial NCT00089128
Conditions: Bladder Cancer
Keywords: transitional cell carcinoma of the bladder recurrent bladder cancer stage III bladder cancer stage IV bladder cancer
Sponsor: Medical University of South Carolina
Start date: 2001-11-01; Completion date: 2008-11-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan.

Secondary

* Determine the duration of response in patients treated with this regimen.
* Determine the tolerance to and toxicity of this regimen in these patients.
* Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond best response.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.

Arms: arm 1: None
Interventions: intervention 1: gemcitabine hydrochloride intervention 2: irinotecan hydrochloride
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00099047
Conditions: Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Smoldering Multiple Myeloma
Sponsor: National Cancer Institute (NCI)
Start date: 2004-11-01; Completion date: 2008-11-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well celecoxib works in preventing multiple myeloma in patients with monoclonal gammopathy or smoldering myeloma. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing multiple myeloma.

Detailed description:
PRIMARY OJBECTIVES:

I. Determine the efficacy of celecoxib vs placebo in reducing serum levels of M-component in patients with monoclonal gammopathy of undetermined significance or smoldering myeloma.

SECONDARY OBJECTIVES:

I. Determine the effects of this drug on secondary biomarkers as surrogate endpoints in these patients.

OUTLINE:

This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and type of monoclonal gammopathy (monoclonal gammopathy of undetermined significance vs smoldering myeloma). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive celecoxib orally (PO) twice daily (BID) for 6 months in the absence of unacceptable toxicity or progression to malignancy.

ARM II: Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.

After completion of study treatment, patients are followed at 1, 6, and 12 months.

Arms: arm 1: Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy. arm 2: Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Interventions: intervention 1: celecoxib intervention 2: placebo intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00100828
Conditions: Head and Neck Cancer
Keywords: thyroid gland medullary carcinoma recurrent thyroid cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2004-11-01; Completion date: 2008-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.

Secondary

* Determine the safety and tolerability of this drug in these patients.

OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: irinotecan hydrochloride
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00104637
Conditions: Pulmonary Disease, Chronic Obstructive Emphysema
Keywords: Chronic Obstructive Pulmonary Disease Emphysema Phosphodiesterase inhibitors Sildenafil Exercise testing Quality of life
Sponsor: Kawut, Steven, MD
Start date: 2005-02-01; Completion date: 2008-11-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.

Detailed description:
Patients with chronic obstructive pulmonary disease (COPD) suffer from impaired exercise capacity and quality-of-life, largely related to shortness of breath. Many of the therapies currently available for COPD are aimed at improving these factors. Exercise capacity is limited in part by high blood pressure in the blood vessels in the lungs. Sildenafil, also known as Viagra, is an FDA-approved therapy for male erectile dysfunction. One of its effects is to relax (or open) the lung vessels, thereby lowering the blood pressure in the lungs. We hypothesize that sildenafil will result in an improvement in exercise capacity, quality-of-life, and shortness of breath.

Enrolled subjects will receive sildenafil or placebo for 4 weeks followed by exercise tests, breathing tests, and administration of quality-of-life questionnaires. Subjects will then receive placebo or sildenafil (whichever one they did not receive for the first 4 weeks) for another 4 weeks, followed by the same testing.

Arms: arm 1: Sildenafil first, followed by washout, followed by placebo arm 2: Placebo first, followed by washout, followed by Sildenafil
Interventions: intervention 1: sildenafil citrate intervention 2: Placebo
Intervention descriptions: intervention 1: sildenafil citrate 25 mg by mouth thrice daily (po tid) intervention 2: 25 mg po tid

Protocol documents:
Clinical trial NCT00105443
Conditions: Carcinoma, Hepatocellular
Keywords: Liver Cancer Cancer
Sponsor: Bayer
Start date: 2005-03-01; Completion date: 2008-11-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

Detailed description:
The following abbreviations were used in the Adverse Event section:

* international normalized ratio (inr)
* Common Terminology Criteria for Adverse Events (ctcae)
* Not Otherwise Specified (nos)
* Gastrointestinal (gi)
* Central nervous system (cns)
* Absolute Neutrophil Count (anc)
* Alanine aminotransferase (ALT)
* Aspartate aminotransferase (AST)
* Creatine phosphokinase (cpk)
* Gammaglutamyltransferase (ggt)
* Genitourinary (gu)
* Atrioventricular (av)

Arms: arm 1: Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study. arm 2: Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. intervention 2: Sorafenib-matching placebo tablets were orally administered twice daily (bid).

Protocol documents:
Clinical trial NCT00106392
Conditions: Erectile Dysfunction Prostate Cancer
Keywords: Treatment effectiveness Treatment efficacy Investigational, Therapies Immunosuppressant Erectile dysfunction Prostatectomy
Sponsor: Astellas Pharma Inc
Start date: 2005-02-01; Completion date: 2008-11-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

Detailed description:
The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

Arms: arm 1: Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up. arm 2: Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
Interventions: intervention 1: Tacrolimus intervention 2: Placebo
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents: