ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00601484
Conditions: Cystitis, Interstitial
Keywords: Painful Bladder Syndrome monoclonal antibody
Sponsor: Pfizer
Start date: 2008-03-17; Completion date: 2009-04-15
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-04383119 intervention 2: Placebo
Intervention descriptions: intervention 1: PF-04383119 200 mcg/kg IV, single dose intervention 2: placebo IV, single dose

Protocol documents:
Clinical trial NCT00571064
Conditions: Mild to Severe Alzheimer's Disease
Sponsor: Eisai Inc.
Start date: 2008-01-01; Completion date: 2009-04-22
Enrollment: 97 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Donepezil HCl
Intervention descriptions: intervention 1: One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water.

Protocol documents:
Clinical trial NCT00662909
Conditions: Urinary Bladder, Overactive
Keywords: Frequency YM178 Overactive bladder (OAB) Micturition Urgency Urinary urge incontinence Urinary incontinence
Sponsor: Astellas Pharma Inc
Start date: 2008-03-28; Completion date: 2009-04-22
Enrollment: 2149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder

Detailed description:

Arms: arm 1: Participants received matching placebo tablets orally once a day for 12 weeks arm 2: Participants received mirabegron 50 mg tablets orally once a day for 12 weeks arm 3: Participants received mirabegron 100 m tablets, orally once a day for 12 weeks
Interventions: intervention 1: Mirabegron intervention 2: Placebo
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT00482729
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-19; Completion date: 2009-04-27
Enrollment: 1246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: Arm 1: drug arm 2: Arm 2: active comparator
Interventions: intervention 1: sitagliptin phosphate (+) metformin hydrochloride intervention 2: metformin
Intervention descriptions: intervention 1: sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period. intervention 2: metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Protocol documents:
Clinical trial NCT00422058
Conditions: Metabolism and Nutrition Disorder Obesity
Sponsor: Novo Nordisk A/S
Start date: 2007-01-10; Completion date: 2009-04-30
Enrollment: 564 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.

Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.

Detailed description:

Arms: arm 1: Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 2: Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 3: Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 4: Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 5: Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) arm 6: Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
Interventions: intervention 1: liraglutide intervention 2: orlistat intervention 3: placebo
Intervention descriptions: intervention 1: Injected s.c. (under the skin) once daily intervention 2: 120 mg capsule. Administered thrice daily intervention 3: Injected s.c. (under the skin) once daily

Protocol documents:
Clinical trial NCT00820950
Conditions: Psoriasis
Sponsor: Incyte Corporation
Start date: 2007-05-31; Completion date: 2009-04-30
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.

Detailed description:

Arms: arm 1: INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days arm 2: INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days arm 3: INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days arm 4: INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days arm 5: INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days
Interventions: intervention 1: Ruxolitinib phosphate cream intervention 2: Dovonex® calcipotriene 0.005% intervention 3: Diprolene® AF betamethasone dipropionate 0.05% cream. intervention 4: Placebo cream intervention 5: Ruxolitinib phosphate cream intervention 6: Ruxolitinib phosphate cream
Intervention descriptions: intervention 1: Ruxolitinib phosphate cream 0.5% intervention 2: Cream applied once or twice daily for up to 56 days. intervention 3: Cream applied once or twice daily for up to 56 days intervention 4: Cream applied once or twice daily for 56 days intervention 5: Ruxolitinib phosphate cream 1.0% intervention 6: Ruxolitinib phosphate cream 1.5%

Protocol documents:
Clinical trial NCT00380068
Conditions: Pulmonary Hypertension
Sponsor: Gilead Sciences
Start date: 2006-08-01; Completion date: 2009-05-01
Enrollment: 224 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in a broad population of participants with pulmonary hypertension (PH). Secondary objectives of this study were to evaluate the effects of ambrisentan on other clinical measures of pulmonary arterial hypertension (PAH), long-term treatment success, and survival.

Detailed description:
This study was to enroll up to 200 participants with PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1); 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHO Group 5). Participants with left heart disease or left heart failure were excluded (WHO Group 2). Participants could be receiving prostacyclin or sildenafil therapy at baseline, and participants who previously discontinued either bosentan, sitaxsentan, or both, due to liver function test abnormalities were eligible.

Arms: arm 1: None
Interventions: intervention 1: Ambrisentan
Intervention descriptions: intervention 1: Oral tablets taken once daily.

Protocol documents:
Clinical trial NCT00546754
Conditions: Hypertension
Sponsor: Organon and Co
Start date: 2007-05-01; Completion date: 2009-05-01
Enrollment: 808 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.

Detailed description:

Arms: arm 1: Drug Arm arm 2: active comparator
Interventions: intervention 1: losartan potassium (+) hydrochlorothiazide intervention 2: Comparator: Valsartan (+) Hydrochlorothiazide
Intervention descriptions: intervention 1: losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide intervention 2: Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide

Protocol documents:
Clinical trial NCT00003659
Conditions: Leukemia
Keywords: stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 1998-09-01; Completion date: 2009-05-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose cyclophosphamide and rituximab in treating patients who have previously untreated chronic lymphocytic leukemia.

Detailed description:
OBJECTIVES:

* Determine the response rate in patients with chronic lymphocytic leukemia treated with sequential fludarabine, high dose cyclophosphamide, and rituximab.
* Survival up to 5 years
* Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal residual disease in these patients.

OUTLINE: This is an open label study.

Patients receive fludarabine IV once daily for 5 days. Treatment is repeated every 4 weeks for 3 or 6 courses.

Three weeks later, cyclophosphamide is administered intravenously every 2-3 weeks for 3 courses. Filgrastim (G-CSF) is administered on days 2-10. Beginning 4 weeks after the last dose of cyclophosphamide, patients receive rituximab by intravenous infusion once weekly for 4 weeks.

Patient are followed every 3 months until death.

PROJECTED ACCRUAL: This study will accrue 30 patients within 3 years.

Arms: arm 1: This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
Interventions: intervention 1: filgrastim intervention 2: rituximab intervention 3: cyclophosphamide intervention 4: fludarabine phosphate
Intervention descriptions: intervention 1: Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients \> 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses. intervention 2: Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses. intervention 3: Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses. intervention 4: Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.

Protocol documents:
Clinical trial NCT00024258
Conditions: Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma
Keywords: metastatic osteosarcoma recurrent childhood rhabdomyosarcoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma stage III childhood liver cancer stage IV childhood liver cancer recurrent childhood liver cancer childhood hepatoblastoma stage III Wilms tumor stage IV Wilms tumor stage V Wilms tumor recurrent Wilms tumor and other childhood kidney tumors intraocular retinoblastoma extraocular retinoblastoma recurrent retinoblastoma recurrent osteosarcoma childhood germ cell tumor metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma localized unresectable neuroblastoma previously untreated childhood rhabdomyosarcoma childhood desmoplastic small round cell tumor untreated childhood medulloblastoma recurrent childhood medulloblastoma previously treated childhood rhabdomyosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor childhood teratoma childhood malignant testicular germ cell tumor childhood malignant ovarian germ cell tumor childhood extragonadal germ cell tumor recurrent childhood malignant germ cell tumor
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2001-03-01; Completion date: 2009-05-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.

Detailed description:
OBJECTIVES:

* Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
* Determine the toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).

Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for 1 year and then annually thereafter.

Arms: arm 1: Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for 1 year and then annually thereafter.
Interventions: intervention 1: arsenic trioxide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00041392
Conditions: Coronary Disease Heart Diseases Cardiovascular Diseases Neurologic Manifestations
Sponsor: Duke University
Start date: 2001-12-01; Completion date: 2009-05-01
Enrollment: 389 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery.

Detailed description:
BACKGROUND:

Approximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the early stages following heart surgery, but it may persist in some individuals. While many people think cognitive impairment is subtle, transient, or subclinical, perioperative decline is associated with 5-year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with heart surgery. However, most strategies have been unsuccessful, met with limited success, or are unrealistic from a cost or risk-benefit ratio for the majority of people. This study will examine the effectiveness of supplemental magnesium at preventing the cognitive decline associated with heart surgery.

DESIGN NARRATIVE:

This study will examine the effect of supplemental magnesium on the neurocognitive function of individuals undergoing CABG surgery. The two hypotheses to be tested include the following: 1) therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after heart surgery; and 2) therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after heart surgery. This double-blind study will enroll 400 individuals and randomly assign them to either the treatment group, which will receive 100 mg/kg of magnesium, or to the control group. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted prior to surgery, and 6 weeks and 1 year following surgery.

Arms: arm 1: 100 mg/kg magnesium arm 2: 100 mg/kg 0.9 % saline
Interventions: intervention 1: Magnesium intervention 2: 0.9% saline
Intervention descriptions: intervention 1: 100 mg/kg intervention 2: Placebo

Protocol documents:
Clinical trial NCT00094172
Conditions: Multiple Sclerosis
Keywords: Early Multiple Sclerosis MS Clinically Isolated Syndrome
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2005-05-01; Completion date: 2009-05-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients.

Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance.

Detailed description:
CIS is a single clinical event indicating temporary disruption of normal nerve function. CIS patients may have a loss of vision in one eye; trouble with balance; double vision; numbness in the face; and tingling, numbness, or weakness in the arms or legs. Some CIS patients may develop MS, but others may not. Studies have shown that when CIS is accompanied by magnetic resonance imaging (MRI)-detected brain lesions that are consistent with those seen in MS, there is a high risk of a second neurologic event and a diagnosis of MS within several years. This study will evaluate the efficacy of atorvastatin, an antihyperlipidemic, in the prevention of MS in CIS patients.

This study will last 18 months. All participants must complete a 3- to 5-day course of corticosteroids at least 28 days before the baseline evaluations. This corticosteroid therapy must be initiated within 60 days of CIS onset. Participants will be randomly assigned to receive 80 mg of either atorvastatin or placebo by mouth daily for 12 months. Study visits will occur at screening and every 3 months thereafter until the end of the 18-month study. Blood collection will occur at selected visits, and other additional evaluations will be performed at Months 1 and 2. Selected participants will undergo MRI brain scans. Participants will be offered interferon beta-1a (Avonex®), free of charge, if they develop disease activity. Participants will be instructed to report any change in their health status to their treating physician within 48 hours of the onset of symptoms.

Arms: arm 1: 80 mg/day arm 2: Once daily.
Interventions: intervention 1: Atorvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: atorvastatin at the dose of 80 mg/day. Participants will be allowed to decrease the daily dose to 40 mg/day if the higher dose is not well-tolerated intervention 2: tablet form

Protocol documents:
Clinical trial NCT00107536
Conditions: Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-10-01; Completion date: 2009-05-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Lapatinib ditosylate 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 lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (complete response \[CR\] + partial response \[PR\]) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria in each group of patients.

SECONDARY OBJECTIVES:

I. To evaluate the progression free survival at 6 months. II. To evaluate the toxicity profile of this treatment in each group of patients.

III. To evaluate median overall survival, 6 and 12 months survival rates. IV. To assess target-epidermal growth factor receptor (EGFR)/EGFR-P protein expression and the genes that regulate the cell cycle and apoptosis, which are either downstream of or cross-talk with the EGFR signaling pathway, to explore their association with clinical outcome.

V. To measure expression profile and mutations of genes critical for EGFR and (v-erb-b2 erythroblastic leukemia viral oncogene homolog 2 (ERBB2 signaling pathways with particular relevance to GW572016, and to explore new gene-drug relationships as relating to hepatocellular and biliary carcinomas.

OUTLINE: This is a multicenter study.

Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 1 year.

Arms: arm 1: Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: Correlative studies

Protocol documents: