ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01093534
Conditions: Detrusor Overactivity Overactive Bladder
Keywords: Vesicare Solifenacin Detrusor Overactivity Urinary Nerve Growth Factor Overactive Bladder Bladder wall thickness
Sponsor: Astellas Pharma Inc
Start date: 2010-01-19; Completion date: 2011-06-23
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment.

Detailed description:
Participants satisfying all selection criteria at the end of the 2-week, single blind, placebo run-in period were randomized to receive 12-week double-blind treatment with solifenacin 5 mg or 10 mg once daily, or placebo.

Arms: arm 1: Participants received 2 placebo tablets once daily for 12 weeks. arm 2: Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks. arm 3: Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
Interventions: intervention 1: Placebo intervention 2: solifenacin
Intervention descriptions: intervention 1: Matching solifenacin placebo tablet intervention 2: Tablet for oral administration

Protocol documents:
Clinical trial NCT02061683
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2010-04-19; Completion date: 2011-06-24
Enrollment: 263 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.

Detailed description:

Arms: arm 1: Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Interventions: intervention 1: Bimatoprost 0.03%
Intervention descriptions: intervention 1: Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.

Protocol documents:
Clinical trial NCT01218204
Conditions: Dyslipidaemias Dyslipidemias
Keywords: Pharmacodynamics Lipids Dyslipidemia Safety GSK1292263 Ezetimibe Statin Pharmacokinetics Tolerability Atorvastatin
Sponsor: GlaxoSmithKline
Start date: 2010-09-14; Completion date: 2011-06-29
Enrollment: 287 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken alone or when co-dosed with atorvastatin to subjects with dyslipidemia.

Detailed description:
This compound has been studied in healthy subjects and subjects with type II diabetes and is now being studied in subjects with dyslipidemia. Because many patients with dyslipidemia are on statins, it is important to study how GSK1292263 behaves when taken with a potent statin, atorvastatin. The cholesterol lowering drug, ezetimibe, is included for comparison.

Arms: arm 1: Subjects on stable 40mg atorvastatin \> 4 weeks may raise their dose to 80mg for 2 weeks in order to qualify for Part A. arm 2: Dosing for 14 days arm 3: Washout for 4 weeks arm 4: Dosing for 4 weeks arm 5: Dosing for 4 weeks arm 6: Dosing for 14 days arm 7: Dosing for 14 days arm 8: Dosing for 14 days arm 9: Dosing for 14 days arm 10: Dosing for 14 days arm 11: Dosing for 14 days arm 12: Dosing for 14 days arm 13: Dosing for 14 days arm 14: Dosing for 14 days arm 15: Dosing for 14 days arm 16: Dosing for 14 days
Interventions: intervention 1: 10mg atorvastatin intervention 2: 80mg atorvastatin intervention 3: GSK1292263 Placebo intervention 4: 100mg GSK1292263 intervention 5: 300mg GSK1292263 intervention 6: 800mg GSK1292263 intervention 7: 10mg ezetimibe intervention 8: Washout
Intervention descriptions: intervention 1: 10mg intervention 2: 80mg intervention 3: Placebo intervention 4: 100mg intervention 5: 300mg intervention 6: 800mg intervention 7: 10mg intervention 8: No interventions - washout period

Protocol documents:
Clinical trial NCT01129024
Conditions: Immune Thrombocytopenia
Keywords: Splenectomy Low Platelet Count Thrombopoiesis Thrombocytopaenia Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenia (ITP) Thrombotic Thrombocytopenic Purpura (ITP) Hematologic Disease Auto-immune Thrombocytopenic Purpura S-888711 Blood Platelet Disorders Relapsed Persistent or Chronic ITP ITP
Sponsor: Shionogi
Start date: 2010-04-29; Completion date: 2011-06-30
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study was to assess the long-term safety of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy.

Detailed description:
This was an open-label, long-term safety study of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy. Patients who participate in this study must have completed the Phase 2 study 0913M0621 (NCT01054443), a double-blind, placebo controlled, parallel group study that evaluated the efficacy and safety lusutrombopag during which they either completed treatment or discontinued treatment due to a platelet count \> 400,000/μL.

Arms: arm 1: Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts. If a subject's platelet count remained \< 50,000/μL, the dose could have been increased by 0.25 mg up to a maximum dose of 2.0 mg.
Interventions: intervention 1: Lusutrombopag
Intervention descriptions: intervention 1: tablet

Protocol documents:
Clinical trial NCT00290745
Conditions: Breast Cancer
Keywords: breast cancer in situ ductal breast carcinoma in situ
Sponsor: University of California, San Francisco
Start date: 2002-02-19; Completion date: 2011-06-30
Enrollment: 79 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.

PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ.

Detailed description:
OBJECTIVES:

* Determine the clinical response in women with estrogen receptor-positive ductal carcinoma in situ (DCIS) treated with neoadjuvant hormonal therapy comprising tamoxifen or letrozole, by evaluating the maximal change in tumor diameter on mammography and MRI following treatment.
* Identify those cellular antigens which are altered by hormonal therapy.
* Determine which cellular antigens are predictive of clinical response to hormonal therapy.
* Evaluate whether genomic changes or gene expression in DCIS are altered by hormonal therapy and find candidate genes which are correlated with response to treatment.

OUTLINE: This is a pilot study.

Patients who are premenopausal receive oral tamoxifen once daily for 3 months in the absence of unacceptable toxicity. Patients who are post menopausal receive oral letrozole once daily for 3 months in the absence of unacceptable toxicity.

After 3 months of hormonal therapy, patients undergo lumpectomy or mastectomy.

After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Arms: arm 1: tamoxifen or letrozole work in treating women with ductal carcinoma in situ
Interventions: intervention 1: letrozole intervention 2: tamoxifen citrate intervention 3: conventional surgery intervention 4: neoadjuvant therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00794417
Conditions: Advanced Carcinoma Non-small Cell Lung Cancer
Keywords: advanced cancer lung cancer NSCLC Non-small Cell Lung Cancer aflibercept chemotherapy
Sponsor: Regeneron Pharmaceuticals
Start date: 2008-11-30; Completion date: 2011-06-30
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).

Detailed description:
The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.

Arms: arm 1: Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. arm 2: Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m\^2) and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. arm 3: Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. arm 4: Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m\^2 and then cisplatin 75 mg/m\^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles.
Interventions: intervention 1: Aflibercept intervention 2: Pemetrexed intervention 3: Cisplatin
Intervention descriptions: intervention 1: Administered in combination with the other two interventions via intravenous infusion. intervention 2: Administered in combination with the other two interventions via intravenous infusion. intervention 3: Administered in combination with the other two interventions via intravenous infusion.

Protocol documents:
Clinical trial NCT00095199
Conditions: Non Small Cell Lung Cancer
Keywords: Recurrent or Progressive Non-Small Cell Lung Cancer Second-line therapy Docetaxel Pemetrexed Cetuximab Failed platinum-based therapy NSCLC
Sponsor: Eli Lilly and Company
Start date: 2005-01-01; Completion date: 2011-07-01
Enrollment: 939 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab \& Pemetrexed or Pemetrexed alone; Cetuximab \& Docetaxel or Docetaxel alone).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Pemetrexed intervention 2: Cetuximab intervention 3: Docetaxel
Intervention descriptions: intervention 1: Pemetrexed 500 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles. intervention 2: Cetuximab 400/250 mg/m\^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. intervention 3: Docetaxel 75 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.

Protocol documents:
Clinical trial NCT00393939
Conditions: Breast Neoplasms
Keywords: advanced breast cancer sunitinib docetaxel Phase 3
Sponsor: Pfizer
Start date: 2007-02-01; Completion date: 2011-07-01
Enrollment: 594 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sunitinib malate intervention 2: Taxotere
Intervention descriptions: intervention 1: Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel) intervention 2: Docetaxel 100 mg/m2 every 3 weeks in the comparator arm

Protocol documents:
Clinical trial NCT00414609
Conditions: Myocardial Infarction
Keywords: myocardial infarction, aliskiren, heart failure Post acute myocardial infarction with systolic dysfunction
Sponsor: Novartis
Start date: 2006-12-01; Completion date: 2011-07-01
Enrollment: 820 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack).

Detailed description:

Arms: arm 1: Core Study: Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for next 34 weeks orally once daily in the morning.

Extension Study: Patients from both the core arms who completed core study and signed informed consent form were included in this arm of extension study.

Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study. arm 2: Core study: placebo for 36 weeks once daily in the morning
Interventions: intervention 1: Aliskiren intervention 2: placebo
Intervention descriptions: intervention 1: Aliskiren was available in 75 mg tablet, 150 mg tablet intervention 2: Placebo tablets matching aliskiren for 36 weeks once daily in the morning for core period only.

Protocol documents:
Clinical trial NCT00527943
Conditions: Atherosclerosis Myocardial Ischemia Myocardial Infarction
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-12-01; Completion date: 2011-07-01
Enrollment: 12944 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional benefit over the existing standard of care in preventing heart attack and stroke.

The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.

Detailed description:

Arms: arm 1: Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care. arm 2: Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
Interventions: intervention 1: Vorapaxar intervention 2: Placebo
Intervention descriptions: intervention 1: oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year intervention 2: oral tablets; matching placebo for vorapaxar; loading and maintenance dosing; once daily for at least 1 year

Protocol documents:
Clinical trial NCT00617669
Conditions: Prostate Cancer
Keywords: Hormone Resistant Prostate Cancer Endothelin A Receptor Antagonist Endothelin A Endothelin A antagonist
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2011-07-01
Enrollment: 1494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

Detailed description:

Arms: arm 1: placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks arm 2: ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Interventions: intervention 1: Docetaxel intervention 2: ZD4054 intervention 3: Placebo
Intervention descriptions: intervention 1: intravenous infusion given every three weeks intervention 2: 10 mg oral once daily dose intervention 3: placebo oral tablet once daily

Protocol documents:
Clinical trial NCT00767507
Conditions: Acute Coronary Syndrome (ACS)
Sponsor: The Medicines Company
Start date: 2008-10-01; Completion date: 2011-07-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.

Detailed description:

Arms: arm 1: Cangrelor was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days. arm 2: A placebo infusion was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days, to maintain the blind.
Interventions: intervention 1: cangrelor intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.

Protocol documents:
Clinical trial NCT00811018
Conditions: Pulmonary Arterial Hypertension
Keywords: Open-label study
Sponsor: Pfizer
Start date: 2003-03-01; Completion date: 2011-07-01
Enrollment: 1192 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Detailed description:
Open-label extension

Arms: arm 1: Sitaxsentan
Interventions: intervention 1: Sitaxsentan
Intervention descriptions: intervention 1: Sitaxsentan 100 mg tablets once daily

Protocol documents:
Clinical trial NCT00902304
Conditions: Hypertension
Keywords: Hypertension valsartan
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2011-07-01
Enrollment: 2337 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.

Detailed description:

Arms: arm 1: Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target arm 2: Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study. arm 3: Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
Interventions: intervention 1: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy intervention 2: Valsartan and amlodipine intervention 3: Usual care intervention 4: Valsartan intervention 5: Valsartan and hydrochlorothiazide (HCTZ) - combination arm
Intervention descriptions: intervention 1: Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally intervention 2: From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally intervention 3: As directed by investigator intervention 4: Valsartan 160mg per day to 320mg per day orally intervention 5: Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally

Protocol documents:
Clinical trial NCT00003590
Conditions: Adult Meningioma
Keywords: recurrent adult brain tumor adult grade I meningioma
Sponsor: SWOG Cancer Research Network
Start date: 1998-11-01; Completion date: 2011-07-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.

Detailed description:
OBJECTIVES:

* Determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea.
* Assess the quantitative and qualitative toxic effects of this drug in this patient population.

OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 months, 6 months, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.

Arms: arm 1: None
Interventions: intervention 1: hydroxyurea
Intervention descriptions: intervention 1: 20 mg/kg/day PO

Protocol documents: