ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00496834
Conditions: Hypertension
Sponsor: Organon and Co
Start date: 2008-02-01; Completion date: 2009-09-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate efficacy, arterial stiffness measured by Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension.

Detailed description:

Arms: arm 1: Losartan or Losartan/HCTZ arm 2: Carvedilol or Carvedilol/HCTZ
Interventions: intervention 1: losartan potassium intervention 2: Comparator: carvedilol intervention 3: Comparator: losartan (+) hydrochlorothiazide (HCTZ) intervention 4: Comparator: carvedilol (+) hydrochlorothiazide
Intervention descriptions: intervention 1: Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) intervention 2: Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) intervention 3: Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) intervention 4: Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)

Protocol documents:
Clinical trial NCT00746512
Conditions: Rheumatoid Arthritis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-01; Completion date: 2009-09-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.

Detailed description:

Arms: arm 1: Prednisone 15 mg tablets once daily for 15 days arm 2: Prednisone 15 mg placebo tablets once daily for 15 days arm 3: Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis. arm 4: Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
Interventions: intervention 1: Prednisone 15 mg intervention 2: Placebo Tablets intervention 3: Prednisone 7.5 mg intervention 4: Placebo Over-Encapsulated Tablets
Intervention descriptions: intervention 1: Prednisone 15 mg tablets once daily for 15 days. intervention 2: Prednisone placebo tablets once daily for 15 days. intervention 3: Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days intervention 4: Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days

Protocol documents:
Clinical trial NCT00787150
Conditions: Atrial Fibrillation
Sponsor: Pfizer
Start date: 2008-06-01; Completion date: 2009-09-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Apixaban intervention 2: Apixaban intervention 3: Warfarin sodium
Intervention descriptions: intervention 1: Apixaban 5 mg tablet BID for 12 weeks intervention 2: Apixaban 2.5 mg tablet BID for 12 weeks intervention 3: At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks

Protocol documents:
Clinical trial NCT00048581
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2002-12-01; Completion date: 2009-09-01
Enrollment: 738 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.

Detailed description:

Arms: arm 1: Short Term Portion of Study arm 2: Short Term Portion of Study arm 3: Long Term Portion of Study:

All participants receive Active Drug
Interventions: intervention 1: Abatacept intervention 2: Placebo intervention 3: Abatacept
Intervention descriptions: intervention 1: Vials, intravenous (IV), \~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months. intervention 2: Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months. intervention 3: Vials, IV, \~10mg/kg abatacept, every 4 weeks, 5.5 years

Protocol documents:
Clinical trial NCT00063622
Conditions: Liver Diseases
Keywords: Non alcoholic steatohepatitis Steatohepatitis
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2005-01-01; Completion date: 2009-09-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Detailed description:
The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

Arms: arm 1: Pioglitazone arm 2: Vitamin E arm 3: Placebo Pioglitazone or Placebo Vitamin E
Interventions: intervention 1: Pioglitazone intervention 2: Vitamin E intervention 3: Matching placebo
Intervention descriptions: intervention 1: 30 mg daily intervention 2: 800 IU daily intervention 3: Daily

Protocol documents:
Clinical trial NCT00127842
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis PsA Commercial product American College of Rheumatology ACR/PASI
Sponsor: Amgen
Start date: 2005-08-01; Completion date: 2009-09-01
Enrollment: 110 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.

Detailed description:

Arms: arm 1: Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: Administered according to the product monograph by subcutaneous (SC) injection

Protocol documents:
Clinical trial NCT00143403
Conditions: Colorectal Neoplasms Liver Neoplasms
Sponsor: Pfizer
Start date: 2001-12-01; Completion date: 2009-09-01
Enrollment: 321 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Irinotecan + 5 FU + folinic acid intervention 2: Folinic Acid + 5 FU
Intervention descriptions: intervention 1: irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks intervention 2: folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks

Protocol documents:
Clinical trial NCT00161473
Conditions: Alzheimer Disease Psychomotor Agitation
Keywords: double-blind treatment prazosin
Sponsor: University of Washington
Start date: 2001-01-01; Completion date: 2009-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other types of dementia in late life.

Detailed description:
Although the occurrence of disruptive agitation behaviors likely are influenced by environmental/ interpersonal factors, it is also likely that behaviorally relevant neurobiologic abnormalities lower the threshold for the expression of such behavior in Alzheimer's disease. Because of the success prazosin has had in the treatment of Posttraumatic Stress Disorder, it is thought that it could be used similarly with disruptive agitation. Originally designed to evaluate Alzheimer's disease patients in nursing homes, the study now includes outpatients. It is a 9-week placebo-controlled trial.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: prazosin intervention 2: placebo (inert substance)
Intervention descriptions: intervention 1: Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.

Duration was 8 weeks. intervention 2: Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.

Protocol documents:
Clinical trial NCT00183274
Conditions: Anxiety Disorders
Keywords: Generalized Anxiety Disorder Chronic Mediation Treatment Double-Blind Placebo Controlled Venlafaxine XR Relapse
Sponsor: University of Pennsylvania
Start date: 2004-01-01; Completion date: 2009-09-01
Enrollment: 268 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment.

Detailed description:
Generalized anxiety disorder (GAD) is a highly prevalent, chronic psychiatric disorder. Despite the fact that GAD frequently demands prolonged treatment with medication, very little is known about the benefits of long-term treatment. GAD is characterized by 6 months or more of exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. People with GAD are unable to relax and often suffer from insomnia. Venlafaxine XR, a drug used to treat depression, has been shown to be effective in the short-term treatment of GAD. However, its benefits over a course of more than 8 weeks have not been assessed. This study will evaluate the effectiveness of venlafaxine XR in treating GAD on a long-term basis and preventing the relapse of GAD after 6 months of treatment versus 12 months of treatment.

Participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine XR. Upon completion of this initial phase, participants will be randomly assigned to either continue on venlafaxine XR or begin taking placebo. After 12 months, participants taking venlafaxine XR will be randomly assigned to continue on the drug or switch to placebo. Participants will have 22 study visits over at least 18 months. Follow-up visits will occur 24 months after enrollment. Relapse of GAD will be assessed with the Hamilton Anxiety Scale and Global Severity and Improvement Scale. A variety of methods, including questionnaires and standardized scales, will be used to assess secondary outcomes.

Arms: arm 1: 6-month randomized phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d arm 2: 6-month randomized, double-blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 6 - 12 of the study arm 3: 6-month randomized, double blind phase of placebo occurring between months 6 - 12 of the study arm 4: 6-month randomized, double blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 13 - 19 of the study arm 5: 6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study arm 6: 6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study
Interventions: intervention 1: Venlafaxine XR intervention 2: Placebo
Intervention descriptions: intervention 1: Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d intervention 2: six month intervention with placebo drug

Protocol documents:
Clinical trial NCT00243191
Conditions: Dermatofibrosarcoma Protuberans
Keywords: newly diagnosed or recurrent
Sponsor: Sarcoma Alliance for Research through Collaboration
Start date: 2006-05-01; Completion date: 2009-09-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the effect of imatinib on dermatofibrosarcoma protuberan tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: imatinib mesylate
Intervention descriptions: intervention 1: 400 mg orally twice a day for 10 - 14 days

Protocol documents:
Clinical trial NCT00252239
Conditions: Stroke
Keywords: stroke tenecteplase TNK ischemic tissue plasminogen activator tPA
Sponsor: University of Virginia
Start date: 2005-11-01; Completion date: 2009-09-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available treatment with tissue plasminogen activator (tPA).

Detailed description:
Stroke is the third leading cause of death and a leading cause of adult disability in the United States and worldwide. To date, the only scientifically-proven and FDA-approved treatment for acute stroke is the clot-busting drug, tissue plasminogen activator (tPA). A newer clot-busting drug, tenecteplase (TNK), has chemical properties that make it a potentially safer and more effective drug for treating stroke. Preliminary testing of TNK in patients with acute stroke has been encouraging enough to warrant further testing.

This study, TNK-S2B, will compare three different doses of TNK with standard tPA treatment in patients with acute stroke. Patients will be chosen randomly to receive either TNK or tPA. Neither the patient nor his/her doctor will know which medication the patient received until the study is completely finished.

The first part of the study will look at results of treatment in the first 24 hours to select the best dose of TNK to carry forward into a more detailed comparison with standard tPA treatment. After at least 100-150 pairs of the best dose of TNK and tPA patients have been enrolled, entry into the study will pause, and the outcomes at 3 months after stroke will be compared to see if the results of TNK treatment are sufficiently promising as an improvement over standard treatment to justify expanding the study to find a definitive answer.

The study, which will be conducted in at least 8 large medical centers, is expected to last about 3 years.

Arms: arm 1: tenecteplase arm 2: tissue plasminogen activator, tPA
Interventions: intervention 1: tenecteplase intervention 2: tissue plasminogen activator, tPA
Intervention descriptions: intervention 1: This study will compare 3 different doses of tenecteplase to tPA. intervention 2: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.

Protocol documents:
Clinical trial NCT00263211
Conditions: Breast Neoplasms
Keywords: Breast Cancer Metastatic Platelet
Sponsor: Washington University School of Medicine
Start date: 2006-01-01; Completion date: 2009-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.

Detailed description:

Arms: arm 1: Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen. arm 2: Observation by treating physician
Interventions: intervention 1: Plavix intervention 2: Aspirin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00267670
Conditions: Nonalcoholic Steatohepatitis Liver Diseases
Keywords: Fatty Liver Disease Liver NASH Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease (NAFLD) Pentoxifylline
Sponsor: Northwestern University
Start date: 2005-03-01; Completion date: 2009-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.

Detailed description:
This is an investigational study looking at subjects who have been diagnosed with nonalcoholic steatohepatitis (NASH) or 'fatty liver disease'. There is currently no FDA approved available treatment for NASH. The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH. The effectiveness of this drug will be determined by taking blood samples and a liver biopsy. To determine if there is any effect of the medication, two-thirds of the patients participating in the study will receive pentoxifylline and one-third will receive placebo (sugar pill). Thus, an individual's chance of receiving the drug is 67%. In addition to receiving a study drug (placebo or pentoxifylline) the subjects will be encouraged to achieve modest weight loss (\~1-2 lbs/week) via low-fat diet and exercise.

The drug (Pentoxifylline) being studied is not approved for use in people who have NASH. Pentoxifylline is considered experimental in this study. Pentoxifylline has been safely used for the treatment of other medical conditions such as alcohol related liver disease and poor circulation. Pentoxifylline is a pill which is taken three times a day.

Arms: arm 1: 400mg PO TID arm 2: 1 pill PO TID
Interventions: intervention 1: Pentoxifylline intervention 2: Placebo
Intervention descriptions: intervention 1: 400mg PO TID intervention 2: 1 pill PO TID

Protocol documents:
Clinical trial NCT00292461
Conditions: Epilepsy
Keywords: Epilepsy seizures
Sponsor: Eisai Inc.
Start date: 2006-03-01; Completion date: 2009-09-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.

Detailed description:

Arms: arm 1: tablet arm 2: tablet
Interventions: intervention 1: Zonisamide intervention 2: Lamotrigine
Intervention descriptions: intervention 1: Tablet once or twice daily orally for 16 weeks intervention 2: Tablet once daily orally for 16 weeks

Protocol documents:
Clinical trial NCT00298766
Conditions: Amyloidosis
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2005-06-01; Completion date: 2009-09-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with VELCADE in patients with previously treated systemic AL-amyloidosis who require further treatment.

Detailed description:

Arms: arm 1: VELCADE
Interventions: intervention 1: VELCADE
Intervention descriptions: intervention 1: Once weekly at: 0.7, 1.0, 1.3 or 1.6 mg/m2

Or

Twice-weekly at: 0.7, 1.0, or 1.3 mg/m2

Protocol documents:
Clinical trial NCT00312923
Conditions: Dyslipidemia HIV Infections
Keywords: HIV lipids dyslipidemia policosanol treatment experienced
Sponsor: Rush University Medical Center
Start date: 2005-09-01; Completion date: 2009-09-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that policosanol will lower levels of LDL cholesterol ("bad" cholesterol) and raise levels of HDL cholesterol ("good" cholesterol).

Detailed description:
As per Brief Summary

Arms: arm 1: 20 mg daily of policosanol arm 2: 20 mg of microcrystalline cellulose daily
Interventions: intervention 1: Policosanol intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg of policosanol in capsular form daily intervention 2: Two capsules of 10 mg of microcrystalline cellulose daily

Protocol documents: