ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00192647
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2004-08-01; Completion date: 2009-03-01
Enrollment: 896 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.

Detailed description:

Arms: arm 1: Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment. arm 2: Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
Interventions: intervention 1: PEG-IFN alfa-2a intervention 2: Ribavirin
Intervention descriptions: intervention 1: PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms. intervention 2: Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.

Protocol documents:
Clinical trial NCT00249873
Conditions: Atrial Fibrillation Vascular Risk
Keywords: Atrial fibrillation Anticoagulant therapy Thromboembolic prevention
Sponsor: Sanofi
Start date: 2003-06-01; Completion date: 2009-03-01
Enrollment: 7554 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.

Detailed description:

Arms: arm 1: Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion) arm 2: Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Interventions: intervention 1: clopidogrel (SR25990C) intervention 2: placebo
Intervention descriptions: intervention 1: oral administration (tablets) intervention 2: oral administration (tablets)

Protocol documents:
Clinical trial NCT00257192
Conditions: Schizophrenia
Keywords: Adolescent Subjects With Schizophrenia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-04-01; Completion date: 2009-03-01
Enrollment: 284 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia

Detailed description:
Termination Reason: On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: Ziprasidone oral capsules
Intervention descriptions: intervention 1: Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing \<45 kg, the doses will range from 20 mg BID to 40 mg BID. intervention 2: Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg BID to a maximum dose range of 80 mg BID. For subjects weighing \<45 kg, the doses will range from 20 mg BID to 40 mg BID.

Protocol documents:
Clinical trial NCT00388505
Conditions: Cystic Fibrosis
Keywords: tobramycin
Sponsor: Novartis Pharmaceuticals
Start date: 2006-02-01; Completion date: 2009-03-01
Enrollment: 517 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

Detailed description:

Arms: arm 1: Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles. arm 2: Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
Interventions: intervention 1: Tobramycin Inhalation Powder intervention 2: Tobramycin Solution for Inhalation
Intervention descriptions: intervention 1: Tobramycin Inhalation Powder (TIP) capsules for inhalation. intervention 2: Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer

Protocol documents:
Clinical trial NCT00413920
Conditions: Renal Transplantation
Keywords: Steroids avoidance, enteric-coated mycophenolate sodium (EC-MPS), de novo renal transplantation
Sponsor: Novartis
Start date: 2007-04-01; Completion date: 2009-03-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.

Detailed description:

Arms: arm 1: Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. arm 2: Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Interventions: intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Prednisone
Intervention descriptions: intervention 1: An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day. intervention 2: Oral tablets

Protocol documents:
Clinical trial NCT00537303
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2007-10-01; Completion date: 2009-03-01
Enrollment: 296 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Detailed description:

Arms: arm 1: Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively. arm 2: Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Interventions: intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin aspart
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin) intervention 2: Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin) intervention 3: Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)

Protocol documents:
Clinical trial NCT00650104
Conditions: Parkinson Disease
Keywords: ropinirole IR efficacy safety open-label long term safety; REQUIP ropinirole XL ropinirole CR Parkinson's disease
Sponsor: GlaxoSmithKline
Start date: 2002-05-01; Completion date: 2009-03-01
Enrollment: 76 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.

Detailed description:

Arms: arm 1: Open label medication - Ropinirole CR
Interventions: intervention 1: Ropinirole XL (formerly CR)
Intervention descriptions: intervention 1: Active Ropinirole CR tablets of 2.0mg, 4.0mg, 8.0mg where subjects can tritrate to an stable optimum dose level of either 2.0mg, 4.0mg, 6.0mg, 8.0mg, 12mg, 16mg, 20mg, or 24mg per day.

Protocol documents:
Clinical trial NCT00677807
Conditions: COPD
Keywords: COPD adults β2-agonist indacaterol
Sponsor: Novartis
Start date: 2008-05-01; Completion date: 2009-03-01
Enrollment: 415 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

Detailed description:

Arms: arm 1: Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 2: Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI).

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 3: Placebo once-daily (o.d.) via SDDPI.

The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol intervention 2: Placebo
Intervention descriptions: intervention 1: Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI) intervention 2: Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Protocol documents:
Clinical trial NCT00734071
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy
Sponsor: Takeda
Start date: 2008-06-01; Completion date: 2009-03-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.

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

The study enrolled 304 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 up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 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 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Vortioxetine placebo-matching capsules

Protocol documents:
Clinical trial NCT00789321
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-07-01; Completion date: 2009-03-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.

Detailed description:

Arms: arm 1: amlodipine arm 2: Placebo to amlodipine
Interventions: intervention 1: Comparator: amlodipine besylate intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Two 5 mg tablets amlodipine daily for 6 weeks. intervention 2: Two 5 mg tablets placebo to amlodipine daily for 6 weeks

Protocol documents:
Clinical trial NCT00945321
Conditions: Chemotherapy-Induced Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-02-01; Completion date: 2009-03-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.

Detailed description:

Arms: arm 1: aprepitant 165 mg arm 2: aprepitant 185 mg arm 3: fosaprepitant 150 mg arm 4: aprepitant with food
Interventions: intervention 1: aprepitant 165 mg intervention 2: Comparator: aprepitant 185 mg intervention 3: Comparator: fosaprepitant 150 mg intervention 4: Comparator: aprepitant with food
Intervention descriptions: intervention 1: Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3. intervention 2: Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3. intervention 3: Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3. intervention 4: Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.

Protocol documents:
Clinical trial NCT00023764
Conditions: Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2001-06-01; Completion date: 2009-03-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of bortezomib in treating patients who have low-grade lymphoproliferative disorders. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the frequency and duration of complete and partial response rates in patients with grade I, II, or III follicular lymphoma or mantle cell lymphoma treated with bortezomib.

SECONDARY OBJECTIVES:

I. Determine the response of minimal residual disease by polymerase chain reaction (PCR) detectable or clonotypic PCR minimal residual disease in bone marrow of patients treated with this regimen.

II. Determine the time to progression and overall survival of patients treated with this regimen.

III. Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients are stratified according to disease type (follicular lymphoma vs mantle cell lymphoma).

Patients receive an infusion of bortezomib over 3-5 seconds once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.

Patients are followed every 3 months for 1 year and then every 4 months for 2 years.

Arms: arm 1: Patients receive an infusion of bortezomib (dose of 1.8 mg/m2) over 3-5 seconds once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
Interventions: intervention 1: bortezomib
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00044655
Conditions: Schizophrenia
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2001-07-01; Completion date: 2009-03-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.

Detailed description:
Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.

Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.

Arms: arm 1: Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. arm 2: Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications.
Interventions: intervention 1: Risperidone intervention 2: Olanzapine intervention 3: Ziprasidone intervention 4: Quetiapine intervention 5: Aripiprazole
Intervention descriptions: intervention 1: As prescribed by routine prescriber (not dictated by study protocol) intervention 2: As prescribed by routine prescriber (not dictated by study protocol) intervention 3: As prescribed by routine prescriber (not dictated by study protocol) intervention 4: As prescribed by routine prescriber (not dictated by study protocol) intervention 5: As prescribed by routine prescriber (not dictated by study protocol)

Protocol documents:
Clinical trial NCT00051168
Conditions: Glaucoma, Open-angle Ocular Hypertension
Keywords: Glaucoma POAG OAG OHT
Sponsor: Alcon Research
Start date: 2006-01-01; Completion date: 2009-03-01
Enrollment: 502 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Travoprost (0.004%)
Interventions: intervention 1: Travatan
Intervention descriptions: intervention 1: Travoprost (0.004%) 1 drop each eye once daily

Protocol documents: