ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00919867
Conditions: Healthy
Keywords: Normal, healthy volunteers (for this Phase 1 study)
Sponsor: Shire
Start date: 2009-06-24; Completion date: 2009-07-30
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: SPD503 intervention 2: VYVANSE intervention 3: SPD503 and VYVANSE
Intervention descriptions: intervention 1: SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. intervention 2: VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. intervention 3: SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

Protocol documents:
Clinical trial NCT00925704
Conditions: Healthy
Sponsor: Shire
Start date: 2009-06-01; Completion date: 2009-07-31
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Calcitriol intervention 2: Lanthanum carbonate + Calcitriol intervention 3: Sevelamer carbonate + Calcitriol
Intervention descriptions: intervention 1: Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. intervention 2: Lanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. intervention 3: Sevelamer carbonate (2400 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.

Protocol documents:
Clinical trial NCT01127256
Conditions: Epilepsy
Sponsor: Eisai Korea Inc.
Start date: 2006-05-31; Completion date: 2009-07-31
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

Detailed description:
To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25\~27 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: zonisamide intervention 2: carbamazepine
Intervention descriptions: intervention 1: Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day. intervention 2: Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.

Protocol documents:
Clinical trial NCT00124982
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2005-04-01; Completion date: 2009-08-01
Enrollment: 1286 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

Detailed description:

Arms: arm 1: In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. arm 2: In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. arm 3: Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
Interventions: intervention 1: Abatacept intervention 2: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD) intervention 3: Anti-Tumor Necrosing Factor (TNF) Therapy
Intervention descriptions: intervention 1: IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months. intervention 2: During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1). intervention 3: Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months

Protocol documents:
Clinical trial NCT00191646
Conditions: Genital Neoplasms, Female Fallopian Tube Neoplasms Ovarian Neoplasms Pelvic Neoplasms Peritoneal Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2002-10-01; Completion date: 2009-08-01
Enrollment: 919 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.

Detailed description:
This study (Study B9E-US-S302) is a multicenter, comparative, open-label randomized, superiority, trial evaluating Gemcitabine and Carboplatin to the standard of care. Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mg/m\^2 given every 28 days for one year. Patients not achieving a complete response will crossover to the opposite single agent.

Arms: arm 1: Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles arm 2: Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles
Interventions: intervention 1: Gemcitabine intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: 1000 mg/m\^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles

If anything other than complete response in Paclitaxel arm patients, 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity intervention 2: 175 mg/m\^2, IV, Day 1, q 21 days x 6 cycles

If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m\^2, IV, 3 hours q 28 days x 12 cycles (1 year)

If no complete response, then Gemcitabine arm patients may receive 175 mg/m\^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity intervention 3: Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles

Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles

Protocol documents:
Clinical trial NCT00249795
Conditions: Atrial Fibrillation Cardiovascular Disease
Keywords: Atrial fibrillation Cardiovascular disease angiotensin II blocker
Sponsor: Sanofi
Start date: 2003-06-01; Completion date: 2009-08-01
Enrollment: 9016 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.

Detailed description:
ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events.

Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel:

* ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone
* ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC).

Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.

Arms: arm 1: 150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit arm 2: Matching placebo up to final follow-up visit
Interventions: intervention 1: Irbesartan intervention 2: placebo
Intervention descriptions: intervention 1: oral administration (tablets) once daily intervention 2: oral administration (tablets) once daily

Protocol documents:
Clinical trial NCT00326716
Conditions: HIV Infection
Keywords: HIV-1 infected pregnant women, either treatment naive or on ATV/RTV combined with ZDV/3TC
Sponsor: Bristol-Myers Squibb
Start date: 2006-06-01; Completion date: 2009-08-01
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Atazanavir + Ritonavir + Combivir
Intervention descriptions: intervention 1: Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks

Protocol documents:
Clinical trial NCT00386425
Conditions: Severe Sepsis
Sponsor: Eli Lilly and Company
Start date: 2006-11-01; Completion date: 2009-08-01
Enrollment: 486 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.

Note: The protocol was amended to remove the option of shorter infusion durations.

Detailed description:

Arms: arm 1: 24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours arm 2: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol) arm 3: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)
Interventions: intervention 1: Drotrecogin alfa (activated)
Intervention descriptions: intervention 1: intravenous

Protocol documents:
Clinical trial NCT00419744
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2007-01-01; Completion date: 2009-08-01
Enrollment: 1200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.

Detailed description:

Interventions: intervention 1: Budesonide/formoterol (SYMBICORT) pMDI intervention 2: Formoterol Turbuhaler
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00594204
Conditions: Smoking Cessation
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2009-08-01
Enrollment: 593 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: varenicline tartrate (CP-526, 555-18) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg twice a day for 12 weeks, starting with a 1-week titration period. intervention 2: matching placebo 1 tablet twice a day for 12 weeks

Protocol documents:
Clinical trial NCT00678210
Conditions: Psoriasis
Keywords: dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2009-08-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo
Intervention descriptions: intervention 1: tablets, 2 mg BID for 12 weeks intervention 2: tablets, 5 mg BID for 12 weeks intervention 3: tablets, 15 mg BID for 12 weeks intervention 4: tablets, BID for 12 weeks

Protocol documents:
Clinical trial NCT00789854
Conditions: Major Depressive Disorder Treatment Resistant Depression
Keywords: Depression MDD TRD
Sponsor: AstraZeneca
Start date: 2008-11-01; Completion date: 2009-08-01
Enrollment: 688 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.

Detailed description:
The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.

Arms: arm 1: Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od).

From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline. arm 2: Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od).

From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline. arm 3: Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
Interventions: intervention 1: Quetiapine XR intervention 2: Lithium carbonate intervention 3: SSRI/Venlafaxine
Intervention descriptions: intervention 1: 300 mg once daily (od) intervention 2: 900 mg once daily (od) intervention 3: SSRI - doses within label, Venlafaxine dose up to 225 mg/day

Protocol documents:
Clinical trial NCT00068367
Conditions: Sarcoma
Keywords: adult neurofibrosarcoma stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage II adult soft tissue sarcoma stage IV adult soft tissue sarcoma
Sponsor: SWOG Cancer Research Network
Start date: 2003-12-01; Completion date: 2009-08-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor.

Detailed description:
OBJECTIVES:

* Determine response (confirmed, complete, and partial) in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.
* Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR) function (e.g., expression, phosphorylation, or markers of signal transduction downstream of EGFR) with response and progression-free and overall survival in patients treated with this drug.
* Determine the feasibility of accruing these patients in the cooperative group setting.

OUTLINE: This is a multicenter study.

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

Patients who achieve at least a confirmed partial response and become resectable undergo surgical resection (with or without radiotherapy) and then receive 2 additional courses of erlotinib. Patients with responding disease who do not become resectable continue erlotinib as above. Patients achieving a complete response (CR) receive 2 additional courses of erlotinib beyond the CR.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Arms: arm 1: Drug: erlotinib hydrochloride

Other Names:

OSI-774 150 mg per day, daily until disease progression
Interventions: intervention 1: erlotinib hydrochloride
Intervention descriptions: intervention 1: 150 mg per day, daily until disease progression

Protocol documents:
Clinical trial NCT00072176
Conditions: Endometrial Adenocarcinoma Endometrial Adenosquamous Cell Carcinoma Endometrial Clear Cell Carcinoma Endometrial Papillary Serous Carcinoma Recurrent Endometrial Carcinoma Stage IIIA Endometrial Carcinoma Stage IIIB Endometrial Carcinoma Stage IIIC Endometrial Carcinoma Stage IVA Endometrial Carcinoma Stage IVB Endometrial Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2004-05-01; Completion date: 2009-08-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well temsirolimus works in treating patients with endometrial cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and has come back after a period of time during which the cancer could not be detected. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the efficacy (response rate \& duration of stable disease) of CCI-779 (temsirolimus) given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium.

II. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium.

III. To correlate objective tumor response with phosphatase and tensin homolog gene (PTEN) expression in the tumor tissue obtained at diagnosis (primary tumor).

IV. To explore the relationship between objective tumor response with other molecular measures in diagnostic tumor tissue.

OUTLINE:

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.

Arms: arm 1: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: temsirolimus intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00076687
Conditions: Stroke Muscle Spasticity Motor Neuron Disease
Sponsor: Allergan
Start date: 2003-10-01; Completion date: 2009-08-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: botulinum toxin Type A intervention 2: botulinum toxin Type A intervention 3: saline
Intervention descriptions: intervention 1: botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18 intervention 2: botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18 intervention 3: Saline injection at Day 1, Week 12, Week 18

Protocol documents: