ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01340209
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2011-04-01; Completion date: 2013-04-01
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, and number of adverse events.

Detailed description:

Arms: arm 1: Tiotropium low dose once daily delivered with Respimat inhaler arm 2: Tiotropium high dose once daily delivered with Respimat inhaler arm 3: Tiotropium placebo once daily delivered with Respimat inhaler
Interventions: intervention 1: Tiotropium Respimat intervention 2: Placebo Respimat intervention 3: Tiotropium Respimat
Intervention descriptions: intervention 1: Tiotropium high dose once daily delivered with Respimat inhaler intervention 2: Tiotropium placebo once daily delivered with Respimat inhaler intervention 3: Tiotropium low dose once daily delivered with Respimat inhaler

Protocol documents:
Clinical trial NCT01341964
Conditions: Drug Action Increased
Keywords: Clopidogrel Aspirin Interaction
Sponsor: Population Health Research Institute
Start date: 2011-05-01; Completion date: 2013-04-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.

Detailed description:
Eligible patients will be randomized to receive clopidogrel 600mg + aspirin 325mg (Group A) or clopidogrel 600mg + aspirin 81mg (Group B). Patients will be fasted for at least 8 hours prior to study drug administration. Blood samples will be collected at 1 hour after study drug administration for measurement of clopidogrel active metabolite levels and genotyping.

Arms: arm 1: Clopidogrel 600 mg plus aspirin 325mg arm 2: Clopidogrel 600mg plus aspirin 81mg
Interventions: intervention 1: Clopidogrel intervention 2: Aspirin intervention 3: Aspirin
Intervention descriptions: intervention 1: 600mg (2 pills) intervention 2: 325mg (1 pill) intervention 3: 81mg (1 pill)

Protocol documents:
Clinical trial NCT01356940
Conditions: Multiple Sclerosis
Keywords: Ambulation
Sponsor: Brown, Theodore R., M.D., MPH
Start date: 2010-11-01; Completion date: 2013-04-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis

Detailed description:
This is a parallel-group, double-blind, randomized controlled crossover trial with a 1:1 randomization. There are two treatment periods of 4 weeks and a two-week off treatment washout period. Treatment periods are DER (dalfampridine ER) followed by placebo (group A) and placebo followed by DER (group B), respectively. All dosages will be administered twice a week. Purpose of the study is to see if using the study drug(dalfampridine Er) for a short period of time will improve the way subjects with multiple sclerosis (MS) walk.

Arms: arm 1: 4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control arm 2: placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid
Interventions: intervention 1: dalfampridine ER intervention 2: placebo
Intervention descriptions: intervention 1: dalfampridine ER 10mg bid for 4 weeks intervention 2: identical placebo tablet administered bid for four weeks

Protocol documents:
Clinical trial NCT01363349
Conditions: Schizophrenia Cognitive Effect on Schizophrenic Patients
Sponsor: BioLineRx, Ltd.
Start date: 2011-05-01; Completion date: 2013-04-01
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, active-controlled, 6 month study designed to evaluate the cognitive effects of treatment with CYP-1020 compared to risperidone. The primary efficacy endpoint will occur after 6 weeks of treatment; additional (secondary) efficacy endpoints will occur after 12 and 24 weeks of treatment.

Up to 450 patients will be randomized to CYP-1020 or risperidone in a 1:1 ratio. The study will utilize a flexible dose escalation scheme designed to allow patients to titrate to their maximally tolerated dose; doses of CYP-1020 may range from a minimum of 15 mg to a maximum of 35 mg, whereas doses of risperidone will range from a minimum of 1 mg to 3 mg BID (2-6 mg daily). To ensure effective blinding across all treatment groups, all patients will be treated twice daily with study drug and/or placebo, as indicated (i.e., double-dummy design).

Detailed description:

Arms: arm 1: Dose titration 15-35mg/day for 6 months arm 2: Dose titration 2-6mg/day for 6 months
Interventions: intervention 1: CYP-1020 intervention 2: Risperidone
Intervention descriptions: intervention 1: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity. intervention 2: None

Protocol documents:
Clinical trial NCT01365455
Conditions: Moderate to Severe Plaque-type Psoriasis
Keywords: Psoriasis plaque plaque-type psoriasis IL-17 blocker subcutaneous psoriatic arthritis injection AIN457 AIN457A secukinumab
Sponsor: Novartis Pharmaceuticals
Start date: 2011-06-01; Completion date: 2013-04-01
Enrollment: 738 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.

Detailed description:

Arms: arm 1: AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week arm 2: AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week arm 3: placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48. arm 4: Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48. arm 5: Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
Interventions: intervention 1: secukinumab 150 mg intervention 2: placebo to secukinumab 150 mg
Intervention descriptions: intervention 1: secukinumab (AIN457) 150mg or 300mg subcutaneous intervention 2: Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous

Protocol documents:
Clinical trial NCT01368081
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2011-05-01; Completion date: 2013-04-01
Enrollment: 1162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms: arm 1: BI 10773 low dose tablet once daily arm 2: BI 10773 high dose tablet once daily arm 3: Metformin tablets 500-2250 mg a day (twice or three times per day)
Interventions: intervention 1: Metformin intervention 2: BI 10773 intervention 3: Placebo (low dose) intervention 4: BI 10773 intervention 5: Placebo (high dose)
Intervention descriptions: intervention 1: Metformin tablets 500-2250 mg a day (twice or three times per day) intervention 2: BI 10773 low dose tablet once daily intervention 3: Placebo tablets once daily intervention 4: BI 10773 high dose tablet once daily intervention 5: Placebo tablets once daily

Protocol documents:
Clinical trial NCT01379664
Conditions: Duration of Hospitalization
Keywords: Sevoflurane Isoflurane volatile anesthetic duration of hospitalization
Sponsor: The Cleveland Clinic
Start date: 2011-07-01; Completion date: 2013-04-01
Enrollment: 1584 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble but more expensive anesthetic sevoflurane. Even a small reduction in the duration of hospitalization would easily compensate for the modest additional cost of sevoflurane. The investigators therefore propose to test the primary hypothesis that duration of hospitalization is longer with isoflurane than sevoflurane.

The investigators will also test the secondary hypotheses that: 1) pain scores are greater in patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid consumption is greater after isoflurane than sevoflurane anesthesia. All statistical analyses will be adjusted for age, gender, race, baseline risk, 9 and procedure.

Detailed description:

Arms: arm 1: Isoflurane is to be administered to patients in this arm during surgery arm 2: Sevoflurane is to be administered to patients in this arm during surgery
Interventions: intervention 1: Isoflurane intervention 2: Sevoflurane
Intervention descriptions: intervention 1: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist intervention 2: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist

Protocol documents:
Clinical trial NCT01404234
Conditions: Cystic Fibrosis Pseudomonas Aeruginosa
Keywords: Cystic fibrosis CF PA Pseudomonas aeruginosa AZLI aztreonam Chronic Pseudomonas aeruginosa
Sponsor: Gilead Sciences
Start date: 2011-12-01; Completion date: 2013-04-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.

Detailed description:

Arms: arm 1: Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment.
Interventions: intervention 1: AZLI
Intervention descriptions: intervention 1: AZLI 75 mg was administered 3 times daily via the investigational nebulizer.

Protocol documents:
Clinical trial NCT01412944
Conditions: Plaque-type Psoriasis
Keywords: Psoriasis plaque inflammatory skin disease scaly patches AIN457 secukinumab Moderate to severe
Sponsor: Novartis Pharmaceuticals
Start date: 2011-12-01; Completion date: 2013-04-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

Detailed description:

Arms: arm 1: During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457. arm 2: During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
Interventions: intervention 1: secukinumab 150mg intervention 2: secukinumab 10mg/kg i.v. regimen
Intervention descriptions: intervention 1: secukinumab 150mg (2 injections per dose) intervention 2: secukinumab 10mg/kg i.v. regimen

Protocol documents:
Clinical trial NCT01421147
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Type 1 Diabetes Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2011-08-01; Completion date: 2013-04-01
Enrollment: 536 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.

Detailed description:

Arms: arm 1: LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks. arm 2: Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
Interventions: intervention 1: LY2963016 intervention 2: Lantus intervention 3: Insulin Lispro
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously intervention 3: Administered subcutaneously

Protocol documents:
Clinical trial NCT01462773
Conditions: Melanoma
Keywords: malignant melanoma
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2006-01-01; Completion date: 2013-04-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety, tolerability and dose limiting toxicities (DLTs) of VELCADE when administered in combination with interferon-alpha-2b (IFN-α-2b) to patients with metastatic malignant melanoma.

Detailed description:
The primary objective of this study is to:

• Determine the safety, tolerability and DLTs of VELCADE when administered in combination with interferon-alpha-2b (IFN-α-2b) to patients with metastatic malignant melanoma.

The secondary objectives of this study are to:

* Document any objective anti-tumor responses that may occur in response to this treatment regimen.
* Document the time to tumor progression in patients receiving this treatment regimen.
* Measure levels of the cell cycle proteins p21 and p27 in PBMCs and tumor biopsies obtained pre-study and during week 4 of Cycle 1 (Day 26).
* Conduct histologic evaluations of microvessel density, tumor apoptosis and lymphocytic infiltrates within tumor biopsies obtained pre- and post-study.
* Measure plasma levels of bFGF and VEGF over the course of the study.
* Monitor the effects of proteasome inhibition on the biological activity of IFN-α within immune cells by measuring Jak-STAT signal transduction in patient PBMCs.

Arms: arm 1: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22 and recombinant interferon alfa-2b SC on days 1, 3, and 5 (days 1 and 3 only in week 4 course 1) of weeks 1-4. Treatment repeats every 5 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bortezomib intervention 2: Interferon Alfa-2b
Intervention descriptions: intervention 1: VELCADE (1.0 mg/m2, 1.3 mg/m2, or 1.6 mg/m2 IV based on patient cohort). After three patients have received 5 weeks of therapy (1 cycle) at the initial dose of VELCADE (1.0 mg/m2, Cohort 1) with no dose limiting toxicity, the dose will be raised to 1.3 mg/m2 for the next cohort of three patients. If this dose level is well-tolerated in three consecutive patients, the dose of VELCADE will be raised to 1.6 mg/m2. intervention 2: I = IFN-α-2b (INTRON A): 5 million units (MU)/m2 SC. INTRON A (5MU/m2) will be administered subcutaneously on Days 1, 3 and 5 of Week 0. During Cycle I, INTRON A will be administered on Days 1, 3 and 5 of Weeks 1-3 of and on Days 1 and 3 of Week 4 to allow for surgical biopsy on Day 5. During Cycles II-V, IFN-α will be administered on Days 1, 3 and 5 of Weeks 1-4. To assess the toxicity profile of IFN-α-2b alone, no VELCADE will be administered during Week 0.

Protocol documents:
Clinical trial NCT01469221
Conditions: Bladder Cancer
Keywords: Bladder Cancer Non-Muscle Invasive Bladder Cancer NMIBC Apaziquone EOquin GU Cancer TURBT
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2012-01-01; Completion date: 2013-04-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.

Detailed description:

Arms: arm 1: Apaziquone (4 mg in 40 mL) arm 2: Matching placebo (40 mL)
Interventions: intervention 1: Apaziquone intervention 2: Placebo
Intervention descriptions: intervention 1: 6 weekly multi-instillation of Apaziquone 4 mg in 40 mL intervention 2: 6 weekly multi-instillation of matching placebo in 40mL

Protocol documents:
Clinical trial NCT01487161
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-06-01; Completion date: 2013-04-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.

Detailed description:
Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR.

The general tolerability of a single injection of FX006 also was assessed.

Secondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006.

The study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.

Arms: arm 1: Single 3 mL intra-articular (IA) injection Extended-Release Formulation arm 2: Single 3 mL intra-articular (IA) injection Extended-Release Formulation arm 3: Single 3mL intra-articular (IA) injection Extended-Release Formulation arm 4: Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide
Interventions: intervention 1: FX006 intervention 2: TCA IR
Intervention descriptions: intervention 1: Single 3 mL intra-articular injection intervention 2: Single 1 mL intra-articular injection

Protocol documents:
Clinical trial NCT01496183
Conditions: Healthy
Sponsor: State University of New York at Buffalo
Start date: 2007-10-01; Completion date: 2013-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Olanzapine intervention 2: Placebo
Intervention descriptions: intervention 1: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days. intervention 2: Placebo capsule administered orally at bedtime for 14 days

Protocol documents:
Clinical trial NCT01497366
Conditions: Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3)
Sponsor: Gilead Sciences
Start date: 2011-12-01; Completion date: 2013-04-01
Enrollment: 527 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Detailed description:

Arms: arm 1: Participants were randomized to receive sofosbuvir+RBV for 12 weeks. arm 2: Participants were randomized to receive PEG+RBV for 24 weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: PEG intervention 3: RBV
Intervention descriptions: intervention 1: Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily intervention 2: Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection intervention 3: Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

* Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg
* Dose of PEG+RBV group: 800 mg

Protocol documents: