ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01466673
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris Ethinyl estradiol Norgestimate Desogestrel Tricilest Oilezz
Sponsor: Janssen-Cilag Ltd.,Thailand
Start date: 2008-12-01; Completion date: 2010-03-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment of female participants with mild to moderate acne vulgaris (pimples).

Detailed description:
This is a single-blind (physician does not know the name of the assigned drug) and randomized (study drug assigned by chance) study to compare the effectiveness and safety of EE/NGM and EE/DSG in female participants using oral contraceptive and have mild to moderate acne vulgaris. Tablets of EE/NGM and EE/DSG will be administered orally once daily for 6 months and will be instructed to visit for evaluation at Month 1, 3 and 6 post-administration. The efficacy will be evaluated efficacy primarily through total acne lesions count, which will be recorded at these evaluation visits. Unused study medications will be collected and drug accountability will be documented. Participants' safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ethinyl estradiol/Norgestimate (EE/NGM) intervention 2: Ethinyl estradiol/Desogestrel (EE/DSG)
Intervention descriptions: intervention 1: Ethinyl estradiol/Norgestimate encapsulated oral tablet will be administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each. intervention 2: Ethinyl estradiol/Desogestrel oral formulation will be administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.

Protocol documents:
Clinical trial NCT01533116
Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-03-01; Completion date: 2010-03-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the effect of BIA 9-1067 in steady-state conditions on the levodopa pharmacokinetics

Detailed description:
Single centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of healthy subjects

Arms: arm 1: 5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 arm 2: Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28. arm 3: 15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28 arm 4: 30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: levodopa/carbidopa intervention 4: levodopa/benserazide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01742091
Conditions: Healthy
Keywords: Postmenopausal females Volunteers
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2010-03-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes the body to get rid of it, the overall effect of the study drug on the body, and whether antibodies to the study drug are formed.

Detailed description:

Arms: arm 1: 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. arm 2: 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. arm 3: 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. arm 4: 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. arm 5: 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. arm 6: Placebo administered IV or SC once every 2 weeks for 8 weeks.
Interventions: intervention 1: LY2541546 - SC intervention 2: LY2541546 - IV intervention 3: Placebo - SC intervention 4: Placebo - IV
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered IV intervention 3: Administered SC intervention 4: Administered IV

Protocol documents:
Clinical trial NCT01755702
Conditions: Headache, Tension-Type
Keywords: caffeine paracetamol tension headache
Sponsor: GlaxoSmithKline
Start date: 2009-07-01; Completion date: 2010-03-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.

Detailed description:

Arms: arm 1: Placebo arm 2: paracetamol marketed forumulation arm 3: ibuprofen marketed formulation arm 4: experimental paracetamol + caffeine formulation
Interventions: intervention 1: Placebo intervention 2: Experimental paracetamol + caffeine formulation intervention 3: ibuprofen marketed formulation intervention 4: Paracetamol marketed formulation
Intervention descriptions: intervention 1: Placebo intervention 2: experimental paracetamol + caffeine formulation intervention 3: ibuprofen marketed formulation intervention 4: Paracetamol marketed formulation

Protocol documents:
Clinical trial NCT01784614
Conditions: Sleep Initiation and Maintenance Disorders
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2010-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy Japanese participants. The study has four treatment periods. Participants will receive a single dose of LY2624803 or placebo in each treatment period.

Detailed description:

Arms: arm 1: Single dose of 0.1 mg LY2624803 administered orally in up to 2 of 4 treatment periods arm 2: Single dose of 1.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods arm 3: Single dose of 3.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods arm 4: Single dose of 6.0 mg LY2624803 administered orally in up to 2 of 4 treatment periods arm 5: Single dose of placebo administered orally in up to 1 of 4 treatment periods
Interventions: intervention 1: LY2624803 - Solution intervention 2: LY2624803 - Capsule intervention 3: Placebo - Solution intervention 4: Placebo - Capsule
Intervention descriptions: intervention 1: Administered orally as reconstituted solution intervention 2: Administered orally as a capsule intervention 3: Administered orally as solution intervention 4: Administered orally as a capsule

Protocol documents:
Clinical trial NCT02034565
Conditions: Healthy Volunteers
Sponsor: Bristol-Myers Squibb
Start date: 2010-02-01; Completion date: 2010-03-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.

Detailed description:

Arms: arm 1: Apixaban Film coated Tablet Single dose 10 mg orally arm 2: Apixaban Solution Single dose 10 mg orally
Interventions: intervention 1: Apixaban
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02469116
Conditions: Ovarian Cancer
Sponsor: Washington University School of Medicine
Start date: 2006-01-01; Completion date: 2010-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study the investigators will be using an AUC of 6 based on creatinine clearance using the Carboplatin dosing formula used for Gynecologic Oncology Group protocols.

Given that myelosuppression was significant using the docetaxel dose of 75 mg/m\*2 in the SCOTROC trial, the prophylactic use of pegylated G-CSF in this Phase II trial is warranted. The expectation would be that patients will be able to receive their cycles in a more timely fashion, with less delays, thereby allowing for improved outcomes and decreased hospitalizations due to myelosuppression.

Detailed description:

Arms: arm 1: * Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles
* Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles
Interventions: intervention 1: Docetaxel intervention 2: Carboplatin intervention 3: Pegylated G-CSF
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00179413
Conditions: Hepatitis C Virus Advanced Fibrosis Cirrhosis
Keywords: hepatitis C cirrhosis interferon colchicine
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2000-01-15; Completion date: 2010-03-03
Enrollment: 549 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study Peg-Intron will be tested to see if it will give better results than Colchicine. At this time, there is currently no recommended maintenance treatment for patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced fibrosis. The purpose of this study is to compare two treatments to slow down the progression of liver disease and to prevent liver failure and liver cancer. The treatment will not cure Hepatitis C, but is being evaluated to see if it can slow down disease progression.

Detailed description:
We are proposing a randomized trial of Peg-Intron 0.5mcg per kg weekly versus colchicine 0.6mg bid in prior non-responders to Interferon, Rebetron, PegIntron, or PegIntron \& Ribavirin or any third agent such as Pegasys, CellCept, Amantadine with advanced fibrosis/cirrhosis. The specific aims of this proposal are to evaluate the role of long term Peg-Intron therapy on the natural history of patients with advanced chronic HCV infection with a primary focus on prevention of hepatic decompensation, progression of fibrosis and hepatoma development.

The study design will focus on 3 monthly clinical evaluation for decompensation of liver function, rigorous clinical screening for development of hepatocellular cancer and liver biopsies for determination of progression of liver fibrosis every second year.

Arms: arm 1: PEG-Intron 0.5mcg/kg once a week SC arm 2: 0.6mg twice a day
Interventions: intervention 1: PEG -Intron intervention 2: Colchicine
Intervention descriptions: intervention 1: None intervention 2: 0.6mg twice a day

Protocol documents:
Clinical trial NCT00796107
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-01-28; Completion date: 2010-03-03
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.

Detailed description:

Arms: arm 1: Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
Interventions: intervention 1: RG1507 intervention 2: Letrozole
Intervention descriptions: intervention 1: R1507 was administered at a dose 16 mg/kg every 3 weeks. intervention 2: Letrozole was administered orally at a dose 2.5 mg daily.

Protocol documents:
Clinical trial NCT00708552
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease Cognition SB-742457
Sponsor: GlaxoSmithKline
Start date: 2008-07-04; Completion date: 2010-03-09
Enrollment: 576 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.

Detailed description:

Arms: arm 1: SB-742457 - 15mg arm 2: None arm 3: SB-742457 - 35mg arm 4: None
Interventions: intervention 1: SB-742457 intervention 2: Donepezil intervention 3: Placebo
Intervention descriptions: intervention 1: investigational drug intervention 2: comparator intervention 3: comparator

Protocol documents:
Clinical trial NCT00724971
Conditions: Lymphoma, B-Cell
Keywords: B-cell Non-Hodgkin's Lymphoma NHL
Sponsor: Pfizer
Start date: 2008-07-04; Completion date: 2010-03-10
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Inotuzumab Ozogamicin (CMC-544) intervention 2: Rituximab (Rituxan)
Intervention descriptions: intervention 1: 1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs. intervention 2: 375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.

Protocol documents:
Clinical trial NCT00750919
Conditions: Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-07; Completion date: 2010-03-10
Enrollment: 184 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).

Detailed description:

Arms: arm 1: Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months.
Interventions: intervention 1: esmirtazapine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00921024
Conditions: Complicated Urinary Tract Infection
Keywords: Complicated Urinary Tract Infection Pyelonephritis Antimicrobial Cephalosporin Intravenous
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2009-06-30; Completion date: 2010-03-11
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection

Detailed description:
This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days.

Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical signs and symptoms of infection. A Late Follow Up evaluation (21 to 28 days after the last dose of study drug) occurs for those subjects who respond to therapy. The primary assessment of effectiveness is the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy.

Arms: arm 1: CXA-101 arm 2: Ceftazidime
Interventions: intervention 1: CXA-101 intervention 2: Ceftazidime
Intervention descriptions: intervention 1: intravenous intervention 2: intravenous

Protocol documents:
Clinical trial NCT00702715
Conditions: Anesthesia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-24; Completion date: 2010-03-15
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.

Detailed description:
The results of previous trials showed that the safety profile of sugammadex

observed in subjects with impaired renal function are not appreciably different from subjects with normal renal function. Reoccurrence of neuromuscular blockade was not observed, and sugammadex was safe and generally well tolerated in subjects with severe renal impairment. In a previous trial, subjects (n=15) with severe renal impairment received a dose of 2.0 mg.kg-1 of sugammadex. The effects of the other proposed recommended dose for routine reversal, 4.0 mg.kg-1, on efficacy, safety and pharmacokinetics had not been studied thus far in subjects with severe renal impairment. The objectives of this trial were to assess equivalence with respect to the efficacy of sugammadex in subjects with normal renal function or severe renal impairment, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

Arms: arm 1: Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance \<30mL/min. arm 2: Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance \>=80mL/min.
Interventions: intervention 1: sugammadex
Intervention descriptions: intervention 1: Each subject will receive an

intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After

this dose, maintenance doses of 0.1 - 0.2 mg.kg-1

rocuronium may be given. In case of maintenance dosing, the target depth of

neuromuscular blockade has to be maintained at 1-2 post-tetanic counts (PTC). After the last dose of rocuronium has been administered, the subject will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC.

Protocol documents:
Clinical trial NCT00950807
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Dose ranging Chronic Bronchitis Long-acting muscarinic antagonist cross-over COPD Emphysema Chronic Obstructive Pulmonary Disease (COPD) anticholinergic
Sponsor: GlaxoSmithKline
Start date: 2009-09-01; Completion date: 2010-03-15
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.

Detailed description:
This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered once-daily and 3 doses of GSK573719 administered twice-daily over 14 days in subjects with COPD and will include tiotropium as an open-label active control. The pharmacokinetic profile of GSK573719 will also be evaluated.

Arms: arm 1: Placebo arm 2: Tiotropium arm 3: GSK573719 1000mcg once daily arm 4: GSK573719 500mcg once daily arm 5: GSK573719 250mcg once daily arm 6: GSK573719 125mcg once daily arm 7: GSK573719 62.5 mcg once daily arm 8: GSK573719 250mcg twice daily arm 9: GSK573719 125mcg twice daily arm 10: GSK573719 62.5mcg twice daily
Interventions: intervention 1: Tiotropium intervention 2: Placebo intervention 3: GSK573179
Intervention descriptions: intervention 1: long-acting muscarinic receptor antagonist; 18mcg once-daily intervention 2: Inactive/ excipients only intervention 3: GSK573179 investigational drug

Protocol documents:
Clinical trial NCT00826514
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: Chronic Prostatis
Sponsor: Pfizer
Start date: 2009-03-25; Completion date: 2010-03-17
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tanezumab intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous, 20 mg, single dose. intervention 2: Intravenous placebo, single dose

Protocol documents:
Clinical trial NCT01119846
Conditions: Diabetes Mellitus, Type 2
Keywords: Tolerability Pharmacokinetics Safety Pharmacodynamics Glucose
Sponsor: GlaxoSmithKline
Start date: 2009-06-05; Completion date: 2010-03-19
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to see if GSK1292263 is safe and well-tolerated when administered to type 2 diabetics, and to get preliminary information about whether it may be effective in the treatment of type 2 diabetes.

Detailed description:
Data from this study will be used to assess the potential of GSK1292263 as a treatment for T2DM, and will aid the design and dose selection of future studies of longer duration in T2DM subjects that will evaluate GSK1292263 alone or in combination with other anti-diabetic drugs.

Arms: arm 1: Part A (Cohort 1) is a single-blind, randomized, placebo-controlled, 5-period crossover in which drug naïve T2DM subjects will receive escalating doses of GSK1292263 in each of 3 periods and placebo and open-label sitagliptin in the other 2 periods. The sequence will be randomized, but will maintain the low, medium and high dose order for GSK1292263. arm 2: Part B (Cohort 2) is a single-blind, randomized, 2-period study in which T2DM subjects will receive a single dose of GSK1292263, fasted or fed. arm 3: Part C (Cohort 3, optional Cohort 4) is a single-blind, randomized, placebo-controlled, 5-arm study of 14 days of dosing with GSK1292263, placebo or open-label sitagliptin. An optional Cohort 4 may be enrolled to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1292263 when dosed in a BID regimen.
Interventions: intervention 1: GSK1292263 intervention 2: GSK1292263 matching placebo intervention 3: Sitagliptin
Intervention descriptions: intervention 1: GSK1292263 is an immediate-release round, white, film-coated tablet provided in 3 strengths, 25mg, 75mg and 200mg being developed for the treatment of type 2 diabetes. intervention 2: Matching placebo to active drug GSK1292263 intervention 3: Sitagliptin (Januvia) 100mg tablets are beige, round, film-coated tablets with "277" on one side.

Protocol documents: