ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01784211
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2013-02-01; Completion date: 2013-11-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to measure how much of the study drug or insulin glargine gets into the blood stream and how long it takes the body to get rid of it. The effect of exercise will also be evaluated.

This study has two parts. In Part A, each participant will receive a daily injection of LY2605541 or insulin glargine for about 15 days. Some participants may continue into Part B. In Part B, participants will receive a daily injection of LY2605541 or insulin glargine with or without exercise. Part B lasts about 6 days.

Participants will remain on their regular physician-prescribed mealtime insulin throughout the study.

Detailed description:

Arms: arm 1: 0.5 units per kilogram (U/kg) LY2605541 subcutaneously (SC) once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14. Participants remained on their regular physician-prescribed mealtime insulin. arm 2: 0.5 U/kg insulin glargine SC once daily for 15 days. Part A involved 3 clamp procedures on Days 8, 11, and 14. Participants remained on their regular physician-prescribed mealtime insulin. arm 3: 0.5 U/kg LY2605541 SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 17 (no exercise on Day 20).Participants remained on their regular physician-prescribed mealtime insulin. arm 4: 0.5 U/kg LY2605541 SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 20 (no exercise on Day 17). Participants remained on their regular physician-prescribed mealtime insulin. arm 5: 0.5 U/kg insulin glargine SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 17 (no exercise on Day 20). Participants remained on their regular physician-prescribed mealtime insulin. arm 6: 0.5 U/kg insulin glargine SC once daily for an additional 6 days, beginning on Day 16. Exercise challenge on Day 20 (no exercise on Day 17).
Interventions: intervention 1: LY2605541 intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01794741
Conditions: Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2013-02-01; Completion date: 2013-11-01
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis

Detailed description:

Arms: arm 1: azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months arm 2: fluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Interventions: intervention 1: Dymista Nasal Spray intervention 2: Fluticasone propionate nasal spray
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01808547
Conditions: Ocular Inflammation
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2013-05-01; Completion date: 2013-11-01
Enrollment: 268 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ISV-303 intervention 2: DuraSite Vehicle
Intervention descriptions: intervention 1: 0.075% bromfenac in DuraSite dosed BID intervention 2: DuraSite vehicle dosed BID

Protocol documents:
Clinical trial NCT01831960
Conditions: Acne Vulgaris
Keywords: Cassiopea clascoterone cortexolone 17α-propionate anti-androgen CB-01-03
Sponsor: Intrepid Therapeutics, Inc.
Start date: 2013-04-01; Completion date: 2013-11-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve hours for two weeks, in subjects with acne vulgaris ages 12 years or older.

Detailed description:

Arms: arm 1: Topical cream, 1.0% concentration, applied every twelve hours
Interventions: intervention 1: cortexolone 17α-propionate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01836198
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-05-01; Completion date: 2013-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part A are divided into two cohorts (groups). Each cohort will participate in two study periods. Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and will also involve screening within 27 days of the start of the study. Part B is only open to participants who successfully completed Part A of the study. Participants in Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day 4. Part B will last for 29 days and will also involve screening within 27 days of the start of the study.

Detailed description:
Part B was added to the trial in August 2013, per protocol amendment.

Arms: arm 1: Part A, Period 1. Participants will receive a single 20-milligram (mg) oral dose of LY2409021 on Day 1. arm 2: Part A, Period 2. Participants will receive a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21. Participants will also receive a single 20-mg oral dose of LY2409021 on Day 4. arm 3: Part A, Period 1. Participants will receive a single 20-mg oral dose of LY2409021 on Day 1. arm 4: Part A, Period 2. Participants will receive a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4. arm 5: Part B. Participants will receive a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.
Interventions: intervention 1: LY2409021 intervention 2: Gemfibrozil intervention 3: Ketoconazole intervention 4: Clarithromycin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01840605
Conditions: Dermatitis Atopic
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2013-03-01; Completion date: 2013-11-01
Enrollment: 303 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.

Detailed description:
This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284.

Arms: arm 1: Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day, once after breakfast and once before bed. arm 2: Two TAU-284 5mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day, once after breakfast and once before bed.
Interventions: intervention 1: Bepotastine besilate intervention 2: ketotifen fumarate
Intervention descriptions: intervention 1: Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day intervention 2: Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day

Protocol documents:
Clinical trial NCT01843972
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-04-01; Completion date: 2013-11-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

Detailed description:

Arms: arm 1: single dose given as oral solution arm 2: single dose given as oral solution arm 3: single dose given as oral solution arm 4: single dose given as oral solution arm 5: single dose given as oral solution arm 6: single dose given as oral solution arm 7: single dose given as oral solution arm 8: placebo solution arm 9: single dose given as 1 tablet arm 10: single dose given as oral solution
Interventions: intervention 1: BI 691751 intervention 2: BI 691751 intervention 3: Placebo intervention 4: BI 691751 intervention 5: BI 691751 intervention 6: BI 691751 intervention 7: BI 691751 intervention 8: BI 691751 intervention 9: BI 691751 intervention 10: BI 691751
Intervention descriptions: intervention 1: oral solution BI 691751, dose 6 intervention 2: oral solution intervention 3: placebo solution intervention 4: oral solution BI 691751, dose 2 intervention 5: oral solution BI 691751, dose 5 intervention 6: 1 tablet intervention 7: oral solution BI 691751, dose 3 intervention 8: oral solution BI 69175, dose 4 intervention 9: oral solution BI 691751, dose 7 intervention 10: oral solution BI 69175, dose 1

Protocol documents:
Clinical trial NCT01844531
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-04-01; Completion date: 2013-11-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflozin/500 mg metformin \[Test 2\]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet \[Reference 1\] and low dose empagliflozin tablet + Glucophage® 500 mg tablet \[Reference 2\]) when administered together after a high fat, high caloric meal.

The assessment of safety and tolerability will be an additional objective of this trial.

Detailed description:

Arms: arm 1: fix dose combination tablet after intake of a high fat, high caloric meal arm 2: single tablets after intake of a high fat, high caloric meal arm 3: fix dose combination tablet after intake of a high fat, high caloric meal arm 4: single tablets after intake of a high fat, high caloric meal
Interventions: intervention 1: empagliflozin intervention 2: metformin (Glucophage®) intervention 3: metformin (Glucophage®) intervention 4: empagliflozin intervention 5: empagliflozin and metformin intervention 6: empagliflozin and metformin
Intervention descriptions: intervention 1: single tablet empagliflozin intervention 2: single tablet metformin intervention 3: single tablet metformin intervention 4: single tablet empagliflozin intervention 5: FDC tablet empagliflozin and metformin intervention 6: FDC tablet empagliflozin and metformin

Protocol documents:
Clinical trial NCT01866163
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2013-06-01; Completion date: 2013-11-01
Enrollment: 426 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.

Detailed description:

Arms: arm 1: LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) arm 2: Aerosol foam vehicle
Interventions: intervention 1: LEO 90100 intervention 2: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01873417
Conditions: Relapsing Forms of Multiple Sclerosis
Sponsor: Biogen
Start date: 2013-05-01; Completion date: 2013-11-01
Enrollment: 237 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (GI)-related events reported by participants with relapsing forms of multiple sclerosis (MS) initiating therapy with dimethyl fumarate (DMF) in the clinical practice setting.

The secondary objectives of this study are as follows:

* To evaluate GI-related events requiring symptomatic therapy and the role of those therapies over time in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.
* To evaluate GI-related events that lead to DMF discontinuation after the use of symptomatic therapy in participants with relapsing forms of MS initiating therapy with DMF in the clinical practice setting.

Detailed description:

Arms: arm 1: 120 mg DMF twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants will be instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
Interventions: intervention 1: BG00012 (DMF)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01875185
Conditions: Acute Coronary Syndrome Thrombosis
Keywords: acute coronary syndrome clotting hormones women
Sponsor: Johns Hopkins University
Start date: 2012-12-01; Completion date: 2013-11-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators are attempting to determine if the response to aspirin in women is related to the level of estrogen and progesterone that a woman has.

Detailed description:
Thrombosis plays a significant role in both acute coronary syndromes (ACS) and early saphenous vein graft (SVG) failure. Women with coronary heart disease have higher levels of the inflammatory mediator thromboxane, which is produced by platelets, monocytes, macrophages and the endothelium. Data show that higher levels of urinary thromboxane (UTXB2) are associated with SVG failure 6 months after Coronary Artery Bypass Graft (CABG). Women in the study cohort had higher levels of UTXB2 and higher odds of graft failure when compared to men. The elevated urinary thromboxane seen in the women in our study cohort may represent a marker and/or an etiology of thrombosis.

Are the levels of UTXB2 higher in women due to hormonal differences? In a prior pilot study we investigated whether hormonal levels are associated with changes in urinary thromboxane. We looked at hormonal and urinary thromboxane levels in 48 postmenopausal and 52 premenopausal women. We found that postmenopausal women had higher levels of UTXB2 than did premenopausal women (2495 vs. 2299, p=.02) and that in premenopausal women a higher estrogen/progesterone ratio was associated with the highest levels of urinary thromboxane.

The goal of the current study is to measure the response to seven days of aspirin administration as it relates to urinary thromboxane levels in pre and post-menopausal women. With this study we will be able to examine the change in UTXB2 comparing the premenopausal to post menopausal women. We will also be able to see if the change in UTXB2 in response to aspirin is affected by hormone levels in the premenopausal women. Lastly this study will provide reference data for more far-reaching studies exploring how global changes in hormonal balance (as seen in pregnancy or menopause) or in the level of inflammation (as seen in aging or with Coronary Artery Disease (CAD) risk factors), affect UTXB2 and platelet hyperreactivity.

Arms: arm 1: The patients are given aspirin 81 mg orally for 7 days.
Interventions: intervention 1: Aspirin 81 mg
Intervention descriptions: intervention 1: Aspirin 81 mg orally daily for 7 days

Protocol documents:
Clinical trial NCT01889667
Conditions: Diabetes Mellitus Type 2
Keywords: Oral Insulin Diabetes Mellitus Type 2 Safety Pharmacodynamics Pharmacokinetics
Sponsor: Oramed, Ltd.
Start date: 2013-06-01; Completion date: 2013-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and pharmacodynamics of an oral formulation of insulin in subjects with Type 2 Diabetes.

Detailed description:
This is a single-center, Phase II(a), randomized, double-blind, placebo-controlled, parallel group, inpatient study preceded by a 5-day single-blind outpatient placebo run-in period.

Arms: arm 1: Oral Insulin Formulation arm 2: Oral Insulin Formulation arm 3: Oil Capsules
Interventions: intervention 1: ORMD-0801 Dose # 1 intervention 2: ORMD-0801 Dose # 2 intervention 3: Placebo
Intervention descriptions: intervention 1: Oral Insulin Formulation intervention 2: Oral Insulin Formulation intervention 3: Oil Capsules

Protocol documents:
Clinical trial NCT01900054
Conditions: Perennial Allergic Rhinitis
Keywords: TAU-284 Bepotastine besilate Histamine H1 receptor antagonists children
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2013-06-01; Completion date: 2013-11-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Detailed description:
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.

Arms: arm 1: Two TAU-284 5mg tablets will be taken orally twice a day, once after breakfast and once after dinner (or before bed).
Interventions: intervention 1: Bepotastine besilate
Intervention descriptions: intervention 1: Two TAU-284 5mg tablets will be taken orally twice a day

Protocol documents:
Clinical trial NCT01903434
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-07-01; Completion date: 2013-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to measure and compare the amounts of the study drug evacetrapib found in the blood after taking two different formulations. The study has 3 periods. Participants will take each formulation by mouth at least once. A minimum of 14 days will pass between study drug doses. The safety and tolerability of the study drug will also be examined. Information about any side effects that may occur will also be collected. This study will last approximately 6 weeks.

Detailed description:

Arms: arm 1: Single oral dose of 130 milligram (mg) evacetrapib tablet on Day 1 of up to 2 of 3 periods arm 2: Single oral dose of 130 mg evacetrapib tablet on Day 1 of up to 2 of 3 periods
Interventions: intervention 1: Evacetrapib
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01924299
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-08-01; Completion date: 2013-11-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to look at the effect of ketoconazole and fluconazole on how much baricitinib gets into the blood stream. The study will also look at the tolerability of baricitinib and ketoconazole when given together and the tolerability of baricitinib and fluconazole when given together.

Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each treatment group will participate in 2 study periods. Participants will take baricitinib alone in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This study will last approximately 7 weeks.

Detailed description:

Arms: arm 1: Baricitinib - 10 milligrams (mg) administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.

Ketoconazole - 400 mg administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2. arm 2: Baricitinib - 10 mg administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.

Fluconazole - 400 mg administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
Interventions: intervention 1: Baricitinib intervention 2: Ketoconazole intervention 3: Fluconazole
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01925144
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-10-01; Completion date: 2013-11-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to find out how the body will react to a study drug called baricitinib when taken with another drug called omeprazole.

For each participant, this study will include 2 periods in fixed order. The study will last approximately 25 days, not including screening.

Detailed description:

Arms: arm 1: Baricitinib - 10 milligram (mg) tablet administered orally, once, on Day 1. arm 2: Baricitinib - 10 mg tablet administered orally, once, on Day 10. Omeprazole - 40 mg capsule administered orally once daily (QD) for 8 days (Days 3 through 10).
Interventions: intervention 1: Baricitinib intervention 2: Omeprazole
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01925781
Conditions: Nicotine Addiction Smoking Cessation
Keywords: Smoking Cessation Nicotine Addiction e-Cigarette electronic nicotine delivery device electronic cigarette nicotine replacement therapy
Sponsor: Creighton University
Start date: 2013-08-01; Completion date: 2013-11-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.

Detailed description:

Arms: arm 1: STAM 1100mAh CE4 eGo Clearomizer e-Cigarette arm 2: Nicotine Replacement gum
Interventions: intervention 1: Nicotine polacrilex intervention 2: STAM 1100mAh CE4 eGo Clearomizer
Intervention descriptions: intervention 1: 2 mg and 4 mg gum will be used according to the FDA approved product labelling intervention 2: None

Protocol documents:
Clinical trial NCT01934582
Conditions: Pulmonary Arterial Hypertension
Sponsor: United Therapeutics
Start date: 2013-08-01; Completion date: 2013-11-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A sub-study to the TDE-PH-304 protocol to assess the pharmacokinetics of patients transitioning from a twice daily dosing regimen of oral treprostinil to a three times daily dosing regimen.

Detailed description:
As noted above in "Brief Summary".

Arms: arm 1: None
Interventions: intervention 1: UT-15C SR intervention 2: treprostinil diethanolamine
Intervention descriptions: intervention 1: None intervention 2: Open label study drug.

Protocol documents: