ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01946542
Conditions: Heart Failure
Keywords: exercise heart failure fatigue physical endurance functional food
Sponsor: Jason Allen, Ph.D.
Start date: 2014-02-01; Completion date: 2014-09-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this project will be to determine whether consumption of beet juice concentrate prior to exercise may acutely improve exercise tolerance in patients with heart failure.

Detailed description:
Participants will complete up to four study visits. The first visit will involve completion of the informed consent process followed by a screening for study eligibility. The screening will consist of questionnaires pertaining to detailed medical history, diet, physical activity, and health-related quality of life (KCCQ). Anthropometric measures and a general health screening (including heart rate, resting blood pressure, and small blood (\<15 mL) and urine samples will be collected). Volunteers meeting eligibility requirements will be scheduled for a screening maximal cardiopulmonary exercise test. Immediately prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing. Qualified subjects will then undergo a maximal cardiopulmonary exercise (CPX) test.

Following successful completion of the screening CPX test, volunteers meeting eligibility requirements will be scheduled for two testing visits, at least one week apart. At one visit, participants will consume a small cup of beet juice concentrate, and at the other, they will consume placebo. Treatment will be double-blinded and administered in random order.

Arms: arm 1: placebo drink, single dose, taste and color-matched to experimental drink arm 2: single dose of beet juice concentrate, roughly 70 mL
Interventions: intervention 1: beet juice concentrate intervention 2: placebo
Intervention descriptions: intervention 1: single dose of beet juice concentrate, roughly 70 mL intervention 2: None

Protocol documents:
Clinical trial NCT01957215
Conditions: Ankle Sprain
Sponsor: GlaxoSmithKline
Start date: 2013-10-01; Completion date: 2014-09-01
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch

Detailed description:
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which reduces pain, fever, stiffness and swelling in acute skeletal musculature injuries involving joints. However, oral Indomethacin formulations predisposes for some systemic side effects. To avoid the systemic side effects of oral Indomethacin, a topical Indomethacin formulations have been developed and approved in some countries as an Over the counter product. Present study is to investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients.

Arms: arm 1: Indomethacin patch to be applied on the sprained ankle twice a day (BID). arm 2: Placebo patch to be applied on the sprained ankle BID.
Interventions: intervention 1: Indomethacin intervention 2: Placebo
Intervention descriptions: intervention 1: Topical indomethacin intervention 2: Placebo patch

Protocol documents:
Clinical trial NCT01982539
Conditions: Pain
Keywords: pain NSAID moderate pain mild pain acute pain mild acute pain moderate acute pain mild or moderate acute pain
Sponsor: Depomed
Start date: 2013-11-01; Completion date: 2014-09-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.

Detailed description:
Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

Arms: arm 1: 25mg/every 6hrs/up to 4 days treatment
Interventions: intervention 1: Zipsor®
Intervention descriptions: intervention 1: Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.

Protocol documents:
Clinical trial NCT01994486
Conditions: Hepatitis C, Chronic
Keywords: HCV Genotype 1 Hepatitis C Virus Genotype 1 HCV TVR
Sponsor: University of Florida
Start date: 2013-12-01; Completion date: 2014-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.

Detailed description:
Starting on Day 1 and for up to 12 weeks, you will receive Telaprevir (TVR) and Sofosbuvir (SOF).

You will take one (1) 400 mg tablet of SOF and 3 tablets (1125 mg each) of TVR. You should take these together by mouth every morning. You will take another 3 tablets (1125 mg each) of TVR by mouth 12 hours after you take your morning dose.

Arms: arm 1: All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.
Interventions: intervention 1: Telaprevir and Sofosbuvir
Intervention descriptions: intervention 1: All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10.

Protocol documents:
Clinical trial NCT01998438
Conditions: C.Surgical Procedure; Cardiac
Keywords: tranexamic acid cardiac surgery cardiopulmonary bypass
Sponsor: Hongwen Ji
Start date: 2012-09-01; Completion date: 2014-09-01
Enrollment: 955 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.

Detailed description:

Arms: arm 1: 10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery arm 2: 20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery arm 3: 30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
Interventions: intervention 1: Tranexamic Acid
Intervention descriptions: intervention 1: The loading doses were given in 15 minutes when incision.

Protocol documents:
Clinical trial NCT02001181
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis Atopic Eczema Eczema topical treatment skin diseases tofacitinib CP-690 550 Janus Kinase inhibitor
Sponsor: Pfizer
Start date: 2013-12-01; Completion date: 2014-09-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tofacitinib ointment 20mg/g intervention 2: Placebo ointment (Vehicle)
Intervention descriptions: intervention 1: Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks intervention 2: Placebo ointment (vehicle) twice daily (BID) for 4 weeks

Protocol documents:
Clinical trial NCT02016885
Conditions: Hyperhidrosis
Sponsor: Journey Medical Corporation
Start date: 2013-11-01; Completion date: 2014-09-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

Detailed description:
This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.

Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.

Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK samples will be taken from 20 to 30 subjects participating in the study.

Arms: arm 1: glycopyrrolate Topical Wipes, 1.0% arm 2: glycopyrrolate Topical Wipes, 2.0% arm 3: glycopyrrolate Topical Wipes, 3.0% arm 4: glycopyrrolate Topical Wipes, 4.0% arm 5: Vehicle Topical Wipes
Interventions: intervention 1: glycopyrrolate, 1.0% intervention 2: glycopyrrolate, 2.0% intervention 3: glycopyrrolate, 3.0% intervention 4: glycopyrrolate, 4.0% intervention 5: Vehicle
Intervention descriptions: intervention 1: glycopyrrolate Topical Wipes, 1.0% intervention 2: glycopyrrolate Topical Wipes, 2.0% intervention 3: glycopyrrolate Topical Wipes, 3.0% intervention 4: glycopyrrolate Topical Wipes, 4.0% intervention 5: Vehicle Topical Wipes

Protocol documents:
Clinical trial NCT02017379
Conditions: Upper Gastrointestinal Bleeding
Keywords: upper gastrointestinal bleeding melena hematemesis
Sponsor: Texas Tech University Health Sciences Center, El Paso
Start date: 2014-06-01; Completion date: 2014-09-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy.

Detailed description:
To compare the efficacy of pre-endoscopic interventions namely erythromycin, metoclopromide vs control in improving the outcomes of endoscopy in ICU patients admitted upper GI bleeding.

Specific aims:

1. Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa .
2. Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Arms: arm 1: Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure arm 2: Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy arm 3: no medications will be given prior to endoscopy
Interventions: intervention 1: Erythromycin intervention 2: Metoclopromide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02032407
Conditions: Acne Vulgaris
Sponsor: Allergan
Start date: 2013-12-01; Completion date: 2014-09-01
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.

Detailed description:

Arms: arm 1: Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Interventions: intervention 1: Dapsone Gel
Intervention descriptions: intervention 1: Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.

Protocol documents:
Clinical trial NCT02037893
Conditions: Acute Otitis Media
Sponsor: Currax Pharmaceuticals
Start date: 2013-11-01; Completion date: 2014-09-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.

Detailed description:
Reduction of pain symptoms will be measured by using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) and the Faces pain Scale Revised (FPS-R).

Arms: arm 1: antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping arm 2: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping arm 3: benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping arm 4: Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping
Interventions: intervention 1: Antipyrine and Benzocaine otic solution intervention 2: Antipyrine Otic Solution intervention 3: Benzocaine Otic Solution intervention 4: Placebo Otic solution
Intervention descriptions: intervention 1: antipyrine 54 mg and benzocaine 14 mg intervention 2: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL intervention 3: benzocaine 14 mg and glycerine dehydrated to 1.0 mL intervention 4: Placebo otic solution will be glycerin that is dehydrated

Protocol documents:
Clinical trial NCT02044848
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes mellitus
Sponsor: Novartis Pharmaceuticals
Start date: 2014-02-01; Completion date: 2014-09-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.

Detailed description:

Arms: arm 1: Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year arm 2: Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Interventions: intervention 1: Secukinumab intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo

Protocol documents:
Clinical trial NCT02054754
Conditions: Safety Tolerability Pharmacokinetics Cancer
Keywords: Dexanabinol Oral Safety Tolerability Pharmacokinetics
Sponsor: e-Therapeutics PLC
Start date: 2014-01-01; Completion date: 2014-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.

Detailed description:

Arms: arm 1: Single oral dose of dexanabinol arm 2: Single oral dose of dexanabinol arm 3: Single oral dose of dexanabinol arm 4: Single oral dose of dexanabinol arm 5: Single oral dose of dexanabinol arm 6: Single oral dose of matching placebo
Interventions: intervention 1: Dexanabinol Dose Level 1 intervention 2: Dexanabinol Dose Level 2 intervention 3: Dexanabinol Dose Level 3 intervention 4: Dexanabinol Dose Level 4 intervention 5: Dexanabinol Dose Level 5 intervention 6: Placebo
Intervention descriptions: intervention 1: Oral formulation of dexanabinol intervention 2: Oral formulation of dexanabinol intervention 3: Oral formulation of dexanabinol intervention 4: Oral formulation of dexanabinol intervention 5: Oral formulation of dexanabinol intervention 6: None

Protocol documents:
Clinical trial NCT02059642
Conditions: ADHD Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type
Sponsor: Alcobra Ltd.
Start date: 2014-03-01; Completion date: 2014-09-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD.

Detailed description:
This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg once daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD. The study comprises a Screening Visit at which initial assessment will be made and then a Washout Period during which prospective subjects must discontinue ADHD medication for 14 days (for psychotropic medications other than fluoxetine) or for 28 days (for fluoxetine) before randomization into the study. The Washout Period is 14 days, but may be extended to 28 days for a fluoxetine washout. Subjects requiring either a 14-day or a 28-day Washout Period will have an Interim Visit (off drug) on or about Day -8 (Day -10 to Day -3) for CAARS-Inv assessment after the Washout Period. The Baseline CAARS Inv assessment will be conducted on Day 0. If there is a ≥25% change in the CAARS-Inv results between the Interim Visit (off drug) assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. Following the Washout Period for those requiring a washout, or following the Screening Visit for those subjects who do not require a washout, eligible subjects will undergo baseline assessments and be randomized on Day 0 to MG01CI 1400 mg or to matching placebo and begin the Double-blind Treatment Period. The Double-blind Treatment Period will be 6 weeks in duration. There will be a 2-week Follow-up Period after the last dose of study treatment or early termination.

Arms: arm 1: Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily arm 2: MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily
Interventions: intervention 1: MG01CI (1400 mg) intervention 2: placebo
Intervention descriptions: intervention 1: MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily intervention 2: Placebo 1400 mg administered orally once daily

Protocol documents:
Clinical trial NCT02081001
Conditions: Hypoglycemia
Keywords: Hypoglycemia Glucagon Artificial Pancreas
Sponsor: Xeris Pharmaceuticals
Start date: 2014-03-01; Completion date: 2014-09-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.

Detailed description:

Arms: arm 1: G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg arm 2: Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Interventions: intervention 1: Novo Nordisk GlucaGen® intervention 2: G-Pump™ (glucagon infusion)
Intervention descriptions: intervention 1: single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg intervention 2: single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Protocol documents:
Clinical trial NCT02085135
Conditions: Major Depressive Disorder
Keywords: depression major depressive disorder Alkermes ALKS 5461 samidorphan buprenorphine
Sponsor: Alkermes, Inc.
Start date: 2014-02-01; Completion date: 2014-09-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ALKS 5461
Intervention descriptions: intervention 1: Sublingual tablet taken once daily

Protocol documents:
Clinical trial NCT02106195
Conditions: Psoriasis Vulgaris
Sponsor: Kadmon Corporation, LLC
Start date: 2014-04-01; Completion date: 2014-09-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to assess the safety and tolerability of 200 mg of belumosudil administered orally once daily for 28 days.

Detailed description:
This will be a Phase 2a, open-label, single-arm, safety and tolerability study of belumosudil given daily for treatment of psoriasis.

Eight subjects with moderately severe psoriasis who have failed at least 1 line of systemic therapy will be enrolled.

Treatment Period Eligible subjects who have failed at least 1 line of systemic therapy will be entered and treated for 4 weeks (28 days) with 200 mg of belumosudil given orally once daily (QD).

Subjects will undergo medical history evaluations, physical examinations, vital sign measurements, weight, adverse event assessments, concomitant medication assessments, and laboratory testing including but not limited to blood sample collection for hematology and chemistry, urinalysis, coagulation, lipid panel, electrocardiogram, pregnancy test for females of childbearing potential, testing with the Psoriasis Area and Severity Index (PASI) scale and Physician Global Assessment (PGA) scale, and pharmacokinetic sampling.

Follow-up Period:

Visit will occur 4 weeks after the last dose of study drug in the Treatment Period of the study. This visit must be done within ± 3 days of the scheduled visit. The same assessments will be performed as in the Treatment Period.

The duration of the study is 12 weeks: up to 4 weeks for screening, 4 weeks of treatment, and 4 weeks of follow-up.

Arms: arm 1: Belumosudil 200 mg (two 100 mg capsules) orally once daily for 28 days
Interventions: intervention 1: Belumosudil
Intervention descriptions: intervention 1: None

Protocol documents: