ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01541930
Conditions: Malodorous Infected Cutaneous Ulcer
Sponsor: Galderma R&D
Start date: 2012-04-01; Completion date: 2012-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days of treatment.

The clinical hypothesis is that the success rate is no worse than 70% in the population of interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of treatment, as assessed by the Study Investigator.

Detailed description:

Arms: arm 1: GK567: Metronidazole Gel 0.75% Once or twice daily, for 14 days, up to 30g
Interventions: intervention 1: GK567
Intervention descriptions: intervention 1: Once or twice daily, for 14 days, up to 30 g per day

Protocol documents:
Clinical trial NCT01545843
Conditions: Depression
Keywords: depression sleep treatment
Sponsor: University of Michigan
Start date: 2009-03-01; Completion date: 2012-12-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.

Detailed description:
Depression is common and associated with social and economic costs. Although antidepressant medications are an effective treatment for depression, it can take as long as 6-8 weeks before symptoms improve, and 20-35% of individuals who use antidepressants still experience depression symptoms.

New treatments that accelerate response to antidepressants are important to reduce the burden of depression. The objectives of the proposed study are (1) to evaluate the effects of partial sleep deprivation compared to no sleep deprivation for improving response to 8 weeks of fluoxetine 20-40 mg treatment and (2) to examine the underlying sleep mechanisms of treatment response.

Participants who are eligible for the study will be randomly assigned to one of three sleep schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in bed), late bedtime (6 hours time in bed, with 2 hour bedtime delay) or early risetime (6 hours time in bed, with 2 hour advancement of rise time). Participants will spend a total of 7 nights in our sleep laboratory and will be followed on fluoxetine for an 8-week period.

Arms: arm 1: Sleep scheduling plus fluoxetine. 8 hours time in bed for two weeks plus fluoxetine for 8 weeks arm 2: Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours. arm 3: Sleep scheduling plus fluoxetine. 6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Risetime advanced by 2 hours.
Interventions: intervention 1: Sleep scheduling intervention 2: Fluoxetine
Intervention descriptions: intervention 1: 8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime intervention 2: 20-40 mg fluoxetine daily for 8 weeks

Protocol documents:
Clinical trial NCT01559012
Conditions: Hyperemesis Gravidarum
Keywords: Hyperemesis Gravidarum treatment transdermal clonidine
Sponsor: A.O.U. Città della Salute e della Scienza
Start date: 2012-02-01; Completion date: 2012-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a crossover design.

Detailed description:
Setting. The trial is performed at a single hospital setting after admission of patients.

Ethics. The study has been approved by our local Ethics Committee and women are requested to sign an informed consent. No pharmaceutical company is involved in any phases of the trial including protocol design, study conduction, coordination and monitoring, data handling and analysis.

Randomization. The patients are allocated to a random list to receive first placebo and then TD clonidine or the other way round.

Blinding. Neither the patients nor their attending caregivers know the order of administration . The outcome assessors are blinded as well.

Treatment.The patients are randomly treated with and without TD clonidine for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, metoclopramide, ondansetron) and anti- reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis. All patients receive intravenous hydration and supplementation with thiamine.

Assessment. Physical condition of patients are assessed daily: blood pressure (lying and standing), body weight, morning ketonuria. Two different clinical self administered scores as PUQE (Pregnancy Unique Quantification of Emesis) and VAS (Visual Analogue Scale) are employed to check daily the intensity of symptoms and the sense of wellbeing. The consumption of antiemetic and anti-reflux drugs administered in the two periods is monitored .

Arms: arm 1: in this group patients are treated with transdermal clonidine first for 5 days then switch to placebo for 5 days arm 2: in this group patients are treated with placebo first for 5 days then with transdermal clonidine for next 5 days
Interventions: intervention 1: Clonidine
Intervention descriptions: intervention 1: transdermal clonidine patch 5 mg q. 5 days

Protocol documents:
Clinical trial NCT01573949
Conditions: Diabetes Heart Failure
Keywords: Heart Failure Diabetes Pre-diabetes Early type II diabetes Metformin Pharmacotherapy with metformin for prevention of DM in HF patients with pre-diabetes (pre-DM) and glycemic control in HF patients with early type II DM
Sponsor: University of California, Los Angeles
Start date: 2011-12-01; Completion date: 2012-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will assess the use of the medication metformin to improve quality of life, exercise capacity, and improved outcomes in heart failure patients with pre-DM or early DM (type II).

If the patient participates in this study, the patient will receive the drug metformin for approximately 3 months. During the study the patient will undergo comprehensive testing which includes blood draws and echocardiograms. The patient will also fill out a questionnaire. The patient must be 18 years old to participate.

Detailed description:

Arms: arm 1: Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month for a duration of 3 months.

Protocol documents:
Clinical trial NCT01583647
Conditions: Hypercholesterolemia, Familial Heterozygous Familial Hypercholesterolemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-06-01; Completion date: 2012-12-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial hypercholesterolemia.

Detailed description:

Arms: arm 1: Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg arm 2: Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
Interventions: intervention 1: MK-0524A intervention 2: MK-0524A
Intervention descriptions: intervention 1: 1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally intervention 2: 2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally

Protocol documents:
Clinical trial NCT01596842
Conditions: Hemodialysis Patients Vitamin D Insufficiency Vitamin D Deficiency
Keywords: Omega-3 fatty acid vitamin D ergocalciferol hemodialysis
Sponsor: Dong-A University
Start date: 2012-05-01; Completion date: 2012-12-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Omega-3 fatty acid ethylester 90 intervention 2: Olive oil intervention 3: cholecalciferol
Intervention descriptions: intervention 1: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks intervention 2: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks intervention 3: if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks

Protocol documents:
Clinical trial NCT01613248
Conditions: Migraine
Sponsor: Allergan
Start date: 2012-07-01; Completion date: 2012-12-01
Enrollment: 834 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effectiveness, safety and tolerability of a range of doses of MK-1602 versus placebo in the treatment of acute migraine.

Detailed description:

Arms: arm 1: MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. arm 2: MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. arm 3: MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. arm 4: MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. arm 5: MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary. arm 6: Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
Interventions: intervention 1: MK-1602 intervention 2: Placebo-matching MK-1602 intervention 3: Rescue medication
Intervention descriptions: intervention 1: Single 1, 10, 25, 50 or 100 mg dose of MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve the various MK-1602 dose levels to be studied. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache. intervention 2: Single administration of placebo-matching MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve placebo study medication. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache. intervention 3: If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours,

Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\]), anti-emetics, triptans or other medication not explicitly excluded.

Protocol documents:
Clinical trial NCT01622348
Conditions: Actively Extending Plaque Psoriasis Moderate to Severe Plaque Psoriasis
Keywords: Psoriasis Plaque Psoriasis
Sponsor: Idera Pharmaceuticals, Inc.
Start date: 2012-05-01; Completion date: 2012-12-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

Detailed description:
To evaluate the safety, tolerability and treatment effect of different dose levels of IMO-3100 compared to placebo administered for 4 weeks to patients with moderate to severe plaque psoriasis.

Arms: arm 1: Saline for Injection arm 2: IMO-3100 at 0.16 mg/kg SC once weekly based on body weight at screening, not to exceed 20 mg per injection arm 3: IMO-3100 at 0.32 mg/kg SC q wk x 4 wk based on body weight at screening, not to exceed 40 mg per injection
Interventions: intervention 1: IMO-3100 at 0.16 mg/kg intervention 2: Saline for Injection intervention 3: IMO-3100 at 0.32 mg/kg
Intervention descriptions: intervention 1: IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection intervention 2: Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL intervention 3: IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection

Protocol documents:
Clinical trial NCT01625169
Conditions: HIV
Keywords: Pharmacokinetics HIV Breast milk
Sponsor: University of Southern California
Start date: 2010-04-01; Completion date: 2012-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
HIV positive pregnant women who receive potent combination antiretroviral therapy over at least the last trimester of pregnancy, and who have proper obstetric interventions and are able to avoid breast feeding, decrease the risk of having an infected infant to about 1%. Breast milk HIV-1 RNA (cell free) viral load is significantly associated with breast milk transmission, and a 2-fold increased risk of transmission associated with every 10-fold increase in breast milk viral load has been reported. In addition, cell associated virus (HIV DNA) was associated with a significant increase in risk of transmission independent of the level of cell-free viral RNA.

However, multiple studies of HIV positive women giving birth have shown that exclusive breast-feeding carries a much lower risk of HIV transmission than mixed breast-feeding (defined as breast milk along with complementary food, other milk, and/or infant formula). The proposed study will measure the antiretroviral (ARV) drug etravirine concentrations in blood and breast milk in postpartum HIV positive women on HAART therapy. The short-term goal is to determine how much etravirine penetrates into breast milk, and whether it leads to undetectable HIV viral load in the breast milk and therefore has the potential to decrease the risk of transmission of HIV through breast milk. The long term goal is to see if breast milk HIV levels can be lowered sufficiently to prevent maternal to child transmission (MTCT) of HIV in infants receiving only breast feeding in resource poor areas.

Detailed description:

Arms: arm 1: Etravirine pharmacokinetics in breast milk and plasma. Etravirine 200mg PO BID for 14 days with PK on days 5 and 14
Interventions: intervention 1: Etravirine pharmacokinetics in breast milk and plasma
Intervention descriptions: intervention 1: HIV+ pregnant women will receive etravirine 200mg PO BID for 14 days postpartum. PK will be done on postpartum days 5 and 14.

Protocol documents:
Clinical trial NCT01639040
Conditions: Atopic Dermatitis
Sponsor: Regeneron Pharmaceuticals
Start date: 2012-07-01; Completion date: 2012-12-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).

Detailed description:

Arms: arm 1: Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days arm 2: Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days
Interventions: intervention 1: Dupilumab intervention 2: Placebo (for Dupilumab) intervention 3: Topical Corticosteroid (TCS)
Intervention descriptions: intervention 1: Dupilumab 300 mg once weekly (QW) for 4 weeks intervention 2: Placebo (for Dupilumab) once weekly (QW) for 4 weeks intervention 3: TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%

Protocol documents:
Clinical trial NCT01644240
Conditions: Gastrointestinal Motility Disorder
Sponsor: Theravance Biopharma
Start date: 2012-09-01; Completion date: 2012-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy elderly subjects 65 to 85 years old. A healthy elderly subject population is included to evaluate the safety, tolerability, and PK of TD-8954 IV. Pharmacodynamic effects on bowel movements will also be evaluated. Screening for all cohorts will be conducted within 21 days before the first dose.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: TD-8954 intervention 2: Placebo - saline
Intervention descriptions: intervention 1: Intravenous infusion intervention 2: Intravenous infusion

Protocol documents:
Clinical trial NCT01650324
Conditions: Diabetes Mellitus, Type 2
Keywords: DBPR108 DPP4 Diabetes GLP-1 Incretins
Sponsor: National Health Research Institutes, Taiwan
Start date: 2012-07-01; Completion date: 2012-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.

Detailed description:
This study represents the first administration of dipeptidyl peptidase 4 (DPP4) inhibitor DBPR108 to humans to evaluate the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties following single oral doses in healthy subjects.

DPP4 is a validated drug target for the treatment of human type 2 diabetes. Objectives of the study will be to characterize the safety and tolerability of single doses of DBPR108; to characterize the single dose PK of DBPR108 in plasma and urine; to characterize the single dose PD of DBPR108 on glucose, glucagon, dipeptidyl peptidase 4 activity, and total and active forms of glucagon-like peptide-1 (GLP-1) in plasma levels and insulin and C-peptide in serum levels.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: DBPR108 intervention 2: matching placebo
Intervention descriptions: intervention 1: DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg. intervention 2: Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.

Protocol documents:
Clinical trial NCT01659853
Conditions: Erythema Rosacea
Sponsor: Galderma R&D
Start date: 2012-09-01; Completion date: 2012-12-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Detailed description:
Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Arms: arm 1: In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence.

During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days).
Interventions: intervention 1: CD07805/47 gel 0.5%/CD07805/47 Vehicle intervention 2: azelaic acid gel 15%
Intervention descriptions: intervention 1: To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle.

During each treatment period (baseline to Day 15):

CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily intervention 2: During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Protocol documents:
Clinical trial NCT01673425
Conditions: Influenza
Keywords: Influenza Influenza Vaccines Vaccines, Attenuated Immunity, Mucosal
Sponsor: National Center for Occupational Health and Infection Control
Start date: 2012-09-01; Completion date: 2012-12-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus.

Detailed description:
This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV of healthy Veterans and VA employees between the ages of 20 and 49 years old.

Specific Aims

1. The primary aim of the study is to evaluate whether people with high mucosal IgA antibodies against flu have a lower immune response to the seasonal LAIV.
2. The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.

Arms: arm 1: Single intervention study- all participants will receive LAIV instead of injectable flu vaccine.
Interventions: intervention 1: Live Attenuated Influenza Vaccine
Intervention descriptions: intervention 1: All participants will be given FluMist.

Protocol documents: