ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01830205
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2012-09-01; Completion date: 2013-06-01
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.

Detailed description:
Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study

Arms: arm 1: Daclatasvir 60 mg tablet by mouth single dose on Day 1 arm 2: Daclatasvir 60 mg tablet by mouth single dose on Day 1 arm 3: Daclatasvir 60 mg tablet by mouth single dose on Day 1 arm 4: Daclatasvir 60 mg tablet by mouth single dose on Day 1
Interventions: intervention 1: Daclatasvir
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01833078
Conditions: Frailty in Aging
Sponsor: University of Pennsylvania
Start date: 2013-02-01; Completion date: 2013-06-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In this study, the investigators are trying to find out if repeated daily doses of ghrelin will help frail older people improve food intake for multiple days in a row.

Detailed description:
The study design is an open label, repeated dose administration study in which we will examine the safety and efficacy of repeated subcutaneous ghrelin administration in frail individuals. There will be a screening visit plus three additional study visits at the CTRC on Days 1, 2, and 7. Participants will receive an injection of ghrelin subcutaneously once daily on Days 1 and 7 and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home. A food record will be kept from Day -3 to Day 6. We will assess the efficacy of repeated ghrelin doses to sustainably increase caloric intake from pre-treatment baseline without hyperglycemia or raising of cortisol levels.

Arms: arm 1: All participants will receive an injection of ghrelin (7.5mcg/kg) dose subcutaneously once daily on Days 1, 2 and 7 in the research center and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home.
Interventions: intervention 1: ghrelin
Intervention descriptions: intervention 1: ghrelin administration subcutaneously for 7 days

Protocol documents:
Clinical trial NCT01835899
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-04-01; Completion date: 2013-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

Detailed description:

Arms: arm 1: placebo arm 2: powder for oral solution arm 3: powder for oral solution arm 4: powder for oral solution arm 5: powder for oral solution
Interventions: intervention 1: Placebo intervention 2: BI 1015550 intervention 3: BI 1015550 intervention 4: BI1015550 intervention 5: BI 1015550
Intervention descriptions: intervention 1: Placebo to BI 1015550 intervention 2: medium dose 1 powder for oral solution intervention 3: medium dose 2 powder for oral solution intervention 4: low dose 2 powder for oral solution intervention 5: low dose 1 powder for oral solution

Protocol documents:
Clinical trial NCT01847443
Conditions: Smoking Cessation
Keywords: nicotine nicotine replacement therapy nicotine gum
Sponsor: GlaxoSmithKline
Start date: 2013-05-01; Completion date: 2013-06-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.

Detailed description:

Arms: arm 1: A single dose of Nicotine Mint Gum (2 mg) to be chewed. arm 2: A single dose of Nicotine Mint Gum (4 mg) to be chewed. arm 3: A single dose of reference nicotine gum (2 mg) to be chewed. arm 4: A single dose of reference nicotine gum (4 mg) to be chewed.
Interventions: intervention 1: Nicotine (2 mg) intervention 2: Nicotine (4 mg)
Intervention descriptions: intervention 1: 2 mg nicotine gum in two formulations intervention 2: 4 mg nicotine gum in two formulations

Protocol documents:
Clinical trial NCT01857362
Conditions: Healthy
Keywords: Orfadin Nitisinone Bioequivalence
Sponsor: Swedish Orphan Biovitrum
Start date: 2013-05-01; Completion date: 2013-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.

Detailed description:
This is an open, randomized 2-way crossover study in 12 healthy volunteers. Subjects will receive single oral 20 mg doses of nitisinone administrated as one 20 mg capsule or as two 10 mg capsules of Orfadin. There will be a 3-week washout period between the doses.

There will be a screening visit within 3 weeks prior to the first dose. During each treatment period, subjects will be admitted to the clinic from the afternoon on the day before drug administration (i.e., on Day -1) and remain at the clinic until the 48-hour post-dose blood sample has been collected in the morning of Day 3. They will then return for ambulatory visit in the morning of Day 4 (72-hour sample). A follow-up visit will take place 7-14 days after the last dose.

Arms: arm 1: Two nitisinone 10 mg capsules by mouth as a single dose arm 2: One nitisinone 20 mg capsule by mouth as a single dose
Interventions: intervention 1: Nitisinone 20 mg intervention 2: Nitisinone 10 mg
Intervention descriptions: intervention 1: Nitisinone 20 mg capsules intervention 2: Nitisinone 10 mg capsules

Protocol documents:
Clinical trial NCT01872715
Conditions: Papulopustular Rosacea
Keywords: Papulopustular Rosacea Oracea anti inflammatory doxycycline
Sponsor: Galderma R&D
Start date: 2013-03-01; Completion date: 2013-06-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.

Detailed description:

Arms: arm 1: Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.

Oral dose for 12 weeks
Interventions: intervention 1: Oracea
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01883427
Conditions: Upper Respiratory Tract Infections
Keywords: Days with URTI symptoms
Sponsor: Krister Tano
Start date: 2012-10-01; Completion date: 2013-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.

Detailed description:
Children below 4 years of age and in public day care were invited to participate in this prospective study. The children started with a visit to an ENT doctor and after inclusion the children started to spray twice daily with glucose oxidase+glucose or only saline+glucose for 3 months. During this period the parents were asked to fill in a home protocol recording upper respiratory tract symptoms as: rhinitis, cough, fever, ear ache. After 6 weeks and 12 weeks the children had scheduled visits to the ENT department, where an ENT doctor examined the throat, nasal cavity and the ear drums for otitis media. After 12 weeks of treatment a nasopharyngeal swab was taken for bacterial culture.

Arms: arm 1: Subjects received nasal spray containing both saline+glucose twice daily for 3 months arm 2: Nasal spray in a bag-on-valve device with 50U/ml containing both glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.
Interventions: intervention 1: Placebo intervention 2: Glucose oxidase
Intervention descriptions: intervention 1: placebo containing saline+glucose intervention 2: a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.

Protocol documents:
Clinical trial NCT01886781
Conditions: Irritable Bowel Syndrome
Keywords: only constipation and diarrhea predominant no mixed or alternating types
Sponsor: University of Stellenbosch
Start date: 2011-01-01; Completion date: 2013-06-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.

Detailed description:
Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.

Arms: arm 1: Lactobacillus plantarum 299v capsules arm 2: Placebo capsule, filled with micro-crystalline cellulose powder arm 3: Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced. arm 4: Wash out period of two weeks, no treatment.
Interventions: intervention 1: Lactobacillus plantarum 299v intervention 2: Placebo comparator intervention 3: Run in period intervention 4: Wash - out period
Intervention descriptions: intervention 1: two capsules of 5 X 10 \^9 c.f.u each intervention 2: Micro-crystalline cellulose powder, identical taste, texture and appearance intervention 3: Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo intervention 4: Wash - out period following treatment phase of eight weeks

Protocol documents:
Clinical trial NCT01909713
Conditions: Acne Prone Skin
Keywords: acne, pediatric
Sponsor: Galderma R&D
Start date: 2013-05-01; Completion date: 2013-06-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.

Detailed description:
This was a open-label, single center study conducted in the United States that evaluated the tolerability of Cetaphil® DermaControl™ skin care products used at least once daily for 22 days in male and female subjects age 7 to 11 with acne prone skin. There were 4 visits during the course of the study: screening (within 7 days of visit 1), visit 1(baseline /day1), visit 2 (day 8), and visit 3 (day 22/exit). Tolerability assessments were performed by a board certified dermatologist at all visits. Subjects completed the baseline skin care regimen questionnaire at visit 1. Hydration assessments were competed at visits 1, 2, and 3. A subject satisfaction questionnaire was completed at visit 3. Adverse event assessments were conducted for all subjects at every clinic visit after informed consent/assent was signed.

Arms: arm 1: All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.
Interventions: intervention 1: Facial Cleanser and Moisturizer SPF 30
Intervention descriptions: intervention 1: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30

Protocol documents:
Clinical trial NCT01915108
Conditions: Respiratory Complication
Sponsor: Sangjin Park
Start date: 2012-07-01; Completion date: 2013-06-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to determine the optimal dose of remifentanil that can prevent the complications associated with the removal of LMA without delaying emergence.

Detailed description:
Patients were randomly assigned to one of four groups. All patients received a predetermined effect-site concentrations (Ce) of remifentanil by target-controlled infusion (TCI) according to their group assignments (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml) from 10 minutes before the end of surgery to LMA removal. Airway complications (airway obstruction, desaturation, breath holding, and coughing), nausea, and vomiting were assessed during the emergence phase.

Arms: arm 1: remifentanil Ce of 0 ng/ml arm 2: remifentanil Ce of 0.5 ng/ml arm 3: remifentanil Ce of 1.0 ng/ml arm 4: remifentanil Ce of 1.5 ng/ml
Interventions: intervention 1: Remifentanil
Intervention descriptions: intervention 1: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).

Protocol documents:
Clinical trial NCT01957930
Conditions: Ischemic Foot Ulcer
Keywords: HbA1c Iontophoresis Intensified insulin treatment Ischemic foot ulcer Type 1 diabetes
Sponsor: Karolinska Institutet
Start date: 1984-01-01; Completion date: 2013-06-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).

Detailed description:
The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomiz (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.

In the present study, 96 patients from the SDIS study were asked to participate in current study and to investigate their skin microcirculation, in which 72 patients agreed (ICT; n=35 vs. ST; n=37). Also, nineteen healthy subjects participated as controls for the method of iontophoresis, with no intention to be followed-up. Exclusions criteria were; any history or ongoing ischemic foot ulcer or peripheral artery disease or osteoartropathy. The iontophoresis investigation took place 5.5 years ± 2 months, after the primary randomization ceased (7.5 years). All participants (except the control subjects) were then followed-up until first time hospitalization for ischemic foot ulcer or until 31 december 2011.

Arms: arm 1: Basal (Monotard) insulin; ones a day Bolus (Actrapid) insulin; thrice a day arm 2: Mixed Insulin (2-3 times a day) arm 3: These people were solely controls for the iontophoresis method used in the study. With no intervention or follow-up-
Interventions: intervention 1: Intensified insulin treatment intervention 2: Standard treatment
Intervention descriptions: intervention 1: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact. intervention 2: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months

Protocol documents:
Clinical trial NCT01971203
Conditions: Major Depressive Disorder Generalized Anxiety Disorder
Keywords: seroquel XR quetiapine XR major depression generalized anxiety disorder CBT co-morbid MDD
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2009-09-01; Completion date: 2013-06-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether quetiapine extended-release in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo in treating depressive and anxiety symptoms in patients with both major depression and generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about 45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which medication will be discussed. Both clinician administered and self-report measures will be used to compare groups before and after 16 weeks.

Detailed description:
This study will evaluate the efficacy of quetiapine extended-release as adjunctive therapy to cognitive behavioral therapy (CBT) compared to CBT plus placebo in the treatment of patients with comorbid major depression and generalized anxiety disorder. We will also evaluate the quality of life in patients with comorbid MDD/GAD, the response and remission rates by treatment group, changes in sleep quality, and tolerability of adjunctive quetiapine to CBT.

Arms: arm 1: quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day 16 weeks of treatment including CBT arm 2: treatment group receiving placebo pill plus CBT
Interventions: intervention 1: seroquel xr intervention 2: CBT
Intervention descriptions: intervention 1: Quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day intervention 2: 16 weeks of treatment

Protocol documents:
Clinical trial NCT01988402
Conditions: Gout
Keywords: gout allopurinol
Sponsor: 59th Medical Wing
Start date: 2007-12-01; Completion date: 2013-06-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double blind placebo controlled study to determine whether starting allopurinol during a treated acute gout attack will have any effect on the duration of the attack.

Detailed description:
Traditional teaching holds that starting allopurinol during an acute gout attack will prolong the attack. Recent expert opinion from the American College of Rheumatology Guidelines is that allopurinol may be started during an acute, treated gout attack. This study is designed to test the hypothesis that allopurinol does not prolong an acute, treated gout attack. Patients will either take allopurinol capsules or and identical capsule containing no allopurinol (placebo) over 28 days, starting within 72 hours of a gout attack that is being treated with other standard measures. During the study, neither the patient nor the examiner will know what pills are being taken. The time to resolution of the attack is the primary outcome measure. Pain level, serum uric acid level, and complications of therapy will also be monitored. A minimum of 32 patients completing the study are needed for a meaningful conclusion.

Arms: arm 1: Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days arm 2: Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.
Interventions: intervention 1: allopurinol intervention 2: Placebo (sugar pill)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02097745
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2004-06-01; Completion date: 2013-06-01
Enrollment: 341 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methotrexate intervention 2: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: a 10-25 mg stable dose given orally or parenterally throughout study intervention 2: 1 g given by intravenous infusion on Days 1 and 15 of each treatment course

Protocol documents:
Clinical trial NCT02254252
Conditions: Slow Coronary Flow Normal, or Near Normal Coronary Angiography Stable Angina
Keywords: Slow coronary flow phenomenon Angina pectoris chest pain nicroandil
Sponsor: Mashhad University of Medical Sciences
Start date: 2012-03-01; Completion date: 2013-06-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed opacification of epicardial arteries in the absence of significant arterial narrowing and blockade. Endothelial dysfunction at the level of microarteries have been proposed as the main pathological mechanism in this regard. Available evidence suggest that standard anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is hypothesized that anti-angina medications which exert vasodilatory effects in large coronary arteries as well as small dividing branches might be superior to nitroglycerin in amelioration of angina symptoms. The present randomized clinical trial was thus designed and conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina medication with effects on both large and small coronary vessels) with nitroglycerin in a group of patients with slow coronary flow presented with frequent angina episodes.

Detailed description:

Arms: arm 1: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor) arm 2: nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)
Interventions: intervention 1: Nicorandil intervention 2: Nitroglycerin
Intervention descriptions: intervention 1: nicorandil (10mg tablets, two times a day) intervention 2: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)

Protocol documents:
Clinical trial NCT01081145
Conditions: Attention-deficit/Hyperactivity Disorder
Sponsor: Shire
Start date: 2010-05-11; Completion date: 2013-06-03
Enrollment: 528 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents (6-17 years) with attention-deficit/hyperactivity disorder (ADHD) who respond to an initial open-label, short term treatment with SPD503.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Extended-release Guanfacine Hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on age and weight. intervention 2: Matching placebo will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on age and weight.

Protocol documents: