ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02356900
Conditions: Exercise Training
Keywords: interval training hyperbaric oxygen VO2 max altitude exercise performance mitochondrial oxidative capacity mitochondrial biogenesis
Sponsor: Duke University
Start date: 2015-02-01; Completion date: 2016-05-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric environment for exercise performance at altitude. Subjects will complete a short, high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after this training phase, all subjects will be tested for maximum aerobic capacity at a simulated high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of mitochondrial oxidative capacity in a skeletal muscle biopsy.

A group of individuals of similar characteristics completing this training program in a normoxic-normobaric environment will serve as a control.

Detailed description:

Arms: arm 1: Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber. arm 2: Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.
Interventions: intervention 1: Hyperoxic hyperbaric interval exercise training intervention 2: Normoxic, normobaric, interval exercise training intervention 3: Oxygen
Intervention descriptions: intervention 1: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber. intervention 2: Six 30-min high-intensity interval training sessions completed 3-times a week. intervention 3: Used in Hyperoxic hyperbaric interval exercise training intervention

Protocol documents:
Clinical trial NCT02374593
Conditions: Congenital Hypothyroidism
Sponsor: Erica Eugster
Start date: 2014-03-01; Completion date: 2016-05-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. The main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.

Detailed description:

Arms: arm 1: Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.
Interventions: intervention 1: Levothyroxine intervention 2: Ultrasound
Intervention descriptions: intervention 1: Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound. intervention 2: None

Protocol documents:
Clinical trial NCT02415439
Conditions: Healthy
Keywords: Safety tolerability pharmacokinetics adult volunteers
Sponsor: ReveraGen BioPharma, Inc.
Start date: 2015-01-01; Completion date: 2016-05-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the safety, tolerability, and PK of various increasing single and multiple doses of VBP15 in healthy adult subjects.

Detailed description:

Arms: arm 1: Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. arm 2: Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. arm 3: Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. arm 4: Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. arm 5: Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions. arm 6: Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high high calorie meal. arm 7: Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions. arm 8: Subjects were orally administered a placebo under fasted conditions. arm 9: Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions. arm 10: Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions. arm 11: Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions. arm 12: Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions. arm 13: Subjects were orally administered placebo for 14 days under fasted conditions.
Interventions: intervention 1: VBP15 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02433340
Conditions: Rheumatoid Arthritis
Keywords: Tolerability Methotrexate Safety
Sponsor: AbbVie
Start date: 2015-04-01; Completion date: 2016-05-01
Enrollment: 158 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week \[EOW\], 120 mg EOW, or 120 mg every week \[EW\]) or adalimumab 40 mg EOW given on background methotrexate.

Detailed description:

Arms: arm 1: All subjects receive open-label ABT-122 120 mg EOW subcutaneously, with the first dose administered at the last visit of Study M12-963 randomized controlled trial.
Interventions: intervention 1: ABT-122
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02444533
Conditions: Tonsillectomy Tonsillitis Post-operative Pain
Keywords: Liposomal Bupivacaine
Sponsor: Mayo Clinic
Start date: 2015-05-01; Completion date: 2016-05-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether liposomal bupivacaine (long acting injectable anesthetic) provides greater post operative pain relief compared to the standard post operative pain regiment for tonsillectomy patients.

Detailed description:
Subjects will be screened in the clinic when being evaluated for indications for tonsillectomy. Once the decision to proceed with tonsillectomy is made, the patient will be given the information on the study, provided time to review the information and interested patients will be consented.

There will be two stages in the study. The first will be the operative stage, which includes the injection during the operation. The second stage is the patient participation stage. During this stage, the patient records the amount of oral pain medication usage, oral intake after their procedure, in addition to their pain scores. These scores are recorded and brought back (or mailed in) to the clinic for collection during the follow up visit, approximately 1 month later (patients will keep records for two weeks). The patients will be freed from participation in the study after the one month visit.

Arms: arm 1: Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy arm 2: Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Interventions: intervention 1: Liposomal Bupivacaine
Intervention descriptions: intervention 1: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.

Protocol documents:
Clinical trial NCT02487771
Conditions: Pregnancy
Keywords: DHA childhood development
Sponsor: Susan Carlson, PhD
Start date: 2008-07-01; Completion date: 2016-05-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.

Detailed description:
Numerous trials show benefits of postnatal DHA supplementation for visual acuity. There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function. Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development. The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: DHA intervention 2: Placebo Capsule
Intervention descriptions: intervention 1: 600 mg DHA capsule intervention 2: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA

Protocol documents:
Clinical trial NCT02496039
Conditions: Pseudobulbar Affect (Involuntary Laughing and/or Crying)
Keywords: PBA involuntary crying involuntary laughing
Sponsor: Avanir Pharmaceuticals
Start date: 2015-09-01; Completion date: 2016-05-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.

Detailed description:
Eligible patients for this study must have a diagnosis of a neurological disorder affecting the brain of at least 3 months duration prior to baseline and which is not rapidly progressing and must have a diagnosis of Pseudobulbar affect (PBA).

This is a multicenter, open label study consisting of 6 months of treatment.

Approximately 125 patients will be enrolled at approximately 25 centers in the United States.

Arms: arm 1: NUEDEXTA capsules (20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate) administered orally, once a day from Days 1 to 7 and twice a day from Days 8 to 180
Interventions: intervention 1: NUEDEXTA®
Intervention descriptions: intervention 1: NUEDEXTA® only

Protocol documents:
Clinical trial NCT02512042
Conditions: Glaucoma
Sponsor: Actavis Inc.
Start date: 2015-04-01; Completion date: 2016-05-01
Enrollment: 973 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories, Inc. in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.

Detailed description:
Study will be conducted in adult subjects, above 18 years inclusive, males and non pregnant females, diagnosed with chronic open angle glaucoma or ocular hypertension in both eyes. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0/hour 0 i.e., 8:00 am) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.

Each study subject will use one drop of test or reference Ophthalmic Suspension in both the eyes three times daily at approximately 8:00am, 04:00 pm and 10:00 pm for 42 days (6 weeks). The dose and mode of treatment chosen in this study is the dosage approved by United States Food and Drug administration (US FDA) for use in treatment of patients of Chronic Open Angle Glaucoma.

The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject primary endpoint evaluation will be assessed after 2 weeks (14 days) and 6 weeks (42 days) of treatment for each study subject deemed eligible for evaluation, (i.e., at Visit III - Day 14 ± 2 days and Visit IV - Day 42 ± 3 days).

The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes at four time points, i.e., at approximately 8:00 am and 10:00 am at the Day 14 (± 2 days) and Day 42 (± 3 days) visits.

Arms: arm 1: Brinzolamide Pharmaceutical dosage form: Ophthalmic suspension Strength: 1% Manufactured by: Indoco Remedies, Ltd for Watson Pharma Pvt. Ltd arm 2: Azopt® (Contains Brinzolamide) Pharmaceutical dosage form: Ophthalmic suspension Strength: 1% Manufactured by: Alcon Laboratories, Inc
Interventions: intervention 1: Test-Brinzolamide 1% Ophthalmic suspension intervention 2: Reference-Brinzolamide 1% Ophthalmic suspension
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02571049
Conditions: Rapidly Escalating Migraine
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2015-09-01; Completion date: 2016-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous DFN-11 in subjects with rapidly escalating migraine headaches.

Detailed description:
Pilot study to compare the proportion of subjects experiencing pain freedom at 60 minutes post-treatment between headache treated with Strength A of DFN-11 and Strength B of DFN-11

Arms: arm 1: DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections arm 2: Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo
Interventions: intervention 1: DFN-11
Intervention descriptions: intervention 1: Sumatriptan 3 mg versus 6 mg

Protocol documents:
Clinical trial NCT02579772
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Queen's University
Start date: 2015-07-01; Completion date: 2016-05-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose of this study is to determine whether pharmacological treatment with N-acetylcysteine improves central and peripheral cardiorespiratory control and physical capacity in COPD patients with mild-to-moderate airflow obstruction.

Detailed description:
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Cardiovascular complications constitute the main causes of poor physical capacity and healthcare resources utilization in COPD. There is emerging evidence that these impairments have a major impact on the health of patients with mild-to-moderate disease, the largest sub-population of COPD. This important problem, however, is currently neglected as no specific pharmacological treatment is offered to these patients. Recent studies indicate that vascular abnormalities are mediated, at least in part, by circulating inflammatory substances and direct damage of the arteries by oxygen radicals (oxidative stress). The current investigation will test the hypothesis that N-acetylcysteine (NAC), via its anti-inflammatory and antioxidant properties, improves systemic vascular function and physical capacity in COPD patients with mild-to-moderate airflow obstruction.

Arms: arm 1: Pharmacological treatment with N-acetylcysteine (NAC) pills arm 2: Treatment with placebo pills
Interventions: intervention 1: N-acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: Pharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment. intervention 2: Placebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.

Protocol documents:
Clinical trial NCT02614469
Conditions: Healthy
Sponsor: Michael Alan Schwarzschild
Start date: 2015-03-01; Completion date: 2016-05-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effects of food on the amount of urate in the body after a single oral dose of inosine.

Detailed description:
Eighteen (18) eligible healthy male subjects will be randomly assigned to two groups with 9 subjects per group to receive a single oral dose of 1000 mg inosine with or without food on day 1 after an overnight fast. Subjects who receive inosine with food on day 1 will receive a second dose of inosine without food on day 8 after an overnight fast. Subjects who receive inosine without food on day 1 after an overnight fast will receive a second dose of inosine with food on day 8 after an overnight fast.

Subjects will be admitted to the clinic before dinner on days 0 and 7, the days before dosing, and will stay in the clinic for 48-h post-dose. During the clinic stay, blood samples will be taken for urate measurements.

Arms: arm 1: Group 1 subjects will take inosine with food on day 1 after an overnight fast and will take a second dose of inosine without food on day 8 after an overnight fast. arm 2: Group 2 subjects will take inosine without food on day 1 after an overnight fast and will take a second dose of inosine with food on day 8 after an overnight fast.
Interventions: intervention 1: Inosine
Intervention descriptions: intervention 1: Inosine, 1000 mg

Protocol documents:
Clinical trial NCT02695446
Conditions: Acne
Sponsor: BioPharmX, Inc.
Start date: 2016-03-01; Completion date: 2016-05-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the skin and plasma concentrations of minocycline in subjects undergoing treatment of acne vulgaris with oral extended release minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.

Detailed description:
This will be an open label, non randomized, interventional pilot study evaluating the plasma and skin levels of minocycline in 10 subjects with moderate to severe acne vulgaris. Subjects with non inflammatory acne of nodular acne will not be enrolled. Subjects will be on an oral extended release minocycline regimen of up to 2mg/kg once a day for 4 weeks.

Steady state levels of minocycline in plasma and skin will be determined.

Arms: arm 1: Oral extended release minocycline - up to 2mg/kg once a day for 30 days.
Interventions: intervention 1: Minocycline
Intervention descriptions: intervention 1: Oral extended release minocycline

Protocol documents:
Clinical trial NCT02737397
Conditions: Veisalgia
Sponsor: Sen-Jam Pharmaceutical
Start date: 2016-03-01; Completion date: 2016-05-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. It is the investigators hypothesis that a combination of two drugs can alleviate or significantly reduce these symptoms when taken before the start of moderate alcohol consumption.

Detailed description:
Some people who consume alcohol in moderation experience veisalgia. These symptoms include a long list of adverse effects that include headache, fatigue and thirst. The mechanism by which these effects occur has not been fully elucidated. Although, it has been documented that alcohol causes the release of a large number of substances into the blood stream that cause a number of physiologic changes.

A 4-arm study will help to determine the effect each agent contributes to decreasing the alcohol induces physiologic changes and the effect when the two agents are delivered concurrently.

Arms: arm 1: JMI-001 (SJP-304 and SJP-223) arm 2: SJP-304 and placebo arm 3: SJP-223 and placebo arm 4: placebo and placebo
Interventions: intervention 1: JMI-001 (SJP-304 and SJP-223) intervention 2: SJP-304 intervention 3: SJP-223 intervention 4: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02752087
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-04-01; Completion date: 2016-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.

Detailed description:

Arms: arm 1: LY900014 test dose administered via subcutaneous (SC) injection arm 2: LY900014 reference dose administered via SC injection
Interventions: intervention 1: LY900014
Intervention descriptions: intervention 1: Administered SC

Protocol documents:
Clinical trial NCT02779166
Conditions: Hip Labral Tears
Keywords: hip arthroscopy
Sponsor: Northwestern University
Start date: 2012-08-01; Completion date: 2016-05-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures. It has been shown to be successful in assisting in pain control for knee arthroscopy. It has not previously been studied in hip arthroscopy. This is a double blinded randomized controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip arthroscopy.

Detailed description:
This study examines the efficacy of perioperative dose of celecoxib in pain management after hip arthroscopy. Perioperative administration of celecoxib has been shown to improve pain control after knee arthroscopy, but this has not yet been studied in the hip. In this study, patients are randomized to receive either 400mg celecoxib or placebo 1 hour prior to undergoing hip arthroscopy surgery. Postoperatively, patients are monitored for pain on the VAS scale, narcotic use, and meeting discharge criteria. The study will enroll 100 patients. Patients are approached for informed consent on the day of surgery. Pain scores, narcotic use, and time to discharge in the celecoxib group are compared to the placebo group.

Arms: arm 1: Received 400mg celecoxib prior to surgery arm 2: Received placebo pill prior to surgery
Interventions: intervention 1: Celecoxib intervention 2: placebo
Intervention descriptions: intervention 1: Received 400mg celecoxib prior to surgery intervention 2: None

Protocol documents:
Clinical trial NCT03617289
Conditions: Renal Colic
Sponsor: Henry Ford Health System
Start date: 2016-01-01; Completion date: 2016-05-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.

Detailed description:

Arms: arm 1: Receiving Magnesium Sulfate arm 2: Receiving Dextrose 5% in Water (D5W)
Interventions: intervention 1: Magnesium Sulfate intervention 2: D5W
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: