ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02504554
Conditions: Gastrointestinal Problems Autism Spectrum Disorders
Keywords: children
Sponsor: Arizona State University
Start date: 2014-07-01; Completion date: 2016-04-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders.

The combination therapy includes beneficial bacteria.

Detailed description:
This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders.

It involves a combination therapy including beneficial bacteria.

Arms: arm 1: This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. arm 2: This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
Interventions: intervention 1: oral Vancomycin intervention 2: MoviPrep intervention 3: Prilosec intervention 4: human fecal material; processed, frozen administered orally intervention 5: human fecal material; processed, frozen; administered orally and rectally
Intervention descriptions: intervention 1: an antibiotic intervention 2: a bowel cleanse intervention 3: a stomach acid suppressan intervention 4: human fecal material; processed, frozen, administered orally intervention 5: human fecal material; processed, frozen; administered orally and rectally

Protocol documents:
Clinical trial NCT02506257
Conditions: Acanthamoeba Keratitis
Sponsor: SIFI SpA
Start date: 2015-11-01; Completion date: 2016-04-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic solution compared to placebo in healthy subjects

Detailed description:
The primary objective of the study is to establish the ocular safety and tolerability, and systemic safety of 3 different concentrations of preservative-free PHMB in healthy subjects. Safety and tolerability will be compared to those of a placebo.The PHMB bioavailability in plasma will also be assessed

Arms: arm 1: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days arm 2: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days arm 3: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days arm 4: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
Interventions: intervention 1: 0.04% PHMB intervention 2: 0.06% PHMB intervention 3: 0.08% PHMB intervention 4: PHMB Vehicle
Intervention descriptions: intervention 1: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days intervention 2: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days intervention 3: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days intervention 4: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days

Protocol documents:
Clinical trial NCT02508259
Conditions: Autism Spectrum Disorders
Keywords: mitochondria purinergic signaling cell danger response
Sponsor: University of California, San Diego
Start date: 2015-05-01; Completion date: 2016-04-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to test the safety and efficacy of a single, intravenous dose of suramin in autism spectrum disorders (ASD).

Detailed description:
This study is designed to test a new theory of the origin and treatment of ASD. In this theory, ASD is caused by both genes and environment interacting to produce a persistent cell danger response (CDR; Naviaux RK, 2014) that interferes with and alters normal child brain development. Gut microbiome and immune systems are also affected. In this theory, the pathological persistence of the cell danger response is traceable to mitochondria, and maintained by purinergic signaling mediated by the release of extracellular nucleotides like adenosine triphosphate (ATP), adenosine diphosphate (ADP), uridine triphosphate (UTP), and uridine diphosphate (UDP). Suramin inhibits excess purinergic signaling by acting as a competitive inhibitor of nucleotide signaling at both ionotropic purinergic (P2X) receptors, and G-protein coupled, metabotropic purinergic (P2Y) receptors. Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism (Naviaux JC, et al. 2015; Naviaux JC, et al. 2014; Naviaux RK, et al. 2013). This study will test the safety and efficacy of a single dose of suramin in children with ASD. While it is not anticipated that a single dose will produce benefits for more than a few weeks, if successful, this study may lead to the development of newer and safer drugs for autism treatment.

Arms: arm 1: 20 mg/kg suramin in 50 ml of saline by intravenous infusion over 30 minutes arm 2: 50 ml of saline by intravenous infusion over 30 minutes
Interventions: intervention 1: Suramin intervention 2: Saline
Intervention descriptions: intervention 1: 20 mg/kg IV in 50 ml saline over 30 minutes intervention 2: 50 ml IV over 30 minutes

Protocol documents:
Clinical trial NCT02512302
Conditions: COPD
Keywords: COPD
Sponsor: Sunovion Respiratory Development Inc.
Start date: 2015-10-01; Completion date: 2016-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:
This is a randomized, open-label, single-dose per dosing period, five-way crossover study in subjects 40 to 70 years of age with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines. After a subject provides consent for study participation, there will be a Screening Period lasting up to 3 weeks to determine study eligibility and to allow for appropriate washout of prohibited medications.

Eligible subjects will be randomized to one of 10 treatment Sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned.

Subjects with a ≥ 20% decrease in forced expiratory volume in one second (FEV1) based on review of the Visit predose value compared with the Screening value will be evaluated by the investigator for continuation in the study.

Subjects taking theophylline will not be able to participate in the study.

Arms: arm 1: 50 mcg glycopyrrolate via Electronic Nebulizer arm 2: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal arm 3: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI arm 4: : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal arm 5: 50 mcg glycopyrrolate via IV infusion
Interventions: intervention 1: SUN-101 via eFlow nebulizer intervention 2: SUN-101 via eFlow nebulizer with activated charcoal intervention 3: Seebri® Breezhaler® intervention 4: Seebri® Breezhaler® with activated charcoal intervention 5: Glycopyrrolate Injection
Intervention descriptions: intervention 1: 50 mcg glycopyrrolate via Electronic Nebulizer intervention 2: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal intervention 3: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI intervention 4: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal intervention 5: 50 mcg glycopyrrolate via IV

Protocol documents:
Clinical trial NCT02530294
Conditions: Hyperhidrosis
Sponsor: Journey Medical Corporation
Start date: 2015-08-01; Completion date: 2016-04-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.

Detailed description:
This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis.

Safety will be assessed through lab tests, ECG, physical exams and vital signs.

Arms: arm 1: glycopyrronium Topical Wipes arm 2: glycopyrronium Topical Wipes, Vehicle
Interventions: intervention 1: glycopyrronium Topical Wipes intervention 2: Vehicle
Intervention descriptions: intervention 1: Topical wipes containing glycopyrronium intervention 2: Vehicle (placebo) topical wipes

Protocol documents:
Clinical trial NCT02539134
Conditions: Epilepsy
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-09-01; Completion date: 2016-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple rising doses of TAK-935 in healthy participants.

Detailed description:
The drug being tested in this study is called TAK-935. This study will look at the pharmacokinetics, safety and tolerability of TAK-935 in healthy participants. The study will enroll approximately 56 participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 5 cohorts in Part 1, which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

* Part 1, Cohort 1: TAK-935 100 mg QD
* Part 1, Cohort 2: TAK-935 300 mg QD
* Part 1, Cohort 3: TAK-935 300 mg BID
* Part 1, Cohort 4: TAK-935 600 mg QD
* Part 1, Cohort 5: TAK-935 400 mg QD Participants will be asked to take the oral solution once or twice a day at the same time for 14 days. An optional Part 2 may be conducted for collecting data to assess the engagement by TAK-935 of the central molecular target cholesterol 24S-hydroxylase (CH24H) by measuring the changes of levels of the metabolite 24S-hydroxycholesterol (24HC). In Part 2, participants will be assigned to up to 2 treatment groups at doses based on the data from other ongoing TAK-935 trials, combined with the safety and tolerability data from Cohorts 1-4 of Part 1.

This single center trial will be conducted in the United States. The overall time to participate in this study will be approximately 30 days. Participants will be admitted in the clinic for the first 14 days, and will be contacted by telephone on Day 28 for a follow-up assessment.

Arms: arm 1: TAK-935 100 milligram (mg), solution, orally, once daily (QD) or TAK-935 placebo-matching solution, orally, QD for up to 14 days. arm 2: TAK-935 300 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days. arm 3: TAK-935 300 mg, solution, orally, twice daily (BID) or TAK-935 placebo-matching solution, orally, BID for up to 10 days. arm 4: TAK-935 600 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 10 days. arm 5: TAK-935 400 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days. arm 6: TAK-935 first decided dose as determined from other TAK-935 trials and Cohorts 1 to 4 of Part 1, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days. arm 7: TAK-935 second decided dose as determined from other TAK-935 trials and Cohorts 1 to 4 of Part 1, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days.
Interventions: intervention 1: TAK-935 intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-935 oral solution intervention 2: TAK-935 placebo-matching oral solution

Protocol documents:
Clinical trial NCT02549365
Conditions: Influenza Vaccines Efficacy and Safety
Sponsor: Imperial College London
Start date: 2015-10-01; Completion date: 2016-04-01
Enrollment: 276 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The UK Departments of Health now recommend annual influenza vaccination for all children 2-7 years of age, with children over 7 years eligible for vaccination if in certain higher risk clinical categories. Though data are available documenting the safety and immunogenicity of LAIV in this age group, there are little data to assess efficacy and immune correlates in UK children, and in particular atopic children. This study will enrol 200 children (and at least 200 unvaccinated household sibling controls), many with a history of asthma or recurrent wheezing, and allow an assessment of efficacy, safety and immune correlates in these children, and how this varies with prior administration of pandemic influenza vaccine and/or LAIV.

Detailed description:

Arms: arm 1: Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. arm 2: Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.
Interventions: intervention 1: Live attenuated influenza vaccine intervention 2: Surveillance (nasal swabbing) during influenza season
Intervention descriptions: intervention 1: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season intervention 2: None

Protocol documents:
Clinical trial NCT02553629
Conditions: Surgical Conditions
Sponsor: Leiden University Medical Center
Start date: 2015-09-01; Completion date: 2016-04-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.

Detailed description:

Arms: arm 1: rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches arm 2: rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches
Interventions: intervention 1: Rocuronium
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02559622
Conditions: Psoriasis
Sponsor: Novartis Pharmaceuticals
Start date: 2014-04-01; Completion date: 2016-04-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on endothelial dysfunction and arterial stiffness after 12 weeks and for up to 52 weeks in subjects with chronic plaque-type psoriasis. Furthermore soluble biomarkers were assessed to evaluate the influence of secukinumab on cardiovascular risk. Magnetic resonance imaging (MRI) was performed in a sub-population to assess the treatment effect on arterial vessel wall morphometry in atherosclerosis prone vascular beds.

Detailed description:

Arms: arm 1: 300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection) arm 2: 150 mg secukinumab every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection) arm 3: Placebo until week 12 followed by 300 mg secukinumab every week for 4 weeks followed by 300 mg secukinumab every 4 weeks until week 48 (last injection) arm 4: Placebo until week 12 followed by 150 mg secukinumab every week for 4 weeks followed by 150 mg secukinumab every 4 weeks until week 48 (last injection)
Interventions: intervention 1: Secukinumab intervention 2: Placebo intervention 3: Placebo intervention 4: Secukinumab
Intervention descriptions: intervention 1: 300 mg secukinumab intervention 2: Placebo followed by 300 mg secukinumab intervention 3: Placebo followed by 150 mg secukinumab intervention 4: 150 mg secukinumab

Protocol documents:
Clinical trial NCT02598778
Conditions: Dental Caries
Keywords: Streptococcus Mutans Saliva
Sponsor: Montefiore Medical Center
Start date: 2015-11-01; Completion date: 2016-04-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compared four mouth rinses/chews for their ability to reduce Streptococcus Mutans after usage. The four that were compared were chlorhexidine gluconate (0.12%), sodium fluoride (0.05%), paraffin wax chewing gum (sugar free), and deionized water. The paraffin wax chewing gum replaced the originally planned coconut oil and served as a placebo comparator.

Detailed description:
The study was a randomized controlled clinical trial, unblinded. After obtaining consent and assent, respectively, and following review of medical history with regard to inclusion/exclusion criteria, if the participant met eligibility criteria, the participant was randomly assigned to one of four groups being studied: chlorhexidine gluconate (0.12%), sodium fluoride (0.05%), paraffin wax chewing gum (sugar-free) or deionized water with a randomization ratio of 1:1:1:1. A pre rinse/chew salivary sample was obtained by having the participant spit into a sterile test tube. The participant then either rinsed with 10mL of the assigned rinse for a timed 30 seconds and expectorated, or chewed paraffin wax chewing gum for 2 minutes. A post rinse/chew salivary sample was taken similarly to the pre rinse/chew sample. The samples were transported to a microbiology lab for incubation and quantitative analysis of Streptococcus Mutans. Morphological identification of the bacterial colonies was then confirmed using Matrix Assisted Laser Desorption/Ionization Time of Flight (MALDI-TOF) mass spectrometry.

Arms: arm 1: An oral rinse given to pediatric patients in routine practice within the standard of care. arm 2: An oral rinse given to pediatric patients in routine practice within the standard of care. arm 3: A food product. Minimum of 2 minutes of chew time prior to salivary sample being obtained. arm 4: Water that has had the majority of its ions removed.
Interventions: intervention 1: Chlorhexidine gluconate (0.12%) intervention 2: Sodium Fluoride (0.05%) intervention 3: Paraffin wax chewing gum (sugar-free) intervention 4: Deionized water
Intervention descriptions: intervention 1: 30 second oral rinse of 10mL of solution intervention 2: 30 second oral rinse of 10mL of solution intervention 3: Approximately two minutes of chew time intervention 4: 30 second oral rinse of 10mL of solution

Protocol documents:
Clinical trial NCT02604550
Conditions: Anterior Cruciate Ligament Reconstruction
Sponsor: Emory University
Start date: 2015-11-01; Completion date: 2016-04-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Detailed description:
This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery.

The objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.

Arms: arm 1: Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery. arm 2: Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Interventions: intervention 1: Ropivacaine 0.5% intervention 2: Percocet 7.5/325 intervention 3: Naprosyn 500 mg
Intervention descriptions: intervention 1: Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal. intervention 2: Percocet 7.5/325 will taken as needed up to every four hours. intervention 3: Naprosyn 500 mg will be taken twice daily.

Protocol documents:
Clinical trial NCT02622113
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2014-12-01; Completion date: 2016-04-01
Enrollment: 139 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)

Detailed description:
This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.

Arms: arm 1: None
Interventions: intervention 1: Canagliflozin (TA-7284) intervention 2: Insulin
Intervention descriptions: intervention 1: The patients will receive Canagliflozin orally for 36 weeks intervention 2: None

Protocol documents:
Clinical trial NCT02665728
Conditions: Constipation
Sponsor: Braintree Laboratories
Start date: 2015-12-01; Completion date: 2016-04-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety and efficacy of BLI400 laxative in constipated adolescent subjects.

Detailed description:

Arms: arm 1: BLI400 Laxative
Interventions: intervention 1: BLI400 Laxative
Intervention descriptions: intervention 1: None

Protocol documents: