bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Ezogabine (Retigabine) in ALS Subjects
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect of retigabine (600 mg/day, 900 mg/day, or placebo) on motor
      neuron activity in people with Amyotrophic Lateral Sclerosis (ALS). The total study duration
      is approximately 14 weeks. ALS subjects will take study drug for approximately 10 weeks.
    

Detailed description: 
      One of the major disease features of ALS is the progressive death of motor neurons. Human,
      rodent and stem cell-based model studies support the hypothesis that neuronal
      hyperexcitability may contribute to neurodegeneration in both sporadic and familial ALS. The
      investigators are doing this research study to find out whether retigabine will reduce motor
      neuron excitability in people with ALS. the investigators will also determine whether the
      drug is tolerable and safe for patients with ALS.

      The proposed study will determine how the potassium channel opener ezogabine (retigabine)
      affects neurophysiological measures of upper and lower motor neuron excitability in ALS
      patients as assessed by transcranial magnetic stimulation (TMS) and threshold tracking nerve
      conduction studies (TTNCS), respectively. The study will include the recruitment of
      approximately 60 unmatched healthy control subjects for analysis of variability of the
      neurophysiological tests prior to recruitment of ALS subjects. There will also be 12 matched
      healthy control subjects, recruited at the same time as ALS subjects.
    

Intervention name(s): Ezogabine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.; Matched placebo
Other intervention name(s): Potiga; Retigabine
Intervention MeSH terms: Ezogabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; ALS; Lou Gehrig
Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption
Condition: Ankle Injuries
MeSH terms: Ankle Fractures; Ankle Injuries
Study type: Observational

Summary: 
      Ankle fractures are common injuries that are being operated routinely. In order to restore
      the long term function and prevent arthritis of the ankle the broken fragments should be put
      in place precisely. Inadequate reduction can result in pain and long term disability.
      Recently, based on MRI studies and clinical studies, a significant number of ankle fractures
      are apparently fixed with less than optimal results. We suggest that the use of a new device
      that enables better three dimensional imaging will improve the quality of operations
      performed for ankle fractures.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with fracture in the ankle with Syndesmosis disruption
Examining the Longitudinal Relationship Between Sleep and Weight Gain in College Students
Condition: Healthy; Overweight
MeSH terms: Overweight; Weight Gain
Study type: Observational

Summary: 
      This two-year prospective, observational study examines the relationship between habitual
      short sleep and weight gain, as well as the association between habitual short sleep and
      behaviors that put people at risk of weight gain. Habitual short sleep is defined as sleeping
      <6 hours per night on average. Participants will be healthy freshmen college students who are
      normal weight or overweight. Exclusion criteria include pregnancy, an inability to be
      ambulatory, currently taking a medication that could influence or interfere with sleep, or
      reporting a past/current neurological problem, past/current head injury, past/current sleep
      disorder, current mood, anxiety, or substance use disorder, current psychosis, or current
      suicidal ideation/plans. Recruitment will be during new student orientations that occur prior
      to fall semester. Eligibility will be determined using a screening interview, the DSM-5
      Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult, and DSM-5 Self-Rated Level 2
      measures. Eligible participants will be assessed at baseline (time 1), and 8, 16, and 24
      months after Time 1. Sleep, physical activity, food/beverages, substance use, and technology
      use will be collected daily during each eight day recording period. Sleep will be measured
      with a sleep monitor, activity will be assessed using an accelerometer, food/beverages will
      be obtained using the National Cancer Institute's Automated Self-Administered 24-hour Dietary
      Assessment Tool, and substance use and technology use will be measured via self-report.
      Participants will attend a session after each recording period to have weight and height
      measured, be scanned via Dual-energy x-ray absorptiometry (DXA), and complete a packet of
      questionnaires about demographics, health, sleep quality and beliefs, life events, food
      cravings, and physical development. It is hypothesized that participants will have different
      habitual sleep trajectories over time. It is also hypothesized that two particular sleep
      trajectories (stable habitual short sleep and increasingly shorter habitual sleep across
      time) will be significantly related to weight gain, increased body fat percent, and weight
      gain risk behaviors (i.e., increased caloric intake and decreased physical activity).
      Finally, it is hypothesized that the two sleep trajectories will be significantly associated
      with higher rates of media and technology use and higher rates of problematic sleep-related
      beliefs/behaviors.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        College freshmen
      
Keywords: sleep; obesity; body fat composition; young adults; diet; activity; Dual X-ray Absorptiometry
The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia
Condition: Infection by Trichuris Trichiura
MeSH terms: Infections; Communicable Diseases; Trichuriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris
      trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the
      most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH
      and more than one billion individuals are thought to be infected, of which 450 million have
      significant morbidity attributable from their infection, school-aged children in particular.
      In this population infections cause stunting of the linear growth, anemia, reduce the
      cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are
      highly prevalent, affecting more than 60% of the children (data not published).

      Current efforts to control STH infections involve periodic mass drug anthelmintic treatment
      of infected children in endemic areas and are likely to intensify as more attention is
      addressed to the importance of these neglected diseases. Monitoring drug efficacy in these
      control programs has become indispensable in order to detect the emergence of resistance
      and/or identify confounding factors affecting the drug efficacy. Recently a study has
      evaluated a single dose albendazole (ALB) in school age children across 7 countries,
      including Ethiopia, revealing that this regime is highly efficacious for the treatment of A.
      lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this
      parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate.
      Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose
      10mg/kg), of which the latter holds promise as it can also be administrated to children
      between 6 months and 2 years. The main objective of the present study, therefore, is to
      assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren
      in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x
      500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).
    


Intervention name(s): Albendazole, 2 x 400mg; Albendazole 400mg; Mebendazole 500mg; Mebendazole 2 x 500mg; Pyrantel-oxantel + mebendazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Albendazole 2 x 400mg; Albendazole 400mg; Mebendazole 500mg; Mebendazole 2 x 500mg; Pyrantel-oxantel + mebendazole
Intervention MeSH terms: Albendazole; Mebendazole; Piperazine; Piperazine citrate; Pyrantel; Oxantel; DMP 777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MPC Versus PID for Closed Loop Insulin Delivery
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The goal of this proposed study is to compare use of a PID (Proportional-Integral-Derivative)
      controller versus an MPC (Model Predictive Control) controller algorithm in an artificial
      pancreas system, all other components and study design being equal. The study design, power
      calculation and endpoints were developed based on the results of an initial feasibility study
      (ClinicalTrials.gov Identifier: NCT01987206) that has already been completed.
    

Detailed description: 
      This randomized crossover study consists of an evaluation of either type of control algorithm
      (MPC or PID) as a part of the Artificial Pancreas (AP) device during two periods of 27.5-hour
      closed-loop control in a minimally supervised setting (outpatient research area at the
      William Sansum Diabetes Center, Santa Barbara, CA) separated by a minimum of 5 days and a
      maximum of 2 weeks. The 27.5-hour period includes: 2 announced meals (dinner and breakfast of
      65g and 50g CHO respectively) preceded with a dose of rapid-acting insulin equivalent to 100%
      bolus based on each subject's Insulin to Carbohydrate (I:C) ratio and 1 unannounced meal
      (lunch of 65g carbohydrates, same meal content as dinner); complete night from 12:00 am to
      7:00 am. The goal is to demonstrate that the AP device is able to maintain the subject blood
      glucose within a safe range at all times.
    

Intervention name(s): PID control algorithm; MPC control algorithm
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas; Type 1 Diabetes; MPC; PID
Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to investigate the effect of nitroglycerin on vericiguat in patients
      with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat
      acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in
      the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important
      to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used
      as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.
    


Intervention name(s): Vericiguat (BAY1021189); Placebo; Nitroglycerin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vericiguat up-titration from 2.5 mg to 10 mg in an interval of 14 +/- 3 days: 2.5 mg vericiguat for 14 +/-3 days given as 2 x 1.25 mg tablets followed by 5 mg vericiguat for 14 +/-3 days given as 1 x 5 mg tablet followed by 10 mg vericiguat for 14 +/-3 days given as 2 x 5 mg tablets; Placebo for 14 +/-3 days given as 1 or 2 tablets [o.d.].; 0.4 mg nitroglycerin spray administered at 2.5 hours before treatment (vericiguat [trough] or placebo) on day 12, day 26 and day 40 at 4 hours after treatment (vericiguat [peak] or placebo) on day 13, day 27 and day 41
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Audio Health Engagement Analysis in Diabetes: The AHEAD Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Despite multidisciplinary care and advancements in therapeutics and technology, health
      outcomes remain suboptimal in pediatric diabetes centers world-wide. A major contributor to
      poor outcomes is suboptimal diabetes management in pediatric patients and their families. The
      premise of this research project is that patients and families do not have adequate resources
      to meet the level of diabetes management that translates to better outcomes. Therefore, we
      will give them a valuable tool to improve their overall management. The tool is CareCoach.

      Research shows that enhancing communication and partnership among patients, parents, and
      providers is especially critical for optimal outcomes in pediatric diabetes. Communication
      gaps and conflict can complicate the already complex provider-patient interactions and daily
      management. We have therefore designed, refined, and made available to consumers a new
      mobile-based intervention, CareCoach, to improve communication; build trust among providers,
      patients and parents; and increase overall satisfaction with the quality of diabetes care.
      This web/mobile application is designed to help patients unobtrusively audio record their
      clinical encounters, track their medical consults and treatment plans, review information
      from past visits, create visit discussion guides, and track adherence to medication and
      dosing schedules. In addition, because mobile-based applications are inexpensive to
      administer, portable, and available at all times of day, CareCoach holds great promise for
      communication coaching and contributing to improved diabetes management.

      We hypothesize that CareCoach will improve patient-parent-provider communications, build
      patient-parent-provider trust, and increase overall satisfaction with clinical interactions
      in a sample of children with type 1 diabetes and their parents. These improvements will lead
      to significant gains in diabetes management, setting the stage for optimal health outcomes.
      To test the effectiveness of CareCoach, we will conduct a randomized controlled trial
      comparing the CareCoach intervention to standard care in a sample of 60 children with type 1
      diabetes and their parents.
    


Intervention name(s): CareCoach mobile application to assist in diabetes management
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; parents; mobile application; diabetes management
Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide
      2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously
      treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline
      Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
    

Detailed description: 
      This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel
      Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"
    

Intervention name(s): Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel; Vehicle Gel
Intervention type(s): Drug; Drug
Intervention description(s): Topical Gel to the face, once daily in the evening for 24 weeks.; Topical Gel to the face, once daily in the evening for 24 weeks.
Other intervention name(s): Adapalene-BPO gel
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne
WAVE~Ripples for Change: Obesity Prevention in Active Youth
Condition: Childhood Obesity Prevention
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Intervention targets youth ages 14 - 19 participating in soccer teams. The intervention group
      will be given face to face nutrition lessons and have access to an online immersive learning
      environment. The comparison group will not. The project will test if the immersive learning
      environment is effective in preventing unhealthy weight gain.
    

Detailed description: 
      Active youth are just as likely to develop poor dietary habits that can contribute to obesity
      later in life, after high school sports has ended. However, youth in sports may provide a key
      "window of opportunity" to teach them about eating health foods if that information is tied
      to sport performance. This project will test to see if that is true.

      The virtual world is an idea medium for learning for this project. The project will test
      whether it indeed can result in behavior change more effectively than just more traditional
      face to face learning.
    

Intervention name(s): Nutrition lessons; Virtual world learning environment; Newsletter
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Face-to-face interactive group lessons delivered in the classroom.; Every participant has their own unique avatar in the virtual world learning environment named Rippleville. They can choose to complete quests, watch archived nutrition video lessons, explore, and socialize with other avatars. They receive rewards (Rippleville dollar and badges) for their efforts.; All participants in the intervention and comparison groups receive up to 10 professional newsletters on topics related to sports nutrition and performance, healthy eating and active living tips.
Other intervention name(s): Rippleville
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: There is one intervention group and one comparison group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: adolescent; sports; nutrition; physical activity; body mass index; virtual world
Remifentanil in Children With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This investigation tested the hypothesis that children with obstructive sleep apnea have an
      increased pharmacodynamic sensitivity to the miotic and respiratory depressant effects of the
      prototypic μ-opioid agonist remifentanil.
    


Intervention name(s): Remifentanil Infusion
Intervention type(s): Drug
Intervention description(s): 15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min
Intervention MeSH terms: Remifentanil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group study comparing patients with obstructive sleep apnea undergoing tonsillectomy or tonsillectomy and adenoidectomy to controls with no history of obstructive sleep apnea undergoing general anesthesia for any procedure. The study will be conducted in the patient's preoperative holding area room. Two intravenous catheters will be placed, one for a remifentanil infusion and one for blood draws to measure the blood concentration of remifentanil. Patients will have standard ASA monitors placed with vital signs monitored on a portable monitor, and a remifentanil infusion will be started. Blood draws will be taken at seven time points: zero, one, two, four, six, ten and fifteen minutes. Concomitantly, recordings of end tidal CO2, respiratory rate, and pupil diameter will be made at the seven time points.
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and
      safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and
      Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy
      male subjects
    


Intervention name(s): DA-5206(Fasting); DA-5206(Fed); TALION®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Test drug l : DA-5206(Fasting); Test drug ll : DA-5206(Fed); Reference drug : Talion®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the relative bioavailability of sotagliflozin following single doses of 3
      sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet
      formulation in fasted conditions in healthy subjects.

      Secondary Objectives:

        -  To assess the pharmacokinetic characteristics of sotagliflozin and its 3-O-glucuronide
           following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3
           and of the reference formulation in fasted conditions in healthy subjects.

        -  To assess the clinical and laboratory safety of single oral doses of 3 sotagliflozin
           prototype tablet formulations p1, p2 and p3 and the reference tablet formulation in
           fasted conditions in healthy subjects.
    

Detailed description: 
      Total duration is 37 to 75 days for each subject, with 2 to 21 days screening period; 4
      dosing days, i.e. one in each of the 4 treatment periods. Observation period in each
      treatment period is 6 days. Washout between dosing days is 7 to 10 days. Follow-up visit is
      14-21 days after last dosing.
    

Intervention name(s): sotagliflozin (SAR439954)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: tablets
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research