bioihbjkbjnl/mcl2 huggingface dataset:
Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Researchers are assessing the effects of weight loss medication vs a placebo among
      participants provided with a wearable activity tracker, digital wellness devices and
      lifestyle recommendations.
    


Intervention name(s): Phentermine-Topiramate Extended Release; Placebo; Online support system
Intervention type(s): Drug; Drug; Other
Intervention description(s): Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily; Placebo looks exactly like the study drug, but it contains no active ingredient; VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Other intervention name(s): Qsymia
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Research Study of How a New Medicine NNC0148-0287 C (Insulin 287) Works in the Body of People With Kidney Problems
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to look at the effect of decreased kidney function when getting
      one dose of insulin 287 and to guide dosing recommendations in people who have altered kidney
      function. Insulin 287 works in the body for a long time (long-acting). It is taken once a day
      by injecting under the skin. The main target patient group for insulin 287 is people with
      type 2 diabetes. Participants will get just one injection. The study will last for up to 80
      days. Participants will have 11 out-patient visits with the study doctor and one in-house
      visit of 3 days and 2 nights. Participants will have some assessments like several blood
      draws, electrocardiograms (ECGs), urine collections and capillary blood sugar tests.
      Participants cannot take part if they are hypersensitive to the study medicine, if they
      received any investigational product within 90 days before screening, or if they have certain
      diseases e.g. HIV or hepatitis or heart problems. Participants have to take photos if they
      experience any allergic reactions and send them to their study doctor. Participants' kidney
      function will be examined by a so called "Iohexol test".
    


Intervention name(s): Insulin icodec
Intervention type(s): Drug
Intervention description(s): Participants will receive single dose of Insulin 287 subcutaneously (under the skin) on Day 1
Other intervention name(s): Insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Berlin Beat of Running Study
Condition: Cardiac Arrhythmia; Brain Lesion; Stroke
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      This prospective observational study will investigate the frequency of new onset atrial
      fibrillation (AF) and of further cardiac arrhythmias as well as of (clinically silent)
      cerebral lesions in endurance runners before, during and after the BMW-Berlin Marathon 2011.
    

Detailed description: 
      Up to 120 experienced marathon runners will participate in the "Berlin Beat of Running Study"
      and will wear a transportable electrocardiogram (ECG) recorder at least 24 hours before,
      during and 24 hours after the BMW-Berlin Marathon. All participants will undergo brain MRI
      examinations to detect cerebral lesions within days before and after the marathon race,
      respectively. Moreover, serial blood samples will be taken a few days before, immediately
      after as well as a few days after the BMW-Berlin Marathon.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Experienced marathon runners
      
Biospecimen description: 
      Whole blood samples
    
Keywords: Marathon running; Brain MRI; ECG recording; Blood tests
Short Term Effects of Increasing Sleep Duration
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      A series of studies are proposed to develop an intervention to increase sleep duration and
      study the effects on eating, exercise, and weight control. The hypothesis is that increasing
      sleep duration will help improve weight loss and maintenance.
    

Detailed description: 
      Study 1 is conducted in a sleep laboratory. Participants sleep short duration (approximately
      four hours per night) on one weekend and long duration (approximately nine hours per night)
      on another weekend.

      Study 2 is examining ways to increase sleep duration in overweight individuals with short
      sleep and examining the effects on short term weight loss.

      Study 3 is comparing a standard weight loss program with a novel Sleep+Weight Loss
      intervention.
    

Intervention name(s): Sleep Duration; No change in sleep
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects are taught sleep hygiene strategies to increase their sleep; they record their sleep in a diary and wear an actigraph and call in their sleep to the office each day.; This group is taught to maintain their current sleep habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight loss; Sleep duration
Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism
Condition: Autism; Enuresis; Incontinence
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis; Autistic Disorder
Study type: Interventional

Summary: 
      This pilot study is designed to investigate the feasibility of comparing a standard
      behavioral intervention and an innovative intervention that incorporates the use of a
      wireless moisture alarm in training children with autism how to independently use the toilet
      for urination. We hypothesize that the study protocol will be feasible, as measured through
      review of achieved recruitment targets, successful randomization, and >80% retention of
      subjects with com- plete data collection. Our second hypothesis is that therapists will
      deliver experimental and standard behavioral treatment intervention with ≥80% fidelity and
      parents in both intervention groups will adhere to the intervention with ≥80% fidelity. A
      secondary aim of this study is to examine trends in outcome data by conducting a small RCT (N
      = 30) of wireless moisture alarm and standard behavioral toilet training, with the hypothesis
      that the moisture alarm intervention will result in fewer toileting accidents, a higher rate
      of toileting success and greater parental satisfaction.
    


Intervention name(s): Wireless Moisture Pager (WMP)
Intervention type(s): Device
Intervention description(s): The WMP is composed of a three key components: (1) the disposable sensor; (2) the transmitter; and (3) the receiver. The disposable sensor is placed by the parent in the child's underwear and detects small amounts of urine. The transmitter is housed in hardened plastic, attached to the disposable sensor, and, upon activation, emits a radio signal to the receiver. The receiver is an iPod-based app that emits an audible and/or vibration signal to the parent and child at the onset of a toileting accident. A step-by-step manualized curriculum is used to teach parents how to incorporate the device in the toilet training of their child.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; enuresis; toilet-training
A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.
Condition: Healthy Volunteers; Pharmacodynamics of Mirabegron
Study type: Interventional
Phase: Phase 1

Summary: 
      To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will
      be given a beta-blocker at the same time as mirabegron.
    

Detailed description: 
      Impedance cardiography parameters will be assessed and compared when mirabegron (or placebo),
      is taken in combination with a selective beta-blocker, a non-selective beta-blocker or
      placebo.
    

Intervention name(s): mirabegron; Bisoprolol; propranolol; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral; oral; oral; oral
Other intervention name(s): YM178
Intervention MeSH terms: Propranolol; Bisoprolol; Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Mechanisms of Pharmacological Action; Pharmacodynamics; Pharmacokinetics
Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to to
      determine whether insulin aspart can be used effectively and safely in paediatric patients.
    


Intervention name(s): insulin human; insulin lispro; insulin aspart
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimal Time for In-situ Dry Needling to Affect the Autonomic Nervous System
Condition: Healthy
Study type: Interventional

Summary: 
      Assessing for optimal time dry needles need to remain inside the body to have positive effect
      on the nervous system
    

Detailed description: 
      The purpose of this study is to determine what most optimal dry needling duration effect on
      the autonomic nervous system.

      Design: The researchers will conduct a pilot study to assess the effect of dry needling on
      the autonomic nervous system
    

Intervention name(s): Dry needling
Intervention type(s): Procedure
Intervention description(s): Paravertebral dry needling C7-T4. Total of 8 needles.
Intervention model: Single Group Assignment
Intervention model description: Single group pre-test post test study design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dry needling; Autonomic nervous system; pupillometry
A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine
Condition: Migraine; Common Migraine; Classic Migraine; Headache
MeSH terms: Migraine Disorders; Migraine with Aura; Migraine without Aura; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate
      (50 milligrams[mg], 100mg, and 200mg per day) compared with placebo in the prevention of
      migraine. The study will also assess the dose response relationship and the efficacy of
      treatment with topiramate versus placebo on Health-Related Quality of Life.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to
      evaluate the efficacy and safety of three different doses of topiramate (50mg, 100mg, and
      200mg daily) in migraine prophylaxis. The study consists of five phases: Baseline
      (determination of whether patients meet the eligibility criteria and tapering of any migraine
      medication patients are already taking), Double-Blind (patients receive either 50
      milligrams[mg], 100mg, 200mg of topiramate, or placebo), Blinded Transition Phase (doses of
      study medication are adjusted over 7 weeks in preparation for the Open-Label Extension
      Phase), Open-Label Extension Phase (patients continue the study medication in open-label
      manner for up to 6 months; doses are adjusted to maximize effectiveness and minimize side
      effects), Taper/Exit Phase (study medication is slowly discontinued over 2 weeks). The
      primary study hypothesis is that one or more of the three doses of topiramate (50, 100, 200
      mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in
      monthly (28 day) migraine period rate from the Prospective Baseline Period to the
      Double-Blind Phase. Topiramate tablets (50milligrams [mg], 100mg, 200mg, or placebo) taken by
      mouth as twice-daily regimen during the 26-week Double-Blind Phase. Doses are adjusted and
      continued during the 6 month Open-Label Extension Phase after which they are tapered over 2
      weeks.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Migraine; Common Migraine; Classic Migraine; Headache; Topiramate; Prophylaxis; Prevention
Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years
Condition: PAH
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral
      treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who were (1)
      transitioning from parenteral Remodulin therapy; (2) transitioning from inhaled prostacyclin
      therapy; or (3) not currently receiving prostacyclin therapy.
    

Detailed description: 
      Study TDE-PH-206 was a multicenter, open-label study designed to investigate the safety,
      tolerability, and PK of oral treprostinil administered 3 times daily (TID) or 4 times daily
      (QID), at the discretion of the Investigator, with food in pediatric PAH subjects aged 7 to
      17 years of age (1) transitioning from continuous IV/SC Remodulin, (2) transitioning from
      inhaled prostacyclin, or (3) as add-on to current PAH therapies in de novo prostacyclin
      subjects. Eligible subjects were assigned to a cohort based upon their background therapy.
      All subjects received oral treprostinil provided as 0.125, 0.25, 1, or 2.5 mg
      extended-release tablets. Subjects in Cohort 1 began the transition from IV/SC Remodulin in
      the hospital with a goal of complete transition to oral treprostinil within 5 days. The
      initial dose of oral treprostinil for Cohort 1 was calculated from the subject's dose of
      IV/SC Remodulin and weight. Subjects in Cohorts 2 and 3 were initiated on 0.125 mg TID or QID
      oral treprostinil with dose escalations possible every 24 hours in increments of 0.125 mg TID
      or QID at the discretion of the Investigator during the first 4 weeks, and in increments of
      either 0.125 mg or 0.25 mg every 24 hours thereafter. Cross titration occurred for Cohorts 1
      and 2 such that doses of IV/SC Remodulin or inhaled prostacyclin were decreased as subjects
      were fully transitioned to oral treprostinil.
    

Intervention name(s): oral treprostinil
Intervention type(s): Drug
Other intervention name(s): Orenitram
Intervention MeSH terms: Treprostinil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; treprostinil; transition; Remodulin
Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide
      mononucleotide" on metabolic health in people.
    

Detailed description: 
      This study is is looking at the effect of the dietary supplement "Nicotinamide
      mononucleotide" (NMN) on key cardiovascular and metabolic functions, specifically those that
      are important risk factors for diabetes and cardiovascular disease. Accordingly, the
      investigators will evaluate the effect of NMN on how well the hormone insulin works to
      control blood sugar. The investigators will also look at the effects of NMN on blood lipids;
      body fat and liver fat; and other blood, fat tissue and muscle tissue markers of
      cardiovascular (heart) and metabolic health. Data from studies conducted in rodents have
      shown that NMN supplementation has beneficial effects on cardiovascular and metabolic health,
      but this has not yet been studied in people.
    

Intervention name(s): NMN supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Intervention will last at least 8 weeks in the form of two capsules (250 mg total).; Intervention will last at least 8 weeks in the form of two capsules.
Other intervention name(s): nicotinamide mononucleotide
Intervention MeSH terms: Niacinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Reproducibility of the Functional Movement Screen Test
Condition: Locomotor Pain Disorder
MeSH terms: Rheumatic Diseases; Somatoform Disorders
Study type: Observational

Summary: 
      The main objective of the study is to determine the inter-evaluator and intra-evaluator
      reproducibility of the FMS test as an evaluation tool in amateur rugby players.

      The secondary objective of the study is to evaluate the abilities of the FMS test as a
      predictive tool for detecting possible injuries during a sports season in amateur rugby
      players.
    

Detailed description: 
      Rugby is a very popular sport in France, since it has more than 300,000 dismissed. The 2023
      World Cup will take place in France, and in view of the enthusiasm that is created around the
      "XV de France" team, there will be a great number of new players. Yet there are many injuries
      in this sport, despite the adaptations of the French Rugby Federation. The injuries of these
      amateur players will handicap their performance within their club (an injured player will be
      injured more easily in the future) and have a impact on their personal and professional life.
      With this in mind, it would be desirable to have a predictive tool for possible wounds. For
      this, Agullo et al. had in the previous study "Reproducibility of the Functional Movement
      Screen (FMS) test in the amateur Rugby player" (ID-RCB: 2018-A03490-55) selected this tool
      already evaluated in the context of prediction injuries in other sports (hockey or American
      football). The FMS offers an overall assessment of the subject, based on seven so-called
      movements fundamentals, combining mobility and stability, making it possible to assess the
      deficiencies of the individual; a prevention plan will then be adapted to the subject.
    

Intervention name(s): functional movement screen
Intervention type(s): Other
Intervention description(s): The volunteer subjects had to perform the FMS test at the request of the investigator, which is made up of seven movements: the squat, the crossing of the hurdle, the line lunge, the active elevation with the straight leg, a movement concerning the mobility of the shoulders, a rotational stability assessment movement and a core stability assessment movement.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects recruited are rugby players aged 18 to 55, playing or having played in the
        "Amateur" and "Senior" categories.
      
Keywords: FMS, rugby
Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated
      hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.
    

Detailed description: 
      Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty
      acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)

      This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each
      other on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with
      vitamin D deficiency.

      This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3
      weekly and 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on
      serum leptin and Glycated hemoglobin (Hb A1C) levels .
    

Intervention name(s): VD3 group; omega 3 FA group; VD3 and omega- 3FA group; control group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): VD3 50000 IU/ week for 8 weeks; omega 3 FA group 300 mg once daily for 8 weeks; 50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks; no intervention was given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vitamin D3; vitamin D deficiency; leptin; A1C; omega-3 fatty acid