bioihbjkbjnl/mcl2 huggingface dataset:
Play as a Method to Reduce Overweight and Obesity in Children.
Condition: Childhood Obesity; Sleep Apnea in Obese Children; Studying Maternal and Family Factors That Cause Obesity in Children
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      Introduction Overweight and obesity are characterised by excess fat, which results in weight
      gain and is identified by the Body Mass Index (BMI). Studies show that overweight and obesity
      are the result of a complex interaction between genetic and environmental factors, which
      begins prenatally. Various studies have shown that physical exercise is an important
      component of weight loss programmes and that it also benefits the metabolic profile. Other
      authors have reported that greater weight loss is achieved by a programme that includes both
      diet and exercise, rather than either of these alone.

      Aim The aim of this study is to analyse an intervention based on play as a means of improving
      the body composition of children with overweight or obesity.

      Design / Method The design of the Kids-Play study is based on cases and controls. The study
      was conducted in Granada (Spain) The analysis sample of 98 children was divided into two
      groups: cases, consisting of 49 children, who participated in an intervention programme based
      on physical activity, play and nutritional advice (to both the child and the parents); and
      controls, another 49 children, who received only nutritional advice.
    


Intervention name(s): The intervention consisted of physical activity based on play
Intervention type(s): Behavioral
Intervention description(s): The intervention consisted of physical activity based on play, with four 90-minute sessions per week for nine months (the school year). The total of sessions was 144, the minimum number of sessions to consider valid that a child has completed the intervention was 115 (80%) in order to perform the minimum level of physical activity recommended for their ages. In parallel, twice-monthly theoretical and practical sessions of nutritional advice were given to the children and their families. The study group performed the physical activity and received the nutritional advice, while the control group received only the theoretical and practical sessions on nutrition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight, obesity, play, physical activity, accelerometry.
Long-Term Outcome Following the Treatment of Pediatric Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Evaluate the long-term outcomes following operative and nonoperative treatment of childhood
      scoliosis.
    

Detailed description: 
      The investigators hypothesize that sagittal alignment and thoracic volumes will predict
      successful treatment outcomes as measured by improved pulmonary function and health-related
      quality of life in adolescent idiopathic scoliosis patients at a minimum 20-year follow-up.
      Significant focus has been placed on the coronal plane in order to determine treatment
      indications for scoliosis, but with new understanding about the important of sagittal balance
      and pulmonary function, the treatment indications should be broadened. Thus, the
      investigators propose the following study to explore parameters associated with a durable and
      acceptable outcome following scoliosis treatment, minimizing the need for further surgery and
      to optimizing quality of life and pulmonary health. Beyond the standard radiographs and
      Scoliosis Research Society (SRS) scores, this study undertakes a comprehensive assessment of
      health-related quality of life, chest asymmetry and body satisfaction scoring, sagittal plane
      parameters, and 3D modeling of the childhood and current spinothoracic deformity. Thus, the
      investigators research team is uniquely poised to determine broader treatment indications for
      scoliosis. The overarching goal of this research effort is to determine new parameters based
      on thoracic volume and sagittal plane alignment in addition to coronal deformity in order to
      determine the appropriate treatment threshold for surgical intervention in children with
      adolescent idiopathic scoliosis.
    

Intervention name(s): Long-term outcomes
Intervention type(s): Other
Intervention description(s): Patients with a history of adolescent idiopathic scoliosis will return at a minimum of 20 year follow-up for new spine xrays, clinical exam, pulmonary function testing, and assessment of health related quality of life based on survey responses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: scoliosis; long-term outcomes; sagittal plane; quality of life; curve progression; pulmonary function
A Cold Physical Treatment to Manage Insulin Resistance
Condition: Insulin Resistance; Hyperglycemia; Hyperinsulinemia; Diabetes; Obesity
MeSH terms: Insulin Resistance; Hyperglycemia; Hyperinsulinism
Study type: Interventional

Summary: 
      Insulin resistant volunteers will choose to undergo an 8-week cold treatment, 2 hours per
      day, to selective regions of the body enriched with brown fat including neck, supraclavicular
      and interscapular regions) in combination with electroacupuncture (EA). Their insulin
      sensitivity and glucose and lipid homeostasis will be measured. The brown fat activation will
      be assessed by positron emission tomography and computed tomography (PET/CT)-scans and/or
      serum marker measurements.
    


Intervention name(s): Selective Cold; Electroacupuncture
Intervention type(s): Procedure; Device
Intervention description(s): The volunteers of intervention group will undergo Selective Cold treatment below 10 degree celsius to neck, supraclavicular interscapular regions for 2 hours daily for 8 weeks. The electroacupuncture is conducted by commercially available device. Hyperinsulinemic euglycemic clamp, glucose tolerance test, blood parameter measurements, and PTC-CT scans will be conducted before and after the intervention. The participants will be instructed to maintain their normal behavior and calorie intake.; Electroacupuncture (EA) is an add-on treatment and it is applied when starting the cold treatment at the cold treated region to patients.The device is Huatuo SDZ-II model made by Suzhou Medical Appliance Factory, China.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery
Condition: Fusion of Spine
Study type: Interventional

Summary: 
      STRATAFIX Symmetric PDS Plus sutures will reduce the time required for fascial closure
      following spinal surgery. A pilot study will aide in the design of a larger randomized
      controlled trial to compare suture closure time of the STRATAFIX Symmetric PDS Plus sutures
      versus traditional Vicryl sutures.
    

Detailed description: 
      Effective and secure suture is integral in spinal surgery, creating a strong barrier for
      tissue repair and a seal which prevents infection of the surgical site. The goal of any
      suture is to close the wound while minimizing risks of complications such as wound dehiscence
      and surgical site infection . A new type of suture, barbed suture, uses integrated barbs to
      secure the suture to the tissue without requiring knots for fixation. The result is a suture
      that evenly distributes tension along the length of the incision, while requiring less time
      to close . Additionally, STRATAFIX sutures offer a "Plus" antibacterial option for their
      knotless sutures, which further increases the safety and efficacy of this product.

      Barbed suture technologies have been utilized in a variety of specialties, but neurosurgery
      remains unstudied in this respect. The primary aim of this study is to assess the time to
      closure using STRATAFIX technology. Decreased time to closure directly translates into
      decreased operating room time, and thus increased savings, especially for high-volume
      institutions. The secondary aim of this study is to determine the risk for surgical
      complications using STRATAFIX. Previous studies in other specialties have shown no
      significant difference in rate of adverse consequences when utilizing barbed sutures. To
      assess this aim, patients will be evaluated for wound dehiscence, SSI, deep infection, and
      30-day rate of readmission for wound infection.
    

Intervention name(s): Barbed
Intervention type(s): Device
Intervention description(s): Barbed Suture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
I PREVENT - Irbesartan In Hypertensive Diabetic Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      -  To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg
           and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.

        -  To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline
           (if any at the inclusion visit) in this population.

        -  To demonstrate the safety of Irbesartan in this population.
    


Intervention name(s): Irbesartan (Aprovel)
Intervention type(s): Drug
Intervention description(s): Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet/day per os.
Intervention MeSH terms: Irbesartan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Potential Drug Interaction Between ALXN2040 and Rosuvastatin
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and
      rosuvastatin.
    

Detailed description: 
      This is an open-label, 2-treatment, 2-period, fixed-sequence DDI study in healthy adult
      participants.

      This study will comprise of:

        -  Screening duration of 27 days.

        -  Two treatment periods: Approximately 14 days. Treatment Period 1: 6 days Treatment
           Period 2: 8 days

        -  Follow-up: 7 (± 2) days following the final dose of study intervention.

      There will be a washout period of at least 5 days between the single dose of rosuvastatin in
      Treatment Period 1 and the first dose of ALXN2040 in Treatment Period 2.

      Each participant will be involved in the study for approximately 48 days.
    

Intervention name(s): Rosuvastatin; ALXN2040
Intervention type(s): Drug; Drug
Intervention description(s): In Treatment Period 1, participants will receive a single oral tablet of rosuvastatin in the morning of Day 1. In treatment period 2, on the morning of Day 4, participants will receive a single 20 mg dose of rosuvastatin (co-administered with the morning dose of ALXN2040).; In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7.
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-drug interaction; Breast cancer resistance protein; organic-anion transporting polyprotein
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone
      vaccine.

      Objective:

        -  To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in
           a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices
           (ACIP) recommendations, in children 6 months to < 9 years of age.

      Observational Objectives:

        -  To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine,
           administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in
           children 6 months to < 9 years of age.

        -  To submit remaining available sera from subjects to the Center for Biologics Evaluation
           and Research (CBER) for further analysis by the World Health Organization (WHO), the
           Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration
           (FDA) to support selection and recommendation of strains for subsequent years' influenza
           vaccines.
    

Detailed description: 
      All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses
      of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be
      administered during Visit 2.

      Total duration of participation in the study is approximately 28 days for participants
      receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.
    

Intervention name(s): Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose; Fluzone®; Influenza Virus Vaccine, No Preservative
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL dose, Intramuscular; 0.5 mL dose, Intramuscular
Other intervention name(s): Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation; Fluzone® (Influenza Virus Vaccine) 2012 2013 Formulation
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation; Influenza virus vaccine; Trivalent Inactivated Influenza Vaccine
Efficacy of Hypnotherapy for Agoraphobia
Condition: Agoraphobia
MeSH terms: Agoraphobia
Study type: Interventional

Summary: 
      The purpose of the study is to compare the efficacy of Hypnotherapy for the treatment of
      Agoraphobia compared to a wait-list control group.
    

Detailed description: 
      With the present study, the efficacy of 8-12 sessions of individual Hypnotherapy will be
      compared to a wait-list control groups. At study entry and at the end of treatment with
      Hypnotherapy, the Agoraphobia symptoms will be assessed via clinician-rating and self-report.
      It is expected that Hypnotherapy will be superior to a wait-list control regarding the
      percentage reduction of the anxiety symptoms after three months of treatment.
    

Intervention name(s): Hypnotherapy for Agoraphobia
Intervention type(s): Behavioral
Intervention description(s): see description of the experimental arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypnosis; Wait-list
Evaluation of [11C]Cimbi-36 as an Agonist PET Radioligand for Imaging of 5-HT2A Receptors
Condition: Healthy
Study type: Interventional

Summary: 
      The serotonin 2A (5-HT2A) receptor is the most abundant excitatory serotonin (5-HT,
      5-hydroxytryptamine) receptor in the human brain, and multiple positron emission tomography
      (PET) studies have investigated the 5-HT2A receptors in the human brain using antagonist
      radioligands. However, the currently available antagonist PET radioligands bind the total
      pool of 5-HT2A receptor receptors whereas a 5-HT2A receptor agonist binds the high-affinity
      subgroup of the receptors which are also G-protein coupled, and thus hypothesized to be the
      functional relevant population of receptors. At the Center for Integrated Molecular Brain
      Imaging (CIMBI), a novel agonist PET radioligands for brain imaging of 5-HT2A receptors was
      recently validated in animals (Ettrup et al. 2011, EJNMMI). In the human brain, [11C]Cimbi-36
      was validated as a selective 5-HT2A receptor agonist PET radioligand through a blocking study
      with the 5-HT2A receptor antagonist pharmaceutical ketanserin. In this validation study, the
      biodistribution and kinetic modelling of [11C]Cimbi-36 binding in the human brain was also
      validated. With these studies, investigators will test the most promising of these,
      [11C]Cimbi-36, in clinical trials, where it will provide a novel method for detecting
      dysfunction in the 5-HT system. The specific aim of this clinical trial is:

      - To examine the effect of acute alterations in 5-HT levels on cerebral [11C]Cimbi-36 binding
      in healthy volunteers who will be PET-scanned at baseline and after pharmacological or
      dietary interventions that either increase or decrease cerebral 5-HT levels.

      It is hypothesized that this novel agonist radioligand will provide both a more physiological
      relevant measure of the 5-HT2A receptors and also reflect levels of cerebral 5-HT in humans,
      more specifically:

      BP will decrease after pindolol and selective serotonin reuptake inhibitor (SSRI) treatment
      and increase after acute tryptophan depletion (ATD). Placebo will leave binding potential
      (BP) unchanged.
    


Intervention name(s): Citalopram and Pindolol; Placebo; Acute tryptophan depletion
Intervention type(s): Drug; Other; Dietary Supplement
Intervention description(s): Citalopram: selective serotonin reuptake inhibitor
Pindolol: non-selective beta blocker and 5-HT1A receptor antagonist; On the second PET scanning day, subjects received a protein drink as well as a 50 ml saline infusion over 1 hour starting 30 min before PET scanning.
Other intervention name(s): Seropram; Hexapindol®; Amino acid drink without tryptophan
Intervention MeSH terms: Pindolol; Citalopram; Tryptophan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Positron Emission Tomography; Serotonin; 5-HT2A; Radioligand
Evaluation of the Accuracy of the POGO Score
Condition: Intubation
Study type: Observational

Summary: 
      A classification method describing the larynx appearance during laryngoscopy accepted by all
      anesthetists has not been defined yet. In one study, it was shown that anesthetists mis
      classed the glottis image by 50%. The most commonly used classification method is the Cormack
      Lehane (CL) classification. This classification classifies the larynx appearance during
      direct laryngoscopy form 1 to 4. The modified CL classification is criticized as it does not
      predict difficult intubation and especially grade 2 is operator dependent and partial view is
      not well defined. The numerical expression of the percentage of the glottic aperture (POGO =
      percentile of glottic opening) is another score. In this score, A POGO score of 100% accounts
      for full visualization of the larynx starting from anterior commissure to the posterior
      cartilage, while 0% indicated a complete absence of glottic opening.

      The use of a standard and effective classification method will facilitate and accelerate
      communication between anesthetists in difficult life-threatening situations such as difficult
      airway / difficult intubation / difficult ventilation and contribute to patient safety. The
      use of common terminology can also facilitate the evaluation of the performance of intubation
      tools.

      The aim of this study was to evaluate the accuracy and intra and inter rater reliability of
      the POGO score.
    

Detailed description: 
      Anesthesiologist will be asked to score still images of laryngeal views, which will be
      obtained from patients requiring intubation for general anesthesia, after obtaining written
      informed consent.

      The images of the larynx will be captured first with the Macintosh blade and thereafter with
      the D blade. A group of independent anesthesiologist will score these images with the Cormack
      Lehane and POGO scores. The set of images will be prepared from patients with both difficult
      and normal airway anatomy. Some images in the series will be repeated to assess intra rater
      variability.

      The anesthesiologist will be asked to rate 20 images both with the CL and POGO scores.

      The experience of the raters in airway management, their experience with videolaryngoscopy
      and scoring systems used currently when documenting videolaryngoscopy and demographic data
      will be also obtained.

      The POGO scores of the participants and investigators will be compared.

      The outcome of interest is the correct POGO score rate of the participants.
    

Intervention name(s): Videolaryngoscopy
Intervention type(s): Device
Intervention description(s): Patient will be intubated by using videolaryngoscope
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing surgery and those who are intubated
      
Keywords: Intubation; Laryngeal view; Scoring systems; Larynx
Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of ibuprofen, acetaminophen, chewing gum
      in reducing orthodontic pain. This study include 81 patients to be classified into 4 groups
      of 19 each: ibuprofen (400 mg), acetaminophen (500 mg), chewing gum and control. The patients
      in each group will receive 1 method immediately after placement of the initial archwire and
      every 6 hours for a week if they experiences pain. Pain perception will be recorded by the
      patients while jaw rest position and fitting back teeth at 2 hours, 24 hours, 2 days, 3 days,
      7 days and 21 days after archwire placement, using a visual analog scale.
    


Intervention name(s): Ibuprofen; Acetaminophen; Chewing gum
Intervention type(s): Drug; Drug; Other
Intervention description(s): prescription of ibuprofen 400 mg; prescription of acetaminophen 500 mg; prescription of one tablet of chewing gum
Other intervention name(s): non steroidal drug; paracetamol
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; orthodontics