bioihbjkbjnl/mcl2 huggingface dataset:
Laryngeal Mask Supreme™ Versus the I-gel™
Condition: Patients Undergoing Elective General Anesthesia
Study type: Interventional

Summary: 
      We evaluate two new developed airway devices, which provide patent airway during general
      anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a
      difficult airway by using an extrication device collar). We then place consecutively both
      airway devices in the mouth and check for ease of insertion and time used.
    

Detailed description: 
      The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide
      patent airways during general anesthesia. So far, prospective randomized controlled trials
      comparing their performance are not yet published. Both devices can be used in difficult
      airway situations, pre-hospital and in the hospital. In this prospective, randomized,
      controlled cross-over trial, we are going to evaluate the performance of both devices in a
      simulated difficult airway scenario using an extrication collar to limit both mouth opening
      and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will
      place both airway devices consecutively and ventilate the patients. First attempt success
      rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure
      leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is
      that no difference exists between the two devices. Our 0-hypothesis is that there is a
      difference
    

Intervention name(s): I-gel and LMA Supreme: supraglottic airway devices
Intervention type(s): Device
Intervention description(s): Insertion of a supraglottic airway device
Other intervention name(s): Laryngeal Mask Supreme, supraglottic airway device
Intervention MeSH terms: Chlorhexidine
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Asthma Intervention Research 2 (AIR2) Trial
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The objective of this randomized, double blind, sham-controlled study is to demonstrate the
      safety and effectiveness of the Alair System in a population of subjects with severe asthma
      who are still symptomatic despite being managed on conventional therapy of high doses of
      inhaled corticosteroids and long-acting β2-agonists.

      The primary efficacy endpoint will be the difference between Study groups in the change in
      Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from
      the 6-, 9-, and 12-month follow-up visits.

      All other outcome measures assessed at 12 months post-treatment.

      This will be a multicenter, randomized, double-blind, sham-controlled study comparing the
      effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids
      (ICS) and long-acting β2-agonists (LABA).

      A Bayesian adaptive approach to sample size selection is used with a randomization scheme of
      2:1 (two Alair Group Subjects for every one Control Group Subject).
    


Intervention name(s): Alair System; Alair System
Intervention type(s): Device; Device
Intervention description(s): Treatment of airways with the Alair System; Sham treatment of airways with the Alair System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma
The Svendborg-project
Condition: Obesity, Childhood; Risk Factor, Cardiovascular; Sports Injury; Physical Activity; Motor Activity
MeSH terms: Pediatric Obesity; Athletic Injuries
Study type: Interventional

Summary: 
      The main aim of this study is to describe differences in development of health and motor
      performance over time in relation to type of school and other background variables.
    


Intervention name(s): Augmented physical education program
Intervention type(s): Behavioral
Intervention description(s): Augmented physical education program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group receiving 270 minutes of weekly physical education Control group receiving 90 minutes of weekly physical education Intervention group physical education teachers receiving physical education courses (ATK-concept)
Masking: None (Open Label)
Primary purpose: Prevention
Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on
      hunger, and the brain mechanism lying behind it.
    


Intervention name(s): Erythromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): physiological saline
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function
Condition: Hepatic Impairment; Healthy Participants
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in
      subjects with varying degrees of impaired hepatic function compared to match control subjects
      with normal hepatic function
    

Detailed description: 
      This is a Phase 1, non-randomized, open label, single-dose study to evaluate the effect of
      varying degrees of impaired hepatic function (i.e., mild, moderate, and severe Hepatic
      Impairment (HI)) on the PK, safety, and tolerability of linzagolix and its major metabolite,
      KP017.

      Up to 28 adult female participants will be enrolled.
    

Intervention name(s): Linzagolix
Intervention type(s): Drug
Intervention description(s): A single dose of 200 mg linzagolix (2 tablets of 100 mg) will be administered orally under fasting conditions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Linzagolix; OBE2109; Hepatic Impairment; Hepatic Insufficiency; Liver Diseases; Clinical pharmacology study
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the correct prasugrel dosage to be given to
      children with sickle cell disease (SCD).
    


Intervention name(s): Prasugrel
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): Effient; Efient; LY640315; CS-747
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sickle cell disease; pediatrics; SCD; children; child; kids; pain crisis; sickle cell anemia; sickle cell pain
Individualized Analgesia After Adenotonsillectomy
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      A high incidence of respiratory morbidity after adenotonsillectomy is reported in children
      with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind,
      randomized controlled study to determine the effects of individualized opioid analgesia
      compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy
      in Children with OSAS.
    

Detailed description: 
      All children were randomized 2 groups based on a computer-generated random number. The main
      interventions were occurred in post anesthetic care unit (PACU). In the operating room, all
      patients received a standardized anesthetic regimen by one anesthetist. Sevoflurane was used
      for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory
      was recovered. All the patients were given 1 mcg/kg fentanyl intravenous injection after the
      end of the procedure. The positive result was defined as spontaneous respiratory rate
      decreased more than 50%, the others were defined as negative result. The result of fentanyl
      test submitted to assistant, and prepared the rescue analgesic drugs according to this
      result. One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.
      Another group: all received 25μg/kg morphine .The trachea was extubated when patients were
      awake, and then transported to the PACU. Patients with a Children's Hospital of Eastern
      Ontario Pain Scale score>6 received rescue analgesic drugs and observe respiratory morbidity
      in each group.
    

Intervention name(s): Individualized opioid analgesia; conventional opioid analgesia
Intervention type(s): Drug; Device
Intervention description(s): (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.; (b) all received 25μg/kg morphine
Other intervention name(s): IP; CP
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: respiratory adverse events; adenotonsillectomy; opioid analgesia; children
Effect of Yoga Vs. Stretching on Chronic Back Pain
Condition: Chronic Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the effectiveness of yoga classes, exercise classes, and a self-care
      book in the management of pain and function for people with low back pain.It will also for
      physical, psychological and physiological factors associated with improvement in back pain.
    


Intervention name(s): Yoga; Exercise; Self-care book recommendations
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Yoga for back pain; exercises for back pain; Self-care book for back pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Low Back Pain; Yoga
Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on Pharmacokinetics of Tamsulosin in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of CYP3A4 inhibition by ketoconazole on the single oral dose
      pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability
    


Intervention name(s): Tamsulosin HCl; Ketoconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketoconazole; Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Retrospective Analysis of Incisional Hernia Repair's Postoperative Recurrence
Condition: Incisional Hernia; Recurrent Hernia
MeSH terms: Hernia; Recurrence; Incisional Hernia
Study type: Observational

Summary: 
      ABSTRACT Purpose：A retrospective study was conducted among patients with incisional hernia in
      our hospital to analyse the factors associated with postoperative recurrence of abdominal
      wall incisional hernia.

      Methods：Patients with a diagnosis of incisional hernia obtained from our hospital's
      electronic medical record system were divided into primary incisional hernia group and
      recurrent incisional hernia group according to whether or not they had a recurrence after
      surgery. Baseline information on these patients was recorded and statistically analysed after
      our review.
    


Intervention name(s): Recurrence after surgery
Intervention type(s): Behavioral
Intervention description(s): Recurrence after repair was the main outcome
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Inclusion Criteria:

          -  Inclusion criteria: diagnosis of incisional hernia of the abdominal wall and primary;
             surgical treatment for hernia repair at our hospital; all patients originating from
             outpatient clinics rather than emergency clinics; age of 18 to 80 years at the time of
             admission; and those with a well-established preoperative examination.

        Exclusion Criteria:

          -  Exclusion criteria: severe organ dysfunction (ASA score of IV, V, VI); unconsciousness
             and poor cooperation with various preoperative examinations; correction of other types
             of abdominal hernia by perfect examination after admission; incomplete necessary
             information.
A Drug-Drug Interaction Study of Digoxin and PA21
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if Digoxin is affected by PA21.
    


Intervention name(s): PA21; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): The maximum dose of PA21 will be 15.0 g/day.; The maximum dosage of Digoxin will be 0.5 mg/day
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction; Pharmacokinetics; PA21
Motivation to Exercise in People With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The purpose of this research study is to determine the importance and level of physical
      activity in people with Anorexia Nervosa.
    

Detailed description: 
      A laboratory paradigm that uses a progressive ratio computerized work task will be used to
      determine the reinforcing value of exercise in hospitalized patients with AN, both before and
      after weight gain. In addition, we will examine the relationship between the reinforcing
      value of exercise and free-living physical activity in this population. We will also examine
      the relationship between the reinforcing value of exercise and measures of depression,
      anxiety, and cortisol, which we have found in previous studies to be associated with other
      measures of physical activity and exercise motivation. In order to determine whether physical
      activity in women with AN differs from that of non-eating disordered women, we will extend
      studies of physical activity to free-living control participants. All adult patients and
      controls will undergo body composition assessment once to measure the association between
      physical activity and percent body fat. Finally, to determine the impact of exercise
      reinforcement and physical activity on outcome in women with AN, we will conduct follow-up
      assessments in all patient participants for one year after discharge from the inpatient
      treatment unit."
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be patients with anorexia nervosa on the inpatient unit at New York State
        Psychiatric Institute
      
Biospecimen description: 
      fasting blood draws to measure cortison and leptin levels
    
Keywords: Anorexia Nervosa; Eating Disorders; Exercise; Physical Activity
Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous
      negative external pressure) for the treatment of obstructive sleep apnea during two weeks of
      home use in subjects of Japanese ethnicity.
    


Intervention name(s): cNEP
Intervention type(s): Device
Intervention description(s): subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
Other intervention name(s): continuous negative external pressure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ethnic Japanese
Study of EXPAREL in Patients Undergoing Breast Augmentation
Condition: Mammoplasty; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, prospective, open-label, non-randomized, sequential study with two
      treatment groups differing only in the technique used for EXPAREL administration
      (instillation or infiltration).
    

Detailed description: 
      Each subject underwent bilateral augmentation mammoplasty and received the same dose of
      EXPAREL. This primary objective of this study was to assess the efficacy of EXPAREL when
      administered via infiltration versus instillation as part of bilateral augmentation
      mammoplasty. The secondary objectives were to further assess other efficacy measures and the
      safety profile of EXPAREL.
    

Intervention name(s): Instillation - EXPAREL; Infiltration - EXPAREL
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.; IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
Other intervention name(s): bupivacaine liposomal injectable suspension; bupivacaine liposomal injectable suspension
Intervention MeSH terms: Bupivacaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mammoplasty; Postoperative pain; Analgesia
Wellness Program for Elementary School Personnel
Condition: Obesity; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The goal of the project is to develop, implement, and evaluate, through a randomized
      controlled trial at a worksite, an intervention to promote increased physical activity
      behavior and healthier eating behavior to reduce overweight and obesity among elementary
      school personnel.
    

Detailed description: 
      BACKGROUND:

      The dramatic increase in the prevalence of overweight and obesity among adults in the United
      States during the past two decades is related to increased cardiovascular disease,
      hypertension, dyslipidemia, diabetes, and other chronic diseases. With 63.9% of working-age
      adults employed, worksites are targets for prevention and intervention programs to control
      overweight and obesity. Worksite interventions have the potential to reach a large number of
      individuals in a common and shared environment.

      DESIGN NARRATIVE:

      This is a group-randomized trial involving 20 elementary schools in Jefferson Parish public
      schools. Schools will be the unit of randomization; 10 schools will be randomly allocated to
      implement the intervention, and 10 schools will serve as controls. The primary aim of the
      program is to reduce mean body weight. Secondary aims relate to changes at both the
      individual level and the environmental level. The intervention will address the two major
      determinants of overweight and obesity: physical activity and diet. A School Wellness
      Committee at each site will be instrumental in identifying and implementing components of the
      intervention.
    

Intervention name(s): Diet; Physical Activity; Environment; Control Group
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Diet; Physical Activity; Environment; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Aerobic Training in Patients With Congenital Myopathies
Condition: Congenital Myopathy
MeSH terms: Muscular Diseases
Study type: Interventional

Summary: 
      Congenital myopathies are clinical and genetic heterogeneous disorders characterized by
      skeletal muscle weakness. Most patients experience muscle weakness and fatigue throughout
      their life. However, progression of symptoms is rare. There are no specific treatments for
      congenital myopathies. Training has been shown to benefit several other muscle diseases with
      weakness, but the defect in congenital myopathies involves contractile proteins of the
      sarcomere, why the effect of training is uncertain in these conditions. The investigators
      will therefore investigate the effect cycle-ergometer training for 30 minutes, three times
      weakly, for ten weeks in 15 patients with congenital myopathy. Another 5-10 congenital
      myopathy patients, who do not train, will serve as controls for the trained patients. The
      study starts and ends with a test day, where efficacy based on VO2max, performance in
      functional tests and a questionnaire will be assessed.
    

Detailed description: 
      10 weeks of cycle-ergometer training at home. Intensity at 70% of maximal VO2,max.
    

Intervention name(s): Exercise on a cycle-ergometer
Intervention type(s): Other
Intervention description(s): Home training on an ergometer-cycle 30 minutes every other day or at least three times a week. Subject will exercise in a pulse interval corresponding to 70% of their maximal VO2.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Congenital myopathy; Exercise
Photochemical Tissue Bonding
Condition: Basal Cell Carcinoma; Squamous Cell Carcinoma; Atypical Nevus
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The broad aim of this study is to evaluate the efficacy of photochemical tissue bonding (PTB)
      for the closure of skin excisions. We will test the hypothesis that full thickness skin
      excisions treated with PTB can heal with less scarring than those treated with the
      conventional suture closure method.
    

Detailed description: 
      Hypertrophic scarring is a frequent endpoint after traditional surgical excision of skin
      cancers of the chest. These scars create significant long-term morbidity to the patient.
      There is a clinical need for an alternative treatment that would reduce factors associated
      with hypertrophic and possibly keloid scar formation by providing minimal tension, low
      infection risk and an absence of foreign body material. This would result in a normal
      appearing and healed scar without associated patient morbidity. Photochemical tissue bonding
      may provide this alternate treatment. PTB differs from sutures by continuously joining the
      tissue surfaces on a molecular level rather than only at discrete suture points. In addition,
      PTB does not incite foreign body reactions nor create tissue injury during passage of the
      needle and tying a knot, injuries that may initiate scarring.
    

Intervention name(s): tissue bonding; sutures
Intervention type(s): Procedure; Procedure
Intervention description(s): application of rose bengal and treatment with green light; interrupted superficial sutures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: skin cancer; skin excision; laser; superficial sutures; wound healing