bioihbjkbjnl/mcl2 huggingface dataset:
Zero Positive End-expiratory Pressure Before Emergence Prevents Postoperative Atelectasis.
Condition: Atelectasis; Oxygenation
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      A study on healthy patients undergoing anesthesia for non-abdominal surgery - evaluation of
      positive end-expiratory pressure versus zero positive end-expiratory pressure on the amount
      of atelectasis in the early postoperative period.
    

Detailed description: 
      Positive end-expiratory pressure (PEEP) is often used during mechanical ventilation to
      preserve end-expiratory lung volume. After emergence and extubation, this volume will
      diminish instantly. Some patients will have difficulties to restore functional residual
      capacity (FRC) during the early phase of recovery. If routine high FIO2 has been delivered
      together with maintained PEEP prior to extubation, several important prerequisites are
      established for the development of postoperative atelectasis. The investigators hypothesize
      that establishing zero positive end-expiratory pressure (ZEEP) immediately prior to emergence
      preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal
      areas of the lungs, and thereby prevent postoperative atelectasis formation.

      This randomized controlled study will study patients undergoing non-abdominal day case
      surgeries under general anesthesia. The patients in the two study groups will receive
      mechanical ventilation with identical settings, comprising low TV, moderate PEEP, and no RM.
      At the end of surgery, the lungs will be examined by CT, and any atelectasis areas will be
      calculated. Randomization will occur after the first CT. The patients will be allocated to
      zero PEEP (ZEEP) or maintained PEEP during emergence preoxygenation and extubation.
      Importantly, the intervention group will have ZEEP established while still having low ETO2
      levels, prior to any preoxygenation. The study subjects will be examined with CT no.2
      approximately thirty min after extubation. Primary endpoint measure will be atelectasis area
      as a percentage of total lung area. Blood gases will be collected for comparison of
      oxygenation as a secondary outcome measure.
    

Intervention name(s): ZEEP; PEEP
Intervention type(s): Procedure; Procedure
Intervention description(s): Zero positive end-expiratory pressure (ZEEP) during emergence preoxygenation and awakening.; Positive end-expiratory pressure remains during emergence preoxygenation and awakening and until the study subject is extubated.
Other intervention name(s): Device: Ventilatory setting ZEEP; Device: Ventilatory setting PEEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atelectasis; Oxygenation; Positive end-expiratory pressure; Mechanical ventilation; General anesthesia; Computed tomography
Effects of Deep Brain Stimulation (DBS) Frequency on Neural Synchrony
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of low frequency deep brain stimulation
      on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the
      cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech.
      This study will provide insight into what the effects of low frequency stimulation are on
      neural synchrony.
    


Intervention name(s): DBS (Deep Brain Stimulation)
Intervention type(s): Other
Intervention description(s): Applying low frequency and high frequency deep brain stimulation to subthalamic nucleus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; DBS; Deep Brain Stimulation; Subthalamic Nucleus
Comparison Between Sit-to-stand Test and Six-minute Walk Test in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Comparison between sit-to-stand test and six minutes walking test in chronic obstructive
      pulmonary disease patients
    


Intervention name(s): sit-to-stand test; six-minutes walking test
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that checking blood sugar and taking long and short acting insulin before
      lunch at school may improve overall blood sugar control, grades, and decreases school
      absences in children and teens with poorly controlled T1DM.
    

Detailed description: 
      The Diabetes Control and Complications Trial (DCCT), for type 1Diabetes (T1DM), showed the
      importance of intensified diabetes control in helping reduce complications associated with
      poorly controlled diabetes. However, adolescents with T1DM continue to be a high-risk
      population due to the difficulties in coping with the physical, emotional, and social demands
      associated with managing diabetes themselves.

      We propose to use the school nurse to help with lunchtime blood sugar monitoring (BSM) and
      with a lunchtime insulin injection. We want to see if this will improve blood sugar control,
      improve school grades, and decrease absences from school in adolescents with poorly
      controlled diabetes. Subjects will receive 12 weeks of this treatment to see if they will
      have improved glucose control. We hope to improve blood sugar control, school grades and
      decrease absences from school in teens with poorly controlled diabetes.
    

Intervention name(s): glargine insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Poorly controlled glucose; adolescents
Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The investigators know that adherence to medications in children with cystic fibrosis (CF) is
      poor. Forgetfulness has often been reported as a barrier to adherence by both CF patients and
      their parents. Many of the investigators patients also report being motivated by the results
      of their lung function studies (PFTs) to stay adherent to their medications. In this study,
      the investigators would like to see if providing medication reminders and allowing patients
      to measure their lung function at home will lead to better adherence. This will be a pilot
      study to determine the feasibility of providing such as a device to children with CF.
    

Detailed description: 
      This is a randomized controlled trial to assess the impact of home lung function monitoring
      and medication reminders on adherence, clinical outcomes and quality of life in children with
      cystic fibrosis (CF) who are between 10 and 21 years of age.

      Participants will be randomly assigned to either an intervention group or a control group.
      Those in the intervention group will receive a personal spirometer device that provides
      medication reminders and allows for lung function monitoring at home. The control group will
      receive the current standard of care. All participants will be aware that their adherence is
      being monitored over the course of the study using prescription refill data. Changes in lung
      function, body mass index and rate of hospitalization will be used as measures of clinical
      outcome. Responses to age-appropriate well-validated patient questionnaires will be used to
      assess the impact of the investigators interventions on quality of life and perceptions of
      treatment burden.

      Since this device has never been previously studied in this patient population, the
      investigators would like to do a pilot study with 5 patients (3 in the intervention group and
      2 in the control group) over a 3-month period to determine feasibility. This will also help
      us with the investigator power calculations and ultimately deciding the number of
      participants that will be needed for the larger study.
    

Intervention name(s): Spiro PD personal spirometer
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Safety and Efficacy of KW-136 and Sofosbuvir for Treatment of Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed to evaluate the safety and efficacy of KW-136, an investigational
      anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults
      chronically infected with HCV. Thirty (30) non-cirrhotic subjects were medicated with KW-136
      30 mg daily, 60 non-cirrhotic subjects with KW-136 60 mg daily, and 30 cirrhotic subjects
      with KW-136 60 mg daily; all the 120 subjects received sofosbuvir 400 mg daily. The treatment
      course lasted 12 successive weeks and thereafter all the study participants entered into a
      12-week treatment-free follow-up period.
    

Detailed description: 
      It is estimated that China has a population of over 10 million infected with HCV and also a
      highly variable HCV genotype geographic distribution. A simple, universal,
      non-genotype-specific treatment regimen is preferred for anti-HCV treatment in clinical
      practice and public health. KW-136 and sofosbuvir are potent anti-HCV agents targeting at
      different HCV proteins, namely, nonstructural protein 5A and 5B, respectively. The
      combination regimen of KW-136 and sofosbuvir is expected to completely suppress HCV
      replication in subjects chronically infected with HCV and achieve a sustained virologic
      response, namely, HCV not detected or below a predefined limit in plasma, 12 or 24 weeks
      after cessation of treatment.

      As KW-136 and sofosbuvir are both pan-genotypic anti-HCV agents (in simple words, effective
      for all known common genotypes of HCV), the combination of these two agents is also supposed
      to be efficacious for treatment of subjects chronically infected with HCV of all major
      genotypes and subtypes. An apparent clinical benefit of this pan-genotypic anti-HCV treatment
      regimen is that no complex, delicate HCV genotype sequencing is required before initiation of
      treatment to determine genotype-specific treatment alternatives of choice. This advantage is
      of great significance in the primary care setting.
    

Intervention name(s): KW-136; Sofosbuvir
Intervention type(s): Drug; Drug
Intervention description(s): KW-136 30 mg was provided in 3 capsules, 10 mg each, and KW-136 60 mg in a single capsule of 60 mg.; Sofosbuvir was provided in a single tablet of 400 mg.
Other intervention name(s): Coblopasvir
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel, stratified assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Hepatitis C virus; KW-136; sofosbuvir; nonstructural protein 5A; nonstructural protein 5B; panogentypic regimen
Growth of Airways and Lung Tissues in Premature and Healthy Infants
Condition: Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Asthma
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth; Infant, Premature, Diseases
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the growth of the lung and how easily gas can be
      taken up by the lung in healthy infants born at full term without any breathing problems and
      infants born prematurely.
    

Detailed description: 
      SPECIFIC AIM # 1: Determine the relationship between parenchymal tissue and alveolar volume
      with normal lung growth early in life We hypothesize that during the first two years of life
      that parenchymal surface area and alveolar volume increase with somatic growth; however, the
      ratio of surface area to volume remains constant, while ventilation within the lung becomes
      more homogenous.

      SPECIFIC AIM # 2: Determine the pulmonary sequelae of premature birth and assess the
      effectiveness of early treatment strategies upon the pulmonary sequelae.

      We hypothesize that premature birth impedes growth and development of the lung parenchyma and
      the airways at a corrected-age of 1-year. In addition, initiating continuous positive airway
      pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will
      improve lung growth and lung function compared to treatment with early surfactant and
      conventional ventilation.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We are recruiting premature infants from Riley Hospial for Children, Methodist Hospital and
        IU NICu's. We also recruit from the Infant Lung Disease clinic at Riley Hospital for
        Children. Healhy full term infant are recruited through advertisements.
      
Biospecimen description: 
      Buccal Cells are being obtained.
    
Keywords: infant, premature; Bronchopulmonary dysplasia; asthma
Cognitive Training for Depression II
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study is evaluating the effects of two brain training exercises on: memory, cognitive
      processing and depression symptoms.
    

Detailed description: 
      There is an urgent public health need to develop more effective and well tolerated treatments
      for patients with major depressive disorder (MDD); cognitive training interventions aiming to
      modify cognitive and affective processing abnormalities underlying MDD represent a promising
      new strategy. This research project translates a well established cognitive bias in major
      MDD, working memory bias, into a novel intervention target. In a double-blind, randomized,
      controlled study, MDD participants undergo 6 weeks of cognitive training sessions, with three
      sessions per week.
    

Intervention name(s): Cognitive Training A; Cognitive Training B
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive training; Depression
Laser Acupuncture for Postpartum Weight Retention
Condition: Postpartum Weight Retention
MeSH terms: Body Weight; Gestational Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective: To determine the therapeutic effect of acupuncture on postpartum weight retention.

      Methods: 66 subjects after delivery with postpartum weight retention will be randomly divided
      into laser acupuncture and control group. A single-blind clinical trial will be conducted and
      the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. After
      about 3 weeks of treatment, the differences of the subjects' body weight, body mass index,
      and waist circumference will be analyzed with ANOVA between laser acupuncture and control
      group.
    

Detailed description: 
      Objective: Gestational weight gain and weight retention at 1 year after delivery are
      associated with long-term obesity. The investigators aimed to investigate the effect of laser
      acupuncture therapy (LAT) on postpartum weight control.

      Methods: The investigators randomly assigned 66 subjects with postpartum weight retention to
      a laser acupuncture group and control group. The subjects were treated at acupoints including
      the Stomach and Hunger points of the ear, ST25 (Tianshu), ST28 (Shuidao), ST40 (Fenglong),
      SP15 (Daheng), CV9 (Shuifen), and SP6 (Sanyinjiao) by using verum or sham laser acupuncture
      over 5 sessions per week. After 12 treatment sessions, the differences in the body mass index
      (BMI), body fat percentage (BFP), and waist-to-buttocks ratio (WBR) of the patients were
      analyzed, and compared between the laser acupuncture and control groups via analysis of
      variance, chi-square tests, and stepwise regression tests.
    

Intervention name(s): laser acupuncture; sham laser acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total.; Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group.
Other intervention name(s): low-level laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser acupuncture; Postpartum weight retention; Obesity
Effect of Snacks on Appetite Control
Condition: Healthy Canadians; Appetite Control
Study type: Interventional

Summary: 
      This clinical trial is being conducted to study whether eating certain snacks will reduce
      your desire to eat and for a longer period of time compared to other snacks. The
      investigators are testing 2 different snacks. Study #1 will involve eating 2 different
      seed-like snacks or water. Study #2 will involve eating pita bread with jam, bread with jam
      or water. The test snack is higher in protein and/or fibre compared to the reference product.
    

Detailed description: 
      Healthy adults will be recruited to participate in a randomized, controlled, crossover study
      to investigate whether or not eating snacks made with buckwheat would increase satiety and
      reduce their energy intake when compared to a comparable snack. Water was included as a
      non-caloric control. The study consisted of 3 visits and participants would receive a
      different treatment at each visit. Visits were scheduled at least 7 days apart. Visual analog
      scales will be used to assess appetite related sensations at 7 time points, fasting, 30
      minutes after consuming the snack and then at 30 minute intervals for 180 minutes.
      Participants will be provided with a lunch and the amount of food consumed will be weighed. I
      addition, participants will be asked to maintain a food record for the remainder of the day.
    

Intervention name(s): gluten-free high protein snack #1; gluten-free snack with similar energy density but 1/2 the protein as snack #1; non-caloric control; gluten-free high protein and high fibre snack #2; gluten-free snack with similar energy density, but less protein and fibre than snack #2
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): buckwheat groats 30g serving; 32g serving of corn nuts; water; buckwheat and pinto bean flour pita bread 50g serving; 50g serving of rice bread
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover
Masking: Single (Participant)
Primary purpose: Other
Keywords: satiety; appetite; snack
SUBLIVAC FIX Birch Phase III Short-term Efficacy
Condition: Birch Pollen Induced Rhinitis/Rhinoconjunctivitis
MeSH terms: Rhinitis; Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in
      reducing birch allergy induced symptoms and birch allergy medication usage.
    


Intervention name(s): SUBLIVAC FIX Birch
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sublingual immunotherapy; birch pollen; allergic rhinitis / rhinoconjunctivitis; efficacy
Employing eSBI in HIV Testing for At-risk Youth
Condition: HIV; Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility, acceptability and test the initial
      efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with
      STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who
      have sex with men) and YTW (young transgender women) on frequency of substance use and
      engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis)
      care continuum.
    

Detailed description: 
      The purpose of this study is to assess the feasibility, acceptability and test the initial
      efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with
      STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who
      have sex with men) and YTW (young transgender women) on frequency of substance use and
      engagement within the HIV and PrEP (pre-exposure prophylaxis) care continuum. We will do this
      with the following aims:

      Aim 1: Assess the feasibility, acceptability and initial efficacy of electronic Screening &
      Brief Intervention + Seek, Test, Treat and Retain (eSBI+ STTR) compared to STTR-only to
      reduce alcohol and other substance use among 450 YMSM and YTW in Chicago, ages 16-25, at 1,
      3, 6, and 12 months post-intervention.

      Aim 2: To explore the initial efficacy of eSBI+STTR in comparison to STTR-only on secondary
      exploratory outcomes within the HIV and PrEP care continuum among YMSM and YTW.

      Aim 3: Determine the degree to which sub-groups of youth are differentially impacted by
      eSBI+STTR based on socio-demographic characteristics and co-morbid mental health problems to
      inform future targeting and/or tailoring of the intervention.
    

Intervention name(s): Alcohol Use BI; Nutrition Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Those who are randomized to the intervention will complete eSBI, an electronic brief intervention for substance use, which is comprised of 11 topical areas, each with a single webpage, in a motivational interviewing (MI) format. MI is a client-centered behavioral change approach.; Those randomized to the control will complete the attention control modules, a non-active brief time-matched attention control intervention of equal length (i.e., encouraging nutrition).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Substance Use