bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Lung Structure and Function of Infants Born Prematurely
Condition: Premature Birth; Bronchopulmonary Dysplasia; Asthma
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth
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. 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: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will be selected from Infant Lung Disease Clinics at Riley Hospital,
        flyer in the community, and the neonatal intensive care unit (NICU) at Riley Hospial for
        Children, Indiana University and Methodist Hospital.
      
Keywords: Infant, Premature; Bronchopulmonary dysplasia; asthma
Mentors in Motion: A Physical Activity Intervention for Obese Adolescents
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Assesing the impact of mentoring on the lifestyle choices of adolescents who are overweight
    

Detailed description: 
      Randomized controlled trial of the impact of weekly contacts with mentors to improve physical
      activity pattern, self esteem, and weight loss in obese teenagers over a 6 month period.
    

Intervention name(s): Behavior modification
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Mentoring; Fitness; Self-esteem
A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, randomized, placebo-controlled, dose-escalation study. Enrollment is
      planned to occur at approximately 14 global sites. Approximately 24 subjects with CF.
    

Detailed description: 
      This is a multicenter, randomized double-blind, placebo-controlled dose-escalation and
      parallel-arm, dose-ranging study. Enrollment is planned to occur at approximately 14 global
      sites. Approximately 24 subjects with CF who are homozygous for the F508del-CFTR mutation
      will be enrolled in two cohorts.
    

Intervention name(s): FDL169; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CFTR corrector; Placebo for FDL169
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cystic Fibrosis
Cereals and Intestinal Function
Condition: Endotoxemia; Diet, Healthy
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      The aim of the present study is to determine the effect of dietary fiber on intestinal
      function in healthy subjects.
    

Detailed description: 
      In the intervention study normal weight participants will receive defined amounts of
      different cereal flakes for several days. Before and after intervention parameters of
      intestinal function will be assessed.
    

Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): Dietary intervention: Participants receive dietary fibers for a defined number of days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management
Condition: Venous Insufficiency; Diabetes
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the
      management of chronic wounds.

      Other goals of this study are to gain feedback from patients and healthcare providers on the
      ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the
      efficacy of DermaStream(tm) in chronic wound management.
    

Detailed description: 
      Until now no expected or unexpected adverse events were occurred
    

Intervention name(s): DermaStream(tm) application and Streaming of Saline
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Pilates-Based Core Stabilization Training in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis (MS) is a chronic, autoimmune and neurodegenerative disease characterized
      by inflammation and progressive demyelination of the central nervous system. It is
      characterized by muscle weakness, balance and coordination disorder, which is more common in
      the lower extremities and trunk muscles. Over time, these symptoms decrease the individual's
      level of physical activity, mobility and quality of life, leading to further deterioration of
      the disorder. One of the most important problems that cause these problems in individuals
      with MS is reduced core stabilization. Decrease in core stabilization affects the quality of
      limb movements as well as trunk stability when considering the kinetic chain in the body.
      Pilates-based core stabilization training (PBCST) are a controlled exercise form used to
      improve the stabilization of trunk muscles. There are no studies on the effect of this
      training on lower extremity isokinetic muscle strength in individuals with MS. The aim of
      this study is to determine the effect of PBCST on lower extremity muscle strength, postural
      sway and kinetic chain in individuals with MS.
    

Detailed description: 
      The study was planned as randomized controlled. Individuals included in the study wiil
      randomly allocate to the group receiving the supervised PBCST and the home exercise group.
      While the supervised exercise group receives PBCST for 2 days and 8 weeks in the clinic, the
      home exercise group will perform the same exercises at home for the same time as the
      brochures prepared for them. The exercise program will show progression at 2-week intervals.
      A session will be held for both groups to teach the basic principles of pilates and will not
      be counted in the 8-week program. At the beginning and end of treatment, individuals will be
      evaluated for isokinetic muscle strength, balance and postural sway, fatigue level, quality
      of life and functional capacity parameters. PBCST is thought to reduce postural sways and
      increase lower extremity muscle strength by increasing core stability with the effect of
      kinetic chain and increased stabilization.
    

Intervention name(s): Pilates Based Core Stabilization Training; Home based exercise
Intervention type(s): Other; Other
Intervention description(s): Pilates-based core stabilization training (PBCST) is a controlled form of exercise provided improvement in stabilization of abdominal and back muscles.; Home exercises which include pilates based core stabilization training will be structured for the people with MS according to their physical condition and will perform at home by them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Pilates; Core stability; Isokinetic strength; Postural sway
Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      The researchers will investigate whether exercise could provide positive effects on general
      brain functions in elderly people with impaired glucose tolerance.
    

Detailed description: 
      The age-related degradation of cognitive functions even to the point of neurodegenerative
      disorders such as Alzheimer's disease are a growing public-health concern with devastating
      effects.

      Referring to animal data, empirical studies, and pilot human trials, exercise should improve
      cognitive functions such as learning and memory. To test this hypothesis, the researchers
      study general brain functions in elderly subjects (50-80 years old) with impaired glucose
      tolerance during a short term exercise program.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 6 months of aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise; elderly; cognition; prevention; cognitive decline; Lifestyle
Self-efficacy Enhancement and Exposure Therapy
Condition: Specific Phobia
MeSH terms: Phobic Disorders
Study type: Interventional

Summary: 
      Self-efficacy refers to the perceived belief to cope effectively, by personal efforts, with
      challenging situations and problems (Bandura, 1977). Basic research has shown that increases
      in perceived self-efficacy can enhance the extinction of fear (Zlomuzica et al., 2015). This
      study is aimed at translating these findings into a useful clinical application to augment
      exposure-based treatment outcome.
    

Detailed description: 
      In this study, the effects of self-efficacy enhancement on treatment outcome in patients with
      height phobia will be investigated.

      Participants will be randomly assigned to one of the following conditions: i) virtual reality
      exposure + self-efficacy enhancement; ii) virtual reality exposure + control intervention;
      iii) virtual reality exposure only. The amount of exposure is identical across groups (i.e.
      maximum of 1 hour of exposure). The self-efficacy and the control intervention involve the
      retrieval of the exposure session with or without a focus on personal mastery
      experiences/achievements, respectively.

      Treatment-induced changes as well as the effects of self-efficacy enhancement will be
      measured on the subjective level (i.e. in-vivo Behavioral Approach Tests, BATs; church
      tower), physiological level (heart rate during the BATs), and subjective level (subjective
      fear during the BATs as well as height-phobia related questionnaires) at each of the three
      assessments (i.e. pretreatment, after which the exposure will conducted on the same day, i.e.
      day 1; posttreatment, which is scheduled approximately 2-3 days after exposure, and follow-up
      assessment, which will take place 1-month after exposure).
    

Intervention name(s): Self-efficacy enhancement; Control intervention
Intervention type(s): Other; Other
Intervention description(s): specific instructions regarding the retrieval of mastery experiences during exposure will be given (e.g., pointing out discrepancies between expected negative consequences and actual outcome during exposure; focus on achievements); specific instructions regarding the retrieval of the exposure session will be given without an emphasis on personal mastery experience (e.g., description of details regarding the virtual reality environment)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: specific phobia; height phobia; exposure; virtual reality; extinction; self-efficacy
Influence of Central Nervous Insulin Sensitivity on Insulin Secretion
Condition: Insulin Secretion
Study type: Interventional

Summary: 
      Insulin resistance is a central pathophysiological component of type 2 diabetes and is
      associated with a high risk of cardiovascular disease. The tissue in which it manifests are
      mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is
      independent of insulin, this organ has traditionally not been studied in this regard. In
      animal experiments, however, knockout of the insulin receptor in the brain leads to obesity
      and peripheral insulin resistance. This finding of insulin action in the brain could also be
      confirmed in human studies.

      The investigators intend to investigate whether central nervous insulin action affects
      insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15
      minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion.
      Insulin sensitivity of the brain is measured by a an established protocol with functional
      magnetic resonance imaging before and after nasal insulin administration.
    


Intervention name(s): intranasal insulin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Controls
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Observational

Summary: 
      Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental
      factors, and particularly toxic drug exposure, in the genesis of scleroderma has been
      suggested.

      This prompted us to conduct this prospective, case-control, multicentric study, including 2
      groups of subjects:

        -  100 patients with scleroderma

        -  300 sex- and age-matched healthy controls. The aim of our study is to determine whether
           exposure to toxics is higher in patients with scleroderma compared with healthy
           controls.
    

Detailed description: 
      The data of patients with scleroderma and healthy controls will be compared regarding:

        -  a standardized questionnaire about "cursus laboris" at initial inclusion

        -  a search for toxics in blood, urine and hair: at initial exvaluation, 6 month and 2
           year-follow-up
    

Intervention name(s): Questionnary for environmental factors research
Intervention type(s): Other
Intervention description(s): Questionnary for environmental factors research
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100 Patients With Scleroderma and 300 Healthy Controls
Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet
      form of the same drug. This study will also study the effect of food on the tablet form of
      the drug.
    


Intervention name(s): AZD2624; AZD2624
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 40 mg AZD2624 liquid suspension, PO; Single dose of 40 mg AZD 2624 (2x20mg tablets), PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers
LumaENT and Patient Satisfaction
Condition: Thyroid
Study type: Interventional

Summary: 
      Patient satisfaction is an important metric currently used to rate quality of healthcare in
      hospitals. Maximizing patient satisfaction scores is therefore significantly beneficial to
      any hospital establishment. Recent studies have shown patient satisfaction depends on
      multiple factors, including patient involvement in treatment decision-making processes and
      patients' knowledge of treatment options. Internal review of departmental patient
      satisfaction survey scores revealed deficits in the aforementioned areas of patient
      satisfaction, with the domains of "how well concerns were addressed", "explanation of tests
      and procedures" and "effort to include patients in decisions" having the lowest scores on
      patient satisfaction surveys. This highlights the gap in patient satisfaction that the
      Otolaryngology department seeks to improve on, so as to maximize patient satisfaction, and in
      turn, the quality of healthcare provided.

      The aim of this study is to assess the improvement in patient satisfaction scores that can be
      obtained by incorporating LUMA ENT™, a disease-specific multimedia patient education
      software, into the treatment decisions for thyroid disorders. LUMA ENT™ is a leading patient
      education software that provides visual anatomic animations of disease processes, disease
      progression and treatment options to improve patients' knowledge. Thyroid disorders have been
      chosen for study due to their high frequency of occurrence in the patient population and
      generalizability to a wide medical audience.

      The investigators will perform a single-blinded randomized-controlled study of patients
      visiting the physician practices of the Department of Otolaryngology for management of
      thyroid disorders. Participants will be randomized into control and intervention groups. Upon
      completion of the routine physician-patient clinical encounter, the intervention group will
      view a 5- minute LUMA ENT™ video discussing their specific thyroid condition, its natural
      progression history, and treatment options. They will have an opportunity to ask the
      physician any further questions that arise from viewing the video. The control group will not
      view the LUMA ENT video. Patient satisfaction surveys will then be provided to both groups at
      the end of the visit as is routinely done and scores subsequently compared.
    


Intervention name(s): LUMA ENT™; Survey
Intervention type(s): Behavioral; Other
Intervention description(s): Demographic and Patient Satisfaction Survey
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab
Condition: Healthy Participants Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC
      dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous
      (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers.
    

Detailed description: 
      This will be a multicenter, randomized, open-label, parallel group Phase 1 study.

      After meeting the eligibility criteria, all eligible participants will be randomized
      1:1:1:1:1:1 to a device group (APFS or AI) for an anatomical injection site as defined in the
      protocol. Randomization will be stratified by protocol defined body weight categories and
      clinical unit.

      The study will comprise:

        -  A Screening Period up to 28 days.

        -  One treatment period during which eligible participants will be admitted to the Clinical
           Unit on Day -1 to reassess their eligibility. Participants who meet eligibility criteria
           will be randomized to receive a single subcutaneous (SC) dose of anifrolumab by either
           APFS or AI device on Day 1. Participants will be discharged on Day 3.

        -  The participants will return to the center for Follow-up Visits on Days 6, 8, 12, 15,
           22, 29, and 43.

        -  A final Follow-up Visit on Day 57.
    

Intervention name(s): Anifrolumab; Autoinjector; Accessorized Pre-Filled Syringe
Intervention type(s): Drug; Device; Device
Intervention description(s): Participants will receive SC doses anifrolumab via AI or APFS.; Autoinjector will be use to administer single SC dose of anifrolumab.; Accessorized Pre-filled syringe will be use to administer single SC dose of anifrolumab.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Monoclonal Antibody; Anifrolumab; Anifrolumab administered using autoinjector; Anifrolumab administered using accessorized pre-filled syringe
NAD+ Precursor Supplementation in Friedreich's Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to test the safety and tolerability of short-term therapy with a
      nicotinamide adenine dinucleotide (NAD+) precursor (MIB-626) in adults with Friedreich's
      Ataxia (FA) without overt heart failure and with a left ventricular ejection fraction ≥ 40%.
      A key secondary objective is to test the effects of MIB-626 on cardiac and skeletal muscle
      bioenergetics.
    

Detailed description: 
      The primary focus for this protocol is safety and tolerability. We will systematically assess
      for adverse events using a safety monitoring uniform report form. We will also use cardiac
      31-Phosphorus-Magnetic Resonance Spectroscopy (MRS) to measure the
      Phosphocreatine(PCr)/Adenosine triphosphate (ATP)- γ ratio before and after treatment with
      MIB-626. In addition, if time permits we will use proton (1H)-MRS to measure skeletal muscle
      nicotinamide adenine dinucleotide (NAD+) before and after treatment.
    

Intervention name(s): MIB-626
Intervention type(s): Drug
Intervention description(s): Two (2) 500 mg Tablets, By Mouth, Daily
Intervention model: Single Group Assignment
Intervention model description: Open Label, 14 Days (+/- 2 Days)
Masking: None (Open Label)
Primary purpose: Other