bioihbjkbjnl/mcl2 huggingface dataset:
Respiratory Health Study of Children in Kiryat Tivon
Condition: Bronchial Asthma; Signs and Symptoms, Respiratory; Allergy
MeSH terms: Asthma; Signs and Symptoms, Respiratory
Study type: Interventional

Summary: 
      Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate
      the health status of children living in K. Tivon.

      The health status will be evaluated using health questionnaires and spirometry.
    

Detailed description: 
      Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate
      the health status of children living in K. Tivon.

      The health status will be evaluated while using health questionnaires and spirometry.

      Objective: To evaluate the respiratory health of K. Tivon children with comparatives, with
      respect to local air pollution levels.

      Material and Methods: All the school children from K. Tivon (1800 children) will be included
      in the study, after both parents and the children (above 12 years of age) will sign an
      informed consent form.

      First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be
      filled in by the parents.

      Second step: Spirometry checking of the children.

      In parallel, air pollution levels will be measured and provided by a network of ground
      monitoring stations maintained by the Haifa District Municipality Association for the
      Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of
      gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation
      window. Additional meteorological data are also collected.

      Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which
      accounts for ambient concentrations of selected pollutants and the heterogenic spatial
      distribution of several demographic and socio-economic indexes in the region.

      The prevalence of pulmonary disease will be evaluated according to the risk maps.
    

Intervention name(s): Minato A 500 AS spirometer
Intervention type(s): Device
Intervention description(s): Spirometry at rest
Other intervention name(s): Spirometer MINATOm AS 500 JAPAn
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Asthma; Allergy; Respiratory; Pollution; Children; Air pollution
Growth Hormone and Endothelial Function in Children
Condition: Growth Hormone Deficiency; Panhypopituitarism; Short Stature
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: This study is designed to determine whether growth hormone treatment in children 8
      to 18 years of age alters function of the lining of the arteries. This may play a role in
      increasing or decreasing the risk of heart disease.

      Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be
      studied before and 3 months after starting growth hormone. Subjects can be on other hormonal
      replacements but no other medications.

      Each study will be done in the fasting state. The blood vessel function will be determined by
      measuring the change in forearm blood flow before and after blocking flow to the arm for 5
      minutes. Blood will be drawn after the test to measure glucose, insulin and fats.
    

Detailed description: 
      The purpose of the research is to learn more about how the lining of arteries in the body
      (called the endothelium) is affected by growth hormone treatment in children and adolescents.
      Poor function by the blood vessels is associated with increased risk of heart disease or
      stroke. This research is being done because growth hormone treatment has been shown to make
      the endothelium work better in adults. Growth hormone treatment may have the same or
      different effects in children because the dose is larger in children.

      Children between 8 and 18 years who are to be started on growth hormone will be eligible to
      participate. Blood vessel function will be studied before starting growth hormone and 3
      months after. This will be done by measuring blood flow to the arm before and after 5 min of
      stopping blood flow to the arm. The three months of growth hormone will be given free.
    

Intervention name(s): growth hormone
Intervention type(s): Drug
Intervention description(s): Growth Hormone treatment
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: growth hormone; endothelial function
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and
      37.5 mg) given to participants daily in the morning compared to placebo in the treatment of
      adults aged 18 to 55 years diagnosed with ADHD.
    


Intervention name(s): SHP465 12.5mg capsules (one capsule daily); Placebo; SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
Intervention type(s): Drug; Other; Drug
Intervention description(s): one capsule daily; Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily); One capsule daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomised Controlled Trial Comparing the Impact of Virtual Reality, Paper and Pencil and Conventional Methods on Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more
      ecologically valid context. The purpose of this study is to determine whether this
      methodology has more impact on stroke rehabilitation than a paper and pencil personalised
      program and conventional therapy, which is motor-focused.
    

Detailed description: 
      Cognitive impairments after stroke are not always given sufficient attention despite its
      limitations in activities-of-daily- living (ADL's). Current cognitive rehabilitation methods
      mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent
      with everyday-life. Besides limited ecological-validity, paper-and-pencil tasks are not
      accessible for most stroke patients whose dominant arm is paretic. Virtual Reality (VR) has
      shown to be a solution for the development of accessible and ecologically valid systems, but,
      does it have more impact than a paper and pencil personalised intervention?

      Through a participatory design approach, with health professionals, the investigators have
      developed:

        -  a motor-accessible and cognitive-personalized VR-based system, where conventional
           cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and;

        -  a web tool which generates personalised paper and pencil tasks( Task Generator).

      The investigators objective is to have a sample of 60 stroke patients between 40 and 70 years
      old, randomly allocated in three groups: the experimental group 1 were participants will
      perform 30 minutes of the VR training with Reh@City; the experimental group 2 were
      participants will perform 30 minutes of the paper and pencil training with the Task
      Generator, and the control group were participants will perform 30 minutes of conventional
      therapy (occupational therapy).
    

Intervention name(s): Virtual Reality; Paper and Pencil; Conventional Therapy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Intervention of 30 minutes, 3 times a week until reaching 12 sessions.; Intervention of 30 minutes, 3 times a week until reaching 12 sessions.; Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; Cognitive Rehabilitation; Motor Rehabilitation; Ecological validity; Personalisation
Deep Friction Massage Effects: Asymptomatic
Condition: Deep Friction Massage
Study type: Interventional

Summary: 
      Despite DFM being a widely-used technique and the empirical grounding regarding the
      importance of the pressure applied, there is no study characterizing the pressure applied
      during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known
      how the amount of pressure applied may influence pain mechanisms and, consequently how it
      affects the time needed promote an analgesic response.

      Having this, our general objective is to establish a dose-response relationship between the
      pressure applied during DFM and time of onset of analgesia, in the asymptomatic patellar
      tendon.
    


Intervention name(s): Deep friction massage P50; Deep friction massage P25; Deep friction massage P75
Intervention type(s): Other; Other; Other
Intervention description(s): Deep friction massage as described by Dr. James Cyriax, applied with the mean pressure (P50); Deep friction massage as described by Dr. James Cyriax, applied with the percentile 25 of the mean pressure (P25); Deep friction massage as described by Dr. James Cyriax, applied with the percentile 75 of the mean pressure (P75)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
Condition: Obesity; Insulin Resistance
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to find out if spironolactone, a drug that blocks the action of
      aldosterone, can make the blood vessels work better in people with obesity. The investigators
      also want to find out whether spironolactone causes changes in levels of insulin and markers
      of inflammation.
    


Intervention name(s): Spironolactone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg once daily for 6 weeks.; Placebo-matching spironolactone once daily for 6 weeks.
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Obesity; Insulin resistance; Mineralocorticoid receptor
Physiological Assessment of the Endothelium - Circadian Rhythm and Role of the Sympathetic Nervous System
Condition: Endothelial Function
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether interventions aimed at increasing
      sympathetic tone modify endothelial function measures as assessed by the measurement of
      flow-mediated dilation (FMD) and constriction (FMC). The investigators hypothesize that the
      three interventions under study will increase FMC while causing a blunting in FMD.

      Further, the investigators plan to study the circadian variability of FMC and FMD. The
      investigators hypothesize a peak of FMD in the late hours of the day and a peak of FMC in the
      early hours.
    


Intervention name(s): Mental stress; no intervention; Myogenic activation; Cold pressure test
Intervention type(s): Procedure; Other; Procedure; Procedure
Intervention description(s): Subjects will be asked to perform complex mathematic operations at a very fast pace; control visit; A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.; A hand will be placed in ice-cold water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endothelial function; sympathetic nervous system
Motor Performance Modulation After Total Knee Replacement
Condition: Total Knee Replacement
Study type: Observational

Summary: 
      Functional recovery after total knee replacement (TKR) is characterized by an incomplete
      muscle strength due to arthrogenic muscle inhibition (AMI) and tendency to estimate the
      functional level. These deficits could be related to alteration of sensory feedback, and
      could influence the ability to modulate patients' motor performance.

      To date, there are not studies investigatin the ability to modulate the motor performance in
      patients with TKR compared to healthy age-matched subjects.

      In this study 20 patients with TKR and 20 healthy will be included . Inclusion criteria are:
      age between 40 and 80 , TKR for primary knee osteoarthritis, knee flexion ≥ 90° and complete
      knee extension, ability to perform a sit to stand on a 46 cm high chair and to walk for at
      least 50 meters without aids. Exclusion criteria: patients undergoing TKR after traumas,
      previous tibial or femoral osteotomy, partial or complete revision surgery. subjects with
      psychiatric and/or cognitive impairments, or with neurological, musculoskeletal or other
      disorders that could influence motor or functional recovery will be also exluded.

      The aim of the study is to investigate the ability in motor performance modulation in
      patients after TKR compared to healthy age-mtched subjects.

      Primary endpoint is to investigate this ability during a leg extension performed in open
      kinetic chain. This ability will be also evaluated during a Sit To Stand and during walking
      (with 10 Meters Walking Test). Secondary endpoint is to investigate pain, rate of perceived
      exertion and perceived load symmetry during the three tests. In both healthy and TKR groups
      these outcomes will be detected two times. In particular, in TKR group, patients will be
      tested the day before surgery and 5 days after surgery.

      This study is aimed at conducting a survey in healthy subjects and in a population of
      subjects undergoing TKR . Participants will undergo an acquisition similar to others already
      described in the literature and without adverse events. Tests will last about 60 minutes and
      during them, will be used the equipment of Motion Analysis Lab of "Humanitas Research
      Hospital".
    


Intervention name(s): TKR
Intervention type(s): Procedure
Intervention description(s): No intervention provided, but investigation of the ability to modulate motor performance during specific and functional tasks in subjects undergoing TKR compared with healthy subjects.
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients: subjects undergoing total knee replacement intervention because of primary
        gonarthrosis.

        Healty subjects: people with no known significant health problems who are recruited to
        participate as controls for a patient Group.
Metformin Use and Vitamin B12 Deficiency
Condition: Vitamin B12 Deficiency; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Vitamin B 12 Deficiency
Study type: Observational

Summary: 
      The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on
      metformin therapy for diabetes.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Outpatient and hospitalized patients with type 2 diabetes mellitus
      
Keywords: metformin; vitamin B12; type 2 diabetes; methylmalonic acid; deficiency
Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces
Condition: Respiratory Device Comfort
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research study will test the comfort of two noninvasive respiratory monitoring sensors
      (the connection to a monitor worn by a person-not the monitor). The two sensors, Masimo
      Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by
      the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting.
      People who enter into the study will wear the two interfaces, one after the other, for 20
      minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without) and
      rate the comfort of each with a seven question survey. A total of 30 participants will be
      recruited.
    


Intervention name(s): Respiratory monitor patient interface.
Intervention type(s): Device
Intervention description(s): Wear each interface for 20 minutes
Other intervention name(s): Masimo Rainbow Acoustic Monitoring sensor; Oridion Smart Capnoline Plus H sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Patient Monitoring; Capnography; Human Engineering
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared
      to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given
      concomitantly with routine paediatric vaccinations.
    


Intervention name(s): 13 valent pneumococcal conjugate vaccine with Polysorbate 80; 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Vaccine; Infant
Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI
Condition: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this clinical study is to compare the lung exposure of the contents of the trial
      drug after administration of the fixed combination between beclomethasone and formoterol
      delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and
      formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device.
      To determine lung exposure, the treatments are administered with charcoal block.
    


Intervention name(s): BDP/Formoterol
Intervention type(s): Drug
Intervention description(s): One single day treatment of CHF 1535 100/6 NEXT DPI®: CHF 1535 dry powder for inhalation (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg per actuation) administered via the NEXT DPI® dry powder inhaler with charcoal block.
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthmatic patients
Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain
Condition: Sacro-Iliac Spondylosis
MeSH terms: Arthralgia; Spondylosis
Study type: Interventional

Summary: 
      Sacroiliac joint injection in sacroiliitis
    

Detailed description: 
      Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection
    

Intervention name(s): Sacroiliac joint injection
Intervention type(s): Device
Intervention description(s): Injection of sacroiliac joint with local anesthetic and steroid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sacroiliac
Detection of COVID-19 Using Breath Analysis - Validation Study
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
    

Detailed description: 
      A diagnostic prospective single-site study, with no anticipated risks or constraints.

      Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to
      distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison
      to the gold-standard testing methodology.
    

Intervention name(s): Breath Biopsy Analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Analysis of a single breath Biopsy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers
Condition: Denture Retention
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a methodology to determine the ability of a denture
      adhesive to restrict food ingress underneath dentures during eating.
    

Detailed description: 
      This will be a single centre, controlled, open label, randomized, three-treatment,
      three-period, cross-over design in participants with full upper and full lower dentures. Each
      treatment period will consist of one day of testing with at least two days between adjacent
      treatment visits. This study will consist of four visits: Visit 1 - Screening Visit; Visit 2
      - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit.
      (Participants will use Test product (denture adhesive) applied to the dentures either in a
      pattern consistent with standard application or applied to the dentures in a pattern of
      continuous strips. Participants will also use no adhesive as a control. Participants will
      cross-over between treatments so that all participants will participate in all 3 treatment
      arms. An hour after the participant has worn their denture, they will chew a portion of
      peanuts in a controlled manner. The peanuts that migrate under the denture during this
      chewing procedure will be collected, washed, dried and weighed. Participant will also answer
      a short questionnaire on the procedure and record the number of times their denture dislodged
      during the chewing procedure. The study hypothesis is that this methodology will enable
      comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of
      denture adhesives at restricting food ingress under dentures during eating.
    

Intervention name(s): Denture Adhesive Cream (Conventional Application); Denture Adhesive (Continuous Strip Application); No Adhesive
Intervention type(s): Device; Device; Other
Intervention description(s): The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05g for the maxillary and 0.60±0.05g for the mandibular dentures.; The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05 g for the maxillary and 0.60±0.05 g for the mandibular dentures.; No adhesive applied.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science