bioihbjkbjnl/mcl2 huggingface dataset:
Study of Airway Inflammation in Relation to Exercise in Elite Athletes
Condition: Exercise Induced Asthma
MeSH terms: Asthma, Exercise-Induced; Inflammation
Study type: Observational

Summary: 
      High school elite training programs are today more and more under development in several
      'elite sport schools' in Belgium, in order to select and train future elite athletes already
      at young age. Little is known about the effects of sustained training on the potential
      development of asthma in adolescents during lung growth. It would be of great importance to
      be able to select the individuals at risk to develop exercise-induced asthma, already at the
      start of their enrollment in the 'elite sport school. This would allow physicians to follow
      their lung function parameters very closely and regularly; and, if necessary, start treatment
      early after the first signs of exercise-induced asthma.
    

Detailed description: 
      Competitive swimmers, competitive indoor athletes and control individuals performing sports
      at a recreational level will be recruited for the study.

      They will perform a sport-specific training (swimmers and controls: swimming for 90 minutes,
      indoor athletes: basketball or volleyball for 90 minutes)

      Baseline measurements:

        -  Airway inflammation upper and lower airways will be assessed by collection of nasal
           fluid (nasal sponge will be inserted in nostril for 5 minutes), Fraction of exhaled
           Nitric Oxide measurement and sputum induction.

        -  Upper and lower airway symptoms will be assessed by questionnaires (SinoNasal Outcome
           Measure-22, Visual Analogue Score, Asthma Symptom Score and Juniper Score)

        -  Allergy will be assessed by skin prick test (on skin) and immunocap test (in blood, 1
           tube of 10 ml).

        -  Lung function and nasal patency will be measured by spirometry and Peak Nasal
           Inspiratory Flow measurement.

        -  Exercise induced bronchoconstriction will be assessed by eucapnic voluntary
           hyperventilation test.

      Measurements immediately after training:

        -  Collection of nasal fluid

        -  Assessment of upper airway symptoms (Visual Analogue Score)

        -  Spirometry and Fraction of Exhaled Nitric Oxide measurement

        -  Peak Nasal Inspiratory Flow measurement

      Measurements 24 hours after training:

        -  Collection of nasal fluid

        -  Assessment of upper airway symptoms (Visual Analogue Score)

        -  Spirometry and Fraction of Exhaled Nitric Oxide measurement

        -  Peak Nasal Inspiratory Flow measurement

        -  Sputum induction

        -  Venous puncture (1 tube of 10 ml)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Competitive swimmers, competitive indoor athletes and healthy individuals
      
Biospecimen description: 
      induced sputum sample nasal fluid venous blood (serum)
Role of Angiotensin II in Insulin-induced Microvascular Activity
Condition: Insulin Sensitivity; Microcirculation
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      In this study we hypothesize infusion of Angiotensin II improves the insulin-induced
      microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does
      infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced
      insulin-mediated microvascular function in healthy subjects?
    


Intervention name(s): Angiotensin II; Phenylephrine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Angiotensin II; Phenylephrine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Angiotensin II; Giapreza; Angiotensinogen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Angiotensin II
A User Study With Vernivia® for Bacterial Vaginosis.
Condition: Bacterial Vaginoses
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional

Summary: 
      This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness,
      and measure time from start of treatment to symptom relief and measure the clarity of
      instructional material.

      The study will be conducted at seven sites in Sweden, the study population will consist of up
      to 100 female subjects.
    


Intervention name(s): D005 vaginal mousse
Intervention type(s): Device
Intervention description(s): D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
Other intervention name(s): Vernivia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With Phenylketonuria
Condition: Phenylketonuria; Healthy
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This Phase 1/2a, first-in-human, oral single and multiple dose-escalation, randomized,
      double-blinded, placebo-controlled study is evaluating SYNB1618 in healthy volunteers (HV)
      and subjects diagnosed with phenylketonuria (PKU), a rare inherited metabolic disorder that
      occurs in people who are missing an enzyme that the body needs to use phenylalanine (Phe).
      Eligible subjects receive investigational product (IP) in the clinic and undergo safety
      monitoring, evaluations, and subsequent follow-up after IP administration.
    

Detailed description: 
      This study is evaluating the safety, tolerability, kinetics, and pharmacodynamics of SYNB1618
      within the following 2 study parts:

      Part 1 comprises a single-ascending dose (SAD) study conducted over 4 days in HV male and
      female subjects in up to 6 dose cohorts (3 treated:1 placebo) to identify the maximum
      tolerated dose (MTD) within the single-dose range studied. Up to 24 HV subjects are planned
      for enrollment in this part of the study. Following attainment of the MTD in HV, a SAD cohort
      of up to 4 subjects (male and female, ≥ 18 years old) previously diagnosed with PKU will be
      enrolled (3 treated:1 placebo).

      Part 2 comprises a multiple-ascending dose (MAD) study conducted in an inpatient setting (6
      treated:2 placebo) over 10 days in HV male and female subjects in up to 4 cohorts at doses
      not exceeding the MTD from the SAD part of the study to identify the MTD of SYNB1618 within
      the multiple-dose range studied. Up to 32 HV subjects are planned for enrollment in this part
      of the study. Once the highest MAD cohort and the SAD PKU cohort are completed, a
      multiple-dose cohort of male and female subjects (≥ 18 years old) previously diagnosed with
      PKU are evaluated. Up to 20 subjects with PKU are planned for enrollment in the MAD PKU
      cohort (12 treated:8 placebo).
    

Intervention name(s): SYNB1618; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SYNB1618 is supplied in a buffered solution in 5 mL polypropylene cryovials with a nominal 5 mL fill volume, administered with 100 mL of masking buffer solution.; Subjects receive placebo orally in a chilled buffered solution (100 mL).
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose-escalating, randomized, double-blinded, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PKU
The Effect of Ylang Ylang Oil and Lemon Oil
Condition: Pain, Labor; Anxiety; Aromatherapy
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      This study was conducted as a randomized controlled experimental study.To evaluate the
      effects of aromatherapy, one of the non-pharmacological pain methods, on labor pain and
      anxiety in the active phase in primiparous pregnant women.

      The main questions it aims to answer are:

      Is ylang ylang oil applied as an inhaler effective in reducing labor pain and anxiety? Is
      lemon oil applied as an inhaler effective in reducing labor pain and anxiety? Participants
      randomized according to the closed envelope method into the lemon oil group (n=15), ylang
      ylang oil group (n=15) and control group (n=15). In the active phase (cervical dilatation
      ≥5), a drop of essential oil was instilled onto square cotton balls to the intervention
      groups and renewed as one drop every hour until labor occurred. In the control group, 1 drop
      of saline was dripped onto square cotton balls. Visual pain scale (VAS) and state anxiety
      ınventory were applied to the intervention groups and control groups before the application.
      After the application, VAS and state anxiety ınventory were evaluated at 5-7 cm dilatation,
      and only with VAS at 8-10 cm dilatation. The trait anxiety ınventory was administered to the
      volunteers after birth.
    


Intervention name(s): essential oils (Ylang ylang oil); placebo (saline solutions); essential oils (lemon oil)
Intervention type(s): Other; Other; Other
Intervention description(s): inhaler aromatherapy; placebo saline solutions; inhaler aromatherapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: primiparous; labor pain; aromatherapy; lemon oil; ylang ylang oil
A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency
Condition: Pediatric Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase III, Randomized, open-label, positive-drug parallel control, Study to Evaluate the
      Efficacy and Safety of TJ101 in Child subject with growth hormone deficieney.
    


Intervention name(s): TJ101; NordiFlex
Intervention type(s): Drug; Drug
Intervention description(s): TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive TJ101 1.2 mg/kg once a week until 52 weeks back site, investigator evaluate effectiveness and safety.; TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive Recombinant Human Somatropin Injection 0.034 mg/kg once a day, until 52 weeks back site, investigator evaluate effectiveness and safety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456)
      compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)
    


Intervention name(s): Vardenafil (Levitra, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vardenafil 10 mg orally on demand prior to intercourse; Matching placebo
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Vardenafil
Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases
Condition: Chronic Obstructive Pulmonary Disease; Pulmonary Fibrosis
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      To understand current practices of pulmonary physicians in relation to Advanced Care Planning
      (ACP) in order to develop future disease-specific tools that will improve patient-physician
      communication about ACP.
    

Detailed description: 
      The study will be a retrospective, observational study and analysis of charts of patients
      with Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis treated as
      outpatients at the Ohio State University Wexner Medical Center Lung Center. Using
      pre-existing data, we will determine if advanced care planning has been discussed with these
      patients and record this information. For all patients, we will gather data about specific
      demographic and clinical characteristics that may have contributed to the presence or absence
      of these discussions. The study is descriptive in nature and is not powered to detect a
      difference between the two groups. Instead, we aim to describe the characteristics most
      frequently associated with advanced care planning discussion in these two particular groups.

      Potential subjects will be identified with assistance from the Information Warehouse. After
      identification, data will be abstracted from pre-existing data in the electronic medical
      record and collected in a coded fashion for each subject. Each subject will be assigned an
      anonymous subject identification number and all links to identifying information will be
      destroyed prior to analysis. All study data will be stored on a secure password protected
      data base to which only study personnel will have access.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with COPD or pulmonary fibrosis
      
Keywords: Chronic obstructive pulmonary disease; Pulmonary fibrosis; Advanced care planning
Neural Mechanisms of Motor and Cognitive Networks
Condition: Normal Volunteers; Cognition Disorders; Motor Disorders
MeSH terms: Cognition Disorders; Motor Disorders
Study type: Observational

Summary: 
      This study investigates the neural mechanisms of motor and cognitive networks using cognitive
      assessment, reaction time measurement, high-density EEG and fMRI.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers: Advertising recruitment Persons with cognitive impairments: from
        inpatients and outpatients Persons with motor deficits: from inpatients and outpatients
A Study of MK0777 in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-020)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will look at the effect of MK0777on reducing anxiety in subjects with general
      anxiety disorder.

      This is an early phase trial and some specific protocol information is in progress and not
      publicly available at this time. (Full information is available to trial participants).
    


Intervention name(s): MK0777
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of BMS-986195 in Healthy Male Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
    


Intervention name(s): BMS-986195
Intervention type(s): Drug
Intervention description(s): specified dose on specified days
Intervention MeSH terms: Branebrutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Hyperoxia During Cardiopulmonary
Condition: Cardiac Complications
MeSH terms: Hyperoxia
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass
      by his heart preconditioning effect is associated with a lower incidence of cardiac
      arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of
      myocardial ischemia-reperfusion injury in cardiac surgery postoperative.
    


Intervention name(s): medical oxygen
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ESWT as a Treatment for Chronic NHO in TBI Patients
Condition: TBI Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Ossification, Heterotopic
Study type: Interventional

Summary: 
      Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in
      Traumatic Brain Injured (TBI) patients

      Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known
      late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is
      used in various medical situations and is being tested for feasibility of use in TBI
      patients.
    

Detailed description: 
      PROTOCOL SYNOPSIS Title Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic
      Heterotopic Ossification in Traumatic Brain Injured (TBI) patients.

      The investigators primary objective is to determine whether Extracorporeal Shock Wave Therapy
      (ESWT) is effective in reducing pain and improving function in people with traumatic brain
      injury who have heterotopic ossification around the hip or knee.

      The investigators hypothesize that four applications of ESWT to the affected hip or knee
      joint in the patient group will demonstrate a positive physiological effect and this will
      lead to a reduction in pain and improved function.
    

Intervention name(s): ESWT - Extracorporeal Shockwave Therapy
Intervention type(s): Device
Intervention description(s): Patients will receive:
Four applications of EWST to be delivered to the affected hip and /or knee over a period of eight weeks : starting week 8\52 from baseline until and including week 14\52, one dose every two weeks ± 3 days), administered by the principal investigator.
Dosage will be calculated for each participant, by the manufacturer, according to the size of NHO as recorded on X-ray.
The energy flux density (EFD) will be 'high level'
All participants will be supplied with headphones to reduce the noise level emitted by the machine.
Other intervention name(s): Minispec™ extracorporeal shockwave therapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TBI Traumatic Brain Injury; HO Heterotopic Ossification; NHO Neurogenic Heterotopic Ossification; ESWT Extracorporeal Shock Wave Therapy
Emerging Invasive Fungal Infections in Critically Ill Patients
Condition: Fungal Infection; ICU Acquired Weakness
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Study type: Observational

Summary: 
      Rationale: Beside Candida and Aspergillus, emerging invasive fungal infections (EIFIs) are
      increasing in intensive care setting and are associated with high morbidity and mortality.
      However, data are scarce, particularly in ICU settings and for EIFIs other than mucormycosis.

      Objectives: to describe epidemiological trends and clinical features of EIFIs in intensive
      care units (ICU) and to assess their outcome.

      Methods: All records of adult patients diagnosed with an EIFI in a medical ICU between 2006
      and 2019 were analyzed retrospectively. In-ICU mortality was assessed, then factors
      associated with mortality were identified. Survival at day-90 was calculated by the
      Kaplan-Meier method.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients majeurs hospitalisés en reanimation et présentant une infection fongique invasive
        autre qu'une candidose ou une aspergilloses
      
Biospecimen description: 
      NC
    
Keywords: Emergind invasive fungal infection; mucormycosis; ICU
Financial Incentives to Exercise for Adolescents
Condition: Insulin Resistance; Obesity; Sedentary Lifestyle
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Among youth populations, American Indians have the highest prevalence of diabetes in the
      United States. This study will use exercise as the principal lifestyle modification approach
      to reduce the risk of diabetes in this population. The Choctaw Nation of Oklahoma has several
      excellent, but underutilized wellness facilities in their Health Services Area in rural
      Southeast Oklahoma, a low socioeconomic region. It has been established that exercise lowers
      diabetes risk, and many overweight/obese, insulin resistant American Indian youth who live in
      this region would benefit from an increase in regular exercise. The challenge is to modify
      behavior so that routine exercise is established and maintained. The proposed study will test
      whether monetary incentives can elicit greater frequency and duration of exercise in American
      Indian youth when transportation and access barriers are reduced.
    

Detailed description: 
      Study participants in the intervention arm of the study will be asked to exercise on 3 days
      per week for 48 weeks. Clinical and physical assessments will be performed at baseline and
      after 16, 32 and 48 weeks. Participants will be randomized into one of two groups. Each group
      will receive payment for exercise sessions completed but one group will be on a fixed
      schedule of compensation and the other will have a schedule that incentivizes frequency or
      duration of exercise. In addition, two reference groups of age-matched participants who are
      normal weight and subclassified as having either low or high levels of physical activity and
      fitness will be tested. The reference groups will complete baseline tests and will not enter
      the exercise intervention program.
    

Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Gut Permeability and Stress
Condition: Stress
Study type: Observational

Summary: 
      The purpose of this study is to analyse gut permeability and stress.
    

Detailed description: 
      Healthy male volunteers (aged 19-35 years) participate in Trier social stress test while
      saliva and blood samples are withdrawn.

      Saliva will be used for analysis of cortisol and blood will be used for analysis of various
      biomarkers.
    

Intervention name(s): Trier social stress test
Intervention type(s): Other
Intervention description(s): Volunteers perform Trier social stress test
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Healthy men aged 19-35 years old
      
Biospecimen description: 
      Saliva Plasma/Serum