bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Camouflaged Syringe vs Conventional Syringe
Condition: Dental Anxiety; Behavior
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study evaluates the efficacy of Camouflage syringe vs Conventional syringe in reducing
      Dental Anxiety and increasing behaviour rating.Half of the participants received local
      anesthesia using camouflaged syringe, while others received using conventional syringe.
    

Detailed description: 
      Dental anxiety and phobia result in avoidance of dental care. Since the injection itself can
      be painful, pain reduction procedures warrant continued investigation. Camouflage design
      deals with the visual impact of the needle and syringe though the tactile sensation remains
      unaltered. In our study, post treatment anxiety levels in camouflaged syringe was reduced as
      compared to conventional syringe group and this might be because, patients with low anxiety
      tend to have high pain thresholds.
    

Intervention name(s): Conventional Syringe; Camouflage Syringe
Intervention type(s): Device; Device
Intervention description(s): local anesthesia was administered in first group using Conventional syringe; local anesthesia was administered in second group using Camouflage syringe
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: local anesthesia is administered by using either camouflaged syringe or conventional syringe and was compared for reduction in anxiety levels in both groups
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety; Camouflaged syringe; Conventional syringe
PD2i Analysis of Heart Rate Variability in Competitive Sports
Condition: Autonomic Dysfunction
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias
Study type: Observational

Summary: 
      This is a double blind observational analysis of changes in heart rate variability using PD2i
      analyser in competitive athletes during strenuous exercise and competition.
    


Intervention name(s): PD2i Analyzer
Intervention type(s): Device
Intervention description(s): Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        College athletes on competitive teams.
      
Keywords: Heart rate variability; Autonomic dysfunction; Exercise; Sports; Competition; Athletes
The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety
Condition: Hysterectomy; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Purpose: In this study, it was aimed to determine the effect of information and coping with
      anxiety training given to women before they undergo hysterectomy on their anxiety levels.

      Design and Methods: The parallel group post-test randomized controlled experimental design
      was used in the study. The study sample comprised 59 women.
    


Intervention name(s): Information and Coping with Anxiety Training
Intervention type(s): Other
Intervention description(s): Informing and Coping with Anxiety Training was given to the experimental group before the operation through a prepared booklet.The information booklet about the training was created by the researchers by reviewing the current literature. The booklet provides information for patients scheduled for hysterectomy about how to cope with surgery-related anxiety. The booklet provides information on what the hysterectomy is, why it is performed, what risks it has, what should be done before, during and after the hysterectomy, what rules the patient should comply with after hysterectomy, in which cases she should present to the health institution, what changes she might experience in her social, physical, sexual and emotional life after the surgery. The booklet also provides information about discharge training and coping with anxiety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Intestinal Microbiota in COPD and Asthma
Condition: Chronic Respiratory Diseases
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      The composition of the intestinal microbiota, the level of lipopolysaccharides, TMAO in the
      blood, and other parameters of patients with COPD (n=50), asthma (n=50) and the control
      (n=40) will be assessed as factors associated with exacerbations and respiratory symptoms in
      the prospective study (12 months).
    

Detailed description: 
      The patients from "Biobank of blood and feces for the development of a clinical and
      biological platform as a basis for an innovative approach to the prevention of chronic
      non-infectious diseases based on the composition of the intestinal microbiota" study will be
      included (cross-sectional study). The protocol of the above study included the assessment of
      socio-demographic, anthropometric data, clinical blood pressure (BP), ECG, blood tests, fecal
      microbiota studies, spirometry data, diet questionnaire. ABPM, HBP, other questionnaires
      (mMRC, CAT, ACQ-5, GMBQ) will be added to initial data (=visit 1). Than the four visits
      (2-5th visits) in 3 each months will be performed to assess respiratory symptoms,
      exacerbations of COPD/asthma, respiratory infections, therapy, BP, and other parameters. The
      standard statistical methods will be used.
    

Intervention name(s): Identification of the composition of the intestinal microbiota
Intervention type(s): Diagnostic Test
Intervention description(s): Identification of the composition of the intestinal microbiota
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients without COPD, asthma, chronic bronchitis and other lung diseases for control
        group. Patients asthma/COPD with for asthma/COPD groups.
      
Keywords: intestinal microbiota; COPD; asthma; lipopolysaccharides; trimethylamine-N-oxide; course of the diseases; exacerbation
Bioequivalence Study of Sodium Divalproate Tablets 500 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to establish the bioequivalence of two valproic acid
      formulations through the estimation of valproic acid in plasma samples, according to Food and
      Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance
      Institute for Drugs and Food (INVIMA) guidelines.
    

Detailed description: 
      This will be a single-center, open-label, four-period, two-treatment, two-sequence,
      randomized, single-dose, crossover study. 30 healthy adults will be randomized to receive a
      single dose (500 mg) of the test formulation of valproic acid and reference formulation of
      valproic acid separately in each treatment period. There will be two treatment sequences (AB,
      BA) and a 7 day washout between the two treatment periods.
    

Intervention name(s): Valproic Acid 500 MG; Valcote 500 mg
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 500 mg of Valproic Acid; Administration of 500 mg of Valproic Acid
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pre-flight Evaluation of Adult Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of the study is to investigate the relationship between hypoxemia achieved during
      Hypoxia Altitude Simulation test and sea level values of pulmonary function, arterial blood
      gases, pulse oximetry and cardiopulmonary exercise test variables. In addition, to study the
      effect of slow walk in a hypoxic environment, comparable to slow walking along the aisle.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with cystic fibrosis
      
Keywords: Blood gas response; Exercise; Gas exchange; Hypoxia altitude simulation test; Pulmonary function
Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations
Condition: Undernutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      Undernutrition is a widely under-diagnosed public health problem, including in pediatrics
      department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.

      Until now, there has been no national consensus on the criteria to be used to diagnose
      paediatric undernutrition. Until now, assessment focused on a range of non-consensus
      arguments that allowed the health care team to make its diagnosis. So, in the absence of
      well-defined criteria, diagnosis was based in part on experience and assesment team.

      Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has
      suggested recommendations to standardize pediatric undernutrition diagnosis.

      The investigators offer to evaluate undernutrition prevalence differences diagnosed according
      to new HAS criteria compared to the previous diagnostic methodology.

      The investigator's secondary aim is to identify profiles of children who do match between the
      two diagnostics methods.
    

Detailed description: 
      The investigators will conduct a prospective cohort without change in care.

      Following classic patient admission in involved departments, the investigating team moves to
      the department to collect data.

      The measurements and informations collected are no different from those taken in the context
      of normal care.

      All anthropometric measurements correspond to recommendations of good practice.
      Anthropometric measurements will be carried out by the healthcare team.

      With collected data the investigators will evaluate undernutrition for each child, according
      to the 2 diagnostics methods.

      For any diagnosis of undernutrition, the department dietician will be alerted so that the
      patient can be taken care of so it is done normally.

      Data collected are as follows:

      Simple demographic characteristics: Age, sex, departmentsand principal diagnosis
      Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date
      of term of pregnancy. Clinical history: all pathologies or clinical events that may be
      related to a weight variation.

      Assessment of ingesta. A non-opposition will be asked
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children under 18 admitted for hospitalization in the pediatric deparment of the
        Montpellier University Hospital
      
Keywords: Nutrition; Antromopemtric data; Pediatry
A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung
      function in mild asthmatic subjects following allergen challenge.
    

Detailed description: 
      This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way
      cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory
      indices in mild, allergen-reactive asthmatic subjects undergoing allergen challenge.
    

Intervention name(s): IPI-145, a PI3K Inhibitor; Placebo to match IPI-145
Intervention type(s): Drug; Drug
Intervention description(s): Active drug; Comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Allergen Challenge
A Non-investigational Product (IP) Study to Investigate Lung Function in Women in the Third Stage of Labour
Condition: Haemorrhage
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      The purpose of this study is to record and compare the inhalation profiles of non pregnant
      women and those who are in the third stage of labour. The inhalation profiles will be
      recorded from consenting women as they inhale with maximal effort through an inhalation
      profile recorder [Glaxosmithkline (GSK), Ware]. The recorder will simulate resistance to
      airflow and will be representative of a dry powder inhaler of moderate resistivity. The
      inhalation endpoints will include Peak Pressure Drop, Peak Inspiratory Flow Rate, Inhaled
      Volume, Inhalation time, Average Inhalation Flow Rate and Acceleration rate which will be
      compared between the two female cohorts. Inhalation profiles recorded in this way may
      subsequently be used to study the in-vitro performance of investigational materials across
      inhalation parameters representative of the target patient population.

      An appropriate number of subjects will be consented so that approximately 40 subjects (20
      non-pregnant females and 20 stage three labour subjects) complete assessments. The inhalation
      profiles will be recorded on the same day of screening or at another time within a span of 50
      days
    


Intervention name(s): Inhalation profile recorder
Intervention type(s): Device
Intervention description(s): Up to three inhalation profiles will be recorded whilst inhaling with maximal effort
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women: pregnant and non-pregnant non-pregnant female subject is eligible to participate in
        the study if she is in the age group of 18 to 30 years pregnant female will be eligible to
        participate in the study if she belongs to the age group of 18 to 30 years
      
Keywords: Post Partum; Inhaled Oxytocin; Inhalation Profiles
Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
Condition: Behçet Disease; Uveitis
MeSH terms: Behcet Syndrome; Uveitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Brief summary: This study compares the long-term efficacy and safety of interferon (IFN) α2a
      and cyclosporine (cyclosporin A, CsA) following suppression of acute attack by high-dose oral
      glucocorticosteroid in patients with refractory Behçet's uveitis (BDU). Half of the
      participants will receive IFNα2a while the other half will receive CsA.
    

Detailed description: 
      Detailed description: Both CsA and IFNα2a have been shown to be effective for long-term
      control of BDU, however, randomized prospective comparative studies are scarce, particularly
      in East Asian populations. Our preliminary data gave us the impression that IFNα2a might be
      more effectiveness than CsA in long-term control of refractory BDU, and this study aimed to
      compare their effectiveness and safety profiles in a well-designed prospective study.
      Refractory BDU is defined as relapse of posterior or pan- uveitis with at least 10mg daily
      prednisone (or equivalent) and one traditional immunomodulatory treatment (IMT) agents. The
      acute attack is controlled with large dose oral corticosteroid (60mg daily prednisone) for 4
      weeks, and then the patients are randomly assigned to the IFN arm and the CsA arm, in which
      patients are treated with IFNα2a (3×10^6 IU qd for 4 weeks and qod thereafter) and CsA (100mg
      bid), respectively, along with a fixed tapering regimen of corticosteroid. Patients were
      followed up until relapse, or for 12 months.
    

Intervention name(s): Interferon Alfa-2A; Cyclosporine Pill
Intervention type(s): Drug; Drug
Intervention description(s): 3×10^6 IU， subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter; 100mg， oral, bid
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: effectiveness, safety
A MOBILE APPLICATION DEVELOPED FOR CHILDREN WITH URINARY INCONTINENCE
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The study included 2 stages: In the first, a mobile application with content including
      urotherapy training and patient follow-up was developed. In the second, a pilot study with
      the developed mobile application was carried out with 10 children.
    

Detailed description: 
      The study include two stages. In the first, a mobile application was developed that can be
      used by children with urinary incontinence and their parents. The mobile application includes
      the training on urinary incontinence and urotherapy in children as well as all the test
      results of the child and ensures the follow-up of the children's compliance with the
      treatment. The developed mobile application is operatable on smartphones and tablets with
      Android and IOS operating systems.

      This was followed by the second phase, during which the mobile application developed was
      pilot tested with 10 children. Based on the feedback received from the users, the mobile
      application was finalized.

      Mobile application development process

        1. Content Creation For Goals

        2. Interface design development on MS Word and Photoshop

        3. Evaluation by specialists for content and design

        4. Converting to mobile application on Android and IOS platforms

        5. A pilot study with 10 children to evaluate the usability and suitability of the
           application

        6. Get feedback on the mobile app

        7. Based on this feedback, the mobile application was revised.

        8. Its final version was created
    

Intervention name(s): Mobile Application
Intervention type(s): Behavioral
Intervention description(s): a mobile application was developed that can be used by children with urinary incontinence and their parents.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mobile Application; Child; Quality of Life
Trial of Vitamin D3 Supplementation in Paediatric Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Epidemiological and observational studies have linked vitamin D deficiency with increased
      asthma/allergy incidence . Vitamin D insufficiency (<75nmol/L) has been associated with
      increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated
      with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower
      airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and
      allergy and asthma appears to be stronger in children than adults, with some even suggesting
      that childhood asthma may may be caused by VDD.
    

Detailed description: 
      Asthmatic children will be recruited in winter. After baseline testing, children will be
      randomized to take 2,000iu vitamin D or placebo daily for 15 weeks. After the 15 weeks,
      testing will be repeated. Tests involve blood draws, questionnaires and breathing tests.
    

Intervention name(s): Placebo; VItamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.; Soft gel capsules will contain 2,000IU vitamin D.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      To characterize circulating DC subsets from healthy controls and IBD patients and to assess,
      following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and
      golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators
      on both the GI production of soluble immune mediators and the mucosal capacity to alter the
      recruitment capacity of circulating DC subsets. It is expected that such approach will
      provide further information on the action mechanisms of such therapies on IBD patients,
      allowing a better understanding of the pathophysiology of this disease and the identification
      of tissue-specific therapeutic targets, thus avoiding collateral problems associated with
      systemic immunomodulation.
    


Intervention name(s): Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab
Intervention type(s): Biological
Intervention description(s): Ex-vivo conditioning of lamina propria and peripheral blood mononuclear cells.
Here, we will address whether the current available biological therapies for IBD patients (infliximab, golimumab, adalimumab, vedolizumab and ustekinumab) elicit a differential effect on the mucosal capacity to recruit circulating leukocytes on an ex-vivo approach using transwell culture systems.
Intervention MeSH terms: Adalimumab; Infliximab; Golimumab; Ustekinumab; Vedolizumab
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy controls and patients with active inflammatory bowel disease (ulcerative colitis
        and Crohn´s disease).
      
Biospecimen description: 
      Cell culture supernatants