bioihbjkbjnl/mcl2 huggingface dataset:
NSAID Drug Interaction Study
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study in healthy volunteers to evaluate the potential
      pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and
      leinurad on the non-steroidal anti-inflammatory drugs.
    

Detailed description: 
      Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both
      prophylactically for the prevention of, and as a treatment for, acute gout flares.
      RDEA594-126 is an open-label study designed to assess the potential effect of multiple doses
      of naproxen and indomethacin on the single-dose PK of lesinurad, and to assess the potential
      effect of multiple doses of lesinurad on the multiple-dose PK of naproxen and indomethacin.
    

Intervention name(s): lesinurad 400 mg; naproxen 250 mg; indomethacin 25 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Naproxen; Indomethacin; Lesinurad
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Prolonged Slow Expiration Technique on Blood Gases Among Pneumatic Neonates
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Pneumonia is a medical condition that, if not treated promptly, can lead to life- threatening
      complications. The prolonged slow expiration technique is a new type of chest physiotherapy
      that helps infants discharge bronchial secretions which accumulated due to pneumonia.
    

Detailed description: 
      Pneumonia is an infective lung condition that is one of the most common risk factors for
      neonatal death. Pulmonary infections, most common caused by anaerobic bacterial infection,
      result in the accumulation of pus in the pleural cavity. Preterms, neonates with respiratory
      infections, and underdeveloped lungs all require the use of a prolonged slow expiration
      technique.

      Prolonged slow expiration technique is the only chest clearance technique that provides both
      effective clearance and a soothing effect. Another recommendation for this technique is lack
      of application of emerging techniques of respiratory physiotherapy. Although the technique is
      effective, it is rarely in practice over the conventional methods of chest physiotherapy.

      During prolonged slow expiration, intrathoracic pressure gradually rises due to
      thoracoabdominal compression, preventing bronchial collapse and flow disruption that occurs
      during forced expirations.
    

Intervention name(s): Traditional chest physiotherapy; Prolonged slow expiration technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Postural drainage: the patient is positioned in postural drainage so that gravity had the maximum effect on the lung segment that needed to be drained, all lung zones are emphasised in positional initiatives for babies.
Percussion is the rhythmic striking of the chest wall with cupped hands for 1 to 2 minutes at a time.
Vibration is performed by placing fingers on the chest wall over the segment being drained and isometrically contracting the forearm and hand muscles to produce a vibratory motion.
Vibration is accomplished either through manual vibratory motion of the therapist's fingers on the infant's chest wall or through the use of a mechanical vibrator ( Foreo vibrator).; The therapist places one hand on the thorax below the suprasternal notch and the other hand over the upper abdomen while the neonate is supine. Both hands will have hypothenar contact with the thorax and abdomen. At the end of the expiratory phase, the therapist places a compression force with both hands. Compression at the end of expiration with hypothenar eminence is kept for 2 or 3 breathing cycles. This technique is repeated several times, with a rest time between applications of about 5 or 10 spontaneous breaths.
Other intervention name(s): Postural drainage; Percussion; Vibration; Foreo Vibrator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation
Condition: Uterus; Scar
Study type: Observational

Summary: 
      We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them
      in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique)
    

Detailed description: 
      It is thought that the formation of the uterine niche may be mostly due to the surgical
      technique.We aimed to compare 3 different uterotomy suture techniques with each other and
      evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN
      technique).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who need to have a cesarean section will be included in the study.participants
        will be randomly divided into 3 groups according to the cesarean section technique.During
        the cesarean section, the uterus will be closed using different techniques for each of the
        3 groups.6 weeks after the operation, they will be called for control and evaluated in
        terms of niche formation. and rezidue myometrial tissue
Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Background: Recent observational studies have reported possible arrhythmogenic effects with
      long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been
      associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object
      of a recent signal in trials of LABAs submitted for marketing approval.

      Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two
      long-acting bronchodilators as well as from monotherapy use of each of the long-acting
      bronchodilators.

      Methods: A series of population-based cohort studies, using both cohort and nested
      case-control analyses will be conducted using data from the United Kingdom's Clinical
      Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting
      bronchodilators from Jan 2002 until Aug 2012, age >= 55 with chronic obstructive pulmonary
      disease (COPD) and at least two years of baseline medical history information. The
      high-dimensional propensity score technique will be used to match new users of each
      long-acting bronchodilator and new users of two bronchodilators with comparable subjects from
      the base cohort, with one-year follow-up for outcomes of acute myocardial infarction, stroke,
      heart failure, arrhythmia and community acquired pneumonia. Data will be analysed using
      time-dependent Cox proportional hazard regression models and conditional logistic regression
      models.
    

Detailed description: 
      Purpose:
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Users of tiotropium or long-acting beta agonists
Yoga for Chronic Headache in Adolescents
Condition: Tension Type Headache; Migraine
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      A randomized controlled trial to investigate the efficacy of yoga on tension type headache
      and / or migraine in adolescents between 12 and 16 years, consisting of a four group design
      which includes an 12 week yoga course and a three-month follow-up period. Both adolescent and
      one parent will be randomized either to yoga or no treatment. Primary outcome will be pain
      frequency in adolescents considering pain catastrophizing of parents.
    


Intervention name(s): Yoga for adolescents; Yoga for parents
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 week hatha yoga course for adolescents; 12 week hatha yoga course
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacity and Safety of Metformin XR in CKD Stage 1 to 3
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and
      there is no available data in chronic kidney disease (CKD). The planned study aims to provide
      data on glucose plasma level in relation to metformin plasma level in Diabetes Type II
      patients.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively)
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes type 2; Metformin; chronic kidney disease; CKD
Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study
Condition: Life Experiences
Study type: Interventional

Summary: 
      The process by which the body responds to stressors to maintain homeostasis is called
      allostasis and is dependent on the integrated function of the nervous, endocrine, and immune
      systems. ACEs adversely affect these system, cause allostatic load, and can modify
      development of allostatic systems. However, the central hypothesis is that exercise can
      reduce allostatic load by positively augmenting function of each of these three systems. No
      previous studies have examined the effects of structured exercise interventions in
      individuals with ACEs. The investigators are studying the effects of 8-weeks of structured
      resistance and aerobic exercise on biomarkers related to nervous, endocrine, immune, and
      metabolic function and several clinical outcomes in young adult women with ACEs. The specific
      aims will test several hypotheses, and are as follows: SPECIFIC AIM 1: Conduct a feasibility
      study to explore whether progressive, structured exercise can help mitigate the adverse
      physiological effects of stress and trauma early in life. SPECIFIC AIM 2: Determine whether
      progressive, structured exercise can help improve health-related quality of life, anxiety,
      and traits like hope, self-efficacy, or self-control, resilience. SPECIFIC AIM 3: Determine
      whether the type and timing of exposure to ACEs has a significant influence on the severity
      of psychopathology and long-term physiological response to ACEs.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Participants assigned to the exercise group will undergo structured, progressive resistance and aerobic exercise for 8 weeks. Resistance training and aerobic training will each be completed twice weekly for a total of 16 resistance and 16 aerobic exercise training sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adverse Childhood Experiences; Exercise Intervention; Inflammation; Resilience; Health
Efficacy of Roflumilast in the Treatment of Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Roflumilast (Daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4
      (PDE4), is used for severe chronic obstructive pulmonary disease. Recent research suggest
      roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial
      is to study the efficacy of oral roflumilast in patients with plaque psoriasis. This has not
      previously been done.
    

Detailed description: 
      Aim: To investigate the efficacy of roflumilast in the treatment of psoriasis.

      Design: Multicentre, double-blinded, randomised, placebo-controlled, clinical trial.

      Participants: Patients ≥18 years with plaque psoriasis.

      Method: Twelve weeks treatment with either roflumilast or placebo tablets. Both groups
      continue for an additional 12 weeks open-label treatment.

      Primary endpoint: Proportion of patients achieving at least 75% reduction from baseline
      psoriasis area and severity index (PASI75) at week 12.
    

Intervention name(s): Roflumilast
Intervention type(s): Drug
Intervention description(s): Treatment according to national roflumilast guidelines
Other intervention name(s): Daxas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Medical Nutrition Therapy Program for Pregnant Women With Diabetes
Condition: Gestational Diabetes; Type 2 Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      No dietary strategies have been designed and proved for Mexican pregnant women with diabetes.
      This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and
      gestational diabetes that were followed every two weeks until labor to assess the impact of
      the MNT program on metabolic control, maternal and fetal nutritional status and cost
      effectiveness. Participants were randomly assigned to one of three medical nutrition therapy
      (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a
      nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with
      an intensive educational component; MNT2 group (n=50) had the same treatment, but included
      only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital
      treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and
      postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose
      concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence
      of complications)will be measured at labor.
    


Intervention name(s): medical nutrition therapy program
Intervention type(s): Other
Intervention description(s): the dietary guidelines were based on the Nutrition Practice guidelines for gestational diabetes developed by the American Dietetic Association. Dietary strategies were based on carbohydrate counting and/or restriction of high glycemic index foods. Even carbohydrate distribution throughout the day was emphasized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: gestational diabetes; medical nutrition therapy program; glucose monitoring; metabolic control; nutritional status; cost effectiveness
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin
      Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults.
      Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose
      of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.
    

Detailed description: 
      This study will be a Phase 1, single-center, randomized, double-blind, placebo-controlled
      design to assess safety and PK of COVID-HIGIV in healthy adults.

      In total, 28 healthy adult subjects are to be enrolled and randomized 2:2:2:1 into four study
      treatment arms to receive a single intravenous (IV) infusion of one of three COVID-HIGIV dose
      levels or saline placebo, respectively.

      The enrollment/dosing of the first seven subjects in the study will be staggered. Available
      safety data will be reviewed by Study Monitoring Committee (SMC) after seven subjects have
      completed at least 72 hours of safety follow-up. Subjects will be followed up for safety and
      PK up to 84 days post-administration.

      The SMC will perform overall ongoing review of safety data during the study.
    

Intervention name(s): COVID-HIGIV; Placebo (saline)
Intervention type(s): Biological; Other
Intervention description(s): COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.; The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
Other intervention name(s): NP-028
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Coronavirus disease 2019; Severe acute respiratory syndrome coronavirus 2; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Artificial Intelligence Assisted Insulin Titration System
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-center, open-labeled, parallel group, randomized controlled trial to access
      the effect and safety of the Artificial Intelligence Assisted Insulin Titration System in
      patients with Type 2 Diabetes Mellitus.
    

Detailed description: 
      The study enrolls 44 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment
      with insulin for at least 3 months. They are randomly allocated into 2 groups at a ratio of
      1:1 after screening for the inclusion and exclusion criteria. Patients in the Intervention
      group receive insulin regimen set by the AI assisted system and patients in Control group
      receive insulin regimen set by physicians. This study will be conducted in the Department of
      Endocrinology, Zhongshan Hospital,Fudan University and consist of a 7-day intervention
      period. Patient allocation will be stratified by HbA1c, BMI and previous total insulin
      doses.The primary endpoint is the percentage of time of sensor glucose measurements in
      targeted range (3.9-10 mmol/L) during the 7-days trial period.
    

Intervention name(s): AI assisted insulin system; Physician based insulin regime
Intervention type(s): Drug; Drug
Intervention description(s): The patients receive the insulin regime set by AI assisted insulin titration system; Patients receive the insulin regime recommended by physicians
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A paralle group, randomized, controlled study to assess the effect and safety of artificial intelligence assisted insulin dosage titration system on glucose control in type 2 diabetic patients
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients
Condition: Malignant Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      vaccination protocol to induce specific immune responses against melanoma associated antigens
      by intradermal injections of mRNA coding for the corresponding antigen
    

Detailed description: 
      vaccination protocol to induce specific immune responses against melanoma associated antigens
      by intradermal injections of mRNA coding for the corresponding antigen. Antigens used are
      Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. GM-CSF is used as an adjuvans.
      Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma
      patients.
    

Intervention name(s): mRNA; GM-CSF s.c.
Intervention type(s): Biological; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor
      agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in
      subjects with GERD who have persistent symptoms while on PPI therapy.
    


Intervention name(s): SSP-002358 (0.1 mg) + PPI; SSP-002358 (0.5 mg) + PPI; SSP-002358 (2.0 mg) + PPI; Placebo + PPI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI; 0.5 mg tablet t.i.d. taken in addition to a PPI; 2.0 mg tablet t.i.d. taken in addition to a PPI; Placebo t.i.d. taken in addition to a PPI
Other intervention name(s): SPD557
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase I Trial Evaluating Safety and Tolerability of CAIV-T in Healthy Japanese Male Adults
Condition: Healthy Japanese Male Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to investigate the safety and tolerability of CAIV-T
      liquid formulation in healthy Japanese male adults.
    

Detailed description: 
      The primary objective of the study was to investigate the safety and tolerability of CAIV-T
      liquid formulation in healthy Japanese male adults by evaluating the incidence of
      influenza-like symptoms, and the type, incidence, and severity of adverse events.
    

Intervention name(s): CAIV-T; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Trivalent cold adapted temperature sensitive attenuated Types A and Type B influenza virus live vaccine (CAIV-T); 0.2 mL of 0.01 mol/L potassium phosphate buffer containing 0.85% sodium chloride (pH 7.2).
Other intervention name(s): 0.2 mL, by nebulizer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention