bioihbjkbjnl/mcl2 huggingface dataset:
Prenatal Administration of Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Fetal Rabbit
Condition: Premature Birth; NEC
MeSH terms: Premature Birth
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Infections, particularly on the gastrointestinal tract, has been known to be one of the
      leading causes of death in preterm infants. This is due to the immaturity of the intestinal
      epithelial cells. Recent studies have shown that polyamines have a role on the development of
      cells during embryonal phase. By this experimental study, the investigators would like to
      evaluate the administration of spermine on the maturation of premature fetal gut epithelial
      tight junction.
    

Detailed description: 
      This experimental study is conducted with minimum 24 subjects which divided into 6 groups; 1)
      24-days pregnant and is given prenatal spermine, 2) 26-days pregnant and is given prenatal
      spermine, 3) 28-days pregnant and is given prenatal spermine, 4) 24-days pregnant and is not
      given prenatal spermine, 5) 26-days pregnant and is not given prenatal spermine, and 6)
      28-days pregnant and is not given prenatal spermine. At the end of desired pregnancy period,
      hysterectomy is done and fetus are born. From each parent subject, three fetal samples are
      chosen using a random sampling. Intestinal tissues are taken from each fetal sample to be
      examined. Several data will be collected i.e. occludin, β-catenin, and β-actin, as well as
      histological morphologies.
    

Intervention name(s): Spermine
Intervention type(s): Biological
Intervention description(s): Spermine is a polyamine. It is an organic molecule that is involved in cellular metabolism and development.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Premature Birth; Spermine; Necrotizing Enterocolitis; Tight Junction
Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery
Condition: Bariatric Surgery; Obesity; Weight Loss
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      The goal of this observational study is to assess the efficacy of Realize My Success (RMS),a
      website that allows patients and providers to maintain contact via the website. We will
      compare RMS users on a number of different variables with the goal of identifying which
      variables are associated with optimal outcomes (larger weight losses) at one year (and
      potentially beyond). The study has two primary objectives. The first is to assess changes in
      body weight at postoperative year 1 in frequent v. infrequent RMS users. We predict that
      frequent users will achieve significantly greater reductions in weight at 6 and 12 months
      (and beyond) than infrequent users. The second objective is to assess changes in body weight
      at postoperative year 1 in persons who use different features of the RMS site. We hypothesize
      that persons who, on a regular basis, record their food intake, track their physical activity
      and make specific behavioral goals will experience significantly greater reductions in weight
      beginning 6 months after surgery as compared to those who do not use these features of the
      RMS site.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be men and women, 18-65 years old, with a BMI of 40-70 kg/m2 (or 35-70
        kg/m2 in the presence of co-morbidities) who have registered in the RMS system and have log
        into the system at least once postoperatively.
Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women
Condition: Iron-deficiency; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency (ID) with or without anemia is a major public health problem worldwide,
      especially in women of reproductive age. Iron supplementation can be an effective strategy to
      prevent and treat ID and iron deficiency anemia (IDA). Recent studies suggests that giving
      oral iron every other day would be an optimized dosing regimen with maximized absorption and
      a lower incidence of gastrointestinal side effects compared to consecutive day dosing.
      Long-term trials in which participants and investigators are blinded to the dosing interval
      with iron status and gastrointestinal side effects as study outcomes are needed.
    


Intervention name(s): Consecutive Day Dosing; Alternate Day Dosing
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.; 100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: iron supplementation; dosing regimen; iron sulfate; women of reproductive age
Simulation in Physical Therapy Students
Condition: Simulation Training
Study type: Interventional

Summary: 
      This randomized trial included physiotherapy students, randomized in two groups, experimental
      one included simulation for developed competencies related to clinical reasoning in
      physiotherapy interventions for people with low back pain. The second group developed
      role-playing. this protocol allows us to compare two strategies with simulation for to
      promote clinical decisions in physiotherapy practice.
    

Detailed description: 
      Low back pain (LBP) is symptomatology with a high global prevalence; health professionals,
      including physiotherapists, must have the skills to create professional interaction plans
      that permit a better quality of life for consultants. Clinical simulation can be a pedagogic
      setting that facilitates students with adequate training to acquire skills that improve
      professional reasoning in this clinical situation. The objective of this study was to compare
      the effects of clinical simulation with a simulated patient (SP) versus simulation with
      role-playing (RP) in physiotherapy students for decision-making in clinical skills while
      caring for a person with LBP. Methods. An experimental study, with 42 participants from two
      Colombian universities, randomized into two groups (SP n = 21, RP n = 21). The clinical skill
      was evaluated during the interaction with a person with LBP for which the Objective
      Structured Clinical Examination (OSCE-ML) was validated for individuals with low back pain;
      thereafter, a pedagogical method was conducted that included clinical simulation and,
      finally, the OSCE-ML was applied again to compare both groups.
    

Intervention name(s): Pedagogyc Strategy
Intervention type(s): Behavioral
Intervention description(s): Simulation can be used as a pedagogic tool that provides students with significant learning regarding decision-making in interacting with people, in this case patients with LBP. It is a potential strategy for developing diverse skills focused on the safety of the patient and the therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
A Study of LY2409021 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to
      determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of
      the drug after the dose. This study will last approximately 28 days, not including screening.
      Screening can occur within 30 days prior to the start of the study.
    


Intervention name(s): LY2409021
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery
Condition: Pain, Acute; Opioid Misuse; Obstetric Pain; Cesarean Section Complications
MeSH terms: Acute Pain; Labor Pain; Opioid-Related Disorders
Study type: Interventional

Summary: 
      Background: There is scarce literature investigating how patients dispose of unused opioid
      supplies after their cesarean postoperative pain has faded. The Office of the Surgeon General
      has identified research on the prevention of opioid use disorder area as well as research on
      the management of pain as a "Surgeon General Priority" that needs urgent investigation.

      Hypothesis: At least 33% of postpartum women discharged home with an opioid prescription and
      a drug deactivation pouch will use the pouch to dispose of remaining opioids within 30 days
      of delivery.

      Methods: This is a prospective single arm interventional pilot study.
    


Intervention name(s): Deterra activated charcoal pouch
Intervention type(s): Other
Intervention description(s): drug disposal pouch
Intervention MeSH terms: Charcoal
Intervention model: Single Group Assignment
Intervention model description: This is a prospective single arm interventional pilot study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: opioid disposal; drug deactivation; Deterra
A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral
      semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.
    


Intervention name(s): Furosemide; Rosuvastatin; SNAC; Semaglutide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration A total of three single doses.; Oral administration. A total of three single doses.; Oral administration. A total of five single doses.; Oral administration. Once daily.
Intervention MeSH terms: Furosemide; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease
Condition: Acute Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK,
      activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in
      infants, children, and adolescents ages ≥28 days to <18 years old with either grade II-IV
      aGvHD or grade II-IV SR-aGvHD. The trial design includes four age groups: Group 1 includes
      patients ≥12y to <18y, Group 2 includes patients ≥6y to <12y, Group 3 includes patients ≥2y
      to <6y, and Group 4 includes patients ≥28days to <2y.
    

Detailed description: 
      The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK,
      activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in
      infants, children, and adolescents ages ≥28 days to <18 years old with either grade II-IV
      aGvHD or grade II-IV SR-aGvHD. The trial design includes four age groups: Group 1 includes
      patients ≥12y to <18y, Group 2 includes patients ≥6y to <12y, Group 3 includes patients ≥2y
      to <6y, and Group 4 includes patients ≥28days to <2y.
    

Intervention name(s): Ruxolitinib
Intervention type(s): Drug
Intervention description(s): Ruxolitinib taken orally (5mg tablets) or oral pediatric formulation and dosage based on age group
Other intervention name(s): INC424
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graft versus host disease; GvHD; acute graft versus host disease; aGvHD; Steroid refractory acute graft versus host disease; SR-aGvHD; Ruxolitinib; INC424; allogeneic stem cell transplantation; treatment naive
A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study)
Condition: Type 2 DM Patients With Moderate or Severe Renal Impairment
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal
      impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor
      gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term
      peirod (52 weeks).
    


Intervention name(s): Gemigliptin; Placebo to Linagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: renal impairment
Prognosis of SRD Patients in the ICU
Condition: Systemic Rheumatic Diseases; Intensive Care Unit; Corticosteroids
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Observational

Summary: 
      Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision
      of rheumatic and critical care in recent years. Recent comprehensive data regarding
      in-hospital mortality and most importantly long-term outcome are scarce. The aim of this
      study is to assess short and long-term outcome of patients with SRD admitted to the ICU in a
      retrospective cohort study (2006 - 2016).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive SRD patients admitted to ICUs during the study period
      
Keywords: outcomes; prognostic factors
B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim was to measure the effect of green tea extract, tyrosine and caffeine on
      energy expenditure, appetite ratings and spontaneous energy intake together with recording of
      side effects in healthy normal weight subjects.
    

Detailed description: 
      Background: Long-term weight maintenance of a weight loss is often unsuccessful. Often a
      weight regain is observed in most studies that could indicate that most subjects are not able
      to change their eating habits. There is a need for simple and safe methods to prevent weight
      gain and re-gain i.e. by increasing thermogenesis and decrease spontaneous energy intake
      (EI). Studies have shown that nutritional and food-related non-nutritional factors influence
      the adjustment of EI and EE as the compounds can enhance the diet-induced thermogenesis (DIT)
      and suppress appetite.

      Method: The present study was designed as a 4-way crossover, randomised, placebo controlled,
      dou-ble-blind study. Each treatment was separated by >3 d washout period. All treatments were
      administered as tablets containing either 500 mg green tea extract (whereof 125 mg
      cate-chins), 400 mg tyrosine, 50 mg anhydrous caffeine, or placebo.

      on each test day body weight and composition was assessed. All participants underwent a 4.5-h
      assessment of energy expenditure by indirect calorimetry in a ventilated hood. Energy intake
      recorded of an ad libitum pasta salad brunch served after the last hood measurement

      Subjects: Twelve healthy lean (20<BMI<25) weight stable non-smoking subjects between 18-40
      years of age were tested 4 times each with a wash-out period of at least 3 days.
    

Intervention name(s): tyrosine, green tea, caffeine
Intervention type(s): Drug
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: green tea; caffeine; tyrosine; energy expenditure; energy intake
Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain
Condition: Pelvic Pain; Chronic Pain
MeSH terms: Chronic Pain; Pelvic Pain
Study type: Interventional

Summary: 
      The aim of study is to find out the effects of muscle energy technique versus aerobic
      exercises on pain and disability in patients with chronic pelvic pain.
    


Intervention name(s): Muscle Energy Technique; Aerobic Exercises
Intervention type(s): Other; Other
Intervention description(s): Muscle energy technique (Post Isometric relaxation) three times per week for 8 weeks.
MET of the Iliopsoas
MET of Piriformis muscle
MET of Quadratus Lumborum muscle
MET of Erector Spinae muscle; Aerobic exercise (treadmill walking) three times per week for 8 weeks
Warm-up phase: in which each patient alternately steps their legs forward, backward, and sideways in each direction for 5 min
Active phase: Treadmill speed was 3km/hour for 5 weeks and progress to 4km/hour after 5 weeks for 20 min.
Cool down phase: During a cool down period take a deep breath with both arms overhead and exhale while bringing the arms down, shaking out the legs and arms for 5 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pelvic Pain; Female; Exercise
Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
Condition: Retinal Detachment
MeSH terms: Retinal Detachment
Study type: Interventional

Summary: 
      The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative
      analgesia in intravitreal silicone evacutaion surgery
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study
      and randomized into two groups. Intravenous (IV) cannule with Ringer Lactate fluid,
      non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on
      the subjects in the operation room. Co-induction was done with midazolam 0,05 mg/kg and
      fentanyl 2 mcg/kg. Induction was done with propofol 1-2 mg/kg, followed by Laryngeal Mask
      insertion facilitated by atracurium 0,5 mg/kg. Maintenance was done with sevoflurane 1-2
      vol%, O2:H2O = 1:2, flow 2 liter/minute. Surgery started. After final stitching, Group 1
      received subconjunctival bupivacaine 0,5% 2,5ml in between stitches; Group 2 received
      subconjunctival NaCl 0,9% in between stitches. Both groups received paracetamol 20 mg/kgBW IV
      as post-operative analgesics. Hemodynamic, pain degree (using Visual Analog Scale / VAS), and
      nausea/vomiting incidence, and the time for first requested additional analgesia were
      recorded. Data was analyzed using SPSS (Statistical Package for Social Scientist), for
      numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using
      Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov
      test. Significant value is p<0.05.
    

Intervention name(s): Bupivacaine 0,5%; NaCl 0,9%
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches; NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: bupivacaine; intravitreal; analgesia; silicone oil removal; retinal detachment; subconjunctival
Study of Safety, Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 b placebo-controlled study in healthy volunteers to study safety, efficacy and
      pharmacokinetics of Topical ACD440 on normal skin, skin optimized for penetration and skin
      exposed to ultraviolet radiation
    

Detailed description: 
      This is an exploratory study, no primary or secondary endpoints are being defined.
    

Intervention name(s): ACD440; PLAC
Intervention type(s): Drug; Drug
Intervention description(s): Double blind, parallel within subject comparison; Double blind, parallel within subject comparison
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The addition of heparin and prednisolone increases pregnancy outcome parameters in women
      undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.
    


Intervention name(s): Prednisolone and Heparin during COH for IVF; COH for IVF
Intervention type(s): Drug; Drug
Intervention description(s): Low Molecular Weight Heparin (LMWH) (Enoxaparin Sodium, Clexane, Sanofi-Aventis, Australia) at a dose of 1 mg/kg/day and 5 mg prednisolone p.os (Prezolon; Nycomed Hellas SA) were to be initiated on the first day of injections in both protocols until the pregnancy test. In cases of pregnancy, prednisolone and enoxaparin were to be continued up to the 12th and 34th week, respectively; Both GnRH agonists (long, starting at day 2 or 21) with Triptorelin acetate 0.1 mg (Gonapetpyl daily; Ferring, Kiel, Germany) and antagonists' with ganirelix 0.25 mg (Orgalutran; Organon, Oss, The Netherlands) or cetrorelix 0.25 mg (Cetrotide; Serono, Rome, Italy) protocols will be used; for ovarian stimulation both recombinant FSH (Puregon; Organon, Oss, Netherlands or Gonal F; Serono, Rome, Italy) and human menopausal gonadotrophin (Menopur; Ferring Pharmaceuticals, Langley, Berkshire, UK) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the hCG triggering and for luteal phase support 600 mg progesterone tablets (Utrogestan; Laboratoires Besins- Iscovesco, Paris, France) or gel 8% intravaginally (Vasclor; Verisfield Ltd, UK) will be applied.
Intervention MeSH terms: Prednisolone; Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low molecular weight heparin; Prednisolone; Glucocorticoids; Recurrent implantation failure; Pregnancy rate