bioihbjkbjnl/mcl2 huggingface dataset:
Self-Management Assistance for Recommended Treatment (SMART) Portal
Condition: Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Colitis; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      The purpose of the study is to develop, evaluate, and optimize an interactive website (the
      SMART portal). The SMART portal will use IBD-specific and general assessments and
      interventions to reduce the burden of common barriers to treatment adherence and enhance
      self-management skills. This study aims to build and revise the SMART portal according to
      feedback and testing from participants.
    

Detailed description: 
      The study consists of three phases for development and evaluation of the SMART portal. Phase
      1 is the development of online assessments and intervention components. There will be no
      participant interaction with the portal during Phase 1. Phase 2 will consist of one,
      individual interview with patients, caregivers, and clinicians/nurses to interact with a
      portal prototype and provide feedback. Phase 3 will contain an open trial for patients and
      caregivers with baseline, 2-6 months interacting with the portal and progressing through
      applicable intervention components, and post-treatment. Patient test data will also be loaded
      into the portal during Phase 3 for clinicians/nurses to interact with for 2-6 months.
      Feedback from all users will be collected at post-treatment for optimization of the portal.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, caregivers, clinicians, and nurses will be recruited from the IBD clinic at
        Cincinnati Children's Hospital Medical Center.
Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Condition: Craniopharyngiomas; Hypothalamic Obesity
MeSH terms: Craniopharyngioma; Adamantinoma; Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.

      The purpose of the study is to compare the change of body weight after 6 months treatment
      with a lifestyle intervention + exenatide compare to the one after the same lifestyle
      intervention+ placebo in adults patients suffering from a hypothalamic obesity due to
      treatment of craniopharyngioma.
    

Detailed description: 
      The development of glucagon-like peptide-1 (GLP-1) analogues might be a solution since native
      GLP-1 suppresses appetite and energy intake in both normal weight and obese individuals as
      well as in people with type 2 diabetes and delays gastric emptying. The underlying mechanisms
      that mediate the effects of weight involve not only central regions like the hypothalamus and
      the solitary tractus nucleus and area postrema but also peripheral regions as the
      gastrointestinal tract. These extra hypothalamic effects are of particular interest in the
      cases of obesity due to hypothalamic lesions.

      Exenatide is a glucagon-like peptide-1 (GLP-1) analogue with a high structural homology to
      human GLP-1, a gut derived incretin hormone. Since exenatide causes a dose-dependent weight
      loss, decreasing concentration of glycosylated haemoglobin as well as improving ß-cell
      function and systolic blood pressure, it could be an attractive treatment for both type 2
      diabetes and obesity. In a double-blind placebo-controlled 24-week trial, it has been
      recently shown that non diabetic obese patients maintained on exenatide 10µg x 2/j lost
      significantly more weight than did those on placebo (5.1 kg versus 1.6).
    

Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: glucagon-like peptide-1; exenatide; placebo; multicenter trial
Feasibility Study of a Belt Applicator
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a
      belt applicator. Applicator design and treatment parameters will be evaluated.
    

Detailed description: 
      The Zeltiq CoolSculpting System technology for cold-assisted lipolysis will be used with a
      modified belt applicator for the reduction of fat on the outer thigh. This is an open label,
      interventional, non-randomized feasibility study.
    

Intervention name(s): The Zeltiq System with Modified Belt Applicator
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipolysis; Cryolipolysis; Fat Reduction
EBV-TCR-T Cells for EB Virus Infection After HSCT
Condition: EBV Emia and EBV Positive PTLD After Allogenic HSCT
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, single arm, open-label, phase I study to evaluate the safety and
      efficacy of EBV-TCR-T cells in patients with EB virus infection after HSCT.
    

Detailed description: 
      EBV infection is a common virus infection of HSCT, and which is highly related with the
      failure of transplantation and survival time of transplant patients. To evaluate the safety
      and efficacy of allogenic EBV-TCR-T cell therapy in subjects with EBV infection, patients
      with EBV emias or EBV positive PTLD will be enrolled, and donor derived
      EBV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of
      0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be
      monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
    

Intervention name(s): EBV-TCR-T cells
Intervention type(s): Biological
Intervention description(s): EBV-TCR-T cells are prepared via lentiviral infection. patients with EBV emias or EBV positive PTLD will be enrolled, and donor derived EBV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to observe clinical effectiveness of canagliflozin by mean
      haemoglobin A1c (HbA1C) and body weight changes from baseline to 12 weeks in Indian type 2
      diabetes participants.
    


Intervention name(s): Canagliflozin 300 mg
Intervention type(s): Drug
Intervention description(s): Participants who are initiated on canagliflozin 300 mg will be observed. No study treatment will be administered as a part of this study.
Intervention MeSH terms: Canagliflozin
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include Indian type 2 diabetes mellitus (T2DM) participants with body mass
        index (BMI) greater than (>)25 kilogram per meter square (kg/m^2), initiated canagliflozin
        300 milligram (mg) as part of their treatment regimens, in real world clinical setting.
Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      A unicentric, blind, non-comparative clinical study to evaluate the efficacy of a moisturizer
      in reducing clinical symptons of atopic dermatites in children through clinical, subjective
      and instrumental evaluations.
    

Detailed description: 
      A unicentric, blind, non-comparative clinical study to evaluate the efficacy of a moisturizer
      in reducing clinical symptons of atopic skin dermatites in children through clinical,
      subjective and instrumental evaluations.

      Participants will be divided into 2 groups - (Group 1) Microbiome analysis; and (Group 2)
      Acceptabily and efficacy

      Group 1: It will be necessary 13 participants aged between 05 and 12 years old with
      historical of atopia

      The participant will remain in the study for 30 days using the product. Visits will be
      scheduled in D0 and D30. On both visits, samples will be collect to quantify Staphylococcus
      aureus using qPCR

      Group 2: It will be necessary 36 participants aged between 05 and 12 years old with
      historical of atopia

      The participant will remain in the study for 60 days using the product. Visits will be
      scheduled in D0, D7, D30 and D60.

      Instrumental evaluations: It will be evaluate on each visit:

      Skin hidration using Corneometer - D0, D7, D30, D60 Transepidermic water loss using TEWL -
      D0, D7, D30, D60 Skin barrier restoration using Confocal Microscopy - D0, D30, D60

      Participants will respond to a subjective assessment using a questionnaire to capture
      possible feelings of discomfort during the study e subjective efficiency.

      A dermatologist will be available to monitor the participants throughout the study and
      respond a assessment of clinical efficiency.
    

Intervention name(s): Moisturizer containing saccharide isomerate and niacinamide
Intervention type(s): Other
Intervention description(s): Moisturizer containing saccharide isomerate and niacinamide
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cosmetics
Safe Time for Apnea After Preoxygenation
Condition: Anesthesia, General
Study type: Interventional

Summary: 
      The use of 100% oxygen during the induction of general anesthesia is always preferable to
      have enough time to secure the airway by endotracheal intubation, because preoxygenation with
      a low oxygen concentration may reduce the safe time for apnea. However, using a low oxygen
      concentration during preoxygenation might prevent the formation of atelectasis. There is
      still no clear conclusion about the best oxygen concentration for preoxygenation. Our study
      is designed to evaluate the safety of preoxygenation with 80%, 60%, 40%, 30% and 21% oxygen
      by the safe time for apnea during the induction of general anesthesia.
    

Detailed description: 
      We decide to add 3 groups (80%, 60%, and 40% oxygen) in our study to fully evaluate the
      safety of preoxygenation with different oxygen concentration.

      Zijia Li 2018.3.2
    

Intervention name(s): 100% Oxygen; 30% Oxygen; 21% Oxygen; 40% Oxygen; 60% Oxygen; 80% Oxygen
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Conventional preoxygenation with 100% oxygen; preoxygenation with 30% oxygen; preoxygenation with 21% oxygen; preoxygenation with 40% oxygen; preoxygenation with 60% oxygen; preoxygenation with 80% oxygen
Other intervention name(s): 100% O2; 30% O2; 21% O2; 40% O2; 60% O2; 80% O2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Preoxygenation; Oxygen Concentration
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
Condition: Hypertension; Vascular Diseases
MeSH terms: Hypertension; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which
      aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise in Europe)
      for renal denervation therapy in patients with treatment resistance hypertension, in
      comparison with the sham procedure.
    

Detailed description: 
      Patients with treatment resistance hypertension is defined patients being treated on 3 or
      more different classes of antihypertensive medications including diuretics.
    

Intervention name(s): PRDS-001 Renal Denervation Ultrasound System; Sham Procedure
Intervention type(s): Device; Procedure
Other intervention name(s): renal denervation; renal angiography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: denervation; resistant hypertension
Soy Formula Feedings in Healthy, Term Infants
Condition: Gastrointestinal Tolerance
Study type: Interventional

Summary: 
      This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term
      infants with reported intolerance to a milk-based formula.
    


Intervention name(s): Experimental Infant Formula 1; Experimental Infant Formula 2; Experimental Infant Formula 3; Active Comparator: Control Infant Formula
Intervention type(s): Other; Other; Other; Other
Intervention description(s): method A phytate reduction and 5% protein hydrolysis; method A phytate reduction and 10% protein hydrolysis; method B phytate reduction and 5% protein hydrolysis; Ready-to-Feed (RTF) Soy Infant Formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether calcium plus vitamin D supplementation is
      conducive to weight and fat loss during energy restriction in very-low calcium consumers.
    

Detailed description: 
      Due to the contradicting findings in the hypothesis of calcium supplementation on weight and
      fat loss, which might be explained by the difference in initial calcium intake, the present
      study is aimed to evaluate the effect of calcium plus vitamin D supplementation on
      accelerating weight and fat loss in overweight or obese subjects with very-low calcium
      consumption(<600mg/day).

      The hypotheses to be tested are:

      Calcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight
      or obese young adults during energy restriction 12 weeks after randomization.
    

Intervention name(s): Calcium Carbonate; Energy restriction
Intervention type(s): Drug; Behavioral
Intervention description(s): tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks; A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Other intervention name(s): Caltrate® 600 + D; Code:1007300
Intervention MeSH terms: Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Calcium Carbonate; Vitamin D; Body weight; Body fat; Metabolic parameters; Energy restriction; Very-low calcium consumers; Obesity; Overweight
Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fasting Condition
Condition: Fasting State
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single
      dose pivotal study. The purpose of this study is to assess the bioequivalence between Test
      Product and the corresponding Reference Product under fasting condition in normal, healthy,
      adult, human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India and the
      corresponding Reference Product: Seroquel® (Quetiapine fumarate) Tablets 25 mg of M/s
      AstraZeneca Pharmaceuticals LP, USA, under fasting condition in normal, healthy, adult, human
      subjects in a randomized crossover study.

      The study was conducted with 54 healthy adult subjects. In each study period, a single 25 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Quetiapine Fumarate Tablets 25 mg; Quetiapine Fumarate
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg tablet once a day; 25 mg tablet once a day
Other intervention name(s): Test Product; Seroquel®
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Probiotic Yogurt in Obese Women
Condition: Obesity; Dysbioses
MeSH terms: Dysbiosis
Study type: Observational

Summary: 
      This study aimed to examine the effects of using probiotic yogurt on body components (body
      weight, height, etc.) and digestive system (distention, gas, etc.) in obesity (obese women),
      which is an important public health problem all over the world.
    

Detailed description: 
      Obesity is an important public health problem worldwide and is associated with
      non-communicable diseases such as Type 2 Diabetes, hypertension, coronary heart disease,
      hyperlipidemia, non-alcoholic fatty liver, some neoplasms, and infertility disease.However,
      it is supported by the literature that nutrition and obesity cause microbial dysbiosis.

      In this study, it was aimed to use probiotics and yogurt with the thought that nutrition can
      manipulate the microbiota.

      It was aimed to investigate the effects of probiotic yogurt consumption on anthropometric
      measurements, metabolic parameters, and gastrointestinal symptoms in obese women (25-45 years
      old) with the prospective method.

      The study was carried out in patients who were diagnosed with obesity by the doctor,
      consulted the Dietitian, and accepted + signed the voluntary consent form.

      Total data and measurements were followed and recorded by the same Dietitian. Compliance with
      medical nutrition therapy, recording of scales were followed weekly.Patients diagnosed with
      COVID-19 during the study were excluded from the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        She was diagnosed with obesity by a doctor at Malatya Turgut Özal University Training and
        Research Hospital and was consulted to the Diet Polyclinic for appropriate Medical
        Nutrition Therapy; patients aged 25-45, female, with a BMI of 27 -35 kg/m2, who read and
        signed the voluntary consent form.
Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia
Condition: Pregnant Women
Study type: Interventional
Phase: Phase 3

Summary: 
      The addition of morphine to a local anesthetic when performing an epidural analgesia during
      labor analgesia has improved the efficiency and the action duration of analgesia. One
      limitation of this technique is the time of installation of the analgesic effect (about 30
      minutes) when using the only epidural. Therefore, the technique of sequential combined spinal
      epidural was introduced. This is to shorten the installation time by direct injection into
      the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been
      shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the
      effect of the local anesthetic.
    

Detailed description: 
      Compare the results of obstetric analgesia by sequential combined spinal epidural with local
      anesthetic injection associated with morphine and a sequential obstetric analgesia by
      sequential combined spinal epidural with local anesthetic injection alone
    

Intervention name(s): experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil).; control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone.
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sufentanil; Morphine; Levobupivacaine; Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
Condition: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
MeSH terms: Substance-Related Disorders; Amphetamine-Related Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension,
      hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare
      cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of
      cardiovascular and adverse effects of MDMA is unknown.
    

Detailed description: 
      We investigated the interactive effects of the beta-blocker pindolol (20 mg) with MDMA (1.6
      mg/kg) on heart rate, blood pressure, body temperature, and adverse effects in a double-blind
      placebo-controlled study in 16 healthy subjects.
    

Intervention name(s): MDMA; Pindolol
Intervention type(s): Drug; Drug
Intervention description(s): capsule, 1.6 mg/kg body weight, single dose; capsule of 20mg pindolol, single dose 1h before MDMA
Intervention MeSH terms: Pindolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MDMA; beta adrenergic; Ecstasy