bioihbjkbjnl/mcl2 huggingface dataset:
Active Video-game Playing and Food Intake in Children
Condition: Appetitive Behavior
Study type: Interventional

Summary: 
      The purpose of this experiment is to investigate the effect of active video game playing for
      30 minutes on food intake and subjective appetite. The investigators hypothesize that video
      game playing will affect food intake in children. Food intake will be measured at 30 minutes
      following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg
      Sucralose® in 250ml of water) beverage with or without active video game playing. Subjective
      appetite will be measured at 0, 15, 30 and 60 minutes.
    


Intervention name(s): Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Repeated measures cross-over design.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: appetite, food intake, active gaming
Rudolph: Nasal Microbiota With Red and Sore Nose
Condition: Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      This pilot study will utilize the experimental rhinovirus infection model to study changes in
      skin microbiota in relation to skin erythema and soreness.
    


Intervention name(s): Rhinovirus Challenge
Intervention type(s): Other
Intervention description(s): Challenge with HRV-16 virus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food
      effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers
    

Detailed description: 
      Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral
      administration of the appropriate IP(2 tablets in single dose: actual medication)
    

Intervention name(s): CKD-379(Empagliflozin+sitagliptin+metformin) Test drug; CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
Intervention type(s): Drug; Drug
Intervention description(s): oral, once; oral, once
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 2 Trial of OPC-64005 for Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to
      assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major
      depressive disorder (MDD).The primary endpoint is the mean change from baseline in
      Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 of the double-blind
      treatment period in the OPC-64005 20-mg group compared with the placebo group
    


Intervention name(s): OPC-64005 20 mg , Once-daily; OPC-64005 10 mg , Once-daily; Placebo, Once-daily
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active, High Dose; Active, Low Dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Supportive Versus Immunosuppressive Therapy for the Treatment Of Progressive IgA Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 3

Summary: 
      -  Evaluation of the efficacy of an immunosuppressive therapy added to a comprehensive
           supportive therapy to induce a clinical remission in patients at risk for progressive
           IgAN

        -  Investigation of differences between the treatments regarding the number of patients
           loosing more than 15 ml/min of GFR.
    

Detailed description: 
      The best treatment of glomerular diseases of the kidney is currently not well defined. This
      study aims to answer if in patients with IgA nephropathy, the most common type of
      glomerulonephritis an immunosuppressive treatment (with the use of steroids and chemotherapy)
      added to a supportive treatment is more effective than a supportive treatment alone (with the
      use of drugs lowering the blood pressure and the urinary protein loss).
    

Intervention name(s): supportive therapy with: ACE-inhibitor / ARB / Statin; supportive and immunosuppressive therapy
Intervention type(s): Drug; Drug
Intervention description(s): Antihypertensive therapy with a target blood pressure below 125/75 mmHg (following current clinical guidelines).
ACE-inhibitors (ARB when an ACE-inhibitor is not tolerated)
Other antihypertensive medications depending on the clinical decision and following current guidelines.
Statin therapy
Dietary counseling for a low-sodium diet and, if GFR is below 60 ml/min, for a protein intake of 0.8 g/kg/day.; supportive therapy as outlined above
depending on GFR:
methylprednisolone and prednisolone
cyclophosphamide and prednisolone; after 3 months azathioprine with prednisolone
Concomitant medication with the immunosuppressive treatment following current clinical practice
Intervention MeSH terms: Immunosuppressive Agents; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise and Asthma in Obese Adults
Condition: Asthma in Overweight Adults
MeSH terms: Asthma; Overweight
Study type: Interventional

Summary: 
      This pilot study will use an unmasked, parallel group, randomized design. Thirty adult
      overweight or obese subjects with mild-moderate persistent asthma will be randomly assigned
      to one of two groups: 12-weeks of home-based moderate intensity aerobic exercise versus no
      intervention. The study will include 2 clinic visits and 12 telephone calls. Exercise testing
      to assess physical fitness levels will occur during visits 1 and 2. Blood sampling for
      biomarkers, inflammatory markers, and other assessments will be done.
    

Detailed description: 
      The primary aim of this pilot study is to recruit and retain obese adults with mild-moderate
      persistent asthma for a study protocol that includes exercise at a moderate intensity level
      in a home-based setting. The investigators primary hypothesis is that compared to no
      intervention, 12-weeks of moderate intensity aerobic exercise will attenuate serum levels of
      adipokines (leptin, adiponectin), and other pro-inflammatory markers. The investigators will
      also analyze the effect of the intervention on fitness levels, pulmonary function, asthma
      symptoms, asthma control, and asthma-related quality of life.

      Given that this is a proof of concept/feasibility study, there is no primary outcome measure.
      The following measures will be assessed:

        -  Obesity related biomarkers and other markers of inflammatory responses:

        -  Asthma symptoms and asthma control measures:

        -  Lung function

        -  Fitness levels and physical activity levels:
    

Intervention name(s): Home-Based Aerobic Exercise
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      In this randomized clinical trial, patients with undergoing open heart valve surgery will be
      enrolled into the study. Participants will be divided into two groups based on the priming
      solution type. The first group will receive hydroxyethyl starch (HES) 130/0.4 additive to
      ringer lactate (RL) and the second group will be given only RL as priming solution. All
      patients will be observed closely during postoperative days. Through follow up,
      bleeding/coagulopathy, renal function, hepatic function, and cerebral oxygenation will be
      recorded in both groups.
    

Detailed description: 
      Cardiopulmonary bypass (CPB) pump is a device for circulating blood in the body while the
      heart is undergone surgery. For providing circulating volume in the body we need to add about
      1.5 to 2 lit fluids as priming solution in the CPB pump. Some fluids mainly included
      crystalloids, colloids, starch, and gelatin in an only fluid or in a combined formula. During
      CPB time, the blood dilution is caused by adding prime solution into the circulating volume,
      and consequently it decreases blood viscosity. Moreover, in addition to a decrease in
      hematocrit level, coagulation factors and plasma proteins can dramatically decreased. These
      processes may lead to bleeding events and tissue hypoperfusion and organ damages. To decrease
      complications, some modalities such as adding colloids to crystalloids have been implemented.
      On the other hand, any regimen for priming solution has its shortcomings need to be
      considered based on patient condition and surgical issue.

      In this double blinded randomized clinical trial study, we aimed to compare the the effects
      of six percent HES 130/0.4 and RL as priming solutions on coagulation factors, renal
      function, hepatic function, and cerebral oxygenation in patients undergoing open heart valve
      surgery.
    

Intervention name(s): Six percent hydroxy ethyl starch 130/0.4; Ringer lactate
Intervention type(s): Drug; Drug
Intervention description(s): 6% HES 130/0.4 additive to ringer lactate as prime solution; Ringer lactate as prime solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
Condition: Stroke
MeSH terms: Stroke; Hemorrhagic Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose is to establish whether acupuncture in addition to conventional rehabilitation
      programme can improve the functional outcome and quality of life of surgical patients with
      haemorrhagic stroke, as compared to conventional rehabilitation programme alone.
    

Detailed description: 
      The investigators aim to recruit 60 patients over a 30 month period. Each patient will have
      six week of acupuncture treatment (either early within the first six week, or delayed after
      the first six week of observation and assessment of primary outcome).

      Primary outcome measures:

      Clinical outcome at the end of week 6 acupuncture treatment: Glasgow Outcome Score extended.

      Secondary outcome measures:

      Modified Rankin Score, Functional Independence Measure (FIM) score, Modified Aschoff Score,
      Neurocognitive State Examination (NCSE) score, Barthel index, Modified Rivermead Mobility
      Index (MRMI), Modified Functional Ambulation Category (MFAC) and motor scores of upper limb
      and lower limb with Fugl-Meyer Scale at the end of week six acupuncture treatment.
    

Intervention name(s): Acupuncture; Conventional rehabilitation
Intervention type(s): Procedure; Procedure
Intervention description(s): Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.; In-patient physiotherapy, occupational therapy and speech therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupuncture,Intracerebral hemorrhage, Stroke
Impact of SARS-CoV-2 Pandemic on Psychological State of Health Care Workers
Condition: SARS-CoV-2
Study type: Observational

Summary: 
      In COVID-19 pandemic, many health-care workers (HCWs) have worked in high-pressure
      environments. They have been exposed to and faced moral dilemmas in addition to infection
      exposure risk are increasing the risk of mental health disorders.
    

Detailed description: 
      Throughout the SARS-CoV-2 pandemic, many HCWs have worked in high-pressure environments.
      Moreover, they may have been exposed to trauma and/or faced moral dilemmas relating to
      challenges in the delivery of high-quality care, possibly due to a lack of experience or
      equipment, or as a result of low staffing levels. These unfavorable circumstances and
      exposure risk to infection are likely to increase the risk of mental health disorders such as
      post-traumatic stress disorder (PTSD) or depression, other anxiety disorders, substance
      misuse and suicide In the present study, This study aimed to assess the psychological state
      of HCWs who were facing challenges of SARS-CoV-2pandemic comparing them to non medical staff
      group based on use of the Hamilton Anxiety and Depression Rating Scale.
    

Intervention name(s): other
Intervention type(s): Other
Intervention description(s): questionnaire
Other intervention name(s): questionnaire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All that work in the hospitals either doctors, nurses, dentist, pharmacysit
      
Keywords: SARS-CoV-2; Anxiety; Depression
A Study to Assess the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and
      Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult
      participants.
    

Detailed description: 
      This is a randomized placebo-controlled, double-blind study evaluating the safety,
      tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different
      sequences and schedules to healthy adult participants. The study consists of a screening
      period of up to 28 days, a vaccination period in which participants will be vaccinated at
      Baseline [Day 1] followed by a boost on Day 29 or 57 and a post-boost follow-up, until all
      participants have had their 21-day post-boost visit (Day 50 or Day 78). The participants who
      received active vaccine will enter a long-term follow-up. The total duration of the study
      will be about 1 year for participants who received vaccine and about 3 months for
      participants who received placebo. Immunogenicity and safety will be monitored during the
      study.
    

Intervention name(s): MVA-BN-Filo; Ad26.ZEBOV; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29 or 57.; One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29 or 57.; One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy; Ebola viruses; Ebola Viral Disease (EVD); Filoviruses; Monovalent vaccine; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo); Safety; Immunogenicity
Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training
Condition: Gastrointestinal Neoplasms; Bronchial Carcinoma; Hodgkin Disease; Non-Hodgkin Lymphoma; Weight Loss
MeSH terms: Hodgkin Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Carcinoma, Bronchogenic; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to tests the hypothesis, that N-acetylcysteine (a
      thiol-antioxidant)improves the exercise training effect on cancer patients that experience
      weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.
    


Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cancer cachexia; muscle wasting; weight loss; proteolysis
β-Cell Function in Schizophrenic Subjects on Atypical Antipsychotic drugS
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is to determine whether atypical antipsychotic drugs (commonly
      prescribed for treating schizophrenia) induce changes in anthropometry and metabolism,
      including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when
      given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of
      metabolic syndrome at enrollment.
    

Detailed description: 
      Atypical antipsychotic drugs (AADs) induce weight gain, truncal adiposity and may engender a
      metabolic syndrome which may progress to IFG/IGT or DM. AADs effects in lean schizophrenic
      patients without metabolic syndrome are not documented, especially the relationship between
      weight gain and changes in insulin sensitivity (S), beta-cell function (β), and circulating
      adiponectin. We prospectively determined the outcome of 9-month therapy with AADs on
      anthropometrics, metabolism and adiponectin, including HOMA-modeling of S, β, and βxS
      (hyperbolic product, assessing individual β adjusted for S)in 36 schizophrenic subjects (M:F
      24:12; Caucasian n=23; North-African n=12; South-Asian n=1) aged 35±9 years (mean±1SD) free
      of MetS (NCEP-ATPIII).
    

Intervention name(s): quetiapine or olanzapine or risperidone or aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate
Time perspective: Prospective
Keywords: antipsychotic drugs; schizophrenia; β-cell function; insulin resistance
Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat and Maxilla-Facial Surgery
Condition: Pain, Postoperative; Surgery, Oral
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Our primary aim is to determine whether licorice gargling provides meaningful analgesia after
      oral surgery. Specifically, we propose to test the primary hypothesis that gargling with
      licorice solution reduces pain after oral surgery more than gargling with sugar water.
      Because effective analgesia can reduce pain and/or opioid consumption, we will jointly
      evaluate verbal response pain scores and overall morphine consumption considering licorice to
      be beneficial only if it proves non-inferior on both measures and superior on at least one.
    


Intervention name(s): Licorice; Sugar water
Intervention type(s): Other; Other
Intervention description(s): ExtractumLiquiritiaeFluidum, 1 g diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 3; Sugar gargle: Sirupus Simplex (sugar 5 g) diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 3
Other intervention name(s): Extractum Liquiritiae Fluidum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Pain; Anesthesia; Oral Surgery
The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers
Condition: Lipid Profile
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid
      profile, insulin sensitivity and inflammatory markers.

      Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and
      inflammatory markers postprandially.
    

Detailed description: 
      A randomized, single blind, crossover design was undertaken to test meals enriched with palm
      olein vs olive oil vs lard. Volunteers were asked to participate in three postprandial
      challenges, separated by at least 3-days. Subjects were provided a low fat meal(<10g fat) the
      day before the intervention. Fasting blood was collected the next day and the subjects were
      instructed to consume test meals (50g high fat meal). Further venous blood was collected at
      30 min, 1h, 2h, 3h and 4h postprandially.

      Primary outcome variable: Triacylglycerol (TAG) Secondary outcome variables: Insulin
      sensitivity (glucose, insulin), non esterified fatty acids (NEFA), inflammatory markers
    

Intervention name(s): The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: fat; inflammation; lipids; total cholesterol; Triglycerides; insulin sensitivity
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to evaluate the clinical efficacy and safety of tralokinumab as
      compared to placebo. Investigational product will be administered as subcutaneous injection.
      All patients will continue background therapy for ulcerative colitis as per local standards
      of care in addition to investigational product.
    

Detailed description: 
      A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to
      evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal
      antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in
      patients with active, moderate-to-severe, ulcerative colitis
    

Intervention name(s): tralokinumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 sc injections of every 2 weeks for 12 weeks.; 2 sc injections of every 2 weeks for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tralokinumab; inflammatory bowel disease; moderate to severe ulcerative colitis