bioihbjkbjnl/mcl2 huggingface dataset:
Lipolytic Effects of GH in Human Subjects in Vivo
Condition: Metabolic Diseases; Growth Hormone Treatment
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Growth hormone (GH) induces fat metabolism. The mechanisms underlying the fat metabolizing
      effects of GH remain elusive. However, it is known that insulin suppresses fat metabolism,
      and GH inhibits the expression of certain insulin-dependent signaling proteins. We therefore
      hypothesize that the fat metabolizing effects of GH depend on abrogation of insulin-dependent
      signaling pathways.

      In order to investigate the fat metabolizing effects of GH, we'll analyze consecutive adipose
      tissue biopsies taken after GH exposure and GH blocking, respectively.

      Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in
      long-sight have great importance for the understanding of growth disorders from overweight
      and type 2 diabetes to malnutrition and eating disorders.
    


Intervention name(s): Growth Hormone; Pegisomant
Intervention type(s): Drug; Drug
Intervention description(s): Subjects are receiving one injection of growth hormone (Genotropin) 0,5 mg; One the placebo day the subjects are receiving injection with pegvisomant (Somavert 30 mg) to block the action of endogenous growth hormone
Other intervention name(s): Genotropin; Somavert
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: lipolysis; ATGL
Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation
Condition: Liver Transplant; Complications
Study type: Observational

Summary: 
      The purpose of this study is to formally identify patient and caregiver perceived needs,
      barriers, and facilitators to inform the development of a home-based multimodal
      prehabilitation program for potential LT candidates.
    

Detailed description: 
      After being informed about the study and potential risks, all participants (patients and
      caregivers) giving written informed consent will be invited to participate in one of three
      research activities: interviews (n=10), nominal group technique meetings (n=64), or
      card-sorting and rating survey (n=40).
    

Intervention name(s): Prehabilitation intervention; Caregiver intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The investigators will identify participants' perceived important information to develop a prehabilitation intervention in this study. Prehabilitation intervention consisting of physical activities, nutrition, and stress management.; The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include adult, all gender, and all race patients with end-stage liver
        disease (ESLD) who have been assigned to the liver transplant (LT) waitlist. Nationally,
        the median age of LT candidates is 57 (48, 63) during 2014 to 2018. UAB Liver Transplant
        Center technically does not limit patients over 75 years old for LT (i.e., age alone is not
        an absolute contraindication), but typically as patients age they have less physiologic
        reserve to tolerate transplant so they must have a better pre-transplant functional status
        than a younger patient in order to have a good outcome post-transplant. Participants will
        be identified and recruited from the UAB Liver Transplant Center using a purposive maximum
        variation sampling approach in terms of age, gender, race, and severity of ESLD.
      
Keywords: end-stage liver disease (ESLD); frailty; prehabilitation
A Study to Evaluate Plasma Gelsolin in Healthy Volunteers
Condition: Volunteers; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study BTI-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation,
      parallel design study to evaluate the safety, tolerability, and pharmacokinetics of IV
      rhu-pGSN or saline placebo administered as 5 doses each of 6, 12, 18, or 24 mg/kg of body
      weight. Each of 4 dosing cohorts will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6
      rhu-pGSN subjects:2 placebo subjects). Subjects will be healthy adult volunteers 18-55 years
      of age.
    

Detailed description: 
      Doses will be administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours
      (Day 3), and 84 hours (Day 4). Subjects will be kept in-house until after the last blood
      sample is taken on Day 5. Subjects will return for follow-up 7 days after the initiation of
      therapy (Day 8) and on Day 28 for the End-of-Study (EOS) Visit. After each cohort has
      completed the Day 8 visit, review of the safety results (including labs) will be conducted
      (and unblinded where appropriate) before the initiation of the next higher dose cohort.

      To assess safety and tolerability, subjects will undergo physical examinations (including
      vital sign measurements), adverse event (AE) assessments, concomitant medication assessments,
      and safety laboratory testing. Blood samples will be collected for analysis of pGSN levels
      and antibodies against pGSN.
    

Intervention name(s): Recombinant human plasma gelsolin; placebo
Intervention type(s): Drug; Other
Intervention description(s): intravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours; intravenous administration of saline control at time 0, 12, 36, 60 and 84 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; pharmacokinetics
The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A
Condition: NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      In this research, the investigators tested the effect of 12-week supplementation with soy
      isoflavones on non alcoholic fatty liver disease (NAFLD) management and the level of
      fibroblast growth factor-21 (FGF-21) and fetuin A as markers of NAFLD progression.
    

Detailed description: 
      Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge
      burden on health and economic systems. The aim of the present study was to investigate the
      effect of soy isoflavone intake on hepatic outcomes and the level of fibroblast growth
      factor-21 (FGF-21) and fetuin A in patients with NAFLD. Fifty patients with NAFLD were
      randomized to either receive two tablets of soy isoflavone (100 mg/d) or placebo. Dietary
      intakes, anthropometric parameters, the serum levels of liver function tests including
      alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl
      transferase (GGT), FGF-21, fetuin A and hepatic histological features by Fibroscan assessed
      at study initiation and after week 12.
    

Intervention name(s): Soy isoflavone; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): the subjects in the soy isoflavone group were told to take 2 drugs per day, one in the morning after the breakfast and one at night after the dinner and continue this pattern for 12 weeks.; the subjects in the placebo group were told to take 2 placebo tablets per day, one in the morning after the breakfast and one at night after the dinner and continue this pattern for 12 weeks.
Other intervention name(s): Soyagol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly classified into placebo or soy isoflavone groups using block randomization stratified by menopause status and gender for 12 weeks
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Non-alcoholic fatty liver disease; Isoflavones; Soy foods; FGF21; Liver steatosis
Pharmacologic MRI in Cocaine Addiction
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Study type: Observational

Summary: 
      In the proposed study, the investigators will assess the brain response to medication probes
      the investigators have previously studied with SPECT. The brain response to ondansetron and
      lidocaine infusions will be measured Arterial Spin Labeling and functional connectivity MRI
      (fcMRI).
    

Detailed description: 
      An extensive effort has been mounted to understand the neurobiologic mechanisms involved in
      the development and persistence of cocaine addiction and tendency to relapse. Although the
      last two decades have resulted in an explosion in our understanding of the biological
      mechanisms of reward, establishing the relevance of this knowledge to the addictive process
      has been problematic. Most importantly, this information has been of limited utility in
      offering new pharmacologic treatment approaches to addicted patients - particularly those
      with cocaine addiction. Over the past 15 years our laboratory has published multiple studies
      using pharmacologic probes to explore the biologic underpinnings of cocaine addiction using
      single photon emissions computerized tomography (SPECT) technology. More recently, however,
      functional magnetic resonance imaging (fMRI) has offered several advantages over SPECT and is
      now a favored approach, e.g. fMRI allows the continuous measurement of neural responses
      rather than a very limited time period with SPECT (1-3 minutes every 48 hours). Using fMRI
      [including both ASL (Arterial Spin Labeling) and fcMRI (functional connectivity], the neural
      response can be measured throughout the 60 min that follows infusion, allowing identification
      and capture of the maximal brain response period that may occur at any time during this 60
      min. In the proposed study, we will assess the brain response to two of the probes
      (scopolamine and lidocaine) we have previously studied with SPECT.
    

Intervention name(s): ondansetron, lidocaine
Intervention type(s): Drug
Intervention description(s): Ondansetron: Ondansetron (0.15 mg/kg) will be administered through the IV line over 15 min at a constant rate of infusion.
Lidocaine: Lidocaine will be administered as a 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg/kg/hour for 55 min (60 min total infusion).
Other intervention name(s): Zofran, Xylocaine
Intervention MeSH terms: Lidocaine; Ondansetron
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with cocaine addiction will be recruited from patients requesting treatment for
        addiction at the Dallas VA Medical Center and Homeward Bound,Inc. Recently using cocaine
        patients and healthy controls will be recruited from flyers and internet ads.
      
Keywords: cocaine addiction; neuroimaging; functional magnetic resonance imaging (fMRI)
Effect of Body-mass Index (BMI) on Median Effective Dose of Intrathecal Hyperbaric Bupivacaine
Condition: Arthroplasty, Knee
Study type: Interventional

Summary: 
      The effect of Body-mass index (BMI) on requirements of local anesthetics used in spinal
      anesthesia has not been well established. The investigators tried to quantify the effect of
      BMI on spinal anesthesia by comparing the median effective dose of intrathecal bupivacaine
      between two different BMI groups.
    

Detailed description: 
      The effect of BMI on requirements of local anesthetics used in spinal anesthesia has not been
      well established. The investigators tried to quantify the effect of BMI on spinal anesthesia
      by comparing the median effective dose (ED50)of intrathecal bupivacaine between two different
      BMI groups. The investigators determined the ED50 and ED 95 of intrathecal hyperbaric
      bupivacaine of subjects with BMI below 27.5 kg/m2, and subjects with BMI over 27.5 kg/m2,
      respectively. By comparing the difference of ED50 and ED95 between the groups, the
      investigators tried to quantify the effect of BMI on the bupivacaine dose requirement.
    

Intervention name(s): BPV6NO; BPV7NO; BPV8NO; BPV9NO; BPV10NO; BPV11NO; BPV6O; BPV7O; BPV8O; BPV9O; BPV10O; BPV11O
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2; intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2; intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2; intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2; intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2; intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2; intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2; intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2; intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2; intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2; intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2; intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2
Other intervention name(s): bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine; bupivacaine; epinephrine
Intervention MeSH terms: Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: spinal anesthesia; intrathecal bupivacaine; median effective dose; height
Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty
Condition: Deviated Nasal Septum; Nasal Septal Defect; Nasal Septum, Irregular
Study type: Interventional

Summary: 
      Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is
      responsible for an increase in quality of life related to nasal obstruction when compared to
      no intervention in rhinoseptoplasty inferior turbinate?

        -  Population: patients eligible for functional rhinoseptoplasty and / or aesthetic

        -  Intervention: surgery, turbinectomy of inferior turbinates

        -  Comparison: the absence of intervention in inferior turbinates

        -  Primary endpoint: Quality of life related to nasal obstruction
    


Intervention name(s): Rhinoseptoplasty; Partial turbinectomy; Endoscopic partial turbinectomy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Rhinoseptoplasty without turbinectomy procedure; After medial dislocation of the inferior turbinate, proceed partial resection of the inferior turbinate in all its inferior extension in range. Possible bleeding is cauterized.; Endoscopy to medial dislocation of the inferior turbinate with instrument
Other intervention name(s): Turbinectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rhinoseptoplasty
Effects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP)
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      In this study, the investigators aim to assess the clinical and neurophysiological effects of
      a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)-
      on cortical plasticity and motor learning in children with cerebral palsy. Investigators will
      use different assessment techniques, such as transcranial magnetic stimulation (TMS) and
      kinematics (sensors) to measure changes through the trial.
    


Intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): Subjects will receive tDCS stimulation 1x per day for 5 days (over the period of 1 week). Each session will be 20 minutes long. The subject will receive active stimulation for the entire 20 minutes.
Other intervention name(s): 1x1 direct current stimulator; soterix medical; transcranial stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor learning; cortical plasticity; direct current stimulation
Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of the conducted study was to determine the efficacy of lupin kernel
      fibre-enriched food (Lupinus angustifolius Boregine) on prevention of risk factors for
      gastrointestinal or cardiovascular diseases.
    

Detailed description: 
      Dietary fibre is suspected to effect the faecal concentration and excretion of bile acids by
      binding the bile acids and by increasing the faecal mass. Bile acids, especially the
      secondary bile acids, are potential risk factors for colorectal cancer. A high bile
      acid-binding ability of fibre could lead to lower blood cholesterol concentrations by
      interrupting the enterohepatic circulation. There is evidence that the consumption of lupin
      kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify
      bowel health.

      A total of 133 subjects were recruited for this study. Sixty moderate hypercholesterolemic
      volunteers (total cholesterol > 5.2 mmol/L) fulfilled the selection criteria and were
      randomly assigned three groups. Forty-five subjects (mean age of 47 years, 34 women and 20
      men) completed the double-blind, randomized crossover trial.

      The subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per
      day and a low-fibre diet (placebo) for four weeks each. After baseline, each volunteer had to
      pass all three periods in different order with a two-week wash-out period between each.

      At the end of each intervention period, subjects consumed a standardized diet for three days.
      Furthermore, a quantitative stool collection took place and fasting blood samples were drawn.
    

Intervention name(s): fabricated food
Intervention type(s): Dietary Supplement
Intervention description(s): The subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per day and a low-fibre diet (placebo) for four weeks each. After a one-week run-in period, each volunteer had to pass all three periods (arms) in different order with a two-week wash-out period between each.
Other intervention name(s): diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dietary fibre; lupin kernel fibre; bile acids; cholesterol metabolism; blood lipids; hypercholesterolemia; fibre-enriched food; moderate hypercholesterolemia
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy of a single, oral dose of
      baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in
      patients with uncomplicated influenza virus infection.
    


Intervention name(s): Baloxavir Marboxil; Placebo to Baloxavir Marboxil; Oseltamivir; Placebo to Oseltamivir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 to4 X 20-mg tablets taken orally; 2 to4 X 20-mg tablets taken orally; 75 mg capsules taken orally; Placebo capsules matching oseltamivir 75 mg capsules
Other intervention name(s): S-033188; Tamiflu®
Intervention MeSH terms: Oseltamivir; Baloxavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Flu; Baloxavir Marboxil; Oseltamivir; Tamiflu®
Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults
Condition: Sedentary; Aging
Study type: Interventional

Summary: 
      This project will determine the independent and combined effects of aerobic exercise and time
      restricted fasting on cardiovascular risks among sedentary middle-aged and elderly adults.
      The online intervention period will be eight weeks. Before and after the intervention,
      arterial stiffness, cardiac autonomic nervous, body composition, glucolipid metabolism, sleep
      and eating habits, inflammatory reaction, sedentary behavior and physical activity level will
      be measured and compared between groups who are doing either aerobic exercise, time
      restricted fasting, both aerobic exercise and time restricted fasting, or who are in a
      control group. Adverse reaction, sleep and eating quality, life quality and adherence to the
      interventions and hunger/satiety will also be measured.
    


Intervention name(s): Aerobic Exercise; Time Restricted Fasting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Three weekly, supervised exercise sessions with aerobic exercise. Each session will last for 60-65 minutes, each period will be consist of 5 min warm up, 45 min formal training and 5-10 min relaxation training. Intervention period will be eight weeks.; Restricted daily window of caloric intake to maximum 8 hours. Intervention period will be eight weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention