bioihbjkbjnl/mcl2 huggingface dataset:
Barley Beta-glucan, Glycemic Control, and Appetite
Condition: Diet, Healthy; Blood Sugar; High; Diabetes; Appetite and General Nutritional Disorders; Appetitive Behavior
MeSH terms: Nutrition Disorders; Hyperglycemia
Study type: Interventional

Summary: 
      Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve
      population health through improving glycemic control. Sweetened and unsweetened wholegrain
      barley foods were tested in a randomized, controlled, crossover human clinical trial to
      assess impact on postprandial appetite and food intake.
    


Intervention name(s): WR; LB; MB; HB; WR+50g HFCS; LB + 50 g HFCS; MB + 50 g HFCS; HB + 50 g HFCS
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Unsweetened preload condition: 240 mL white glutinous rice, 250 kcal, 0 g β-glucan; Unsweetened preload condition: 240 mL low β-glucan barley, 250 kcal, ~4 g β-glucan; Unsweetened preload condition: 240 mL medium β-glucan barley, 250 kcal, ~5 g β-glucan; Unsweetened preload condition: 240 mL high β-glucan barley, 250 kcal, ~6 g β-glucan; Sweetened condition with high fructose corn syrup (HFCS): 240 mL white glutinous rice + 50g HFCS, 391 kcal, 0 g β-glucan; Sweetened condition with high fructose corn syrup (HFCS): 240 mL low β-glucan barley + 50 g HFCS, 391 kcal, ~4 g β-glucan; Sweetened condition with high fructose corn syrup (HFCS): 240 mL medium β-glucan barley + 50 g HFCS, 391 kcal, ~5 g β-glucan; Sweetened condition with high fructose corn syrup (HFCS): 240 mL high β-glucan barley + 50 g HFCS, 391 kcal, ~6 g β-glucan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Beta-glucan; Fiber; Glycemic Control; Appetite
Pandemia And Exercise in Turkey in University Students of Turkey
Condition: Sedentary Behavior; Covid19
Study type: Observational

Summary: 
      The aim of this study is to determine to what extent university students' physical activities
      are affected by staying at home during the pandemia.
    

Detailed description: 
      The aim of our study is to determine to what extent university students' physical activities
      are affected by staying at home during the pandemia considering that they spend hours working
      by a computer. The state of physical inactivities will be questioned by an online survey for
      Inernational Physical Activity Questionnaire (short form). Then average energy expenditure
      following stepping and/or exercise will be asked from health application of mobile phones.
    

Intervention name(s): survey
Intervention type(s): Other
Intervention description(s): International Physical Activity Questionnaire (short form)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  Being a university student

          -  Having sufficient devices (cell phone or computer) to access the electronic survey
A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the efficacy of HS-25 (5, 10, 20 or 30 mg) in reducing low density
      lipoprotein-cholesterol (LDL-C) levels after a 4-week period of treatment in adults with
      primary hypercholesterolemia.
    

Detailed description: 
      This is a 4-week, randomized, double-blind, placebo-controlled study designed to assess the
      effects of the cholesterol absorption inhibitor HS-25 on LDL-C levels in adults who have
      untreated LDL-C levels ranging from 130-189 mg/dL and fasting triglyceride levels < 350
      mg/dL. Eligibility is restricted to 18-65 year old men or women who are using a highly
      effective birth control method or are not of childbearing potential. Patients with diabetes,
      a history of myocardial infarction or other clinical evidence of atherosclerotic vascular
      disease are not eligible for participation in the study.
    

Intervention name(s): HS-25; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.; Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypercholesterolemia; cholesterol absorption inhibitor; placebo-controlled trial
Stress-related Predictor Profiles in Human Addiction
Condition: Alcohol Use Disorder; Stress Reaction; Social Stress; Craving; Relapse; Addiction; Risk Behavior
MeSH terms: Recurrence; Alcoholism; Fractures, Stress; Behavior, Addictive
Study type: Interventional

Summary: 
      Long-term aim is the definition of a setup of mobile sensors and their integration in a
      mobile infrastructure that allows the prediction of stress related alcohol intake in an
      ambulatory setting. Here, we aim to identify stress- and alcohol cue-related physiological
      markers in a lab experiment to assess interactions between acute psychological vs. physical
      stress exposure and alcohol cue-exposure regarding their effects on measures relevant for the
      development and maintenance of Alcohol Use Disorder (AUD). Further, we aim to identify neural
      correlates in brain circuits of motivational, cognitive, and affective processing. In
      addition to applying established stress-related markers, we will integrate innovative
      sensor-based measures.
    

Detailed description: 
      In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving,
      cue-reactivity and relapse risk. Here, we aim to identify stress- and alcohol cue-related
      physiological markers in a lab experiment to assess interactions between acute psychological
      vs. physical stress exposure and alcohol cue-exposure regarding their effects on (1) alcohol
      craving and related markers (attentional bias to alcohol-cues, implicit association task,
      neural cue-reactivity), (2) their predictive capacity for future alcohol intake, (3) the
      identification their neural correlates in brain circuits of motivational, cognitive, and
      affective processing. In addition to applying established stress-related markers (cortisol in
      saliva, heart-rate variability, systolic blood pressure and electrodermal activity), (4) we
      will integrate portable sensors (wearables) to allow a future integration in ambulatory
      assessments and to test innovative measures currently under investigation (e.g. voice stress
      analysis) to identify whether these additional parameters increase the predictive
      significance. Our long-term aim is the definition of a setup of mobile sensors and their
      integration in a mobile infrastructure that allows the prediction of stress related alcohol
      intake in an ambulatory setting.
    

Intervention name(s): Trier Social Stress Test; Ergometer; Barlab-Exposure; Reading Newspaper
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Test to induce high levels of acute social stress, including actors and a faked exam situation; Riding ergometer; Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.; Participants read newspaper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis
Condition: Prurigo Nodularis; Pruritis
MeSH terms: Pruritus; Prurigo; Neurodermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of
      Vixarelimab (KPL-716) in subjects with prurigo nodularis.
    

Detailed description: 
      This is a Phase 2a/b randomized, double-blind, placebo-controlled study to investigate the
      efficacy, safety, tolerability, PK and immunogenicity of Vixarelimab administered
      subcutaneously (SC) in subjects with prurigo nodularis experiencing pruritus.

      Phase 2a portion (completed):

      Forty-nine subjects with moderate to severe PN experiencing moderate to severe pruritus were
      treated in the Phase 2a portion of the study. At Baseline, subjects were randomized 1:1 to
      receive double-blind Vixarelimab or placebo: Vixarelimab 720 mg loading dose followed by 360
      mg every week; Placebo loading dose followed by placebo every week. The treatment Period was
      8 weeks or 16 weeks (treatment duration was reduced from 16 weeks to 8 weeks in a protocol
      amendment [Protocol Version 3]).

      Phase 2b portion (enrolling):

      The Phase 2b study (Figure 1) will consist of a 4-week Screening Period and a 16-week
      Double-Blind Period, followed by a 36-week Open-Label-Extension (OLE) Period. Approximately
      180 subjects with PN, experiencing severe pruritus, will be randomized (at 1:1:1:1 ratio)
      into one of 4 arms (3 active arms and one placebo arm). A total of 4 doses of study drug will
      be administered during the Double-Blind Period to measure the efficacy, safety, and PK of
      Vixarelimab. After the Double-Blind Period, all subjects will have the option to receive
      Vixarelimab during the OLE Period to evaluate the long-term safety and PK.
    

Intervention name(s): vixarelimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): solution for injection; solution for injection
Other intervention name(s): KPL-716
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2a (completed): 2 arms; Phase 2b (enrolling): 5 arms (4 arms during Double Blind Period and 1 arm during Open Label Extension)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Camp High 5: Evaluation of the Effect on Upper Limb Function
Condition: Neurological Injury; Hemiplegia
MeSH terms: Hemiplegia; Trauma, Nervous System
Study type: Interventional

Summary: 
      Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as
      compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP)
      following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and
      hand-arm bimanual intensive training (HABIT).
    


Intervention name(s): Constraint induced movement therapy (CIMT); Hand-arm bimanual intensive training (HABIT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity; Facilitates the translation of gains to improve goal-directed bimanual performance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Condition: Post Operative Pain; Hyperalgesia
MeSH terms: Hyperalgesia; Pain, Postoperative
Study type: Interventional

Summary: 
      Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents
      opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal
      surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a
      N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative
      Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia
      after abdominal surgery.
    

Detailed description: 
      not desired
    

Intervention name(s): ketamine infusion; Methadone PCA
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery; Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)
Other intervention name(s): hyperalgesia-blocker; hyperalgesia-blocker
Intervention MeSH terms: Ketamine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hyperalgesia; Patient controlled analgesia; morphine; methadone; ketamine
Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Insulin Resistance; Hypersensitivity; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Stress hyperglycemia during myocardial infarction (MI) is related to mortality at short and
      long term. Recent studies, however, revealed that chronic statin treatment may decrease both
      insulin sensitivity and secretion immediately after statin therapy initiation. This study aim
      was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in
      the acute phase of MI.
    

Detailed description: 
      Stress hyperglycemia during myocardial infarction (MI) is a predictor of worse prognosis at
      short and long term. From the mechanistic standpoint, hyperglycemia can attenuate
      thrombolysis, increase platelet aggregation, induce coronary vasoconstriction, reduce oxygen
      transport and prolong endothelial inflammation after MI. Consistently, observational data
      indicates that glucose normalization improves survival in hyperglycemic patients hospitalized
      with MI.

      High dose potent statins have been included in the early treatment of acute coronary
      syndromes (ACS) based upon a broad range of potentially beneficial mechanisms. Recent
      studies, however, revealed that chronic statin treatment may increase the incidence of type 2
      diabetes mellitus in a dose-dependent manner. Moreover, according to studies in cellular and
      animal models, such decrease in insulin sensitivity may be observed immediately after statin
      therapy initiation. By inference, one may speculate that statin treatment initiated at the
      acute phase of MI may potentially favor the appearance or aggravation of stress
      hyperglycemia. To date, however, this hypothesis has not been investigated. Hence, this study
      aim was to investigate the dose-dependent effect of statins on insulin sensitivity in
      patients in the acute phase of MI.
    

Intervention name(s): Simvastatin 80mg; Simvastatin 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Simvastatin 80mg once a day; Simvastatin 10mg once a day
Other intervention name(s): Zocor; Zocor
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Statin; Myocardial infarction; Insulin sensitivity
Phase II Study of Heart Polypill Safety and Efficacy in Primary Prevention of Cardiovascular Disease
Condition: Cardiovascular Disease; Hypertension; Hyperlipidemia; Heart Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases; Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      Cardiovascular is a major cause of mortality in Iran, accounting for 45.7% of deaths. In
      Golestan (North Eastern Iran) preliminary findings from follow-up of the Golestan Cohort are
      consistent with national figures: with 45% (at least 22 of 48 deaths) of all deaths
      attributed to cardiovascular events. Cardiovascular diseases will become an increasing
      problem as the Iranian population ages.

      In 2003 Law and Wald proposed prevention of cardiovascular disease using fixed-dose
      combination therapy combining antihypertensive, lipid lowering and antiplatelet drugs in a
      single preparation. They proposed that this treatment should be offered to all persons at
      high risk of cardiovascular disease whether or not they have elevated blood pressure or
      elevated serum lipid concentrations.

      This pilot study aims to investigate the safety and efficacy of fixed-dose combination
      therapy with two antihypertensive drugs, aspirin and atorvastatin in a population who would
      not currently be considered eligible for antihypertensive treatment or for lipid lowering
      treatment.

      Methods:

      This is a double-blind randomized controlled trial. The intervention group will be assigned
      to take a tablet consisting of a single daily tablet comprising Aspirin 81mg,
      Hydrochlorothiazide 12.5mg, Enalapril 2.5mg and Atorvastatin 20mg. The control group will be
      assigned to an identical placebo.

      The population studied includes men aged 50 to 80 (inclusive) and women aged 55 to 80
      (inclusive) who are currently not eligible for or taking antihypertensive or lipid lowering
      therapy. Persons who are found at baseline to have blood pressure >160/100 mm Hg, total
      cholesterol >240mg/dL, existing cardiovascular disease or to be taking antihypertensive ore
      lipid lowering therapy are excluded.

      It is intended to randomize and follow up 500 subjects for 12 months. The primary outcome for
      the purpose of sample size calculation is change in systolic blood pressure. Additional
      outcomes include change in diastolic blood pressure, change in LDL cholesterol and occurrence
      of adverse events.
    


Intervention name(s): Polypill; Placebo drug
Intervention type(s): Drug; Drug
Intervention description(s): Fixed dose combination therapy - aspirin 81mg, hydrochlorothiazide 12.5mg, enalapril 2.5mg and atorvastatin 20mg Once daily; Inactive tablet Once a day Identical in appearance to intervention drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiovascular disease; primary prevention; Polypill; efficacy; safety; ADR; Diabetes; Adherence; Compliance
Virtual Reality During Intrathecal Pump Refills in Children
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of the current study is to explore the effect of virtual reality on pain in children
      who undergo an intrathecal pump refill compared to usual care and distraction.
    

Detailed description: 
      Virtual reality (VR) is a technological rehabilitation tool that allows the user to
      experience the interaction with a computer-generated environment. It may provide some
      advantages over conventional care: it allows the simulation of realistic environments and
      patients feel more motivated by this kind of virtual environment. VR constitutes an enriched
      environment with augmented multiple sensory feedbacks (auditory, visual, tactile VR enriched
      environment) that has already shown some efficiency in reducing chronic pain. There is
      mounting evidence from acute pain conditions, such as wound care, that VR could play a role
      as an additional treatment method to relieve pain A possible explanation for its mechanism of
      action is provided by "the gate-theory of attention". VR reduces the perception of pain by
      diverting attention away from the pain. Most children experience pain and fear when receiving
      a medical treatment; two feelings which are closely related and affecting one another.
      Moreover, children often describe procedures involving needles as the most stressful portion
      of the hospital experience. Children who have been implanted with an intrathecal baclofen
      (ITB) pump, need to come to the hospital for a refill approximately every 3 months, depending
      on the exact dose. During the refill, the physician places a needle directly into the
      reservoir to refill the pump. To alleviate the pain and fear with these refill procedures, it
      is hypothesized that VR could alleviate pain and make these refills more feasible. Therefore,
      the aim of this study is to evaluate whether VR is reducing pain during a refill procedure,
      in children receiving intrathecal drug delivery compared to usual care.
    

Intervention name(s): Intrathecal pump refill with Virtual Reality; Intrathecal pump refill with distraction; Intrathecal pump refill
Intervention type(s): Other; Other; Other
Intervention description(s): VR game; Video; daily routine care for pump refill
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality
Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Compatibility
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the absence of irritation potential (primary dermical irritability and
      cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd
      PHDETINLYN Sweet Flower.
    


Intervention name(s): Dermacyd PH_DETINLYN (Lactic Acid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Primary purpose: Supportive Care