bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Nap Restriction on Preschoolers' Empathy, Prosocial Behaviors and Executive Function
Condition: Sleep Restriction
Study type: Interventional

Summary: 
      Cross-sectional evidences suggest a relationship between early childhood sleep and cognitive
      as well as socio-emotional functions. However, the casual relation has not been fully
      revealed. The current study aims to perform a randomized lab-based crossover nap restriction
      study on preschoolers, to determine the effects of sleep restriction on preschoolers empathy,
      prosocial behaviors as well as executive functions.
    

Detailed description: 
      The study will enroll preschoolers with regular nap habits. Under a randomized
      repeated-measures crossover design, they follow a strict sleep schedule (≥ 12.5 hours' time
      in bed every 24 hours) for 5 days, before each of two pseudorandomly assigned afternoon
      assessments following nap-rested or nap-restricted conditions. Actigraphy is applied to
      monitor sleep, and occipital alpha power is detected from resting-state EEG to objectively
      measure sleepiness. Empathy (Empathic for Pain Event-related Potential Paradigm) and
      prosocial behaviors (Concern for Others Behavioral Paradigm) were measured at each
      assessment. The effects of nap restriction were analyzed with paired t-test/Wilcoxon
      matched-pairs sign rank test and repeated-measures ANOVA.
    

Intervention name(s): Nap restriction
Intervention type(s): Behavioral
Intervention description(s): There are 2 interventions in the single-arm, that is, the nap rested condition and the nap restriction condition. The sequence of nap intervention followed randomization.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: nap restriction; preschooler; socio-emotional development; executive function; event-related potential
Decrease Opioid Consumption With Intra-Venous (IV) Acetaminophen After Colorectal Surgery (DOCIVA)
Condition: Pain Control Post Colorectal Surgery
Study type: Interventional

Summary: 
      The investigators hypothesis is that use of IV acetaminophen will significantly decrease use
      of post-operative opioid consumption and enhances recovery after colorectal surgery.
    

Detailed description: 
      All patients undergoing laparoscopic and open colorectal surgery are randomized to receive
      either IV acetaminophen or placebo. All patients received an opioid patient controlled
      anesthesia (PCA). IV acetaminophen (1 gram) or placebo is given 30 minutes prior to operation
      and every 6 hours thereafter for up to 5 days post-operatively or discharge.

      The investigators primary endpoint is to evaluate opioid consumption during the patient's
      hospital stay. The investigators secondary endpoints are to evaluate return of
      gastrointestinal function (ROGIF), time to diet ordered (TTDO), length of hospital stay
      (LOHS) and occurrence of ileus. Pain is measured with the pain visual analog scale score
      (PVASS) at 3, 8, 24 and 48 hours.
    

Intervention name(s): IV Acetaminophen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 gram every 6 hours; 100 ml of normal saline every 6 hours
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IV acetaminophen; Colorectal Surgery; Enhance Recovery; Opioid Consumption; Pain Management
ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease
Condition: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Restenosis; Heart Diseases; Coronary Stenosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis; Coronary Restenosis
Study type: Observational

Summary: 
      The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting
      bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery
      lesions in all-day clinical practice.
    

Detailed description: 
      Bioresorbable scaffolds are transient implants. They act like drug-eluting metallic stents
      (DES) during the first 3 months by supporting the vessel wall thereby keeping the artery
      patent. Subsequently, resorption of the scaffold begins and its structure loosens. As a
      result of everolimus release, neointimal growth is inhibited similar to DES. Finally the
      implant is reabsorbed completely in about 2-3 years. BVS in terms of late stent thrombosis
      may be safer than DES. Transiently scaffolded vessels may regain their natural curvature and
      angulation as well as response to nitroglycerine and endothelial function.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with cardiovascular disease
      
Keywords: Drug eluting stent; Bioabsorbable; Bioresorbable; Coronary Stent; Scaffold; Stents; Angioplasty; Coronary Artery Disease; Stentthrombosis
PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics,
      pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese
      healthy subjects
    

Detailed description: 
      Primary: The evaluation of pharmacokinetic properties of repeating PHP-201 topical eye drop
      Secondary: The evaluation of pharmacodynamic, safety and tolerability of repeating PHP-201
      topical eye drop
    

Intervention name(s): PHP-201 0.5% ophthalmic solution (topical eye drop)
Intervention type(s): Drug
Intervention description(s): D1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2~D6: PHP-201 0.5% topical eye drop OU TID
Other intervention name(s): PHP-201 5mg/ml
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
7 Year Follow-up Study of the DanRisk Population
Condition: Cardiovascular Disease; Coronary Artery Calcification; Atherosclerosis
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Observational [Patient Registry]

Summary: 
      OBJECTIVES: To investigate the incidence of cardiovascular events as well as progression of
      coronary artery calcium (CAC) in healthy middle-aged subjects over a period of 7 years, and
      the relation to traditional as well as new cardiovascular risk factors.

      METHODS: The Danrisk cohort was established in 2009-2010 based on random retrieval from the
      Danish national civil registry (N=1825). Initially, distribution of gender, area of residence
      and year of birth (1949 or 1959) were equal among the 4 involved centres (OUH, Svendborg,
      Vejle and Esbjerg). A total of 1257 subjects (69%) accepted the invitation to undergo
      cardiovascular risk evaluation including non-contrast enhanced cardiac CT-scan for CAC
      estimation, and a total of 1227 subjects were found free of cardiovascular disease (CVD) and
      diabetes (DM), and was included in the study back then.

      In 2014-2015 the DanRisk cohort was invited to a 5 year follow-up examination. The
      investigators examined a total of 1031 subjects (82%) in the investigators 4 regional
      centres. The follow-up examination included general health evaluation and estimation of CAC
      by non-contrast enhanced cardiac CT-scan. Information of death, cardiovascular events and
      medication usage was obtained from the Danish national patient register, the Danish register
      of causes of death and the Danish national database of reimbursed prescriptions in 2016.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Danrisk cohort was established in 2009-2010 based on random retrieval from the Danish
        national civil registry (N=1825). Initially, distribution of gender, area of residence and
        year of birth (1949 or 1959) were equal among the 4 involved centres (OUH, Svendborg, Vejle
        and Esbjerg). A total of 1257 subjects (69%) accepted the invitation to undergo
        cardiovascular risk evaluation including non-contrast enhanced cardiac CT-scan for CAC
        estimation, and a total of 1227 subjects were found free of CVD and DM, and was included in
        the study back then.

        In 2014-2015 the DanRisk cohort was invited to a 5 year re-examination. The investigators
        examined a total of 1031 subjects (82%) in the investigators 4 regional centres.
      
Biospecimen description: 
      a biobank consisting of plasma and serum was established in 2009 and also in 2014-15.
Vascular Effect of Tibolone Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery
Condition: Flow-mediated Dilation Evaluation of the Brachial Artery
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the vascular effects of tibolone on climateric women
      measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound
      and compare to placebo.
    


Intervention name(s): Tibolone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Livial
Intervention MeSH terms: Tibolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hormone replacement therapy; Dopplervelocimetry; Flow-mediated dilation; menopause; tibolone
A Mobile App to Address Student Loneliness
Condition: Loneliness
Study type: Interventional

Summary: 
      The purpose of this trial is to assess the effects of a positive psychology and CBT-based
      skills intervention-delivered through a mobile app called Nod-on loneliness and other mental
      health and institutional satisfaction outcomes. The primary outcome is self-reported
      loneliness at 2 and 4-weeks post baseline.
    

Detailed description: 
      This study is a pilot eight-week randomized controlled intervention. It employs a "waitlist"
      control strategy for the first 4 weeks of the study (considered to be the active study
      period).

      Randomization will be to one of two conditions:

        1. Experimental group: Immediate access to the Nod app

        2. Waitlist control group: Participants will be granted access to the app four weeks after
           the experimental group

      Assessments will occur at baseline, 2, 4, and 8 weeks follow up. Assessments will include
      measures of loneliness, and other mental health and institutional satisfaction measures
      listed in the secondary outcome measures section.
    

Intervention name(s): Loneliness Intervention
Intervention type(s): Behavioral
Intervention description(s): 28 days of engagement with the Nod app, which consists of interactive exercises drawn from cognitive behavioral therapy (e.g behavioral activation and cognitive reframing exercises), positive psychology (e.g. acts of kindness), and mindful self-compassion programs (e.g. loving-kindness meditations)
Other intervention name(s): A mobile app called Nod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
10 Years Evaluation of Composite Restoration
Condition: Dental Restoration, Permanent
Study type: Interventional

Summary: 
      This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I
      and Class II restorations made of microhybrid composite and applied using two polymerisation
      protocols,
    


Intervention name(s): Astralis 10 HPM; Astralis 10 RM
Intervention type(s): Device; Device
Intervention description(s): The cavity to be filled is in quadrant I or III; The cavity to be filled is in quadrant II or IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: composite; restoration; polymerization
The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether dexketoprofen administered by phonophoresis
      or iontophoresis is more effective in the treatment of subacromial syndrome that the
      conventional therapy with ultrasounds.
    

Detailed description: 
      It is a question of valuing the decrease of the pain (by means of the visual analogic scale
      pain score) and the increase of the functionality of the joint (by means of Dash and Constant
      scores) of three different treatments from physical therapy to establish the most effective
      protocol for the treatment of the subacromial syndrome.

      Determine the best physiotherapy treatment for subacromial syndrome with 20 sessions of
      different treatments.

      A group will receive the conventional treatment with ultrasounds without drugs, another group
      will receive dexketoprofen by phonophoresis and the third group will receive dexketoprofen by
      iontophoresis.
    

Intervention name(s): Ultrasound; Phonophoresis; Iontophoresis; Exercises; Cryotherapy
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Ultrasound of 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.; Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.; Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 mA, 20 minutes, for 20 sessions.; Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.; Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Subacromial syndrome; Dexketoprofen; Phonophoresis; Iontophoresis; Ultrasounds; VAS; DASH score; Constant score
A Study of the Neurobiology of Depression
Condition: Major Depressive Disorder; Healthy Participants
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Previous research studies have shown that depression is associated with changes in structure
      and activity in different parts of the brain and that antidepressant medication can affect
      brain activity in different parts of the brain in individuals suffering from depression. The
      primary purpose of the study is to find out more about how the antidepressant medication
      duloxetine affects brain activity and structure in individuals with depression.
    

Detailed description: 
      This study will evaluate participants with depression before treatment is initiated and
      during treatment, and compare them to a control group of healthy participants. The aim will
      be to better understand both the neurobiology of depression and how the neurobiology changes
      in response to treatment of depression and the outcome of treatment. The study will include a
      variety of assessments of the neurobiology of depression including: scans of brain areas are
      involved in depression by looking at structures in the brain and how they work and blood
      tests and how these change in relation to several measures of depression severity.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): 60 milligrams (mg) administered orally daily for 8 weeks then 60-120 mg if non remitter or 60 mg if remitter for 4 additional weeks
Other intervention name(s): Cymbalta, LY248686
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Factors Affecting Anesthesia Preferences of Gravid Women
Condition: Caesarean Section, Anaesthesia, Questionnaires
Study type: Observational

Summary: 
      The investigators aim to evaluate the preferences for anaesthesia methods of gravid women who
      are to deliver baby by caesarean section, the rates of general anaesthesia and regional
      anaesthesia, the reasons for preferences of general anaesthesia and regional anaesthesia and
      the factors affecting these preferences.

      A questionnaire consisting of 20 questions were applied to gravid women applying for delivery
      by elective caesarean operation, at Ankara University Faculty of Medicine Hospital for
      Gynaecology and Obstetrics between February 2010 and February 2011, in order to study the
      anaesthesia technique the patients prefer and the reason behind their preferences. Those
      gravid women who accepted to take part in the study were provided information about the
      questionnaire and their oral and written approvals were obtained.
    

Detailed description: 
      The questionnaire was applied to the patients in visit queue a day before or while the
      patients were in waiting room for caesarean operation. The gravid women who were between 26th
      and 40th week of their pregnancy were included in the questionnaire. Those who were taken
      into emergency service, those with communication problems, those whose mental conditions
      deter them to answer questions and those who did not want to answer the questions on the
      questionnaire were excluded from the study.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): A questionnaire was performed to gravid women who are to deliver, regarding theri anesthesia preferences.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A questionnaire consisting of 20 questions were applied to gravid women applying for
        delivery by elective caesarean operation, at Ankara University Faculty of Medicine Hospital
        for Gynaecology and Obstetrics between February 2010 and February 2011
      
Keywords: Caesarean section; Anaesthesia; Questionnaires
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group,
      multicenter study to evaluate the safety, efficacy, and PK of oral administration of
      PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of
      PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening
      visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and
      anti-cytokine therapies except MTX. After the washout period, patients determined to be
      eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or
      placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after
      the last treatment visit. The primary efficacy endpoint will be the proportion of patients
      meeting the ACR 20 response criteria after 12 weeks of treatment.
    

Detailed description: 
      The study will be conducted in North America and Europe at approximately 50 to 60 sites.
      Approximately 270 patients will be randomized, of which 189 are expected to complete the
      study.

      The study will consist of a screening visit followed by a washout period for all disease
      modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout
      period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine,
      etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for
      abatacept.

      After the washout period, the patients determined to be eligible will be randomized to
      receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will
      be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the
      last treatment visit (Week 16). Patients will not initiate new therapies until after the
      4-week follow-up is completed. Liver function tests will be evaluated at every visit.

      The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response
      criteria after 12 weeks of treatment.
    

Intervention name(s): PG-760564; Placebo dose; PG-760564
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg BID, of oral PG-760564; placebo, BID, oral for 12 weeks; 25 mg BID, of oral PG-760564
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of theobromine on blood lipid parameters
      in healthy subjects. Secondary objectives are to determine the effect of cocoa and an
      interaction effect of cocoa and theobromine on blood lipid parameters.

      Hypothesis: theobromine has a positive effect on blood lipid parameters.
    


Intervention name(s): Theobromine; Cocoa; Cocoa and theobromine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 200 ml drink with added theobromine (no cocoa added); 200 ml drink with cocoa (no theobromine added); 200 ml drink with added cocoa and theobromine; 200 ml drink (no added theobromine or cocoa)
Intervention MeSH terms: Theobromine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Blood lipids; risk factor for cardiovascular diseases
Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research
Condition: Bone Mineral Density
Study type: Observational

Summary: 
      Our overarching aim is to set up a procedural, analytic and developmental framework to
      establish CT of the central and peripheral skeleton as a clinically useful biomarker for
      skeletal strength in the clinical research and ultimately in the clinical setting. To
      accomplish this, the investigators will develop and validate phantoms and scanning procedures
      to standardize strength and structure measurements between different vQCT scanners and
      develop standardized acquisition, analytical, and quality control techniques for HR-pQCT with
      an emphasis on optimization for multi-center studies.
    

Detailed description: 
      The investigators will develop new calibration phantoms to address inter and intra scanner
      variability in vQCT and HRpQCT. Phantom sets to evaluate inter-scanner disparity and
      determine corrections to apply to in vivo scan data in the multi-center settings. These
      methods will be validated in a multi-center phantom study and in a 120 patients
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy men and women aged 65-80
      
Keywords: spine and hip scan; BMD