bioihbjkbjnl/mcl2 huggingface dataset:
Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery
Condition: Cardiac Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Backgrounds: Monitoring of Bispectral index (BIS) has been regarded as useful to determine
      the degree of intraoperative hypnosis. Major factors of postoperative recovery after cardiac
      surgery include patient's recovery in cognitive function from the postoperative residual
      effects of anesthetics, such as opioids and sedatives, administered during intraoperative
      period. Therefore employing anesthetic regimens which can provide earlier recovery in
      cognitive function would be beneficial in facilitating fast-track cardiac surgery with
      earlier postoperative extubation and discharge from the intensive care unit (ICU).

      Previous investigations suggested efficacy of BIS in evaluating the degree of postoperative
      hypnosis in the ICU.

      The present study compares the time for reaching BIS greater than 80 after using 2 different
      anesthesia regimens for cardiac surgery, remifentanil-based regimen and
      sevoflurane-sufentanil balanced regimen.

      Analyzing the changes immediately after cardiac surgery would be useful to determine the
      degree of patient's postoperative emergence.

      Materials and Methods:

      During study period, patients undergoing elective cardiac surgery in Konkuk University
      Medical Center are randomly assigned to get remifentanil-based regimen consisting of
      remifentanil 0.75 mcg/kg/min and supplemental propofol for maintaining BIS 40-60 (Group R) or
      sevoflurane (end-tidal 1.2-2.8 vol%) and sufentanil (0.015 mcg/kg/min) balanced regimen in
      Group S.

      All patients get intravenous patient controlled anesthesia consisting of alfentanyl and
      ondansetron after surgery. Supplemental remifentanil 0.25-0.3 mcg/kg/min is administered
      during postoperative 2 hours in Group R.

      As a primary objective, inter-group difference in the time for achieving BIS greater than 80
      is determined.
    


Intervention name(s): remifentanil-based; sevoflurane-sufentanil balanced
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sufentanil; Remifentanil; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bispectral index; extubation; recovery; remifentanil
Smoking Cessation, Anxiety, Pain Relationship
Condition: Smoking Cessation; Anxiety; Pain
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Smoking, anxiety and pain are clearly related conditions. We aimed to reveal the relationship
      between smoking cessation before surgery and preoperative anxiety, postoperative anxiety and
      pain in chronic smokers.

      METHODS ASA I-II group patients without chronic disease and history of drug use were included
      in the study. Those who did not want to participate in the study, patients with ASA III and
      above were excluded from the study. The patients were randomized into 2 groups: smokers
      (Group S, n = 60) and non-smokers (Group NS, n = 60). Group S was asked to quit smoking 2
      weeks before the operation. Preoperative period and postoperative 0, 2, 4. And 6. hour
      Spielberger State-Trait Anxiety Inventory (STAI) values, postop 0., 2., 4., 6. hour Visual
      Analogue Scale (VAS) values were recorded.
    

Detailed description: 
      it has been revealed in the current study that smoking, pain and anxiety are interrelated
      with each other. In the preoperative period, high anxiety scores are related to surgery and
      anesthesia stress. High anxiety scores in the smoker group both in the preoperative period
      and in the postoperative period are associated with smoking cessation. While the pain scores
      were similar in the postoperative period, high anxiety scores strengthened the idea of
      smoking withdrawal and this study gained value. We believe that future studies with a large
      number of patients, with different parameters and multiple centers will strengthen the
      results.
    

Intervention name(s): The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
Intervention type(s): Other
Intervention description(s): Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Smoking Cessation; anxiety; pain; VAS Scores; STAI Values
Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
Condition: Epilepsy With Simple or Complex Partial Onset Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an 18-week, double-blind, multicenter study with gradual conversion from previous
      antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial
      epilepsy.
    

Detailed description: 
      This is an 18-week, double-blind, randomized, historical control, multicenter study with
      gradual conversion to monotherapy in subjects with partial onset seizures who are not well
      controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week
      period for titration of study drug, 6-week period for taper or conversion off AEDs, and a
      10-week monotherapy period. Subjects not entering an optional open-label extension study will
      enter a 1-week period to taper off study drug followed by an end of study visit (week 19).
      This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired
      by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to
      Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Eslicarbazepine acetate; Eslicarbazepine acetate
Intervention type(s): Drug; Drug
Intervention description(s): 1600 mg QD; 1200 mg QD
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seizure; Epilepsy; Anticonvulsant; Historical Control; Monotherapy
Experimental Research on Deep Carious Lesion Treatment of Molars
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Maintaining dental pulp vitality is crucial for tooth preservation and functionality.
      Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth
      and well-being. The first permanent teeth erupt around 6 years old. These are the first
      molars (FPM), which are frequently affected by caries, soon after their eruption.

      In the present application, our main goal is to determine whether two treatment groups (MTA
      and TheraCal) are long-term effective in preserving pulp vitality among children' FPM
      affected by deep caries.
    

Detailed description: 
      Among the most frequently used materials for pulp capping are calcium hydroxide, mineral
      trioxide aggregate (MTA), and, more recent, TheraCal. All of them are biocompatible and
      induce the formation of coronal hard tissue barriers (tertiary reparative dentin). Calcium
      hydroxide, considered for a long time the gold standard of direct pulp capping materials, has
      excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially
      at moist dentin, and reparative dentin is less homogenous.

      MTA proved to stimulate protective dentin bridge formation without inflammatory changes and
      least necrosis. It is also moisture tolerant, but it is more expensive, has poor handling
      characteristics and slow setting time.

      TheraCal bonds to deep moist dentin, has strong physical properties, no solubility, high
      radioopacity and higher calcium releasing abilities than MTA or calcium hydroxide.
    

Intervention name(s): TheraCal; MTA
Intervention type(s): Other; Other
Intervention description(s): Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal; Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental pulp; deep carious lesions; treatment effect
A Comparison of PRK and LASIK for Correction of Myopia
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study compares the precision and accuracy of two laser refractive techniques, PRK and
      LASIK, for correction of nearsightedness between -6 and -8 diopters.
    


Intervention name(s): PRK; LASIK
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Excimer laser
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigation of the efficacy and safety of a new potential treatment of Major depressive
      disorder (MDD) in paediatric participants (age 7 to 11 years).
    


Intervention name(s): Vortioxetine 10 mg/day; Vortioxetine 20 mg/day; Fluoxetine 20mg/day; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed; Encapsulated tablet, orally
Other intervention name(s): Brintellix ®; Lu AA21004; Brintellix ®; Lu AA21004
Intervention MeSH terms: Vortioxetine; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: paediatric
Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      The main aim of this study is to evaluate the long-term maintenance of efficacy of LDX after
      administered to children and adolescents aged 6-17 with ADHD for at least 6 months
    


Intervention name(s): Lisdexamfetamine dimesylate (LDX); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods); Placebo capsule once per day (double-blind period)
Other intervention name(s): Vyvanse, SPD489
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg
      tablets and 200mg granules will be given to healthy Participants under fasting conditions.

      Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.
    


Intervention name(s): ZSP1273 tablet; zsp1273 granules
Intervention type(s): Drug; Drug
Intervention description(s): Participants receive ZSP1273 tablet orally.; Participants receive ZSP1273 granules orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes
Condition: Type 1 Diabetes; Celiac Disease
MeSH terms: Celiac Disease; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the immune response causing celiac disease
      is related to the autoimmune response causing type-1 diabetes.
    

Detailed description: 
      Participants meeting eligibility criteria will have blood collected before and after a
      three-day oral gluten challenge. This blood will be tested for biomarkers associated with
      islet autoimmunity and gluten-specific cellular immunity.
    

Intervention name(s): Gluten Challenge; Sham Challenge
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Three-day gluten containing dietary challenge.; Three-day sham (gluten free) dietary challenge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants
Condition: Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)
MeSH terms: Severe Acute Respiratory Syndrome; COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety,
      Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV
      in Healthy Participants
    


Intervention name(s): MBS-COV; Placebo
Intervention type(s): Drug; Other
Intervention description(s): MBS-COV is a potent siRNA treatment for mild to moderate COVID-19.; Normal saline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Outpatient Nurse Monitoring Under the Prevention of Recurrent Suicidal
Condition: Mood Disorder; Reactive Depression
MeSH terms: Mood Disorders; Adjustment Disorders
Study type: Interventional

Summary: 
      To evaluate the impact of a specific nursing management (personalized and close, through
      consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the
      suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in
      patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.
    

Detailed description: 
      Main objective: To evaluate the impact of a specific nursing management (personalized and
      close, through consultation at the hospital, at home or by phone) monitoring in
      post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year
      following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar)
      or reactive depression.

      Secondary objectives:

      Studying during the year following the suicide attempt index, the impact of this device on:

        -  The frequency and intensity of suicidal ideation

        -  the spontaneous use of emergency care

        -  the death rate from suicide and other causes

        -  the cumulative duration of hospitalization for suicidal behavior

        -  The patient's quality of life

        -  the number of patients lost to at the end of search

      Studying patient compliance with intensive nursing monitoring program.

      To study the role of the nurse to determine the factors that promote the construction of a
      therapeutic alliance.

      Establish a mapping of needs and resources suicidal patient for nursing care in
      post-emergency.
    

Intervention name(s): Supported with intensive nursing follow post hospitalization
Intervention type(s): Other
Intervention description(s): Intensive nursing follow post - hospitalization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Molecular and Hormonal Responses to Diet-Induced Insulin Resistance
Condition: Healthy
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This study determined the effect of 7 days of high-fat overfeeding on whole-body glycaemic
      control, glucose kinetics, skeletal muscle insulin signalling, and markers of skeletal muscle
      microvascular function in 15 healthy young individuals.
    

Detailed description: 
      Fifteen healthy, young individuals underwent metabolic testing before and after 7 days of
      high-fat overfeeding. We determined whole-body glycaemic control, glucose kinetics, skeletal
      muscle insulin signalling, and markers of skeletal muscle microvascular function. Stable
      isotope tracers were used to assess the rate of appearance of glucose from the gut, liver
      glucose output and whole-body glucose disposal. Insulin signalling was determined by Western
      blotting of skeletal muscle tissue. Microvascular function was assessed through the use of
      quantitative immunofluorescence microscopy. These measurements were performed both
      postabsorptively and following the ingestion of 50 grams of glucose + 15 grams of protein.
    

Intervention name(s): High-fat, high-energy diet
Intervention type(s): Dietary Supplement
Intervention description(s): Participants consumed a diet that was high in fat and high in energy
Intervention model: Single Group Assignment
Intervention model description: 15 healthy individuals were assessed before and after consuming a high-fat, high-energy diet for 7 days.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: High-fat diet; Insulin; Glucose; Muscle; eNOS; Isotopes
Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes
Condition: Myopia; Hyperopia; Presbyopia
MeSH terms: Myopia; Presbyopia; Hyperopia
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical study has been planned to determine the effectiveness of a special laser
      treatment intended to correct both near and distance vision in patients who have undergone
      previous cataract surgery.
    

Detailed description: 
      This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACOR
      presbyopic excimer laser treatment algorithm for near myopic and near hyperopic indications,
      with or without astigmatism, when performed on the cornea of pseudophakic eyes implanted with
      a monofocal IOL.
    

Intervention name(s): Supracor
Intervention type(s): Device
Intervention description(s): The presbyopic treatment consists of a standard treatment for distance vision and the procedure known as SUPRACOR addition to correct near vision.
The SUPRACOR addition provides a multifocal ablation with a central near addition with an aberration controlled transition zone towards the periphery, thereby allowing good focus over a range of object distances.
Other intervention name(s): PresbyLASIK; Multifocal Ablation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia; Hyperopia; Presbyopia; Pseudophakia; LASIK
Safety, Tolerability and Pharmacokinetics of KX826 in Healthy Male Subjects With Androgenetic Alopecia Following Topical Single Ascending Dose Administration
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation
      Study in Healthy Male Subjects with Androgenetic Alopecia to Evaluate the Safety,
      Tolerability and Pharmacokinetics of KX-826 Following Topical Single Ascending Dose
      Administration
    

Detailed description: 
      A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug
      and 8 subjects randomized to receive placebo in a double-blind fashion (ten subjects in each
      dose cohort with two subjects randomized to placebo for total of four dose cohorts).Subjects
      were to be assigned to 1 of the 4 dose levels, 3 mg. 12 mg, 48 mg and 96 mg of KX-826 or
      placebo to match the active product, administered as a topical application.
    

Intervention name(s): KX0826; Placebo
Intervention type(s): Drug; Other
Intervention description(s): AR antagonist; Placebo of KX-826
Other intervention name(s): Pyrilutamide; KX-826
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Changes in Speed, Endurance and Balance in Women Patients With Multiple Sclerosis After 4 & 8 Weeks of Aquatic Exercise Training
Condition: Multiple Sclerosis; Aquatic; Exercise
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Background: It has been shown that adults with Multiple sclerosis (MS) have less leg strength
      than their peers, as well as impaired balance, which has led to an increased prevalence of
      falls in this population.The purpose of this study was to assess the effects of 8-weeks
      aquatic exercise training in balance, endurance and speed in women with MS.

      Methods: In this semi-experimental study, 32 women with clinically-definite
      relapsing-remittent MS who were registered through the Isfahan MS association volunteered for
      this study. They randomly selected an aquatic exercise (n = 17) and control (n = 15) groups.
      Aquatic exercise group completed a 8-week aquatic exercise training program consisted of
      three sessions per week, each session lasting 45 to 60 minutes 50 to 75 percent of their
      maximum heart rate reserve on 20-25 degree centigrade's, whereas the control group was
      instructed to maintain their current lifestyle. The balance of angry was surveyed with using
      of Berg analyze, speed and endurance 6 minutes walking test before starting of exercise
      program and after 4 weeks and at the end of 8 weeks was analyzed. The obtained data's were
      analyzed using analysis of variance with repeated measures.
    


Intervention name(s): Exercise; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8-week aquatic exercise training program; Control group did not do the exercise training.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment