bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery
Condition: Patients Undergoing Major Abdominal Surgery; Postoperative Confusion
MeSH terms: Confusion
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effects of two different analgesic methods
      (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status
      of patients.
    

Detailed description: 
      The purpose of this study is to investigate the effects of two different analgesic methods
      (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status
      of patients. In particular, whether there is a correlation between type of anesthesia and the
      appearance of postoperative cognitive disorder (POCD), including type of anesthesia and
      levels of pro and anti inflammatory cytokines and investigate whether there is an association
      between presence or absence of POCD and cytokines levels
    

Intervention name(s): Remifentanil; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): In group A induction of anesthesia will be performed with Propofol (2mg/kg), Cisatracurium (0.15mg/kg)and continous infusion of Remifentanil (0.15mcg/kg/min).Anesthesia will be maintained by Sevoflurane with oxygen (Fi=40%)and air, with a MAC value to maintain BIS between 40 and 60. Intraoperative analgesia will be obtained with Remifentanil 0.15-0.25mcg/kg/min. Additional boluses of Cisatracurium (0.02mcg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum bolus of morphine (0.1mg/kg)and acetaminophen 1g will be administered. Propofol and remifentanil infusions will be interrupted at the end of wound closure.; In group B anesthesia will be induced by Propofol (2mg/kg), Fentanyl (2mcg/kg)and Cisatracurium (0.15mg/kg). Anesthesia will be maintained by Sevoflurane, oxygen (Fi=40%) and air and boluses of Fentanyl (50mcg). additional boluses of Cisatracurium (0.02mg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum acetaminophen 1g will be administered.
Intervention MeSH terms: Fentanyl; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Major abdominal surgery; analgesic method; Fentanyl; Remifentanyl; Postoperative cognitive disorder; Pro and anti inflammatory cytokines
Effects of Electroconvulsive Therapy (ECT) on Serotonin-1A Receptor Binding
Condition: Unipolar Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      In treatment-resistant depression, electroconvulsive therapy (ECT) has been shown to
      effectively reduce depressive symptoms, though the underlying neurobiological mechanism is
      still unclear. The serotonergic system, and in particular the inhibitory serotonin-1A
      (5-HT1A) receptor, appears to be significantly involved in the effectiveness of ECT. The aim
      of the study is to assess the effects of ECT on the 5-HT1A receptor binding potential (BPND)
      and distribution in humans in vivo using positron emission tomography (PET) and the
      radioligand [carbonyl-11C]WAY-100635.

      12 patients suffering from severe, therapy-resistant unipolar depression will undergo 3 PET
      scans, two of these scans taking place before the ECT treatment, consisting of 6-14 ECTs, the
      third scan taking place after the ECT treatment.

      This imaging study hypothesizes that upon completion of the ECT, the overall 5-HT1A receptor
      BPND in the brain of depressed patients will significantly change.

      This study would be the first to demonstrate an effect of electroconvulsive therapy on the
      5-HT1A receptor binding in humans in vivo. Given the involvement of the 5-HT1A receptor in
      the pathophysiology of mood disorders, the present study would be an important step towards a
      better understanding of antidepressant treatment and treatment response. By comparing
      treatment effect and the underlying biological mechanism, the study might help to identify
      biomarkers that distinguish patients who are likely to benefit from ECT from patients who
      will rather be non-responders. Finally, by investigating the role of the 5-HT1A receptor in
      ECT, is highly discussed relevance for antidepressant action will be further elucidated and
      might prepare the ground for new therapeutic strategies.
    


Intervention name(s): ECT
Intervention type(s): Procedure
Intervention description(s): ECT series consisting of 6 to 14 ECTs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Development and Validation of a Digital Optotype for Near Vision in Greek Language.
Condition: Presbyopia; Low Vision; Near Vision
MeSH terms: Vision, Low; Presbyopia; Myopia
Study type: Observational [Patient Registry]

Summary: 
      Primary objective of our study is to develop and validate a computer-based digital
      near-vision optotype based on the Greek version of the print MNREAD.
    

Detailed description: 
      Present study aims to develop and validate a computer-based digital near-vision optotype
      based on the Greek version of the print MNREAD.

      Specifically, it aims to evaluate the level of agreement between the conventional printed
      greek MNREAD chart and the corresponding digital chart, as well as test-retest reliability of
      the digital optotype.

      To address these aims, four reading parameters measured with the print and the digital
      version are compared. These parameters are the following:

        1. Reading Acuity (RA)

        2. Maximum Reading Speed (MRS)

        3. Critical Print Size (CPS)

        4. Accessibility Index (ACC)

      All the comparisons take place in two groups: a) a Normal Vision Group (NVG), and b) a Low
      Vision Group (LVG) in order to estimate the reading capacity in a population with a wide
      range of vision.
    

Intervention name(s): MNREAD testing
Intervention type(s): Diagnostic Test
Intervention description(s): One randomly selected eye is included for each study participant. Participants respond to the near vision chart with defined environmental circumstances at 40cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Normal- and low-sighted participants aged 18 to 75 years
      
Keywords: digital near vision chart; critical print size; reading acuity; reading speed; digital Greek MNREAD
Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts
Condition: Unspecified Symptoms and Signs Involving Cognitive Functions Following Unspecified Cerebrovascular Disease; Heroin Addicts; Executive Function; Negative Thinking/Affect
MeSH terms: Cerebrovascular Disorders; Substance-Related Disorders
Study type: Interventional

Summary: 
      The goal of this [type of study: exercise intervention study] is to test in describe
      participant health conditions. The main questions it aims to answer are:

        -  [Whether physical exercise improves executive function of male heroin addicts]

        -  [Whether physical exercise improves negative thinking/affect psychological experience of
           male heroin addicts] Participants will be randomly selected for medium-intensity
           strength training (resistance exercise,n=30), 30 will be selected for 1-hour long
           balloon volleyball sessions (aerobic exercise) at 60-70% volume of oxygen uptake during
           peak exercise, weekly 5 times for 12 weeks; and 30 will be assigned to the no-exercise
           control group, Participants will perform Executive function tests and the Symptom
           Checklist-90 Revised questionnaire at pre and post intervention.

      Researchers will compare resistance exercise group,aerobic exercise group and no-exercise
      control group to see if effects of exercise on executive function and negative
      thinking/affect psychological experience of male heroin addicts.
    


Intervention name(s): Aerobic exercise; Resistance exercise
Intervention type(s): Behavioral
Intervention description(s): To investigate affect/effect of dissimilar modes of exercise, Aerobic exercise versus Resistance exercise, on execution function and psychological symptoms in heroin addicts, 1 hour of characteristic exercise protocols aiming to (a) maximize the strain on the cardiovascular system with Aerobic exercise(60-70% of heart rate recovery) and (b) promote the greatest hypertrophy response with Resistance exercise(65% of 1 repetition maximum & repeated up to 15 time) were used. Both exercise programs were designed to match the male heroin addicts, with medium-intensity Strength-Trained for Resistance exercise and playing balloon volleyball for Aerobic exercise. Two exercise groups performed at 65% of their pre-determine peak oxygen uptake.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Tomosynthesis in Screening Mammography
Condition: Breast Density >25%
Study type: Interventional

Summary: 
      Tomosynthesis is a new digital mammographic tool which can be performed at the same time as
      routine screening mammography. It creates CT-like slices through the breast, minimizing the
      tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by
      increasing cancer detection rates, decreasing false negative rates and false positive rates.
      This trial will help determine if tomosynthesis is useful in a screening setting.
    

Detailed description: 
      We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We
      will collect data on interpretation time, recall rates, cancer detection rates, and interval
      cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less
      than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will
      then conduct a study with larger numbers to better evaluate cancer detection rates and
      interval cancer rates.
    

Intervention name(s): 2D Mammogram; Tomosynthesis
Intervention type(s): Procedure; Procedure
Intervention description(s): Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.; Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Tomography; Mammography; Breast Neoplasms; Prevention and Control
A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
Condition: House Dust Mite Allergy
MeSH terms: Dust Mite Allergy; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet
      given once daily compared to a placebo tablet in the treatment of house dut mite allergic
      rhinits.

      Additionally the secondary objective of the trial is to evaluate the safety and tolarability
      of the ALK house dust mite tablet.

      Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite
      induced allergy. This trial is planned to investigate if clinically relevant improvements in
      rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects
      with a history of poor didease control despite of use of symptomatic medications.
    


Intervention name(s): AIT Tablet
Intervention type(s): Biological
Intervention description(s): 1 tablet per day in 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions
Condition: Healthy Adults
Study type: Interventional

Summary: 
      Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide
      range of fluid intake behaviors
    


Intervention name(s): Water; No intervention
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate
      the PK, safety and tolerability of SR419 in healthy subjects.
    

Detailed description: 
      The study is a Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy
      volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 2 multiple-dose
      cohorts (Part A and part B respectively), a total of 5 cohorts, and each cohort includes 3
      stages: screening and baseline, treatment and safety monitoring, and safety follow-up.
    

Intervention name(s): SR419 capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single and multiple doses of SR419 orally; Ascending single and multiple doses of placebo orally
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Identification of Interscalene Brachial Plexus on Ultrasonography Using a Deep Neural Network
Condition: Ultrasound Therapy; Complications
Study type: Interventional

Summary: 
      The purpose of the study is to develop and validate an algorithm based on deep neural
      networks (DNNs) to identify interscalene brachial plexus on ultrasonography automatically.
    

Detailed description: 
      The investigators plan to develop a deep learning-based network to automatically identify
      interscalene brachial nerves on ultrasound images. The trained model will be validated on an
      independent dataset. The performance of the network will also be compared against practicing
      anesthesiologists.
    

Intervention name(s): ultrasound examination
Intervention type(s): Procedure
Intervention description(s): the participants will be placed in the supine position, with head turned slightly away from the operating side and arms beside the body. The operator will identify right and left interscalene brachial plexuses by ultrasound equipment (Sonosite EDGE or GE LOGIQ e). Clear images and videos of brachial plexus will be captured and saved.
Intervention model: Single Group Assignment
Intervention model description: Patients who have been scheduled to surgery will be recruited for collecting ultrasound images.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: peripheral nerve block; ultrasound image; deep neural network; brachial plexus
The Effect of Web-Based Education in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Educational Problems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This research was designed as a randomized controlled study to develop a web-based training
      program and evaluate the program's impact on diabetes management. This research was carried
      out on 89 patients diagnosed with type 2 diabetes in the Department of Endocrinology and
      Metabolic Diseases of Akdeniz University. The preparation of the web page and its content has
      benefited from the latest literature, national and international websites, and expert
      opinions. Individuals in the survey scope have been stratified random method with as
      intervention group (n=44) and control group (n=45). Individuals who were taken in the
      initiative group were informed by web page, SMS, e-mail prepared for a period of three
      months. Personal information forms Metabolic Control Variable Form, Diabetes Self-Care
      Activities Questionnaire, Self-Efficacy Scale for Type 2 Diabetic Individuals,
      Diabetes-Specific Quality of Life Scale and Web Site Analysis and Measurement Inventory were
      used as the data tools. The informed consent was obtained from the patients and all data were
      collected by author during face-to-face interviews.
    


Intervention name(s): Web-Based Education; Control Group
Intervention type(s): Other; Other
Intervention description(s): Participants in the intervention group had unlimited access to the Web site, free of charge. The Web site was designed to run on personal computers and smartphones.; The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Nursing; Type 2 diabetes; Web based education program; Self efficacy; Quality of life
Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to evaluate the absolute bioavailability of a
      single, fixed sub-cutaneous (SC) dose of aducanumab compared with a single, weight-based
      intra-venous (IV) dose in healthy participants and to characterize the pharmacokinetics (PK)
      profile of aducanumab. The secondary objectives are to evaluate the safety and tolerability
      of aducanumab administered via SC and IV routes in healthy participants and to characterize
      additional PK parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose
      in healthy participants.
    


Intervention name(s): aducanumab
Intervention type(s): Drug
Other intervention name(s): BIIB037
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Reverse Genetic H9N2 Influenza Vaccine Study in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to identify the optimal dose level of a reverse genetic (RG)
      reassortant H9N2 pandemic influenza vaccine for further product development.
    


Intervention name(s): Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine
Intervention type(s): Biological
Intervention description(s): Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults
Condition: Muscle Loss; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      To evaluate the effects of protein-enriched soup plus exercise on muscle mass and muscle
      strength.

      Besides, the investigators use the valued-based healthcare standard set as well as the Center
      for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive
      Assessment , and Mini Nutritional Assessment as outcome measures and to use the trial in
      validate additional supplement protein-enriched soup plus exercise could improve the vitality
      and health of mid-aged and old adults.
    

Detailed description: 
      With aging, functions of every organs become to decline. Muscle mass, is one of the decline.
      According to previous research, adults would lose 40% among from aged 20 to 70. If muscle
      mass decline combining with the decline of muscle strength is so called Sarcopenia.When
      muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In
      addition, activity and life quality are also responsible for falling, cognitive difficulty,
      disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia
      through this program and develop prevention strategy and model to mollify the the negative
      effect of rapid aging society.
    

Intervention name(s): protein-enriched soup
Intervention type(s): Other
Intervention description(s): The participants in experimental group have a protein-enriched soup a day and do exercise a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Laurel Corporation; Protein-Enriched Soup
A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel,
      multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment
      for patients with moderate to severe atopic dermatitis.

      The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will
      be compared to placebo and improvement in atopic dermatitis will be assessed using the
      Investigator's Global Score (IGA)
    


Intervention name(s): Drug: SHR0302
Intervention type(s): Drug
Intervention description(s): The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment