bioihbjkbjnl/mcl2 huggingface dataset:
Metabolic Effect of High-protein Meals in Men
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the clinical study is to investigate the effect of the protein quality of
      high-protein meal replacements on the management of post-prandial blood glucose in healthy
      men.
    

Detailed description: 
      It was a double-blind, single center, randomized, crossover adaptive study design with 7
      arms.

      The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test
      meal) in randomized order preferably a week apart. The 7 test meals were isocaloric,
      isonitrogenous and differed in their protein quality.
    

Intervention name(s): Whey protein native; Whey protein microgels; Hydrolyzed whey protein; Casein native; Hydrolyzed casein; Total milk protein native; Hydrolyzed milk protein
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Whey protein native against the 6 other arms; Whey protein microgels versus the six other arms; versus the six other arms; versus the six other arms; versus the six other arms; versus the six other arms; versus the six other arms
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glucose; Insulin
Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration
Condition: Articular Cartilage Disorder of Knee
MeSH terms: Cartilage Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to compare histologic and MRI evaluation of articular cartilage
      regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling
      followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without
      peripheral blood stem cells (PBSC)
    

Detailed description: 
      The purpose of this study was to compare histologic and magnetic resonance imaging (MRI)
      evaluation of articular cartilage regeneration in patients with chondral lesions treated by
      arthroscopic subchondral drilling followed by postoperative intra-articular injections of
      hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)
    

Intervention name(s): Peripheral blood stem cells and hyaluronic acid injections; Hyaluronic Acid
Intervention type(s): Biological; Drug
Intervention description(s): Peripheral blood stem cells and hyaluronic acid injections; Hyaluronic acid injections
Other intervention name(s): PBSC and HA; HA
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Reliability And Validity Of A Smartphone App
Condition: Rheumatoid Arthritis; Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The goal of this observational study is to validate a smartphone app called Angulus. The main
      question it aims to answer is:

      • Is an Angulus App valid and reliable system for masuring hand and wrist range of motion?

      Participants will be evaluated by goniometers which is a gold standart for range of motion
      assessment.
    


Intervention name(s): Angulus
Intervention type(s): Diagnostic Test
Intervention description(s): Smartphone app
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy
      
Keywords: reliability; validity; range of motion
Diabetes Engagement and Activation Platform
Condition: Type 2 Diabetes (T2D)
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The following are hypothesized:

        1. The Diabetes Engagement and Activation Platform (DEAP) can be integrated into primary
           care workflow to facilitate the care of patients with type 2 diabetes.

        2. The DEAP intervention will be feasible and acceptable to patients with type 2 diabetes.

        3. The DEAP intervention will enhance patient activation and improve type 2 diabetes self
           management and glucose control
    

Detailed description: 
      Aim 1: To evaluate how primary care practices adopt and integrate DEAP into routine workflow
      including identification of barriers and facilitators to support acceptable, feasible, and
      sustainable use of the system.

        -  Sub-aim 1.1: Measure the proportion of clinicians and care team members who engage
           patients through the DEAP intervention as well as the types of patient support
           activities they address; assess the representativeness of participating clinicians and
           care team members in relation to all practice staff; and assess how they integrated DEAP
           into the care of type 2 diabetes patients.

        -  Sub-aim 1.2: Assess how practices redesign workflow, overcome barriers, and enhance
           facilitators in order to integrate DEAP.

        -  Sub-aim 1.3: Determine processes for sustaining DEAP beyond the project funding period .

      Aim 2: To compare, relative to usual care, the effectiveness of the DEAP intervention.

        -  Sub Aim 2.1: Measure the proportion and representativeness of eligible patients who
           choose to enroll; access the DEAP curriculum; complete the DEAP curriculum; and contact
           care team members. .

        -  Sub Aim 2.2: Compare the change in the average glycosylated hemoglobin (primary
           outcome), Body Mass Index, systolic blood pressure, and type 2 diabetes (T2D)
           medications and patient activation (secondary outcomes) from baseline to 3 months and
           from 3 to 6 months for patients randomized to DEAP versus usual care.

      Sub Aim 2.3: Assess the clarity, readability and acceptability of the DEAP curricula
      materials for T2D patients enrolled in the intervention.
    

Intervention name(s): Usual Care
Intervention type(s): Other
Intervention description(s): Patients will not be given the intervention but receive usual care for T2D.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Intravenous Cardioversion of Atrial Fibrillation (AF) With AZD1305
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being carried out to see which dose of AZD1305 is safe and effective in
      cardioverting atrial fibrillation into normal heart rhythm.
    


Intervention name(s): AZD1305; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (iv) single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes; iv single infusion given intravenously until successful conversion of Atrial Fibrillation (AF) to Sinus Rhythm (SR) occur or for a maximum of 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: AZD1305; intravenous cardioversion of Atrial Fibrillation
Combined Effects of Meal Frequency and Protein Load on Cardiometabolic Risk Factors
Condition: Metabolic Disease; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Metabolic Diseases
Study type: Interventional

Summary: 
      This study examines the effect of meal frequency and meal composition on risk factors of
      cardiometabolic disease.
    

Detailed description: 
      Cardio-Metabolic Disease (CMD) is the leading cause of death globally & in Singapore. Large
      scale epidemiological evidence confirmed that elevated postprandial Glucose, Insulin,
      Triglycerides are major risk factors for CMD. Recent evidence suggests benefits from high
      protein diets but the health effects of eating smaller meals remain enigmatic. The aim of
      this study is to examine Meal frequency (2-large vs 6-smaller isocaloric meals), under High
      or Low Protein loads on acute postprandial health biomarkers . The investigators hypothesized
      that Higher Protein & Higher Meal Frequency would be beneficial for cardiometabolic health.
    

Intervention name(s): Meal (Eating) Frequency; Protein Composition
Intervention type(s): Other; Other
Intervention description(s): Dividing meal intake into 2 or 6 meals with equal energy content; Consuming meals with higher or lower protein.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Is Prophylactic Antibiotics Necessary In Otherwise Healthy Adult Patients Undergoing Ureteroscopic Procedures for Ureteral Stones?
Condition: Ureteral Stones
MeSH terms: Ureteral Calculi; Ureterolithiasis
Study type: Observational [Patient Registry]

Summary: 
      The present study aims to investigate the relative efficacy, safety and risk of a single-dose
      prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for
      ureteral stones.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cohort study
      
Keywords: prophylactic antibiotics, urinary tract infection.
Aging, Cognition, and Hearing Evaluation in Elders Study
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      The investigators will conduct a small pilot study that will randomize ~ 40 70-84 year-old
      adults with hearing loss to best-practices hearing rehabilitative treatment (hearing
      assessment, counseling, fitting of amplification devices) versus a successful aging
      intervention (one-on-one counseling/education sessions on successful aging topics).
      Participants will be followed for 6 months, and outcomes will focus on communication, quality
      of life, cognition, and other functional surveys. This pilot study is in preparation for a
      larger planned trial to investigate if hearing loss treatment can reduce cognitive decline
      and dementia in older adults.
    


Intervention name(s): Best practices hearing rehabilitative treatment; Successful aging intervention
Intervention type(s): Other; Other
Intervention description(s): Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.; One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder
Condition: Major Depression
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

        -  To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily,
           and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as
           assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton
           Depression Rating Scale (HAM-D) total score.

      Secondary Objectives:

        -  To evaluate the tolerability and safety of SSR125543 in outpatients with major
           depressive disorder

        -  To evaluate plasma concentrations of SSR125543
    

Detailed description: 
      This duration of this trial is 11 weeks.
    

Intervention name(s): SSR125543; escitalopram; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: capsule
Route of administration: oral; Pharmaceutical form: encapsulated tablets
Route of administration: oral; Pharmaceutical form: capsule
Route of administration: oral
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center
Condition: Anesthesia; Surgery
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an I-gel laryngeal mask airway (LMA) has a
      higher oropharyngeal leak pressure compared to an Ambu Auragain in adult patients in an
      ambulatory surgery center.
    

Detailed description: 
      Patients who are scheduled for elective ambulatory surgery under general anesthesia will be
      randomized to one of two groups. Group 1 will receive an I-gel laryngeal mask airway (LMA)
      and group 2 will receive an Ambu Auragain LMA.
    

Intervention name(s): I-Gel Laryngeal Mask Airway; Ambu Auragain Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): The I-Gel Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness.; The Ambu Auragain Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who are scheduled for elective ambulatory surgery under general anesthesia will be randomized to one of two groups. Group 1 will receive an I-gel laryngeal mask airway (LMA) and group 2 will receive an Ambu Auragain LMA.
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation
Condition: Allergy; Rhinitis; Conjunctivitis
MeSH terms: Rhinitis; Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and Safety from a high-dosed sublingual grass pollen preparation
    


Intervention name(s): Allerslit forte; Allerslit forte
Intervention type(s): Biological; Biological
Intervention description(s): sublingual placebo preparation, daily; Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sublingual grass pollen preparation; IgE-mediated Allergic Disease attributed to grass pollen
Ultrasound Lung Fluid Responsiveness During Hysterectomy
Condition: Fluid Overload
Study type: Interventional

Summary: 
      Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of
      B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially
      after excessive fluid administration. B-lines have been acknowledged as sonographic signs of
      pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific
      evidence on optimal intraoperative fluid management has resulted in large variations of
      administered fluid regimens in daily practice. The restricted perioperative intravenous fluid
      regimen reduces complications after elective surgeries, however other studies had shown that
      intraoperative liberal fluid administration improves postoperative organ functions and
      recovery and shortens hospital stay after elective surgeries.
    

Detailed description: 
      A review of patients undergoing major abdominal surgery, excluding high-risk patients,
      compared liberal and restrictive ﬂuid regimens; concluded that it is difficult to define
      'liberal' or 'restrictive' protocols in clinical practice. patients undergoing moderate-risk
      surgery seem to benefit from the more liberal fluid administration, while patients undergoing
      high-risk or major surgery seem to benefit from restrictive or conservative strategies. Lung
      ultrasound used for comparison between liberal and restrictive fluid therapy in laparoscopic
      hysterectomy patients by detecting the B-lines intraoperatively or immediately
      postoperatively. The aim is to evaluate the lung ultrasound as a guide for intraoperative
      fluid management, being an index for increased extravascular lung water (ECLW). This
      operation is a moderately complex procedure that implies the Trendelenburg position. This
      position - in addition to liberal fluids - will increase venous return and increase the
      challenge on the cardiac muscle under anesthesia in these patients.
    

Intervention name(s): 30 ml/Kg/h crystalloid; 10 ml/Kg/h crystalloid
Intervention type(s): Drug; Drug
Intervention description(s): Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 30 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.; Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 10 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: lung ultrasound, fluid, hysterectomy, B lines
Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to assess protectivity following four doses of bOPV which given simultaneously
      with Pentabio® and 1 dose of IPV at the 4th visit
    

Detailed description: 
      To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the
      antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which
      given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit
    

Intervention name(s): bOPV; Pentabio; IPV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Batch Number: 2042015; Batch number: 5050115 The vaccine shall be given intramuscularly.; The vaccine shall be given intramuscularly.
Other intervention name(s): bivalent Oral Polio Vaccine; DTP-HB-Hib Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
[18F]THK-5351 Positron Emission Computed Tomography Study of Normal, Mild Cognitive Impairment, Alzheimer's Disease and Other Neurodegenerative Disease
Condition: Alzheimer's Disease; Mild Cognitive Impairment; Neurodegenerative Diseases
MeSH terms: Alzheimer Disease; Neurodegenerative Diseases; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a cross-sectional and longitudinal study to evaluate the clinical utility of
      [18F]THK-5351 positron emission computed tomography in cognitively healthy volunteers, mild
      cognitive impairment (MCI), Alzheimer's disease (AD) and other neurodegenerative patients.
    


Intervention name(s): [18F]THK-5351
Intervention type(s): Drug
Intervention description(s): Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other intervention name(s): FluoroTau
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tau, neurodegeneration, positron emission computed tomography
Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted in order to determine if intratumoral chemotherapy will be
      helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial
      brachytherapy.
    

Detailed description: 
      Injections of cisplatin are given in conjunction with the brachytherapy procedure. If the
      direct intratumoral injections result in a decrease in the endobronchial obstructed airways
      and if the therapy is well tolerated, there will be immediate clinical benefit to this
      minimally invasive method, the most obvious being an improved quality of life. Approximately
      2 mg cisplatin per cubic centimeter of tumor are injected into each tumor through a flexible
      bronchoscope. A total of four to six injections are administered one week apart. Response to
      therapy is assessed based on improvement in intraluminal obstruction by tumor, as assessed by
      endobronchial observation.
    

Intervention name(s): Cisplatin
Intervention type(s): Drug
Intervention description(s): 1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
Intervention MeSH terms: Cisplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung; Chemotherapy; Cisplatin; Intratumoral; Bronchoscope; Brachytherapy
Telemark Polyp Study, a Trial on Colonoscopy Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been
      implemented in many western countries. The estimated effect is based on case-control and
      observational studies. There are no randomized trials quantifying the effect of colonoscopy
      screening on CRC incidence and mortality.

      The present study investigates the effect of a population-based once-only colonoscopy
      screening with polypectomy on the incidence of CRC in an average risk population.

      In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population
      registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy
      screening examination, and 400 individuals were not offered any screening. In 1996, the
      remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new
      age and sex matched control group, not being offered screening, was randomly drawn from the
      same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and
      all-cause mortality through national Norwegian registries.
    

Detailed description: 
      This as a randomized study of once-only colonoscopy screening (n=685) vs/no screening(care as
      usual)(n=684). Men and women at 63-72 years of age are recruited from the population
      registry. The intervention group is invited for screening after a bowel cleansing regimen at
      home. Follow-up is restricted to trace events (colorectal cancer incidence and deaths)
      through national registries.
    

Intervention name(s): Flexible Sigmoidoscopy Screening arm
Intervention type(s): Procedure
Intervention description(s): sigmoidoscopy screening
Other intervention name(s): polypectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention