bioihbjkbjnl/mcl2 huggingface dataset:
Short-pulse Subthreshold vs Infrared Micropulse for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional

Summary: 
      When applied according to manufacturer recommendations, short-pulse system may yield more
      temporary reduction in edema while infrared micropulse system may yield slightly better
      functional outcomes.
    

Detailed description: 
      Purpose: To assess both anatomic and functional outcomes between short-pulse continuous
      wavelength and infrared micropulse lasers in the treatment of DME.

      Materials and Methods: A prospective interventional study from tertiary care eye hospital -
      King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Patients with center-involving
      diabetic macular edema were treated with subthreshold laser therapy. Patients in the
      micropulse group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX
      Corporation, Mountain View, CA, USA). Laser was applied according to manufacturer
      recommendations for MicroPulseTM in a confluent mode (low intensity/high density) to the
      entire area of the macular edema. Patients in the short-pulse group were treated with grid
      pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan)
      with EndPoint algorithm, which was either 30% or 50% of testing burn. Main outcome measures
      included best-corrected visual acuity (BCVA) and foveal thickness at baseline and the last
      follow-up visit.
    

Intervention name(s): Macular Laser
Intervention type(s): Procedure
Intervention description(s): All treatments were performed using SPCW EndPoint 30% and 50% protocols and STMP laser. Patients in the STMP group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA) at 15% duty cycle. Laser was applied in the confluent mode (low intensity/high density) to cover the entire area of the macular edema and leakage as imaged by OCT and/or fundus fluorescein angiography. Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn with one burn width apart. In both groups, subthreshold power was determined by titrating burn to light (barely visible) burn and switching to either micropulse mode with 15% duty cycle or 30% and 50% EndPoint value.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: micropulse laser
Reliability Study Using Electrodermal Activity to Measure Sensory Processing in Children With and Without Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      The purpose of this study is tTho establish test-retest reliability of electrodermal markers
      used to quantify physiologic response to sensation using the Sensory Challenge Protocol in
      children with and without Autism Spectrum Disorder (ASD).
    

Detailed description: 
      This methodological research design is a prospective exploratory test-retest design assessing
      the use of electrodermal activity (EDA) as an index of sensory processing. EDA will be
      measured using skin conductance response (SCR). The purpose of this study is to investigate
      if using EDA is a reliable measure over time within the context of response to sensation.
      Scores from test one and test two of each subject will be correlated to determine reliability
      of EDA measure. Reliability in this context will establish the utility of EDA as an index of
      sensory processing. Testing will occur two times within a six week period.
    

Intervention name(s): Sensory Challenge Protocol
Intervention type(s): Other
Intervention description(s): Measurement of electrodermal activity in response to sensation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample of boys between the ages of 4 - 11 years with and without a diagnosis
        of Autism Spectrum Disorder were recruited from private and public New Jersey Schools,
        Barpak Occupational Therapy clinic, Bergenfield, New Jersey and Seton Hall University
        campus.
Study of Febrile Illness for Dengue-Endemic Areas in Latin America
Condition: Dengue Fever; Fever
MeSH terms: Dengue; Fever; Hyperthermia
Study type: Observational

Summary: 
      The purpose of this study is to detect acute febrile episodes and dengue infection in five
      Latin American countries to assess dengue seroprevalence.

      Primary objectives:

        -  To identify acute febrile episodes among the cohort in order to detect the presence of
           dengue infection.

        -  To describe the dengue seroprevalence among the cohort at baseline and at the end of the
           study.
    

Detailed description: 
      All participants will make two visits to a study site, an enrollment visit and a termination
      visit. Additional visits will be made if febrile episodes occur: an acute visit and a
      convalescent visit. Participants or their parents/guardians will be contacted weekly to
      monitor the occurrence of febrile episodes and ensure appropriate assessment and care.

      No vaccine will be provided or administered in this study
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants aged 9 to 16 years in 4 countries in Latin America: Brazil, Mexico, Colombia
        and Puerto Rico
      
Keywords: Dengue Fever Fever Seroprevalence
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed
      fixed dose combination (FDC) tablets containing empagliflozin & metformin and the single
      tablets of empagliflozin and metformin when administered singularly.
    


Intervention name(s): Empagliflozin/Metformin XR, FDC; Empagliflozin/Metformin XR FDC; 25 mg Empagliflozin/1000 mg Metformin XR, FDC; 1 tablet Empagliflozin/2 tablets Metformin XR; 1 tablet Empagliflozin/3 tablets Metformin XR; 1 tablet Empagliflozin/2 tablets Metformin XR
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Experimental: high dose empagliflozin/metformin XR, FDC tablet; Experimental: low dose empagliflozin/metformin XR, FDC tablet; Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet; Active Comparator: 1x empagliflozin/2x metformin XR tablets; Active Comparator: 1x empagliflozin/3x metformin XR tablets; Active Comparator: 1x empagliflozin/2x metformin XR tablets
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long Term Follow-Up of Burn Injuries
Condition: Burn
MeSH terms: Burns
Study type: Observational

Summary: 
      The purpose of the study is to investigate the psychological effects of burn injuries as
      experienced by patients.
    

Detailed description: 
      We are interested in determining how people adjust to burn injuries as a way of facilitating
      optimal recovery. This is done by conducting several questionnaires at the time of the
      discharge in the hospital, and later follow up with the patients up to two years.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        burn patients
      
Keywords: Long Term Follow-Up
A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare a study drug known as Insulin glargine with Lantus in
      healthy Chinese participants. Blood samples will be taken to compare how the body handles the
      drugs and how they affect blood sugar levels. Side effects and tolerability will be
      documented. The study will last at least 18 days, not including screening. Screening is
      required within 4 weeks prior to the start of the study.
    


Intervention name(s): Insulin Glargine; Lantus
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2963016; Basaglar; Insulin Glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Hypocol® on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose
Condition: Hyperlipidemia; Glucose Metabolism Disorders
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias; Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine to what degree Hypocol® (Red Yeast Rice) may lower
      low density lipoprotein (LDL)-cholesterol in a European population. The effect of Red Yeast
      Rice on fasting blood glucose and inflammatory markers will also be investigated.
    

Detailed description: 
      Clinical end-point trials have demonstrated that lowering cholesterol levels with statins
      reduces the incidence of cardiovascular events and mortality. Subgroup analyses of the large
      clinical studies, the West of Scotland Coronary Prevention (WOSCOP) and Cholesterol and
      Recurrent Events (CARE), have suggested that the beneficial effects of statins may extend to
      mechanisms beyond cholesterol reduction. A variety of mechanisms accounting for these effects
      have been suggested. Among these, the anti-inflammatory activity is particularly attractive
      because inflammation is considered an early step in the development of atherosclerosis. Thus,
      statin therapy has been shown to lower high-sensitivity C-reactive protein (CRP), a plasma
      marker of inflammation, in hypercholesterolemic patients. Furthermore, statins may possess
      anti-inflammatory properties by their ability to reduce the number of inflammatory cells in
      atherosclerotic plaques. Red Yeast Rice contains Lovastatin and lowers LDL-cholesterol.
      However, it is not known to what degree Red Yeast Rice may lower LDL-cholesterol in a
      European population. Some reports have suggested an effect of Red Yeast Rice on fasting blood
      glucose by an unknown mechanism.
    

Intervention name(s): HYPOCOL®
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hypocol; Red yeast rice; Patients with mild Type IIa, Type IIb or IV hyperlipidaemia (LDL-cholesterol >3.0 mmol/L< 6.0 mmol/L.; Mildly elevated blood glucose
Knee Function in Patients With Two or More Episodes of Patella Dislocations
Condition: Joint Instability
MeSH terms: Joint Instability; Patellar Dislocation
Study type: Interventional

Summary: 
      Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included
      into a randomized prospective study. This study comparess the outcome of two forms of
      treatment for recurrent patella dislocation. One group is offered reconstruction of the
      medial patellofemoral ligament (MPFL), the second group is offered a standardized training
      program.
    

Detailed description: 
      Introduction:

      Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged
      10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently
      cause long-term disability and reduced physical activity among adolescents and young persons.
      Surgery in this patient group requires a low tolerance for complications, meaning that
      physical therapy might offer more successful outcomes in many knee injury cases. The proposed
      project studies a particular patient cohort subjected to recurrent dislocation of the
      patella.

      Aim:

      The principal objective of this clinical, randomized controlled trial is to evaluate and
      compare knee function and symptoms in patients with recurrent patella dislocation randomized
      into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with
      those of patients in a standardized physiotherapy program designed to stabilize the patella
      and improve patient function.

      Materials and methods:

      Patients aged 12-30 years who have experienced two or more patella dislocations are
      randomized into groups receiving either MPFL reconstruction or physical therapy only.
      Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores,
      arthroscopic examination, and cartilage-specific MRI protocols for the knee.
    

Intervention name(s): MPFL Group; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): MPFL reconstruction or standard treatment followed by physiotherapy; Arthroscopy followed by active rehabilitation
Other intervention name(s): MPFL surgery; Arthroscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patella luxation
Effects of Positive End-expiratory Pressure on Intracranial Pressure in Patients With Severe Traumatic Brain Injury
Condition: Traumatic Brain Injury; Mechanical Ventilation Complication
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The impact of PEEP on ICP was dependent on the difference between elevated CVP levels and
      baseline ICP levels. ICP would increase once elevated CVP through PEEP adjustment exceeds the
      baseline ICP.
    

Detailed description: 
      all patients were exposed to incremental PEEP levels of 0, 5, 10, and 15cmH2O with 100% of
      FiO2. The measurements were done bedside on stabilized hemodynamics and intracranial
      pressure. The measurement was discontinued if the following situation presented and remedies
      were applied accordingly: (1) CPP < 60 mmHg (norepinephrine at 0.3~1.0μg/kg.min was used);
      (2) ICP > 25 mmHg (PEEP was restored to 0); (3) increase of pressure plateau > 35 cmH2O
      (tidal volume was decreased and PetCO2 was maintained at 30~35mmHg); (4) SpO2 < 90% (PEEP was
      restored to 0); and (5) suspicion of pneumothorax (PEEP was restored to 0 and chest
      radiography was performed). An equilibration period (at least 90 seconds) was entailed to
      ensure a normalized baseline PetCO2 through modulating tidal volume and respiratory rate.

      ICP, CVP, Pj, and MAP were measured twice or more at each level of PEEP for consecutively
      five days after admission. CPP was calculated according to the following equation:
      CPP=MAP-ICP. The difference between baseline ICP and CVP was categorized into the following
      three groups according to the previous findings: Group I,IVPD ≤ 3mmHg, Group II, 3 < IVPD ≤ 6
      mmHg, Group III, IVPD > 6 mmHg. Relationships between PEEP and ICP, CVP and MAP, CVP and Pj
      were analyzed in each group respectively.
    

Intervention name(s): PEEP at 5cmH2O; PEEP at 10cmH2O; PEEP at 15cmH2O
Intervention type(s): Other; Other; Other
Intervention description(s): Effect of PEEP at 5cmH2O on ICP; Effect of PEEP at 10cmH2O on ICP; Effect of PEEP at 15cmH2O on ICP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Positive end-expiratory pressure(PEEP); intracranial pressure(ICP); central venous pressure(CVP); intracranial central venous pressure difference(IVPD)
Walnut Intervention on Metabolic Syndrome (WIMS)
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether a daily supplement of 30 grams of walnut is
      effective in the treatment of metabolic syndrome (MetS).
    

Detailed description: 
      Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central
      obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the
      development of type 2 diabetes and CVD. It has become one of the major public health
      challenges in China due to rapidly nutrition transition and the nature of obesity epidemic.
      Treatment of MetS in China is very important for the prevention of the epidemic of its
      consequences (such as CVD and type 2 diabetes).

      Compelling evidence from recent human studies has demonstrated that diet and lifestyle
      modifications are effective means in MetS management. Walnut is a complex food source
      containing high amounts of polyunsaturated fatty acids (PUFA), as well as plant protein,
      Vitamin E and other substances that may have an impact on health. Therefore, the aim of this
      study is to investigate the effect of walnut supplementation on the management of MetS in
      adult Chinese men and women in a randomized, controlled clinical trial. A total of 200
      participants with MetS (defined by NCEP-ATPⅢ criteria) will be randomly assigned to a
      walnut-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. Effects
      of walnut supplementation will be evaluated by measuring metabolic profile (BMI, blood
      pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin,
      HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function (E-selectin,
      ICAM-1 and VCAM-1), and fatty acid profile.
    

Intervention name(s): healthy life style education
Intervention type(s): Behavioral
Intervention description(s): healthy life style education
Other intervention name(s): Dietians provided healthy lifestyle education accroding to; AHA recommendation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Walnut; Lipids; Blood Glucose
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to test the hypothesis that glycemic control, as
      measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is
      superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2
      diabetes who are naïve to antidiabetes agents, or patients who are being treated with
      metformin, an SU, or a combination of metformin and an SU
    


Intervention name(s): Placebo; Exenatide; Exenatide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous injection, twice a day; Subcutaneous injection, 5 µg, twice a day; Subcutaneous injection,10 µg, twice a day
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; adolescents; exenatide; Astra Zeneca
Buteyko Method for Children With Asthma
Condition: Asthma; Child; Breathing Exercises
MeSH terms: Asthma; Respiratory Aspiration
Study type: Interventional

Summary: 
      This study has the aim to assess the effectiveness of the Buteyko method as an adjunct
      therapy in the treatment of children with asthma.
    

Detailed description: 
      Children from 7 to 12 years old with asthma diagnose will be included. Children in the
      intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko
      Method. Children assigned to the control group will receive, along with their parents,
      educational interventions in relation to asthma. The investigators will assess quality of
      life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), pulmonary function
      (spirometry) and the six-minute walk test. Vital signs, pulmonary auscultation and oxygen
      peripheral saturation will also be assessed during the tests. In addition, information will
      be collected on the numbers of hospitalizations, occurence of absence in school due to
      exacerbation of the disease, asthma symptoms and Beta2-agonists usage .
    

Intervention name(s): Buteyko; Asthma education
Intervention type(s): Other; Other
Intervention description(s): Intervention will be held twice a week during 3 weeks.; Educational interventions in relation to asthma will be given to children assigned to the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Physical Therapy Specialty; Breathing Exercises; Child; Clinical Trail
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose
      A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8
      tablets (reference).
    


Intervention name(s): Sotorasib
Intervention type(s): Drug
Intervention description(s): Oral tablet
Other intervention name(s): AMG 510
Intervention MeSH terms: Sotorasib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sotorasib; AMG 510; Bioequivalence