bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The principal hypothesis of this study is that the micro and macro vasculature of young
      diabetes mellitus type 1 (DM1) patients is particularly susceptible to atherogenic factors
      which cause vascular dysfunction at multiple levels of the arterial vasculature and that this
      dysfunction is demonstrable using state-of-the-art ultrasound methods. The investigators
      further hypothesize that interventions, such as exercise, that are readily integrated into
      the daily life of individuals with DM1 can mitigate or reverse these early vascular changes
      and thereby diminish the otherwise predictable longer-term development of cardiovascular
      disease (CVD) in type 1 DM
    


Intervention name(s): Definity microbubbles
Intervention type(s): Drug
Intervention description(s): Definity microbubbles are used as a contrast agent to image blood flow in skeletal muscle
Other intervention name(s): Definity
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        DM1 and healthy controls
      
Keywords: Type 1 diabetes; adolescents; exercise; vascular function
Molar Intrusion in Open Bite Treatment
Condition: Anterior Open Bite
MeSH terms: Open Bite
Study type: Interventional

Summary: 
      This experimental study will evaluate the effect of different methods for the molar intrusion
      (compared with the control group) in adolescent and adult patients with open bite
      malocclusion. The study sample will consist of 45 patients with anterior open bite. The
      sample will be randomly allocated into two experimental groups, in addition to a control
      group.

      The investigators will apply a modified version of the Open Bite Appliance (OBA), by Erverdi
      and Usumez, for all patients in upper posterior teeth. For this purpose, miniplates will be
      used in the first treatment group, while miniscrews will be used in the second treatment
      group. In the control group, only OBA will be used. The skeletal and dentoalveolar changes
      occurring after intrusion of posterior teeth will be assessed by using posteroanterior and
      lateral cephalometric radiographs. Pre- and post- treatment changes for each group will be
      evaluated, in addition to the comparison of the post-treatment skeletal and dental changes
      that occurs between groups.
    

Detailed description: 
      Open bite malocclusion is considered one of the most difficult orthodontic problems to
      correct because it appears as a result of the interaction of numerous etiological factors
      (genetic, dental, skeletal, functional, soft tissue, and habit) that contribute to its
      development. Various therapeutic approaches have been proposed for the treatment of an
      anterior open bite. These approaches vary depending on the causative factors and involve
      myotherapy, preventive treatment, functional therapy, orthognathic surgery, and orthodontic
      treatment using anterior teeth extrusion or posterior teeth intrusion. Among the non-surgical
      orthodontic treatment methods are the temporary anchorage devices (TADs) including miniplates
      and miniscrew or micro-screw implants. The intrusion of posterior teeth with temporary
      anchorage devices was suggested to lead to decreased lower facial height by a
      counterclockwise rotation of the mandible; this may resemble the orthognathic surgery
      outcomes for any open bite patients. To the best of the investigators current knowledge, this
      is the first randomized controlled trial evaluating the effect of molar intrusion in
      adolescence and adult patients in the permanent dentition stage.
    

Intervention name(s): OBA; Miniplates; Miniscrews
Intervention type(s): Device; Device; Device
Intervention description(s): The intrusion of posterior teeth using removable appliance "OBA".; The intrusion of posterior teeth using temporary anchorage "Miniplates".; The intrusion of posterior teeth using temporary anchorage "Miniscrews".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Open bite; Molar intrusion; Temporary anchorage devices
Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study is a randomized controlled trial comparing Interpersonal Psychotherapy-Adolescent
      Skills Training (IPT-AST) to group counseling (GC) for the prevention of depression in
      adolescents. The project will: (1) identify adolescents with elevated depressive symptoms but
      who do not meet criteria for a current mood disorder diagnosis; (2) randomize eligible
      adolescents to either IPT-AST (N = 100) or GC (N = 100); (3) assess depressive symptoms,
      depressive disorders, global functioning, interpersonal functioning, comorbid conditions and
      school related indices at baseline, mid-intervention, post-intervention, and at 6-, 12-, 18-,
      and 24-month follow-up; (4) examine the effects of IPT-AST on depression and various domains
      of functioning at each time point; and (5) conduct analyses to examine potential mediators
      and moderators of the association between IPT-AST and depression outcomes. This study will
      yield data on the efficacy of IPT-AST relative to GC for the prevention of depressive
      symptoms and depressive disorders. It will also provide information about the mechanisms of
      action of IPT-AST and determine for whom IPT-AST is most effective.
    


Intervention name(s): IPT-AST; Group Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A school-based group prevention program that includes 2 individual pre-group sessions, 8 weekly 90 minute group sessions, an individual mid-group session and 4 booster sessions; Usual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions
Other intervention name(s): Interpersonal Psychotherapy-Adolescent Skills Training; Usual group counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Depression; Prevention; Adolescents
Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of single, subcutaneous (SC) doses of BIIB059 in
      healthy Japanese subjects.
    


Intervention name(s): BIIB059; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting
Condition: Antiplatelet Therapy of Coronary Artery Bypass
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid
      dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients
      undergoing CABG surgery.
    

Detailed description: 
      Patients undergoing coronary artery surgery routinely receive aspirin therapy, as a standard
      treatment for preserving bypass graft patency. Although the dual antiplatelet therapy post
      CABG has not been recommended by guideline, present studies indicated the patients could
      benefit from the dual anti-platelet therapy. Using clopidogrel+aspirin could significantly
      reduce the early saphenous vein graft occlusion. . Many surgeons empirically prescribe dual
      anti-platelet therapy in spite of the indeterminacy of the clinical effects. ticagrelor is a
      novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET
      Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than
      high-loading-dose clopidogrel in patients with stable CAD. ticagrelor is a novel, reversibly
      binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows
      that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose
      clopidogrel in patients with stable CAD.
    

Intervention name(s): ticagrelor; clopidogrel; asprin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.; After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.; All patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center prospective randomized controlled study
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: CABG; antiplatelet therapy; ticagrelor
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Condition: Jet Lag Type Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Jet Lag Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy
      individuals after a phase advance in jet lag type insomnia.
    


Intervention name(s): Tasimelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19
Condition: SARS-CoV Infection
MeSH terms: Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the safety, reactogenicity, and immunogenicity of three
      groups of healthy volunteers who receive either intranasal single dose (vaccine on Day 0 and
      placebo on Day 28) or two-dose (vaccine on Day 0 and 28) of BBV154 vaccine or Placebo (on Day
      0 and day 28). A total of 175 subjects will be enrolled in 2:2:1 ratio and will be conducted
      in a double-blinded manner.

      To assess the safety of the vaccine, each participant will record symptoms in a diary card
      for 7 days after each dose. Safety and laboratory tests and physical exams will also be
      performed.

      Blood samples and saliva samples be collected to assess the immune response from the vaccine.

      An interim report based on the safety and immunogenicity of the vaccine (BBV154) will be
      notified to the Central Drugs Standard Control Organization (CDSCO), India, for further
      progressing the clinical development of the vaccine. This unblinded interim report will
      contain a detailed analysis of the data based on the primary and secondary objectives of all
      visits through Day 42 (Immunogenicity & Safety).
    


Intervention name(s): BBV154 Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) NLT 1X10^10 Virus Particle.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Validity and Reliability of Smartphone Use in Measuring Joint Position Sense in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      This study will investigate the concurrent validity and intra-rater reliability of using
      smartphone in assessing joint position sense in patient with knee osteoarthritis.
    

Detailed description: 
      Knee osteoarthritis is the most common arthritis. Such disease is complicated by many
      musculoskeletal dysfunction such as disturbed joint position sense, which impairs their
      ability to perform their regular daily activities. As rehabilitation should target impairment
      in function, it is essential that therapists assess joint sense during baseline and follow-up
      evaluation of patients to decide on needed therapeutic interventions. Joint position sense
      can be assessed by various methods such as motion tracking systems and the isokinetic
      dynamometer, yet these equipment are expensive and are not readily available at regular
      clinical settings.

      Smartphone has been introduced as an assessment tool in rehabilitation of musculoskeletal
      disorders. For the knee joint, smartphone has been validated for measuring range of motion
      and joint position sense in healthy population, yet it has never been validated in patients
      with knee osteoarthritis. Therefore, this study will investigate smartphone validity and
      reliability as an assessment tool of knee position sense in patients with knee
      osteoarthritis.
    

Intervention name(s): Smartphone application (Goniometer Pro )
Intervention type(s): Device
Intervention description(s): Knee repositioning error will be measured simultaneously by smartphone and Biodex isokinetic dynamometer by a single blind assessor. All assessments will be done with eyes closed and repeated over two separate sessions, with one-week interval in-between. For active repositioning, the participant will actively extend the knee to reach a predetermined target position45° flexion at an angular velocity of 10°/sec. For passive knee repositioning, the isokinetic dynamometer will move the knee at 5°/s to a predetermined angle between 5° and 80° of flexion and the participant should stop the movement when the predetermined angle is reached.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects between 40 to 60 years old with symptomatic knee osteoarthritis and age-matched
        healthy control.
      
Keywords: Position sense; Smartphone; Validity; Reliability; Knee osteoarthritis
Evaluate Performance of Callisto Eye vs. Wavetec AnalyzOR
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The goal of this clinical trial is to evaluate two separate operating room cataract measuring
      tools in predicting the residual astigmatism (prediction error) in patients with corneal
      astigmatism.

      The main question it aims to answer is:

      Show the refractive predictability comparing the use of Operating Room cataract toric lens
      placement tools against the standard manual technique.

      Participants will be implanted with the TECNIS Toric II IOL Lens Model ZCU; the second eye,
      if applicable, is to be implanted within 45 days of the first-eye surgery.

      Researchers will compare two Operating Room cataract lens placement tools: the Zeiss CALLISTO
      vs. the Wavetec AnalyzOR to determine refractive predictability.
    

Detailed description: 
      To evaluate two separate operating room cataract measuring tools in predicting the residual
      astigmatism (prediction error) in patients with corneal astigmatism (maximum allowable up to
      3.0D) comparing the ZEISS CALLISTO eye and the Wavetec AnalyzOR at the one-month
      post-operative visit. Both surgery rooms will be using Veracity, IOL Master and Zeiss Opmi
      Lumera i Operating Room Microscopes. Operating Room #1 will be utilizing the ZEISS CALLISTO
      eye for axis alignment, along with Veracity and IOL Master for lens selection, and Operating
      Room #2 will be utilizing the Wavetec AnalyzOR for lens selection and axis alignment.
      Procedure times for the ZEISS CALLISTO eye and the Wavetec AnalyzOR will be obtained by using
      a start/stop watch, including phakic power calculation and toric positioning. In addition,
      the suction on (start of LenSx), treatment time of LenSx in seconds, suction off (end of
      LenSx), start time of primary incision, the beginning of Phaco, end of phaco, CDE (Combined
      Diffused Energy) total and the end time of procedure will all be documented. All times will
      be analyzed and compared between Operating Room #1 and Operating Room #2.
    

Intervention name(s): CALLISTO eye; Wavetec AnalyzOR
Intervention type(s): Device; Device
Intervention description(s): Cataract toric lens placement tool; Cataract toric lens placement tool
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing unilateral or bilateral cataract extraction
      
Keywords: cataract; toric; cataract surgery; residual astigmatism
Effect of Preoperative Oral Carbohydrates on Postoperative Insulin Resistance in Patients Undergoing OPCAB(Off- Pump Coronary Artery Bypass Surgery)
Condition: Coronary Artery Occlusive Dissease
Study type: Interventional

Summary: 
      Surgical stress creates a state of insulin resistance which has been related to increased
      postoperative complications. Fasting before surgery induces a catabolic state that
      contributes to the development of insulin resistance. The aim of this study is to evaluate
      the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients
      undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79
      years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30)
      groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml
      carbohydrate beverage in the evening before surgery and in the morning of the operation day
      (3 hours before their scheduled operation). In contrast, patients in the control group
      consume no food or drink after midnight before their surgery. The primary endpoints are
      postoperative insulin resistance measured by short insulin tolerance test.
    


Intervention name(s): carbohydrate beverage
Intervention type(s): Dietary Supplement
Intervention description(s): 400ml of 12.8 g/100 ml carbohydrate beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients
Condition: Anal Cancer
MeSH terms: Anus Neoplasms
Study type: Observational

Summary: 
      The study compares two patient setups (Standard Prone vs. Genital Drop Technique) with
      identical radiation treatment technique and parameters. After the two setups have been
      planned, the treating faculty reviews the setups and will choose the setup he feels that will
      give the patient improved dosimetry to the local regions and hopefully reduce toxicity and
      improve treatment tolerability.
    

Detailed description: 
      This is a study of two different setups when treating a patient with standard of care
      radiation doses. The study compares two patient setups (Standard Prone vs. Genital Drop
      Technique) with identical radiation treatment technique and parameters. After the two setups
      have been planned, the treating faculty reviews the setups and will choose the setup he feels
      that will give the patient improved dosimetry to the local regions and hopefully reduce
      toxicity and improve treatment tolerability.

      Patients will not be randomized or stratified by demographic or disease risk assessment, but
      treatment will be tailored to stage specific current standards of care.

      An extra (non standard of care) CT is required to analyze the data.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Male anal cancer and distal rectal cancer patients 18 years or older.
      
Keywords: anal; cancer; rectal; IMRT; genital; sparing; drop; technique
A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the product performance of PureVision2 HD contact
      lenses.
    


Intervention name(s): PureVision2 HD contact lenses; Spectacles
Intervention type(s): Device; Device
Intervention description(s): Lenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.; Spectacles to be worn throughout 1/2 of an HD movie.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment