bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC)
      tablet of canagliflozin and metformin immediate release (IR) in comparison with the
      individual components of canagliflozin and metformin IR.
    

Detailed description: 
      This is an open-label (identity of study drug will be known to volunteer and study staff),
      single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when
      administered orally (by mouth) as individual components (ie, separate tablets of
      canagliflozin and metformin IR) (Treatment A) and when administered as a fixed dose
      combination (FDC) tablet (ie, canagliflozin and metformin IR in the same tablet) (Treatment
      B). Healthy volunteers participating in the study will be randomly (by chance) assigned to
      receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a
      period of approximately 15 days between treatments.
    

Intervention name(s): A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets); B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/1000, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2; Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/1000, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Bioequivalence; Canagliflozin (JNJ-28431754); Metformin IR
The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance
Condition: Transverse Maxillary Deficiency
Study type: Interventional

Summary: 
      This study aims to evaluate the effects of dentoalveolar, dentoskeletal, nasal resistance,
      and airway changes by applying rapid palatal expansion appliances in patients with maxillary
      constriction and the post-pubertal growth spurt stage.
    

Detailed description: 
      Fifty eight patients were divided into 4 groups. The first group (n: 15, 15.6 ± 1,1 years of
      age) was Full Coverage Rapid Palatal Expansion (FCRPE). The second group ( n:14, 15.3 ± 0,9
      years of age) was Modified McNamara Rapid Palatal Expansion (MMRPE). The third group (n:14,
      15.7 ± 1,1 years of age) was Miniimplant Assisted Rapid Palatal Expansion (MARPE). The fourth
      group (n:15, 15.4 ± 1,0 years of age) was control group. Polygraphy for respiratory
      evaluation, rhinomanometry for nasal airway resistance, study model, and posteroanterior
      radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory
      polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior
      to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests
      were used to compare the expansion appliances.
    

Intervention name(s): Tooth Tissue Borne Rapid Palatal Expansion; Tooth Bone Borne Rapid Palatal Expansion
Intervention type(s): Device; Device
Intervention description(s): In all rapid palatal expansion groups, the appliances were cis bonded after being made by the same technician. The expansion screw was turned twice a day until the desired width was achieved.; After the Marpe appliance was attached, 4 miniscrews were applied to the midline of the palate with a miniscrew driver. The expansion screw was turned twice a day until the desired width was achieved.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty eight patients were divided into 4 groups: FCRPE group (n: 15, 15.6 ± 1,1 years of age), MMRPE group (n:14, 15.3 ± 0,9 years of age), MARPE group (n:14, 15.7 ± 1,1 years of age), Control group (n:15, 15.4 ± 1,0 years of age). Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maxillary expansion; Respiratory polygraphy; Rhinomanometry; MARPE
Post-exercise Hypotension After a Power Training Session in Older Adults With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The main purpose of the present study was to evaluate the effect of a power training session
      on office and 24h ambulatory blood pressure in older adults with hypertension. As secondary
      outcomes, the investigators compared post-exercise hypotension, BP variability, and
      endothelial function between older men and women with hypertension.

      The working hypothesis was that a single bout of power exercise would decrease both office
      and 24 h BP in comparison to a non-exercising control session and men and women would respond
      differently after a power training session.
    

Detailed description: 
      Participants randomly performed two experimental sessions: power exercise training (PT) and
      non-exercising control at seated rest (Con). They maintained their current antihypertensive
      medications throughout the trial. Each session was composed of 20 min of rest in the supine
      position, 40 min of PT or Con protocols, and 60 min of rest in supine position after
      protocols. The PT was composed of 3 sets of 8-10 repetitions of 5 exercises performed in the
      following order: leg press, bench press, knee extension, upright row, and knee flexion, using
      an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and
      exercises. The concentric phase of exercises during each repetition was performed "as fast as
      possible" while the eccentric phase lasted 1-2 seconds. During the Con, the participants
      remained seated rest on the same exercise machines, but without any exercise. Standardized
      office BP was performed before and during the first hour (in intervals of 15 min) after
      exercise and control sessions. Together with the office BP evaluation in the pre and post
      sessions, the endothelium-dependent brachial vascular function was evaluated using
      Flow-mediated dilation. Afterwards, participants underwent 24h ambulatory BP monitoring..
    

Intervention name(s): Power Training Session
Intervention type(s): Behavioral
Intervention description(s): 3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized controlled clinical trial with crossover design was performed in order to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Aging; Ambulatory Blood Pressure Monitoring; Power Exercise
Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in
      patients with Meniere's disease.
    

Detailed description: 
      Created by Dr. Diao, DiaoShi Jifa is a well-known traditional Chinese Medicine approach to
      treat dizziness in patients with chronic diseases. The investigators designed this randomized
      clinical trial to examine whether Diaoshi Jifa significantly decreases dizziness in patients
      with Meniere's disease. There are 2 arms in this trial: One arm is DiaoShi Jifa plus
      conventional Western medical treatment, another is conventional Western medical treatment
      only. The dizziness handicap inventory (DHI) will be used to evaluate the treatment effect.
    

Intervention name(s): Diaoshi Jifa therapy plus the Western medical treatment.; drug
Intervention type(s): Other; Other
Intervention description(s): Diaoshi Jifa treatment; the Western medical treatment alone.
Other intervention name(s): Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po; Western medical treatment: Ginkgo 20 ml qd iv, Merision 6mg tid po
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dizziness; Meniere's disease; Diaoshi Jifa therapy
Metabolic Syndrome Diagnosis and Education Trial
Condition: Metabolic Cardiovascular Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study is being done to gain knowledge on how effective different approaches of providing
      a diagnosis and varying educational tools that include DVDs and multimedia or printed
      instruction sheets on your readiness to increase the subject's level of exercise, lose more
      weight, eat a healthier diet; and to assess the subject's awareness of their risk of heart
      disease and their readiness to participate in a comprehensive lifestyle modification program.
    


Intervention name(s): High-Tech Education; Low-Tech Education
Intervention type(s): Other; Other
Intervention description(s): Patients will be told that they have the metabolic syndrome and will subsequently watch two 10-minute videos on the metabolic syndrome and on getting started with exercise. They also receive all the paper-based educational material as in arm 2; Patients will be told that they have the metabolic syndrome and will subsequently receive paper-based educational material on the metabolic syndrome,pre-diabetes, and hypertension. They also receive pamphlets on dietary management of high cholesterol and triglycerides, and the importance of exercise and weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Metabolic Cardiovascular Syndrome
A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability, and efficacy of
      IONIS-GHR-LRx subcutaneous (SC) injection as monotherapy in patients with acromegaly.
    

Detailed description: 
      This is a multi-center, open-label, randomized, Phase 2 study of IONIS-GHR-LRx in up to 40
      participants with acromegaly. Participants will be randomized to 1 of 3 treatment groups to
      receive a single dose of IONIS GHR-LRx monthly for 73 weeks. At the end of 73 weeks,
      participants will enter a 14-week post-treatment (PT) evaluation period.
    

Intervention name(s): IONIS-GHR-LRx
Intervention type(s): Drug
Intervention description(s): IONIS-GHR-LRx will be administered by SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acromegaly; IONIS-GHR-LRx
Health-e-Access Telemedicine in Primary Pediatric Care
Condition: Common Childhood Illnesses; Non-emergent Care
Study type: Interventional

Summary: 
      This study aims to take the existing model from the pilot of Telemedicine in Daycare and
      expand it to other suburban childcare centers and both urban and suburban elementary schools.

      An assessment of the value of telehealth in the child programs will then be initiated to
      detail the impact of utilization and costs.

      An assessment of the value of integrating telehealth into primary care practice will also be
      evaluated. The impact of continuity of care, well child visit rates, and immunization status
      will be among the various measures used in this evaluation.
    

Detailed description: 
      This involves estimating the impact of reduced absence due to illness on parents and their
      employers and estimating the value of a telehealth visit to these stakeholders. An interview
      instrument was developed to administer before experience with telehealth and again after a
      family has had experience with the program. In addition program attendance (childcare or
      school) records will be collected to document changes in absenteeism pre and post telehealth
      service implementation.

      This study involves a before and after research design including both historical and
      concurrent controls comparing a detailed utilization of health services including telehealth
      visits, emergency department services and illness related office visits. Analyses will
      include center-level analyses of service utilization on a weekly basis pre and post as well
      as a child-level analyses including utilization before enrollment in a participating
      childcare center or school through program participation and, eventually, telehealth
      participation.

      This is a descriptive observational study of the feasibility and acceptability of integrating
      telehealth service into 10 primary care pediatric practices. This study will document the
      integration process by maintaining a log of key communications relating to decision making
      (meeting minutes, memos, written agreements, protocols) and by interviewing key staff such as
      residents, nurse practitioners, attending physicians, staff nurses, and administrative
      leaders following the study period.
    

Intervention name(s): Health-e-Access
Intervention type(s): Other
Intervention description(s): telemedicine intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: telehealth; telemedicine
Extubation Times in Postoperative Congenital Cardiovascular Surgeries
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational [Patient Registry]

Summary: 
      Background: Anesthesia management in pediatric cardiac surgeries focuses on reducing
      morbidity and mortality, early mobilization and discharge, using health resources sparingly
      and increasing the quality of life of patients. The duration of postoperative mechanical
      ventilation is one of the most important factors affecting the process after pediatric
      cardiac surgery. Besides the view that postoperative mechanical ventilation is safe, there
      are opposing views that it causes an increase in complications; It caused disagreements about
      extubation times. In our study, we aimed to investigate the factors affecting extubation
      times after pediatric cardiac surgery.

      Methods: 72 ASA≥III pediatric patients undergoing cardiac surgery with cardiopulmonary bypass
      were included in our study. The patients were divided into 3 groups according to their
      extubation time. Those that were extubated in the operating room (OR) or in 6 hours after
      surgery (Immediate Extubation or IE), those that were extubated within 6-48 hours of
      admission to the ICU (Early Extubation or EE) and those that were extubated sometime after 48
      hours or not extubated (Delayed Extubation or DE). Many variables of preoperative,
      peroperative and postoperative periods were recorded to see which factors correlated with
      extubation times.
    

Detailed description: 
      Children with critical congenital heart disease may need surgical or interventional
      procedures at some point in their lives.In pediatric cardiac anesthesia, it is important to
      reduce the need for postoperative mechanical ventilation in order to minimize morbidity,
      provide optimal vital functions, and reduce unnecessary use of health resources. Researchers
      aimed to examine the relationships of perioperative and postoperative hemodynamics,
      laboratory, oxygenation parameters and demographic data with extubation times in pediatric
      cardiac surgery cases taken in the hospital.
    

Intervention name(s): Congenital Cardiovascular Surgery
Intervention type(s): Procedure
Intervention description(s): Relationship between perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in our hospital.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        72 patients
      
Keywords: Congenital heart disease; perioperative management; pediatric cardiac surgery; extubation
Early Intervention With Fluoxetine in Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a pilot study to evaluate the feasibility and safety of conducting a year long,
      double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance
      developmental processes in core areas impacted by autism.
    

Detailed description: 
      Autism, a brain disorder that affects a small percentage of Americans, often results in a
      lifetime of impaired thinking, feeling, and social functioning. The disorder generally
      becomes apparent in children by the age of 3. Autism typically affects a person's ability to
      communicate, form relationships with others, and respond appropriately to the external world.
      Some people with autism can function at a relatively high level, with speech and intelligence
      intact. Others have serious cognitive impairments and language delays, and some never speak.
      This study will assess the safety and effectiveness of treating autistic children with
      fluoxetine to enhance developmental processes in core areas impacted by autism.

      Each participant was randomly assigned to treatment with double-blinded placebo or fluoxetine
      for 12 months. After initial screening and randomization, participants were assessed every
      two weeks for approximately the first 3 months, or until the dose of medication is
      stabilized. After this initial period, they were assessed on a monthly basis. Dosing was
      flexible as determined by the adverse and beneficial responses to treatment although there
      was a suggested titration schedule.
    

Intervention name(s): Fluoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.; Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism
Study of Medial-Lateral Center of Pressure Displacement in Unilateral Transfemoral Amputees
Condition: Unilateral Transfemoral Amputation
Study type: Observational

Summary: 
      The purpose of this study is to examine the path and velocity of the center of mass (CoM) and
      center of pressure (CoP) during double support of persons walking with a unilateral
      above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and
      effective length on CoM and CoP.Persons with a lower limb amputation walk with compensatory
      movements that affect the smooth trajectory of the center of mass (CoM) during weight
      transfer. The lack of control in the foot/ankle complex reduces fine motor movements,
      influencing the progression of the CoM and transfer of ground reaction forces represented by
      the center of pressure (CoP). Without control of the ankle joint, prosthetic users "fall" off
      of their trailing prosthetic limb during weight transfer, resulting in much more abrupt CoM
      and CoP transfers from trailing to leading limb. These abrupt movements during transfer not
      only increase stress on the sound limb, but also decrease the subject's energy efficiency
      during ambulation. The current study will further examine the CoP path and velocity in
      relation to the CoM path and velocity during double support of men with a transfemoral
      prosthesis, as well as explore how prosthetic foot ankle stiffness and effective length
      affects the CoP path and velocity.
    


Intervention name(s): Level overground ambulation
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons with unilateral transfemoral amputation who are ambulatory with a prosthesis and no
        assistive device.