bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Childhood Dyslipidemia on Endothelial and Renal Function
Condition: Dyslipidemias; Children, Only; Endothelial Dysfunction; Renal Dysfunction; Hypercholesteremia in Children
MeSH terms: Renal Insufficiency; Dyslipidemias; Hypercholesterolemia
Study type: Observational

Summary: 
      The aim of the study is to assess if abnormal lipid levels in childhood could cause early
      damage of the inner layer of the vessels, the endothelium. Dysfunction of the endothelium is
      the first event in the development of atherosclerosis, is present at all stages of
      atherosclerosis and is potentially reversible in childhood. It has been suggested that
      dyslipidemia, via its detrimental effects on endothelium, could impair renal function. This
      study will assess the dysfunction of the kidneys in children with dyslipidemia.
    

Detailed description: 
      In children recruited in the study, family history of dyslipidemia or premature
      cardiovascular disease will be recorded. Furthermore, anthropometric and clinical
      characteristics will be noted and lipid measurements will be obtained at recruitment after a
      fasting period.

      The investigators will test in children the flow-mediated dilation (FMD) which assesses the
      vasodilation due to the production of nitric oxide from the endothelium in response to
      occlusion-induced hyperaemia of the branchial artery and the carotid intima-media thickness
      (cIMT). These non-invasive ultrasound indices detect early vascular damage.

      Renal function will be assessed in children with dyslipidemia by a new marker in serum,
      cystatin C, which is more accurate and reliable than creatinine. Also, creatinine serum
      levels and estimated glomerular filtration rate (eGFR) will be evaluated. Additionally, total
      protein, albumin, electrolyte and β2-microglobulin excretion in urine will be measured.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The group of children with dyslipidemia will be selected from children referred to the
        Outpatient Lipid Clinic for Children and Adolescents and to the Pediatric Nephrology
        Department of the University Hospital of Ioannina. These are centers of excellence for
        assessing children with dyslipidemia and renal function in Northwestern Greece.

        The referrals are due to abnormal lipid levels in routine blood samples or family history
        of dyslipidemia and/or family history of premature cardiovascular disease.

        The group of controls will be selected from children attending the Outpatient Pediatric
        Clinic of University Hospital of Ioannina for follow-up of headache, heart murmur,
        constipation and loss of consciousness.
      
Biospecimen description: 
      Serum
Effect of Two Exercise Programs on Obese Patients
Condition: Obesity; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of the study is to compare the effectiveness of two exercise programs (High
      Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on
      decreasing fat mass and preserving lean body mass in obese patients. What the investigators
      are proposing is that HIIT is less effective because it will most likely decrease lean body
      mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.
    


Intervention name(s): Exercise Type
Intervention type(s): Other
Intervention description(s): The implementation of 2 types of exercise programs to reduce body fat
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a case/control study comparing overweight/obese patients of three different groups (control, HIIT, LIT). The goal of a case/control is to show whether exposure to HIIT, two times a week for 6 weeks will decrease lean body mass versus control and LIT. If it turns out that lean body mass does decrease, then HIIT is not an effective exercise modality for overweight/obese patients, and in fact LIT or control may be a better option.
Masking: Single (Participant)
Primary purpose: Prevention
Delivery of Pharmacogenetic Testing in a Community Pharmacy Setting
Condition: Pharmacogenetics
Study type: Interventional

Summary: 
      This study aims to compare patient use of and satisfaction with community
      pharmacist-delivered pharmacogenetic (PGx) testing delivered along or as part of a medication
      therapy management (MTM) service. Pharmacist and patient outcome measures will be collected
      by surveys, interviews, and review of pharmacy records.
    

Detailed description: 
      This study aims to investigate the delivery of pharmacogenetic (PGx) testing alone or in
      combination with Medication Therapy Management (MTM) in the community pharmacy setting in
      order to assess and compare the two delivery models. Using a clust randomized trial, these
      effects of these two models will be compared. Pharmacist and patient outcome measures will be
      collected by survey, interviews, and review of pharmacy records. The investigators intend to
      compare the effect of PGx alone and PGx with MTM from the pharmacy perspective (to assess
      impact on workflow/operations) and patient perspective (to assess acceptance of testing,
      understanding of results, medication adherence, and overall satisfaction with delivery
      model). In the PGx only arm, pharmacists will offer PGx testing to patients who are
      prescribed one of the 10 eligible drugs (aripiprazole, carisoprodol, celecoxib, citalopram,
      clopidogrel, metoprolol, nortriptyline, paroxetine, simvastatin, warfarin) and will return
      results to the patient and physician with any recommendations for drug or dosage changes
      based on results. In the PGx and MTM arm, pharmacists will offer PGx testing to patients
      prescribed one of the 10 eligible drugs and provide two MTM sessions: one at the time of
      testing, and one when results are returned. All patients will be surveyed before PGx testing
      and 3 months after receiving results. Pharmacists will be surveyed prior to their
      participation and following the conclusion of the study. Pharmacists will also conduct a
      chart review of patients and document all interactions with enrolled patients and their
      providers.
    

Intervention name(s): Medication Therapy Management; Pharmacogenetic testing
Intervention type(s): Other; Other
Intervention description(s): Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing; Community pharmacist will provide pharmacogenetic testing.
Other intervention name(s): MTM + PGx; PGx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Physical Activity in the Medical Workplace
Condition: Physical Activity
Study type: Interventional

Summary: 
      Decreased physical activity is not only associated with multiple chronic medical conditions,
      including obesity, but also with depressed mood, and other negative emotions. As many
      employed adults spend a great deal of time at work where we are predominantly sedentary,
      strategies to increase physical activity at work are being pursued to help improve the
      physical and mental health of Americans. This 17 week randomized controlled trial will
      investigate changes of occupational physical activity in three groups: those provided with a
      FitBit® but not able to monitor their activity level, and those provided with activity goals
      and individual physical activity challenges, and those who do not use a FitBit®.
    

Detailed description: 
      All subjects will be entered into a 4 week run-in phase where subjects will wear a blinded
      Fitbit during work hours. The baseline work activity is collected at this time. This phase is
      followed by a randomization to one of 3 groups: the blinded Fitbit group, the unblinded
      Fitbit group, and the group which will not wear any activity monitors. During these 12 weeks
      we will collect data on activity levels during work hours. Everyone will have a final contact
      at week 17 to close out the study.
    

Intervention name(s): Blinded Fitbit; Unblinded Fitbit
Intervention type(s): Device; Device
Intervention description(s): Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.; Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sleep Therapy for Insomnia and Depression
Condition: Depression; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      In this study we are testing 2 different forms of sleep therapy to help people with insomnia
      and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to
      see how these sleep therapies help insomnia in people with depression.
    

Detailed description: 
      The first group is the sleep hygiene group. If you are assigned to the sleep hygiene group
      you have 1 session with a clinician to learn about different things you can do to improve
      your sleep.

      The second group is the intensive sleep retraining group. If you are in this group you will
      spend about 1 day at our sleep lab, starting around your usual bedtime and ending the
      following day. Over a 20 hour period you will complete a sleep retraining session, which
      involves an opportunity to fall asleep every 30 minutes; we will wake you after a few minutes
      if you fall asleep.

      For both groups, after the treatment session, you will complete questionnaires online and
      talk with a study clinician who will ask you questions about your mood every two weeks for 8
      weeks.
    

Intervention name(s): Intensive Sleep Retraining; Sleep Hygiene
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this group you will spend just over 1 day at our sleep lab, starting around their usual bedtime and ending the following day. Over a 20 hour period participants will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake participants up after a few minutes if they fall asleep.; Participants in this group will complete one session with a clinician focused on psychoeducation regarding sleep positive practices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that
      participate in a Stress Reduction Intervention show a brain activation pattern (assessed by
      MRI) indicative of improved emotion regulation compared to an active control intervention.
    


Intervention name(s): Stress Reduction Intervention; Active Control intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): eight week group program, plus daily homework practice; weekly group meetings for eight weeks, plus daily homework practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
LEO 32731 - A Study in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-man trial is to determine the safety and tolerability of
      ascending single and multiple doses of LEO 32731 in healthy male subjects. The trial will be
      performed in three parts. In Part 1, single doses of LEO 32731 will be administered to
      healthy male subjects. In Part 2, the effect of food on the single oral dose pharmacokinetic
      will be investigated. In Part 3, multiple doses of LEO 32731 will be administered to healthy
      male subjects.
    


Intervention name(s): LEO 32731
Intervention type(s): Drug
Intervention description(s): Part 1 and 2: Oral single dose of oral solution or capsule
Part 3: Twice daily dose of oral solution or capsule for 7 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Exploratory study in healthy subjects
A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS
Condition: Multiple Sclerosis; Spasticity, Muscle
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central
      nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic
      disability in adults in North America. Spasticity is a common complication in MS and occurs
      in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement
      characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes.
      Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT)
      for the treatment of spasticity in patients with MS.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to
      evaluate the safety and efficacy of oral AERT in MS patients with spasticity. Two doses of
      AERT, 40 mg and 80 mg, will be compared with placebo. The treatment groups will be randomized
      in a 1:1:1 ratio. Eligible patients will undergo a washout period for withdrawal of all
      medications used for anti-spasticity and/or muscle relaxation prior to randomization. A
      baseline clinical evaluation will be performed (Visit 2) to confirm eligibility for study
      randomization, and subjects will be randomly assigned to 1 of 3 treatment arms. Subjects will
      remain on maintenance treatment for approximately 3 months.
    

Intervention name(s): Arbaclofen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Arbaclofen Extended Release Tablet; Placebo comparator
Other intervention name(s): AERT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Assess the Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to directly assess the effects of vildagliptin on gastric emptying in
      people with type 2 diabetes.
    


Intervention name(s): Vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Vildagliptin; Type 2 diabetes
ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients with Moderate to Severe
      Active Rheumatoid Arthritis (RA) who have had an Inadequate Response to MTX Alone
    

Detailed description: 
      This is a Phase 2b, Randomized, Multicenter, Double-blind, Parallel Group, Placebo
      Controlled, Dose Ranging Study to Investigate the Efficacy, Safety, Tolerability,
      Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ATI-450 Plus Methotrexate (MTX)
      Versus Placebo Plus MTX in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)
      who have had an Inadequate Response to MTX Alone
    

Intervention name(s): ATI-450 50mg oral tablet BID; Placebo oral tablet; Methotrexate; ATI-450 20mg oral tablet BID
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral, small molecule MK2 inhibitor; Placebo tablet manufactured to match ATI-450 in appearance; 15 mg to 25 mg weekly; Oral, small molecule MK2 inhibitor
Other intervention name(s): zunsemetinib; zunsemetinib
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid; Arthritis; RA
Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of this study is to confirm the biomechanical effects and evaluate functional
      benefits of a new knee brace combining valgus inducing effect on medial compartment and leg
      external rotation during the stance phase in patients with symptomatic medial knee
      osteoarthritis.
    


Intervention name(s): PROTEOR Internal unicompartmental knee brace
Intervention type(s): Device
Other intervention name(s): trademark : " PROTEOR " : code name 2H-200
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children
Condition: Local Anesthesia
Study type: Interventional

Summary: 
      This is a randomized clinical trial that aims to test the effect of using sugar-free flavors
      as a sensory distraction technique during local anesthesia on pain perception and anxiety
      when compared to negative control group. We expect that using the flavor before injecting
      local anesthesia will distract the child and reduce pain and anxiety.
    

Detailed description: 
      Background: Distraction techniques can be very useful in managing children on the dental
      chair and to guide their attention away from a painful stimulus. No studies so far have used
      a sugar-free solution as a distraction method.

      Aim: To test the effect of using sugar-free flavors as a sensory distraction technique during
      local anesthesia on pain perception and anxiety when compared to negative control group,
      using a split-mouth randomized study design.

      Methods: A total of 84 children, aged 4-10 years with no previous dental experience and
      require the same treatment on the upper primary first or second molars bilaterally will be
      included in this study. Each child will receive two injections. The children will be randomly
      allocated into two groups, group 1 will receive the first injection after applying a flavor,
      and group 2 will receive the first injection after applying sterile water. The children will
      receive the first injection either on the right or left side, and switch sides on the next
      visit, resulting in (n=168) total injections. The observed pain perception will be assessed
      using the SEM scale. Wong-Baker Faces pain rating scale will be used to assess the pain
      reported by the child. Pulse rate, BMI, and sweet taste preference will also be recorded by
      an independent observer to ensure blinding.

      Expected results: Using a sugar-free candy flavor before injecting local anesthesia will
      distract the child and reduce pain and anxiety accompanying local anesthesia.
    

Intervention name(s): Local Anesthesia 1; Local Anesthesia 2
Intervention type(s): Procedure; Procedure
Intervention description(s): Local anesthesia injection after applying a candy flavor; Local anesthesia injection after applying sterile water
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Role of Whey and Lupin in Glycemic Control (Nutritional Pre-Study)
Condition: Whole Body Glucose and Insulin Metabolism
Study type: Interventional

Summary: 
      The study compared the acute effects of the supplementation of a standardized meal with
      either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism.
    

Detailed description: 
      The nutritional pre-study had the following key objectives:

      Primary objective:

      - Lupin protein lowers the postprandial blood glucose level equivalent to or to a greater
      extent than whey protein.

      Secondary objective:

      - Lupin protein has an equivalent or a stronger insulinotropic effect than whey protein.
    

Intervention name(s): Lupin Protein; Whey Protein; Reference
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Subjects received a standardized test meal rich in carbohydrates and supplemented with lupin protein.; Subjects received a standardized test meal rich in carbohydrates and supplemented with whey protein.; Subjects received a standardized test meal rich in carbohydrates and not supplemented with any protein.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Dexmedetomidine in Pediatric Tonsillectomy
Condition: Pediatric Adenotonsillectomy; Post Operative Analgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis of this study is that the administration of an intra-operative dose of
      dexmedetomidine will result in adequate analgesia without respiratory depression thereby
      resulting in an early discharge from the post anesthetic care unit following
      adenotonsillectomy.
    

Detailed description: 
      Dexmedetomidine, an alpha 2 agonist provides some analgesia without respiratory depression.
      Children undergoing tonsillectomy and adenoidectomy occasionally have episodes of respiratory
      obstruction in the recovery room following administration of opioids.

      As dexmedetomidine provides some analgesia without respiratory depression,an intra-operative
      dose of dexmedetomidine may provide adequate analgesia without significant side effects
      thereby allowing for quick post operative recovery.
    

Intervention name(s): Dexmedetomidine 0.75 mcg/kg; Morphine 50 mcg/kg; Morphine 100 mcg/kg; Dexmedetomidine 1 mcg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.; Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia; Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia; Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
Other intervention name(s): Precedex; Morphine; Morphine; Precedex
Intervention MeSH terms: Dexmedetomidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adenotonsillectomy; Postoperative analgesia; Pediatrics