bioihbjkbjnl/mcl2 huggingface dataset:
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
Condition: Prosthesis-Related Infections
MeSH terms: Prosthesis-Related Infections
Study type: Interventional

Summary: 
      The primary purpose of this study is to compare the re-infection rates in patients undergoing
      2-stage revision arthroplasty who receive additional oral antibiotic therapy to those
      patients who received in-hospital perioperative antibiotic only. Patients will be monitored
      for re-infection following hospital discharge, defined as deep infection of the joint
      space/capsule that requires return to the operating room within 24-months of the
      re-implantation procedure.
    


Intervention name(s): Oral Antibiotics
Intervention type(s): Other
Intervention description(s): Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Revision; Knee; Hip; Arthroplasty; Oral; Antibiotics; Infection
Effects of Growth Hormone Administration on Muscle Strength and Body Composition in Men Over 50 Years Old
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The growth hormone (GH) secretion declines gradually with age, with studies demonstrating a
      progressive reduction of 14% secretion per decade of life beginning in the second decade.
      Other studies suggest a disruption in GH secretion in elderly people. These findings suggest
      a possible association between growth hormone deficiency (GHD) and the ageing process.GH
      replacement is well known to improve body composition, leading to a decrease in total body
      fat and an increase in lean body mass. However, GH replacement has only shown an effect on
      muscle strength in GH-deficient adults subjected to long-term GH therapy. Few studies have
      evaluated the effect of GH replacement on muscle strength in elderly people engaged in a
      program of exercise training.Our purpose is to evaluate the effect of GH therapy on muscle
      strength in healthy, non-sedentary men over 50 years old.
    

Detailed description: 
      At baseline, subjects are submitted to evaluation of GH secretion, testosterone level, body
      composition, and muscle strength. Absence of GHD and normal testosterone levels were
      necessary for the inclusion in the study. These parameters will be evaluated after 6 months
      of GH use x placebo.
    

Intervention name(s): growth hormone
Intervention type(s): Drug
Intervention description(s): GH group intervention: use of GH - initial dose of 0.5 UI/day (0.2 mg/day), with readjustments to 1.0 UI/day (0.4 mg/day) and 1.5 UI/day (0.6 mg/day) after 1 and 2 months of treatment, respectively. The last GH dose will be maintained until the end of the study. These GH dosages were based on the dose used for adults of the same age with GHD. Subjects will be re-evaluated after 6 months of GH therapy or placebo according to muscle strength and body composition .The other group received placebo using the same scheme as the GH group.
Other intervention name(s): somatotropin
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Muscle Strength; Growth Hormone; men
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the
      effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and
      tolerability of dapagliflozin with be assessed alone and while taking glimepiride
    


Intervention name(s): Dapagliflozin; Glimepiride; Dapagliflozin + Glimepiride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 20 mg, once daily, single dose; Tablets, Oral, 4 mg, once daily, single dose; Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose
Intervention MeSH terms: Dapagliflozin; Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Low Sodium Diet on Idiopathic Hyperaldosteronism
Condition: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Hyperaldosteronism; Hyperplasia
Study type: Interventional

Summary: 
      This study was a single-center randomized controlled trial which lasted 14 days and consisted
      of two stages (run-in period (stage I) and intervention period (stage II) each contain 7 days
      without potassium supplement. If participants meet the enrollment criteria at the end of
      stage I, they were assigned to the low sodium group (50mmol/d) or normal sodium group
      (100mmol/d), and then continued to finish stage II. The primary outcome was the change in
      serum potassium after exposure to normal sodium / low sodium diet and the secondary outcome
      was the assessment of BP change following a normal sodium / low sodium diet. Patients were
      given nifedipine controlled-release tablets 30 mg/d to lower blood pressure and were not
      provided any potassium supplements during the two stages. If the subject has an increase in
      BP (>180/110 mmHg), the dose of nifedipine controlled-release tablets will be increased to 60
      mg/d. Patients will be withdrawn from the study if they cannot tolerate the diet or their
      serum potassium were below 2.8 mmol/L.
    


Intervention name(s): Sodium
Intervention type(s): Dietary Supplement
Intervention description(s): 50 IHA patients were randomized into two groups with low sodium (50mmol/d) and normal sodium (100mmol/d) without potassium supplement. A 14 days dietary intervention was performed respectively to compare the changes in blood pressure (BP) and serum potassium in two groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Conjugated Linoleic Acid in Obese Women
Condition: Lipid Metabolism Disorders; Obesity
MeSH terms: Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation
      associated with aerobic exercise on body fat and lipid profile in obese women.
    

Detailed description: 
      The aim of this investigation was to analyze the effects of eight weeks of CLA
      supplementation associated with aerobic exercise on body fat and lipid profile in obese
      women. The investigators performed a randomized, double-blinded and placebo-controlled trial
      with 28 obese women who received 3.2 g/d of CLA or 4 g/d of olive oil (placebo group) while
      performing an 8-week protocol of aerobic exercise. Dietary intake (food record), body fat
      (DXA) and biochemical analysis (blood sample) were assessed before and after the intervention
      period.
    

Intervention name(s): CLA; Placebo
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): CLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%). Aerobic exercise associated with CLA; Placebo group received 4 g/day of olive oil. Aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BIBW 2992 Administered as Tablet (Final Formulation) Compared to BIBW 2992 Drinking Solution and BIBW 2992 Tablet (Trial Formulation II) in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to investigate the relative bioavailability and
      pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet
      (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in
      comparison with the drinking solution and in comparison with the trial formulation II tablet,
      which was administered in phase II clinical trials and also partly in phase I trials.
    


Intervention name(s): BIBW 2992 MA2; BIBW 2992 MA2; BIBW 2992 MA2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): film-coated immediate release tablet - final formulation; film-coated immediate release tablet - trial formulation II; powder for oral solution
Intervention MeSH terms: Afatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of the Transcendental Meditation (TM) Program on Blood Pressure, Psychological Distress, and Coping
Condition: High-normal Blood Pressure; Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to show that the Transcendental Meditation program can decrease
      blood pressure in young adults (college students) and is associated with decreased
      psychological distress and coping ability.
    

Detailed description: 
      Psychological distress contributes to the development of hypertension in young adults. This
      was a randomized controlled trial of 296 university students randomly allocated to either the
      Transcendental Meditation® program or wait-list control. At baseline and after three months
      posttest, systolic and diastolic blood pressure, psychological distress (total mood
      disturbance, anxiety, depression, anger/hostility) and coping ability (global constructive
      thinking) were measured.
    

Intervention name(s): Transcendental Meditation program
Intervention type(s): Behavioral
Intervention description(s): a natural effortless mental technique
Other intervention name(s): TM
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Transcendental Meditation; blood pressure; psychological distress; high psychological distress
Suture Anchor Comparison in Rotator Cuff Repairs
Condition: Rotator Cuff Injury
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX
      Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They
      will be asked to complete questionnaires throughout the study and will receive an MRI, CT and
      multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at
      the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The
      clinical and radiological outcomes will be compared between the study and control groups. It
      is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL
      REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.
    


Intervention name(s): Suture Anchor HEALOCOIL; Suture anchor Twinfix Ultra HA
Intervention type(s): Device; Device
Intervention description(s): Rotator cuff tears will be repaired intraoperatively using suture anchors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rotator cuff; Ossification; Suture anchors
Rhythm and Music to Rehabilitate Reading Disorders
Condition: Reading Disability
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether music training is an effective treatment of
      reading disorders
    

Detailed description: 
      Introduction: Children with dyslexia show deficits in temporal processing, both in language
      and in music. Musical activity increases phonological awareness, word segmentation, working
      memory, as well as reading abilities in children with typical development, a compelling
      evidence for a role of music training in fostering brain plasticity. Within this theoretical
      framework, we investigate the hypothesis that music training, by improving temporal
      processing and rhythm abilities, improves phonological awareness and reading skills in
      children with dyslexia.

      Methods: The study is a prospective, multicenter, open randomized controlled trial,
      consisting of test, rehabilitation and re-test
    

Intervention name(s): Music training; Visual arts
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This program was based on the Kodaly and Orff pedagogy and adapted to focus on rhythm and temporal processing.; This program emphasized visual-spatial and hand skills as well as creativity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: music training, rhythm
Healthy Aging Through Functional Food
Condition: Glucose Intolerance; Aortic Stiffness; Vasodilation
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are
      effective in improving metabolic and vascular health.
    

Detailed description: 
      The aim of the study is to evaluate dietary inducers of glyoxalase 1 for effects on metabolic
      and vascular health in overweight volunteers at risk of developing type 2 diabetes. The
      research objectives are:

      (i) To evaluate dietary inducers of glyoxalase 1 for effects on markers of glucose metabolism
      during an oral glucose tolerance test (oGTT), (ii) To evaluate dietary inducers of glyoxalase
      1 for effects on vascular function on three levels, using finger fold capillary density by
      capillaroscopy (FFCD), arterial stiffness by aortal pulse wave velocity (aPWV) and flow
      mediated dilatation (FMD); and effects on metabolic and pro-inflammatory markers in
      circulating blood and urine.
    

Intervention name(s): Glyoxalase 1 (Glo1) inducer; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary bioactive; Mannitol, 108 mg
Other intervention name(s): trans-resveratrol, 90 mg + hesperetin, 120 mg (combination)
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oral glucose tolerance test; Flow mediated dilatation; Aortal pulse wave velocity; Finger-fold capillary density by capillaroscopy
A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy Volunteers
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study (Parts A and B), the purpose of which is to determine the safety of
      LY2979165 in healthy people, and any side effects that might be associated with it, and to
      understand how the body handles LY2979165. In addition, Part B, will also look at levels of
      LY2979165 in spinal fluid. Doses investigated will be in the range of 20-1000 mg.
    


Intervention name(s): LY2979165; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): administered orally; administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Different Types of Progestin on Sleeping of Menopausal Women
Condition: Menopausal and Postmenopausal Disorders
Study type: Interventional

Summary: 
      Investigators have found that sleeping disorder is an important problem in menopausal women.

      There have been papers reporting the effect of hormonal therapy on sleeping, but fews have
      reported the effect of different progestogens on sleeping quality. There is a need for more
      in-depth study and more conclusive evidence about the progestins which have the most
      beneficial effects on sleeping disorders in menopausal women.

      This study is going to collect the data from newly identified menopausal patients who are
      eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The
      affects of the therapy will be monitored for 3 months.
    

Detailed description: 
      New patients who are eligible for hormonal therapy will be selected.

      They will be allocated randomly into 2 different groups, each group being prescribed 1 of 2
      regimens of hormonal therapy:

        -  17 beta estradiol 1mg/day plus oral micronized progesterone 100mg/day

        -  17 beta estradiol 1mg/day plus dydrogesterone 10mg/day Patients will have their sleeping
           quality accessed using the Pittsburgh sleep quality index(PSQI) at their 1st visit and
           once a month for 3 months. The first and third PSQI score will be analysed.
    

Intervention name(s): 1mg 17 beta-estradiol; Dydrogesterone; micronized progesterone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Comparing sleeping quality between micronized progesterone and dydrogesterone users.; Comparing sleeping quality between micronised progesterone and dydrogesterone users.; Comparing sleeping quality between micronised progesterone and dydrogesterone users
Other intervention name(s): Estrogen; Duphaston; Utrogestan
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Estrogens; Progesterone; Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sleeping quality; menopause; climacteric; progestin; dydrogesterone; micronized progesterone
Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain
Condition: Flexibility
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      PURPOSE: this study aimed to investigate the effect of opposite knee position on hamstring
      flexibility BACKGROUND Hamstrings tightness is one of the most common findings in patients
      with LBP. It is thought that, due to the attachments of hamstrings to the ischial tuberosity,
      hamstrings tightness generates posterior pelvic tilt and decreases lumbar lordosis, which can
      result in LBP.

      HYPOTHESES There will be significant difference in the hamstring flexibility with changing
      position of opposite knee (flexed or extended) in patients with mechanical low back pain.

      RESEARCH QUESTION: Will changing position of opposite knee (flexed or extended) affect the
      hamstring flexibility in patients with mechanical low back pain?
    

Detailed description: 
      -  The subject will be instructed to maintain 90° hip flexion in the supine position.

        -  Then asked to actively extend the knee joint.

        -  The degree of achieving active knee extension will be measured using a universal
           goniometer.

        -  The average of three active knee extension measurements will be recorded used as the
           hamstring muscle length for the data analysis (Dong-Kyu Lee, et al., 2018).

        -  This test will be done for the same limb with opposite leg extended and with opposite
           flexed.
    

Intervention name(s): Hamstring Flexibility
Intervention type(s): Other
Intervention description(s): The active knee extension test has been proposed as the gold standard for assessment of hamstring flexibility, as it utilizes readily available equipment and offers a quick, reliable, and low-cost alternative for measurement of hamstring flexibility (Connor et al; 2015).
The subject will be instructed to maintain 90° hip flexion in the supine position.
Then asked to actively extend the knee joint.
The degree of achieving active knee extension will be measured using a universal goniometer.
The average of three active knee extension measurements will be used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al; 2018).
the procedures will be done with opposite-leg flexed, then repeated with opposite-leg extended.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  Male and female

          -  Age range from 18-40 years old

          -  With previous mentioned inclusion criteria
Quality of Life and Fixed-ratio Combination of Insulin Degludec and Liraglutide (iDegLira)
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This work is aimed at improving the quality of life of older patients affected by type 2
      diabetes. The investigators will try to amiliorate the complexity of hypogliceamic treatment
      in a little group of older patients with type 2 diabetes reducing the number of pills and/or
      insulin administration using a single daily dose of a fixed combination of insulin degludec
      and liraglutide. This therapeutic semplification will be done indipendently of pre-existent
      glicaemic control.
    

Detailed description: 
      Older patients with type 2 diabetes often have numerous coexisting medical problems for which
      these subjets prescribed multiple medications. Actually, diabetes, hyertension,
      cardiovascular diseases (CVDs), neurodegenerative diseases (NDDs), digestive and respiratory
      disorders are common in aged peolple and tend to coexist. Unfortunally, the complex therapy
      of these diseases increases the risk of adverse drug events. Furthermore, there is marked
      heterogeneity in health status and functional capacity in older diabetic subjects, often
      making prescribing decisions complex and challenging. On the other hand, despite of the use
      of many medicines, undertreatment is also frequent present in the elderly and the probability
      of underprescription increased significantly with the number of medicines.Both conditions
      have a detrimental effect on quality of life (QoL) of elderly subjects increasing the risk of
      disability and death. Therefore, older people should benefit greatly of a simplification of
      drug regimens and reduction of pill burdens as well as better explanations of the reason for
      the prescriptions. The combination of insulin degludec (100 units/mL) and liraglutide (3.6
      mg/mL), termed IDegLira, was approved in 2014 for the treatment of type 2 diabetes
      inadequately controlled with oral glucose-lowering agents alone or in combination with a
      GLP-1 receptor agonist or basal insulin (European indication). Interestingly, RCTs and
      real-world evidence provided insights into effectiveness and safety in routine clinical
      practice. However, beyond its known metabolic efficacy IDegLira has a very small
      hypoglicaemic rate, with a single daily and flexible administration dose and a very good
      safety profile that makes it suitable for fragile diabetic old patients.
    

Intervention name(s): IDegLira
Intervention type(s): Drug
Intervention description(s): A single administration of IDegLira, dose depending on glicaemic control, in place of any pre-existing hipoglycaemic therapeutic scheme
Intervention MeSH terms: Xultophy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: elderly, diabetes, safety, quality of life