bioihbjkbjnl/mcl2 huggingface dataset:
Improving Diet and Exercise in Acute Lymphoblastic Leukemia (IDEAL Weight in ALL)
Condition: B Precursor Type Acute Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional

Summary: 
      This study tests the ability of a focused dietary, exercise, and activity intervention to
      reduce fat gain during induction therapy for childhood acute lymphoblastic leukemia to
      improve disease response and reduce toxicity.
    

Detailed description: 
      In our previous study, we have observed that: 1) nearly half ALL patients are overweight or
      obese at diagnosis, 2) all patients, regardless of starting weight, gain significant fat mass
      over the first month of therapy (on average 20-30%), and 3) obesity at the time of diagnosis
      is associated with a higher likelihood of poor response to chemotherapy as evidenced by
      persistent leukemia (minimal residual disease) after induction therapy. Together, these data
      show that body fat is a significant risk factor for ALL treatment failure, and that its
      negative effects are evident within the first month of treatment. Recent laboratory and
      clinical data illustrates the ability of diet restriction and physical activity to improve
      chemotherapy efficacy, reduce treatment-related toxicities and better overall quality of
      life.

      Given the importance of successful induction therapy for ALL in predicting long term survival
      and the negative role of obesity on treatment success, this study tests a complete
      personalized dietary and exercise intervention for pre-adolescents, adolescents, and young
      adults newly diagnosed with B-precursor ALL ("pre-B ALL") that aims to reduce fat gained
      during induction therapy and thereby improve treatment response, toxicity rates, and quality
      of life.
    

Intervention name(s): Dietary Intervention; Activity and Exercise Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.; Beginning at the time of diagnosis, the exercise and activity component uses an "activity menu" to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Ketamine and Propofol in Otoacoustic Emissions (OAE) in Children
Condition: Normal Healthy Ears; Ketamine and Propofol Effects on Hemodynamics; Ketamine and Propofol Effects on TEOAE and DPOAE
Study type: Observational

Summary: 
      Otoacoustic emissions (OAEs) are non-invasive, easy to apply and objective test methods which
      are widely used to determine the presence of hearing in audiology clinics. Under some
      circumstances and children, the study should be applied under general anaesthesia. The aim of
      this study was to find out the influence of propofol (P) and ketamine (K) on OAE
      measurements. .

      Methods: Thirty- healthy children who will underwent adenoidectomy and tonsillectomy will be
      included in this study after Institutional ethics committee approval and informed consent of
      parents. Children will be evaluated one day before surgery by tympanometry. Psychologically
      prepared children will be admitted to the operating room. Following EMLA (Eutectic Mixture of
      Local Anesthetics ) cream application IV line will be inserted. ECG and non-invasive blood
      pressure will be monitored. Transient evoked otoacoustic emissions (TEOAEs) and distortion
      product otoacoustic emissions (DPOAEs) will measured in both ears of each patient (n=20 ears)
      prior to P or K administration( Pre-P and Pre-K). Propofol will be given 2mg/kg or ketamine
      2mg/kg intravenously and 40% O2 in air will be given by mask ventilation. Five minutes later
      TEOAE and DPOAE measurements will be repeated (Post-P and Post-K). After this measurement the
      routine general anaesthesia and surgical protocol will be commenced. Heart rate, blood
      pressures TEOAE and DPOAE measurements will be compared at pre and post stages by paired
      Student's t- test.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children ages 4-15 years ASA I-II Tonsillectomy and/or adenoidectomy Normal ear hearing
        tests
      
Keywords: transient evoked otoacoustic emissions; distortion product otoacoustic emissions; ketamine; propofol; child
OSHES - Observational Study on Hemostasis in Surgery (TC-022-IT)
Condition: Blood Loss, Surgical; Hemostasis
MeSH terms: Blood Loss, Surgical
Study type: Observational

Summary: 
      OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register
      settled in Italy with the purpose of collecting data on 800 patients intra-operatively
      treated with hemostatic supporting agents/techniques in addition to the standard surgical
      procedures in 40 surgical wards. The availability of these data will allow for a better
      understanding of the therapeutic needs in the area of hemostatic supporting
      agents/techniques.
    


Intervention name(s): Fibrinogen (human) + thrombin (human) (TachoSil)
Intervention type(s): Drug
Intervention description(s): Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures
Intervention MeSH terms: Thrombin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who are candidates for a specific type of surgery where a supportive hemostyptic
        agent will be used and who issued an informed consent. A special procedure will be
        implemented for use in emergency situations.
      
Keywords: Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures
Bariatric Surgery, Hormones, and Quality of Life
Condition: Obesity; Hormone Disturbance; Quality of Life; Hyperandrogenism
MeSH terms: Hyperandrogenism; Endocrine System Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the hormonal status in fertile women undergoing
      laparoscopic gastric bypass, pre- and postoperatively, and evaluate if there is a correlation
      between health-related quality of life and proposed hormone changes post-operatively.
    

Detailed description: 
      Sex hormone levels in women with obesity are altered in comparison to normal weight subjects.
      Most previous studies have focused on questionnaire surveys, and on the
      emotional/psychological aspect of health-related quality of life (HRQoL). It has been shown
      that bariatric surgery can affect reproductive ability, but the relationship between hormonal
      changes and HRQoL has been sparsely studied.

      Hormone balance is affected by fat allocation, insulin levels and liver function, and these
      factors are all influenced postoperatively. Also body image and altered body mass composition
      can influence sexuality in diverse ways.

      This leads us to theorize that liver production of SHBG will change after surgery and impact
      serum concentrations of sex hormones. Normalized levels of testosterone and estrogen may lead
      to reduced symptoms of hyperandrogenism, restitution of normal menstrual cycles and changes
      in sexual functioning.

      The focus of this study is to analyze sexual and health-related quality of life through
      questionnaire analyses, and to investigate levels of sex hormones pre- and postoperatively in
      women undergoing bariatric surgery. Results from questionnaire analyses and hormone data will
      be tested for possible correlations.
    

Intervention name(s): Laparoscopic gastric-bypass surgery
Intervention type(s): Procedure
Intervention description(s): Female participants with BMI >30, between age 18-50, will be operated with laparoscopic gastric bypass surgery by an experienced gastric bypass surgeon.
Intervention model: Single Group Assignment
Intervention model description: With-in group comparison of pre- and postoperative data.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bariatric surgery; Sex hormones; Women; Quality of life
Magnetic Nanoparticle Sperm Separation for Teratozoospermia Male and Women Older Than 35 Years
Condition: Infertility
MeSH terms: Infertility; Teratozoospermia
Study type: Interventional

Summary: 
      Women over 35 years old are likely to suffer from impaired oocyte repair capacity.
      Teratozoospermia is a condition reflects morphological affection of sperm. These spermatozoa
      would add an extra burden on the oocyte after ICSI. Whether selecting mature sperm by
      magnetic nanoparticle protocol would provide a more competent sperm to a likely affected
      oocyte would improve ICSI outcomes is the question of this research.
    


Intervention name(s): Sperm preparation for ICSI
Intervention type(s): Other
Intervention description(s): A new protocol for sperm preparation for ICSI cycles with teratozoospermia in over 35 years old women
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Comparison of Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Rotator Cuff Tendinopathy
Condition: Rotator Cuff Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff
      tendinopathy is the most common cause of shoulder pain.

      The aim of this study is to compare the effects of ultrasound-guided subacromial ozone
      (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.
    

Detailed description: 
      Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff
      tendinopathy is the most common cause of shoulder pain.

      There are limited studies comparing the efficacy of ozone and corticosteroid injections in
      rotator cuff tendinopathy. In this context, the aim of this study is to compare the effects
      of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients
      with chronic rotator cuff tendinopathy.
    

Intervention name(s): Ozone (O2-O3) injection; Corticosteroid injection
Intervention type(s): Procedure; Procedure
Intervention description(s): US-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. 3 sessions (1 session/week) of 5 mL of ozone (O2-O3) will be injected (with a concentration of 10 μg/mL in the first session, 15 μg/mL in the second session, and 20 μg/mL in the third session).; US-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. A mixture of 1 mL corticosteroid (betamethasone 3 mg/mL) and 1 mL lidocaine (20 mg) will be injected (1 session).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rotator cuff tendinopathy; ozone; steroid; ultrasonography
Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events
Condition: Reperfusion Injury; STEMI
MeSH terms: Reperfusion Injury; ST Elevation Myocardial Infarction; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized,
      double-blind, placebo-controlled study designed to assess the safety, tolerability, and
      efficacy of IV administered elamipretide (also known as MTP-131, or Bendavia) on a background
      of standard-of-care therapy for reduction of reperfusion injury in patients with first time
      acute, anterior wall ST-segment elevation myocardial infarction (STEMI).
    

Detailed description: 
      The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized,
      double-blind, placebo-controlled study designed to assess the safety, tolerability, and
      efficacy of IV administered elamipretide on a background of standard-of-care therapy for
      reduction of reperfusion injury in patients with first time acute, anterior wall STEMI.

      Patients were randomized to receive either an infusion of elamipretide at 0.05 mg/kg/hr or an
      identically appearing placebo administered as an IV infusion at 60 mL/hr. The infusion began
      at least 15 minutes but no more than 1 hour prior to the anticipated reperfusion event and
      continued through approximately 1 hour following re-establishment of blood flow through the
      culprit vessel.

      The reduction of reperfusion injury, or infarct size, was estimated using the area under the
      curve (AUC) of the serum creatine kinase (CK) isoenzyme, as well as using magnetic resonance
      imaging (MRI) performed on the Day 4±1 and on Day 30±7 (both MRI assessments measured infarct
      size and the ratio of infarct size to myocardial mass). The analyses of cardiac MRI data were
      performed for both the primary endpoint population and also in all patients who had adequate
      Day 4/Day 30 cardiac MRI studies.

      After completion of the percutaneous coronary intervention (PCI) and stenting, patients
      received standard medical treatment.
    

Intervention name(s): Bendavia (MTP-131); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.05 mg/kg/hr; Identically appearing placebo
Other intervention name(s): MTP-131; Elamipretide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Myocardial Reperfusion; Primary PCI; Stenting for ST-segment Elevation Myocardial Infarction
Quad Helix and Correction of Mandibular Asymmetry
Condition: Mandibular Asymmetry; Functional Shift of the Mandible
Study type: Observational

Summary: 
      To compare the effectiveness of the Quad Helix, an orthopaedic conventional appliance, in the
      correction of skeletal mandibular asymmetry, on frontal x-ray, in subjects treated before or
      after 7 years.
    

Detailed description: 
      Introduction : Unilateral posterior crossbite (UPCB), often from dysfunctional and
      para-functional causes, leads to positional mandibular asymmetries that can develop at a very
      young age into skeletal mandibular deviation; hence the interest of early maxillary
      expansion. The purpose of this retrospective study was to compare the impact of maxillary
      expansion by Quad Helix (QH) on mandibular skeletal asymmetry correction before and after 7
      years of age.

      Materials and methods : All children with UPCB and skeletal mandibular asymmetry, who were
      treated by QH in the orthodontic department between February 2017 and August 2018 and who
      have done a radiography file at baseline (T0) and 12 months later (T1) have been included.
      The patients were divided into two groups according to age: under 7 years of age (early group
      G1) with QH adjusted on second primary molars and over up to 13 years old (late group G2)
      with QH adjusted on first permanent molars. The differences between the right and left sides
      of the mandible in corpus length L (main eligibility criterion) and ramus height H (secondary
      criterion) were compared between groups. X² test, Fisher's exact test and Wilcoxon rank-sum
      tests were used for baseline comparisons. A multifactorial analysis allowing adjustment on
      possible confounding factors was used with R software at a significance level of 5%.
    

Intervention name(s): Maxillary expansion with conventional Quad Helix bonded on molars.
Intervention type(s): Device
Intervention description(s): Maxillary expansion with conventional Quad Helix bonded on molars
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of Orthodontic Department of the CHU of Montpellier
      
Keywords: Early treatment; Posterior unilateral cross bite; Quad helix
Impact of Hibiscus on Cardiovascular Disease Risk
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a
      cold or hot drink and is available in the United Kingdom (UK) markets in different forms
      including tea bags. There is preliminary data that support the hypothesis that HSC extract
      consumption has beneficial effect on blood vessel health and blood pressure reduction.
      Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key
      modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death
      throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the effect
      of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa calyces
      (HSC) compared with a matched control (water) on blood pressure and blood vessels function
      will be investigated after a high - fat mixed meal. This is with a view to determining the
      impacts of the extract on postprandial (after meal) blood pressure and other CVD risk
      factors. Results from the PHYTOVAS study could lead to identification of more dietary
      approaches that will contribute to CVD risk prevention and management.
    


Intervention name(s): Hibiscus sabdariffa calyces extract as a cold drink
Intervention type(s): Dietary Supplement
Other intervention name(s): Hibiscus flower tea; Hibiscus tea; Roselle
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hibiscus sabdariffa calyces; Blood Pressure; Vascular Function; Inflammation; Cardiometabolic risk markers; Systemic antioxidant capacity
Audiological Evaluation of Anesthetists
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Observational

Summary: 
      The investigators aim to investigate the effect of operating room noise on anesthetist
      hearing
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        anesthetist doctor who subject to noise in operating rooms
Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
Condition: Spastic Cerebral Palsy
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Aquatic intervention had been applied in children with neuromotor impairment for years, yet
      there has been little progress toward objective identifications of therapy goals,
      interventions, and outcomes. Thus, we attempt to design aquatic intervention activity for
      children with cerebral palsy to evaluate the effect of hydrotherapy.

      Purpose:

      To evaluate the effects of pediatric aquatic therapy on motor performance, daily activity and
      social participation in children with spastic cerebral palsy.

      Method:

      The study enrolled 27 children with spastic cerebral palsy aged from 4 to 12 years old.These
      children were dived into two groups: traditional rehabilitation therapy (control group), and
      hospital based pediatric aquatic therapy program. We evaluate the motor performance, daily
      activity and social participation before and after the intervention and compared the
      difference in improvement between groups. The measurements include modified Ashworth score,
      Gross Motor Function Measure (GMFM -66), Vineland Adaptive Behavior Scale (VABS) , and
      Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL).

      Expect effect:

      We suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor
      function and daily activity.Children could improve self-esteem and we hypothesize this could
      improve social participation.
    

Detailed description: 
      -  We conducted a well-designed study to investigate the effectiveness of PAT on motor
           function, activities of daily living (ADL),and health related quality of life(HRQOL)
           perspectives for children with CP.

        -  A convenience sample of 27 children was recruited for the study from the outpatient
           clinics of the Department of Physical Medicine and Rehabilitation of two tertiary
           hospitals: Chang Gung Memorial Hospital and Taipei Veterans General Hospital.

        -  The study was designed as a single blinded, prospective, case control study.

        -  The pediatric aquatic therapy group got more improvementon motor performance measured by
           GMFM-66.
    

Intervention name(s): aquatic therapy
Intervention type(s): Procedure
Intervention description(s): two hours per week, one hour per time, total 12 weeks
Other intervention name(s): physical therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Gross motor function performance; pediatric aquatic therapy; spastic cerebral palsy