bioihbjkbjnl/mcl2 huggingface dataset:
Intralipid for Recurrent Miscarriage
Condition: Abortion, Spontaneous; Abortion, Habitual
MeSH terms: Abortion, Spontaneous; Abortion, Habitual
Study type: Interventional
Phase: Phase 4

Summary: 
      Intralipid infusion can improve the outcome in NK cells positive females with history of
      recurrent miscarriages undergoing IVF/ICSI cycles.
    


Intervention name(s): Intralipid
Intervention type(s): Drug
Intervention description(s): IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.the intralipid infusion is then repeated within the 1st week of positive pregnancy test and every 2 weeks till end of first trimester
Other intervention name(s): intralipid 20%
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Recurrent miscarriage; Implantation failure; Intralipid; ICSI / IVF failure
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the safety and describe the steady-state plasma
      pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation)
      following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension
      patients.
    


Intervention name(s): Travoprost ophthalmic solution, 0.004% (new formulation)
Intervention type(s): Drug
Intervention description(s): Travoprost ophthalmic solution, 0.004%, new formulation
Intervention MeSH terms: Travoprost; Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric glaucoma; pediatric ocular hypertension; travoprost
Rosuvastatin and Ischemia Reperfusion
Condition: Ischemia
MeSH terms: Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Statins, including rosuvastatin, are drugs that lower plasma cholesterol and prevent
      atherosclerotic disease. Recent preclinical evidence suggests that statins also increase
      tissue tolerance to ischemia-reperfusion injury.

      This is a randomized, double blind, parallel designed study comparing the effect of 1 week
      treatment with rosuvastatin (20 mg, once a day) with placebo on forearm ischemia-reperfusion
      injury in healthy male volunteers. Forearm ischemia-reperfusion injury is quantified with
      Tc-99m-annexin A5 scintigraphy of the hands after a standardized ischemic exercise test. For
      this purpose, Tc-99m-rh-annexin A5 (400 MBq; < 5 mSv) is injected intravenously upon
      reperfusion, followed by scintigraphy of both hands with a gamma camera at 1 and 4 hours
      after injection. Annexin A5 targeting is calculated as the percentage difference in activity
      (counts/pixel) between the thenar muscles of both hands.
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ischemia-reperfusion; Annexin A5
Immunological Follow-up of Patients With Basedow's Orbitopathy
Condition: Graves Orbitopathy
MeSH terms: Graves Ophthalmopathy
Study type: Observational

Summary: 
      Graves' disease is characterized by the combination of anti-TSH receptor antibodies
      (Thyroid-Stimulating Hormone or thyroidotropic hormone), specific to this disease, with
      inconsistent symptoms such as hyperthyroidism, orbitopathy, goiter, or myxedema
      dermatological involvement. The activation of TSH receptors (RTSH) by these antibodies (known
      as "TRAK") causes the secretion of thyroid hormones as well as the development of the thyroid
      gland, responsible for a goiter. The cellular infiltrate responsible for the goiter consists
      mainly of T-lymphocytes but also of activated B lymphocytes secreting TRAK. Although Graves'
      disease is antibody mediated, cytokine secretion by Th1 therefore seems essential to
      pathogenesis. The treatment of orbitopathy requires primarily euthyroidism and the
      discontinuation of smoking. Despite these measures, moderate to severe attacks may require
      immunomodulatory treatment to limit local inflammation. This treatment is currently based on
      a first-line corticosteroid treatment (per os or preferably by weekly intravenous infusions).
      In the context of inadequate response, the therapeutic strategy is not very well established
      since some immunosuppressive treatments targeting B-cells or T- cells have been studied but
      with little benefit.

      Many new concepts concerning immune tolerance and autoimmunity have emerged in recent years,
      particularly in Graves' disease, with sometimes complex cellular interactions. Certain
      mechanisms could occur either independently or in combination: i) modulation of T cell
      activation, differentiation and apoptosis; ii) inhibition of BL maturation and immunoglobulin
      production; iii) alteration of the balance between T helper (Th)-17 and T regulatory
      lymphocytes (Treg), by promoting Treg differentiation and inhibiting Th17 differentiation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Graves' disease
      
Biospecimen description: 
      NC
    
Keywords: Graves orbitopathy; TRAK; Immune monitoring
Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars
Condition: Acne Vulgaris; Scars
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This study aim to assess the efficacy of Er-YAG laser 2940nm and PRP as a single line of
      treatment in comparison with combined treatment in atrophic post acne scars.
    


Intervention name(s): Fractional Erbium Yağ Laser; Platelet Rich Plasma
Intervention type(s): Device; Procedure
Intervention description(s): Multiple sessions of Fractional Erbium Yağ Laser; Multiple injections of Platelet Rich Plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne scars; Erbium-YAG laser; platelet-rich plasma
Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Many patients with type 2 diabetes have difficulty attaining cholesterol goals, partly due to
      the recommendations for fasting measurements that may not be practical in the typical
      clinical setting. Focus toward therapy is shifting toward non-fasting assessments but little
      is known about the usefulness of this approach in diabetes, where postmeal cholesterol levels
      are more abnormal. This is an observational study examining fasting and postmeal lipids
      (cholesterol) in patients with type 2 diabetes using standard means and NMR.
    

Detailed description: 
      Current treatment guidelines for dyslipidemia focus on fasting lipid panels, specifically LDL
      cholesterol (LDL) but compliance has been shown to be poor. Therefore, focus has shifted to
      non-fasting measurements. However, there has been limited data in patients with type 2
      diabetes and further study is needed to illuminate the lipid changes that occur in the
      non-fasting state. This observational study examines fasting and postprandial lipids in
      patients with type 2 diabetes using standard chemical analysis and NMR. For comparison, lipid
      panels will be obtained at baseline and 3 hours following a standard meal in 30 patients with
      type 2 diabetes. These measurements will then be analyzed based on current ATP III
      guidelines. We will investigate the degree to which the postprandial assessments agree with
      the fasting assessments and the agreement between LDL and the two alternative measures ---
      non-HDL and NMR-LDL.
    

Time perspective: Prospective
Keywords: type 2 diabetes; hyperlipidemia; dyslipidemia; fasting lipids; postprandial lipids; Non-HDL cholesterol; NMR lipoanalysis; ATP III guidelines
Trial on Laparoscopic Simulation Based on Mentoring
Condition: Performance of Wrong Procedure (Operation)
Study type: Interventional

Summary: 
      More than 50 residents in surgical specialities (OB&G, General surgery and Urology) from a
      single university in Italy will be randomized into two groups, after a stratification based
      on residency year and laparoscopic/simulator experience. The first one will train to FLS
      (fundamentals of laparoscopic surgery) following pre-recorded instruction from course
      materials; the second one will be mentored by a proctor in single training section. The aim
      is to evaluate the best way to train residents applying for the very first time in an
      extensive way the "fundamentals of laparoscopic surgery" program in an Italian Institution.
    

Detailed description: 
      A complete 5-skills based FLS (fundamentals of laparoscopic surgery) curriculum is proposed
      to each resident enrolled in the trial. The first group trains with videos and written
      instructions, without any kind of support from a tutor. The second group is aided by a tutor,
      receiving tailored teaching and mentoring.

      The primary goal was to asses the impact of tutoring in Passing the FLS examination at the
      end of a 3-months training: the outcome is the dichotomous PASS/DON'T PASS THE EXAM. At the
      same time the investigators assess the performance to record and evaluate any differences in
      groups and subgroups (year of residency, gender, specialty, etc.).

      The evaluation was based on FLS program standards, recording time and penalties.

      The training and evaluation setting was created to exactly reproduce the FLS one, mostly
      using the FLS material itself, or using FLS admitted/compatible instrumentation.
    

Intervention name(s): Self-learning; Mentoring
Intervention type(s): Other; Other
Intervention description(s): Every resident will train following the video instruction included in the FLS course material and related written instruction only; A tutor will follow each resident during learning, giving instruction, examples and any kind of suggestions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Residents; Training; simulation; mentoring; proctor
The EVOLVE China Clinical Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and effectiveness of the SYNERGY™ Coronary
      Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length
      (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual
      estimate)
    

Detailed description: 
      The EVOLVE China clinical trial is designed to assess the safety and effectiveness of the
      SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of
      subjects with atherosclerotic lesion(s) in native coronary arteries in China. The SYNERGY™
      Stent System (Boston Scientific Corporation [BSC Corporation], Natick, Massachusetts, United
      States) is based on the well characterized Element™ stent platform and utilizes a
      bioabsorbable poly(DL-lactide-co-glycolide) (PLGA) polymer to deliver everolimus.

      While SYNERGY is a new generation DES, the safety and effectiveness of the Element stent
      platform in combination with everolimus in the form of the PROMUS Element stent has been
      established in the PLATINUM Clinical Trial Program.The PROMUS Element Plus stent (control
      device) uses the same stent platform as PROMUS Element stent with a modified balloon
      component on the Stent Delivery System to improve overall system deliverability. In addition,
      the previous version of the SYNERGY stent, the SYNERGY First Human Use stent (SYNERGY FHU
      stent) has been investigated in the EVOLVE FHU trial which has completed its primary endpoint
      and demonstrated comparable safety and efficacy profile of SYNERGY FHU to PROMUS Element up
      to 1-year follow-up (28). SYNERGY has been approved by CE Mark.
    

Intervention name(s): SYNERGY Investigational Device; PE Plus Investigational Device
Intervention type(s): Device; Device
Intervention description(s): percutaneous coronary intervention; percutaneous coronary intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell
      transplantation, in patients with type 1 diabetes mellitus who have a stable kidney
      allograft.
    

Detailed description: 
      1. To reverse hyperglycemia and insulin dependency by islet cell transplantation, in
           patients with Type 1 Diabetes Mellitus who have a stable kidney allograft;

        2. To eliminate the incidence of hypoglycemic coma and unawareness by islet cell
           transplantation;

        3. To assess long-term function of successful islet cell transplants;

        4. To determine whether the natural history of the microvascular, macrovascular and
           neuropathic complications of Diabetes Mellitus are altered following successful
           transplantation of islet cells.

        5. To assess the effect of exenatide to improve islet graft function and survival in
           subjects that demonstrate partial graft loss and have returned to using exogenous
           insulin.

        6. To assess the ability of exenatide to improve islet survival at time of islet
           transplantation
    

Intervention name(s): Islet Transplantation
Intervention type(s): Drug
Intervention description(s): Islet Transplantation in subjects with a previous kidney transplant.
Other intervention name(s): islet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Islet Transplantation
HIgh Flow Versus NIV for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED
Condition: Cardiogenic Pulmonary Edema
MeSH terms: Respiratory Insufficiency; Pulmonary Edema; Edema
Study type: Interventional

Summary: 
      The purpose of this study is to compare non invasive ventilation to high flow nasal cannula
      oxygen for the management of patients admitted with an acute respiratory failure due to an
      acute cardiogenic pulmonary edema.
    

Detailed description: 
      Acute cardiogenic pulmonary oedema is a leading cause of acute respiratory distress in
      patients admitted in an Emergency Department. With diuretics and nitrite derivative,
      noninvasive ventilation is the first-line treatment of acute pulmonary oedema recommended by
      the European Society of Cardiology. Noninvasive ventilation is able to reduce the respiratory
      rate faster than standard oxygen therapy, to improve oxygenation, and some data suggest it
      could reduce the mortality rate. NIV may be poorly tolerated in certain patients, in whom it
      is associated with failure of treatment and poor outcomes. High-flow nasal cannula heated and
      humidified oxygen (HFNO) is a ventilatory support used in ICU and recently introduced in
      Emergency Departments. As compared NIV and standard oxygen therapy, HFNO reduces the
      mortality rate in patients with acute hypoxemic respiratory failure hospitalized in an ICU.
      In addition, in these patients, HFNO is also better tolerated than noninvasive ventilation.
      Some data suggested HFNO is superior to standard oxygen therapy in acute pulmonary oedema and
      could have a similar clinical effect to NIV. However, there is no research that has compared
      tolerance of patients admitted in an ED with acute pulmonary oedema and treated by HFNO or
      NIV.

      Included patients will be treated with NIV or HFNO. NIV will be provided with an emergency
      and transport ventilator (Monnal T60, Airliquide, Antony, France) and HFNO will be provided
      with an AirVO2 device (Fisher and Paykel, New Zealand). Patients will be treated in an
      Emergency Department immediately after their admission and their consent. Treatment will be
      provided for a minimum of one hour. Tolerance of patients will be measured under treatment
      using a comfort numerical scale from 0 - well comfortable to 10 extremely uncomfortable.
      Clinical and biological patterns will be also recorded. Patients will be followed from their
      inclusion to 28 days after their inclusion.
    

Intervention name(s): Non invasive ventilation; High-flow nasal cannula heated and humidified oxygen
Intervention type(s): Device; Device
Intervention description(s): Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France); AirVO2 device (Fisher and Paykel, New Zealand)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supine vs Prone Position During Delayed Cord Clamping
Condition: Newborn; Anemia; Umbilical Cord Problem
MeSH terms: Anemia, Neonatal
Study type: Interventional

Summary: 
      This study is conducted to evaluate if the prone position of the newborn on the chest of his
      mother at birth before delayed cord clamping leads to better hematocrit and hemoglobin at
      24-48 hours of life compared to supine position.
    

Detailed description: 
      At 30 hours of life, laboratory personnel drew a capillary sample from the infant's heel for
      hemoglobin, hematocrit, and total serum bilirubin at the same time as the newborn metabolic
      screening sample. There is no added heelstick to routine care, as current standard in our
      institution requires the bilirubin to be drawn at 30 hours of life.

      During universal screening for congenital cardiac defects (30 hours of life), a value of
      cerebral saturation (CrSO2) is measured using NIRS with INVOS (In Vivo Optical Spectroscopy,
      INVOS System, Covidien, Dublin, Ireland, Somanetics). Sensors are placed over the forehead
      and the newborn is in supine position.
    

Intervention name(s): supine or prone position
Intervention type(s): Procedure
Intervention description(s): Before delivery, a sealed enveloppe is opened by the physician or nurse present at delivery. Immediately at birth the team in charge of delivery place the newborn in skin to skin contact on the mother's chest where he is dried. Umbilical cord clamping is delayed in both intervention arms to 1 minute after birth.
The newborn is placed in the prone or in the supine position depending on allocation. The nurse in charge of the newborn uses a stopwatch to check the time at which clamping was accomplished.
All subsequent nursery care are conducted according to hospital protocol.
Other intervention name(s): delay cord clamping
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised two arms study
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Delayed cord clamping
Changes in Plantar Preassures and Ankle Range of Motion After the Technique of Neuromeningeal Mobilization
Condition: Postural Balance; Rehabilitation; Foot; Therapy
Study type: Interventional

Summary: 
      Neuromeningeal mobilization or neurodynamics is a movement-based technique whose purpose is
      to restore peri- and intraneural homeostasis (1). It is based on principle that nerves have
      to lengthen and shorten to maintain normal muscle tension and range of motion (1) This
      technique has been shown to be effective in recovering tissue mobility (2), reducing pain in
      low back pain (3) and neck pain (1) and pain intensity in the elderly, and increasing joint
      range of motion and muscle flexibility (4 )

      Regarding balance, sciatic nerve sliding has been shown to immediately improve balance to one
      leg ( dinamic balance) after application in a comparative study before and after (4,5)

      No study has been realised in for the Posterior Tibial, Deep Peroneal, Medial Dorsocutaneous
      and Lateral Nerves, and no study has verificated standing balance and range of motion in
      ankle joint
    

Detailed description: 
      The study will consist of recording before and after applying the nerve mobilization
      exercise. Measurements will be made on the same day without the need to go at another time.

      In this study, participants will be asked to stand on a pressure platform several times in a
      relaxed manner and with eyes open and closed before and after a neuromeningeal mobilization
      technique indicated for the treatment of pain in your feet. In addition, the mobility of the
      ankle will be measured with the knee flexed and stretched. The measurements or tests to be
      carried out are totally innocuous and do not carry any risk to your health and integrity.

      Participants will have to remain barefoot for a maximum of 30 seconds, a total of 8 times on
      a pressure platform
    

Intervention name(s): Neural mobilization of the deep peroneal, posterior tibial and medial medial and lateral dorsocutaneous nerves.
Intervention type(s): Other
Intervention description(s): In lateral decubitus the patient with the help of the clinician will perform neuromeningeal mobilization of the posterior tibial dorsocutaneous lateral, intermediate and medial nerves and deep peroneal nerve too.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platform; neural movilization