bioihbjkbjnl/mcl2 huggingface dataset:
ITA Vs LAD; Evaluation of Inflammatory Burden in OP-CABG Patients
Condition: Ischemic Heart Disease; Coronary Artery Disease; Atherosclerosis; Inflammation
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Atherosclerosis; Inflammation
Study type: Observational

Summary: 
      Introduction. Ischemic cardiomyopathy is one of the death leading causes in industrialized
      countries. Up-to-date ESC guidelines recommend a surgical approach (coronary by pass graft)
      in patients with multivessel coronaropathy, with involvement of left main (LM) or proximal
      left anterior descending (LAD) artery. In any case, is recommended the use of the internal
      thoracic artery (ITA) as conduct of choice.

      In consideration of the very strong evidence supporting the use of ITA, the study objective
      is to analyze and compare some blood markers collected from ITA blood vs. LAD blood, with the
      purpose of better understanding the technique benefits from a biological point of view, being
      the hemodynamic one already evident.

      Methods. Forty patients scheduled for coronary bypass graft (CABG) surgery at the Cardiac
      Surgery Unit of European Hospital of Rome will be enrolled. Patients which intervention
      includes off-pump ITA-LAD anastomosis will be included. For each patient blood sample from
      ITA and LAD will be collected. On those samples, polymorphonuclear leukocytes and platelets
      activity, endothelial dysfunction, oxidative stress and inflammatory burden will be analysed.
      In patients in which a pre-operative coronary CT scan is available, findings will be
      correlated with atherosclerotic plaque morphology.

      Expected results. Diseased LAD's blood will have a deranged markers profile compared with
      ITA's, with augmented inflammatory burden, reduce NO availability and increased platelet
      activation. In the patients subgroup with available coronary CT scan will be possible to
      esteem the effective blood mixing and speculate on a possible pharmacological effect of CABG,
      in terms of dilution of inflammatory burden in the target vessel.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited among the all-comers surgical candidates at European Hospital of
        Rome, which includes out patient clinic, internal transfers from cardiology unit, urgent
        transfers from other regional hospitals.
      
Biospecimen description: 
      Blood collected for internal thoracic artery and left descending artery
    
Keywords: coronary artery bypass graft; coronary revascularization
Solitaire FR Thrombectomy for Acute Revascularisation
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Observational

Summary: 
      The objective of this study was to obtain prospective clinical data on the safety and
      efficacy of the Solitaire™ FR device for patients diagnosed with acute ischemic stroke.
    

Detailed description: 
      The Study was a multi-center, single-arm, prospective, observational evaluation. The
      Solitaire™ FR Device has been certified for CE mark. This protocol evaluated the safety and
      efficacy of the Solitaire™ FR Device when used in routine practice and according to its
      Instructions for Use.
    

Intervention name(s): Solitaire™ FR device
Intervention type(s): Device
Intervention description(s): Mechanical Thrombectomy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke
        who presented within 8 hours of stroke symptoms onset with the study device were considered
        for inclusion in the study.
      
Keywords: Solitaire FR Device; Mechanical Thrombectomy; Recanalization; Brain artery recanalization; Neurovascular intervention; Interventional Neuroradiology; STAR; Acute Ischemic Stroke
Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor
      reducing surgery, for example IRE going to be investigated.
    

Detailed description: 
      Pancreatic tumor will be removed using tumor reducing surgery such as IRE. PBMC of the
      healthy donor will be separated from peripheral blood. After making them potential cancer
      killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment.
    

Intervention name(s): IRE surgery; IRE plus γδ T cells
Intervention type(s): Procedure; Biological
Intervention description(s): IRE surgery will be used in local tumor; Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunotherapy; γδ T Cell; Pancreatic Cancer
Retinal Blood Flow and Microthrombi in Type 1 Diabetes
Condition: Diabetes; Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The project aims to find mechanisms for the abnormal retinal blood flow that in diabetic
      patients often precedes any evidence of clinical retinopathy and may contribute to the
      development of retinopathy.

      Specifically, the projects tests the hypothesis that reduced retinal blood flow found in
      young patients with type 1 diabetes reflects increased resistance in the small vessels of the
      retina caused by the formation of small blood clots, called microthrombi; and that
      antiplatelet agents normalize the reduced retinal blood flow.
    

Detailed description: 
      The ultimate goal of this research is to contribute to the development of strategies to
      prevent diabetic retinopathy. This project will test the hypothesis that antiplatelet agents
      normalize the reduced blood flow observed early in the course of type 1 diabetes. If the
      hypothesis is proven correct, the results will indicate that the formation of small blood
      clots (microthrombi) occurs early in diabetic retinal vessels. In turn, because
      microthrombosis could readily account for the occlusive microangiopathy that causes the
      sight-threatening stages of diabetic retinopathy, the results will propose the desirability
      of antiplatelet therapy for the prevention of diabetic retinopathy.

      We have three specific aims:

        1. To confirm that, under basal conditions, retinal blood flow measured with the laser
           Doppler method in a group of type 1 diabetic patients with no or minimal retinopathy
           differs from the flow measured in age- and sex-matched nondiabetic control subjects;

        2. To determine whether the response of retinal blood flow to low-dose aspirin (81 mg/day)
           administered for 2 months versus placebo, differs between type 1 diabetic patients with
           no or minimal retinopathy and age- and sex-matched nondiabetic control subjects;

        3. To determine whether in type 1 diabetic patients with no or minimal retinopathy the
           response of retinal blood flow to low-dose aspirin differs from the response to
           clopidogrel, a drug that interferes with platelet function downstream of the site of
           aspirin action.
    

Intervention name(s): aspirin; clopidogrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: retinal blood flow; diabetic retinopathy; microthrombosis; aspirin; clopidogrel
Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC
Condition: Brain Injuries
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether NNZ-2566 is safe and effective in the
      treatment of Traumatic Brain Injury (TBI).
    

Detailed description: 
      Moderate to severe traumatic brain injury frequently results in persistent problems with
      memory, attention span, mood and more complex brain functioning such as planning and
      organizing. There are currently no drugs available to reduce the brain damage or the
      persisting symptoms that result from TBI. The longer term goal of this study is to provide
      physicians with a safe and effective treatment for TBI
    

Intervention name(s): NNZ-2566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for intravenous infusion.
Intravenous bolus infusion over 10 minutes followed by a continuous intravenous maintenance infusion for a total of 72 consecutive hours.; Sodium Chloride 0.9% Injection
Other intervention name(s): Glycyl-L-2-Methylprolyl-L-Glutamic Acid; Sodium Chloride 0.9% Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Major and Macular Branched Retinal Venous Occlusion
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional

Summary: 
      Although it is important in the clinical management to classify BRVO into subtypes based on
      the location of the occlusion (major or macular), few studies have provided such
      information[8,9]. The aim of this study was to evaluate the outcome of patients with macular
      edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab
      injection and to determine the concentrations of cytokines in the aqueous humor according to
      the site of the occlusion.
    

Detailed description: 
      Branch retinal vein occlusion is the second most frequent major retinal vascular disease
      after diabetic retinopathy. One of the main reasons for visual loss in BRVO is the
      development of macular edema. Treatment options for BRVO include grid laser treatment,
      intravitreal injection of steroids, surgical procedures, and off-label treatment with
      intravitreal anti-vascular endothelial growth factor (VEGF) agents. During recent years,
      intravitreal anti-VEGF treatment with bevacizumab has been shown to efficiently reduce
      macular edema and improve visual acuity in numerous case series and prospective or
      retrospective studies.
    

Intervention name(s): intravitreal bevacizumab
Intervention type(s): Procedure
Intervention description(s): Intravitreal injections of bevacizumab were performed under sterile conditions in the operating room. a 27-gauge needle was inserted through the corneal limbus to withdraw 0.05 ml of aqueous humor and soften the globe. Then, 1.25 mg (0.05 ㎖) of bevacizumab was injected into the vitreous in the superior temporal quadrant with a 30-gauge needle that was inserted into the eye 3.5 mm from the limbus. The postoperative medications included topical antibiotics.
Intervention MeSH terms: Bevacizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: macular edema secondary to retinal benous occlusion
ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular
      access surgery with native vein for hemodialysis can increase the maturation rate of
      arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1
      randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2
      and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks
      after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after
      surgery by duplex in all patients.
    


Intervention name(s): Duplex ultrasonography
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: duplex study; hemodialysis access; maturation rate; endovascular intervention
Pilot Evaluation of a Healthy Lifestyle Intervention for Adolescent and Young Adult Survivors of Pediatric Cancer
Condition: Pediatric Cancer
Study type: Interventional

Summary: 
      This is a feasibility and acceptability trial to test a newly developed healthy lifestyle
      intervention for adolescent and young adult survivors of pediatric cancer.
    


Intervention name(s): Healthy Lifestyles; Education-Only Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 telehealth sessions. The first 5 visits include psycho/medical education plus a motivational interviewing component. The second 7 sessions include psycho/medical education plus a problem solving training component.; This control condition includes meeting with a clinician for one telehealth visit to review nutrition and physical activity recommendations.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a small feasibility study. We will enroll 24 participants on the intervention arm and 12 participants to an education-only control arm.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric cancer; Survivorship; Child; Adolescent; Weight; Obesity; Physical activity; Motivational interviewing; Problem solving; Culture; Exercise; Nutrition
Acute-phase Response & Periodontal Treatment in Patients With Hypertension
Condition: Periodontitis; Hypertension
MeSH terms: Periodontitis; Hypertension; Acute-Phase Reaction
Study type: Interventional

Summary: 
      The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus
      full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical
      periodontal treatment in patients affected by periodontitis and high blood pressure.
    

Detailed description: 
      Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation
      of the root surface (scaling and root planing), will be performed by a single periodontist on
      patients with periodontitis and hypertension.

      The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus
      full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical
      periodontal treatment in patients affected by periodontitis and high blood pressure.

      Treatment will be provided using both hand and ultrasonic instrumentation with ﬁne tips.

      FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four
      quadrants sessions of periodontal treatment with an interval of 1 week between sessions.

      Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline,
      24 hours after the first treatment and after 3 months. Periodontal parameters will be
      evaluated at baseline and after 3 months.
    

Intervention name(s): FM-SRP; Q-SRP
Intervention type(s): Procedure; Procedure
Intervention description(s): Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.; Supra- and sub-gingival mechanical instrumentation of the root surface will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a "quadrant" of the dentition will be instrumented.Performed in 3 weeks time frame.
Other intervention name(s): Full mouth scaling and root planing; Quadrant scaling and root planing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Health Effects of Reducing Sedentary Behavior
Condition: General Population
Study type: Interventional

Summary: 
      A recent review indicated that sedentary behavior has been associated with increased
      morbidity and mortality but the intervention studies frequently focus only on changing
      sedentary behavior (reducing sedentary time) without measuring health-associated outcomes.
      Elevated cortisol (related to stress) has been linked with health risks. Improved physical
      fitness has been linked with improved cortisol responses to psychosocial stressors. In
      addition, increased physical activity induced favorable effects upon low density lipoprotein,
      high density lipoprotein, and total cholesterol. Previous study also indicated that
      increasing daily steps have positive effect on blood glucose in people with impaired glucose
      tolerance. Ultimately, the investigators think that sedentary intervention and stress
      management may have benefits on these health indicators. As such the investigators will
      examine whether sedentary intervention or stress management can have positive effect on human
      health by measuring salivary cortisol, blood lipid profile, fasting blood glucose, blood
      pressure, resting energy expenditure, and body composition.
    


Intervention name(s): Reducing sedentary behavior; Reducing stress; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Educational handouts for sedentary behavior and strategies reducing sedentary behavior and weekly videos related to reduced sedentary behavior; Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management; An educational handout for sedentary behavior and weekly neutral topic videos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of Ultrasound Guided Erector Spinae Plane Block
Condition: Hemodynamic Instability; Patient Satisfaction; Postoperative Pain; Regional Block
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Thoracic epidural and paravertebral blocks are the most widely regional technique used for
      postoperative analgesia after surgery, but they are difficult to perform and carry a risk of
      serious complication. In this study, investigator asses the efficacy of ultrasound ESPB on
      intraoperative and postoperative hemodynamics and patient satisfaction
    

Detailed description: 
      This prospective, double-blinded, randomized, controlled study was conducted at the period
      from October 2018 to December 2019. Sixty adults' patients ASA I-III, their ages ranged from
      25-60 years undergoing abdominal surgery under general anesthesia. Each patient assigned
      written informed consent before the block performance.

      Patients refused, known allergy to the used drugs, with history of coagulopathy, major organ
      failure and obesity (BMI>40 kg/m2) were excluded from the study.

      Patients were randomly allocated into two equal groups by a computerized randomization table:
      ESPB group, and control group. The patient and the staff providing the postoperative care
      were blinded to the group assignment.

      ESPB group: Will undergo ESP block with 40 ml bupivacaine 0.25% (20 ml on each side) control
      group: anesthetized with the protocol followed by Minia University Hospital.

      Anesthetic technique was standardized for all patients.
    

Intervention name(s): Erector spinae plane block; control
Intervention type(s): Procedure; Other
Intervention description(s): The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes using ultrasound guide.; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: ESPB; postoperative pain; Regional block
Analyze Changes in Respiratory Rate When Using the Scare Respirator
Condition: Apnea of Newborn; Preterm Labor
MeSH terms: Obstetric Labor, Premature
Study type: Interventional

Summary: 
      Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal
      observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours
      with a 20cycles/minute with "scare ventilator", and 2 hours of 40 cycles/minute with "scare
      ventilator"
    

Detailed description: 
      With this pilot study the investigator's want to see if the "scare respirator" can modify the
      vital signs of the newborn (NB) and if there is a relationship according to the frequency per
      minute given by the scare respirator and the patient's respiratory rate.

      The "scare respirator" has been used many times to prevent central apnea in the newborn. This
      involves using a mechanical ventilator, but instead of connecting it to the patient's trachea
      to inflate his lungs, the air flow is connected to a surgical glove that inflates and
      deflates, with the optimal respiratory rate that the patient should have. This will be placed
      on the back to stimulate it tactically giving the necessary impulse of inspiration so that
      the patient alone can acquire the movement.

      The importance of the development of this study is that it has been seen that the "scare
      respirator" could avoid central apneas, but no studies have been done on the change in
      respiratory rate that occurs with the device or if it bothers the NB or alters its
      wakefulness sleep pattern.

      It is intended to evaluate 10 premature infants, during 3 observation periods. Heart rate
      (HR), Respiratory rate (RR) and saturation, pain scale and aEEG sleep wake pattern will be
      evaluated; first a rest period between feeds as baseline, then with a scare respirator at 20
      cycles per minute and finally at 40 cycles per minute. The differences of qualitative and
      quantitative variables will be assessed with ad-hoc statistical tests.
    

Intervention name(s): No intervention; scare ventilator at 20; scare ventilator at 40
Intervention type(s): Device; Device; Device
Intervention description(s): Basal analysis; To set scare ventilator by 20 cycles per minute; To set scare ventilator by 40 cycles per minute
Intervention model: Sequential Assignment
Intervention model description: 10 preterms are going to be put on random measures in 2 hours blocks of, no intervention 2 hours of scare ventilator settled at 20 cycles per minute, and 2 hours of scare ventilator at 40cycles per minute
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: respiratory rate; scare ventilator; sleep wake cycle