bioihbjkbjnl/mcl2 huggingface dataset:
Protective Immunity Project 01
Condition: Kidney Transplantation; Immunity; Immunosuppression
Study type: Observational

Summary: 
      Patients who undergo kidney transplant must take medications to prevent organ rejection.
      There are standard immunosuppressant medications such as prednisone, tacrolimus (Prograf),
      mycophenolate mofetil(Cellcept) or sirolimus (Rapamune) that are given to patients to prevent
      rejection. It is well known that patients on immunosuppressant medications are at increased
      risk from viral infections, such as influenza. However, it is not well understood how
      immunosuppressive medications may uniquely affect the immune response to infection. This
      study will determine whether there are unique differences in the effects on the immune system
      by these different immunosuppressive medications, particularly differences between tacrolimus
      and sirolimus.
    

Detailed description: 
      While the benefits of transplantation to society are substantial, the ever-growing population
      of immunosuppressed recipients poses a unique challenge in development of immunization and
      containment strategies to protect the population from communicable pathogens and weaponized
      infectious agents. The immunosuppressive regimens that have allowed the emergence of
      successful transplant therapy not only inhibit T cell-dependent rejection but also cause
      systemic immunosuppression, which attenuates the response to vaccines in general and
      precludes the use of live attenuated vaccines. To date, there has been relatively little
      detailed systematic study of the immune alterations that accompany either the short- or
      long-term immunosuppressive regimens used in clinical organ transplantation. Despite the
      recent development of increasingly effective, but also increasingly complex, regimens using
      drugs with very distinct molecular targets, current policies on vaccination of transplant
      recipients are generic and remain based on old concepts rather than on any new understanding
      of the cellular and molecular effects of these therapies on the human immune system. This
      proposal seeks to improve our understanding of the biological mechanisms that underlie the
      distinct immunosuppressive regimens in practice today (calcineurin-inhibitor, or CNI, and
      sirolimus-based regimens) and in emerging regimens that employ agents with novel mechanisms
      of action, such as the CD28 costimulation blockers, and/or JAK3 kinase inhibitors. Such
      knowledge will be critical to strategies for enhancing desirable immune responses while not
      precipitating rejection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing deceased or living donor renal transplant
      
Biospecimen description: 
      Whole blood, serum, PBMCs
    
Keywords: Transplant; Immunity; Immunosuppression
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is
      effective in treating asthma when used 'as needed' in patients with milder asthma. The
      efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler
      twice daily plus terbutaline Turbuhaler 'as needed'
    

Detailed description: 
      A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in
      patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort
      (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' compared with Pulmicort
      (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'
    

Intervention name(s): budesonide/formoterol 'as needed' + budesonide placebo bid; budesonode bid + terbutaline 'as needed'
Intervention type(s): Drug; Drug
Intervention description(s): Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment; Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Intervention MeSH terms: Budesonide; Terbutaline; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Probiotics for Chalaziosis Treatment in Children
Condition: Chalazion
MeSH terms: Chalazion
Study type: Interventional

Summary: 
      There is growing evidence encouraging the use of probiotics in many conditions in children.
      The aim of the investigator's study is to define the possible beneficial impact of probiotics
      on paediatric patients affected by chalaziosis.
    

Detailed description: 
      Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be
      randomly divided in two groups. One group will receive conservative treatment and the other
      one will receive conservative treatment and a daily supplementation of probiotics. All
      patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear
      or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will
      be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months
      according to the results.
    

Intervention name(s): probiotics; conservative treatment
Intervention type(s): Dietary Supplement; Other
Intervention description(s): use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis; lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective comparative pilot study with two groups randomly divided
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: microbiome/microbiota; probiotics; chalaziosis; children
Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study was to characterize the difference in prepubescent growth
      velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with
      triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo
      (NASACORT® AQ placebo group) for 12-months.

      The secondary objectives were to compare the following in prepubertal participants treated
      with TAA nasal spray versus placebo:

        -  the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure
           the Hypothalamic-Pituitary Adrenal [HPA] axis function)

        -  the rate of treatment-emergent-adverse-events (TEAE)

        -  global efficacy rated by the investigator and the participant separately

        -  the rate of use of rescue medication during the study
    

Detailed description: 
      The study consisted of:

        -  a 4- to 6-month screening/baseline period

        -  a 12-month (up to Day 360+/-5 days) double-blind treatment period starting on Day 1

        -  a 2-month follow-up period (up to Day 420+/-5 days)
    

Intervention name(s): Placebo; Placebo; TAA-AQ, Nasacort® AQ; Claritin®
Intervention type(s): Other; Other; Drug; Drug
Intervention description(s): Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration; Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period; 110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period; Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention
Condition: Sleep; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This pilot study will test acceptability and feasibility of a sleep extension intervention in
      community dwelling, short sleeping, racially/ethnically diverse middle aged adults with
      Metabolic Syndrome (METs). Baseline sleep habits will be assessed and used to guide
      individualized strategies to extend sleep. A 1-group pre-test, post-test study design will
      test the efficacy of this 18 week study (2 weeks of baseline data collection, 1 week of study
      intervention planning, 12 weeks of sleep intervention planning, 12 weeks of sleep
      intervention delivery, final follow up 3 weeks after last day of the 12 week intervention) on
      sleep duration, MetS factors (waist circumference, blood pressure, fasting glucose,
      trigycerides, HDL-c), MetS risk behaviors (poor affective well-being, fatigue) and self
      regulation. Socio-ecological barriers and facilitators to the intervention will be identified
      using a quantitative and qualitative approach.
    


Intervention name(s): Self- management for adequate sleep intervention (SASI)
Intervention type(s): Behavioral
Intervention description(s): Bedtimes and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains >90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
2D Strain of Right Ventricle in Peroperative of Cardiac Surgery
Condition: Aortic Valve Disorder
MeSH terms: Aortic Valve Disease
Study type: Observational

Summary: 
      Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics
      obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .

      TEE is performed for each patient of cardiac surgery during the operation time .

      This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction
      after cardiac surgery.
    

Detailed description: 
      Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac
      surgery :

      In preoperative time After sternotomy After surgery Inclusions of patients elected for aortic
      valve surgery without coronary diseases or previous RV dysfunction.

      Comparison with others echocardiographic parameters of RV evaluation Association with right
      ventricle insufficiency after cardiac surgery.
    

Intervention name(s): Aortic valve surgery
Intervention type(s): Procedure
Intervention description(s): Aortic valve surgery
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient eligible for aortic valve surgery
      
Keywords: Transesophageal echography; Perioperative cardiac surgery; Aortic valve replacement; 2D strain of right ventricle
Protocol in Acute Myeloid Leukemia With FLT3-ITD
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute
      Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.

      The primary efficacy object is to evaluate the impact of midostaurin given in combination
      with intensive induction, consolidation including allogeneic hematopoietic stem cell
      transplantation and single agent maintenance therapy on event-free survival (EFS) in adult
      patients with AML exhibiting a FLT3-ITD.

      Sample size: 440 patients

      The treatment duration of an individual patient is between 18 and 24 months. Duration of the
      study for an individual patient including treatment (induction, consolidation [chemotherapy
      or allogeneic SCT], maintenance and follow-up period: Maximum 8 years
    


Intervention name(s): Midostaurin; Cytarabine; Daunorubicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Induction therapy: 50 mg, oral, twice daily, starting on day 8, thereafter continuous dosing until 48h before start of subsequent chemotherapy cycle.
Consolidation therapy: 50 mg, oral twice daily, starting on day 6, thereafter continuous dosing until 48h before start of conditioning therapy for allogeneic HSCT or 48h before start of subsequent consolidation chemotherapy.
Maintenance therapy:
50 mg oral twice daily over one year.; Induction therapy:
200 mg/m2/day by continuous i.v. infusion on days 1-7 (total dose 1400 mg/m²)
Consolidation therapy:
Younger adult patients (18 to 65 yrs): 3 g/m2 by i.v infusion over 3 hours every 12 hours on days 1, 3, and 5 (total dose 18 g/m2).
Older patients (>65 yrs): 1 g/m2 by i.v. infusion over 3 hours every 12 hours on days 1, 3, and 5 (total dose 6 g/m2).; Induction therapy:
60 mg/m², by 1-hour i.v. infusion, day 1-3 (total dose 180 mg/m²)
Other intervention name(s): PKC412
Intervention MeSH terms: Cytarabine; Daunorubicin; Midostaurin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myeloid leukemia; FLT3-ITD; midostaurin (PKC412)
Pharmacokinetics and Relative Bioavailability Study
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two
      Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial
      Extended Release Capsules
    

Detailed description: 
      Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In
      Powder Blend Extended Release Formulations Compared To The Commercial Extended Release
      Capsules
    

Intervention name(s): tolterodine tartrate; tolterodine tartrate; tolterodine tartrate; tolterodine tartrate; tolterodine tartrate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 4 mg single dose of extended release capsules; 4 mg single dose of microspheres in powder blend; 4 mg single dose of microspheres in powder blend; 4 mg single dose of microspheres in powder blend; 4 mg single dose of microspheres in powder blend
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; relative bioavailability; tolterodine microspheres in powder blend; Overactive Urinary Bladder
A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study to determine the relative bioavailability of two different prototype
      capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and
      fasted conditions. The study is open to healthy female participants of non-childbearing
      potential.
    


Intervention name(s): GDC-0134 F09 Formulation; GDC-0134 F15 Formulation; GDC-0134 F16 Formulation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral dose of GDC-0134 reference capsule F09.; Participants will receive a single oral dose of GDC-0134 prototype capsule F15.; Participants will receive a single oral dose of GDC-0134 prototype capsule F16.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.
Condition: Bronchiolitis
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effectiveness of two airway clearance
      techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in
      hospitalized infants under the age of 2 with acute viral bronchiolitis.
    


Intervention name(s): inhalation 4ml hypertonic saline 3% 3x/day; Intrapulmonary Percussive Ventilation; Assisted Autogenic Drainage
Intervention type(s): Other; Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bronchiolitis; Wang score; Sa02; airway clearance techniques; intrapulmonary percussive ventilation; assisted autogenic drainage
Virtual Reality Pain Control During Burn Wound Care
Condition: Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Using Virtual Reality as a form of Distraction during Burn Care.
    

Detailed description: 
      The purpose of the study is to investigate the effectiveness of virtual reality (a form of
      distraction) in order to reduce patients' procedural burn pain.
    

Intervention name(s): Virtual Reality Distraction
Intervention type(s): Behavioral
Intervention description(s): Using virtual reality distraction during a procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality Distraction
Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass
Condition: Roux-en-Y Gastric Bypass; Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional

Summary: 
      This study investigates whether calcium citrate or calcium carbonate are the optimal
      supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass
      operation.

      Half of the participants will be randomized to receive calcium citrate, while the other half
      will receive calcium carbonate. The study will be double blinded.
    


Intervention name(s): Calcium Carbonate; Calcium Citrate; Placebo; Roux-en-Y gastric bypass
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Procedure
Intervention description(s): Tablet manufactured to mimic a calcium carbonate tablet; Roux-en-Y gastric bypass surgery at least 12 months before study inclusion
Other intervention name(s): Unikalk Forte; Unikalk Citrat
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct
      application to the cardiac fat pads in patients undergoing coronary artery bypass grafting.
      Secondary goals of the study are to assess the potential response of Plexisyl-AF to reduce
      the occurrence of postoperative atrial fibrillation and assess the performance of the
      electrostimulator device to confirm the location of the epicardial fat pads (nerves). The
      occurrence of postoperative atrial fibrillation will be monitored by continuous cardiac
      monitoring.
    

Detailed description: 
      The purpose of this study is to investigate a non-surgical and non-destructive approach to
      providing a temporary, protective parasympathectomy as a means to reducing postoperative
      atrial fibrillation following cardiac surgery. Applications of Plexisyl-AF will be placed in
      the cardiac fat pads as a means for creating a "non-destructive" cardiac denervation.

      This is a randomized assessment to demonstrate the safety of Plexisyl-AF in patients
      undergoing open heart surgery. Eligible patients will be those submitted to undergo
      open-chest CABG. Patients will receive Plexisyl-AF, administered via direct application to
      the SA nodal and AV nodal epicardial fat pads during the surgical procedure.

      Patients will be monitored for the occurrence of atrial fibrillation via the use of
      continuous cardiac monitoring for a period of 120 hours following surgery. Patients will
      return the clinic for brief follow-up, including electrocardiographic recordings, 10 days, 30
      days and 90 days after the date of surgery.
    

Intervention name(s): Plexisyl-AF; No Treatment
Intervention type(s): Device; Other
Intervention description(s): Plexisyl-AF implants; CABG without the experimental treatment
Other intervention name(s): Standard surgery without device; surgery without device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: atrial fibrillation; CABG; ganglionated plexi