bioihbjkbjnl/mcl2 huggingface dataset:
Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma
Condition: Non-hodgkin Lymphoma; Hodgkin Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is comparing whether using a drug called sirolimus for graft versus host disease
      (GVHD) prevention can decrease the chance of the participant's lymphoma relapsing after
      transplantation, compared to using a standard GVHD prevention regimen without sirolimus.
      Since mTOR inhibitors have anti-lymphoma activity, their use after transplantation may lead
      to a decreased risk of relapse and hence better transplantation outcome.
    

Detailed description: 
      -  Because no one knows which of the study options is best, participants will be
           "randomized" into one of the two possible groups for GVHD prophylaxis: 1) a
           sirolimus-containing regimen (tacrolimus, sirolimus and methotrexate) or 2) a
           sirolimus-free regimen (tacrolimus and methotrexate or cyclosporine and mycophenolate
           mofetil).

        -  Participants will receive a reduced intensity conditioning regimen. This is done to
           prepare the body for transplantation. This will consist of a combination of drugs
           (either fludarabine and busulfan or fludarabine, cyclophosphamide and low-dose total
           body irradiation). The purpose of these drugs is to weaken the immune system and lower
           the chance of the body rejecting the donated stem cells.

        -  Participants will also receive the GVHD prophylaxis regimen that they have been
           randomized to. These drugs will lower the chance of rejecting the donor cells and lower
           the chance of developing GVHD.
    

Intervention name(s): Sirolimus; Methotrexate; Tacrolimus; Cyclosporine; MMF
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Taken orally for at least 12 months; Given intravenously on the first, third and sixth day after transplant; Taken orally or given intravenously for at least 6 months; Taken orally or given intravenously for at least 6 months; Taken orally for about 2 months
Other intervention name(s): Rapamycin; Abbreviated MTX; Trade name:Trexall; Prograf; Brand names:; •Gengraf; •Neoral; •Sandimmune; •Sangcya; Mycophenolate mofetil (MMF); Brand Names:; CellCept; Myfortic
Intervention MeSH terms: Cyclosporine; Sirolimus; Mycophenolic Acid; Methotrexate; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allogeneic stem cell transplant; reduced intensity conditioning; graft versus host disease; GVHD; RIC transplantation
Promoting Success for Pre-K Teachers, Families and Children
Condition: Emotional Stress
Study type: Interventional

Summary: 
      The current study examines the impact of ParentCorps in high-poverty Early Education Centers
      in New York City (NYC). The study is conducted within the context of the NYC Department of
      Education (DOE) Pre-K Thrive initiative. As part of this initiative, the Center for Early
      Childhood Health and Development (CEHD) at NYU Langone Health is implementing services to
      strengthen family engagement and support parents and teachers in building safe, nurturing and
      predictable environments for young children. Services include resources to support social
      emotional learning (SEL) and family engagement (FE) for all Pre-K for All (PKFA) programs and
      all PKFA families; Professional Learning to support the use of evidence-based SEL and FE
      practices for teachers and leaders from 350 PKFA programs; and ParentCorps programs for PKFA
      children and families in 50 PKFA programs (which is a subset of PKFA programs receiving
      Professional Learning). The current study evaluates the relative value of Thrive Professional
      Learning plus ParentCorps compared to Thrive Professional Learning.

      This study will include 158 pre-K teachers (teachers and teaching assistants) across 23
      Centers (12 Centers receiving Thrive Professional Learning plus ParentCorps, 11 Centers
      receiving Thrive Professional Learning only). All teachers in the 23 Centers will be invited
      to complete 2 self-report surveys over a two-year period. A sub-set of teachers will be
      randomly selected to participate in 2 interviews during this period. In addition, teachers in
      sites randomized to ParentCorps (12 Centers) will be invited to consent to the use of weekly
      implementation surveys, observational data and semi-structured interviews about experiences
      with implementation, collected as part of standard implementation practice of ParentCorps,
      for the purposes of this study.
    


Intervention name(s): Program for Parents (Parenting Program); Thrive Professional Learning
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Program for Parents (Parenting Program) is implemented by a mental health professional and offered to groups of ~15 parents during the school day and during after school hours. The Program for Parents includes 2-hour sessions provided weekly over a 4-month period. The Program for Students (Friends School Social Emotional Learning Program) is implemented by classroom teachers in the classroom with 90 minute lessons and activities once a week for 14 weeks; Professional Learning is delivered to teachers in groups of 20-40 4 times a year over a two-year period. Professional Learning is delivered to leaders in groups of 20 - 40 three times a year over the same two-year period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Socio Economic Adversity; Child Development; Poverty; racial disparity; ethnic disparity
Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy
Condition: Intrapartum Transperineal Ultrasound
Study type: Interventional

Summary: 
      Investigators aimed to determine the progression of the descent angle and head symphysis
      distance measured by intrapartum transperineal ultrasound as an alternative to vaginal
      examination and bishop score, according to time and cervical dilatation and to draw a
      sonopartograph as a new indicator also aimed to evaluate the success of the use of
      transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration
      and mode of of delivery.
    

Detailed description: 
      Descent angle and head symphysis distances by transperineal ultrasound of pregnant women who
      are in the active phase of labor was measured hourly in the first phase of the active phase
      (the period from 4 cm to full dilation of the cervical opening); every 15 minutes in the
      second phase of the active phase (time from full dilation to delivery of the baby) Cervical
      dilatation and head levels were noted by simultaneous digital vaginal examination. The
      physician who performed the imaging and the physician who made the vajinal examination worked
      independently of each other and did not see each other's results.
    

Intervention name(s): transperineal ultrasound
Intervention type(s): Other
Intervention description(s): descent angle and head symphysis distances by transperineal ultrasound of active phase of labor women.
Intervention model: Single Group Assignment
Intervention model description: 30 nulliparous and 70 multiparous total 100 singleton pregnant women measured descent angle and head symphysis distances by transperineal ultrasound in the active phase of labor.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: head symphysis distance; angle of progression; sonopartograph; intrapartum transperineal ultrasound
A Study of Megestrol Acetate in HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections; Failure to Thrive
Study type: Interventional

Summary: 
      The purpose of this study is to see if megestrol acetate is safe and effective in treating
      HIV-infected children with failure to thrive (FTT).
    

Detailed description: 
      The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label
      drug offered after week 12.
    

Intervention name(s): Megestrol acetate
Intervention type(s): Drug
Intervention MeSH terms: Megestrol; Megestrol Acetate
Masking: Double
Primary purpose: Treatment
Keywords: Placebos; Appetite Stimulants; Megestrol Acetate; Failure to Thrive
Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients
Condition: Anemia; Intensive Care; Cardiac Surgery
MeSH terms: Anemia
Study type: Observational

Summary: 
      Anemia in intensive care and post-operative patients is due to both blood loss (leading to
      iron loss) and inflammation.
    

Detailed description: 
      Anemia in intensive care and post-operative patients is due to both blood loss (leading to
      iron loss) and inflammation. The latter is known to interfere with iron metabolism, inducing
      iron storage instead of using it for hemoglobin synthesis. The discover of a new regulatory
      hormone of iron metabolism, hepcidin, may help us to better understand the link between
      inflammation and iron functional deficit. The aim of our study is to observe the variation of
      usual iron metabolism biological markers and of hepcidin, in order to define the better
      marker of iron loss in these clinical situations.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  For the surgery :population 20 yers to 88 years old

          -  For the reanimation : population to the 41 years to 85 years old
      
Biospecimen description: 
      Blood serum
    
Keywords: anemia; intensive care; cardiac surgery; iron metabolism; hepcidin
Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique
Condition: Other Surgical Procedures
Study type: Interventional

Summary: 
      For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided
      distal subepineural block tested the hypothesis, that intraepineural injection of local
      anesthetic using nerve stimulation technique is common and associated with high success rate.
    

Detailed description: 
      Classical methods for nerve localization (loss of resistance, cause of paresthesias, nerve
      stimulation technique)assumed that the target is a close approximation to the nerve, without
      epineural perforation. Intraneural injections were considered as evitable, with high risk for
      nerve damages.

      Ultrasound guidance provided for the first time a real-time visualization of the spread of
      local anesthetic. Some recent studies proved, that an intraneural injection using nerve
      stimulator technique is common and not necessarily accompanied with nerve damages.

      In the ultrasound group (group US) the investigators tested the hypothesis, that an
      intraneural injection of local anesthetic generate a high success rate and a short onset time
      without clinical apparent nerve damages.

      In the nerve-stimulation group (group NS) the investigators tested the hypothesis, that an
      intraneural injection of local anesthetic is common, and in case of intraneural injection
      accompanied likewise with high success rate and shorter onset time.

      For the sciatic division the investigators tested the hypothesis, that classical methods of
      nerve localization (nerve-stimulation technique, cause of paresthesias) are not able to avoid
      epineural perforation.
    

Intervention name(s): midazolam; Prilocaine 1%; Ropivacaine 0.75%; Prilocaine 1%; ultrasound guidance; nerve stimulation technique
Intervention type(s): Drug; Drug; Drug; Drug; Device; Device
Intervention description(s): Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).; 20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients); 10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients); 10ml Prilocaine 1% for saphenous nerve block; In group US the sciatic nerve localization and needle guidance is realized using ultrasound.; In the group NS sciatic nerve localization and needle guidance is realized using nerve stimulation technique. However, ultrasound is used observing (Observer) the procedure, but blinded for the physician (Anesthetist) performing the block.
Other intervention name(s): Dormicum; Xylonest; Naropin; Xylonest
Intervention MeSH terms: Midazolam; Ropivacaine; Prilocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sciatic Nerve; Ultrasound; Anesthesia, Regional; Orthopedic Surgery
Safety and Performance Study of the CardioGard Cannula
Condition: Aortic Valve Replacement
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the study is to collect additional information related to the safety and
      performance of the CardioGard Cannula during bypass procedures.
    


Intervention name(s): Aortic Cannulas (CardioGard)
Intervention type(s): Device
Intervention description(s): Comparison of aortic cannulas during by pass surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bypass; cannula
Response Predictors of Theta-burst Stimulation for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The study consists of an open label trial designed to treat adult depression with TBS. Our
      aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging
      (MRI) assessments at baseline and after 7-10 days of treatment onset in 70 patients. The
      scientific goal is to test a hypothesis about treatment action: that TBS will reduce negative
      bias (which causally maintains negative mood) after 1 week of treatment, and patients who
      show this neurocognitive change will be the ones who go on to respond clinically after 6
      weeks.
    

Detailed description: 
      Depressive disorders are among the leading causes of incapacity and disability worldwide. The
      burden of depression is expected to increase and is associated with negative impact on
      clinical conditions and physical and cognitive abilities. Given the limited efficacy of
      antidepressant drugs, novel treatments such as theta-burst brain stimulation (TBS), a form of
      repetitive transcranial magnetic stimulation (rTMS), are being developed. However, to further
      advance the field towards treatment personalisation, increasing understanding of TBS
      antidepressant mechanisms and identifying treatment responders are important issues.
      Moreover, no studies have used neuroimaging in TBS trials in depression yet. Our group in
      Brazil is a leading brain stimulation centre, although neuroimaging expertise is lacking. We
      will conduct an open label trial designed to treat adult depression with TBS. Our aim is to
      build capacity in neuroimaging analyses by performing magnetic resonance imaging (MRI)
      assessments at baseline and after 7-10 days of treatment onset in 70 patients. The scientific
      goal is to test a hypothesis about treatment action: that TBS will reduce negative bias
      (which causally maintains negative mood) after 1 week of treatment, and patients who show
      this neurocognitive change will be the ones who go on to respond clinically after 6 weeks.
      Scientifically, this proposal and its outcomes will help advance towards next-generation
      precision brain stimulation, by incorporating cognitive/neuroimaging readouts that inform
      about mechanism and individual response.
    

Intervention name(s): Theta burst stimulation
Intervention type(s): Other
Intervention description(s): It consists of 20 sessions of iTBS over the dlPFC.
Other intervention name(s): TBS
Intervention model: Single Group Assignment
Intervention model description: Active TBS.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; TBS; fMRI; response predictors
Effect of Wound Infiltration by Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress
Condition: Abdominal Cancer
MeSH terms: Abdominal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to compare the effects of local wound infiltration with ketamine versus
      dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower
      abdominal cancer surgery.
    

Detailed description: 
      Patients will be randomly assigned using an online research randomizer into three groups, 30
      patients in each group:

      Group C:

      30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 %
      diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered
      on each side of incision( control group).

      Group K:

      30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 %
      diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20
      ml is administered on each side of incision.

      Group D:

      30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 %
      diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses
      i.e. 20 ml is administered on each side of incision.
    

Intervention name(s): Dexmedetomidine; Ketamine; Bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus dexmetedomidine in two divided doses i.e. 20 ml is administered on each side of incision; local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus ketamine in two divided doses i.e. 20 ml is administered on each side of incision; local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline only in two divided doses i.e. 20 ml is administered on each side of incision
Other intervention name(s): subcutaneous; subcutaneous; subcutaneous
Intervention MeSH terms: Dexmedetomidine; Ketamine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to
      to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan
      CR Tab. in healthy volunteers
    

Detailed description: 
      Eligibility for participation of this study will be determined from demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 4 weeks before study drug administration. Subjects suitable for this study will be
      admitted to the Clinical Trial Center of CHA Bundang Medical Center on the day before dosing
      (Day -1).

      From Day 1 to 5, Subjects will be dosed study drug (Pletaal SR Cap. 200 mg once a day or
      Cilostan CR Tab. 200mg once a day).

      Pharmacokinetic samplings will be done upto 24 hours after 1st study drug dosing and upto 72
      hours after 5th study drug dosing.

      After 9 days of washout period (Day 15), Subjects will be dosed study drug and
      pharmacokinetic samplings will be done by crossover manner.
    

Intervention name(s): Cilostan CR Tab.; Pletaal SR Cap.
Intervention type(s): Drug; Drug
Intervention description(s): Cilostan CR Tab. 200mg once a day for 5 days; Pletaal SR Cap. 200mg once a day for 5 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objectives of this study are to evaluate the efficacy, safety and tolerability of
      imsidolimab in adults with active GPP.
    


Intervention name(s): Imsidolimab
Intervention type(s): Biological
Intervention description(s): Humanized monoclonal antibody
Other intervention name(s): ANB019
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GPP
Elevated Triglyceride Levels and Later Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypertriglyceridemia
Study type: Observational

Summary: 
      Subjects with elevated serum triglycerides in the 4th Tromso study in 1994/1995 were
      re-examined with an oral glucose tolerance test to see predictive value of triglycerides
      regarding development of type 2 diabetes
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        participants in the 4 Tromsø study 1994 and with elevated serum triglyceride levels
      
Biospecimen description: 
      serum
    
Keywords: vitamin D; triglycerides; type 2 diabetes
NHANES 2003-2014 and Sugar-sweetened Beverages in Children
Condition: Sugar Sweetened Beverage Intakes in US Children
Study type: Observational

Summary: 
      The study uses data from the NHANES surveys to evaluate trends in SSB intakes among US
      children. The goal was to determine whether recent declines in intake may have been less
      marked in the more vulnerable groups with a persistently high burden of obesity, including
      race/ethnic minorities and low-income groups.
    

Detailed description: 
      Recent studies suggest sugar-sweetened beverage (SSB) consumption has been declining among US
      children 2-18y. However, most studies focus on changes in mean intake and little is known
      about trends in the high SSB consumers who are most at risk of excess weight gain. There is
      also limited understanding of whether and how these changes over time may have influenced
      disparities in intake among vulnerable groups of children with persistently high levels of
      obesity, including children from low-income households, and several race-/ethnic minorities.

      This analysis of six cycles of US National Health and Nutrition Examination Survey (NHANES)
      dietary surveillance data from 2003-2014 examined shifts over time in SSB intake at both the
      median and 90th percentile among US children. The study evaluated the extent to which
      disparities in intake of total SSBs, as well as major SSB subtypes (regular sodas, fruit
      drinks and other), may have persisted in vulnerable groups, for both median and "heavy"
      intake. The analysis presents data for three age groups: 2-5y, 6-11y and 12-18y by gender,
      and focus on three race-ethnic groups: Non-Hispanic White, Non-Hispanic Black, and
      Mexican-American. Household income is used as the primary socioeconomic status variable.
    

Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        17,579 children aged 2-18 years in US NHANES dietary surveys from 2003-2014 with household
        socioeconomic data