bioihbjkbjnl/mcl2 huggingface dataset:
Allogeneic Stem Cell Transplantation for Children With CML
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In children and adolescents with chronic myeloid leukaemia (CML) stem cell transplantation
      (SCT) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors
      (TKI). This trial aims to evaluate the use of a reduced intensity conditioning regimen (RIC),
      consisting of fludarabine, melphalan and thiotepa in order to minimize transplant related
      mortality and toxic late effects. Strict post-transplant monitoring and reintroduction of TKI
      as well as donor lymphocyte infusions (DLI) in case of relevant residual disease are part of
      the protocol.
    

Detailed description: 
      Chronic myeloid leukaemia (CML) is a rare disease in children with an incidence of 3-5% of
      all paediatric leukaemias. Since the introduction of tyrosinkinase inhibitors (TKI) stem cell
      transplantation (SCT) is no longer the first choice treatment for patients with early phase
      CML.

      However life-long treatment with TKI may not be feasable in several cases due to side effects
      such as growth retardation, non-compliance and resistance. This protocol evaluates the
      feasibility of SCT following a reduced intensity conditioning regimen (RIC) consisting of
      fludarabine, melphalan, thiotepa and thymoglobuline (ATG). Matched siblings and matched
      unrelated donors are permitted for stem cell donation. In case of unrelated donors tissue
      typing has to be done by high resolution molecular typing. Donors with 10/10 or 9/10
      identical allels in the human leukocyte antigen (HLA) system are accepted. Preferred stem
      cell source is bone marrow but peripheral blood stem cells and umbilical cord blood are also
      allowed. Graft-versus-Host-Disease (GvHD)-prophylaxis is achieved with cyclosporine A and
      mycophenolate mofetil.

      Monitoring of the breakpoint cluster region - Abelson (BCR/ABL) rearrangement is performed
      monthly in the first year after SCT. In case of BCR/ABL positivity TKI are given in the first
      year after SCT. Followed by donor lymphocyte infusions (DLI) later on if BCR/ABL positivity
      persists.
    

Intervention name(s): Fludarabine; Thiotepa; Melphalan; ATG; Cyclosporine A; Mycophenolate mofetil; bone marrow or peripheral blood stem cells
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Biological
Intervention description(s): infusion; infusion; infusion; infusion; infusion, orally if possible; infusion; infusion
Other intervention name(s): Fludara; Thioplex; TESPA; Alkeran; Thymoglobulin; Sandimmune; CellCept
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Fludarabine; Melphalan; Thiotepa; Cyclosporins; Thymoglobulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stem cell transplantation; pediatrics
An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Versus the Combined Use of Forxiga™, 10 mg and Two Glucophage® Long, ER Tablets, 500 mg Co-administered to Healthy Volunteers Under Standard Fed Conditions
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to demonstrate bioequivalence of fixed dose combination
      Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg,
      (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg (Bristol
      Myers Squibb Company, USA) and Glucophage® long (Metformin), ER tablets, 1000 mg (2 x 500 mg)
      (Merck Santé S.A.S., France) which are already registered in the Russian Federation.
    

Detailed description: 
      Randomised open-label crossover comparative, single center, two periods, clinical study of
      investigational drug and reference drugs bioequivalence evaluation with a single
      administration of the study drug (1 modified - release film-coated tablets of Dapagliflozin +
      Metformin or 1 film-coated tablets of Forxiga™ + 2 tablets ER of Glucophage® long) under fed
      condition in healthy volunteers.
    

Intervention name(s): Xigduo XR; Metformin ER (Glucophage® long); Dapagliflozin (Forxiga)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release; co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).; co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Xigduo;; bioequivalence;; crossover;; Russia
HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life Assessed by MRI Scanning
Condition: Renal Failure; Cardiovascular Diseases; Congenital Disorders
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to characterise in detail cardiac, cerebral and renal structure,
      function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.
      The effects of a standard prescription haemodialysis (dialysate temperature 37 C) will be
      compared to a thermocontrolled (or isothermic) haemodialysis prescription to ascertain if
      thermocontrolled HD provides a protective effect on organ perfusion and circulatory stress
      when compared to conventional haemodialysis. The BTM (blood temperature monitor, Fresenius)
      offers a way to overcome this to regulate thermal balance during dialysis and achieve a
      neutral thermal balance (isothermic) over the dialysis session. Other dialysis parameters
      will be standardised between treatment arms using blood volume monitoring (BVM) and clinical
      assessments.
    

Detailed description: 
      The purpose of this study is to characterise in detail cardiac, cerebral and renal structure,
      function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.
      The Primary objectives are to investigate the difference in cardiac perfusion, structure and
      function between standard HD and thermocontrolled HD using magnetic imaging techniques, to
      observe the the changes in renal perfusion and oxygenation within one dialysis session and
      the changes to cerebral perfusion within one dialysis session.

      The secondary objectives are to investigate the difference in cerebral perfusion, structure,
      oedema and function between standard HD and thermocontrolled HD, the difference in renal
      perfusion and oxygenation between standard HD and thermocontrolled HD and the differences in
      visual acuity and cognitive assessment across a dialysis session and over a dialysis
      treatment course.
    

Intervention name(s): HD, Magnetic Resonance Imaging (MRI) scans
Intervention type(s): Other
Intervention description(s): HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: monocentric, block randomized, open, crossover study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal replacement therapy; haemodialysis; haemodiafiltration
Interaction of Alcohol With Energy Drinks
Condition: Alcohol-Related Disorders; Drinking and Driving
MeSH terms: Alcohol-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the project is to assess whether there is an interaction between the
      effects of ethanol and energy drinks on driving performance.

      Secondary objectives include: to evaluate subjective effects (drunkenness) after
      administration of alcohol and energy drinks, to assess pharmacokinetics of alcohol, caffeine
      and taurine after alcohol and energy drinks administration and to assess if there is an
      increased risk of bleeding when both drinks are taken together.
    

Detailed description: 
      Consumption of energy drinks improve psychomotor performance and alertness. These drinks
      contain mostly caffeine, taurine and vitamins. Its consumption associated with ethanol may
      reduce feelings of drunkenness as the stimulant effects of caffeine could counteract the
      depressing effects of ethanol on the central nervous system. Reducing the perception of
      intoxication may predispose the intoxicated person to engage in risky behaviors such as
      driving under the influence of ethanol and therefore can increase the risk of a traffic
      accident. Furthermore, the combination of both beverages may increase the risk of bleeding in
      case of injury as anticoagulant effects have been described for ethanol while antiplatelet
      effects have been described for caffeine and taurine. A randomized clinical trial will be
      performed in healthy volunteers administering 4 treatment conditions: alcohol+energy drink,
      alcohol+placebo of energy drink, placebo of alcohol+energy drink and placebo of
      alcohol+placebo of energy drink. A multiple dose will be administered separated by 1 hour.
    

Intervention name(s): Alcohol and energy drink; Alcohol; Energy drink; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Multiple oral dose of alcohol Multiple oral dose of energy drink; Multiple oral dose of alcohol; Multiple oral dose of energy drink; Multiple oral dose of water Multiple oral dose of non-caffeinated soft drink
Other intervention name(s): Non-active treatment
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: alcohol; energy drink; coagulability; caffeine; taurine; driving performance
Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes is
      focused on the evaluation of an original control algorithm that computes appropriate
      subcutaneous insulin infusion in response to continuous glucose measurements The results
      during a 24-hour closed-loop period will be compared with those of the open-loop. The
      implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a preliminary
      a phase of identification of the parameters of the model (insulin pharmacokinetics and effect
      on glucose metabolism) followed by a phase of optimization i.e. a personalized adjustment of
      the damping parameters of EDS.

      The present study aims to formalize this procedure of identification/optimization of the
      parameters of the model and controller EDS. They will be determined in type -1 diabetic
      patients using insulin therapy and under conditions free from disturbances such as those
      generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will
      determine this procedure: blood glucose, insulin concentration and insulin doses.
    


Intervention name(s): Blood samples
Intervention type(s): Other
Intervention description(s): The study will be proposed to four patients hospitalized in the Diabetes Unit for a glucidic fast test carried out during 24 hours (lunch, dinner and breakfast). Blood samples will be taken every 20 minutes during 6 hours and 40 minutes to measure plasma insulin concentration and blood glucose. T0 will correspond to the first modification of the insulin basal flow (in more or less) or to the first insulin bolus corrector, usually administered if capillary blood glucose reaches 1.8 g/l. The capillary blood glucose monitoring will be performed every two hours by the nurse.
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Effects of Resistance Training and Protein Supplementation in Healthy Elderly Men and Women.
Condition: Muscle Loss in Elderly
Study type: Interventional

Summary: 
      The main objective of this study is to examine the effects of resistance type exercise
      training combined with nutritional support on body composition and muscle characteristics in
      healthy elderly men and women. For a comprehensive insight into the potential underlying
      mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad
      range of tests will be performed before, during, and after the intervention period.
    


Intervention name(s): Protein drink; placebo drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): total of 15 g protein/d in a protein drink consumed every morning after breakfast during 24 weeks; subjects consume a placebo drink every morning after breakfast over a period of 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: elderly; sarcopenia; protein drink; resistance training
Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects with depressive episodes will be recruited to undergo a brief 2 week course of IV
      infusions of ketamine in combination with cognitive behavioral therapy for 8 weeks.
    

Detailed description: 
      Twelve subjects with current diagnosis of depressive episode will be recruited to undergo a
      brief course of 4 intravenous infusions of ketamine, given twice weekly for two weeks in
      combination with CBT, given twice weekly. The CBT course will be 16 total sessions (given
      over 8 weeks), will begin the day following the initial ketamine infusion, and will be
      performed by a therapist who has successfully completed extensive training at the Beck
      Institute for Cognitive Therapy and Research and has experience with similar studies.
      Homework assignments will include thought records and activity charts which are used in
      standard practice to facilitate CBT interventions.
    

Intervention name(s): Ketamine; Cognitive Behavioral Therapy (CBT)
Intervention type(s): Drug; Behavioral
Intervention description(s): Subjects will undergo a twice weekly two week course of IV infusions of ketamine; Subjects will undergo twice weekly CBT for a total of 8 weeks
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using MOVE! With Seriously Mentally Ill Veterans
Condition: Mental Illness; Obesity
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      This study involves a controlled trial of an optimized version of a weight management and
      physical activity psycho-educational intervention (called MOVE!) with 200 obese and
      overweight veterans with serious mental illness.
    

Detailed description: 
      This study involves a controlled trial of an optimized version of a weight management and
      physical activity psycho-educational intervention (called MOVE!) for overweight and obese
      Veterans with serious mental illness. The study hypothesizes that MOVE! will result in weight
      loss and improved indicators of cardiovascular risk when compared to usual care. Medical
      outcomes are proportion achieving 4% or higher weight loss, mean weight loss, and reductions
      in cardiovascular risk (blood pressure, glucose and serum lipids). Psychosocial outcomes are
      general health, psychiatric functioning, quality of life, and self-esteem and medication
      adherence. Mediators include physical activity, dietary management, self-efficacy, and
      motivation/readiness to change. The intervention involves a well specified combination of
      individualized and group based services and draws on evidence based techniques and materials
      that are currently well packaged in an existing VA program called MOVE! The Comparison
      condition is operationalized as usual treatment plus monthly weight measurements and
      distribution of educational brochures regarding diet and exercise.
    

Intervention name(s): MOVE!
Intervention type(s): Behavioral
Intervention description(s): group based psychoeducation, motivation and support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Behavioral interventions; Mental Illness; Obesity; Psycho-educational interventions; Weight management
Physiotherapy Treatment Plan in Allergic Bronchopulmonary Aspergillosis: Case Report
Condition: Obstructive Pulmonary Disease
MeSH terms: Aspergillosis; Pulmonary Aspergillosis; Aspergillosis, Allergic Bronchopulmonary; Lung Diseases; Lung Diseases, Obstructive
Study type: Observational [Patient Registry]

Summary: 
      A spirometry study is performed in a patient diagnosed with allergic bronchopulmonary
      aspergillosis. An initial measurement is carried out and the patient is then put on a
      four-week physiotherapy treatment plan. Four spirometry measurements were taken to assess
      different variables and an improvement in all the spirometry values was established.
    


Intervention name(s): spirometer
Intervention type(s): Diagnostic Test
Intervention description(s): different values are measured on the spirometer after training in respiratory physiotherapy.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patient with respiratory insufficiency due to allergic bronchopulmonary aspergillosis
      
Keywords: Obstructive Pulmonary Disease; Physiotherapy
MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma
Condition: Diffuse Intrinsic Pontine Glioma
MeSH terms: Glioma; Diffuse Intrinsic Pontine Glioma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase I/II trial studies the side effects of panobinostat nanoparticle formulation
      MTX110 (MTX110) in treating participants with newly-diagnosed diffuse intrinsic pontine
      glioma. Panobinostat nanoparticle formulation MTX110 may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the safety and tolerability of repeated administration of MTX110 co-infused
      with gadoteridol given by intratumoral convection enhanced delivery in children with newly
      diagnosed diffuse intrinsic pontine glioma (DIPG).

      SECONDARY OBJECTIVES:

      I. To determine the clinical efficacy of repeated administration of MTX110 given by
      intratumoral convection-enhanced delivery (CED) in children with newly diagnosed DIPG in the
      confines of a phase I and early efficacy study.

      OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

      Participants receive panobinostat nanoparticle formulation MTX110 intratumorally (IT) by CED
      infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks
      for up to 24 months in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment participants are followed up at 30 days and then every 2
      months.
    

Intervention name(s): Panobinostat Nanoparticle Formulation MTX110; Convection-Enhanced Delivery (CED)
Intervention type(s): Drug; Drug
Intervention description(s): Given IT; Undergo CED
Other intervention name(s): MTX-110; MTX110 (CN); CED
Intervention MeSH terms: Panobinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of Proteoglycan Depletion in Femoroacetabular Impingement With T1ρ Magnetic Resonance Imaging (MRI)
Condition: Femoroacetabular Impingement; Cartilage, Articular; Hip Joint; MRI
MeSH terms: Femoracetabular Impingement
Study type: Interventional

Summary: 
      Magnetic resonance imaging (MRI) has proven to be one of the best ways to image articular
      cartilage. A tremendous amount of research has focused on cartilage imaging with an emphasis
      of early-osteoarthritis (OA) characterization. One of the techniques which has shown great
      promise is the imaging technique called T1ρ . The advantage of this pulse sequence is that it
      is sensitive to proteoglycans (PG), a major macromolecule degraded in OA. The study objective
      is to determine if T1ρ can acutely assess PG content in femoroacetabular impingement (FAI)
      which may allow physicians to differentiate between normal and early-OA cartilage states in
      FAI patients.
    

Detailed description: 
      Magnetic resonance imaging (MRI) is one of the best ways to image articular cartilage. One of
      the techniques which has shown great promise is the imaging technique called T1ρ (T1-rho).
      T1ρ is a modified pulse sequence from the standard T1 sequence used in the clinical MRI.
      Because the initial phases of arthritis occur at the molecular level, the main advantage of
      the T1ρ pulse sequence is that it is sensitive to proteoglycan. Proteoglycan is a molecule
      that is important to cartilage structure, and is lost as osteoarthritis develops. If we can
      show that this non-invasive tool can accurately assess cartilage damage and levels of
      proteoglycan, the clinical applications are numerous. The results can potentially help
      determine optimal surgical techniques and timing of surgical intervention to halt or slow the
      progression of arthritis, and will assist in the study of the effects of FAI and the success
      of the surgery performed to correct FAI.
    

Intervention name(s): Magnetic Resonance Imaging (MRI)
Intervention type(s): Diagnostic Test
Intervention description(s): T1 rho MRI is a modified pulse sequence from the standard T1 sequence used in the clinical MRI.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other