bioihbjkbjnl/mcl2 huggingface dataset:
Rituximab in Patients With Acute ST-elevation Myocardial Infarction Study
Condition: Ischemic Heart Disease; Myocardial Infarction; Inflammation
MeSH terms: Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; ST Elevation Myocardial Infarction; Inflammation; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RITA-MI aims to develop of a novel therapeutic concept to target the immune response in
      patients with acute myocardial infarction (MI) by depleting B-cells with a single injection
      of Rituximab which is approved for clinical use in cancer, autoimmune disease and
      inflammatory conditions. The goal is to re-purpose the drug, and translate the discovery into
      benefit for patients at high risk of cardiovascular events. Rituximab is expected to limit
      infarction size and improve the healing process, as complementary to other therapeutic
      strategies.

      The applicants intend to perform a clinical study in patients with acute myocardial
      infarction (MI). The objective is to find the optimal dose (lowest dose with highest
      biological efficacy and best safety profile) for peripheral blood B cell depletion during the
      first 6 days after injection, and selective molecular signatures associated with improved
      heart function through analysis of peripheral blood samples.

      The study rationale is to decrease the inflammatory reaction upon tissue necrosis following
      heart muscle ischemia.
    


Intervention name(s): RiTUXimab Injection
Intervention type(s): Drug
Intervention description(s): Single dose of Rituximab given intravenously within 48hours of myocardial infarction
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Intervention model description: Phase 1/2 unblinded interventional dose escalation study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituximab; B cells
Trial of PCIT-ED in School for Preschoolers in Poverty
Condition: Childhood Mental Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      A shorted form of the previously tested, Parent Child Interaction Therapy Emotion Development
      (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of behavioral
      problems as rated by teacher. Children aged 3-7 will be randomized to a 12-week PCIT-ED
      delivered by trained therapists in the school setting or an on-line parent training called
      "Parenting Wisely (PW)". Children will have a 60% chance of being randomized to PCIT-ED and
      40% to PW. The treatment will be provided to eligible children in the Jennings School
      District at the school site. In order to test the efficacy of PCIT-ED, to estimate accurate
      effect sizes, and to investigate mediators and moderators of treatment response, participants
      will complete comprehensive pre- and post-assessments at Washington University School of
      Medicine Early Emotional Development Program.

      Preschoolers over age 3 will be offered the option of enrolling in an add-on
      electroencephalography and magnetic resonance imagery study, to investigate neural changes
      associated with PCIT-ED or PW.

      Compared to those randomized to PW, we expect preschoolers who undergo PCIT-ED will show
      significantly increased rates of remission of behavioral problems, greater reductions in
      symptoms, and decreases in impairment. We hypothesize that they will show significantly
      greater increases in emotional competence measured by the ability to accurately identify
      emotions in themselves and others and the ability to effectively regulate intense emotions.
      Compared to those on the PW, parents who undergo PCIT-ED will show significantly greater
      increases in emotion skill learning and reductions in MDD symptoms and parenting stress.
    


Intervention name(s): PCIT-ED; Parenting Wisely
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 sessions of PCIT-ED therapy; Teaches parents how to set more effective limits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preschool; Parent-Child Relationship; Emotion Development; Therapy
Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance
Condition: Insulin Resistance; Deteriorated Glucose Homeostasis; Inactivity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The incretin effect in patients with type two diabetes is reduced. The investigators have
      previously shown that it is possible to induce a defect in the incretin effect in healthy
      individuals. The purpose of this study is to evaluate the insulinotropic affect of the
      incretin hormones in healthy individuals before and after a deterioration of the glucose
      homeostasis.
    

Detailed description: 
      The incretin effect in patients with type two diabetes is reduced. The investigators have
      previously shown that it is possible to induce a defect in the incretin effect in healthy
      individuals. The purpose of this study is to evaluate the insulinotropic affect of the
      incretin hormones in healthy individuals before and after a deterioration of the glucose
      homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic
      clamps.
    

Intervention name(s): Steroid hormone; No intervention
Intervention type(s): Behavioral; Other
Intervention description(s): Steroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day
Other intervention name(s): Prednisolone
Intervention MeSH terms: Prednisolone; Hormones
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Incretin hormones; Glucagon; Insulin/c-peptide; Plasma glucose; Insulin resistance; Deteriorated glucose homeostasis; Inactivity
CoROnary SinuS Reducer implantatiOn for ischemiA reDuction
Condition: Refractory Angina Pectoris
MeSH terms: Angina Pectoris; Ischemia
Study type: Interventional

Summary: 
      Patients with refractory angina pectoris have low quality of life and reduced exertional
      capacity. Studies have shown that the coronary sinus reducer (CSR) implantation improves the
      quality of life. However, to date there are no firm objective data on improvement of
      exertional capacity. Studies have shown a large influence of placebo effect after
      interventional procedures, which is even more pronounced than in medically treated patients.
      As angina pectoris presents entirely subjective perception of chest discomfort, its
      improvement may be influenced by this effect in up to 30 %. The investigators will study
      weather the CSR implantation improves aerobic exertional capacity in comparison to optimal
      medical therapy alone. Further, the investigators will explore the extent of myocardial
      reversible ischemia reduction and possible influence on hrECG markers of left ventricular
      arrhythmogenicity. 40 patients with refractory angina CCS class (Canadian cardiovascular
      society) II-IV and confirmed reversible ischemia will be included. Patients will be
      randomized into two groups. The first group will undergo CSR implantation procedure. The
      second group will present a sham control group with placebo procedure. At inclusion and after
      6 months the investigators will perform cardiopulmonary exercise test (CPET), single photon
      emission tomography for detection of reversible ischemia (SPECT), high resolution ECG
      (hrECG), echocardiography and asses the subjective burden of angina according to CCS score
      and the quality of life according to the Seattle angina Questionnaire (SAQ).
    


Intervention name(s): Coronary Sinus Reducer device; Sham procedure
Intervention type(s): Device; Other
Intervention description(s): Coronary sinus reducer device (Neovasc, Richomnd, Canada) implantation in the coronary sinus. The procedure is performed in the cardiac catheterization laboratory through right internal jugular vein.; Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: angina pectoris; coronary sinus reducer; quality of life; reversible ischemia; exercise testing; oxygen consumption
Glycemic Response to Different Food Combinations
Condition: Postprandial Glycemia
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of combining starch rich foods with low pH
      foods on the glycemic response to meals
    

Detailed description: 
      Low pH foods can attenuate the glycemic response to starch-rich foods. It has been
      demonstrated that lemon juice, due to its low pH (pH≈2.3) inhibited key digestive enzymes
      thereby interrupting gastric digestion of starch in vitro. This effect can significantly
      reduce the glycemic response in humans. In particular, adding lemon juice to a starch rich
      meal reduced the mean blood glucose concentration peak by 30%.

      Considering the panoply of food options available, it is likely that other combinations have
      similar effects but no work has been conducted to develop a consolidated knowledge base to
      exploit this strategy. GlucoMatchMaker will go beyond the state-of-the art by addressing this
      knowledge gap. The main goal is to develop and test the real-life impact of pH-based food
      combination strategies on glycemic responses.
    

Intervention name(s): Test meals and food baskets
Intervention type(s): Other
Intervention description(s): Interventional dietary study using standardized test meals and personalized food baskets to investigate the impact of food combination on the glycemic response. The study period is organized as follows:
(Day 1: Continuous blood glucose monitoring system (CGM) activation) Days 2 and 3: Two standardized daily menus (breakfast, lunch, afternoon snack and dinner) provided on a randomized crossover basis.
Days 4 to 7: four standardized test meals, participants will be asked to substitute one meal each day (lunch or dinner) for a test meal according to a pre-defined randomization plan.
Days 8 to 10: Participants will be asked to prepare all meals using a food basket containing a mix of standardized and personal preference items.
Days 11 to 13: Participants will be asked to prepare all meals using a food basket containing a mix of standardized and personal preference items and following dietary recommendations developed by the study staff.
(Day 14: CGM sensor removed)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Digestion; Starch; Glycemic Index
The Effect of Calisthenic Exercise on Aerobic Capacity, Muscle Strength and Quality of Life in Hemodialysis Patients
Condition: Physical Activity; Patient; Quality of Life; Hemodialysis
Study type: Interventional

Summary: 
      The aimed this study is to examine the effects of calisthenic exercises on aerobic
      capacities, muscle strength and quality of life in patients receiving hemodialysis treatment.
    

Detailed description: 
      The study is a randomized single-blind placebo-controlled study. . At the beginning and end
      of the study, all patients will be asked to answer questions including demographic
      information and a quality of life questionnaire for kidney patients. A 6-minute walking test
      and a 30-second sit-stand test will be applied by the research physiotherapist to measure
      their aerobic capacity. Again, a dynamometer will be used to measure muscle strength.

      The hypotheses the investigators will test for this purpors; H0 Calisthenic exercise in
      hemodialysis patients increases aerobic capacity. H1Calisthenic exercise in hemodialysis
      patients increases muscle strength.H2 Calisthenic exercise in hemodialysis patients improves
      the quality of life.
    

Intervention name(s): Calisthenic exercise
Intervention type(s): Other
Intervention description(s): Exercises involving major muscle groups will be given. Before starting the calisthenic exercises, they will be asked to perform 10 repetitive warm-ups and breathing exercises. The intensity of the calisthenic exercises will be adjusted on a weekly basis.
Calisthenic exercises are repeated 10-15 times in the first and second weeks; third and fourth weeks 15-20 repetitive; In the five, six, seven and eight weeks, it will be done with 25-30 repetitions.
Patients will be asked to keep an exercise diary and weekly follow-ups will be made over the phone.
Within eight weeks, each patient will come for control twice a month and will be asked to perform the exercises individually under the supervision of a physiotherapist. Patients will be asked to do the exercises three times a week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Exercise; Hemodialysis; Quality of life
Efficacy of Pea Hull Fiber - Phase 2
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber
      on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota
      composition and activity.
    

Detailed description: 
      An 8-week randomized, cross-over study will be carried out to assess the efficacy of pea hull
      fiber. Participants will complete a 2-week baseline period during which appetite, stool
      frequency, and stool consistency (transit time) will be collected by an online questionnaire,
      and participants will collect a single stool. Dietary data (Automated Self-Administered
      24-Hour diet recall) will be obtained at baseline and at each study visit. Participants will
      be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week
      control period, and snacks with added pea hull fiber for a 2-week treatment period separated
      by a 2-week washout period. In both intervention periods, participants will complete daily
      questionnaires to assess stool frequency and consistency (transit time). An online
      questionnaire assessing appetite will be administered once per week. The GSRS will be
      competed at each study visit. During washout periods, the same data will be collected as will
      be done during the baseline and intervention periods. Participants will be asked to collect
      one stool during baseline and during weeks 4, 6, and 8 for a total of 4 stools. Stool samples
      will be analyzed for changes in the microbiota.
    

Intervention name(s): Pea Fiber; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls; Baked goods (2 snacks) without added fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Growth and Safety Clinical Trial on a New Infant Formula.
Condition: Healthy Growth
Study type: Interventional

Summary: 
      The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic
      milk-based infant formula.
    

Detailed description: 
      A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate
      growth and tolerance of healthy infants fed milk-based infant formula. The study has been
      designed in accordance with Good Clinical Practice guidelines and the requirements of the
      Code of Federal Regulations 21 CFR 106.96
    

Intervention name(s): Control Infant Formula; Organic Infant Formula
Intervention type(s): Other; Other
Intervention description(s): Powder, standard commercial infant formula.; Powder, organic milk-based infant formula.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A controlled, decentralized, double-blind trial of healthy, term, formula-fed infants randomized to one of two infant formulas:
Control Formula (a standard, commercially available infant formula) or Investigational Formula for 16 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: infant formula; cow milk; growth
A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical trial in which healthy volunteers will be administered one or two
      experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA
      Pfs25-IMX313 in a prime-boost regime.

      All vaccines will be administered intramuscularly.

      Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^9 vp.

      Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp.

      Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10^10 vp and one dose of MVA
      Pfs25-IMX313 at 1x10^8 pfu eight weeks later.

      Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10^10 vp and one dose of MVA
      Pfs25-IMX313 at 2x10^8 pfu eight weeks later.

      The study will assess the safety of the vaccinations, and the immune responses to the
      vaccination. Immune responses are measured by tests on blood samples.

      Healthy volunteers will be recruited in Oxford and Southampton, England.
    


Intervention name(s): ChAd63 Pfs25-IMX313; MVA Pfs25-IMX313
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Vaccine; Immune Response
Strategies for Teaching Verbs
Condition: Language Development Disorders; Down Syndrome; Child Language
MeSH terms: Down Syndrome; Language Development Disorders
Study type: Interventional

Summary: 
      This study is designed to evaluate whether children with Down syndrome and children with
      typical development exhibit different levels of accuracy demonstrating novel verbs taught
      under three conditions: semantic cues (perform action), syntactic cues (sentence frame), and
      combined (syntactic and semantic cues). The participants complete an eligibility evaluation
      and then one verb learning session (approximately 60 minutes in length). During that verb
      learning session they are taught sets of words under each condition (i.e., within-subjects
      design) and then asked to identify and label those target words immediately after
      instruction.
    


Intervention name(s): Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues
Intervention type(s): Behavioral
Intervention description(s): Verb Learning Session Teaching phase. The examiner labels each target word and performs the action 6 times in each condition. She elicits the target word from the participant 2 times per word per condition and provides feedback on accuracy.
Testing phase. Receptive probes are administered after every 2 words are taught. Expressive probes are at the end of the condition. For receptive probes, the examiner asks the participant to identify novel verbs and for expressive probes, the examiner asks the child to label the novel action. Testing after 2 items is designed to decrease memory load. Participants have a brief break between conditions.
Data are collected on: a) child responses on standardized assessments, (b) responses to verb learning probes, (c) parent responses to intake form, and (d) relevant medical history from electronic medical record.
None of the above procedures present more than minimal risk to participants or research staff. Vanderbilt IRB approved all procedures.
Intervention model: Single Group Assignment
Intervention model description: All participants complete the three intervention conditions within a single session. Order of conditions is counterbalanced across participants.
Masking: None (Open Label)
Primary purpose: Treatment
Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe Hemophilia
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Observational

Summary: 
      Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe
      hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia
      B (coagulation factor IX [FIX] ≤2%).
    


Intervention name(s): Non-treatment, seroprevalence
Intervention type(s): Other
Intervention description(s): Non-treatment study examining the prevalence of preexisting immunity to adeno-associated virus (AAV)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hemophilia A and hemophilia B patients who receive treatment at Hemophilia Treatment
        Centers.
The Effects of Self-Moxibustion Therapy on Subjective Physical Symptoms and Health-related Quality of Life of the Elderly. The Effects of Self-Moxibustion Therapy
Condition: Health Improvement of the Elderly
Study type: Interventional

Summary: 
      There will be significant differences between control and experimental group after the
      moxibustion intervention as to, subjective physical symptoms and quality of life.
    


Intervention name(s): moxibustion
Intervention type(s): Other
Intervention description(s): modernly developed moxibustion treatment device with safe cover on top of it.
Other intervention name(s): Shinkigoo (신기구); company: bosungsa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Conventional With Sonography Assisted Breast Surgery
Condition: Breast Cancer Surgery
Study type: Interventional

Summary: 
      Aim of the study is to test whether surgical removal of a tumor under sonographic control as
      compared to conventional method reduces the rate of resections and local relapse
    


Intervention name(s): Sonography assisted breast surgery
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment