bioihbjkbjnl/mcl2 huggingface dataset:
Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies
Condition: Acute Lymphoblastic Leukemia; Acute Myelocytic Leukemia; Chronic Myelocytic Leukemia; Hodgkin's Disease; Myelodysplastic Syndrome
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms; Hodgkin Disease; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if participants who receive the GVHD prophylaxis
      medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The
      study is estimated to have sufficient statistical power to ascertain at least a 20%
      improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin
      recipients.
    

Detailed description: 
      Participants will be randomized to receive either methotrexate (MTX) or pentostatin for
      graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow
      transplant from an HLA-matched related or unrelated donor. All participants will receive a
      standard backbone GVHD prophylaxis regimen (tacrolimus and sirolimus) and conditioning
      (cyclophosphamide/TBI). A risk-adapted approach will be used during conditioning to further
      minimize the risk of leukemia relapse based on two factors:

        1. Lymphoid versus myeloid primary disease.

        2. KIR compatibility between donor and host.
    

Intervention name(s): Methotrexate; Pentostatin
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be randomized to receive either methotrexate (MTX) or pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor.; Participants will be randomized to receive either methotrexate (MTX) or pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor.
Intervention MeSH terms: Methotrexate; Pentostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic Bone Marrow Transplantation; Graft versus host disease; Tacrolimus; Sirolimus; Methotrexate; Pentostatin
Pilot Stair Climbing Study
Condition: Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      This pilot study seeks to demonstrate feasibility to conduct data collection and illustrate
      potential for effect of fractionalized bouts of stair climbing on glucose control in adults
      at risk for type 2 diabetes.
    

Detailed description: 
      Objective: Compare the short-term effects of two different fractionalized stair climbing bout
      protocols on glucose control among adults at risk for type 2 diabetes.

      Rationale: Fractionalized physical activity is associated with reduced BMI, glycated
      hemoglobin, lower 2-hr plasma glucose and insulin sensitivity in cross-sectional studies.
      Yet, few studies have examined the effects of fractionalized or intermittent physical
      activity in a prospective manner. Furthermore, the research is limited to patients with
      diagnosed type 2 diabetes, or using exercise of a moderate intensity.

      The hypothesis is that stair climbing, a vigorous-intensity activity, may have a greater
      health effect. However, this has not been tested in short bouts of activity that are spread
      out during a day.

      Implications: Fractionalized physical activity may be more feasible for adults at risk for,
      or with diagnosed type 2 diabetes who are not currently active. These short bouts can
      increase energy expenditure throughout the day, rather than in one long continuous bout as
      currently recommended.
    

Intervention name(s): Stair Climbing Frequency
Intervention type(s): Behavioral
Intervention description(s): Includes 1 sedentary day prior to completing crossover phases.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This is a single-center, randomized control trial The aim of this study is to compare PRP
      with placebo as the treatment of knee OA Conducted at Puri Raharja Hospital Bali in
      January-June 2022 Sample consisted of 106 patients with knee OA grades 2-3 Kellgren-Lawrence,
      randomized into PRP group and placebo group Samples were injected with 2 ml PRP or normal
      saline twice at one-week interval The severity of knee OA was assessed by Western Ontario and
      McMaster Universities Osteoarthritis Index (WOMAC) before injection and two weeks after the
      first injection.
    


Intervention name(s): PRP; Normal Saline
Intervention type(s): Procedure; Other
Intervention description(s): 2 ml of platelet rich plasma intraarticular injection twice in one week interval; NaCl 0.9%
Other intervention name(s): T_Biyoteknoloji LTD, Turkey; NaCl 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Rod Shape Changing After Scoliosis Correction Surgery
Condition: Scoliosis Idiopathic; Scoliosis, Severe
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The change of the fixation-rod after posterior srew-rod fixation segmentdesis is not widely
      known. The recent development of the 3D scanning technics and the opportunities of the EOS
      2D/3D system made us possible to have the exact rod shape immediately after implantation, and
      at each control examination. These progressions made us available to follow up the shape
      changing of the fixation-rod, hereby the changing of the correction.
    

Detailed description: 
      The adolescent idiopathic scoliosis can affect the 0,5-2% of the European population. One of
      the widely accepted treatment of severe scoliosis (Cobb angle is over 40-50°, or more than
      10° progression observed a year) is posterior correction segmentdesis with screw and rod
      instrumentation. As a scoliosis treatment center, about 90-110 scoliosis correction surgeries
      are performed in our department, using conventional preoperative planning, coronal and
      sagittal translation technique from posterolateral approach.

      An EOS 2D/3D system is available in our department making possible the scanning of the
      patient with upright biplanar ultra-low dose x-rays technique. The SterEOS software makes us
      possible to reconstruct the surface of the spine, pelvis and lower limb. The biplanar
      modality of the images makes possible to 3D reconstruct any simple shape using CAD
      (computer-aided design) softwares.

      The recent updates in the 3D scanning technology also made us possible to perform
      intraoperative scannings without harming the sterility.

      The aim of the study to define the change of the fixation-rod's shape after scoliosis
      correction surgery.

      Main hypothesis: there is significant change in the rod shape after implantation

      Secondary hypothesis 1: during the implant of the rod, it will loose from the prebent
      correction depending of the severity and rigidity of the curve.

      Secondary hypothesis 2: in the early stage of the rehabilitation, after the mobilization the
      shape of the rod (and the spinal parameters) can change Secondary hypothesis 3: after the 3.
      month postoperatively the shape of rod does not change anymore
    

Intervention name(s): 3D Scanning; EOS 2D/3D scanning
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): 3D scanning of the rod using Artec Eva Spider type manual 3D scanner; EOS Micro Dose imaging will be done on the third day after surgery, on the third, the sixth, the twelfth and twenty fourth month after surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: scoliosis; posterior segmentdesis; 3D scanning; EOS 2D/3D
A Challenge Study to Assess the Protective Efficacy of Two Malaria Vaccine Candidates
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to assess the safety and effectiveness of four new candidate malaria
      vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS & MVA ME-TRAP. These vaccines consist of viruses
      (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans
      and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP).
      The hope is that these vaccines will induce immune responses in vaccinees that are able to
      prevent malaria.

      This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria
      infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP.

      The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and
      Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in
      Southampton, UK. The malaria challenge will take place at the insectary at Imperial College
      (Infection and Immunity Section) in London, UK.
    


Intervention name(s): ChAd63-MVA CS; ChAd63-MVA ME-TRAP; Controlled Human Malaria Infection Administered by Mosquito Bite
Intervention type(s): Biological; Biological; Other
Intervention description(s): 1 dose of ChAd63 CS 5 x 10^10 vp intramuscularly and 1 dose MVA CS 2 x 10^8 pfu intramuscularly 8 weeks later.; 1 dose of ChAd63 ME-TRAP 5 x 10^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10^8 pfu intramuscularly 8 weeks later.; Approximately 3 weeks post MVA dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Malaria; Vaccine; Plasmodium; falciparum
Bioactive Glass in the Treatment of Enamel White Spot Lesions
Condition: White Spot Lesion of Tooth
MeSH terms: Exanthema
Study type: Interventional
Phase: Phase 3

Summary: 
      the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison
      to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel
      white spot lesions
    


Intervention name(s): BiominF; Novamin; CPP-ACP
Intervention type(s): Drug; Drug; Drug
Intervention description(s): in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached; in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached; applied in accordance with the manufacturer's specifications
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bioactive glass; CPP-ACP; Remineralization; White spot lesions
A Study Exploring Whooping Cough Protection in Children and Adults
Condition: Pertussis
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to investigate the effects of aP booster vaccination in children, young
      adults and elderly on the (long-term) immune response to B. pertussis in three European
      countries with a different epidemiological background and primary vaccination schedule for
      pertussis.
    

Detailed description: 
      The study will be performed in three European countries (UK, Finland and the Netherlands)
      with a different epidemiological background for pertussis incidence and different age groups
      will have had different primary schedules with whole cell pertussis (wP) or aP vaccines in
      their first year of life. Long-term memory responses will be analysed following aP booster
      vaccination including a detailed assessment of antigen-specific B and T cell responses,
      serology assays for pertussis antigens and the effect of booster vaccination on dynamic
      changes in immune cell subsets and gene transcription.

      There will be four cohorts of healthy volunteers:

      Cohort A - children aged between 7-10 years

      Cohort B - children aged between 11-15 years

      Cohort C - adults aged between 20 to 34 years

      Cohort D - adults aged between 60-70 years

      Participants will receive one injection of reduced diphtheria toxoid, tetanus toxoid and
      reduced acellular pertussis vaccine (dTap)-IPV, (Boostrix® IPV, GlaxoSmithKline (GSK))
      combination vaccine intramuscularly in the upper arm. Children (cohorts A and B) will be
      asked to donate blood four times at different time points, and young and older adults
      (cohorts C and D) will be asked to donate blood at set time points five times in total over
      the 12 months duration of the study. The time points will be:

        -  Timepoint 0 - day of vaccination

        -  Timepoint 1 - 1 day after T0 +/- 4 hours

        -  Timepoint 2 - 7 days after T0 +/- 1 day

        -  Timepoint 3 - 14 days after T0 +/- 4 days

        -  Timepoint 4 - 28 days after T0 +/- 4 days

        -  Timepoint 5 - 1 year after T0 +/- 4 weeks
    

Intervention name(s): Boostrix®-IPV combination vaccine
Intervention type(s): Biological
Intervention description(s): A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Changing Habits in Anorexia Nervosa: Novel Treatment Development
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      The investigators are examining what types of psychotherapy are most helpful for patients as
      they undergo weight restoration treatment for anorexia nervosa. In this study, patients who
      are receiving care on our inpatient unit will also receive 4 weeks of one two types of
      psychotherapy: Supportive Psychotherapy or Regulation Emotions and Changing Habits.
    

Detailed description: 
      Patients will be receiving specialized inpatient treatment for anorexia nervosa on the Eating
      Disorders Unit at the New York State Psychiatric Institute, where care is provided free of
      charge.

      Study procedures will begin after one week of acclimating to the inpatient unit. Patients
      will be randomly assigned to receive either Supportive Psychotherapy (focused on the
      transition to the inpatient unit) or REACH (focused on changing routines or habits that have
      become part of the eating disorder). Each treatment consists of 12-sessions, delivered 2-3
      times per week.

      Before and after treatment, patients will be asked to participate in interviews,
      questionnaires, and a lunch meal.
    

Intervention name(s): REACH; Supportive Psychotherapy; Inpatient Behavioral Treatment
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): REACH is a 12-session intervention, delivered 2-3 times per week for 45 minutes. The treatment focuses on identifying and changing behaviors and routines that have become entrenched and help perpetuate the illness.; The Supportive Psychotherapy is based on the Specialist Supportive Care (McIntosh et al, 2005), and modified for the current research procedures. Supportive Psychotherapy is a 12-session intervention, delivered 2-3 times per week as 45 minute sessions, focusing on symptoms of anorexia nervosa during the transition to the inpatient unit.; Inpatient treatment at the NYSPI is a behaviorally-based treatment program for anorexia nervosa. This is a non-research, clinical intervention for individuals with anorexia nervosa.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eating Disorders; Psychotherapy; Anorexia Nervosa; Treatment
Evaluating Violence Against Women Screening in Mexico
Condition: Domestic Violence
Study type: Interventional

Summary: 
      The overall goal of this proposed study is to develop the state of knowledge in the area of
      gender-based violence and reproductive health by conducting a randomized controlled trial to
      improve the health care provider's capacity to screen for intimate partner violence and to
      mitigate associated risk among women health clinic patrons of reproductive age (ages18-44)
      with recent experiences of physical or sexual partner violence in Mexico City and its
      surrounding area.

      The specific research objectives are as follows:

        1. To increase mid-level health care providers' capacity to identify Intimate Partner
           Violence (IPV) and assist women with risk mitigation

        2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health care
           worker screening and counselling program on (a) past year severe IPV (sexual or
           physical), including severe IPV; (b) reproductive coercion (c) use of community-based
           resources and safety planning; and (d) quality of life; versus minimum standard of care

        3. To qualitatively examine which programmatic components may serve as mechanisms for
           observed changes stated in the second objective

        4. To synthesize study findings and a) create recommendations for clinic-based intervention
           programs to address IPV in low and middle income countries and b) disseminate
           information as reports, presentation, and peer-reviewed publications
    


Intervention name(s): Integrated Screening
Intervention type(s): Behavioral
Intervention description(s): The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Global Vascular Effects of Intermittent Pneumatic Compression-Pilot Study
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      Intermittent pneumatic compression (IPC) of the lower extremities is a well-established
      technique for preventing deep vein thrombosis (DVT) and for treating venous stasis. IPC will
      be done in the home for 3 divided hours every day for 4 weeks. Lab tests, brachial ultrasound
      and MRI testing will be performed at baseline and after 4 weeks of daily IPC therapy.

      See detailed description for increase in healthy control subjects.
    

Detailed description: 
      Intermittent pneumatic compression (IPC) of the lower extremities is a well-established
      technique for preventing deep vein thrombosis (DVT) and for treating venous stasis.

      Four categories of discoveries suggest that there may be potential of IPC to have global
      vascular benefits:

        1. IPC of the arms prevents DVT in legs;

        2. Nitric oxide released by vascular endothelial cells exerts protective effects on blood
           vessels;

        3. IPC increases nitric oxide availability locally in the lower extremity;

        4. Nitric oxide may be transported in blood and released at distant sites, particularly in
           a hypoxic setting. Therefore, we propose to test the effects of lower extremity IPC on
           global nitric oxide availability.

      We will enroll 4 categories of subjects.

      The first 3 categories will have only 1 hour of leg compression. Baseline cholesterol will be
      drawn for screening labs Brachial ultrasound and NO measurements will be done before and
      after 1 hr of IPC. No MRI will be done on these groups.

      Category 4 will have baseline labs and testing to include:

      Brachial ultrasound,NO measurements and MRI will be done before and after 4 weeks of daily
      IPC therapy.

      Category 1, 21-40 yrs healthy male or female

      Category 2, 50 yrs plus healthy males or females

      Category 3, 50 yrs plus aged matched controls with known heart disease

      Category 4, 50 yrs plus12 patients with coronary artery disease.
    

Intervention name(s): Intermittent pneumatic compression of the lower extremities
Intervention type(s): Device
Intervention description(s): IPC will be done for 3 divided hours daily for 4 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: intermittent pneumatic leg compression; nitric oxide; vascular endothelial cells; IPC; EECP; atherosclerosis
A Study of JNJ-73763989 in Healthy Chinese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the single-dose Pharmacokinetics of JNJ-73763976 and
      JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in healthy
      Chinese adult participants at 2 different doses, Dose 1 (Panel A) or Dose 2 (Panel B).
    


Intervention name(s): JNJ-73763989
Intervention type(s): Drug
Intervention description(s): JNJ-73763989 will be administered (high or low dose) as single SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other