bioihbjkbjnl/mcl2 huggingface dataset:
Transfusion Reaction by Washed Red Blood Cell (RBC)
Condition: Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The hypothesis is that transfusion of washed red blood cell can decrease the complication by
      transfusion.
    


Intervention name(s): Washing of packed RBC by normal saline
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
An Intervention Study to Increase Physical Activity and Maternal Well-being During Pregnancy
Condition: Pregnancy; Depression
MeSH terms: Depression
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To refine, implement and evaluate a motivationally-tailored exercise intervention for
      increasing physical activity and mental health during pregnancy and the postpartum.
    

Detailed description: 
      Pregnancy appears to pose a further barrier to exercise, as women remain inactive or cease to
      exercise all together. Yet, regular physical activity during pregnancy in healthy women has
      been shown to be safe and positively associated with physical and psychological health
      benefits. To date interventions to promote physical activity have not targeted pregnant
      women. We are proposing to pilot the first study to evaluate a theory-derived intervention
      designed to promote physical activity during pregnancy. We anticipate that pregnant women
      assigned to the motivationally-tailored exercise intervention will show a significant
      increase in physical activity from baseline at the post-treatment follow-up (32 weeks
      gestation). We expect that the motivationally-tailored intervention will positively influence
      physical and mental health status during pregnancy.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Tailored exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy, Exercise, Depression
Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases
Condition: Primary Immune Deficiency Disorder
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      CLINICAL PHASE 3 STUDY TO MONITOR THE SAFETY, TOLERABILITY, AND EFFICACY OF SUBCUTANEOUS
      HUMAN IMMUNOGLOBULIN (CUTAQUIG®) ADMINISTERED AT MODIFIED DOSING REGIMENS IN PATIENTS WITH
      PRIMARY IMMUNODEFICIENCY DISEASES
    


Intervention name(s): CUTAQUIG
Intervention type(s): Drug
Intervention description(s): Human normal immunoglobulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized phase III trial is studying how well music therapy works compared to
      listening and discussing books on tape in improving quality of life in young patients
      undergoing stem cell transplant. Music therapy or book discussion may improve quality of life
      in patients undergoing stem cell transplant. It is not yet known whether music therapy is
      more effective than book discussion in improving quality of life in patients undergoing stem
      cell transplant.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Test the efficacy, in terms of resilience and quality of life, of a therapeutic music
      video (TMV) intervention vs listening and discussing books on tape (control group) for
      adolescents and young adults (AYA) undergoing autologous or allogeneic transplantation for
      cancer.

      II. Qualitatively describe the perception of helpfulness and meaningfulness of a sub-group of
      both interventions for AYA and family members 100 days post-transplant.

      OUTLINE: This is a randomized, controlled, limited multicenter study. Patients are randomized
      to 1 of 2 arms.

      ARM I (books on tape [control group]): Patients undergo six 1-hour sessions twice a week for
      3 weeks with a trained counselor in which they choose up to 3 books on CD and listen to the
      book and/or discuss their impressions and thoughts about the contents with the counselor.
      Patients are provided with a portable CD player to listen to the books during their
      hospitalization.

      ARM II (therapeutic music video [TMV] intervention): Patients undergo six 1-hour sessions
      twice a week for 3 weeks with a music therapist, designed specifically for the pre-transplant
      and acute phase of treatment. Phases of patient participation include song writing, recording
      the song with a digital accompaniment track, completing a video layout worksheet, taking
      photos or making drawings for the video, viewing clip art and pictures on a computer, and
      sharing the final video with family members and hospital staff.

      In both arms, patients complete questionnaires before and after sessions 2, 4, and 6 with the
      music therapist. Patients also complete computer-based questionnaires before hospitalization,
      after session six during hospitalization, and at 100 days post-transplantation.
    

Intervention name(s): Music Therapy; Psychosocial Assessment and Care; Quality-of-Life Assessment
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Undergo therapeutic music video therapy; Undergo books on tape therapy; Ancillary studies
Other intervention name(s): Psychosocial Care/Assessment; Quality of Life Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Peginterferon Beta-1a in Japanese and Caucasian Adult Healthy Participants.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017
      (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese
      and Caucasian adult healthy participants. The secondary Objective is to assess the safety and
      tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian
      adult healthy participants.
    


Intervention name(s): Peginterferon Beta-1a
Intervention type(s): Biological
Intervention description(s): As specified in the treatment arm
Other intervention name(s): Plegridy; BIIB017
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anodal Transcranial Direct Current Stimulation on Strength in Subacute Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Loss of strength is a common complication post stroke which leads to loss of balance and
      walking ability. Variety of interventions are adopted to improve muscle strength after
      stroke. These include progressive resistance training, specific task training or functional
      training, functional electrical stimulation and high intensity aerobic exercises
    

Detailed description: 
      Transcranial direct current stimulation (TDCS) is a relatively new treatment approach for
      stroke recovery. TDCS is a neuromodulation method which involves application of weak direct
      current stimulations over the scalp via electrodes. It could induce plasticity via modulation
      of resting membrane potential and modification of spontaneous discharge rate.

      TDCS has been shown to have beneficial effects on mobility, muscle strength, motor learning,
      lower limb function, balance, gait, functionality and walking ability in post stroke
      patients. TDCS appears to be a promising intervention for stroke patients however its effects
      are not significant if used in isolation. Thus, it should be used as an adjunct to some other
      treatment.

      Review of available literature indicates TDCS can be a good option in short and intermediate
      run but its effects in the long run have not been studied yet. Furthermore, to the best of my
      knowledge there is little literature available about the long-term effects of TDCS on muscle
      strength in subacute stage. Therefore, this study is designed to test the long-term effects
      of TDCS stimulation on subacute stroke patients.
    

Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Other
Intervention description(s): The intensity of TDCS will be 2.5 mA and the duration will be 20 mints. The intervention will be applied twice a day with a time difference of 30 minutes between the two sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Strength; Balance
Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study
Condition: Lumbar Radiculopathy
MeSH terms: Radiculopathy; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The ultimate goal of this study is to interpret Modified Oswestry Low Back Pain Scale into
      Urdu and analyse its reliability and validity in the population of Pakistan lumber
      radiculopathy patients. Examine its correlation with Quebec back pain disability scale and
      the visual analogue scale, as well as the Roland-Morris disability questionnaire.
    

Detailed description: 
      As per preceding commendation, Modified Oswestry Low Back Pain Scale will be translated into
      Urdu language from its English version and adapted culturally in Pakistan. 100 individuals
      will be selected on the basis of convenience sampling with clinical characteristics. The
      patient will answer the questionnaire package that included the Urdu version Modified
      Oswestry Low Back Pain Scale, Quebec back pain disability scale, Roland-Morris disability
      questionnaire and Visual analogue scale on the same day, with a 30-minute delay between the
      first and second application. Observer-1 will be conducting a third assessment after 7 days
      for intra-observer evaluation. Statistical Package of Social Sciences Version 24 will be used
      to enter and evaluate the data. Internal consistency will be measured using the Cronbach
      alpha value. To evaluated test-retest reliability, an intraclass correlation coefficient will
      be employed. The Modified Oswestry Low Back Pain Scale will be evaluated for content
      validity, construct validity, criterion validity, and responsiveness.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pakistani Lumber radiculopathy population with low back pain.
      
Keywords: Modified Oswestry Low Back Pain Scale; Urdu Version; Reliability; Validity; Lumbar Radiculopathy; Low Back Pain
Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy
      subjects and patients with End Stage Renal Disease on hemodialysis.
    


Intervention name(s): Aliskiren
Intervention type(s): Drug
Intervention description(s): All patient and subjects received single dose of aliskiren 300 mg in treatment period.
Other intervention name(s): SPP100
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: End Stage Renal Disease; Dialysis; aliskiren; SPP100A
Innovative Digital Therapeutic for Smoking Cessation
Condition: Smoking Cessation; Nicotine Addiction; Drug Addiction; Drug Dependence; Tobacco Dependence; Tobacco Use Disorder; Substance Use Disorder; Tobacco Smoking
MeSH terms: Substance-Related Disorders; Tobacco Use Disorder; Behavior, Addictive
Study type: Interventional

Summary: 
      This study is comparing the efficacy of two smoking cessation apps.
    

Detailed description: 
      Given that tobacco smoking is the leading cause of preventable death in the US, the
      development of effective cessation programs is critical; mobile phone applications represent
      a novel, accessible platform for helping smokers quit. This research project seeks to compare
      the efficacy of two smoking cessation apps. In a blinded, randomized, controlled study,
      current smokers motivated to quit will use a smoking cessation app for 8 weeks.
    

Intervention name(s): CT-101-M; QuitGuide
Intervention type(s): Device; Device
Intervention description(s): Mobile Application; Mobile Application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
Condition: Pediatric; Colon Capsule Endoscopy
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are
      candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and
      the second generation of colon capsule in comparison second generation of colon capsule
      endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast
      ultrasonography (SICUS) and endoscopy (upper and lower).

      This study aims

        1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the
           evaluation of pediatric Crohn's disease.

        2. To evaluate the safety of CCE-2 in pediatric CD.
    


Intervention name(s): Second generation of colon capsule endoscopy (GIVEN IMAGING)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allo-HSCT for Patients With FLT3-ITD AML
Condition: Acute Myeloid Leukemia; Acute Myeloid Leukemia With FLT3/ITD Mutation; Hematopoietic Stem Cell Transplantation
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      The purpose of this study is to reveal the influence of co-existing mutations on the efficacy
      of sorafenib maintenance after allogeneic hematopoietic stem cell transplantation for
      patients with FLT3-ITD AML.
    

Detailed description: 
      Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been
      reported in 20%-30% of patients with acute myeloid leukemia (AML). FLT3-ITD-positive AML
      patients have an inferior survival, primarily due to lower complete remission (CR) rate and
      higher relapse rate. Our previous studies demonstrated that post-transplantation sorafenib
      maintenance could improve the outcomes of FLT3-ITD-positive AML patients. However, whether
      other co-existing mutations influence the efficacy of post-allo-HSCT sorafenib maintenance
      remains unknown.
    

Intervention name(s): Sorafenib
Intervention type(s): Drug
Intervention description(s): The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity or resistance (dose range, 200-800 mg daily).
Other intervention name(s): Nexavar; BAY 43-9006; BAY-673472; BAY 545-9085
Intervention MeSH terms: Sorafenib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Cases included in this study were from 4 previously published studies of our study group,
        including 3 retrospective and 1 prospective studies.
      
Biospecimen description: 
      Bone marrow and/or peripheral blood were taken from participants upon enrollment for
      diagnosis and detection of co-occurring mutations via PCR, direct sequencing and /or new
      generation sequencing.
    
Keywords: Acute Myeloid Leukemia; FLT3-ITD; Hematopoietic Stem Cell Transplantation; sorafenib
A Study Of Galcanezumab In Participants With Episodic Cluster Headache
Condition: Episodic Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as Galcanezumab in participants with episodic cluster headaches.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in the Preservation of the Tooth Socket
Condition: Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional
Phase: Phase 2

Summary: 
      Twenty patients referring to periodontics department of Boroujerd Azad university of
      dentistry after obtaining consent to participate in teh research project, which TEMPhas more
      TEMPthan 20 teeth, are over 18 years old and require socket preservation surgery to tooth
      extraction for teh periodontal problem, caries or Fractures were selected.
    

Detailed description: 
      20 healthy patients referring to periodontics department of Boroujerd Azad university of
      dentistry after obtaining consent to participate in the research project, which has more than
      20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction
      for the periodontal problem, caries or Fractures were selected. Furthermore, divided the
      socket randomly to two groups(A, B)including A: bone graft wif Alendronate and B: bone graft
      alone, after 3 months wif trephine will collect the samples. following the histomorphometric
      analysis.
    

Intervention name(s): Alendronate 20 mg; Nanocrystal hydroxyapatite
Intervention type(s): Drug; Procedure
Intervention description(s): The Alendronate 20 mg combined with nanocrystalline hydroxyapatite as a synthetic bone substitute for socket preservation after tooth extraction; Postextraction Sockets Preserved With Nanocrystal hydroxyapatite as a synthetic bone substitute alone as a bone graft
Other intervention name(s): Group A; Group B
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period,
      two-sequence, crossover, open-label study to evaluate the effect of food on the
      pharmacokinetics of PA-824. The hypothesis to be tested in this study is that the rate and
      extent of absorption of two doses of PA-824 (50mg or 400 mg and 200mg) are the same after a
      high-calorie, high-fat meal as compared with after a minimum 10-hour fast.

      For each of the two dose levels 16 subjects with approximately 8 men and 8 women, will be
      enrolled for a total of 32 subjects.
    


Intervention name(s): PA-824 200mg; PA-824 50mg
Intervention type(s): Drug; Drug
Intervention description(s): Two single administrations of 200mg PA-824 each administered by four 50mg tablets, one administered in the fed state and one administered in the fasted state. The two administrations were separated by 8 days.; Two single administrations of 50mg PA-824 each administered by one 50mg tablet, one administered in the fed state and one administered in the fasted state. The two administrations were separated by 8 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tuberculosis; PK; PA-824; food effect; pretomanid; CL-009
Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome
Condition: Metabolic Syndrome; Obesity, Metabolically Benign
MeSH terms: Obesity; Metabolic Syndrome; Obesity, Metabolically Benign; Syndrome; Inflammation
Study type: Observational

Summary: 
      Obesity is associated with general low grade inflammation and, consequently, of oxidative
      stress that affects properties and functionality of lipoproteins. Metabolic syndrome
      exacerbate low grade inflammation. The intentional weight loss of at least 5% of the initial
      weight can modulate the pro-inflammatory state and reduce the oxidative stress related to the
      metabolic syndrome, thus diminishing the cardiovascular risk.
    

Detailed description: 
      Metabolic syndrome is a clustering of risk factors for the development of cardiovascular
      disease and type 2 diabetes mellitus. Patients with metabolic syndrome have an increased
      general low grade inflammation and, consequently, of oxidative stress that affects properties
      and functions of lipoproteins (Dandona et al 2005). Intentional weight loss can improve or
      prevent many of the metabolic syndrome-related risk factors and these benefits are often
      found after weight loss of at least 5% of initial weigh.

      Aim: i) to investigate the structure and functionality of plasma lipoproteins, oxidative
      stress and the inflammatory condition in subjects with BMI between 25kg/mq and 35 kg/mq and
      with or without metabolic syndrome; and ii) to test the effects of weight loss of at least 5%
      of initial weigh promoted by an hypo-caloric balanced diet on these parameters.

      Methods: Eighty overweight and moderately obese subjects (BMI: 25 - 35 kg/m2) with or without
      metabolic syndrome were recruited for the study. Fasting blood samples were taken and
      analyzed for routine laboratory analysis, lipoprotein isolation and analysis, and oxidative
      stress and inflammation markers measurements. The subjects received an hypo-caloric balanced
      diet. Fasting blood samples were taken from subjects who had lost at least 5% of their
      initial weight at the end of the intervention period and analyzed for same markers determined
      at baseline.
    

Intervention name(s): hypocaloric balanced diet
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were males and females overweight or moderately obese with or without metabolic
        syndrome on a calorie-controlled diet.

        Those that lost at least 5% of the initial weight were analyzed.
      
Biospecimen description: 
      blood plasma and serum, and erythrocytes