bioihbjkbjnl/mcl2 huggingface dataset:
A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome
Condition: Fragile X Syndrome; FXS; Fra(X) Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, randomized, double-blind, 2-period crossover study to explore the
      effects of BPN14770 on cognitive function and behavior in subjects with Fragile X Syndrome.
      Subjects will receive both active treatment with BPN14770 capsules and matching placebo
      capsules in the course of the study. One treatment will be administered during each of the
      12-week study periods.
    

Detailed description: 
      A total of 30 subjects will be enrolled. The study consists of a screening period of up to 28
      days prior to initial treatment, followed by two double-blind treatment periods, each 12
      weeks long. A final follow-up visit or phone contact for safety is planned one week after the
      conclusion of Period 2.

      Eligible subjects will be randomized in a blinded, balanced (1:1) fashion to receive either
      25 mg BPN14770 capsules or matching placebo capsules during Period 1, followed by the
      opposite treatment during Period 2. One capsule will be taken twice daily during both
      double-blind periods.

      Subjects will return to the clinic at the end of Weeks 2, 6, and 12 of each study period.
      Cognitive and behavioral evaluations will be repeated at Weeks 6 and 12 of each Period.
      Additionally, patients will be monitored for adverse events via a telephone call at the end
      of Week 1 of each Period, and one week following completion of Period 2 or following early
      discontinuation.

      During clinic visits, adverse effects will be assessed, and laboratory measures, vital signs,
      and ECGs will be performed. Suicidality risk will also be evaluated at each clinic visit; if
      a concern is detected, the subject will be referred for further evaluation and treatment.
      Cognitive and behavioral assessments will be performed during each clinic visit.
      Pharmacodynamic measures of CNS function will be obtained to evaluated effects of the drug in
      the brain. Pharmacokinetic samples will be collected to confirm that study drug is present
      and to estimate plasma exposure at Week 12 of each Period.
    

Intervention name(s): BPN14770; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg BPN14770 capsules; Placebo capsules to mimic 25 mg BPN14770 capsules
Intervention MeSH terms: BPN14770
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phosphodiesterase Type 4D; PDE4D; Cognitive Dysfunction; Neurocognitive Disorders; Fragile X Syndrome; Fragile X; FXS; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Cognition Disorders; Enzyme Inhibitors; Nootropic Agents; Developmental Disorder; Autism; Autistic Spectrum Disorder; Genetic Disease; Behavioral Disorder; Learning Disorder
CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology
Condition: Cancer
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This patient support system is designed to help patients regain their professional activity
      after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:

        -  A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist /
           Neuropsychologist)

        -  Monthly information meetings and workshops (TIC'Onco reunions: collective information
           times and Cogit'Onco workshops: cognitive workshops

        -  An information booklet "Prepare the work return" The aim of this research is to evaluate
           efficiency in term of quality of life improvement linked to work status, utility,
           feasibility and patients' satisfaction.

      The aim of this research is to evaluate efficiency in term of quality of life improvement
      linked to work status, utility, feasibility and patients' satisfaction.
    

Detailed description: 
      Unmet need characterize in 4 points:

        -  Cancer and survival: challenges for cancer patients who want to work while being treated

        -  Cancer and career: Job instability for cancer patients

        -  Difficulties and isolation of patients due to a lack of coordination between healthcare
           professionals and colleagues/management

        -  Post-treatment cognitive troubles stress and hindered patient return to employment:
           chemo brain This research-action will propose and evaluate a concrete device: To
           maintain a professional activity with the support of CAP'Onco during treatment, to
           balance between quality of life, managing the "cancer event" and the psychosocial
           consequences for professional experience, to provide an early, durable and multimodal
           support to improve work keeping and anticipate return to employment
    

Intervention name(s): Psychological and Social Consultation
Intervention type(s): Other
Intervention description(s): Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
Intervention model: Single Group Assignment
Intervention model description: Prospective study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Oncology; Work Keeping; Social difficulties; Cognitive Disorders
The Effects of Z-338 in Subjects With and Without Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess in subjects with and without functional dyspepsia the effects of Z-338 on:

        1. Type and severity of symptoms a standardized nutrient challenge

        2. The gastric nutrient distribution and gastric emptying of a standardized nutrient
           challenge

        3. The association of the above with the manifestations of symptoms and symptom pattern
    


Intervention name(s): Z-338
Intervention type(s): Drug
Intervention MeSH terms: Z 338
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gut Health, Inflammation, Hormones
Condition: Aging Well
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Pilot exploratory study on the effect of a Bifidobacterium breve extract, as VMK223, on
      plasma inflammatory markers, saliva hormones, gut microbiota and tolerance in females over
      50years old. Participants are randomised in one of 4 arms: 0.25g/d VMK223, 0.5g/d VMK223,
      0.75g/d VMK223, or placebo.
    

Detailed description: 
      The commensal bacteria colonising the gut and making up the microbiome perform a number of
      functions through their normal life cycle, which provide benefits to their human hosts in
      maintaining homeostasis. The relationship works both ways with the human host providing both
      nutrition and an environment for the bacteria to flourish.

      Ageing is a natural and multifactorial phenomenon characterised by the accumulation of
      degenerative processes that are in turn underpinned by multiple alterations and damage within
      molecular pathways. The alterations and damage ultimately compromise cell and tissue
      functions. As such, ageing is the most profound risk factor for almost all non-communicable
      diseases. Amongst the key processes involved [in ageing], inflammation is of particular
      interest, because ageing is characterised by an increase in the concentration of a number of
      pro-inflammatory molecules in the circulation, a phenomenon that has been termed
      "inflammageing" and is a determinant of the speed of the ageing process and of lifespan.

      Amongst the members of the human microbiome, Bifidobacterium spp. are resident microbiota
      members throughout the invesstigator's lifetime, with their levels across the life course
      aligning with key stages in immune maturation. Bifidobacteria influence this critical
      homeostatic development and programming by impacting on specific immune populations and
      signalling pathways associated with improved host well-being.

      VMK223 is a heat treated Bifidobacterium breve extract, consisting of a low molecular weight
      storage polysaccharide that targets the reduction of NF-κB activation.
    

Intervention name(s): VMK223; Cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Heat killed and purified Bifidobacterium breve polysaccharide-based extract; Bulking agent in food production without probiotic properties
Other intervention name(s): Bifidobacterium breve extract/lysate; Cellulose microcrystalline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, placebo controlled, randomised dose response study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gut microbiota; Postbiotics; Inflammation
Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Observational

Summary: 
      The objective is evaluation of GoCheck Kids, a smartphone application ('App'), for use as a
      photo screening device in a pediatric population to detect amblyopia risk factors (ARFs).
    

Detailed description: 
      Detection of amblyopia risk factors using photo screening app in children of ages from 12
      months to 8 years
    

Intervention name(s): App Vision Screening
Intervention type(s): Device
Intervention description(s): Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will be selected from eye clinics.
      
Keywords: Amblyopia; Myopia; Hyperopia; Risk Factors; Amblyopia Risk Factors; Smartphone Application (App); Photoscreening; Vision Screening; Mobile Vision Screening; Vision Screening App; Preschool children; Objective vision screening
Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant
Condition: Acute Biphenotypic Leukemia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic Cell Transplantation Recipient
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Biphenotypic, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well ibrutinib works in preventing acute leukemia in patients
      after reduced-intensity conditioning and stem cell transplant. Ibrutinib may stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To reduce the incidence of relapse at 18 months after reduced-intensity conditioning (RIC)
      and allogeneic hematopoietic cell transplantation (HCT) for acute myeloid leukemia (AML),
      acute lymphoblastic leukemia (ALL), and chronic myeloid leukemia (CML) in blast crisis from a
      historical baseline of 45% to 25%, using ibrutinib maintenance therapy.

      SECONDARY OBJECTIVES:

      I. To study the incidence and severity of post-transplant complications in subjects receiving
      ibrutinib maintenance after allogeneic HCT.

      II. To study the incidence of infectious complications in subjects receiving maintenance
      ibrutinib after allogeneic HCT.

      III. To study the impact of ibrutinib maintenance on minimal residual disease after RIC and
      allogeneic HCT.

      IV. To study the impact of maintenance ibrutinib on immune reconstitution and alloreactivity
      after allogeneic HCT, specifically on Th1/ Th2 polarization, T follicular cell number, T and
      B cell repertoire, serum immunoglobulin levels, and alloantibody formation.

      OUTLINE:

      Beginning 60-90 days after allogeneic HCT, patients receive ibrutinib orally (PO) once daily
      (QD) for up to 18 months post-transplant in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up for 2 years.
    

Intervention name(s): Ibrutinib; Laboratory Biomarker Analysis
Intervention type(s): Drug; Other
Intervention description(s): Given PO; Correlative studies
Other intervention name(s): BTK Inhibitor PCI-32765; CRA-032765; Imbruvica; PCI-32765
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of a Bladder Training Video for Management of Lower Urinary Tract Symptoms.
Condition: Nonneurogenic Lower Urinary Tract Dysfunction; Dysfunctional Elimination Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Children with non-neurogenic lower urinary tract dysfunction (NLUTD) represent a significant
      subgroup of pediatric urology patients, comprising up to 30 percent of some out-patient
      clinics. These children present with urinary tract infections (UTIs), abnormal voiding habits
      and various other lower urinary tract symptoms (LUTs) such as incontinence, urinary urgency
      and urinary frequency. Furthermore, the effects of NLUTD on a child's physical health, mental
      health and its potential negative clinical sequelae, which includes upper or lower urinary
      tract damage, must be taken into account when treating these children. These patients have
      complex needs requiring a significant amount of health teaching and it is imperative to
      determine the effectiveness of the various modes of delivering urotherapy. To determine the
      best modality to deliver urotherapy, this trial will compare the effectiveness of a 7 minute
      bladder training video to the effectiveness of standard urotherapy provided at a pediatric
      urology clinic at improving NLUTD/DES symptoms and quality of life in children between 5-10
      years of age.
    


Intervention name(s): Educational Intervention
Intervention type(s): Other
Intervention description(s): Bladder Training Video
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Urology; Urotherapy; Nonneurogenic Lower Urinary Tract Dysfunction; Dysfunctional Elimination Syndrome; Randomized Controlled Trial
A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
Condition: Rotator Cuff Syndrome
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in
      comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).
    

Detailed description: 
      This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled,
      pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary
      surgical treatment for full thickness MRCT in comparison to Partial Repair of a full
      thickness MRCT performed during an arthroscopic procedure.
    

Intervention name(s): InSpace sub-acromial tissue spacer system; Partial repair of rotator cuff
Intervention type(s): Device; Procedure
Intervention description(s): Arthroscopic implantation of InSpace sub-acromial tissue spacer system; Arthroscopic partial repair of rotator cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Massive Rotator Cuff Tear; Arthroscopy; Shoulder Joint; Rotator cuff partial repair
Evaluation of the Efficacy of a Food Supplement in Reducing Hair Loss in Male Subjects
Condition: Hair Loss
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      According to the American Hair Loss Association, by the age of 35, two-thirds of American men
      will have some degree of appreciable hair loss, and by the age of 50, approximately 50 to 85%
      of men will have significant hair thinning.

      Hair is an essential aspect of human appearance and can have a significant impact on a
      person's self-esteem, mood and quality of life. Unfortunately, current treatment options can
      be costly, tedious or painful. They are also associated with numerous side effects.

      Here, the investigators aimed at evaluating the effect of a new food supplement on hair
      condition in young men suffering from hair loss. A second goal was to determine tolerability.
    


Intervention name(s): Alline proMEN; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months; 1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Outcomes for Offering Genetic Testing in a Tiered Approach
Condition: Breast Carcinoma; Colon Carcinoma; Malignant Solid Neoplasm; Ovarian Carcinoma; Pancreatic Carcinoma; Prostate Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Pancreatic Neoplasms
Study type: Interventional

Summary: 
      This clinical quality improvement study reviews and develops a clinical operations workflow
      to identify cancer patients who meet criteria for genetic counseling and testing. This study
      may improve utilization of genetic counseling and testing amongst community-based oncology
      providers caring for cancer patients in a rural and underserved area.
    

Detailed description: 
      OUTLINE: Medical oncologists at Olympic Medical Center (OMC) participated in this study and
      received a peer coaching intervention during phase II to help identify patients who meet
      criteria for genetic counseling and testing

      PHASE I: Patients' medical data are collected; no intervention.

      PHASE II: Olympic Medical Center (OMC) patients complete family history questionnaires and
      their medical data are collected. Seattle Cancer Care Alliance (SCCA) subject matter experts
      and OMC providers review patients' medical data at bi-weekly virtual conferences. OMC
      providers will be consenting to release their patients' medical records to SCCA so that SCCA
      subject matter experts (cancer geneticist and/or genetic counselor) can identify patients
      with an underlying hereditary cancer syndrome to be offered genetic counseling and testing.

      OMC providers receive coaching from SCCA subject matter experts for guidance on providing
      genetic counseling and testing to their patients.
    

Intervention name(s): Electronic Health Record Review; Questionnaire Administration; Behavioral Intervention
Intervention type(s): Other; Other; Behavioral
Intervention description(s): Medical data collected; Complete questionnaires; Receive coaching
Other intervention name(s): Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effect of Formula on Infant Behavior
Condition: Gastrointestinal Tolerance
Study type: Interventional

Summary: 
      This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula
      intolerance in healthy term infants.
    


Intervention name(s): Infant Formula supplemented with Oligosaccharides
Intervention type(s): Other
Intervention description(s): sole source nutrition
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Probiotics and Influenza Vaccination Response
Condition: Vaccine Response
Study type: Interventional

Summary: 
      Assess efficacy of oral ingestion of a probiotic product on immune function in a population
      of healthy adult men and women in a clinical vaccination study.
    


Intervention name(s): Probiotic effect on influenza vaccine response
Intervention type(s): Dietary Supplement
Intervention description(s): Seroconversion rate: the percentage of subjects achieving at least a 4-fold increase or an increase from >10 to 40 in Ab titre for seronegative subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine response; seroconversion; antibody
Family Based Interpersonal Psychotherapy (FB-IPT) for Depressed Preadolescents
Condition: Depressive Disorders
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      The investigators proposed a preliminary randomized control trial of Family Based
      Interpersonal Psychotherapy (FB-IPT), a family-based adaptation of Interpersonal
      Psychotherapy for Depressed Adolescents (IPT-A; Mufson et al., 2000). Forty-five
      preadolescent children (ages 8-12) diagnosed with a depressive disorder will be randomized to
      receive a 14-week course of FB-IPT or Client Centered Therapy (CCT), a supportive
      nondirective psychotherapy that closely approximates treatment at usual in community mental
      health clinics. In addition to assessing the feasibility and acceptability of randomization
      and each of the treatment conditions, this project will evaluate the effects of FB-IPT and
      CCT across multiple domains, including symptomatology and psychosocial functioning.
      Preadolescents will be assessed prior to treatment, during treatment (Weeks 3, 7, 11), one
      week post-treatment, and at 3 and 6 months post-treatment to compare changes in depressive
      symptoms, global, social, and family functioning. Data on psychosocial risk factors
      associated with onset and recurrence of preadolescent depression will be collected prior to
      treatment and at specified intervals post-treatment in order to conduct exploratory analyses
      on correlates of positive and negative treatment outcomes for Family Based IPT. This data
      will be used to generate future hypotheses about potential mediators and moderators that will
      be incorporated into an R01 application for an efficacy study of Family Based IPT.
    


Intervention name(s): Family Based Interpersonal Psychotherapy (FB-IPT); Client Centered Therapy (CCT)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SOOTHER Trial to Treat Rectal Itch
Condition: Pruritus Ani
MeSH terms: Pruritus Ani; Pruritus
Study type: Observational

Summary: 
      Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to
      treat rectal itch (pruritus ani)
    


Intervention name(s): Lidocaine Ointment
Intervention type(s): Drug
Intervention description(s): Composite over-the-counter lidocaine ointment administered twice daily for 2 weeks.
Intervention MeSH terms: Lidocaine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with pruritus ani (anal itch/discomfort)
      
Keywords: Pruritus ani; rectal itch; anal itch