bioihbjkbjnl/mcl2 huggingface dataset:
Does Mindfulness Training Change the Processing of Social Threat?
Condition: Healthy; Stress
Study type: Interventional

Summary: 
      Training in mindfulness, the non-judgmental observation of experiences as they arise in the
      present moment, has been increasingly and successfully applied to the treatment of normative
      stress conditions and mental disorders. Yet, the neurological mechanisms that underlie the
      reported improvements are still largely unknown. This longitudinal study will investigate the
      influence of mindfulness training on a key underpinning of mental health, namely emotion
      regulation, and its associated brain activity. Healthy participants will be randomly assigned
      to either a validated eight week Mindfulness-based stress reduction (MBSR) program or to a
      control condition. In a pre-post investigation, participants' subjective reactions to
      aversive emotional stimuli (affective facial expressions) will be assessed, as will the
      associated brain activation using functional magnetic resonance imaging (fMRI). The
      investigators hypothesize that after the training the MBSR participants will rate the
      pictures as less aversive compared to control participants. Furthermore, the MBSR
      participants will show a patter of brain activation indicative of improved emotion
      regulation, relative to control participants. Finally, the effect of MBSR on the gray matter
      structure of the brain will be investigated.
    


Intervention name(s): Mindfulness-Based Stress Reduction
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention, mindfulness meditation in form of yoga, sitting meditation, body scan and mindfulness to routine activities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy but stressed individuals
Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
Condition: Avascular Necrosis of Femoral Head
MeSH terms: Femur Head Necrosis; Necrosis; Shock
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the effect of zoledronic acid over 2 years in preventing
      early collapse and progression of joint dome depression (≥ 2 mm by X-ray) of the femoral head
      in patients with large (> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.
    

Detailed description: 
      Until now, the best treatment option in early (precollapse) large osteonecrosis femoral head
      is vascularizing fibular graft. However, it requires high microsurgical technique. Also it
      needs very long operation time (3-6hours), and morbidity associated with surgery is not low.
      In early stage osteonecrosis, osteoclasts are activated and resorb the necrotic portion of
      bone and osteoblasts are followed to lay down new bone. This process can weaken the bone
      function to support loading and can lead to collapse of bone. Bisphophonate can inhibit this
      osteoclastic bone resorption and enhance osteoblastic new bone formation. Recently, everyday
      oral intake of alendronate with vitamin D and calcium had a high success rate to prevent the
      collapse and decrease of hip joint pain in a short-term follow-up. However, the compliance or
      adherence to everyday oral intake is questionable. Moreover, the exact comparison based on
      MRI according to various classifications is not available currently. There is no report about
      the effect of zoledronic acid to prevent early collapse and progression of joint dome
      depression (≥2 mm by X-ray) of the early stage large nontraumatic osteonecrosis of the
      femoral head or its effect on MRI signal change after infusion of zoledronic acid in
      noncollapsed cases (estimated about 30% of cases) The investigators need a controlled
      randomized multicenter interventional study about the efficacy of bisphophonates in the
      treatment of ONFH.
    

Intervention name(s): zoledronic acid (aclasta)
Intervention type(s): Drug
Intervention description(s): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period
Other intervention name(s): aclasta
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: avascular necrosis of femoral head; bisphosphonate; collapse
Impact of Vitamin D Supplementation on COVID-19 Vaccine Response and IgG Antibodies in Deficient Women.
Condition: COVID-19 Pandemic; D Vitamin Deficiency; Antibody Hypersensitivity
MeSH terms: COVID-19; Avitaminosis; Vitamin D Deficiency; Hypersensitivity
Study type: Interventional

Summary: 
      Decreased immunity in individuals causes a decrease in vaccine response, and vitamin D
      worsens this course. Vitamin D is thought to be a vitamin that can strengthen the innate
      immune response, inhibit the adaptive system, and modulate the vaccine response.

      The effect of vitamin D intake on antibodies was studied.
    


Intervention name(s): Vitamin D supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Only the experimental group (D) received the vitamin D supplement.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: COVID-19 Vaccine; Antibody; IgG; D vitamin; Nutrition
Microbe-Gut Interaction in Microscopic Colitis and Post-Infectious Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Colitis; Irritable Bowel Syndrome; Colitis, Microscopic; Syndrome
Study type: Observational

Summary: 
      Objective: This study aims elucidate the pathophysiological link between the environment in
      the colon (mainly the microbiota), the local immune system and activation of the enteric
      nervous system in patients with post-infectious IBS (PI-IBS) and microscopic colitis (MC)
      with special emphasis on microbial-mucosa interactions and evaluation of the effect on the
      immune activation/response as well as how afferent gut-brain signalling leads to abdominal
      discomfort.

      Method: The project is based on data from three cohorts of patients, one with PI-IBS and one
      with MC as well as a gender- and age-matched cohort of healthy individuals. Measurement of
      perceived sensitivity in the gut will be evaluated by pain-response under mechanical stress
      using a barostat. The HIT (Human intestinal Tissue)-Chip array will be used to characterize
      the diversity, stability and functionality of the intestinal microbiota on mucosa level,
      giving a clue to the interactions with the host and insight to changes leading to the
      development of the two diseases.

      Immunohistochemistry and flowcytometry will be used to analyse the location, frequency and
      phenotype characteristics of lymphoid- and mast cells. Functional analysis of mucosal
      lymphocytes activated in vitro by products from the intestinal microbiota will be examined by
      cytokine production using the LuminexTM system. The Ussing chamber technique will allow
      investigation of the impact of the microbiota and its metabolites on intestinal barrier
      functions. In this method the sample has access to stressors under standard conditions.
    

Detailed description: 
      We will make a characterization of lymphocytes, mast cells and gut microflora. Depending on
      these results we will make stimulations of patient biopsies to find if tissue from patients
      react differently then patients from healthy.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from clinic (endoskopimotagningen) at Örebro University
        Hospital.
      
Biospecimen description: 
      Biopsies and blood
Maternal Thyroid Function in Early Pregnancy and Their Relationship With Gestational Diabetes Mellitus
Condition: Pregnancy; Thyroid Function Tests; Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Thyroid Diseases
Study type: Observational

Summary: 
      This study was conducted to analyze the role of TSH level and TPOAb status in early pregnancy
      and use this information in assessment of the risk of gestational diabetes mellitus at
      different weeks of gestation when the FT4 level is normal.
    

Detailed description: 
      A total of 7,729 women with singleton pregnancies who were receiving antenatal care at
      Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine between
      December 2012 and March 2014 were included in the study. All these women underwent screening
      for thyroid function (TSH,FT4 and TPOAb) at the first antenatal visit and a 75 g oral glucose
      tolerance test at 24-28 weeks of gestation. The correlation between a combination of TSH
      level and TPOAb status and the risk of gestational diabetes mellitus was analyzed.
    

Intervention name(s): 75g oral glucose tolerance test (OGTT)
Intervention type(s): Other
Intervention description(s): All these women underwent the 75g oral glucose tolerance test (OGTT) at 24-28 weeks of gestation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All the pregnant women who were receiving antenatal care at Shanghai First Maternity and
        Infant Hospital, Tongji University School of Medicine were invited to participate in the
        study.Informed consents were obtained from all subjects.
e-Health Education Program at Workplace
Condition: Health Behavior
Study type: Interventional

Summary: 
      The objective this study is evaluate if an e-Health education program at the workplace to
      contributes to improve quality of life from Office Workers. And:Life style modification;
      Improve physical activity Reduces on Anthropometric Measures; Reduces Pain and discomfort in
      the musculoskeletal system
    

Detailed description: 
      Objective: The purpose of this study is evaluate the effectiveness of an e-Health education
      program at the workplace in the quality of life promotion.

      Design: Double Blinded. Randomized clinical trial by cluster. Setting: Office Workers of the
      Universidade Publica do Estado da Bahia, Bahia State, Brazil. Participants: 348 office
      workers are enrollment, both sex, with over 18 year old.

      Intervention: Participants will randomized in: (1) reference group will receive an e-learning
      health education compose by nine video-class according to the dimensions: 1) musculoskeletal
      health, 2) eating health e 3) mental health. A video will available by moodle platform every
      20 days during six months. In this period the workers will monitored regarding to access the
      videos and and reinforcements to remain in the program. (2) intervention group: they will
      receive e-health education program with additional support healthcare tutor everyday.
    

Intervention name(s): eHealth_additional support; eHealth_program
Intervention type(s): Other; Other
Intervention description(s): An e-learning education program whose audiovisual content will be implemented. Nine audiovisual e-Health program will be composed of nine video classes addressing the following topics: 1) musculoskeletal health, 2) healthy diet and 3) mental health were identified through focus group. A communication tool will be adopted is the Moodle environment. All the participants will be able to whipping the web platform and questions regarding access and navigation are answered by e-mail. All participants will be monitored, as viewing the videos, and whenever it is identified that the participants not accessed and lack of interest of reasons. A team of tutors will be responsible for online support providing reinforcing stimuli and clarifying any questions (intervention group) on the content.; The comparative group will receive the same eHealth education program that intervention group. But the comparative group will receive only audiovisuals without additional support. .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Office workers; Quality of life; e-Learning; Occupational health
Body Composition in Children With Inflammatory Bowel Disease
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel
      diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the
      literature that body composition, composed of fat mass and lean mass is altered in children
      with IBD compared with controls. Evidence regarding the effect of different therapeutic
      approaches on body composition in children with IBD is scarce and inconsistent. Furthermore,
      most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for
      body composition assessment, while information on the usefulness of air displacement
      plethysmography (ADP) for this assessment is lacking.

      Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and
      at various intervals during follow up.

      Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider
      Children's Hospital.

      Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative
      colitis (UC).

      Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and
      lean mass at diagnosis and during treatment.

      Secondary outcome measures: Correlation of body composition to skin fold, mid arm
      circumference measurements, BMI, inflammatory markers, gender, disease activity and physical
      activity.
    

Detailed description: 
      Children diagnosed with either Crohn's disease (CD) or Ulcerative Colitis (UC) under
      follow-up at the Pediatric gastroenterology institute, Schneider Children's Hospital, will be
      enrolled. Patients can be enrolled at diagnosis or at any time point during follow-up.
      Patients' characteristics will be retrieved from their medical files including demographic
      details, disease phenotype, anthropometric measures, laboratory evaluation, complication and
      therapeutic regimens. At enrollment all patients will perform body composition assessment by
      air displacement plethysmography (ADP) and DEXA (no greater than 7 days between the 2 methods
      of measurement). At one and two years following initial assessment ADP measurement will be
      repeated, mid arm circumference and skin fold measurements will be taken and the patient will
      fill a physical activity questionnaire. Disease activity score (either Pediatric Crohn's
      Disease Activity Index for CD or Pediatric Ulcerative Colitis Activity Index for UC) will be
      calculated. Similar evaluation will be performed prior and immediately following exclusive
      enteral nutrition or corticosteroid courses and prior to any biologic therapy initiation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children at age 6 year to 17 years diagnosed with IBD
A Lifestyle Intervention for Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      1. The purpose of the study is to test the effectiveness of a new mail-based intervention
           for breast cancer survivors compared with standard lifestyle management and
           no-treatment.

        2. This intervention addresses both lifestyle factors such as dietary and physical
           activities and psychological issues specific to breast cancer survivors to improve
           healthy behaviors.
    

Detailed description: 
      Participants will be assigned randomly to one of three groups: 1) newly developed mail-based
      intervention (Targeting the Teachable Moment Intervention; TTMI), 2) standard Lifestyle
      Intervention (SLM), and 3) usual care. Both TTMI and SLM focus on health behaviors, however
      TTMI additionally addresses psychosocial issues specific to breast cancer survivors.

      All participants will complete questionnaires at the time they start the study, the end of
      the 4 months, and 3 months later for a follow-up.

      If participants are assigned to any of the intervention group, they will receive materials
      every other week for 4 months. If participants are assigned to the usual care group, they
      will receive the same materials as the standard lifestyle intervention et the end of the 7
      months.
    

Intervention name(s): Targeting the Teachable Moment; Standardized Lifestyle Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): TTMI material (every other week for 4 months); SLM material (every other week for 4 months)
Other intervention name(s): TTMI; SLM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer survivors; lifestyle intervention; health behaviors
Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest
Condition: Labor, Obstetric
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be designed as a double-blind, placebo-controlled, parallel-group,
      dose-finding study with one group treated with placebo and three groups treated with
      tafoxiparin in three different infusion concentration levels, respectively. The intravenous
      infusion will be initiated by a pre-defined bolus dose infusion.
    

Detailed description: 
      Primary objective

      To assess the dose-response relationship of tafoxiparin on the labor time defined as the time
      from the start of continuous infusion of tafoxiparin/placebo as an Adjunct Treatment to
      Oxytocin, until partus in term-pregnant, nulliparous women requiring labor augmentation due
      to Primary Slow Progress of Labor including prolonged latent phase and Labor Arrest.

      Secondary objectives

      To assess the safety and efficacy of tafoxiparin based on the safety and secondary efficacy
      parameters evaluated in the protocol. PK (pharmacokinetic) response in pregnant women during
      labor.

      Methodology

      All term-pregnant, nulliparous women presenting to the delivery ward are potential study
      patients unless they have already been enrolled in another clinical study. Subjects may be
      pre-informed about the study through the use of advertisements or information at the
      physician/midwife visits during pregnancy and at hospital admission.

      The whole study includes the following steps:

        -  Screening and Baseline including informed consent and randomization

        -  Labor

        -  Discharge

        -  Follow-up at 8 (+/-1)weeks - End of study

        -  Safety follow up of infant at 6 months, +/-4 weeks, by telephone interview
    

Intervention name(s): DF 01; Oxytocin; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Tafoxiparin; PL1
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary slow progress; Prolonged latent phase; Labor arrest
Tai Chi for Stroke Rehabilitation on Balance and Cognition
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by
      continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the
      integration and balance of mind and body using the fundamental principles of slow, smooth,
      and continuous movement control, and the transfer of body weight while maintaining an upright
      and relaxed posture. The present randomized clinical trial project aims to apply the
      suggested principles as the typical features of Tai Chi applied stroke rehabilitation, and to
      evaluate the effects on physical (balance), psychological, and cognitive function.
    

Detailed description: 
      Cerebrovascular disease is a major global concern. The individuals with stroke would suffer
      from disease associated symptoms which influence their functioning in everyday life. These
      symptom clusters were usually known to be sharing similar underlying mechanisms. It is clear
      that the development of effective stroke rehabilitation involves interdisciplinary team
      approach to manage physical, social, cognitive, and psychological functioning in this
      population.

      Tai Chi, an ancient Chinese martial art, is a low intense aerobic exercise characterized by
      continuous movements that embrace the mind, body, and spirit. Tai Chi addresses the
      integration and balance of mind and body using the fundamental principles of slow, smooth,
      and continuous movement control, and the transfer of body weight while maintaining an upright
      and relaxed posture. The newly developed style of Tai Chi for health programs is the seated
      Tai Chi, which shares the common Tai Chi principles while being modified to adjust the
      movements for patients with limited mobility.

      The present randomized clinical trial project aims to apply the suggested principles as the
      typical features of Tai Chi applied stroke rehabilitation, and to evaluate the effects on
      physical (balance), psychological, and cognitive function. Only a few studies ever addressed
      the feasibility of Tai Chi for stroke rehabilitation, and the relationship between cognition
      and balance in this population is still very early stage of investigation. The main purpose
      of our collaborating project is to explore the direct relationship between cognition and
      balance in stroke patients during their rehabilitation process.
    

Intervention name(s): Tai Chi exercise; symptom management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): exercise twice a week each for one hour; sending text message weekly to manage symptoms related to stroke
Other intervention name(s): seated Tai Chi; message counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: stroke; Tai ji; postural balance; cognition