bioihbjkbjnl/mcl2 huggingface dataset:
Data Collection on the Model Schools Pediatric Health Initiative at 5 SBHC Sites: COVID-19 Questionnaire
Condition: COVID-19 Experience
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The Model School Pediatric Health Initiative arose out of concern about health access
      inequities and disparities among some of Toronto's most vulnerable children living in our
      inner-city neighborhoods. It is well documented that illness, emotional difficulties and
      self-esteem impacts a variety of educational markers including school attendance and
      performance. Providing health care in schools may be the most direct and efficient way to
      ensure that all children have access to the care they need including diagnosis, management
      and follow up of multiple health and school related concerns. American research has
      demonstrated that inner city children who had access to an elementary school-based health
      clinic (SBHC) had less difficulty receiving treatment for illnesses and injuries,
      immunizations, and physical examinations. In addition, rates of enrolment and utilization of
      elementary SBHCs are higher in those children who traditionally have poorer access to health
      care. Given the vast differences in the Canadian and American health systems it is important
      to evaluate SBHCs in Canada before long-term implementation.

      The objective of this study is to collect data including demographic characteristics and
      clinical features of students attending a SHBC at five selected sites in Toronto. In light of
      the COVID-19 pandemic, the research team is additionally interested in asking about families'
      experiences with the pandemic and school closures. It is hypothesized, that these vulnerable
      children who come from lower income families and/or are newcomers to Canada attending these
      SHBCs, are likely to experience more mental health symptoms with the heightened uncertainty
      surrounding the COVID-19 pandemic.

      This study will be a prospective chart review design. A COVID-19 questionnaire will be
      constructed and administered online at three time points: baseline, 6 months upon completion
      of the baseline questionnaire, and 12 months upon completion of the baseline questionnaire.
    


Intervention name(s): COVID-19
Intervention type(s): Other
Intervention description(s): To study the experience of students and their families during the COVID-19 pandemic an online questionnaire will be utilized. This COVID-19 questionnaire will be administered at three time points: baseline, 6 months upon completion of the baseline questionnaire, and 12 months upon completion of the baseline questionnaire.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study collects data on demographic characteristics, clinical features, and COVID-19
        experience of Toronto's most vulnerable children living in the inner city neighbourhoods
        attending five selected SHBCs.
      
Keywords: COVID-19; School-based health center; mental health
Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)
Condition: Medullary Thyroid Carcinoma
MeSH terms: Carcinoma; Thyroid Neoplasms; Carcinoma, Neuroendocrine; Thyroid Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare the effects and safety of Anlotinib with placebo in patients with Medullary
      Thyroid Carcinoma.
    


Intervention name(s): Anlotinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo p.o. qd
Other intervention name(s): Anlotinib p.o. qd
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
Condition: Muscle Weakness; Vitamin D Deficiency
MeSH terms: Muscle Weakness; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th
      parallel were observed to be weak and to have a waddling gate.

      Study 1 was carried out in the setting of an antenatal clinic administered from a primary
      care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in
      Sweden. The investigators chose an initial study period in late spring to reflect the effects
      of the dark season with little ultraviolet B radiation that affects vitamin D production.
      Study 1 was carried out in a short period of time. The recruitment was performed in a
      retrospective design in order to neglect the seasonal effects of ultraviolet B radiation.
      Study 1 was carried out in year 2010. It was a cross sectional baseline study of blood levels
      of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance in 123
      pregnant and new mothers from Somalia (n=52) and Sweden (n=71).

      Study 2: Examines the results on muscular performance, i.e. grip strength and squatting
      ability, from intervention with advice and prescription of vitamin D3 and calcium for 10
      months, in all the women from study 1 with 25-OHD levels <50 nmol/L or 50 nmol/L of 25-OHD.

      Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on delivery
      outcome in birth protocols starting 2016.

      Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and
      strength in the group of Somali women by focus interviews among the Somali women from above.

      A possible fifth study will explore correlations between 25-OHD and pain distribution and
      pain parameters.
    


Intervention name(s): 1 combination tablet of Vitamin D3/calcium per day; 2 combination tablets of Vitamin D3/calcium per day
Intervention type(s): Drug; Drug
Intervention description(s): Combination tablet of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg); Combination tablets of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
Other intervention name(s): 1 tablet Kalcipos D Forte; 2 tablets Kalcipos D Forte
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Early Bandage Removal Post-Cesarean Delivery
Condition: Wound Disruption; Wound Infection
MeSH terms: Wound Infection; Wounds and Injuries
Study type: Interventional

Summary: 
      Women undergoing their first second or third cesarean section will be randomized into two
      groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the
      other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days
      for both groups. The incision will be inspected at the time of staple removal. The 2 groups
      will be compared for incision disruption and infection. Also, the women will be asked about
      their satisfaction for time of bandage removal.
    


Intervention name(s): abdominal bandage
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: cesarean; bandage removal; infection; disruption; satisfaction; patient satisfaction
Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF)
      distributions have a greater impact on children's health than the standard RUSF distributions
      during the hunger gap period (june to september). We estimated that the 12 month RUSF will
      decrease the incidence of severe acute malnutrition by 33% compared to an administration only
      during the hunger gap period (4 month a year).
    


Intervention name(s): Ready-to-Used Supplement Food administration
Intervention type(s): Dietary Supplement
Other intervention name(s): Plumpy 'doz
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: malnutrition; children's health; prevention; ready-to-use supplementary food; lipid based nutrient supplement; chad; children
Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects
Condition: Allergic Rhinitis; Rhinoconjunctivitis; Exposure
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      To assess the reproducibility of the allergic response in the cat allergic subjects, measured
      as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge
      days.
    

Detailed description: 
      To validate the Red Maple Trials Natural Exposure Chamber for cat exposure studies in
      non-asthmatic subjects with perennial allergic rhinitis and allergy to cat dander by
      examining the reproducibility of the response on two allergen challenge days and comparing
      the response of allergic to non-allergic subjects.
    

Intervention name(s): Allergen Exposure
Intervention type(s): Other
Intervention description(s): Subjects will undergo two exposure sessions, one week apart, of up to 1 hour depending on the subject's symptom severity and pulmonary function. During the exposure, subjects will be exposed to cat dander and levels of cat allergen, Fel d1, will be measured using sampling pumps with attached filters.
Other intervention name(s): Environmental Exposure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Environmental Exposure Unit; Cat Allergen; Rhinitis; Subject Validation
Internationally Adopted Children Quality of Life
Condition: Children; Quality of Life
Study type: Observational

Summary: 
      This study evaluates the global quality of life of foreign born adopted children, one to
      seven years following their arrival in France. Investigators will assess global health,
      behavior, school integration for each child who arrived in France between 2008 and 2013,
      through an online anonymous survey. Investigators, then, will identify variables associated
      with a lower quality of life in order to improve the support offered to the children.
    

Detailed description: 
      Investigators will use a known and official quality of life score: the PedsQL®. This score
      has never been used in this population so investigators will first have to test its internal
      validity, so that investigators cannot use it in their global evaluation. The second stage
      will consist of identifying variables associated with a lower quality of life, as previously
      determined. Investigators will send letters to each family through the adoption department of
      each area enrolled in our study, to ensure data. Parents and children will be required to
      login to a safe, anonymous, controlled website in order to input their data. The data will be
      recorded on the internal server of Nantes University Hospital. This study has been accepted
      by both the Computing and Liberties Commission (CNIL) and Nantes University Hospital's Ethics
      group in the field of Health (GNEDS) comities.
    

Intervention name(s): quality of life evaluation
Intervention type(s): Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All international adopted children, who arrived in France between 2008 and 2013, living in
        four French districts (Loire-Atlantique, Ille-et-vilaine, Maine et Loire and Finistère)
      
Keywords: adoption; children; quality of life
Outcome of Women With Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed
      countries over the past 40 years, however, there has also been an increase in relative and
      absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix
      over the same period.

      Our understanding of the natural history and optimal management of AC is limited. It appears
      that AC and SCC of the cervix behave differently. They are different in epidemiology,
      prognostic factors, and patterns of failure after similar treatments. Available data suggest
      that they may also differ in their response to treatment. We postulate that new treatment
      strategies specifically tailored to AC should be explored.

      However, there is few data about outcome of cervical cancer in Taiwan. So we propose this
      proposal for retrospective analysis of clinicopathological parameters and outcomes in
      patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous
      carcinoma.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the cases with cervical cancer
Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Epiretinal Membrane
Condition: Epiretinal Membrane
MeSH terms: Epiretinal Membrane
Study type: Interventional

Summary: 
      Purpose: To evaluate macular sensitivity and its correlation with visual acuity and Spectral
      Domain Optical Coherence Tomography (SD-OCT) in eyes with idiopathic epiretinal membrane
      (ERM).

      Design: Cross sectional case-control series.

      Methods:

      Setting: Dijon University Hospital. Patients: Forty nine patients (49 eyes) with idiopathic
      ERM and twenty-seven healthy patients (27 eyes) as a control group.

      Main outcome measurement: Microperimetry, Spectral Domain Optical Coherence Tomography
      (SD-OCT).
    


Intervention name(s): Epiretinal Membrane Surgical treatment
Intervention type(s): Procedure
Intervention description(s): epiretinal membrane peeling
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Microperimetry; OCT; idiopathic epiretinal membrane
Total Hip Arthroplasty: Fast Track Protocol is the Future?
Condition: Hip Osteoarthritis; Arthropathy of Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Fast-track total hip arthroplasty (THA) is a well-established concept including optimized
      logistics and evidence-based treatment, focusing on minimizing surgical stress and improved
      post-operative recovery. The aim of this protocol is to compare the standard care and fast
      track total hip arthroplasties in terms of functional and subjective outcomes, hospital
      staying, number of transfusions and analgesic consumption.
    

Detailed description: 
      The aim of this protocol is to compare standard care and fast track total hip arthroplasties.
      The fast track care consists of:

        -  preoperative educational lesson in which orthopedic surgeon, anesthesiologist and
           physiotherapist illustrate the operative and post operative path to the patients

        -  antalgic protocol administered only orally

        -  early rehabilitation care. The day of the surgical operation, the physiotherapist helps
           the patient reach the upright position. The standard care consists of usual antalgic and
           physiotherapy post-operative care:

        -  Antalgic protocol consist in intravenous drugs

        -  the first physiotherapy session is the day after surgery.
    

Intervention name(s): Fast Track Protocol; Standard Care Protocol
Intervention type(s): Procedure; Procedure
Intervention description(s): Fast Track Care consists in educational preoperative preparation for patients, particular strategies for controlling pain and intensive early rehabilitation protocol; Standard Care Protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study aims to evaluate the effectiveness of a fast track protocol , which consists of an innovative analgesic therapy scheme and a rapid rehabilitation protocol, and a standard care protocol.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fast track care; total hip arthroplasty
Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first
      stage of labor would be an effective and safe health care procedure for nulliparas. Doulas,
      women with labor experience trained for parturients, is a new way to alleviate the
      psychological stress from the laboring pain. Previous data in our study showed that doula
      accompany is a good method in shortening the progress of labor used in the active phrase of
      the first stage of labor, and decreasing the rate of cesarean delivery. Investigators
      hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be
      a superior means for effective pain relief, decreased rate of cesarean section, and shortened
      duration of labor.
    


Intervention name(s): Doula combined analgesia; Analgesia without doula
Intervention type(s): Procedure; Procedure
Intervention description(s): Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas; Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Doula; Patient-controlled epidural analgesia; Neuraxial analgesia; Labor analgesia
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy
      male subjects following single rising low, medium and high doses.
    


Intervention name(s): BI 655130; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection
      with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.
    

Detailed description: 
      This study is observational :

      This substrate ablation method is performed routinely in the centers involved in the study
      so, patients were not assigned by the investigators to undergo a specific procedure because
      of the study, in all cases patient would have beneficiate from this substrate mapping
      ablation method.

      We assessed procedural and follow up outcomes of this subatrate ablation group and compared
      them with an historical control group undergoing conventional ablation.
    

Intervention name(s): Routine substrate ablation without pulmonary vein Isolation; Routine conventional ablation with pulmonary vein Isolation
Intervention type(s): Procedure; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient from 18 to 85, with AF* (paroxysmal, and persistent AF) and indication of AF
        ablation (including redos)*

        *In accordance with the recommendation of European Society of Cardiology (2010).
Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this
      clinical trial were to determine how baxdrostat might be absorbed and metabolized using
      radioactive [14C] labeled baxdrostat. Subjects were administered a single oral dose of 10 mg
      containing approximately 100 μCi of [14C] baxdrostat. Subjects were to be confined to the
      study site for 9 to 15 days for blood, urine, and feces collections.
    


Intervention name(s): baxdrostat
Intervention type(s): Drug
Intervention description(s): a blood pressure lowering drug, oral dose
Other intervention name(s): CIN-107
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics (PK); metabolism; baxdrostat
Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets in Children
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets,
      in children of 6 to 14 years, comparing a given formula with an improved one with reduced
      mineral content (qualitatively equivalent to the first one) and a comparator product.
    


Intervention name(s): Kiddi® Pharmaton Fizz, effervescent tablets; Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula; Comparator product
Intervention type(s): Drug; Drug; Drug
Intervention description(s): active substances: Vitamin A, Vitamin B1, Vitamin B2, Vitamin B5, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Manganese, Copper, Calcium, Magnesium, Phosphorous, Iron, Zinc, Sodium, Molybden
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment