bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric Normative Movement Analysis Data Collection
Condition: Pediatric ALL
Study type: Observational

Summary: 
      The objective of this project is to collect baseline data from a normative population of
      children that gender and age matches the population of patients expected to be treated by
      Mary Bridge Children's Therapy Services and seen in the Research and Movement Laboratory.
      This project seeks to recruit 25 male and 25 female typically developing children between the
      ages of 3 and 18 years of age. Non-invasive measurements of movement patterns will be
      collected during common activities of daily living over a single data collection session.
    


Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age. Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A group of 50 neurotypical pediatric subjects will be recruited for this data collection.
        Children will be assigned to 1 of 5 age groupings (3-5, 6-8, 9-11, 12-14, 15-18), with an
        equal amount of male/female in each.
Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)
Condition: Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether tranilast at two different dosages compared
      to placebo is effective in patients with active RA when added to continuing methotrexate
      (MTX) therapy.
    

Detailed description: 
      The primary objective of this study is to assess the efficacy and safety of two different
      doses of tranilast as determined by ACR20 response at 12 weeks.
    

Intervention name(s): Tranilast; Tranilast; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mg tranilast tablets, bid, 12 weeks; 75 mg tablets, bid, 12 weeks; Placebo tablets, bid, 12 weeks
Intervention MeSH terms: Tranilast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis
Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children
Condition: Dental Caries in Children; Satisfaction; Cost Effectiveness; Oral Health; Quality of Life
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Tooth decay is one of the most common chronic infectious disease found in children worldwide
      and if left untreated, is rapidly progress. Severe tooth decay in children is not only affect
      child's health and school performance, but also has impact on the family well-being. Oral
      rehabilitation in children requires time, resources and effort of dental specialists, the
      child and parents. Caries is a destructive condition of organic and inorganic components of
      the tooth structures but reversible and most importantly, preventable. Topical fluoride
      therapy, delivered by dentists has been effectively used to speed up the repair process as
      well as to strengthen the surface of intact tooth structure. Topical fluoride is available in
      various preparations. Regular application of sodium fluoride varnish is every three months,
      by far, considered as effective method in preventing new caries, particularly in the
      high-risk children. It has the advantage of containing therapeutic concentration of fluoride
      and ability to flow over and stick to the tooth surface. Whereas silver ion and relatively
      higher fluoride concentration in Silver Diamine Fluoride (SDF) has been shown to be the most
      effective in harden the decay, stop the caries progress and eliminate pathogenic bacteria. It
      can be hypothesize that when use in combination in school children, both reagents might have
      synergistic effect on arresting existing caries as well as preventing new caries.
    

Detailed description: 
      Fluoride varnish is a good choice to consider. For caries prevention in young children, It
      has high efficacy in caries prevention.

      Fluoride varnish has a high F concentration and prolong contact time with enamel, So it can
      prevent new caries and remineralize initial enamel caries. Silver diamine fluoride solution
      is effective in arresting dentine caries. Silver diamine fluoride has high fluoride
      concentration and contain silver ion. when apply dentine caries or cavitated caries can
      increase hardness of dentine and arresting caries.

      When use in combination, it might enhance, the Efficacy in Arresting and Preventing Dental
      Caries in children
    

Intervention name(s): SDF; Fluoride varnish
Intervention type(s): Device; Device
Intervention description(s): 38% silver diamine fluoride solution; 5% sodium fluoride varnish
Other intervention name(s): Silver diamine fluoride; Sodium fluoride varnish
Intervention MeSH terms: Fluorides; Sodium Fluoride; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Silver Diamine Fluoride; Sodium Fluoride Varnish; Arrest caries; Caries prevention; Cost Effectiveness; Oral Health; Quality of Life
mil60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy
      and safety of mil60 with bevacizumab as first-line treatment when combined with standard
      chemotherapy (paclitaxel/carboplatin) in treatment-naive patients with advanced or recurrent
      non-squamous NSCLC.
    

Detailed description: 
      This is a multicenter, double-blind, randomized, parallel-group Phase 3 clinical trial
      evaluating the efficacy and safety of mil60 plus paclitaxel and carboplatin versus
      bevacizumab plus paclitaxel and carboplatin in first-line treatment for patients with
      advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.The
      primary objective of the study was to compare the Objective Response Rate according to RECIST
      1.1 of mil60 in combination with paclitaxel plus carboplatin and bevacizumab plus paclitaxel
      plus carboplatin in the treatment of advanced or recurrent non-squamous NSCLC subjects.
    

Intervention name(s): mil60; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): 15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg; 15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to mil60 at 7.5mg/kg
Other intervention name(s): No other intervention name; Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Psychobiological Effects of Participation in a One-Month Insight Meditation Retreat
Condition: Aging
Study type: Observational

Summary: 
      The purpose of this study was to examine how participation in a 1 month intensive Insight
      (vipassana) Meditation retreat (a) affects biological markers of cellular aging, social
      affiliation, and inflammation, which are important for physical health, longevity, and
      behavior, and (b) to relate observed biological changes to baseline levels and changes in
      psychological traits, which may underlie improvements in personal adaptive functioning.
    

Detailed description: 
      The investigators are specifically assessing the effects of retreat on telomere length and
      telomerase levels in participants' white blood cells, as well as plasma levels of
      interlukin-6 (IL-6), to assess how the retreat experience impacts these markers of cellular
      aging and inflammation. The hypotheses are that retreat participation will increase both
      telomere length and telomerase activity, but decrease IL-6 levels. The investigators will
      also assess the impact of retreat participation on oxytocin-a hormone involved in a number of
      physiological and behavioral processes, including affiliative bonds and stress responses-the
      hypothesis being that participation in the retreat will increase plasma oxytocin levels. The
      investigators will then explore how these and other biomarkers relate to psychological
      processes and personality traits, which may also be altered by participation in the
      meditation retreat.
    

Intervention name(s): Residential Insight Meditation Retreat
Intervention type(s): Other
Intervention description(s): Retreats at Spirit Rock Meditation Center were led by teams of 6 experienced teachers. Participants practiced "noble silence"-refraining from eye contact as well as verbal and written communication-except during meetings with teachers. Teachers lead guided Insight meditation practices, as well as meditations on loving-kindness, compassion, empathetic joy, and equanimity. The daily schedule consisted of sitting and walking meditation sessions (30-45 mins) totaling 8-10 hours/day, meals, and short work meditations (sweeping, dishes, etc.). Seated meditation was practiced as a group in a meditation hall with approximately 80 participants. Walking meditation took place in adjoining halls or on the grounds. Participants lived on-site during the retreat and were provided with a vegetarian diet.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults with meditation experience
      
Biospecimen description: 
      whole blood, peripheral blood mononucleocytes, plasma, serum
    
Keywords: Well-being, affiliation, inflammation
Increased Prevalence of Myopia in a Ophthalmologic Hospital in Goiânia - Goiás
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      The purpose of this study was to evaluate the increased prevalence of myopia among patients
      in different periods in an ophthalmologic hospital in Goiania. There has been an increase of
      myopia prevalence around the world especially in some Asian countries. The investigators
      intend to analyze if this growing tendency is also present in our hospital, and if it exist
      how much is this growth.
    

Detailed description: 
      There were compared data collected in two scientific studies carried out in the same
      ophthalmologic hospital in different periods of time, they evaluated among other factors, the
      refractive errors of the participants, from this data there were compared the percentage of
      patients with myopia between the two studies. And analysed how much was the grown of myopia
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        16.806 students from municipal schools of Goiânia during the period October 1995 to
        December 2000 In the second study there were selected 165 children from 2 to 14 years old
        who were referred to the Institute of Goiânia eyes, look at Brazil project within the
        school environment. The Look Brazil project aims to identify vision problems related to
        refraction.
      
Keywords: Prevalence; Myopia
Staccato Loxapine in Agitated Patients With Schizophrenia
Condition: Patients With Schizophrenia and Acute Agitation
MeSH terms: Psychomotor Agitation; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in
      schizophrenic patients
    

Detailed description: 
      This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2
      dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study
      drug in a 24-hour period, depending on their clinical status. The primary endpoint is the
      change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component
      (also known as PEC) score, performed at 2 hours after the first dose.
    

Intervention name(s): Inhaled loxapine 5 mg; Inhaled loxapine 10 mg; Inhaled placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled loxapine 5 mg; Inhaled loxapine 10 mg; Inhaled placebo
Other intervention name(s): ADASUVE; ADASUVE
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia, agitation, inhaled loxapine, ADASUVE
Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
Condition: Nicotine Dependence, Other Tobacco Product; Tobacco Use; Smoking, Tobacco
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The JUUL 5% Electronic Nicotine Delivery System (ENDS) is being studied as an alternative to
      combustible cigarette use. This study aims to find out how much nicotine is in the blood and
      urine of healthy adult subjects after using three JUUL 5% ENDS compared to smoking usual
      brands of combustible cigarettes and stopping smoking.
    

Detailed description: 
      This study will serve as a clinical evaluation of the exclusive use of selected JUUL ENDS,
      with the purpose of gaining an understanding of toxicant exposure.
    

Intervention name(s): Treatment with JUUL 5%, Virginia Tobacco; Treatment with JUUL 5%, Cool Mint, ENDS; Treatment with JUUL 5%, Mango, ENDS; JUUL 5%, Creme Bruele, ENDS; Combustible cigarette; Smoking Cessation
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): JUUL 5%, ENDS for 5-days in confinement; JUUL 5%, ENDS for 5-days in confinement; JUUL 5%, ENDS for 5-days in confinement; JUUL 5%, ENDS for 5-days in confinement; Exclusive use of combustible cigarette for 5 days in confinement.; No smoking for 5-days in confinement.
Other intervention name(s): JUUL; JUUL; JUUL; JUUL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      The aim of the study is to show that auriculotherapy decreases the number of days with
      painful episodes of migraine and headache after 3 months of treatment
    

Detailed description: 
      Prospective, multicenter, controlled and randomized study.

      At the inclusion:

        -  initial assessment of migraine and headache attacks of the last 3 months with the
           migraine/headache/treatment diary;

        -  quality of life assessment (MIDAS questionnaire).

      Patients are randomized in 2 groups (distribution 2/3 AUR+, 1/3 AUR-):

        -  AUR+: experimental group "Auriculotherapy". Patients benefit from 3 sessions of
           auriculotherapy at one month intervals.

        -  AUR-: control group. Patients do not benefit from auriculotherapy.

      After 3 months, a visit of Algology is carried out :

        -  final assessment of migraine and headache attacks of the last 3 months with the
           migraine/headache/treatment diary;

        -  quality of life assessment (MIDAS questionnaire).
    

Intervention name(s): Auriculotherapy
Intervention type(s): Procedure
Intervention description(s): 3 sessions of auriculotherapy at one month intervals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Auriculotherapy
A Case-Series Examination of a Brief CAT-Informed Intervention (CATCH-Y) for Young People That Have Self-Injured
Condition: Non-Suicidal Self Injury
MeSH terms: Self-Injurious Behavior
Study type: Interventional

Summary: 
      Non-suicidal self-injury (NSSI), the term used for when somebody purposefully hurts
      themselves without intending to end their life. Often, it suggests that there are other
      difficulties going on in someone's life. Talking therapies can be offered to help however
      currently there is little evidence to show which therapies help most. CATCH-Y (Cognitive
      Analytic Therapy for Containing Self-Harm in Young People) is a brief talking therapy which
      has been created to support young people who self-injure. It aims to help young people and
      those around them build to a shared understanding of their difficulties. Previously a group
      of adults, who have a history of self-harm, have engaged in a trial version of CATCH-Y for
      adults, in which it was found to be positive, safe and feasible.

      The study will aim to recruit nine young people who have self-injured in the past.
      Participants must be aged between 13 - 17 years old and have self-injured within the last six
      months. They will be recruited from local Child and Adolescent Mental Health Services (CAMHS)
      and associated 3rd sector organisations. The therapy is five sessions long, with two
      assessment sessions before the therapy begins and one assessment session post-therapy. Online
      assessments will be completed throughout. CATCH-Y involves working with the therapist to
      understand a young person's past and current experiences, linked to their self-injurious
      behaviours. This individualised approach could benefit these young people.

      As a novel treatment, and in accordance with the medical research council (MRC) framework,
      the feasibility and acceptability of CATCH-Y should be considered before progressing to a
      larger trial. This trial will examine the feasibility and acceptability of the CATCH-Y
      intervention through attendance and retention rates, data completion and intervention
      acceptability. As a secondary measure, the trial will investigate whether CATCH-Y shows
      preliminary evidence for positive change.
    


Intervention name(s): Cognitive Analytic Therapy for Containing Self-Harm in Young People
Intervention type(s): Other
Intervention description(s): The intervention will run over five sessions, each lasting around 30 - 40 minutes. Researchers will follow the CATCH-Y manualised treatment guide. CATCH-Y is a brief, five session psychological intervention based upon CAT principles and designed to help young people who have self-injured.
Intervention model: Single Group Assignment
Intervention model description: Single group case series design
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Blueberry Consumption on Metabolic Syndrome & DNA Damage
Condition: Metabolic Syndrome; Insulin Resistance; DNA Damage
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      Obesity usually brings with it disturbances in the body that increase the chances of
      developing serious diseases like diabetes and cancer. These disturbances include one or more
      symptoms of a condition called "metabolic syndrome" that often leads to diabetes. High levels
      of damage to the DNA that makes up our chromosomes have also been observed in obese people.
      It is possible that these two disturbances are connected. The goal of this project is to test
      this whether consumption of blueberries will improve these abnormalities.
    

Detailed description: 
      Unbalanced diets rich in refined carbohydrate calories, saturated fats, and trans fats, but
      low in vitamins, minerals, fiber, polyphenolics and ω-3 fatty acids are common in the United
      States, particularly among the obese. Insulin resistance and high levels of DNA damage
      commonly accompany obesity. There also appears to be a relationship between oxidative
      DNA-damage and biomarkers that characterize metabolic syndrome. The bioactivity of
      blueberries is usually attributed to their high content of polyphenolics which can reduce
      oxidative DNA damage. Since oxidative damage to mitochondrial DNA is a suggested causal
      factor leading to increased insulin resistance, we will test if blueberry consumption can be
      an ameliorative dietary factor for insulin resistance as well. If blueberry consumption both
      shifts metabolism away from insulin resistance and reduces DNA damage, it may be a useful
      tool to assist in understanding relationships between these two obesity-associated
      conditions.
    

Intervention name(s): Blueberry Powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin; diabetes; obesity; DNA damage; metabolic syndrome
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Postural Control in Lowlanders
Condition: Effect of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Prospective interventional trial in lowlanders evaluating the effect of acute exposure,
      acclimatization and re-exposure to high altitude on postural control
    

Detailed description: 
      Baseline measurements including the assessment of the center of pressure during 30s, the
      cerebral oxygen saturation and a sharpened Romberg test will be performed in Santiago de
      Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline
      (5 h flight) and by bus (3 h ride) to the base camp of the Atacama Large
      Millimeter/Submillimeter Array (ALMA) telescope station located at 2900 m near San Pedro de
      Atacama, northern Chile. Participants will stay there for the next 8 nights and they will be
      spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing testing as
      described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m
      will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants will
      return to the Santiago area (520 m) for a 6 day recovery period.

      A second altitude sojourn with an identical schedule as the one described above and a final
      low altitude stay of 3 days will follow.
    

Intervention name(s): altitude exposure
Intervention type(s): Other
Intervention description(s): altitude exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: postural control; high altitude