bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are
      uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One
      possible explanation is that the patient is unable to inhale the dry powder bronchodilator
      medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A
      PIFR < 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device.
      The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured
      at two hours after inhalation of the study medication will be higher with arformoterol
      solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from
      the Diskus.
    


Intervention name(s): arformoterol; salmeterol
Intervention type(s): Drug; Drug
Intervention description(s): 15 mcg administered via nebulizer; 50 mcg delivered vis Diskus
Other intervention name(s): Brovana; Serevent
Intervention MeSH terms: Salmeterol Xinafoate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breathing difficulty
Long-Term Treatment With rhIGF-1 in GHIS
Condition: Growth Hormone Insensitivity Syndrome
MeSH terms: Laron Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study was to evaluate the long-term safety and effectiveness of
      mecasermin (the study drug) in children with growth failure due to severe Primary
      insulin-like growth factor-1 deficiency (Primary IGFD).
    


Intervention name(s): mecasermin
Intervention type(s): Drug
Intervention description(s): injections BID of rhIGF-1, mecasermin
Other intervention name(s): Increlex
Intervention MeSH terms: Mecasermin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: growth; insulin like growth factor; Laron syndrome
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections
Condition: AKI; ARDS; COVID
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing
      positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.
    


Intervention name(s): SCD
Intervention type(s): Device
Intervention description(s): cytopheretic device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of the Head Position on the Occlusion of Implant-supported Fixed Restorations
Condition: Dental Occlusion
Study type: Observational

Summary: 
      The development of a implantology leads to an increasing use of implants in the treatment of
      care for the loss of one or more teeth. The question is whether the existing guidelines,
      originally formulated for the occlusion of natural dentition and conventional prosthetic
      treatment can be applied to the implant prosthodonticsDue to initial differences in the
      vertical mobility of teeth and dental implants, present in the same dental arch, although the
      model of occlusion is ideal, undesirable premature occlusal contacts on the fixed dental
      restorations on implants may be present.

      Objective: To evaluate the effect of different head positions on dental occlusion of the
      natural teeth and fixed dental restorations on implants.

      Methods: Volunteers with complete dentition would be included in this study as the Control
      Group. The Study Group would include subjects with fixed dental restorations on implants in
      the transcanine region. A T Scan III System will be used for occlusal analysis.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who refered to the Clinic for Prosthodontics due to the lack of one or more teeth
        that need to be replaced with dental implants and healthy completely dentate volunteers.
      
Keywords: dental occlusion; head posture; fixed dental restorations; dental implants; implant occlusion; computerized occlusal analysis
Mindfulness Meditation in Chronic Stress
Condition: Aging
Study type: Interventional

Summary: 
      The study purpose is to evaluate efficacy of a mindfulness training intervention and learn
      about cognitive and physiological markers of stress.
    

Detailed description: 
      Subjects will first undergo a phone screening, and if eligible, they will complete three
      study visits at Week 1, Week 8, and Week 15. The study visits involve at-home surveys, voice
      recordings, physical measures (height, weight, waist-to-hip ratio, and blood pressure), EEG
      recordings (including recordings of electrodermal activity and heart rate variability),
      computer tasks, in-lab saliva collection, overnight urine collection, 2-day saliva collection
      at bed waking, 30 minutes post-waking, afternoon, and bedtime, and a small handheld device
      that randomly administers eight short assessments in the subjects' natural environment.
      Subjects will be randomized to receive a 6-week mindfulness meditation course either between
      the first and second study visits or between the second and third study visits. Participants
      who receive training during the first and second visits will continue meditating until the
      third visit. The one-on-one instruction occurs once a week for 1 ½ hours, and participants
      are asked to listen to guided meditations and do other mindfulness-based tasks on a daily
      basis between sessions.
    

Intervention name(s): Mindfulness Meditation Training
Intervention type(s): Other
Intervention description(s): One-on-one mindfulness meditation training, 6 weeks, 1 1/2 hour training once per week, 30-45 min at-home practice per day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress; Mindfulness; Meditation
Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      The current study evaluates the immunogenicity and safety in 4-6 years old female subjects
      (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as
      compared to 4-6 years old female subjects (control group) receiving sequentially Priorix
      (Month 0) and Infanrix (Month 6) vaccines.
    


Intervention name(s): Cervarix; Priorix; Infanrix
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.; 1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.; 1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.
Other intervention name(s): HPV; MMR; DTPa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Immune response; Human papillomavirus; HPV vaccine; Safety
Improving Physical Activity in Young Adult Cancer Survivors
Condition: Physical Activity; Quality of Life
Study type: Interventional

Summary: 
      The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the
      Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the
      Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39
      years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer
      influences will be engaged via a private, social network (e.g. a Facebook group) customized
      for survivors. Measurements will be completed (1) at baseline, prior to randomization, and
      (2) during the final week of the intervention period (follow-up measure). This pilot study
      will provide initial proof of concept and allow for further customization of the intervention
      for cancer survivors in anticipation of a future, larger proposal to study physical activity
      and related outcomes over a multi-year period.

      Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT,
      we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39
      years and between 1.0-5.0 years from the completion of active cancer therapy, (2)
      intervention participants wear the Fitbit Flex on the majority of all intervention days
      during the 12-week intervention period, and (3) ≥75% of all participants complete online
      questionnaire data collection at Time 1 and Time 2.
    


Intervention name(s): Fitbit + Facebook + Coaching Group; Fitbit only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support.; Participants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Comparison and Analysis of Blood Loss Formulas
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      Although it has been pointed that estimates are significantly inexact and different from each
      other, the actual accuracy of them has not been properly investigated and compared.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients electively scheduled for laparoscopic surgery.
Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents
Condition: Obesity; Endothelial Dysfunction; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents
      have a high prevalence of Vitamin D deficiency as well as evidence of endothelial
      dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with
      Vitamin D would lead to improvement in endothelial dysfunction.
    

Detailed description: 
      Subjects had a brief screening visit with one of the study team members. Past medical
      history, current medications and a brief dietary history was taken. The dietary history was
      taken to assess calcium intake in a day and was obtained via the validated Short Calcium
      questionnaire. Blood pressure, heart rate as well as height,weight, waist and hip
      circumference measurement was obtained by study staff. In addition, a brief physical
      examination to determine Tanner stage was also completed. This involved examination of both
      breasts and genitalia for adolescent female and only genitalia in males. A physical activity
      questionnaire (IPAQ) was also administered by the study staff at this visit. A blood draw of
      5 ml to measure plasma 25(OH) D, calcium, phosphorus was obtained as part of the screening
      visit. For girls who had started menstruating, a urine pregnancy test was also obtained.

      After the screening visit eligible subjects had baseline biochemical tests and an endothelial
      function assessment. Study participants received a pill container with six total pills of
      vitamin cholecalciferol (D3) (1 pill = 50,000 IU), with directions to take two pills once a
      month (100,000 IU) at the same time for a period of 3 months. Compliance was assessed at the
      3 month visit by counting the number of pills remaining in the container.

      At 1 month, the subjects had tests for serum calcium and 25 hydroxy vitamin D levels. A urine
      test for random calcium to creatinine ratio was also obtained.

      At 2 months, the serum calcium, 25 hydroxy vitamin D levels, and calcium to creatinine ratio
      tests were repeated.

      At the end of 3 months, biochemical tests and an endothelial function assessment were
      repeated. Medical history, questionnaires, and the physical exam were also repeated.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin D 3 at 100,000 IU once a month for 3 months
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Endothelial dysfunction; Vitamin D deficiency
A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. The
      new treatment intervention is based on the DIR Model. Parents will be coached at the start
      and then every 3-4 months for 1 year. Outcome will be measured at the first session and at
      the end of the study using Functional Emotional Assessment Scale and Childhood Autism Rating
      Scales, Functional Emotional Level, and parent satisfaction rating.

      Hypothesis of the study: Children who get additional treatment of DIR/floortime show much
      improvement in climbing the developmental "ladder" and declining in the autistic behaviors.
    


Intervention name(s): DIR/Floortime parent intervention
Intervention type(s): Behavioral
Intervention description(s): Parent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
Condition: Haemophilus Influenzae Type B; Hepatitis B
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus)
      in healthy infants using a modified process in a combination Haemophilus Influenzae, type
      b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B
      vaccine
    


Intervention name(s): Comparator: Modified Process Vaccine; Comparator: COMVAX™
Intervention type(s): Biological; Biological
Intervention description(s): Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months.; COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Haemophilus Influenza, type b and Hepatitis B
Telerehabilitation in Women With Rheumatic Disease
Condition: Rheumatic Disease
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      This study aims to investigate the effectiveness of the Biopsychosocial Exercise Therapy
      Approach (BETY), which is a biopsychosocial model, on daily living activities, anxiety,
      depression, and biopsychosocial conditions through telerehabilitation in rheumatic patients
      who could not go to the clinics during the COVID-19 pandemic.
    

Detailed description: 
      35 female participants with rheumatic disease were included in the study. Among the
      individuals who participated in face-to-face BETY sessions before, 23 individuals who agreed
      to exercise with telerehabilitation were divided into 2 groups, the exercise group, and 12
      individuals in the control group.

      Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attended
      sessions that lasted for one and a half hours, 3 days a week for 8 weeks, in the company of a
      physiotherapist over the Whatsapp group. The investigators, who provided supervision during
      the sessions, also participated in the exercises simultaneously. The investigators managed
      the individuals according to their exercise number and order, by reminding them of the
      exercises with explanatory messages and positive energy via Whatsapp group. The participation
      of the patients in the exercises was followed up with the answers they gave in the Whatsapp
      group. Patients who did not respond were called by phone and checked to see if they provided
      continuity. Both the exercise group and the control group continued their drug treatments
      during this period.

      Group 2: Control group: Individuals in the control group continued their routine drugs.
    

Intervention name(s): Biopsychosocial Exercise Therapy approach (BETY); Control group
Intervention type(s): Other; Other
Intervention description(s): The BETY intervention is grouped under 4 headings: Patient education on chronic pain, functional body stabilization exercises (mind-body information management), dance therapy-authentic movement (emotion-state information management), and sexual information management.; The control group participants were those who did not want to receive exercise treatment with telerehabilitation and took their routine medications during the 8 weeks period.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatic diseases; Telerehabilitation; Chronic pain; COVID-19; Biopsychosocial Approach
Do Apolipoprotein E Polymorphisms Influence Risk of Cognitive Decline by Modulating Omega-3 Fatty Acid Metabolism?
Condition: Healthy
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      BACKGROUND: Compared to the epsilon 2 or epsilon 3 alleles, the epsilon 4 allele of
      apolipoprotein E (ApoE4) is associated with twice the prevalence of late-onset Alzheimer's
      disease (AD). Epidemiological studies show that risk of AD varies inversely with consumption
      of omega-3 fatty acids from fish and seafood. Despite apparently lower fish intake in AD,
      pooled analysis of the literature shows that plasma and brain docosahexaenoic acid (DHA) is
      actually the same in AD as in healthy age-matched controls. Fish oil trials in AD are also
      not convincing. We recently shown that ApoE4 carriers have 41% higher fasting plasma EPA and
      DHA compared to non-carriers, but the plasma EPA and DHA response to fish oil in ApoE4
      carriers was half that seen in non-carriers.

      HYPOTHESES: (i) Carriers of ApoE4 have altered metabolism of carbon-13 (13C)-DHA as well as
      EPA and DHA provided in a dietary supplement. (ii) A dietary supplement of EPA+DHA will
      improve cognitive performance but only in non-carriers of ApoE4.

      OBJECTIVES: In both carriers and non-carriers of ApoE4, to compare whether- i) ApoE4 alters
      incorporation of 13C-DHA into plasma lipids or its beta-oxidation.

      ii) 13C-DHA metabolism changes while on a dietary supplement of EPA+DHA; iii) Better
      cognitive performance occurs while on EPA+DHA and is linked to raising plasma EPA and/or DHA.

      EXPERIMENTAL METHODS: Participants older than 50 y old and not demented were enrolled. DHA
      metabolism was evaluated using both 13C-DHA and an EPA+DHA supplement (2.4 g/d for 5 mo; n =
      20/gp). Before and in the last month of supplementation, plasma uptake and beta-oxidation of
      50 mg of 13C-DHA was followed during one month. Blood omega-3 fatty acids was evaluated
      monthly during the supplementation period. Cognitive testing was performed before and 4
      months after starting the omega-3 fatty acid supplement.

      IMPLICATIONS: This project will help explain the apparent link that is newly emerging between
      ApoE polymorphisms, altered omega-3 fatty acid metabolism and risk of cognitive decline, and
      should help in the development of nutraceutical-based clinical trials using fish oil for the
      elderly.
    

Detailed description: 
      To come
    

Intervention name(s): omega-3 fatty acid
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will be given four 1 g capsules of fish oil providing 1.4 g/d of EPA and 1.0 g/d of DHA as ethyl esters (Ocean Nutrition, Dartmouth, NS), which is similar to the dose used in previous studies with MCI and AD (20, 21).
Other intervention name(s): Ocean Nutrition, Dartmouth, NS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Individuals
Condition: Primary Ciliary Dyskinesia
MeSH terms: Ciliary Motility Disorders; Dyskinesias
Study type: Observational

Summary: 
      The individuals with primary ciliary dyskinesia (PCD) have lower aerobic fitness and
      anaerobic performance than healthy individuals. Cardiopulmonary exercise test (CPET) provides
      an integrated assessment of integrative exercise responses involving the pulmonary,
      cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems that are not
      adequately reflected by measurement of the function of organ systems. Maximum oxygen
      consumption is measured by performing gas exchange analysis with CPET, offering an objective
      measure of cardiorespiratory fitness. The six-minute walk test (6MWT) and the shuttle walk
      test (SWT) are field tests that produce oxygen consumption results similar to those during
      CPET. There is a need to determine the physiological responses to CPET, SWT and 6MWT in
      individuals with PCD. Additionally, the physiological responses of individuals with PCD to
      different exercise tests will be compared with the responses of healthy individuals. Low
      aerobic capacity in individuals with PCD may affect the physical, emotional, and social lives
      of individuals. This influence may cause a decrease in the quality of life of individuals
      with PCD. The relationship between exercise capacity and quality of life in individuals with
      PSD will be investigated with this study.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The children with primary ciliary dyskinesia and healthy children