bioihbjkbjnl/mcl2 huggingface dataset:
Age-Related Changes and Cycloplegia-Induced Differences in the Human Crystalline Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The ocular biometric parameters of the human crystalline lens including anterior chamber
      depth (ACD), lens thickness (LT), radii of curvature of anterior and posterior lens (ALR and
      PLR), lens equatorial diameter (LED), and lens vault (LV), automatically quantified by the
      CASIA2 (SS-OCT; Tomey, Nagoya, Japan). Images of iridocorneal angle were obtained using
      CASIA2 and the Schlemm' s canal (SC) and trabecular meshwork (TM) were quantified manually.
      Both cycloplegia and non-cycloplegia images were obtained.
    

Detailed description: 
      Healthy individuals aged between 6 and 90 years, without history of ocular disease (except
      age-related cataract and/or myopia), were consecutively included from April to May 2019. All
      participants underwent visual acuity, dry and wet refraction, anterior and posterior segment
      examination, intraocular pressure (IOP), and axial length (AL) using IOL-Master 700 (Carl
      Zeiss Meditec AG). Investigators recruited children under 18 years old at a refraction
      outpatient clinic, who were prescribed cyclopentolate hydrochloride eyedrops (S.A.
      Alcon-Couvreur N.V., Belguim) for cycloplegic refraction. For adults, they were prescribed
      compound tropicamide eyedrops (Mydrin-P, Santen Pharmaceutical Co., Ltd, Osaka, Japan),
      consisting of 0.5% tropicamide mixed with 0.5% phenylephrine hydrochloride, for pupillary
      dilation in order to perform fundus examination at an outpatient clinic. Exclusion criteria
      were as follow:ocular diseases other than cataracts; history of eye surgeries or injuries;
      shallow anterior chamber with a risk of angle closure. The data from right eye was selected
      for analysis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy individuals aged between 6 and 90 years, without history of ocular disease (except
        age-related cataract and/or myopia) at Eye hospital of Wenzhou Medical University
      
Keywords: radius of curvature; lens thickness; equatorial diameter; lens vault; cycloplegia; swept-source optical coherence tomography; schlemm' s canal; trabecular meshwork
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with
      Moderate to Very Severe Chronic Obstructive Pulmonary Disease
    

Detailed description: 
      A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to
      Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to
      Very Severe Chronic Obstructive Pulmonary Disease
    

Intervention name(s): BGF MDI 320/14.4/9.6 μg; GFF MDI 14.4/9.6 μg; BFF MDI 320/9.6 μg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Budesonide, Glycopyrronium, and Formoterol Fumarate; Glycopyrronium and Formoterol Fumarate; Budesonide and Formoterol Fumarate
Other intervention name(s): BGF MDI; GFF MDI; BFF MDI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether oral topic silver nanoparticles are
      effective to reduce potential pathogen microbial loads in mechanical ventilation patients.
    

Detailed description: 
      All patients were performed with oral hygiene as recommended by the clinical practice
      guidelines for the prevention, diagnosis and treatment of pneumonia associated with
      mechanical ventilation. After that, placed the treatment of an innocuous gel compound with
      12ppm of silver nanoparticles or gel alone according to randomization. Then obtain and plant
      samples taken before the treatment 6 hours after. Comparing the results of the baseline
      sample with the final.
    

Intervention name(s): silver nanoparticles; placebo
Intervention type(s): Other; Other
Intervention description(s): Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into an innocuous gel and dished in oral mucosa surface to then compare with another innocuous gel without silver nanoparticles to reduce microbial colony forming units of pathogenic potential.; Compare with another innocuous gel without silver nanoparticles to reduce microbial colony forming units of pathogenic potential using the same procedure to dished the gel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: silver nanoparticles antimicrobial activity
Asthma and Obesity: Pilot Study
Condition: Asthma; Obesity
MeSH terms: Asthma; Obesity
Study type: Interventional

Summary: 
      Develop and pilot test four theory-based educational modules that integrate counseling for
      asthma and obesity to promote greater physical activity among people with asthma.
    

Detailed description: 
      Of the 400 obese and non-obese adult asthmatics in New York City and Denver during the
      18-month observational phase of this study, the study team will randomize 80 participants (40
      in NYC and 40 in Denver) into a 4-week group session pilot study focused on beliefs and
      behaviors associated with asthma and obesity self-management behaviors (SMB). Eligibility
      will be determined based on Asthma Control Questionnaire (ACQ) score and body mass index
      (BMI) at their 12-month visit. Participants will be randomized into an intervention or an
      active control arm after completing their 18-month visit. Participants will be consented into
      the pilot study during or after their 18-month visit. Participants will be put into groups of
      7-10 for the pilot. Once formed, groups will have four 1-hour weekly visits. A person will be
      allowed to make up one missed session. The make-up session will be conducted on the phone or
      in-person depending on scheduling availability of both participant and care coach.
      Participants will be given accelerometers at sessions 1 and 4 that they will be asked to wear
      for seven days and return along with an activity diary. A follow-up survey will be
      administered about 30 days after the last pilot session in order to reassess the patient's
      asthma, obesity, exercise and medication beliefs and their adherence to asthma SMB. At the
      time of the follow-up survey, participants will also be given accelerometers that they will
      be asked to wear for seven days and return along with an activity diary.
    

Intervention name(s): Better asthma self-management and incorporation of physical activity; Asthma Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the asthma and exercise lifestyle change arm will participate in 4 sessions focused on behavioral change and goal-setting education to teach them how to better incorporate exercise into their daily lives and better manage their asthma. Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data.; General asthma education, but no discussion of the role of exercise and other lifestyle habits in asthma self-management. Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Asthma; Obesity; Self-management behaviors
Quetiapine (Seroquel XR) for the Treatment of Fibromyalgia: a Clinical and Mechanistic Pilot Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, randomized, placebo-controlled trial measuring the impact of
      quetiapine on clinical and experimental measures of pain in fibromyalgia and its biochemical
      correlates.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled trial measuring the impact of
      quetiapine on clinical and experimental measures of pain in fibromyalgia. The study also
      seeks to measure the hormonal, immunological and neurochemical correlates of clinical changes
      in time.
    

Intervention name(s): quetiapine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): flexible dosage (50 to 300 mg); placebo
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; pain; quetiapine; randomized placebo controlled trial
A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this pilot study is to examine the initial efficacy of a multi-dimensional
      coaching intervention ("Parentship") for parents of adolescents with High Functioning Autism
      (HFASD).

      The "Parentship" protocol is a short-term intervention program in occupational therapy that
      aims to promote parental resilience and enhance adolescents' participation in daily life.
    

Detailed description: 
      "Parentship" is a structured occupational therapy intervention for promoting parental
      resilience and enhance adolescents' participation in daily life The Parentship protocol uses
      OPC (Graham & Rodger, 2010) as the primary treatment approach. Its primary goal is to lead
      parents into recognition and understanding of their adolescent's multi-dimensional personal
      profile that includes sensorimotor, cognitive-behavioral, and social-communicative and
      personal factors, as required by the International Classification of Functioning (ICF) model
      (WHO, 2007).

      The intervention will be administered by occupational therapists on an individual (or both
      parents) basis, once a week, over 3-4 months.

      10-15 families will be recruited through community advertising. Data will be collected at the
      onset and completion of the intervention. Data will be analysed using quantitative and
      qualitative methods.

      Adverse events, if occur, will be reported to supervising neurologist and the Helsinki
      Committee.
    

Intervention name(s): "Parentship"- a multi dimensional intervention program to improve parental resilience
Intervention type(s): Behavioral
Intervention description(s): "Parentship" is a multi dimensional intervention program to improve parental resilience and adolescent participation using the OPC model.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adolescents; parents; coaching
Food Talk: A New App for Daily Food Monitoring
Condition: Dietary Intake
Study type: Observational

Summary: 
      This project will pilot test a new app for self-monitoring food intake using natural spoken
      language (by voice recognition or text) to provide daily estimates of energy and nutrient
      intakes with a phone app.
    

Detailed description: 
      Self-recording food intake is recommended for weight management and healthy eating. However,
      current methods, including web platforms and apps, are often burdensome leading to short-term
      use by the consumer. The solution uses cutting-edge speech and language understanding
      technology to streamline the food logging process. With this technology, the user simply
      describes what they ate and the system automatically selects the appropriate items and
      quantities consumed from the USDA food database, which calculates the nutrition profile of
      the entry.
    

Intervention name(s): COCO application
Intervention type(s): Behavioral
Intervention description(s): All participants will complete a screening survey to determine their eligibility for the study, if eligible and willing to participate, he or she will sign an informed consent form. Once participants are enrolled in the study, a demographics questionnaire will be completed along with 5 days of food tracking on the COCO application. Between days 3 and 7, participants will complete two 24-hr diet recall, one a day, and a patient satisfaction questionnaire.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Potential subjects will be recruited from the local community around Boston, Massachusetts.
        Recruitment methods include posting flyers, social and local media advertisements, word of
        mouth, and emails to HNRCA mailing lists.
      
Keywords: Voice recognition; 24-hr diet recall; Mobile application; Self-report
Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants
Condition: Calcium Deficiency; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate that the intestinal absorption of calcium from a
      newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount
      of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to
      baseline.
    

Detailed description: 
      The drug being tested in this study is called Calcichew. This study will look at calcium
      absorption in healthy postmenopausal women and healthy men.

      The study will enroll approximately 55 healthy adults. All participants will receive
      Calcichew.

      All participants will be asked to take one chewable tablet at the same time each day for
      three days in period 2 of the trial.

      This trial will be conducted at one clinical site in Germany. The overall time to participate
      in this study is 4 weeks. Participants will make 9 visits to the clinic, and will be
      contacted by telephone 7days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Calcium 500 mg and Vitamin D3 800 IU; Low calcium meals
Intervention type(s): Drug; Other
Intervention description(s): Calcium 500 mg and Vitamin D3 800 IU chewable tablets; A normal Western European diet with reduced calcium content (400 mg per day).
Other intervention name(s): Calcichew-D3 forte 500 mg/800 IU
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Cholecalciferol; Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy; Increase in calcium urinary excretion and PTH decrease in serum
Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa
Condition: Sexual Behavior; Intimate Partner Violence
Study type: Interventional

Summary: 
      The purpose of this study is to test the feasibility and acceptability of Safe South Africa,
      an integrated intervention for preventing HIV and Intimate Partner Violence perpetration for
      male adolescents 15-17 years of age.
    

Detailed description: 
      This study will investigate the acceptability and feasibility of Safe South Africa, an
      integrated intervention to prevent adolescent behavioral risk for human immunodeficiency
      virus (HIV) and perpetration of intimate partner violence (IPV). Safe South Africa is a
      theory-driven, developmentally-tailored and gender-specific intervention designed for male
      adolescents 15-17 years of age. The research will be conducted in South Africa, a country
      with the largest HIV epidemic and some of the highest rates of IPV perpetration in the world.
      Preventive interventions are urgently needed during adolescence when risk for human
      immunodeficiency virus (HIV) and intimate partner violence (IPV) increases exponentially.
      Yet, few behavioral interventions integrate HIV-IPV prevention and are tailored for the
      unique age and developmental needs of adolescents. We will investigate the acceptability and
      feasibility of Safe South Africa with three study aims: (1) a development aim - this aim will
      result in the creation of Safe South Africa, an integrated male adolescent preventive
      intervention for HIV risk behavior and IPV perpetration; (2) an acceptability aim - this aim
      will consist of an evaluation of the social ecology of HIV and IPV risk with a survey of
      N=100 of adolescents, and a test of the acceptability of Safe South Africa through an open
      pilot trial with N=20 male adolescents; and (3) a feasibility aim - this aim will consist of
      a randomized controlled pilot trial with 1- and 6-month follow-up in a sample of N=60 male
      adolescents to assess the feasibility and acceptability for a future fully powered randomized
      controlled trial to evaluate efficacy of the intervention.
    

Intervention name(s): Safe South Africa
Intervention type(s): Behavioral
Intervention description(s): Core components of the Safe South Africa intervention include the following:
Theory driven, best-evidence intervention approaches to adolescent HIV prevention
Linkages between HIV and IPV
Victim Empathy
Healthy Norms Regarding Masculinity
Bystander Intervention Skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Early Life Nutritional Exposures and Long-term Health and Cognitive Outcomes
Condition: Overnutrition; Undernutrition
MeSH terms: Malnutrition; Overnutrition
Study type: Observational

Summary: 
      This study aims to investigate the relationship of the various exposures during infancy and
      childhood on later health and development of adolescents. Various exposures to be assessed
      include, but not limit to, nutritional status, body composition, energy expenditure, dietary
      intake, micronutrient status, breastfeeding, lifestyle, and other environment exposures.

      The study will specifically aim to respond these research questions:

      1.1 What are the factors associated with overweight, obesity, and stunted in adolescents? 1.2
      What are the factors associated with increased risk of NCDs during adolescence? 1.3 What are
      the factors associated with cognitive functioning during adolescence? Since numerous
      variables were collected, additional research questions can be possibly studied or other
      interested variables can be included in the future.
    

Detailed description: 
      A longitudinal data were collected in children in the northeast of Thailand beginning at 4-6
      months of age and every 2 months through 10-12 months of age while children had been given
      iron and/or zinc supplementation. Biochemical, anthropometric, socio-demographic, feeding
      practices, and maternal characteristics data were collected. Children were followed up at 9
      years of age to assess the long-term consequences of supplementation and early life nutrition
      on cognitive functioning and growth. There is a need to continue the follow-up of this study
      in order to address the association between early nutritional exposures and risks of
      cardio-metabolic dysfunction and cognitive and behavioral development later in childhood,
      adolescence and adulthood. Thus, we propose to follow-up these children during adolescence to
      assess the relationship of early life nutrition and exposures during infancy and childhood
      and outcomes including nutritional status, cognitive functioning, and risk for
      non-communicable diseases (NCDs). Findings from this study could provide awareness and
      information in developing policies and timely interventions to maintain optimal nutritional
      status throughout vulnerable life stages and reduce risks of NCDs and disabilities later in
      life.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents who participated in an intervention trial of iron and zinc supplementation and
        a follow-up study at 9 years of age in 3 rural districts in Khon Kaen province, northeast
        of Thailand.
      
Biospecimen description: 
      DNA from blood specimens
    
Keywords: Adolescent; Nutritional status; Body composition; Biochemical status
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
Condition: Mesenchymal Stromal Cells; Psoriasis; Drug Effect; Drug Toxicity
MeSH terms: Psoriasis; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Adipose derived
      Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment with moderate to severe
      psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary
      outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment
      response will be computed from PASI before and after treatment.
    


Intervention name(s): Calcipotriol ointment; adipose-derived multipotent mesenchymal stem cells
Intervention type(s): Drug; Biological
Intervention description(s): The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.; AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg.
Other intervention name(s): AD-MSCs
Intervention MeSH terms: Calcipotriene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled study to evaluate the effects of
      lebrikizumab in patients with asthma who remain inadequately controlled while on chronic
      therapy with inhaled corticosteroids (ICS).
    


Intervention name(s): lebrikizumab (MILR1444A); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous repeating dose; Subcutaneous repeating dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adult Asthma