bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Heredity and Environment on Asthma Development and Severity in Puerto Rican Children
Condition: Asthma; Hypersensitivity
MeSH terms: Asthma; Hypersensitivity
Study type: Observational

Summary: 
      Asthma is a major public health problem among Puerto Ricans. Little is known, however, about
      the effect of heredity and environment on the development and severity of asthma in this
      population. This study will examine the relationship between asthma and certain genetic and
      environmental factors in Puerto Rican children.
    

Detailed description: 
      Asthma is a chronic disease that causes constriction of the airways. People with asthma may
      experience wheezing, coughing, chest tightness, and trouble breathing. Although asthma is a
      major public health problem among Puerto Ricans, little research has been done to determine
      the influence of heredity and environment on the disease in this population. To learn more
      about these relationships, this study will examine the effects of certain genes and allergens
      on the development and severity of asthma in Puerto Rican children.

      This observational study will recruit both children with asthma and children without asthma.
      Participants will meet with study staff twice during the study. The first visit will take
      place at participants' homes. Participants will complete questionnaires about demographics,
      respiratory and general health, and household characteristics. Lung function testing,
      collection of blood samples, and collection of household dust samples will also take place at
      the home-based visit. The second visit will take place at the study site. At this visit,
      participants will undergo allergy tests on the skin and a methacholine challenge test to
      assess their airway responsiveness and asthma severity. The methacholine challenge test will
      involve inhaling mist through a mouthpiece and blowing forcefully into a special apparatus
      called a spirometer. Parents will be asked to provide information about their children's
      exposure to pets in early life. Each visit will last approximately 1.5 hours and will be
      scheduled close to the date on which a participant enters the study.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children of Puerto Rican descent (having four Puerto Rican grandparents) living in Hartford
        (Connecticut) and in the metropolitan areas of San Juan and Caguas in the island of Puerto
        Rico.
      
Biospecimen description: 
      Serum
    
Keywords: Puerto Rican; Allergies
Rare Benign Lesion of Peins
Condition: Skin Diseases; Penile Diseases
MeSH terms: Penile Diseases; Skin Diseases
Study type: Observational

Summary: 
      PEKMB was first named and described by Lortat-Jacob & Civatte in 1961 and by Bart & Kopf
      later. This rare condition is mostly reported in elderly males. The keratotic scales is
      usually micaceous and resembles psoriasis. Most patients are above 50 years of age and are
      circumcised later in life, but also reported in younger age group. This mica like scales
      contains keratin which gets dissolved in 10% potassium hydroxide solution. Disease
      progression may lead to phimosis. Differential diagnosis of this disease entity include
      moniliasis, wart, psoriasis ,penile horn, circinate balanitis, erythroplasia of Queyrat,
      squamous cell epithelioma and verrucous carcinoma. It is primarily a benign entity, it is
      capable of invasiveness. Bart and Kopf considered it to be in intermediate stage between
      benign hyperplasia and squamous cell carcinoma. However, the histological spectrum can range
      from hypertrophic-hyperplastic penile dystrophy to verrucous carcinoma. Fibro sarcoma has
      been reported developing in a same patient. Etiology is unclear. Despite search for a viral
      agent, Human Papilloma Virus (HPV) has not been demonstrated and its role in pathogenesis or
      its transformation to verrucous carcinoma has been proved. The treatment of PEKMB should be
      conservative when there is no histological evidence of malignancy. All such patients should
      be followed up. Treatment choices include potent topical steroids, topical 5% 5-flurouracil
      cream1, 2, cryotherapy, radiotherapy and shaving biopsy plus electro coagulation. When frank
      malignancy is observed, excision with wide margin is the rule.
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        male healthy married
Lurasidone Pediatric Autism Study
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled study designed to evaluate the
      efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks
      compared with placebo in pediatric and adolescent subjects with irritability associated with
      autistic disorder who reside in the community setting.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study designed to evaluate the
      efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks
      compared with placebo in pediatric and adolescent subjects with irritability associated with
      autistic disorder who reside in the community setting.
    

Intervention name(s): Lurasidone 20 mg daily; Lurasidone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lurasidone 20 mg once daily; Lurasidone 60 mg once daily; Placebo
Other intervention name(s): Latuda; Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism, Lurasidone, Latuda
Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults
Condition: Body Weight Changes; Overweight and Obesity; Physical Activity
MeSH terms: Overweight; Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      Body-weight based interval training (IT) performed 3 times per week will lead to reductions
      in abdominal adiposity and reduce overall body fat percentage in overweight and obese
      sedentary adults more effectively than moderate intensity continuous training (MICT).
      Body-weight interval training will improve exercise capacity (peak VO2) in overweight/obese
      adults.
    

Detailed description: 
      Participants will be randomly assigned to one of the two home-based exercise groups.

      The MICT group is the standard care group and will be instructed to walk for 30 minutes, 5
      days per week at a moderate intensity. The goal is to accumulate 150 minutes of continuous
      aerobic exercise each week. Participants will be instructed on the use of the Rating of
      Perceived Exertion (RPE) scale during baseline testing and will be instructed to reach an RPE
      of 12-16. A heart rate monitor will be worn to monitor exercise intensity. Heart rate should
      reach ~70% of maximal heart rate.

      The IT group will perform 5 body-weight exercises in three progressive phases. During the
      first 2 weeks the circuit will be completed twice, 30 second intervals, 90 seconds of rest.
      The exercises will be performed on 3 days of the week with at least one day of rest between
      exercise days (ideally Monday, Wednesday, Friday). The number of repetitions will increase to
      a maximum of 4 while the interval and rest periods increase to a maximum of 45 seconds each.
      The total time spent performing intervals by week 8 will be 15 minutes. A 2 minute warm up
      and 3 minute cool down will be performed, such as jumping jacks or simply walking. A heart
      rate monitor will be used to measure exercise intensity. Heart rate should reach
      approximately 90% of heart rate max during the intervals. Participants will be instructed on
      the use of the Rating of Perceived Exertion scale during baseline testing and will be
      instructed to reach an RPE of ≥17 during the high intensity intervals.
    

Intervention name(s): Interval Training; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interval training is prescribed 3 days per week using 5 body weight exercises in a progressive fashion.; Walking prescribed to meet current exercise guidelines; 150 minutes per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Phase I Rheumatoid Arthritis Study in Healthy Volunteers
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK182771 is a domain antibody targeting the interleukin (IL)-1 receptor which is being
      developed for the treatment of rheumatoid arthritis. This study is being done in healthy
      volunteers to verify the safety and tolerability of GSK182771
    


Intervention name(s): GSK1827771; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1827771 will be administered using injection via subcutaneous (SC) route.; Placebo to GSK1827771 for Injection will be administered via SC route
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: domain antibody; Rheumatoid Arthritis,
Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
Condition: Adenoids
MeSH terms: Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      To document the short term & long term effect of treatment with Nasonex (mometasone furoate
      nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the
      posterior choanae).
    


Intervention name(s): mometasone furoate nasal spray
Intervention type(s): Drug
Intervention description(s): One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Other intervention name(s): SCH 32088; Nasonex
Intervention MeSH terms: Mometasone Furoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Canadian Active & Maintenance Modified Pentasa Study
Condition: Active Ulcerative Colitis; Remission of Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that the new modified oral extended-release
      Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg
      tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of
      quiescent disease.
    

Detailed description: 
      A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and
      safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the
      currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to
      moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission
      of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male
      or non-pregnant female subjects aged 18 to 75 years.

      Subjects were randomised on entry into the trial, and if they were in remission at the end of
      the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the
      24-week Maintenance Phase, remaining on the original randomised treatment.
    

Intervention name(s): 5-ASA (5-Aminosalicylate); 5-ASA (5-Aminosalicylate)
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg tablet (modified extended release); 500 mg tablet
Other intervention name(s): Pentasa®; mesalamine; Pentasa®; mesalamine
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; 5-Aminosalicylate
NIDEK Gonioscope GS-1 for Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The Gonioscope GS-1 is an ophthalmic camera with gonioscopic prism that is intended to
      capture, display and store images of the anterior chamber angle and its peripheral part. This
      study evaluates the efficiency of Gonioscope GS-1 in glaucoma patients.With the captured
      images, the glaucoma diagnosis and post-operative observation are enabled.
    


Intervention name(s): NIDEK Gonioscope GS-1; Standard Digital Gonioscopic Images
Intervention type(s): Other; Other
Intervention description(s): To determine inter-observer repeatability when using this device, two observers will examine each image obtained from NIDEK Gonioscope GS-1 and separately determine the iridocorneal angle. Inter-observer repeatability will be tested using Pearson correlation.; To determine inter-observer repeatability when using this device, two observers will examine each image obtained from NIDEK Gonioscope GS-1 and separately determine the iridocorneal angle. Inter-observer repeatability will be tested using Pearson correlation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Cardiac Elastography to Determine Strain and Strain Rates in the Heart
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      Cardiac elastography is a new technique to analyze strain and strain rates in many organ
      systems, including the heart. In this study, cardiac elastography derived from the analysis
      of raw radiofrequency data obtained from a conventional clinical echocardiograph system will
      be compared to processed information that comes from the same echocardiograph system. The
      purpose of this study is to determine if cardiac elastography can accurately determine strain
      and strain rates as compared to more conventional means.
    


Intervention name(s): cardiac elastography and echocardiography
Intervention type(s): Procedure
Intervention description(s): standard echocardiogram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers and patients with known heart disease caused by myocardial inarction or
        cardiomyopathy
      
Keywords: echocardiography; cardiac elastography; Normal volunteers
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
Condition: Healthy; Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to assess the safety of bivalent vaccine of two new 6:2 influenza virus
      reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist)
      containing them.
    


Intervention name(s): FluMist
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Adoptive Transfer of Haploidentical Natural Killer Cells and IL-2
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study of the infusion of haploidentical NK cells with IL-2 in 5 HIV+
      individuals who are on stable ART with full HIV suppression.
    

Detailed description: 
      Potential subjects will be screened to determine eligibility. Immediately after consent and
      screening, an HLA-haploidentical donor will be identified and will complete eligibility
      screen and consent. At Day -7 the subject will undergo an inguinal lymph node biopsy and
      colonoscopy to obtain ileal and rectal biopsies. Blood samples will be obtained to measure
      chimerisms, plasma HIV RNA, and inflammatory cytokines. PBMCs will be obtained to sort into
      CD4 subsets and measure frequencies of HIV RNA and DNA. On Day -1, the donor will undergo
      apheresis and donor cells will be obtained and incubated overnight with IL-2. On Day 0
      subjects will start aspirin and be infused with IL-2 activated NK cells. Subjects will
      receive 6 million units of IL-2 just after the infusion and they will be monitored on the
      Phase 1 Unit for 24 hours. Plasma will be obtained at 2 hrs, 4 hrs and the following morning
      and stored for measures of inflammatory markers. The subject will return to the outpatient
      clinic on days 2, 4, 6, 8, and 10 after the infusion for administration of 6 million units of
      IL-2 and to obtain plasma and PBMC for measures of inflammatory markers and changes to the
      virus reservoir. On day 14 the subject will stop taking ASA and blood will be obtained to
      measure frequencies of HIV RNA and DNA. On day 21 will have a lymph node biopsy and
      colonoscopy to obtain ileal and rectal tissues. The patient will then be followed until day
      100 post NK cell infusion. Subjects will return every 2 weeks for a toxicity assessment,
      blood draws, and viral level testing. Study participation will end after day 100.
    

Intervention name(s): NK cells and IL-2
Intervention type(s): Biological
Intervention description(s): Natural Killer Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV
Diabetic Ketoacidosis and Its Impact on the Brain
Condition: Diabetes Mellitus
MeSH terms: Ketosis; Diabetic Ketoacidosis
Study type: Observational

Summary: 
      About the Study: This research study is being conducted to see if diabetic ketoacidosis has
      any impact on learning, behavior and development in children with Type 1 diabetes mellitus.
      If there is an impact, is it transient or persistent? Sixty to 80 children between the ages
      of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a
      non-sedated MRI scan of the head performed. The investigators will compare this to a control
      group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus.
      The children with Type 1 diabetes mellitus will not have any changes made to their current
      diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood
      glucose values as required by your doctor and bring their meter(s) for downloading to each
      visit. The children with Type 1 diabetes mellitus should also tell your doctor about the
      frequency of severe low and high blood glucose values.
    

Detailed description: 
      Participant Schedule:

        1. One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological
           testing and to become familiar with the MRI scanner.

        2. Subjects who need to become more familiar with the MRI scanning process will view a
           video tape at home.

        3. One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head
           completed.

        4. Subjects between 10 and 17 years of age will also be asked to complete two additional
           abbreviated neuropsychological tests at one week and one month from enrollment.

        5. Subjects may have the complete neuropsychological testing and MRI scan repeated 15
           months from time of enrollment.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sixty to 80 children between the ages of 4 to 17 years with Type 1 diabetes mellitus will
        have neuropsychological testing and a non-sedated MRI scan of the head performed. We will
        compare this to a control group of 30-40 children between the ages of 4 to 17 years without
        Type 1 diabetes mellitus.
      
Biospecimen description: 
      There is no intervention. All subjects with DM and controls get neurocognitive testing and an
      MRI of the brain. We want to see if the scores are different but no changes in therapy will
      be done.
Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of
      IDX184 in humans. No formal hypotheses are to be tested in this study.
    


Intervention name(s): IDX184; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.; Placebo supplied as size 3, white opaque capsules matching IDX184 capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hepatitis C, healthy volunteers
Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The
      investigators hypothesize that use of a food based prophylactic will decrease incidence of
      rotavirus infection in young children in south India, prevent intestinal damage and overall
      result in lower infection rates and better gut function. This trial will evaluate the
      efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or
      antibody fragments expressed in yeast or placebo are given daily as a food supplement to
      children between the ages of 6 and 12 months. The children will followed for one year and
      rates of rotavirus diarrhoea, antibody responses and gut function will be compared between
      children receiving antibody fragments or placebo.
    

Detailed description: 
      The study will be carried out in an urban slum area in Vellore, south India. Children between
      the ages of 6 and 12 months will be recruited for participation in the study. They will be
      randomized to receive supplementation with ARP or placebo, and will be followed for a period
      of one year, with weekly home visits and monitoring of all episodes of diarrhoea. In
      addition, every two weeks, surveillance stool samples will be collected and tested for
      rotavirus to identify asymptomatic infections by PCR. All episodes of diarrhoea will be
      investigated intensively for bacterial, viral and parasitic agents of diarrhoea using both
      conventional and molecular techniques and all cases will be treated appropriately at the
      study clinic or referral hospital as required. Monthly anthropometric measurements will be
      carried out to estimate rates of growth and to identify growth faltering. Blood samples will
      be taken at 4, 8 and 12 months for estimation of anti-rotavirus IgA and IgG antibodies.
      Studies on intestinal absorption and permeability will be carried out at recruitment, 6 and
      12 months by the lactulose:mannitol test (measured by HPLC detection of sugars). All
      rotavirus strains obtained will be characterized by genotyping.
    

Intervention name(s): Anti-rotavirus protein; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 11mg ARP In 1 Gm Product Daily For 12 Months, given in orange juice; Maltodextrin 1 gm daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention