bioihbjkbjnl/mcl2 huggingface dataset:
Risk of Asthma in Infants With Atopic Dermatitis
Condition: Asthma; Eczema; Dermatitis, Atopic
MeSH terms: Asthma; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      Infants will be enrolled in this study if they have never been diagnosed with asthma or
      wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of
      skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this
      study is to determine whether we can identify infants who will develop asthma.
    

Detailed description: 
      Asthma is a disease characterized by recurrent episodes of wheezing, inflammation of the
      airways, and airways that are very sensitive to stimulation (hyper-responsiveness). Symptoms
      of asthma frequently begin in early childhood; however, it has been difficult to identify
      pre-symptomatic, at-risk infants and toddlers. Family history of asthma and allergy is
      strongly associated with the early onset and persistence of asthma symptoms, and children
      with early onset persistent asthma are more likely to demonstrate allergies. The development
      of allergic disease results from complex interactions between genetic susceptibility and
      environmental factors; however, infants with atopic dermatitis have a 50% chance of
      developing asthma by 6 years of age. Airway inflammation and airway hyper-responsiveness are
      characteristics of asthmatic children. We plan to evaluate whether infants with allergic
      dermatitis have evidence of airway inflammation and hyper-responsiveness, and whether cells
      from the blood and the nose are also hyper-responsive to stimulation prior to the onset of
      clinical symptoms of asthma. In addition we will evaluate whether certain genetic profiles
      are associated with allergic disease in infants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Our population was recruited through primary physician, pediatric practices, and
        dermatology groups through out Indianapolis Indiana and the surrounding counties. We also
        ran ads in local newspapers.
      
Biospecimen description: 
      We have retained nasal cell samples, whole blood cells, and serum.
    
Keywords: Asthma; Eczema; Dermatitis, Atopic; Infant
Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents
Condition: Insulin Sensitivity; Flow-mediated Dilation; Arterial Stiffness
MeSH terms: Insulin Resistance; Hypersensitivity; Dilatation, Pathologic
Study type: Observational

Summary: 
      The overall objectives of this study are to examine the relationships between circulating
      vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine
      whether vitamin D deficiency in AA is responsible for ethnic differences in insulin
      sensitivity and hypertension in AA and EA, as well as mechanisms underlying the association
      between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is
      associated with insulin sensitivity and vascular functioning, independent of adiposity, 2)
      lower insulin sensitivity and vascular functioning in AA relative to EA is due to lower
      circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular
      dysfunction is mediated by 25(OH)D.

      Acronyms: African American (AA), European American (EA), Serum 25-hydroxy vitamin D (25()H)D,
      Body mass index (BMI), Alabama (AL).
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adolescent African American and European American teenagers, ages 14-18, will be
        recruited form the Birmingham, AL community
      
Biospecimen description: 
      Serum
    
Keywords: insulin sensitivity; vascular function; flow-mediated dilation; arterial stiffness; ethnicity; adolescents; females; glucose tolerance; diabetes; hypertension; cardiovascular
Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to investigate whether enhanced external counterpulsation (EECP)
      therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time
      enhance or slow down breakdown of cognitive function in patients diagnosed with mild
      cognitive impairment (MCI).
    


Intervention name(s): External Counterpulsation (EECP)
Intervention type(s): Device
Intervention description(s): A noninvasive neuroimaging technique. Administration of 35 hours EECP therapy over a 7 week period. EECP to be administered for 1 hour, 5 times a week.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; cerebral blood flow; ophthalmic blood flow; blood viscosity
Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      It has been demonstrated that infants and children experience pain in a similar manner to
      adults, however it used to be undertreated when compared to adult.

      Perfusion Index (PI) derived from pulse plethysmography waveform, represents a ratio of
      pulsatile signal (during arterial inflow) to non-pulsatile signal. PI can represent the
      peripheral perfusion dynamics due to change of peripheral vasomotor tone. Low PI values
      suggest peripheral vasoconstriction and high PI values suggest peripheral vasodilation.

      The sympathetic nervous system is inherently involved in the pathophysiological responses
      evoked by painful stimulation.

      In the current study, investigators hypothesise that the PI could be a good objective tool
      for assessment of postoperative pain in children undergoing adenotonsillectomy.
    


Intervention name(s): postoperative pain assessment
Intervention type(s): Other
Intervention description(s): evaluation of the efficacy of PI as an objective measure for postoperative pain assessment in pediatric population undergoing adenotonsillectomy.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 3-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be
        included
Evaluation of Long-Acting Muscarinic Antagonists in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or
      blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the
      airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic
      antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a
      new LAMA called aclidinium has been approved for use in COPD. There are potentially important
      differences between these two medications that might have an impact on the treatment of COPD
      patients.

      In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD.
      The main comparison will be done using a very sensitive breathing test called impulse
      oscillometry
    


Intervention name(s): Tiotropium; Aclidinium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Disease, Chronic Obstructive; Long-acting muscarinic antagonists; Impulse oscillometry
A Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine
      produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind,
      parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged 2
      months in China.
    

Detailed description: 
      There will be two arms. 1200 healthy infants aged 2 months will be randomly assigned (1:1) to
      receive an experimental vaccine or a comparator vaccine in Month 0,2 and 4 (primary
      vaccination). All of them will receive a fourth dose as booster vaccination in Month 10.
    

Intervention name(s): 13-valent pneumococcal conjugate vaccine; Prevnar 13
Intervention type(s): Biological; Biological
Intervention description(s): 0.5ml vaccine produced by Beijing Minhai Biotechnology Co., Ltd.,three doses with 2 month interval, a booster dose 10 months after the first dose; 0.5ml vaccine produced by Wyeth,three doses with 2 month interval, a booster dose 10 months after the first dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: pneumococcal conjugate vaccine; immunogenicity; safety
Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study is an investigation of the dopaminergic neurotransmission in patients with
      schizophrenia, patients at risk for the development of schizophrenia, and healthy controls
      using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging
      technique under amphetamine challenge.
    


Intervention name(s): IBZM-SPECT (bolus and constant infusion paradigm)
Intervention type(s): Procedure
Intervention description(s): single IBZM-SPECT assessment at study inclusion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IBZM-SPECT; Amphetamine Challenge; Schizophrenia; dopaminergic neurotransmission; Persons at risk for the development of schizophrenia; healthy subjects
An Open Label, Multi-Center, Follow-on Study Examining the Long-Term Safety and Efficacy of Insulin VIAject™ in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Follow-on study to the VIAject™ 06J study to evaluate the long-term safety and efficacy of
      VIAject™ when used as prandial insulin in combination with Lantus® in subjects with type 1
      diabetes mellitus.

      The VIAject™ 06J study is the efficacy and safety study for insulin VIAject™ to demonstrate
      equivalent blood glucose control in patients with type 1 diabetes mellitus with insulin and
      regular human insulin as prandial insulin and to demonstrate an equivalent safety profile for
      VIAject™ in comparison to human insulin
    


Intervention name(s): VIAject™
Intervention type(s): Drug
Intervention description(s): Subcutaneous injection 25 IU/mL
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Micro RNAs as a Marker of Aortic Aneurysm in Hereditary Aortopathy Syndromes
Condition: Marfan Syndrome; Loeys-Dietz Syndrome; Thoracic Aortic Aneurysm and Dissection Syndromes; Ehlers-Danlos Type IV Syndrome; Turner Syndrome
MeSH terms: Marfan Syndrome; Arachnodactyly; Loeys-Dietz Syndrome; Turner Syndrome; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Syndrome
Study type: Observational

Summary: 
      The primary objective of this study is to determine whether specific patterns of circulating
      micro-ribonucleic acids (miRNAs) are associated with aortic aneurysm and dissection in
      patients with hereditary aortopathy syndromes. The most common of these syndromes is Marfan
      Syndrome (MFS), but several other recognized aortopathy syndromes are well characterized. The
      investigators propose the use of a simple blood test, from which miRNA profiles can be
      measured in individuals with aortopathy syndromes to be compared with miRNAs observed in a
      control population that has no known predisposition for aortic disease. The investigators
      hypothesize that microRNA profiles in individuals with Marfan syndrome, and related
      disorders, will be distinct from those seen in a control group. The investigators predict
      that up- or down-regulation of certain miRNAs will correlate with the presence and severity
      of aortic aneurysm, responses to medical therapy, and ultimately could be used to determine
      when an individual may be at risk of dissection.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All individuals up to 60 years seen in the Children's Hospital of Colorado and University
        Hospital Marfan Syndrome Clinics will be eligible for enrollment in this study. Individuals
        with a clinical diagnosis of Marfan syndrome with or without genetic confirmation will be
        included as will patients with recognized aortopathy syndromes or family history of
        aortopathy with evidence of aorta disease. Subjects will be primarily recruited through the
        Heart Institute at Children's Hospital Colorado and through the cardiology team at the
        University of Colorado Hospital. Pediatric patients with Marfan syndrome and related
        aortopathy syndromes are primarily followed in the Principal Investigator, Dr. Chatfield's,
        Cardiac Genetics Clinic at Children's Hospital Colorado and will be recruited from this
        clinic. Adult patients with aortopathy syndromes are followed primarily in the Adult
        Congenital Heart Disease Clinic at University of Colorado Hospital.
      
Biospecimen description: 
      Fractionated blood samples will be retained at a part of the study including plasma,
      platelets and mononuclear cells. At this time genetic testing (genotyping) of individual
      biospecimens is not included in the IRB-approved protocol.
    
Keywords: aortopathy syndrome; aortic aneurysm; aortic dissection; connective tissue disorder
A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and
      tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque
      psoriasis. The goal of the study is to assess the safety, local tolerability, and
      pharmacokinetics in healthy subjects.
    


Intervention name(s): PF-06263726; PF-06263726; PF-06263726; Placebo; PF-06263726; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.; Subjects will receive dose strength of 4% PF-06263276 (2.28 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.; Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.; Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.; Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.; Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase 1; Randomized; Placebo-Controlled; Multiple Dose Escalation; Tolerability; Safety; PK; Topical; Healthy; PF-06263276
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This observational study will compare spermatogenesis in male adult renal transplant
      recipients receiving valganciclovir versus untreated matched controls. Data will be collected
      from each participant for up to 52 weeks post transplant.
    


Intervention name(s): Valganciclovir
Intervention type(s): Drug
Intervention description(s): Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
Other intervention name(s): Valcyte®
Intervention MeSH terms: Valganciclovir
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Other
Heartmatters Challenge - First Responders
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The purpose of this protocol is to observe whether providing the first responder population
      with a multi-tiered therapeutic lifestyle modification program, including regular blood
      testing, diet and telephonic lifestyle coaching, daily food journaling using web-based tools
      and smartphone apps can lead to positive changes in behavior, resulting in improvements in
      blood based markers of risk of cardiovascular disease (CVD) as well as improvements in weight
      and waist circumference.
    

Detailed description: 
      A cluster randomization of first responder communities in the metro Boston and metro Phoenix
      areas was performed. First responders attended a one hour lecture on the specific risks of
      CVD in that population and then qualified intervention candidates were enrolled into a
      lifestyle program, consisting of telephone-based coaching sessions with a registered
      dietitian and an online/app based food journaling program. Both groups had blood test draws
      at baseline, 3, 6 and 12 months. The intervention group met with the team practitioner to
      review results and progress after each blood draw. The test panel comprised blood-based
      markers of CVD risk associated with lipid metabolism, metabolics, inflammation and basic
      liver and kidney function.
    

Intervention name(s): Lifestyle Program
Intervention type(s): Behavioral
Intervention description(s): 4 elements: 1) Laboratory test results with diagnostic report describing results, 2) Lifestyle plan generated in online portal with personalized nutritional information based on combination of laboratory results and personal preferences, 3) online or smartphone food journaling application, 4) telephone based lifestyle coaching with Registered Dietitian.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        First responders: fire fighters, police officers, EMT personnel
      
Biospecimen description: 
      Serum, plasma
    
Keywords: Therapeutic Lifestyle Change; Cardiovascular Disease; First Responders; Firefighters; CVD
Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
Condition: Asthma
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects
      on airway constriction by means of methacholine challenge testing.
    


Intervention name(s): fluticasone propionate and salmeterol; budesonide and formoterol
Intervention type(s): Drug; Drug
Intervention description(s): 45/4.5 two puffs twice daily; 80/4.5 two puffs twice daily
Other intervention name(s): Advair; Symbicort
Intervention MeSH terms: Fluticasone; Xhance; Budesonide; Formoterol Fumarate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow
Condition: Asymptomatic Condition
MeSH terms: Asymptomatic Diseases
Study type: Interventional

Summary: 
      This study is designed to evaluate the short term change in blood flow in the superficial
      human tissue layers after the application of 3 min Graston instrumented assisted soft tissue
      mobilization on the plantar aspect of the foot and the trapezius muscle.
    

Detailed description: 
      Instrument assisted soft tissue mobilization (IASTM) is a commonly used physical therapy
      intervention. Graston ® technique is a form of IASTM that requires completion of a
      certification course and utilizes specific stainless-steel tools. IASTM has been found to
      improve range of motion, pain and patient reported function in pathological individuals. One
      method by which these improvements are thought to occur is by increasing blood flow.
      Increased blood flow brings nutrients and oxygen to the area and is thought to contribute to
      tissue remodeling. There is very limited research investigating blood flow changes following
      IASTM. In order to measure blood flow changes following IASTM, doppler ultrasound may be
      used. There are no studies to our knowledge quantifying changes in blood flow following IASTM
      using ultrasound. Power doppler approximates perfusion by detecting a frequency shift from
      movement of red blood cells and color is then encoded proportionally to the number of red
      blood cells. Power doppler imaging quantification (PDIQ) is a feature of musculoskeletal
      ultrasound (MSK) that compares the number of color pixels and the intensity of color within
      these pixels to grey scale pixels within a given image. The aim of this study is to determine
      if there is an increase in blood flow in the trapezius, plantar fascia and medial arch of the
      foot measured following IASTM. Blood flow was measured by using PDIQ ratio in the doppler
      setting of MSK ultrasound.
    

Intervention name(s): Graston Instrument assisted Soft tissue Mobilization
Intervention type(s): Procedure
Intervention description(s): Instrument assisted soft tissue mobilization using the Graston tool and technique for 3 minutes on each of the three locations
Intervention model: Single Group Assignment
Intervention model description: Quasi-experimental study using a single group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Instrument assisted soft tissue mobilization; Musculoskeletal Ultrasound Imaging; Bood circulation; Perception