bioihbjkbjnl/mcl2 huggingface dataset:
The Role of Vitamins E and C in Maintaining Lung Health in People With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine if airway antioxidant levels in allergic asthmatics are enhanced
      with a combination of vitamin E and vitamin C therapy.
    

Detailed description: 
      Eosinophils and neutrophils are inflammatory cells located in the airways and lungs. When
      they are activated, they generate oxidants, which irritates the mucosal cells in the airways.
      As a result, mucus develops in the lungs. Allergens can activate the inflammatory cells,
      thereby worsening the symptoms of asthma in allergic asthmatics. Vitamins E
      (alpha-tocopherol) and C (ascorbate) have been shown to decrease asthma exacerbation
      associated with exposure to ozone. Enhancing antioxidant and anti-inflammatory defenses in
      the airways and lungs is a promising approach for treating respiratory diseases aggravated by
      allergies. This study will determine if airway antioxidants in allergic asthmatics are
      enhanced with a combination of vitamin E and vitamin C therapy.

      Participants in this double-blind study will be randomly assigned to receive either a
      combination of alpha-tocopherol and ascorbate or placebo. Treatments will be administered
      daily for 12 weeks. Baseline assessments will measure airway and circulating antioxidant
      levels, inflammatory cells, lung function, respiratory symptoms, and methacholine reactivity.
      Allergy skin tests will also be performed to determine the state of atopy, which is a
      hereditary predisposition toward developing certain hypersensitivity reactions. Following
      baseline assessments, lung assessments will be conducted weekly for 12 weeks, sputum and
      blood samples will be collected bi-weekly, and methacholine reactivity will be assessed at
      Weeks 6 and 12.
    

Intervention name(s): Vitamin
Intervention type(s): Dietary Supplement
Intervention description(s): This is designed as a placebo controlled study of 500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks, on airway antioxidant levels in asthmatics.
Other intervention name(s): Vitamin C; Vitamin E
Intervention MeSH terms: Vitamins; Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alpha tocopherol; vitamin E; ascorbate; vitamin C; antioxidant; allergic; asthma
SWAP-MEAT Athlete: Three Diets on Athletic Performance
Condition: Health Behavior
Study type: Interventional

Summary: 
      This study aims to investigate the impact of two plant-based diets-whole food plant-based
      (WFPB) and plant-based meat alternatives (PBMA)-vs. an omnivorous diet (Animal) on endurance
      and muscular strength in recreational athletes.
    

Detailed description: 
      Plant-based diets are environmentally sustainable and beneficial for cardiovascular health,
      but athletes are often concerned that these diets do not contain enough protein to support
      athletic performance. However, few randomized trials investigating the effect of plant-based
      vs. omnivorous diets on athletic performance have been conducted. Within this randomized
      crossover trial, recreational runners and resistance trainers will be assigned to three diets
      for four weeks each (WFPB, PBMA, and Animal). PMBA is an emerging, modern type of plant-based
      diet for which the impact on athletic performance has not yet been assessed. Participants
      will complete athletic fields at baseline and after each diet, and athletic performance on
      diets and study feasibility in this cohort of recreational athletes will be assessed. The
      study design was inspired by the original SWAP-MEAT study that investigated cardiovascular
      risk factors in adults consuming 8-week omnivorous and plant-based meat alternative diets
      (Crimarco, 2020).
    

Intervention name(s): Diet order: WFPB, PBMA, Animal; WFPB, Animal, PBMA; PBMA, WFPB, Animal; PBMA, Animal, WFPB; Animal, WFPB, PBMA; Animal, PBMA, WFPB
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants followed the WFPB, PBMA, and Animal diets (in this order) for 4 weeks each.; Participants followed the WFPB, Animal, and PBMA diets (in this order) for 4 weeks each.; Participants followed the PBMA, WFPB, and Animal diets (in this order) for 4 weeks each.; Participants followed the PBMA, Animal, and WFPB diets (in this order) for 4 weeks each.; Participants followed the Animal, WFPB, and PBMA diets (in this order) for 4 weeks each.; Participants followed the Animal, PBMA, and WFPB diets (in this order) for 4 weeks each.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: SWAP-MEAT Athlete is a randomized crossover trial in which 12 recreational runners and 12 recreational resistance trainers are assigned to one of six possible diet orders. Each diet order contains three phases for four weeks each-Animal, Plant-Based Meat Alternatives (PBMA), and Whole Food Plant-Based (WFPB)-in random order.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: muscular strength; endurance; plant-based diets; meat alternatives; omnivore diets
Study of Patients With Strongyloides Stercoralis Infection
Condition: HIV Infection; Nematode Infection; Strongyloidiasis
MeSH terms: Infections; Communicable Diseases; Strongyloidiasis; Nematode Infections
Study type: Observational

Summary: 
      This study will explore faster and easier ways to detect infection with the intestinal
      parasite Strongyloides stercoralis and learn more about the conditions under which it causes
      serious disease. Ordinarily, the Strongyloides helminth (type of intestinal worm) causes only
      few, if any, symptoms, but in people with weakened immunity it may be very serious, and even
      deadly.

      People between 5 and 80 years of age with known or suspected S. stercoralis infection, or
      infection with another helminth, such as filariasis, that might cause a cross-reaction with
      S. stercoralis may be eligible for this study.

      Participants found to be infected with S. stercoralis will be treated with ivermectin,
      thiabendazole, or albendazole. In addition, they will undergo the following tests and
      procedures:

        -  Blood tests and stool samples: Samples will be collected before and after treatment to
           check general health status and immune function, and to look for parasites in stool. Up
           to 50 milliliters (10 teaspoons) of blood will be drawn in adults and up to 25 ml (5
           teaspoons) in children.

        -  Skin tests: A test similar to those used for tuberculosis and allergies will be
           conducted to determine if there is sensitization to products of the parasite. Such a
           test might be used as a rapid method to diagnose the infection. About three drops of
           several different antigens (proteins) are injected into the skin of the arm. After 15 to
           20 minutes, the area is checked to see if a red spot has formed and, if so, the spot is
           measured.
    

Detailed description: 
      This study is directed to patients with known or suspected Strongyloides stercoralis
      infection because it is a relatively common parasitic infection, even in the United States.
      It is difficult to diagnose, and efficacy of treatment is difficult to evaluate. Some
      infected individuals can develop serious even fatal, disease under certain conditions of
      immunosuppression. Because newer diagnostic methods are needed to diagnose this infection, we
      have developed new diagnostics that will be evaluated in comparison to more standard
      diagnostic tests. Serum and cells will also be collected from patients on this protocol to
      understand the cellular and humoral response to the parasite and its antigens. All subjects
      proven to have Strongyloides stercoralis infection will be treated with standard therapy and
      followed to assess both the efficacy of treatment and the changes in humoral and cellular
      immune responses induced by treatment.
    

Keywords: Strongyloidiasis; Immediate Hypersensitivity Skin Test; IgE; Nematode; Immunosuppression; Skin Test; Diagnosis; Intestinal Helminth; Immediate Hypersensitivity
Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This is a randomized prospective study to evaluate the effectiveness of a family-based
      intervention using activity-monitors (I.e. Fitbits) in children and adolescents aged 8-18
      years with a BMI greater than or equal to 95%ile who attend the Cleveland Clinic
      multidisciplinary "Be Well" pediatric obesity clinic.
    


Intervention name(s): Family Based Activity Intervention
Intervention type(s): Behavioral
Intervention description(s): Providing youth and their families with access to the knowledge and resources to increase their physical activity will allow them to lead more healthy lifestyles will provide them with the foundation for a healthier life, and future ahead.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Taekwondo Practice in Adolescents With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common
      neuro-developmental/behavioral disorders among adolescents. Sport and physical activity seem
      to play a major role in the development of cognition, memory, selective attention and motor
      reaction time, especially among adolescents with ADHD. In this context, the objective of this
      study was to investigate the effects of a one and a half year long Taekwondo (TKD)
      intervention on cognitive function in adolescents with ADHD.
    


Intervention name(s): Taekwondo practice; CONTROL
Intervention type(s): Behavioral; Other
Intervention description(s): The Taekwondo intervention program consisted of the technical skill development aspect (e.g., blocking, punching and kicking) of the sport and poomse (forms) for 30-min.; The participants of the control group engaged in physical activities, including athletics, handball and gymnastic, during two sessions of physical education per week at school.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Compare the Oral Absorption of ASP1941 Among Two Types of Tablets
Condition: Healthy; Plasma Concentration of ASP1941
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a
      two-way crossover method in non-elderly healthy male subjects. In addition, the safety of
      these products will be assessed.
    

Detailed description: 
      This study is a open-label randomized two-way crossover study. A single dose of two types of
      ASP1941 tablets are given to non-elderly healthy male subjects (16 subjects for each group,
      32 subjects in total).

      In case the bioequivalence of the 2 formulations cannot be proved in this study due to
      insufficient number of subjects, an add-on subject study will be conducted in this clinical
      trial as needed. Same design and methodology are to be applied to this study and the add-on
      subject study. The add-on subject study may not be conducted.
    

Intervention name(s): ASP1941
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): ipragliflozin
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Open-label design; Bioequivalence; ASP1941
PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this study is to determine an optimal dose and dosing regimen of
      PT001 MDI for further evaluation in later stage studies.
    

Detailed description: 
      The primary objective of this study is to demonstrate efficacy relative to placebo of PT001
      MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within
      the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be
      compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to
      baseline.
    

Intervention name(s): PT001 MDI; Ipratropium Bromide HFA Inhalation Aerosol; Placebo MDI
Intervention type(s): Drug; Drug; Other
Intervention description(s): PT001 MDI administered as two puffs BID for 7 days; Taken as 2 inhalations of the 17 µg per actuation strength MDI QID; Matching placebo to PT001 MDI administered as two puffs BID for 7 days
Other intervention name(s): Atrovent
Intervention MeSH terms: Bromides; Ipratropium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis
Condition: Congenital Muscular Torticollis
MeSH terms: Torticollis
Study type: Interventional
Phase: Phase 4

Summary: 
      Congenital Muscular Torticollis (CMT) is a postural deformity of head and neck detected at
      birth or shortly after birth, primarily resulting from unilateral shortening of
      Sternocleidomastoid Muscle (SCM). Surgery could be chosen for the treatment for some
      children, which is accompanied by moderate pain and discomfort. The investigators focused the
      effectiveness of intermediates cervical plexus block because the dermatome of sensory of
      cervical plexus block is correlated to that of torticollis. So the effect of analgesia could
      decrease the use of analgesics.
    


Intervention name(s): intermediate cervical plexus block; Fentanyl; Ibuprofen
Intervention type(s): Other; Drug; Drug
Intervention description(s): ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg; fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.; ibuprofen in ward when more or equal to FLACC scale 4.
Other intervention name(s): ultrasound guided intermediate cervical plexus block
Intervention MeSH terms: Ibuprofen; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145
      mg fenofibrate tablets in healthy volunteers when administered following a breakfast of
      standard composition. Safety and tolerability of this regimen will also be evaluated.
    

Detailed description: 
      Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The
      primary objective of this study is to evaluate the bioequivalence of 105 mg fenofibric acid
      tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered
      following a breakfast of standard composition. Additionally, the safety and tolerability of
      this dosing regimen will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year
      old, male and female volunteers will be randomly assigned in a crossover fashion to receive
      each of two dosing regimens (fenofibric acid and fenofibrate) in sequence with a 7 day
      washout period between dosing periods. On the morning of Day 1, subjects will receive either
      a single oral dose of the test formulation, fenofibric acid (1 x 105 mg tablet) or a single
      oral dose of the reference formulation, fenofibrate (1 x 145 mg tablet) 30 minutes after the
      initiation of a standard breakfast. After a 7 day washout period, on the morning of Day 8,
      subjects will receive the alternate regimen 30 minutes after the initiation of a standard
      breakfast. Fasting will continue for 4 hours after each dose. Blood samples will be drawn
      from all participants before dosing and for 72 hours post dose at times sufficient to
      adequately define the pharmacokinetics of fenofibric acid. Subjects will be monitored
      throughout their participation for adverse reactions to the study drug and/or procedures.
      Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours
      post-dose. All adverse experiences, whether elicited by query, spontaneously reported, or
      observed by clinic staff, will be documented in the subject's case report form.
    

Intervention name(s): Fenofibric Acid (Fibricor™) 105 mg Tablet; Fenofibrate (Tricor®) 145 mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 105 mg fenofibric acid (Fibricor™) tablet administered 30 minutes after the initiation of a standard breakfast.; 1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast.
Other intervention name(s): Fibricor™; Tricor®
Intervention MeSH terms: Fenofibrate; Fenofibric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy; pharmacokinetics; therapeutic equivalency
Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease
Condition: Intracranial Vascular Disorders
MeSH terms: Cerebrovascular Disorders; Vascular Diseases; Recurrence
Study type: Observational

Summary: 
      The objective of this study is to determine the mechanisms of stroke in patients with
      Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of
      antegrade flow through the stenotic artery, distal tissue perfusion to the affected
      territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging
      biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective
      multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients
      will be studied within 21 days of the index event (allowing appropriate time to arrange for
      diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate
      mechanisms of recurrent ischemia:

        -  Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through
           the stenotic artery.

        -  Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue
           perfusion.

        -  Vasomotor reactivity by Transcranial Doppler using the breath-holding technique
           (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the
           affected artery;

        -  Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery
           embolism that reflects plaque instability.

      Patients will receive standardized medical management and its effectiveness on blood
      pressure, lipid, and glycemic control will be monitored.

      The primary outcome is recurrent stroke in the territory of the stenotic artery during a
      1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI
      in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack
      (TIA) in the distribution of the stenotic artery during a 1-year follow-up period.

      Patients will be recruited at various sites that will be trained and certified on the imaging
      techniques employed. Raw imaging data will be interpreted centrally.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients will have a recent stroke or TIA due to intracranial Atherosclerotic
        Disease (IAD) of 50-99% .
      
Keywords: Intracranial Atherosclerotic Disease; Stroke; Transient Ischemic Attack; Imaging
L-NMMA Dose-response Study in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of different levels of nitric oxide
      inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor
      of the nitric oxide synthase, is administered as bolus injection followed by continuous
      infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA
      dose.
    


Intervention name(s): NG-monomethyl-L-arginine (L-NMMA); NG-monomethyl-L-arginine (L-NMMA); NG-monomethyl-L-arginine (L-NMMA); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour; 6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour; 4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour; Isotonic saline solution IV priming dose + IV infusion for 1 hour
Intervention MeSH terms: omega-N-Methylarginine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: L-NMMA; blood pressure; arterial stiffness; pulse wave velocity; augmentation index; dose-response; healthy subjects; GFR