bioihbjkbjnl/mcl2 huggingface dataset:
Long Term Outcomes of Coronavirus Disease-19 (COVID-19)
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The investigators hypothese that lung involvement due to COVID-19 may cause structural
      changes in the lung in the long term. In this study the effects of structural changes in the
      lung on pulmonary function tests, exercise capacity and quality of life will be examined.
    

Detailed description: 
      Coronavirus disease-19 (COVID-19) has a clinical spectrum ranging from asymptomatic cases to
      severe cases requiring intensive care hospitalization due to respiratory failure. The disease
      mostly infects the lower respiratory tract. Typical computed tomography findings of lung
      involvement are bilateral, peripherally located ground glass density and consolidations.
      There is a close relationship between tomography findings and clinical severity. It is not
      known whether there will be complete recovery in the lungs.

      Investigators will evaluate pulmonary structures with chest computed tomography, respiratory
      capacity with pulmonary function tests (PFTs), exercise capacity with six minutes walk test
      and quality of life with short form-36 (SF-36) im patients who survivors of COVID-19 at least
      6 months after hospital discharge.
    

Intervention name(s): Chest Computed Tomography; Pulmonary Function Tests; Six Minutes Walk Test; Quality of Life
Intervention type(s): Diagnostic Test; Diagnostic Test; Other; Other
Intervention description(s): Evaluation of Lung Structure; Respiratory Capacity; Exercise Capacity; Physical disability assessment tool
Other intervention name(s): SF-36
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Survivors of COVID-19 aged over 18 years old who had been admitted in University of Health
        Sciences, Dr. Suat Seren Chest Disease and Surgery Training and Research Hospital for
        COVID-19 patients in İzmir, Turkey.
      
Keywords: Covid19; Long term outcomes; Chest computed comography; Pulmonary functional tests; Exercise capacity; Quality of life
Physical Activity, Weight and Fitness Outcomes in Children in After-Care
Condition: Obesity; Exercise
Study type: Observational

Summary: 
      The purpose of this study is to compare the effect of two after-school programs on children's
      physical activity, fitness, body composition, and academic performance.
    

Detailed description: 
      Tennessee ranks 4th for the highest prevalence of adult obesity in the nation (30.2%), and
      ranks 5th for the highest rate of youth obesity (36.5%). The Division of General Pediatrics
      at Vanderbilt has a specific research focus to develop community engagement projects that
      measurably reduce childhood obesity. Metro Parks and Recreation has been showcased by the
      National Recreation and Parks Association (NRPA) as a national model for its leadership role
      in community health and wellness. The two have created a unique academic-community
      partnership, guided by principals of community-based participatory research (CBPR), that is
      working to test and disseminate effective Metro Parks-based programs to reduce pediatric
      obesity. The proposed study will examine the impact of the Coleman Community Center
      after-school program on routine physical activity, weight and fitness outcomes in children
      who belong to the low-income and racial and ethnic minority populations at highest risk for
      childhood obesity. This study was requested by Metro Parks and has significant policy
      implications: If the program is deemed effective in improving daily physical activity, weight
      and/or fitness outcomes in students, the proposed study will serve as the rationale to expand
      the program to Metro Parks' 22 community centers, all of which are located in under-resourced
      neighborhoods.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        public school students
      
Keywords: Behavioral Research; Community-Based Participatory Research
Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Extra-renal Lupus Manifestations
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 4

Summary: 
      Azathioprine is still considered the treatment of choice for the non-renal manifestations of
      systemic lupus erythematosus (SLE) with an estimated efficacy of 45%.Recently, several
      studies have demonstrated the efficacy of mycophenolate mofetil/enteric-coated mycophenolate
      sodium in those cases, but so far, no controlled, randomized comparative study between the
      two drugs has been conducted. The aim is to perform a randomized, controlled, phase III/IV
      study comparing enteric-coated mycophenolate (ECMs) with azathioprine for induction and
      maintenance therapy of the non-renal manifestations of SLE. Methods: Patients with non-renal
      SLE flares (SLEDAI≥6 and/or BILAG o 2B refractory to full doses of hydroxychloroquine and
      prednisolone (≥10 mg/d) or with relapsing flares will be included. Patients will be
      stratified according the flare severity (moderate (SLEDAI<12)-severe (SLEDAI≥12)) and
      randomized (1:1) into two groups of treatment, EMCs (2gr/d) or AZA (2-2.5mg/kg/d) according
      to TMPT levels for 6 months. Dose will be progressively tapered based on clinical response up
      to completing a year of treatment. The main aim is the percentage of complete remission
      achieved ((SLEDAI <4 and/or absence of any BILAG A o B) at week 12 and 24 for moderate and
      severe flares, respectively. Secondary objectives include evaluating the reduction in the
      steroid requirement, number of flares post-treatment, effect on the biological parameters,
      and impact on quality of life, damage and drug safety. To detect a 20% difference between the
      two drugs with a 80% statistical power (0.05 alpha error), considering a follow up loss of
      20%, a total of 240 patients is required.
    


Intervention name(s): Azathioprine; Enteric-Coated Mycophenolate Sodium
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose of 2-2.5 mg/kg (according to TMTP levels) for 6 months according the severity of the flare with progressive tapering if complete remission has been obtained; Initial dose of 1440 mg/day for 6 months to be tapered progressively if complete remission had been obtained
Intervention MeSH terms: Mycophenolic Acid; Azathioprine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SLE; non-renal manifestations
A Study Assessing Iron Status and Anemia in Filipino School Children From MIMAROPA Region
Condition: Iron-deficiency; Iron Deficiency Anemia; Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The purpose of this study is to assess the iron status and to confirm the usability of the
      non-invasive ZnPP measurement for screening the different stages of iron deficiency defined
      by standard measurements from blood.
    

Detailed description: 
      Brief description: The purpose of this study is to assess the iron status and to confirm the
      usability of the non-invasive ZnPP measurement for screening the different stages of iron
      deficiency defined by standard measurements from blood.

      Detailed Description:

      The primary objective of this study is to assess the iron status and the prevalence of the
      different stages of iron deficiency measured and defined by the standard blood iron
      measurements and by the non-invasive measurement of red blood cell Zinc Protoporphyrin
      fluorescence in the microcirculation of the lower lip.

      The secondary objective is to compare and to assess the usability of the non-invasive ZnPP
      measurement versus other standard iron status measurements from blood in distinguishing the
      different stages of iron deficiency.

      Subjects will be enrolled into the study after signing an assent form in addition to having
      parental informed consent signed. Total study duration is 1 day.
    

Intervention name(s): TIBAY Meter
Intervention type(s): Device
Intervention description(s): fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.
Intervention model: Single Group Assignment
Intervention model description: Exploratory, interventional, one arm study
Masking: None (Open Label)
Primary purpose: Diagnostic
The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Pain as a result of nerve injury (neuropathic pain) is a particularly severe form of chronic
      pain. Common examples of neuropathic pain are pain due to diabetes and shingles. There is
      good evidence that an intravenous infusion of lidocaine (local anesthetic) is useful for the
      management of neuropathic pain in the short term - up to six hours.
    

Detailed description: 
      This study will examine the role of intravenous lidocaine in the relief of neuropathic pain
      over four weeks following infusion compared to an active placebo infusion of
      diphenhydramine(Benadryl) in normal saline. If we can show that intravenous lidocaine
      provides sustained benefit for up to one month, this will be a major advance in the
      management of individuals suffering from neuropathic pain.
    

Intervention name(s): Lidocaine; Diphenhydramine
Intervention type(s): Drug; Drug
Intervention description(s): Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.; Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.
Other intervention name(s): Xylocaine; Benadryl
Intervention MeSH terms: Diphenhydramine; Promethazine; Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Clinical Study of Lamotrigine to Treat Newly Diagnosed Typical Absence Seizure in Children and Adolescents
Condition: Epilepsy
MeSH terms: Seizures; Epilepsy, Absence
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, uncontrolled, open-label study to evaluate the efficacy and safety of
      lamotrigine monotherapy on newly diagnosed typical absence seizure in children and
      adolescents in Japan and South Korea.

      The study period is composed the baseline, fixed escalation phase, escalation phase,
      maintenance phase, taper phase, and post study examination. During the fixed escalation
      phase, the investigational product is administered at 0.3 mg/kg/day for 2 weeks (Week 1 to
      2), followed by 0.6 mg/kg/day for 2 weeks (Week 3 to 4). Subjects thereafter visit the clinic
      once every 1 to 2 weeks during the escalation phase to increase the dose by 0.6 mg/kg/day up
      to a maximum of 10.2 mg/kg/day or 400 mg/day (whichever was less) until patients are
      confirmed to be seizure-free by HV tests for clinical signs. After seizure free is confirmed
      by HV-clinical signs, the dose is increased by one level and HV-EEG (electroencephalography)
      test (first test) is assessed at the next visit. If seizure free is observed by HV-EEG, the
      same dose is administered. Thereafter, HV-EEG (second test) is assessed at the next visit and
      if seizure free is confirmed again, the subjects enter the 12-week maintenance phase. During
      the maintenance phase, patients visit the clinic once every 4 weeks. The dose can be adjusted
      as necessary within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day (whichever was less)
      taking into account the status of seizures and the safety. The investigational product is
      administered once daily (in the evening). However, if the number of tablets is large,
      twice-daily administration (in the morning and evening) is also allowed. After the completion
      of maintenance phase, subjects who have responded to lamotrigine without tolerability issues
      are eligible to enter the extension phase of the study if clinically indicated.
    


Intervention name(s): Lamictal
Intervention type(s): Drug
Intervention description(s): No comparison
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Testing the Efficacy of Pokemon Go for Increasing Physical Activity
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      Historically, increasing activity was synonymous with exercise; however, it is now thought
      that even much more modest activity levels (e.g., simply walking) or merely decreasing the
      proportion of sedentary time may be sufficient to decrease future morbidity and mortality.
      Some interventions designed to increase activity have shown promise; others have been less
      successful. But even promising interventions are often difficult to generalize to real-life
      clinical settings. One barrier to monitoring the effectiveness of interventions has been the
      lack of availability of accurate, reliable and inexpensive personal activity monitoring
      equipment. The availability of inexpensive pedometers, and, more recently, low cost triaxial
      accelerometers, has now made it much easier to monitor activity levels and provide feedback
      to users. These devices are ideal for capturing activity associated with walking, the most
      popular and acceptable form of exercise, but only if patients actually wear them. Thus, there
      is a need to develop pragmatic approaches that encourage patients to not only wear these
      monitoring devices, but also motivate them to increase their activity.

      In recent years, games have been used in a variety of settings to motivate and change
      behavior. Games not only provide performance feedback to patients, but also provide
      incentives for achieving goals in a context that is fun, intrinsically rewarding, and easy to
      understand. Successful games effectively exploit motivating social factors (e.g.,
      competition, peer support, and entertainment) to maintain interest and engage participants.
      Steps are counted using a commercially available triaxial accelerometer (e.g., a FitBit).
      Pokemon Go is an augmented reality game that encourages players to go outside to search for
      Pokemon creatures.
    


Intervention name(s): Fitbit + Pokemon Go; Fitbit Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received a Fitbit Zip to wear daily for 8 weeks. Participants also received access to the Pokemon Go game.; Participants received a Fitbit Zip to wear daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-group, randomized controlled trial.
Masking: Single (Investigator)
Primary purpose: Prevention
Study of the Inflammation and Airway Changes That Occur After Exposure to Allergen in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol describes a single site mechanistic study to investigate microRNAs (miRNAs)
      that are differentially expressed in the airway epithelium of patients with asthma at
      baseline and in response to allergen challenge. We hypothesize that allergen exposure
      enhances airway smooth muscle contractility and epithelial cell mRNA/miRNA production as a
      consequence of locally increased T-cell derived cytokine production. The study will involve
      three visits over the course of approximately 14 days. At Visit 1, participants will be
      characterized in detail with lung function testing, methacholine challenge testing, and
      allergen skin prick testing. At Visit 2, participants will undergo bronchoscopy with
      segmental allergen administration of either cat or dust mite standardized allergen extract.
      At Visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to collect
      airway samples including bronchoalveolar lavage (BAL), epithelial brushings and endobronchial
      biopsies. Sample analysis will include measurement of miRNA and mRNA expression in epithelial
      brushings (RNAseq and qPCR); analysis of cell surface markers on BAL cells and blood cells;
      and collection of endobronchial biopsies for immunostaining of immune cells localization,
      immunoblotting of smooth cell protein phosphorylation, analysis of mucin content and smooth
      muscle cell subculture. A total of 38 subjects (26 asthmatics with stable or well-controlled
      asthma, 6 allergic non-asthmatics and 6 non-allergic non-asthmatics) will complete the study.
    


Intervention name(s): Segmental airway allergen challenge; Bronchoscopy; Methacholine challenge test; Spirometry; Allergen skin prick test
Intervention type(s): Biological; Procedure; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention MeSH terms: Methacholine Chloride
Intervention model: Single Group Assignment
Intervention model description: Single group before and after administration of allergen
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Asthma; Allergen challenge
Evaluation of the VisuXL® Performance on Ocular Surface Discomfort
Condition: Ocular Discomfort
Study type: Interventional

Summary: 
      VisuXL® is a medical device that is effective in various ocular surface disorders (ocular
      dryness, changes in the continuity of the corneal and conjunctival surface, environmental
      stress, exposure to UV and ionizing radiation, prolonged use of videoterminals, etc.).
      Therefore, the aim of this study is to demonstrate that the clinical benefits and quality of
      life of the swimmers, exposed for a long time to water added with chlorine, are strongly
      linked to the unique composition of the long-term VisuXL® medical device.
    

Detailed description: 
      This is a post-market, monocentric, open-label, randomized study of superiority, with the
      untreated eye considered as a comparator for the eye treated with VisuXL®, to demonstrate the
      effectiveness of VisuXL® in professional water-polo athletes exposed to pool water after
      VisuXL® ocular instillations for 2 months. Considered the category of subjects to study, the
      study is to be considered a fact-finding pilot study in a particular category of subjects.

      The study population will be enrolled only after having signed the informed consent; in each
      enrolled subject, only one eye will be treated with VisuXL®, while the other no, as will be
      considered the comparator, so the two randomized groups will be divided by treated eyes:

        -  Untreated control eye

        -  Eye treated with VisuXL®

      Each enrolled subject will be instructed to instill, TID, 1-2 drops of VisuXL® always in the
      same eye during the entire study, according to the present modality:

        -  Morning

        -  Before training (at least one hour before entering the pool)

        -  After training (maximum one hour after the end of the activity) Subjects will continue
           to instil 1-2 drops of VisuXL®, TID, always in the same eye, even in days without
           training (including weekends).
    

Intervention name(s): VisuXL®
Intervention type(s): Device
Intervention description(s): Treatment of discomfort forms of the ocular surface, in professional water-polo athletes exposed to pool water for prolonged periods.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3041658 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3041658 in
      healthy participants. The study will measure how the body absorbs, breaks down and gets rid
      of LY3041658.
    


Intervention name(s): LY3041658
Intervention type(s): Drug
Intervention description(s): Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetics and Safety Profile of CKD-333
Condition: Hypertension; Dyslipidemias
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330,
      D086 combination
    

Detailed description: 
      An open-label, randomized, fasted, single-dose, three-way crossover study to compare the
      pharmacokinetic characteristics and safety between administration of CKD-333 and
      coadministration of CKD-330 and D086 in healthy male adults
    

Intervention name(s): CKD-333 formulation I; CKD-333 formulation II; CKD-330+D086
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet administered before the breakfast(single-dose); 1 tablet administered before the breakfast(single-dose); 2 tablet administered before the breakfast(single-dose)
Other intervention name(s): Test drug; Test drug; Reference drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Dyslipidemias; CKD-333
Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether olanzapine, compared to risperidone, can
      provide more adequate and timely control of behavioral agitation in acutely ill subjects with
      schizophrenia.
    


Intervention name(s): Olanzapine Hydrochloride; Risperidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of the Systemic Absorption of MOB015B
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study of the Systemic Absorption of Once Daily MOB015B when Applied for 28 Days in Subjects
      with Moderate to Severe Onychomycosis of the Toenails.
    


Intervention name(s): MOB015B
Intervention type(s): Drug
Intervention description(s): Topical formulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other