bioihbjkbjnl/mcl2 huggingface dataset:
Investigating Mucinase Activity in Airway Disease
Condition: Asthma; Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to investigate how mucus (phlegm or spit) is broken down once it
      forms in the airways (bronchial tubes) of people with lung disease. This research study will
      also examine whether blood groups have an effect on lung function or the type of mucus found
      in the lung. This study is not designed to be a treatment for asthma, emphysema, cystic
      fibrosis, or other lung disease. It is designed to help the investigators learn more about
      the causes of airway disease.
    

Detailed description: 
      Accumulation of mucus in the airway involves the process of overproduction and reduced
      clearance of mucin glycoproteins. To date, little attention has been focused on mechanisms of
      mucin clearance from the airway. We hypothesize that there is enzymatic degradation of mucins
      ("mucinase activity") in the airway, which acts to break down mucins and facilitate their
      clearance. We further hypothesize that glycosidases function as mucinases by removing
      peripheral monosaccharides from oligosaccharides, including oligosaccharides on mucins.
      Removal of terminal or capping sugars on mucin side chains may be an important mechanism in
      mucin degradation and clearance from the lung. If mucinase activity exists in the airway then
      mucus collected from human subjects should demonstrate evidence of mucin degradation ex vivo,
      especially at 37º celsius. As part of our protocol we propose to examine changes in airway
      mucus ex vivo under different experimental conditions. Our primary readout will be measures
      of sputum rheology, namely viscosity and elasticity. Our consultant for this methodology will
      be Dr Susan Muller (Chemical Engineering, University of California, Berkeley). In order to
      conduct experimental studies in this way we will need multiple samples from the same
      subjects. Thus, up to 10 or more sputum samples per subject will be collected on different
      days. In addition, we are interested in the biochemical properties of sputum and saliva,
      specifically the composition of mucin molecules found in these fluids.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Volunteers are recruited from community advertisements and health clinics
      
Biospecimen description: 
      Sputum
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compared the incidence of a two-part composite endpoint consisting of de novo
      donor specific antibody (DSA) formation or a designation of immune activation (IA) on
      peripheral blood molecular profiling in participants maintained on twice daily,
      immediate-release tacrolimus versus those maintained on Astagraf XL in the first year
      post-transplant.
    

Detailed description: 
      This was an exploratory, two year (shortened to 1 year due to a stopping rule necessitated by
      the adaptive design), prospective, randomized, multi-center, open-label trial examining
      long-term kidney transplant outcomes through the use of an adaptive design and a two-part,
      composite surrogate endpoint. Specifically, it was designed to compare the effects of twice
      daily, immediate-release tacrolimus and once daily Astagraf XL on DSA formation and the
      development of a peripheral blood molecular profile indicating the presence of IA in de novo
      kidney transplant recipients during the first year following transplantation. For the
      purposes of this study, IA was defined as a positive molecular signature using a molecular
      assay in all participants.

      Participants were screened prior to surgery and randomized 1:1 to receive immediate-release
      tacrolimus, administered twice daily, or Astagraf XL, as a component of a standard
      immunosuppression maintenance regimen also consisting of corticosteroids (if given per
      institutional protocol) and mycophenolate mofetil (MMF) (or Myfortic® equivalent).
      Investigators were encouraged to start participants on the randomized study treatment
      (immediate release tacrolimus or Astagraf XL) within 48 hours of transplantation
      (pre-transplant administration of study treatment was not allowed). However, if medically
      indicated per the treating physician's discretion, initiation of study treatment was delayed
      for up to seven days post-transplant.
    

Intervention name(s): Tacrolimus; Tacrolimus immediate release
Intervention type(s): Drug; Drug
Intervention description(s): Oral Capsule; Oral Capsule
Other intervention name(s): Advagraf; FK506E; Astagraf XL; FK506; Prograf; generic immediate release tacrolimus
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FK506; Kidney Transplantation; Tacrolimus; Astagraf XL
Modulation of Painful Perception
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of the study is to evaluate in healthy volunteers, the influence of empathy on
      pain perception.

      It is widely accepted in the clinical management that the feeling of listening to the
      patients' pain would have a favorable influence on the pain, and conversely, the lack of
      listening would be aggravating.

      In this study, the volunteer will receive painful thermal stimuli in empathetic context (l,
      empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or
      minimize the suffering of the voluntary and the other or the contrary, the subject will
      receive empathy.

      The first part of the project is to verify that the pain is influenced by the empathetic
      context. The second part will be conducted functional MRI, which should isolate the brain
      regions affected by other people's empathy for pain.
    


Intervention name(s): thermal stimulation delivered by a thermode.; functional MRI
Intervention type(s): Device; Other
Intervention description(s): Empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation; MRI realised with thermal stimulations and empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: healthy volunteers
Liraglutide in Newly Onset Type 1 Diabetes.
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once
      daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly
      diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.
    


Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Saline
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: c-peptide; insulin; hypoglycemia; Newly onset; Diabetes; Type 1; Beta cell; Autoimmune; Glucagon; Meal test
Mitochondrial Biomarkers in Huntington's Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Observational [Patient Registry]

Summary: 
      The objective of this study is to discover a panel of mitochondrial metabolomics biomarkers
      for Huntington's disease.
    

Detailed description: 
      This investigator-initiated, single-site longitudinal study seeks to assess the utility of
      mitochondrial metabolomics -- panels of small molecules that affect mitochondrial function --
      to diagnose pre-symptomatic, pre-manifest, and symptomatic Huntington's disease and serve as
      biomarkers for HD severity and progression. It also seeks to demonstrate that this novel
      biomarker in the blood has comparable value to the same analysis in spinal fluid. This
      research study involves 3-4 visits over 18 months. Forty volunteers with HD and 25 volunteers
      without HD will be included. Volunteers who have HD will have a physical examination and
      blood draw at each study visit. Some participants will also volunteer for optional lumbar
      puncture.
    

Intervention name(s): lumbar puncture
Intervention type(s): Diagnostic Test
Intervention description(s): Some participants will have an optional lumbar puncture
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of people with HD and controls without HD
      
Biospecimen description: 
      blood and csf specimens for mitochondrial metabolomics
    
Keywords: Huntington disease; Huntington's disease; biomarker
Gender Influence on Torsadogenic Actions of Droperidol.
Condition: Arrhythmia, Droperidol
MeSH terms: Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting (PONV) is a quite common complication affecting patients
      undergoing general anesthesia. There are a few pharmacological agents of well known
      effectiveness in reducing the risk of PONV. One of them is droperidol, which is a
      butyrophenone derivant. It has been widely used for the prevention and treatment of PONV due
      to its high effectiveness and low cost. Though, droperidol has a relevant side effect, that
      is a repolarization prolongation. This can lead to life-threatening cardiac arrhythmias:
      polymorphic ventricular tachycardia (torsades de pointes, TdP) that can degenerate into
      ventricular fibrillation and cardiac arrest. This was a reason why in 2001 the FDA issued a
      "black box" warning on droperidol. Ever since papers focused on this problem have described
      the influence of small doses of droperidol on TdP genesis as weak. This could be explained by
      the fact, that QT/QTc (corrected QT) interval prolongation, which represents prolonged
      cardiac repolarization on ECG, is not the sole determinant of a drug's potential to cause
      arrhythmia. Another electrocardiographical marker of torsadogenic action is increased
      transmural dispersion of repolarization (TDR). TDR represents differences in the
      repolarization between myocardial "layers" (like epicardium, endocardium, myocardium cells).
      It is believed that the induction of QT/QTc lengthening must coexist with TDR increase at the
      same time to promote torsadogenic changes.

      It has been known, on the basis of research, that females have been more potent to
      torsadogenic actions of pharmacological agents than males. That could be related to estrogen
      influence on ECG parameters, which had been proven on animal model. It hasn't been
      investigated, whether gender is an important factor when considering droperidol's
      torsadogenic potential.

      The aim of this study is to answer a hypothesis, that women are more potent to torsadogenic
      actions of droperidol in comparison with men.
    


Intervention name(s): Droperidol Injectable Solution
Intervention type(s): Drug
Intervention description(s): An electrocardiogram analysis in: 5,10,15,20 minutes after injection of 1.25 mg of droperidol used as PONV prophylaxis.
Other intervention name(s): electrocardiogram analysis
Intervention MeSH terms: Droperidol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: postoperative nausea and vomiting; torsadogenic action; transmural dispersion of repolarisation; corrected QT interval
Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated
      with OROS MPH to those treated with placebo.
    

Detailed description: 
      The hypothesis is that Osmotic Release Oral System (OROS) Extended Release Methylphenidate
      HCL (OROS MPH) is safe and effective in improving Attention Deficit Hyperactivity Disorder
      (ADHD) symptoms in adults with ADHD when compared to placebo as demonstrated using specific
      study measures. This is a double-blind (neither participant nor investigator knows the name
      of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled
      study to evaluate the efficacy and safety of OROS MPH using the optimal dose for each adult
      patient in the study with ADHD. The primary efficacy variable in this study is the change
      from baseline to final evaluation using the Adult ADHD Investigator Symptom Rating Scale
      (AISRS) to measure patient ADHD symptoms. Participants will also be assessed for adverse
      events throughout the study. Patients will initiate treatment with oral OROS MPH 18 mg or
      matching placebo at baseline and continue morning dosing with increases every week until an
      optimal dose is achieved, up to the maximum of 72 mg/day of OROS MPH or matching placebo.
      Eligible patients will remain in the study for a maximum of 6 weeks.
    

Intervention name(s): OROS MPH; Placebo; OROS MPH Tablets; Placebo Tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks; Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily for 6 weeks; Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks; Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osmotic Release Oral System (OROS®) Extended Release Methylphenidate HCl; CONCERTA® (OROS MPH)
Warfarin Versus Aspirin Recurrent Stroke Study
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to compare aspirin to warfarin for the prevention of recurrent
      stroke.
    

Detailed description: 
      This study compared aspirin to warfarin to determine optimal therapy for the prevention of
      recurrent stroke. Both drugs slow clotting of the blood. Blood clots are involved in the
      final stages of the most common type of stroke due to blockage of the vessels that supply
      oxygen-rich blood to the brain. Aspirin affects the blood platelets, while warfarin inhibits
      circulating clotting proteins in the blood. Numerous previous studies have proven that use of
      aspirin reduces recurrent stroke by about 25 percent. Part of the controversy about aspirin
      versus warfarin for stroke prevention has been the thinking among clinicians that warfarin
      may be a better blood thinner than aspirin to prevent almost all forms of stroke, but that it
      has greater side effects, increased risk of hemorrhage, and higher costs due to the need for
      blood tests to monitor the treatment effect for patients.

      To make the aspirin and warfarin arms of the study as unbiased as possible, the investigators
      matched both groups of patients for primary stroke severity, age, gender, education, and
      race/ethnicity. The two groups were also matched for stroke risk factors, including
      hypertension, diabetes, cardiac disease, smoking, alcohol consumption, and physical activity.
      The investigators used an aspirin dose of 325 mg/day and a warfarin dose specifically
      tailored to each individual patient.

      This study found that aspirin works as well as warfarin in helping to prevent recurrent
      strokes in most patients.
    

Intervention name(s): Active Aspirin; Active Warfarin; Aspirin placebo; Warfarin placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 325mg tablet daily; 2mg scored tablet daily; 325mg aspirin placebo pill; 2mg scored placebo tablet
Intervention MeSH terms: Aspirin; Warfarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: stroke; aspirin; warfarin
MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for
      consultation, among the most frequent, in general or pediatric medicine. Among the different
      clinical forms of instability, ADHD appears to be an especially disabling condition for the
      development of the child, both in psychomotor, cognitive, emotional and relational aspects.
      Further, a significant link between ADHD children and some children with High Potential (HP)
      is observed. HP children show overall ahead cognitive developments compared to children with
      the same age. In these children, as well as in children with ADHD, an attention
      vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits
      that significantly contrasted with some of their cognitive skills. Regarding the HP, the
      hypothesis is that children with significantly heterogeneous results (Complex) to the
      Wechsler IV scales are affected by this shift, and hence, by the difficulty of a differential
      diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that are more
      homogeneous (Laminar).

      The goal of this work was to study a population of 80 children aged from 8 to 12 years (20
      subjects per group) to evaluate the functional and structural brain development by:

        -  Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations,
           involving attention, working memory and semantic processing, and emotional stimulations,

        -  fMRI acquisitions at rest (without activation),

        -  diffusion tensor magnetic resonance imaging (DTI) acquisitions,

        -  3D anatomic acquisitions. Identification of developmental differences in certain
           cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or
           functional networks preferentially used by one or other of these groups, will help to
           better understand this disease, and to improve the differential diagnosis in order to
           implement a more appropriate and personalized management of the patients via new
           therapeutic strategies.
    


Intervention name(s): MRI; neuropsychological assessment
Intervention type(s): Other; Other
Intervention description(s): MRI and neuropsychological assessment planned for the study for patient and volunteers
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Laminar HP; Complex HP
A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14
      outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious
      outbreak was considered to be a new epidemic strain, with GP homology of the gene was only
      97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine
      was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry
      products which could be stored at 4℃.

      This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical
      trial. This study will determine the safety and side-effect profile, and immunogenicity of an
      investigational Ad5-EBOV vaccine.
    


Intervention name(s): Low dose Ebola Zaire vaccine (Ad5-EBOV); High dose Ebola Zaire vaccine (Ad5-EBOV); placebo (one dose); placebo (two doses)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV); two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.; placebo, one doses; placebo, two doses, with one dose to each arm at a same time.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Safety,immunogenicity,Ebola
Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section
Condition: Cesarean Section; Dehiscence; Cesarean Scar Niche
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar
      healing after cesarean section by using saline contrast sonohysterography
    

Detailed description: 
      This is a triple blind randomized placebo controlled prospective clinical trial that will be
      conducted in Ain Shams University Maternity Hospital.

      in which a consecutive series of participant attending emergency room 102 women undergoing
      cesarean section for the first time will be randomized into two groups.

      Group A (Study group): 51 women will receive alpha lipoic acid drug ( 600 mg twice daily) for
      6 weeks after cesarean section and saline sonohysterography will be done after that.

      Group B (Control group): 51 women will receive a placebo drug twice daily for 6 weeks after
      cesarean section and saline sonohysterography will be done after that.
    

Intervention name(s): alpha lipoic acid drug (thioctic acid acid); Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.; placebo oral drug have the same shape of thiotacid tablet
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention