bioihbjkbjnl/mcl2 huggingface dataset:
Optical Coherence Tomography in Multiple Sclerosis Patients
Condition: Multiple Sclerosis; Optic Neuritis
MeSH terms: Multiple Sclerosis; Neuritis; Optic Neuritis; Sclerosis
Study type: Observational

Summary: 
      To evaluate the ability of different spectral domain optical coherence tomography (OCT)
      devices, as well as different acquisition and analysis packages, to detect disease
      progression in patients with multiple sclerosis with and without a history of optic neuritis
    

Detailed description: 
      Optical coherence tomography imaging of the retina has been shown to be an effective non
      invasive method to study retinal changes associated with multiple sclerosis induced optic
      neuritis. The retina is a unique structure in that it is an unmyelinated part of the central
      nervous system (CNS). However, it is uncertain which layer of the retina provides the best
      correlation with MS disease. The investigators propose a prospective, case-control study to
      compare OCT measurements from different parts of the retina of MS patients with optic
      neuritis, those without optic neuritis, and healthy controls. The investigators will then
      correlate the OCT measurements to clinical measures of disease. This will allow future
      studies to use OCT technology as a primary outcome in studying MS axonal and cell body injury
      of the CNS, as well as evaluating strategies in treating MS.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective, case-control study of patients from the Mellen Center and Cole Eye Institute
        of the Cleveland Clinic in Cleveland Ohio. The study population will consist of MS patients
        with a prior history optic neuritis in one eye. The affected eye will serve as cases for
        the study. The contralateral, unaffected eye will be used as the control. Controls will
        also be recruited from MS patients without a history of optic neuritis and from healthy
        individuals from Cole Eye Institute.
The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      It is not previously investigated whether, there is a correlation between potassium channels
      and migraine, so it is unclear whether, this signaling pathway through potassium channels has
      an impact on migraine pathophysiology.

      Maxipost (BMS 204352) is a vasoactive molecule that causes vasodilation via the big calcium
      dependent potassium (BKCa) channel signaling pathway. Maxipost decreases the blood pressure
      and maxipost infusion causes headache in healthy volunteers. A possible coherence between
      maxipost and headache/migraine in healthy volunteers and migraine patients is yet to be
      investigated.

      The present study aims to clarify a possible coherence between maxipost and headache/migraine
      and it will help to shed light on the importance of potassium channels in migraine. In
      general, the study will contribute to a greater understanding of migraine pathogenesis and
      possibly lead to development of specific migraine treatment.
    


Intervention name(s): Maxipost; Saline
Intervention type(s): Drug; Drug
Intervention description(s): To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients; To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation
Condition: Colonoscopy
Study type: Interventional

Summary: 
      The purpose of this study is to compare the colon cleansing quality of linaclotide versus
      control in adult patients at high risk of inadequate bowel preparation: one group will
      receive polyethylene glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the
      other group PEG (1 L + 2 L) plus placebo before colonoscopy.
    

Detailed description: 
      The objective of this trial is to compare the colon cleanliness achieved with PEG split dose
      (1 L + 2 L) + linaclotide versus PEG split dose (1 L + 2 L) + placebo for patients scheduled
      for a colonoscopy at high risk of inadequate bowel preparation. The target patients are those
      with constipation, poor bowel preparation history, history of abdominal/pelvic surgery,
      comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), BMI >
      25 kg/m2, age > 70, tricyclic antidepressants usage, or opioid usage, as defined by the
      latest version of Bowel Preparation Guidelines.
    

Intervention name(s): 3 L PEG + linaclotide; 3 L PEG + placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants take a linaclotide capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another linaclotide capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.; Participants take a placebo capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another placebo capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: colonoscopy; inadequate bowel preparation; Boston Bowel Preparation Scale; linaclotide
A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics
      (PK) of eliglustat.

      Secondary Objective:

      To assess the tolerability of eliglustat tartrate given as a single dose in subjects with
      mild, moderate, and severe renal impairment in comparison with matched subjects with normal
      renal function.
    

Detailed description: 
      The total study duration from screening period is approximately 31 days. In stage 1, only
      subjects with severe renal impairment and normal renal function will be enrolled. Subjects
      with mild and moderate renal impairment may be enrolled in stage 2 if the results in subjects
      with severe renal impairment show a substantial effect of reduced renal function on
      pharmacokinetics.
    

Intervention name(s): eliglustat
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: capsule
Route of administration: oral
Other intervention name(s): GZ385660
Intervention MeSH terms: Eliglustat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled
      (clindamycin [CLDM] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to
      demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide [BPO] 3% gel) when applied
      once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when
      applied topically either once or twice daily for 12 weeks.
    

Detailed description: 
      Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global
      Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial
      inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions
      (open and closed comedones), including nasal lesions. The primary objectives are to
      demonstrate the superiority of GSK2585823 twice daily to CLDM twice daily in total lesion
      counts, and to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily
      in total lesion counts. The secondary objectives are to demonstrate the non-inferiority of
      GSK2585823 once daily to CLDM twice daily in inflammatory lesion counts, and to evaluate the
      efficacy of GSK2585823 once or twice daily compared with CLDM twice daily at each visit. A
      total of 800 subjects will be enrolled and randomly assigned to one of the groups.
    

Intervention name(s): GSK2585823(CLDM 1%-BPO 3% gel); CLDM 1% gel twice daily
Intervention type(s): Drug; Drug
Intervention description(s): Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg; Topical gel containing clindamycin 10 mg/1 g gel
Other intervention name(s): GSK2585823; CLDM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: twice daily; once daily; CLDM 1%-BPO 3% gel; Clindamycin (CLDM); benzoyl peroxide (BPO); inflammatory lesion; non-inflammatory lesion; acne vulgaris
Late Permissive Hypercapnia for Intubated and Ventilated Preterm Infants
Condition: Premature Neonate
MeSH terms: Premature Birth; Hypercapnia
Study type: Interventional

Summary: 
      Preterm infants, less than 37 weeks gestation with respiratory distress syndrome, who remain
      ventilated between 7 and 14 days after birth will be randomized to a ventilator strategy of
      either a higher level of permissive hypercapnia or of a lower level of permissive hypercapnia
      to determine if either strategy will increase the number of alive ventilator-free days in the
      28 days after randomization.
    

Detailed description: 
      22.0 to 36.6 weeks gestational age preterm infants with respiratory distress syndrome, who
      remain ventilated between 7 and 14 days after birth will be randomized to one of two
      ventilator strategies: 1) a higher level of permissive hypercapnia or 2) a lower level of
      permissive hypercapnia to determine if either strategy will increase the number of alive
      ventilator-free days in the 28 days after randomization.

      After parental consent obtained, intubated, mechanically ventilated infants will be
      randomized by use of sequentially numbered sealed opaque envelopes to the treatment
      assignment. Randomized infants will be stratified by gestational age at delivery (< 26 weeks,
      ≥ 26 wks but less than 29 weeks, and ≥ 29 weeks). Multiple births will be randomized to the
      same group. The envelope will be opened only on days 7-14 when infant meets criteria.
      Clinicians will follow pre-specified algorithms of extubation and reintubation criteria to
      wean infants from mechanical ventilation. The ventilation algorithms may be set aside until
      the infant is deemed stable enough to allow resumption of the study algorithm.

      Infant will be extubated within 24 hours of meeting extubation criteria and documented on a
      single blood gas. A trial of extubation per attending physician is allowed independent of the
      trial protocol.All other care is per unit standard.

      Reports of routine follow-up after discharge in babies < 27 weeks gestation will be obtained
      to determine neurodevelopmental impairment on this subset of babies.
    

Intervention name(s): Higher permissive hypercapnia; Lower Permissive Hypercapnia
Intervention type(s): Other; Other
Intervention description(s): pCO2 ≥ 60mmHg with an upper limit ≤ 75mmHg;
pH ≥ 7.20 from a capillary or arterial blood sample;; pCO2 ≥ 40mmHg with an upper limit ≤ 55mmHg;
pH ≥ 7.25 from a capillary or arterial blood sample;
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: respiratory distress syndrome; permissive hypercapnia; ventilator strategy
The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      In the present project the investigators will evaluate whether glucagonotropic properties of
      the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be
      utilized as a safeguard against hypoglycemia in the daily life of participants with type 1
      Diabetes
    


Intervention name(s): GIP
Intervention type(s): Drug
Intervention description(s): Infusion of Glucose-dependent insulinotropic peptide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: placebo-controlled, double-blinded, cross-over study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Gastric Inhibitory Polypeptide; Diabetes Mellitus, Type 1; Hypoglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Glucagon; Incretin
Effect of a Nursing Teaching Protocol on Mastitis Prognosis: Quasi-Experimental Research Design
Condition: Mastitis
MeSH terms: Mastitis
Study type: Interventional

Summary: 
      Aim: Evaluate the effect of a nursing teaching protocol on mastitis prognosis. Research
      design: Quasi-experimental research design was utilized. A convenient sample of sixty adult
      female patients diagnosed with mastitis, Patients divided equally into two groups(study and
      control) thirty for each.
    

Detailed description: 
      The study was conducted in the breast unit in general surgery department at Main Assiut
      University Hospital. A convenient sample of sixty adult female patients diagnosed with
      mastitis, their ages range from 20 to 65years old. Patients divided equally into two groups;
      thirty for each. Both groups had been assessed at base line using the following tools:

      Tool (I): An interview questionnaire sheet Tool (II):Mastitis self-care practices Tool (III):
      Numeric pain rating scale Tool (IV): Mastitis prognosis sheet

      The control group exposed to routine care and study group received mastitis teaching
      protocol. After three weeks; both groups had been reassessed by the same tools.

      Data analysis had been performed by using the Statistical Package for the Social Sciences
      (SPSS) Categorical variables described by number and percent (N, %). Continuous variables
      described by mean and standard deviation (Mean, SD). Chi-square test and Fisher exact test
      used to compare between categorical variables .T-test and Pearson's chi-square used to appear
      the association between patients' knowledge, practice, and mastitis prognosis before
      implementation of nursing teaching protocol and three weeks post.
    

Intervention name(s): Mastitis care teaching protocol
Intervention type(s): Other
Intervention description(s): It was developed by the authors based on previous similar studies, articles and library resources. It was introduced to the study group in the form of face to face sessions plus a hand out copy. It consisted of three parts; (1): Theoretical part about mastitis (definition, types, clinical manifestation, possible causes, diagnosis and management). (2):Self-care practices, and (3):Recommendations regarding dietary measures, rest, medication and follow up.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Quasi experimental research design that test for change through manipulation of the independent variable. However, in this study, it lacks one of the three key properties of an experimental design "randomization".
The dependent variables (mastitis knowledge, self -care practice, pain level, and complications associated with mastitis) were measured and compared at base line for both control and study groups, then intervention was introduced to the study group. After three weeks; the dependent variables for both groups were evaluated to test the difference.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether levodopa/benserazide dispersible is
      effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.
    

Detailed description: 
      Delayed ON is one of the motor complications of advanced PD patients that effect of
      anti-parkinsonian medication is delayed more than 40 minutes after intake. In the most severe
      cases, the effect does not appear even until next medication schedule, so called "No ON"
      status. It is important to manage delayed ON properly because it can interfere motor
      functions and quality of life of PD patients.

      Levodopa/benserazide dispersible can be absorbed rapidly in the intestine, so theoretically
      it can break the poor response to conventional treatment of PD patients with delayed ON.
      However, this has not been proven by clinical trials till now.
    

Intervention name(s): Levodopa dispersible; Levodopa
Intervention type(s): Drug; Drug
Intervention description(s): Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover); Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
Other intervention name(s): Madopar dispersible; Madopar
Intervention MeSH terms: Levodopa; Benserazide; Benserazide, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genetic Liability in the Brain Morphology of Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Attention Deficit Hyperactivity Disorder (ADHD) is a heritable psychiatric disorder with
      onset in childhood. Twin and adoption studies indicate that additive genetic factors explain
      up to 80% of the variance underlying susceptibility. The siblings of children with ADHD have
      a three- to fivefold increased risk of having ADHD compared to the siblings of healthy
      control subjects, and the risk is even greater for monozygotic twins with 50-80% concordance
      compared with up to 33% in dizygotic twins). As full siblings share on average 50% of their
      genes, even the unaffected siblings of children with ADHD would be expected to share some of
      the genes involved in the disorder. The neuroanatomical substrate of ADHD is becoming
      increasingly better defined by a growing body of evidence from imaging studies. Evidence from
      neuroimaging studies suggests that this disorder is associated with reductions in brain
      volume up to 5% in these children. In this protocol we collected MRI-scans from boys with
      ADHD and their unaffected siblings, as well as control subjects. In addition, cheekswabs were
      later collected for DNA analysis.
    


Observational model: Case-Control
Time perspective: Other
Keywords: ADHD; MRI; genetics
Effectiveness of an Educational Program in the Prevention of Osteoporosis and Fractures
Condition: Fractures; Osteoporosis
MeSH terms: Osteoporosis; Fractures, Bone
Study type: Interventional

Summary: 
      The study will elucidate the effectiveness of an educational program in the prevention of
      osteoporosis and fractures. A random sample of the female population in Southern Finland
      (Uusimaa region) within the age group of 60-70 years was drawn from the population registry.
      From 1996 through 2000, 2181 women from the population register were recruited and randomly
      assigned to the intervention and to the control group. The subjects in the intervention group
      have been on a multidisciplinary program and the subjects in the control group received
      osteoporosis prevention information through the media and health care system. An end point is
      any fracture during the ten-year follow-up.
    


Intervention name(s): multidisciplinary osteoporosis prevention educational program
Intervention type(s): Behavioral
Intervention description(s): The program includes individualized counseling aimed at improving diet, muscle strength, balance, and informing individuals about home hazards and the use of medicine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vitamin D; bone density
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and
      insulin data will be collected. This will be followed by a 94-day (13-week) hybrid
      closed-loop phase conducted in an outpatient setting, and an optional 12-month extension
      phase.
    

Detailed description: 
      The study schedule will consist of a standard therapy data collection phase followed by a
      hybrid closed-loop phase.

      Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and
      insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at
      home per their usual routine using the study continuous glucose monitoring system (CGM) and
      remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a
      94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects,
      or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated
      Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will
      have the option to continue using the system for an additional 12 months.

      During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of
      supervised meal and exercise challenges.

      The hybrid closed-loop phase will begin on Study Day 1.
    

Intervention name(s): Omnipod Horizon™ Automated Glucose Control System
Intervention type(s): Device
Intervention description(s): The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery.
Intervention model: Single Group Assignment
Intervention model description: single-arm, multi-center, prospective clinical study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T1D; Omnipod