bioihbjkbjnl/mcl2 huggingface dataset:
Drug-drug Interaction Study of KL1333 in Healthy Subjects
Condition: Mitochondrial Disease
MeSH terms: Mitochondrial Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate
      the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and
      CYP3A4 in Healthy Subjects
    

Detailed description: 
      This will be a Phase I, open-label, fixed-sequence, crossover study to investigate the effect
      of coadministration of KL1333 on the PK of repaglinide, caffeine, omeprazole, midazolam,
      bupropion, dextromethorphan, and flurbiprofen in healthy male and female subjects. Potential
      subjects will be screened to assess their eligibility to enter the study within 28 days prior
      to the first dose administration. Subjects will be admitted into the clinical research unit
      (CRU) on Day -1 and be confined to the CRU until discharge on Day 19. Subjects will return to
      the CRU for a follow-up visit 5 to 7 days after the last dose.
    

Intervention name(s): KL1333; Flurbiprofen; Dextromethorphan; Bupropion; Midazolam injection; Omeprazole; Caffeine; Repaglinide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Syrap; Tablet; solution for injection; Capsule; Tablet or capsule; Tablet
Other intervention name(s): Midazolam
Intervention MeSH terms: Repaglinide; Flurbiprofen; Midazolam; Dextromethorphan; Caffeine; Bupropion; Omeprazole
Intervention model: Crossover Assignment
Intervention model description: All subjects are treated in the same arm, but in a crossover manner.
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Spinal Cord Injury Patients for Neurogenic Bladder: Anticholinergic Agent vs. Mirabegron
Condition: Spinal Cord Injuries; Neurogenic Bladder; Cognitive Change
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Neurogenic; Wounds and Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      We propose to test the hypothesis that cognition will improve with substitution of mirabegron
      for the anticholinergic agent (AC) in elderly persons with spinal cord injury (SCI) who
      require neurogenic bladder (NGB) treatment.
    

Detailed description: 
      The strong evidence for detrimental effects of AC agents on cognition, led the American
      Urological Association to update its guidelines in 2015 to include mirabegron as an
      alternative first-line agent for treatment of overactive bladder (OAB). NGB symptoms are very
      similar to OAB so the conditions are often treated similarly; however, data is lacking on the
      use of this promising agent for NGB. We thus propose to test the hypothesis that cognition
      will improve with substitution of mirabegron for the AC agent in elderly persons with SCI who
      require NGB treatment.

      Subjects eligible for enrollment will have been treated with an anticholinergic agent for at
      least 3 months prior to enrollment. Baseline measurements will be recorded for subjects
      currently treated with an AC agent, after enrollment, the subject will start treatment with
      the study drug. Measurements from baseline (AC agent) will be compared to measurements taken
      after study intervention (mirabegron).
    

Intervention name(s): Mirabegron
Intervention type(s): Drug
Intervention description(s): Beta-3 adenoreceptor agonist
Other intervention name(s): MYRBETRIQ
Intervention MeSH terms: Mirabegron
Intervention model: Single Group Assignment
Intervention model description: Open label, pilot study comparing baseline measurement anticholinergic agent vs. study intervention mirabegron (MYRBETRIC ®) to evaluate cognitive impact and efficacy (SCIMYR)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal cord injury; SCI; Neurogenic bladder; Overactive bladder; anticholinergic; mirabegron; cognitive; cognition; NGB; OAB
The Effect of Montelukast Treatment in Wheezy Infants
Condition: Lung Disease, Obstructive; Signs and Symptoms, Respiratory
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Signs and Symptoms, Respiratory
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to evaluate the efficacy of montelukast on symptom-free days in
      unselected group of very young children with wheeze and recurrent asthma like symptoms. The
      secondary aim was to evaluate the effect of montelukast on lung function, airway
      responsiveness, airway inflammation and use of rescue medication.
    

Detailed description: 
      The aim of this study was to investigate the effectiveness of montelukast in wheezy very
      young children with persistent respiratory symptoms. This study was a prospective,
      double-blind, placebo-controlled study of 6 to 24 months old children, who had at least one
      physician-diagnosed wheezing episode and persistent asthmatic symptoms. Patients were
      randomised to placebo or montelukast 4 mg / day for 8 weeks period. The clinical response to
      treatment was determined, the functional residual capacity (FRC) and specific air-way
      conductance (sGaw) was measured using an infant whole-body pletys-mograph, the maximal flow
      at functional residual capacity (V´maxFRC) was re-corded using the squeeze technique and
      airway responsiveness was evaluated by performing a dosimetric methacholine challenge test.
    

Intervention name(s): montelukast
Intervention type(s): Drug
Intervention description(s): montelukast 4mg once per day for 8 weeks period
Other intervention name(s): singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: montelukast, very young children, lung function tests
Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this clinical investigation is to determine the effects of renal sympathetic
      denervation on insulin resistance and muscle sympathetic nerve activity in patients with
      metabolic syndrome.
    


Intervention name(s): Renal Denervation; EnligHTN™ Renal Denervation System.
Intervention type(s): Procedure; Device
Intervention description(s): Renal artery ablation with the EnligHTN™ Renal Denervation System.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Renal denervation; Renal artery; Muscle sympathetic nerve activity
Effect of Smoking on the Expression of Gelatinases in Chronic Periodontitis
Condition: Periodontitis; Smoking
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Observational

Summary: 
      This study comparatively evaluate the expressions of MMP-2 and MMP-9 in smoker vs non-smoker
      chronic periodontitis patients as well as periodontally healthy subjects. the hypothesis of
      this study was that smoking may interfere with periodontal disease by effecting MMP-2 and
      MMP-9 expressions.
    

Detailed description: 
      Smokers have greater risk for developing periodontal disease and smoking is highly correlated
      with greater marginal bone loss. Matrix metalloproteinases (MMP) play a major role in
      periodontal tissue destruction. MMP-2 and MMP-9, called gelatinases, are one of the major
      MMPs that plays important roles in periodontitis. To date, several studies showed the
      increased levels of gelatinases in periodontal disease and only a limited number of study
      investigated the effect of smoking on gelatinases. However, no previous study has directly
      investigated the possible relationship between smoking and gingival tissue gelatinases
      expressions (MMP-2 and MMP-9) in chronic periodontitis (CP) patients relative to
      periodontally healthy subjects.

      Therefore this study is conducted to comparatively evaluate the expressions of MMP-2 and
      MMP-9 in smoker vs non-smoker chronic periodontitis patients as well as periodontally healthy
      subjects. the of this study hypothesis was that smoking may interfere with periodontal
      disease by effecting MMP-2 and MMP-9 expressions.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): this is cross-sectional study
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 80 subjects (35 females, 45 males, with an age range of 16-62 years) were
        included in this study from those patients seeking dental treatment at the Baskent
        University School of Dentistry
      
Keywords: chronic periodontitis; smoking; mmp-2; mmp-9
Perhexiline Therapy in Heart Failure With Preserved Ejection Fraction Syndrome
Condition: Diastolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Diastolic
Study type: Interventional
Phase: Phase 2

Summary: 
      Up to half of all patients with clinical features of heart failure are found to have normal
      heart pumping function. Recently the investigators have shown that a drug called perhexiline
      markedly improved exercise capacity and symptoms in patients with heart failure associated
      with impaired cardiac pump function. In this proposal the investigators will assess whether
      perhexiline has beneficial effects in patients with heart failure and a normal heart pumping
      function.
    

Detailed description: 
      Up to 50% of patients with symptoms of heart failure have a preserved left ventricular
      ejection fraction (HFpEF syndrome). Current therapy for systolic heart failure is targeted at
      inducing vasodilation and counteracting neuro-endocrine activation. There is a lack of a
      corresponding evidence base for the treatment of HEpEF. We have previously shown that
      perhexiline, an agent that increases the efficiency of energy production by shifting
      substrate utilization from free fatty acids towards glucose, was highly effective in
      improving exercise capacity, symptoms and cardiac function in patients with systolic heart
      failure. We have also recently shown that energy deficiency plays a major role in the
      pathophysiology of HFpEF. In this proposal we therefore aim to investigate the effectiveness
      of perhexiline in 70 HFpEF patients, in a 3 month randomised, double-blind, controlled trial.
      An interim analysis is planned after 20 patients.
    

Intervention name(s): Perhexiline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg o bd for 3 months; Placebo one tablet bd for 3 months
Other intervention name(s): Pexsig; Starch Placebo
Intervention MeSH terms: Perhexiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: diastolic dysfunction; cardiac energetics; perhexiline; magnetic resonance spectroscopy
Hemodynamic Measurements in Women With Serious Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      This trial is examining hemodynamic measurements in women with serious preeclampsia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with moderate-to-severe pre-eclampsia
      
Keywords: Cardiac output; Preeclamptic women; systemic vascular resistance; blood pressure
Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the clinical activity and safety of two doses of
      VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.
    


Intervention name(s): VX-702
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Crystalline Exposition During Pediatric Cranial CT Imaging
Condition: Any Pathology Requiring a Cranial CT Imaging
Study type: Observational

Summary: 
      This study focuses on reduction of X-rays dose applied to eye's lens during cranial CT in
      children. Principal objective is to analyse the efficiency of ocular bismuth masks, which are
      associated with an eye's lens dose modulation
    

Detailed description: 
      Eye's lens radiosensitivity represents an important subject of investigation in radiology.
      Indeed, eye's lens is recognised as one of the most radiosensitive organs in human body.[1,2]
      Radiation induced cataracts represent a determining effect of ionising radiations and has
      been widely studied. "International Commission for Radiological Protection" has evaluated
      cataract appearance threshold at 15 Gy in 1977 ",[3] then at 8 Gy [4] and 5 Gy in 2007.[5]
      Finally, in 2011 new studies gave rise to a new limit of appearance of 0.5 Gy. Eye's lens
      radiosensitivity seems to have been underestimated for several years and so there is a
      significant improvement to be made in radioprotection in order to protect to the best of the
      investigator's ability both patient and manipulator. This was also confirmed by the Directive
      EURATOM 2013/59 (which is in the process of being transposed in French legislation)[6] that
      reduces legal limit dose delivered to eye's lens from 150mSv to20mSv, for categories A
      workers.

      This study is performed on 4 sequential groups, of ten patients, whereby one control group
      without ocular protection added. Other groups benefit either from a bismuth ocular
      protection, from a dose modulation applied to the eye's lens, or from both techniques
      associated. For each group, experiment is then focused on dose received by the eye's lens
      (measured using TLD detectors) as well as on Image quality obtained. Currently, there is no
      recommendation regarding lens protection for patient who benefit of a head tomodensitometry.
      Some practices are already used routinely but without a critical analysis of a comparison of
      their respective benefits.
    

Intervention name(s): use or non-use of dose modulator and bismuth mask
Intervention type(s): Other
Intervention description(s): For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask
Intervention MeSH terms: Bismuth
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population include all children for who a cranial CT imaging will be required within
        usual care in the radiology ward of Bordeaux University Hospital
      
Keywords: Radioprotection; dosimetry; tomodensitometry; pediatrics
A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of
      midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577
      when administered alone and in combination with midazolam.
    


Intervention name(s): Midalozam; Aprocitentan
Intervention type(s): Drug; Drug
Intervention description(s): Syrup for oral use; Capsules for oral use
Other intervention name(s): ACT-132577
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway
Condition: General Anesthesia; Elective Surgery
Study type: Interventional

Summary: 
      The purpose of this study is to compare two insertion techniques of large size ProSeal
      laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with
      90-degree rotation would reduce the contact surface between the device and pharyngeal wall
      and make it easy to advance the device over the smooth angle against the posterior pharyngeal
      wall.We compared the success rate and incidence of complication of the standard technique
      with the rotational technique.
    

Detailed description: 
      ProSeal laryngeal mask airway is not easy to be inserted due to its larger cuff especially in
      Asian population. First-time insertion success rate was lower and more time was required to
      achieve an effective airway even in well-trained physician. A number of techniques have been
      described to improve the insertion success rate. However, these techniques are only
      recommended to be used as backup when the digital or introducer tool techniques fail. We
      hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would
      reduce the contact surface between the device and pharyngeal wall and make it easy to advance
      the device over the smooth angle against the posterior pharyngeal wall.We compared the
      success rate and incidence of complication of the standard technique with the rotational
      technique.
    

Intervention name(s): Insertion fo ProSeal laryngeal mask airway
Intervention type(s): Procedure
Intervention description(s): Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: ProSeal Laryngeal Mask Airway; Rotational technique; Success rate; Postoperative complications
Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare pharmacokinetics after single oral administration
      of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in
      healthy male volunteers
    


Intervention name(s): YH4808; Diclofenac; YH4808+Diclofenac
Intervention type(s): Drug; Drug; Drug
Intervention description(s): experimental drug; Depain tablet 25mg
Other intervention name(s): Depain tablet 25mg
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: safety/tolerability and pharmacokinetics/pharmacodynamics
Fixed Diet Plan and Calorie Counting Diet in Adolescents
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Obesity is a chronic illness and multifactorial etiology, related to genetic factors,
      environmental and behavioral. Features association with several metabolic abnormalities in
      childhood, leading to increased risk of cardiovascular disease in adult life. The treatment
      involves lifestyle change, with balanced diet guidance and encouraging physical activity. The
      treatment in this age group have brought limited data, in addition to high drop-out rates. A
      unique type of food guidance is the equivalent calorie count, where calories are converted
      into points. The objective of this study was to evaluate the variance of Z score of body mass
      index (ZIMC) of obese adolescents undergoing orientation of two groups of low-calorie diet:
      traditional and based on the points system, as well as evaluate anthropometric variables,
      body composition, food intake, metabolic changes and self-monitoring.

      METHODS: randomized clinical study with duration of 24 weeks, with 66 adolescents with an
      average age of 13.7 ± 0.7 years of both genders, with scores of BMI >= 2 to <= 4 curve
      adjusted for gender and age of the World Health Organization. Were verified weight, height,
      blood pressure and waist circumference, intensity of physical activity and self- monitoring,
      as well as performed the nutritional guidance to each visit. Laboratory parameters, applying
      the scale of binge eating, pubertal, stage and body composition were evaluated at the
      beginning and end of the action. The patients were divided into two groups: one that received
      guidance of traditional low-calorie diet and meet the food consumption record (RCA), three
      days (Group A) and another that received low-calorie diet guidance based on the system of
      points and meet the daily RCA (Group B).
    


Intervention name(s): Calorie counting diet; Fixed diet plan
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride
      (HCl) (migalastat) in participants with Fabry disease.
    

Detailed description: 
      This was a Phase 2, open-label study in female participants with Fabry disease. The study
      consisted of a 4-week screening period, during which participants' galactosidase (GLA)
      genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat.
      Participants were required to have α-Gal A activity responsive to migalastat. The study
      consisted of a 12-week treatment period, followed by an optional 36-week extension period.
      Participants received migalastat once every other day (QOD) for 12 weeks during the treatment
      period and the optional 36-week extension period for a total treatment duration of up to 48
      weeks. Participants were stratified by α-Gal A enzyme activity (high >40%, and low ≤40%) then
      randomly assigned to receive migalastat at 1 of 3 specified dose levels (50, 150, or 250
      milligrams [mg]).
    

Intervention name(s): migalastat HCl
Intervention type(s): Drug
Other intervention name(s): AT1001; Galafold; migalastat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Substrate
Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Patients Undergoing General Anesthesia
Condition: Heart Rate Variability; STAI; SDS; General Anesthesia; Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Preoperative anxiety can be detected via structured and standardised screening by the State -
      Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The
      investigators evaluate the relation of perioperative anxiety and heart rate variability, also
      the impact of general anesthesia on the change of heart rate variability.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hepatocellular carinoma patients undegoing Hepatectomy with general anesthesia