bioihbjkbjnl/mcl2 huggingface dataset:
the Dietary Effects of VitaSugar/VitaFiber-IMO in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to re-confirm the already established health effects and dose
      tolerance of Isomalto-oligosaccharide or IMO, which is a general health/functional food
      ingredient.
    

Detailed description: 
      Isomalto-oligosaccharide (IMO) is a mixture of natural resistant carbohydrates consisting of
      short-chains of glucose molecules. IMO is made by enzymatic conversion of starch and uses as
      a health food ingredient with health benefits of a low calorie sweetener, prebiotic and
      dietary fiber. IMO have been ingested by humans for last many centuries as it is naturally
      found in rice miso, sake and soy sauce. IMO already got approval from FDA (GRAS) and from
      Health Canada.

      There are number of published studies (in humans and animals) regarding the health benefits
      of IMO as an effective prebiotic, and its role in improving overall human gastric health.
      Studies also showed that IMO have found to be most tolerable with least adverse effects
      compared to other short-chain resistant oligosaccharides. Current clinical studies are
      conducted to verify the above given health benefits in BioNeutra's manufactured
      VitaSugar/VitaFiber-IMO products which including quantitative analysis of Bifidobacteria
      spp., Lactic acid bacteria group and clostridium spp. The production of short-chain
      fatty-acids (SCFA) and effect on blood glucose level are also analyzed in addition to the
      dose tolerance in term of lower and upper permissible dosage with resultant adverse effects
      if any are also observed.
    

Intervention name(s): Isomaltooligosaccharide (digestion-resistant carbohydrates); Isomaltooligosaccharide (digestion-resistant carbohydrates); Sucrose
Intervention type(s): Other; Other; Other
Intervention description(s): 12g/dose; three times a day; 18g/dose, three times a day; 12g/dose, three times a day
Other intervention name(s): VitaSugar; VitaFiber; VitaSugar; VitaFiber; Table top sugar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Isomaltooligosaccharide; Human Consumption; Dose tolerance; Prebiotic; Short chain fatty acids; Blood glucose; Dose tolerance and prebiotic effect
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The study is about comparing asthma home assessments/interventions by telemedicine compared
      to providing education alone. Interactive Video (IAV) defines telemedicine. It allows two-way
      communication in real-time with both audio and visual communication between the subject and
      someone from the study team. It is similar to using Face Time on a mobile device. Asthma home
      assessments/interventions are used to identify things in a home that can make asthma symptoms
      worse, called triggers. Reducing these triggers in the home can improve asthma.
    

Detailed description: 
      In this study, supplies will be given to some participants to help reduce or remove triggers
      from the home. One example is dust mites. These are microscopic bugs that are found in every
      home, cannot be seen by the naked eye, and make asthma symptoms worse. Part of the study
      includes collecting two dust samples from home to check dust mite levels at the beginning of
      the study and at the end. This study may help elucidate whether telemedicine home assessments
      work better than education alone at lowering dust mite levels and improving a child's asthma
      symptoms.
    

Intervention name(s): Standard of Care Education; Interactive Video (IAV) Telemedicine
Intervention type(s): Behavioral; Other
Intervention description(s): Education regarding recognition and removal of in-home asthma triggers; Interactive video assessment of asthma triggers in the home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Asthma; Telemedicine
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
Condition: Narcolepsy; Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Narcolepsy; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of treatment
      with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with
      narcolepsy or OSAHS (obstructive sleep apnea/hypopnea), when administered for up to 12
      months. Safety and tolerability will be evaluated throughout the study by means of adverse
      event information, clinical laboratory test results, vital signs measurements, and body
      weight and height measurements; quarterly physical examination findings; and 12 lead
      electrocardiograph (ECG) evaluations at the end of the study. In addition, the cognitive and
      behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior
      Checklist for Ages 6-18 (CBCL/6-18), a brief psychiatric interview, and the Kaufman Brief
      Intelligence Test (KBIT 2).
    

Detailed description: 
      PROVIGIL is a registered trademark of Genelco, S.A., licensed to Cephalon, Inc.
    

Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Pediatric Narcolepsy; Pediatric OSA; CPAP; Pediatric Narcolepsy or OSAHS
Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      The investigators conducted a pilot study including 17 patients with liver cirrhosis showing
      that a moderate exercise programme during three months increased thigh circumference,exercise
      tolerance and quality of life without adverse effects. The present study aim to more
      accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory
      response in patients with cirrhosis. This study will include 30 patients with compensated
      liver cirrhosis that will be randomized into two groups: exercise group and control group.
      Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will
      be made at the beginning and at the end of the study.
    

Detailed description: 
      Exercise group: will do a physiotherapist supervised exercise programme 1 hour three times
      per week during three months and relaxation after exercise. Control group: only relaxation 1
      hour three times per week during three months.

      Assessment: clinical and laboratory examinations performed at baseline and at the end of the
      study. The investigators will analyze the changes in muscle mass by anthropometric
      measurements and advanced techniques (CT scan, densitometry), effort tolerance (stress test),
      quality of life (sF-36), glutamine synthetase activity in blood, oxidative damage and
      inflammatory response. The investigators will analyze the survival and complications of
      cirrhosis during the study and follow-up.
    

Intervention name(s): Exercise + relaxation; Relaxation
Intervention type(s): Other; Other
Intervention description(s): Exercise + relaxation; Relaxation without exercise Patients will receive only relaxation for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cirrhosis; Exercise; Relaxation; Muscle mass; Effort tolerance
Automated Fastener Device Versus Manually Tied Knot in MiAVR
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Study type: Observational

Summary: 
      The aim of the investigator's study was to evaluate the efficacy and the safety of the
      Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy
      (RAMT).

      Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221
      underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the
      Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.

      The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in
      the AT group compared with the MT group. Clinical outcomes were similar in the two groups,
      whether in the analysis of non-matched or matched groups. There was no difference in 30
      day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is
      an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in
      patients undergoing AVR by right anterior minithoracotomy.
    


Intervention name(s): Cor Knot
Intervention type(s): Device
Intervention description(s): Heart valve replacement with or without the use of automated fastener device Cor Knot
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient operated on an Isolated aortic valve replacement with stented prosthesis by
        Minimally-invasive approach (right anterior minithoracotomy)
Randomized Controlled Trial to Evaluate of Dexmedetomidine for the Effect on Operative Visibility in Patients Undergoing Endoscopic Sinus Surgery
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Various maneuvers are commonly used to achieve the ideal operative field necessary for
      successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor
      agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the
      hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral
      vasoconstriction thus it is thus theologically appropriate for reducing bleeding during
      intranasal operation.

      The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor
      agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to
      remifentanil , an ultrashort-acting opioid.
    


Intervention name(s): Propofol and dexmedetomidine; propofol and remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Both group : propofol effect site TCI 2-4 mcg/ml, Remifentanil group : remifentanil effect site-TCI 2-4ng/ml Dexmedetomidine group: dexmedetomidine 0.5mcg/kg loading and 0.5mcg/kg/hr infusion; Both group : propofol effect site TCI 2-4 mcg/ml, Remifentanil group : remifentanil effect site-TCI 2-4ng/ml Dexmedetomidine group: dexmedetomidine 0.5mcg/kg loading and 0.5mcg/kg/hr infusion
Intervention MeSH terms: Dexmedetomidine; Remifentanil; Propofol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
MPA Pharmacokinetics in Renal Transplantation
Condition: Kidney Transplantation Recipients
Study type: Observational

Summary: 
      Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney
      transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to
      post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to
      tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the
      full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7,
      14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol.
      Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both
      groups but profiles were different according to the CNI regimen and time. The majority of
      patients were underexposed to MPA on day 7 for both groups what reinforces the need of a
      higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after
      day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the
      TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of
      the patients were overexposed to MPA what indicates a time for MPA monitoring and dose
      correction for long-term follow-up. These PK data suggest that changes in MPA profile occur
      according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific
      time-points.
    


Intervention name(s): Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups
Intervention type(s): Drug
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Renal transplant recipients
      
Keywords: mycophenolate mofetil; mycophenolic acid; MPA; MMF; Pharmacokinetics; renal transplantation
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
Condition: Primary Biliary Cirrhosis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 2

Summary: 
      prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate
      safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with
      Primary Biliary Cholangitis. A total 36 subjects will be enrolled in a ratio of 1:1:1 to
      receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo.
    

Detailed description: 
      Study SARO.16.004.02 is a prospective, multicenter, randomized, double-blind,
      placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar
      magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis.

      A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar
      magnesium 2 mg or saroglitazar magnesium 4 mg or placebo. The primary objective is to
      investigate the effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg
      on ALP levels in patients with Primary Biliary Cholangitis.
    

Intervention name(s): Saroglitazar magnesium 2 mg; Saroglitazar magnesium 4 mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.; Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.; Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.
Other intervention name(s): Not any; Not any; Not any
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Fentanyl on the Rate of Anesthesia
Condition: Painful Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Achievement of a deep and long-durated anesthesia is vital before most endodontic procedures;
      therefore, the investigators conducted this study to compare the local infiltration effect of
      epinephrine-containing lidocaine with/ without fentanyl on depth and duration of anesthesia
      in maxillary molars with painful irreversible pulpitis.
    

Detailed description: 
      This study was planned with a randomized double-blind, parallel design clinical trial on 64
      healthy patients after taking into account some inclusion and exclusion criteria. The control
      group were received the mixture of normal saline and 2% lidocaine with 1:200,000 epinephrine
      and the experimental group were received the mixture of fentanyl and 2% lidocaine with
      1:200,000 epinephrine. The depth and duration of pulpal anesthesia were evaluated with an
      electric pulp testing in 5-minute intervals during a period of 60 minutes and the pain
      intensity recorded in five times, before injection, after injection, during access cavity
      preparation, pulpotomy and pulpectomy using visual analog scale(VAS). All data were analyzed
      and compared using chi-squared and Mann-Whitney tests.
    

Intervention name(s): Lidocaine with Epinephrine+ Normal saline; Lidocaine with Epinephrine + fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): local infiltration of 1.8 mL of 2% lidocaine containing 1:200,000 epinephrine along with 0.8 mL of 0.9% sterile normal saline solution; local infiltration of 1.8 mL of 2% lidocaine, containing 1:200,000 epinephrine along with 0.8 mL of fentanyl(40 µg)
Other intervention name(s): Sublimaze,fentanil
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Fentanyl; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Irreversible Pulpitis; Infiltration injection; Fentanyl; Lidocaine
Correlation Between PET and Advanced MRI in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled
      clinicians to measure disease activity but there are inherent limitations.
      Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not
      specific.

      This pilot study is an opportunity to determine the relationship between quantitative
      advanced MRI measures and OCT with PET measurements of microglial activation and myelin
      health.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        4 untreated RRMS, 4 untreated SPMS, 4 untreated PPMS patients, 4 healthy controls and 4 GA
        40mg TIW
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
Condition: Buerger's Disease
MeSH terms: Thromboangiitis Obliterans
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with
      Buerger's disease.
    

Detailed description: 
      Buerger's disease, also known as thromboangiitis obliterans, is a rare disorder that, in most
      cases, affects young or middle-aged male cigarette smokers. It is characterized by narrowing
      or blockage (occlusion) of the veins and arteries of the extremities, resulting in reduced
      blood flow to these areas (peripheral vascular disease). The exact cause of Buerger's disease
      is not known; however, most affected individuals are heavy tobacco users.

      This drug is an autologous cell treatment for necrosis in the legs of patients with Beurger's
      diseases to improve symptoms through vascular regeneration.
    

Intervention name(s): RNL-Vascostem®
Intervention type(s): Biological
Other intervention name(s): Autologous adipose tissue derived mesenchymal stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Cyclosporine in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blinded, placebo-controlled trial of oral Cyclosporine A (CsA)
      in patients with advanced stage chronic obstructive pulmonary disease. The purpose of the
      study is to evaluate the safety and effectiveness of CsA as a therapy for the adaptive immune
      response in advanced stage Chronic Obstructive Pulmonary Disease (COPD).

      Subjects between 45 and 80 years of age with a confirmed diagnosis of advanced stage COPD,
      not responsive to conventional inhaler therapy, who meet all the study requirements, will be
      enrolled in this study. A total of 30 subjects of either sex will be enrolled in this study.
    


Intervention name(s): Cyclosporine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fifteen patients will receive cyclosporine at an initial dosing of 3.0 mg/kg/day.; Fifteen patients will receive will receive placebo.
Other intervention name(s): Neoral
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Cyclosporine; Oral Immunotherapy; Advanced stage
Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs)
Condition: Complicated Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, tolerability and efficacy of ceftazidime and avibactam
      (CAZ-AVI )versus cefepime in children from 3 months to less than 18 years old with
      complicated urinary tract infections.
    

Detailed description: 
      This study will be a single-blind, randomised, multi-centre, active controlled trial.
      Patients aged from 3 months to less than 18 years with complicated urinary tract infections
      (cUTIs) will be randomised to 1 of 2 treatment groups (3:1 ratio): Ceftazidime and avibactam
      (CAZ AVI )or cefepime. Randomisation will be stratified by age cohort.

      Patients will receive intravenous (IV) treatment for a minimum of 72 hours (3 full days, ie,
      9 doses if given 3 times daily, or 6 doses if given twice daily) before having the option to
      switch to an oral therapy . The decision to switch to oral therapy is entirely at the
      Investigator's discretion, if the patient has good or sufficient clinical response, and the
      patient is tolerating oral fluids or food.

      Patients will be assessed for safety and efficacy throughout the study, and blood samples
      will be taken for pharmacokinetic assessment. The duration of each patient's participation in
      the study will be a minimum of 27 days to a maximum of 50 days after start of study treatment
      including (intravenous treatment or oral switch therapy) 7 to 14 days of active treatment.
      The late follow-up visit (LFU) is to be performed 20 to 36 days after the last dose of any
      treatment.

      The assessments at the test of cure (TOC) visit should be performed in person 8 to 15 days
      after last dose of any study drug Maximum duration of study drug or oral switch therapy is up
      to Day 14.
    

Intervention name(s): Ceftazidime -avibactam; Cefepime
Intervention type(s): Drug; Drug
Intervention description(s): Patients randomised (3:1) to the CAZ-AVI or cefepime treatment; Patients randomised (3:1) to the CAZ-AVI or cefepime treatment
Intervention MeSH terms: Ceftazidime; Cefepime; Avibactam; Avibactam, ceftazidime drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Complicated urinary tract infections (cUTIs)