bioihbjkbjnl/mcl2 huggingface dataset:
The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of the present study was to compare salivary MS levels in four different groups of
      children with caries, that have been submitted to intraoral topical treatment with either
      1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days.
      This clinical trial was designed to test two different hypotheses. First, that topical
      vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS
      reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would
      produce a long lasting MS suppression, dispensing repeated antibacterial treatments.
    

Detailed description: 
      The present study aimed to compare the effect of sodium fluoride, chlorhexidine and
      vancomycin on salivary mutans streptococci (MS) levels, on a double-blind, randomized
      clinical trial. Sixty-nine healthy volunteers, aged 4-8 years, with at least one active
      carious lesion and no previous history of allergies were selected to participate in the
      study. A gel formulation containing 1.23% sodium fluoride, 1% chlorhexidine, 3% or 10%
      vancomycin was topically administered to the dentition every 24 hours, during 6 consecutive
      days. Salivary MS levels were measured at baseline (D1), on the 6th (D6), 15th (D15) and 30th
      day (D30). For microbiological analysis, MSB agar medium was used.
    

Intervention name(s): Sodium Fluoride; vancomycin hydrochloride; vancomycin hydrochloride; chlorhexidine digluconate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical application of 1.23% sodium fluoride to the dentition, every 24 hours, during 6 consecutive days; Topical application of 3% vancomycin hydrochloride to the dentition, every 24 hours, during 6 consecutive days; Topical application of 10% vancomycin hydrochloride to the primary dentition, every 24 hours, during 6 consecutive days; Topical application of 1% chlorhexidine digluconate to the dentition, every 24 hours, during 6 consecutive days
Other intervention name(s): Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil; Vanclomin, Laboratório Teuto Brasileiro S.A., Goiás, Brazil
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Listerine; Vancomycin; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: dental caries; vancomycin; chlorhexidine; sodium fluoride; mutans streptococci
Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients
Condition: Irritable Bowel Syndrome With Constipation (IBS-C)
MeSH terms: Irritable Bowel Syndrome; Constipation
Study type: Interventional

Summary: 
      The purpose of this study is to understand how a drug called Linaclotide improves bowel
      function and abdominal pain in patients with Irritable Bowel Syndrome with Constipation
      (IBS-C) as well as to examine whether Linaclotide alters communication between the brain and
      pelvic-floor region.

      Linaclotide has been shown to improve abdominal pain and bowel symptoms in IBS-C, and is
      approved by the FDA for the treatment of this condition. However, how exactly this drug works
      to relieve abdominal pain and discomfort in humans is not clearly known. Studies in animal
      models suggest that patients with IBS-C have hypersensitivity in the gut.

      Consequently, in IBS-C patients, there is rapid and excessive conduction of signals both from
      the brain and central nervous system region towards the pelvic-floor (anorectal axis) and the
      reverse direction. The investigators hypothesize that treatment with Linaclotide may
      improve/normalize these signals and thereby improve bowel symptoms.

      Investigators will test this theory using a new, noninvasive (and established) method of
      studying this communication pathway between the brain and gut.
    

Detailed description: 
      modulate these mechanisms and thereby improve visceral pain.

      Investigators propose three specific aims:

        1. Examine the hyperexcitability of the afferent-pelvic floor brain axis in 60 patients
           with IBS by measuring the cortical evoked potentials (CEP) and sensory thresholds after
           electrical stimulation of the rectum and anus before and after administration of
           linaclotide or placebo for a period of 10 weeks.

        2. Study the efferent brain pelvic floor axis by stimulating the cortex with transcranial
           magnetic stimulation and record the anal and rectal motor evoked potentials (MEP) in 60
           IBS-C patients.

        3. Determine the locus for neuronal modulation i.e are the neuroenteric changes due to
           central or peripheral neuronal sensitization or both, by evoking anal and rectal MEPs
           after selectively stimulating the lumbar and sacral nerves bilaterally, and by comparing
           segmental with transcranial-induced MEPs.
    

Intervention name(s): Linaclotide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Irritable Bowel Syndrome with Constipation (IBS-C); Linaclotide
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
Condition: Complicated Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus
      Metronidazole compared to Meropenem for treating hospitalized patients with complicated
      intra-abdominal infections.
    

Detailed description: 
      A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative
      Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus
      Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In
      Hospitalized Adults
    

Intervention name(s): Ceftazidime-avibactam; metronidazole; Meropenem
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg; Metronidazole 500mg/100ml solution for infusion; Meropenem powder for solution for infusion 1000mg
Intervention MeSH terms: Metronidazole; Meropenem; Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ceftazidime-avibactam,; Metronidazole,; Meropenem,; Anti-Bacterial Agents,; Anti-Infective Agents,; Therapeutic Uses,; Pharmacologic Actions,; Physiological Effects of Drugs
Intranasal Glutathione in Parkinson's Disease
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Excessive free radical formation and depletion of the brain's primary antioxidant,
      glutathione, are established components of Parkinson's disease (PD) pathophysiology. While
      there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some
      preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles
      surrounding currently employed delivery methods have hindered the clinical utility of this
      therapy. Intranasal GSH, (in)GSH, is a novel method of delivery for this popular CAM therapy
      in patients with PD, and bypasses the obstacles associated with other delivery methods. It
      has been used in clinical practice since 2005. The aim of this study is to evaluate safety,
      tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I
      single ascending dose escalation study.
    

Detailed description: 
      Individuals will be randomized to one of three treatment (100 mg GSH/ ml, 200 mg GSH/ ml, or
      placebo) arms in a double-blind fashion. All study medication will be administered 1 ml three
      times daily for three months, with a one-month wash out.
    

Intervention name(s): Intranasal glutathione - (in)GSH; Intranasal glutathione - (in)GSH; Saline Intranasal Delivery
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intranasal glutathione-Tripeptide glutathione 100 mg/ml. 1 ml 3x per day TID X 12 weeks at 2100mg in 15 participants; Intranasal Glutathione-Tripeptide glutathione - 200mg/ml. 1 ml 3x per day TID X 12 weeks at 4200mg in 15 participants; Saline administration 1ml 3x/day 12 weeks in 15 participants
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Neuroprotection; Glutathione; Intranasal
Primary Care Pathway for Childhood Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      At least half of children with asthma have poor disease control, which can result in
      complications requiring emergency treatment and hospitalization. As asthma is one of the most
      common reasons for children to visit emergency departments (ED) and be hospitalized, this
      disease places a heavy burden on the health care system and families. While there is strong
      evidence that timely treatment with preventative therapies can substantially improve asthma
      control, reduce sudden worsening of symptoms, and lower rates of ED visits and
      hospitalizations, a significant proportion of children do not receive these therapies.

      The purpose of this study is to improve the prescription and use of evidenced-based
      preventative therapies for children with asthma with the goal to significantly improve their
      disease control and quality of life, while reducing unnecessary ED visits and
      hospitalizations. The investigators will achieve this by: i) installing a primary care
      clinical pathway for managing childhood asthma into clinicians' electronic medical record
      (EMR) to facilitate the use of best-evidence by practitioners, and ii) training chronic
      disease management (CDM) health professionals to provide targeted and timely asthma education
      to parents and children with asthma. The investigators will test this pathway and education
      project in a representative sample of 22 Alberta primary care practices, using a pragmatic
      cluster controlled trial methodology.
    


Intervention name(s): Primary care clinical pathway; Asthma education; EMR embedded dashboard
Intervention type(s): Other; Other; Other
Intervention description(s): Installing a primary care clinical pathway for managing childhood asthma into clinicians' electronic medical record (EMR) to facilitate the use of best-evidence by practitioners.; Physicians will receive web-based education through an interactive learning module regarding best management for childhood asthma and use of the primary care clinical pathway. Chronic disease management (CDM) health professionals in practices will attend asthma education sessions delivered by an asthma educator. This training will be then used by the CDM professional to provide targeted and timely asthma education to parents and children with asthma.; An EMR embedded dashboard will deliver real-time feedback to clinicians.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II
      Trial of LCB01-0371.
    

Detailed description: 
      This study is designed to explore antituberculosis of LCB01-0371 through the assess of the
      early bactericidal activity, safety of administration.
    

Intervention name(s): LCB01-0371 800mg, QD; LCB01-0371 400mg, BID; LCB01-0371 800mg, BID; Tubes 3~5Tablet, QD; Zyvox 600mg, BID; LCB01-0371 1200mg, QD
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral administration; Oral administration; Oral administration; Oral administration; Oral administration; Oral administration
Other intervention name(s): LCB01-0371; LCB01-0371; LCB01-0371; Tubes Tablet; Zyvox Tablet; LCB01-0371
Intervention MeSH terms: Linezolid; Delpazolid; Oxazolidinones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular Function, Insulin Sensitivity, and Vitamin D
Condition: Insulin Sensitivity; Flow-mediated Dilation; Arterial Stiffness
MeSH terms: Insulin Resistance; Hypersensitivity; Dilatation, Pathologic
Study type: Observational

Summary: 
      The overall objectives of this study are to examine the relationships between circulating
      vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine
      whether vitamin D deficiency in African Americans (AA) and White Hispanics (WH) is
      responsible for ethnic differences in insulin sensitivity and hypertension in AA, WH and
      European Americans (EA), as well as mechanisms underlying the association between insulin
      resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with
      insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin
      sensitivity and vascular functioning in AA and WH relative to EA is due to lower circulating
      25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is
      mediated by 25(OH)D.

      Acronyms: African American (AA), European American (EA), White Hispanics (WH), Serum
      25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  Healthy adults with BMI below 32

          -  Both males and females

          -  Ages 19-60 years

          -  Race: African Americans, White Hispanics, European Americans
      
Biospecimen description: 
      Seum
    
Keywords: Insulin sensitivity; Vascular function; Flow-mediated dilation; Arterial stiffness; Glucose tolerance; Hypertension
Split-tattoo Study Comparing the Safety and Efficacy of 670nm Picosecond Laser Versus 755 nm for Tattoo Removal
Condition: Tattoo Removal
Study type: Interventional

Summary: 
      Study to evaluate safety and efficacy of treatment with the investigational Cutera enlighten
      laser for tattoo removal as compared to treatment with the Cynosure PicoSure laser
    

Detailed description: 
      This is an open-label, split-tattoo, single-center prospective, comparison study in up to 20
      male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing
      single or multi-color ink. Subjects will receive laser treatments, and will be followed at 6
      weeks.
    

Intervention name(s): Cutera enlighten laser; CynoSure PicoSure 755nm laser
Intervention type(s): Device; Device
Intervention description(s): high-powered, Q-switched 670nm Picosecond laser system indicated for tattoo removal; high-powered, Q-switched Alexandrite system that delivers laser energy in the 755 nm wavelength and has received FDA clearance (K133364) for tattoo and benign pigmented lesion removal.
Other intervention name(s): 670nm Picosecond Laser
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial is two-fold. Firstly to see if patients
      suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in
      their shoulder, and secondly to investigate how changes in this blood flow are related to
      pain experience and shoulder function.
    


Intervention name(s): Exercise: local high intensity interval exercise; Exercise: best clinical practice
Intervention type(s): Other; Other
Intervention description(s): The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.; The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shoulder; Exercise therapy
Patient Controlled Regional Analgesia Following Carpal Tunnel Release: A Double-Blind Study Using Distal Perineural Catheters
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was done with the primary aim of assessing the efficacy (as calculated by pain
      intensity difference) of patient controlled regional analgesia (PCRA) technique against oral
      analgesics, which has been the standard of care at our hospital. Secondary objectives were to
      analyze the volume and dose of LA that should be given, patient satisfaction and the
      long-term outcome for patients treated with the PCRA technique.
    


Intervention name(s): Ropivacaine 0.2%; Ropivacaine 0.75%; Normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 ml; 3 ml; 10 ml
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthetics; Local; ropivacaine; Surgery; Hand; carpel tunnel; Carpal tunnel surgery
Comparative Study of Rinsulin R (GEROPHARM) and Humulin Regular (Eli Lilly) Euglycemic Hyperinsulinemic Clamp Method
Condition: Bioequivalence; Therapeutic Equivalency
Study type: Interventional

Summary: 
      Pharmacokinetics and pharmacodynamics of Rinsulin® R, injection solution, 100 IU / ml
      (GEROPHARM LLC, Russia) and Humulin® Regular, injection solution, 100 IU / ml (Lilly France
      ", France) using the euglycemic hyperinsulinemic clamp method.
    

Detailed description: 
      A double-blind, randomized, comparative, crossover study of the pharmacokinetics and
      pharmacodynamics of Rinsulin® R, solution for injection, 100 IU / ml (GEROPHARM LLC, Russia)
      and Humulin® Regular, solution for injection, 100 IU / ml (Lilly France, France) using
      euglycemic hyperinsulinemic clamp method on healthy volunteers
    

Intervention name(s): Humulin® Regular; Rinsulin® R
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection at a dose of 0.3 IU / kg; subcutaneous injection at a dose of 0.3 IU / kg
Other intervention name(s): Reference drug; Test Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment two-way crossover
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: human recombinant insulin; euglycemic hyperinsulinemic clamp
Oat Phenolics Bioavailability
Condition: Healthy
Study type: Interventional

Summary: 
      A diet rich in whole grain is inversely associated with cardiovascular disease risk and this
      benefit could be partly attributed to the phenolic acid content of whole grains. The exact
      absorption, metabolism and excretion of whole grain phenolic acids, however, is not fully
      understood. In a small human intervention trial, the investigators will investigate to what
      extent phenolic acids from whole grain oats are absorbed, excreted in urine and how they are
      metabolised.
    


Intervention name(s): Oat bran; refined grain
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 66g oat bran made up in 350ml skimmed milk; refined grain product and 350ml skimmed milk
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: volunteers; oat; phenolic acid; bioavailability
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level
Condition: Myoma; Hypertension
MeSH terms: Myoma; Hypertension
Study type: Interventional

Summary: 
      The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter
      monitoring and erythropoetin level check.
    

Detailed description: 
      Background:

      Myoma is the most common gynecoid tumor and produces many vasoactive substances, which may be
      a cause for secondary hypertension. Early reports suggested the association of myoma and
      hypertension. We studied the effect of myoma removal on hypertension and erythropoietin level
      to evaluate this hypothesis.

      Patients & Methods:

      In this single centered prospective cohort study, in twenty eight patients who were
      candidates for myomectomy due to myoma, 24 hour holter monitoring of blood pressure and serum
      erythropoietin were checked before and 6 weeks after hysterectomy.
    

Intervention name(s): myoma removal
Intervention type(s): Procedure
Intervention description(s): surgical removal of myoma by hysterectomy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: myoma; hypertension; erythropoetin; blood pressure; erythropoetin level