bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp
Condition: Tooth Decay; Probiotics; Streptococcus Mutans
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      To evaluate the change of S. mutans and Lactobacillus spp. counts after all dental treatments
      were completed under general anesthesia and compare the groups in case of using probiotics
      and not using probiotics with the time for 6-months follow-up period.
    

Detailed description: 
      Fifthy-eight pediatric patients without any systemical diseases whose dental treatments were
      completed under general anesthesia were included in the study. The study was carried out as
      two-groups; Group A: Patients who started using probiotics after general anesthesia and Group
      B: Patients who did not use probiotics after general anesthesia. The counts of S. mutans and
      Lactobacillus spp. were determined by quantitative polymerase chain reaction (qPCR) by
      analysis of saliva samples taken from all patients on the day before the general anesthesia
      (T0), at 1-month (T1), 3-month (T2) and 6-month (T3) follow-up periods. The statistical
      significance level was accepted as p<0.05.
    

Intervention name(s): Probiotic use
Intervention type(s): Dietary Supplement
Intervention description(s): Probiotics were used for 3 months and all participated patients were followed for 6 months.
Other intervention name(s): Follow-up after general anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 separate groups, experimental and control, 6 month follow-up period, randomized distribution
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: tooth caries; probiotics; qPCR; Streptococcus mutans; Lactobacillus
Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a RAD Board
Condition: Radiation Exposure to Operator
Study type: Interventional

Summary: 
      Radiation exposure to operator is an occupational hazard of invasive cardiologists. During
      radial access for diagnostic catheterization, a new radio-dense arm board is advertised to
      reduce operator radiation exposure. The investigators randomize patients to a new radio-dense
      armboard versus a standard radio-transparent armboard during diagnostic catheterization and
      measure radiation exposure to the operator. Both groups have a radio-dense pelvic shield in
      place. The investigators hypothesize that operator radiation dose will be decreased by use of
      the radio-dense armboard.
    

Detailed description: 
      Hypothesis:

      Compared to standard shielding with a lead pelvic drape alone, using a radio-opaque arm board
      in addition to the pelvic drape will decrease operator radiation exposure during radial
      access cardiac catheterization by at least 30%.

      STUDY DESIGN This is a randomized, prospective study where patients will be randomized by
      random numbers in sealed envelopes to standard shielding (pelvic drape alone, the "no-board
      group") or to experimental shielding (pelvic drape plus radiation board, the "board group").

      A robust radiation safety monitoring program is in place. Patient exposure is measured by the
      catheterization laboratory equipment and recorded. Lindauer Microstar Nanodot badges worn at
      waist level above the radiation lead will be used to measure operator radiation exposure. A
      new Nanodot will be used for every case. Radiation exposure to the operator's Nanodot will be
      measured immediately after each procedure by a technician blinded to study assignment.

      All patients 18-89 years old presenting to Geisinger Medical Center for diagnostic cardiac
      catheterization will be evaluated for the study. All interventional or diagnostic
      cardiologists and fellows that will be performing the cardiac catheterization procedure also
      will be study subjects. Approximately 215 Geisinger patients who satisfy inclusion and
      exclusion criteria will be included. Approximately 6 interventional cardiologists, 2
      diagnostic cardiologists and 10 fellows will be included in this study.
    

Intervention name(s): Board; No Board
Intervention type(s): Device; Device
Intervention description(s): Also has radio-dense pelvic shielding; Radio-lucent armboard for radial access with radio-dense drape across pelvis
Other intervention name(s): "Rad Board"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: radiation; radiation injury; occupational risk
POCD: Correlations With the Gene Polymorphism and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12.
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Observational

Summary: 
      To study on the Postoperative Cognitive Dysfunction: Correlations With the Gene Polymorphism
      and the Concentrations of Plasma Homocysteine, Folic Acid and Vitamin B12. To explore whether
      the gene polymorphism and the concentrations of plasma homocysteine, folic acid and vitamin
      B12 could be used as predictor(s) of POCD and to provide reference for POCD prevention, early
      detection and timely diagnosis and treatment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators included 215 Male and female patients undergoing non-cardiac surgery and
        30 healthy volunteers at the affiliated hospital of Xuzhou Medical University.
      
Biospecimen description: 
      blood
    
Keywords: non-cardiac surgery; Postoperative Cognitive Dysfunction
Study of Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee
Condition: Osteoarthritis Patient
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of
      one intra articular injection of sodium hyaluronate 2.0% in patients with painful
      osteoarthritis of the knee
    


Intervention name(s): Ostenil plus
Intervention type(s): Drug
Intervention description(s): 2% Sodium Hyaluronate plus Mannitol injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross
      reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old
      healthy toddlers.
    


Intervention name(s): MenACWY-CRM; MenACWY-TT
Intervention type(s): Biological; Biological
Intervention description(s): MenACWY-CRM; MenACWY-TT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: meningococcal disease; children; vaccination
Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway
Condition: Airway Complication of Anaesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      A laryngoscope is a medical instrument that is used to get a view of the voice box and the
      space in between the vocal cords. A laryngoscope is used to place a breathing tube into the
      trachea (windpipe or airway) to protect the patient's airway and provide a way to help a
      person breathe during surgery; this is called intubation.
    

Detailed description: 
      A laryngoscope is a medical instrument that is used to get a view of the voice box and the
      space in between the vocal cords. A laryngoscope is used to place a breathing tube into the
      trachea (windpipe or airway) to protect the patient's airway and provide a way to help a
      person breathe during surgery; this is called intubation. The placement of a breathing tube
      into the windpipe is a skill that is not easily mastered. In fact, the placement is difficult
      or impossible using the usual technique in 1-3 of every 100 patients. The ease of placing
      this breathing tube depends in part on how easily and how much of the vocal cords are able to
      be seen directly using a laryngoscope.

      In a small number of patients, the Levitan First Pass Success (FPS) Scope has been shown to
      be more effective and easier to insert even in patients who have difficult airways. This
      study will evaluate the use of the LFS compared to the other conventional laryngoscope in
      subjects with a simulated difficult airway. The goal of this study is to determine the
      effectiveness and safety of the LFS in a large number of patients with simulated airway
      difficulties.

      The results obtained during the study may provide useful information to health care providers
      who cannot place a breathing tube in patients that are either in operating rooms or in
      emergency situations requiring intubation by paramedics. An example would be a trauma
      situation where a paramedic is having difficulty attempting an intubation when a patients
      c-spine is being protected from any movements.

      The LFS is an affordable and transportable device, which makes this an attractive asset for
      health providers in smaller community settings or in paramedic vehicles which may not have
      the capacity to stock or ability to afford a variety of different scopes and must choose a
      more limited selection.
    

Intervention name(s): Laryngoscopy order: 1) MAC, 2) Levitan; Laryngoscopy order: 1) Levitan, 2) MAC
Intervention type(s): Device; Device
Intervention description(s): Laryngoscopy with MAC, then Levitan; Laryngoscopy with Levitan, then MAC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      AIR STUDY

      TITLE: Anti-Ischemic effects of Abciximab(Reopro)

      PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small
      stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable
      statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).

      INTERVENTION: Heparin vs. heparin + abciximab during PCI

      PURPOSE: Measure the effects of abciximab on special healing blood stem cells
      (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on
      microvascular blood flow.

      PATIENT ASSESSMENT:

        1. 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.

        2. Measurement of blood flow in selected suitable patients

        3. 10 minute questionnaire before discharge and on visit on day 28.
    


Intervention name(s): Abciximab
Intervention type(s): Drug
Other intervention name(s): Reopro
Intervention MeSH terms: Abciximab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with coronary artery disease undergoing left heart catheterization
Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV-infected Women
Condition: Influenza; Human Immunodeficiency Virus
MeSH terms: Influenza, Human; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in
      HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic
      reactions to the vaccine will also be assessed.
    

Detailed description: 
      Schedule of Events

      Visit 1 (enrollment) Informed Consent Form (ICF) signed Inclusion/ exclusion/ Withdrawal
      criteria Medical history Targeted physical exam Blood draw TIV administered Diary card
      dispensed

      Local/ systematic reactions

      Visit 2: 1 month post enrolment (28-35 days) Inclusion/ exclusion/ Withdrawal criteria
      Medical history Targeted physical exam Blood draw Diary card collected Local/ systematic
      reactions reviewed
    

Intervention name(s): Trivalent Inactivated Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
an A/California/7/2009 (H1N1)pdm09-like virus;
an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus.
Other intervention name(s): Vaxigrip
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Influenza; Human Immunodeficiency Virus
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
Condition: Preterm Infants; Parenteral Nutrition n-3 Fatty Acids
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      The study shall provide evidence for the save and efficient use of a fish oil containing
      lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by
      monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed
      by monitoring of inflammatory parameters.
    


Intervention name(s): Lipofundin MCT/LCT 20 %; Lipidem 20%
Intervention type(s): Drug; Drug
Intervention description(s): daily i.v. infusion for up to 5 days; daily i.v. infusion for up to 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: n-3 Polyunsaturated Fatty Acids (PUFA); parenteral nutrition; preterm infant
Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients
Condition: Moderate Hepatic Impairment; Severe Hepatic Impairment; Liver Diseases
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in
      adult participants with hepatic impairment and healthy adults.
    

Detailed description: 
      This study is being conducted to assess the effect of hepatic impairment on the
      pharmacokinetics of the major Nitazoxanide active metabolite in hepatic impaired (moderate
      and severe according to Child-Pugh categories) and healthy control adults following repeated
      oral dose administration of NTZ 500 mg twice a day for 7 days.
    

Intervention name(s): Nitazoxanide
Intervention type(s): Drug
Intervention description(s): 500 mg Twice Daily for 7 days
Other intervention name(s): NTZ
Intervention MeSH terms: Nitazoxanide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Healthy Volunteer; Liver Disease; Hepatic Impairment; Antiparasitic; Antiprotozoal
Encouraging Positive Parenting Habits Through Digital Media
Condition: ADHD
Study type: Interventional

Summary: 
      This study evaluates the feasibility and preliminary impacts of a new parenting program
      consisting of a series of educational videos, delivered via a popular texting platform. For
      this pilot project, the program content is focused on teaching parents strategies to better
      manage one of the commonly reported challenges that children face, a transition to a
      non-preferred activity. Parents with young children demonstrating behavior consistent with
      ADHD and experiencing difficulties with daily transition routines are invited to participate
      in the study.
    

Detailed description: 
      This pilot study employs a pre-post, open trial design with the primary aim to investigate
      the feasibility of delivering parenting educational materials in a highly accessible format,
      i.e., a widely used texting platform. The training videos demonstrate the applications of
      antecedent- and reinforcement-based behavior management techniques in a specific situation
      and encourage parents to build positive parenting habits. The program usability and
      satisfaction will be assessed through ratings and answers to open-ended questions by
      participating parents. The study targets parents of children demonstrating symptoms of ADHD.
      These families frequently experience difficulties managing everyday routines at home, yet the
      access to psychosocial treatment is limited. The investigators expect parents to engage well
      in the program delivered via digital media. Based on the existing literature on the
      effectiveness of behavior parent training delivered in traditional in-person format, a
      moderate effect size is expected in the pre-post measures of parenting practices and the
      child target behavior for this study.
    

Intervention name(s): HabitE (effective parenting habit) program (in Brazilian Portuguese)
Intervention type(s): Behavioral
Intervention description(s): Parents who enroll in the program will receive a series of 5 videos (~ 7 minutes each), 1 video at a time, generally every 3 days. Parents will also receive daily written texts, which include implementation tips and an assessment of a target (transition) behavior.
Intervention model: Single Group Assignment
Intervention model description: Open, single-group trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Parent Training; Treatment Access
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)
Condition: Glioma
MeSH terms: Glioma
Study type: Observational

Summary: 
      This study will evaluate the test-retest repeatability of lactate and other metabolites
      measured by single voxel magnetic resonance spectroscopy (MRS) and multi-voxel magnetic
      resonance spectroscopic imaging experiments (MRSI) in tumor tissue in patients
      radiographically diagnosed with glioma.

      These measurements will test whether the concentration of lactate in tumor will be higher
      than the concentration of lactate in normal tissue of the same patient.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade
        II or higher
      
Biospecimen description: 
      Tissue
    
Keywords: magnetic resonance spectroscopy (MRS); lactate editing; metabolite content; glioma
Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the
      implantation of foldable intraocular lenses.
    

Detailed description: 
      Intraocular Lenses (IOL) Cartridge is made up of polypropylene material with coating. This
      cartridge is used as lens delivery system for foldable lens implantation while doing cataract
      surgery. The coating is made up of medical grade polyurethane and biocompatible. This coating
      would be useful for smooth delivery of intraocular lens.
    

Intervention name(s): cartridge
Intervention type(s): Procedure
Intervention description(s): IOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with senile cataract or Nuclear Sclerosis grade I and grade II and age between
        40-60
      
Keywords: cartridge IOL
Pilot Data Collection for Activity, Adiposity, and Appetite in Adolescents
Condition: Physical Activity; Sedentary Lifestyle; Metabolism; Energy Balance
MeSH terms: Obesity
Study type: Observational

Summary: 
      The goal of this study is to quantify energy metabolism using indirect calorimetry at rest,
      in the presence of excess energy following a meal, and in response to the demand for energy
      during exercise. The investigators also will examine the individual and joint associations of
      activity and obesity status on neurocognitive domains of appetite control. Participants will
      include adolescent males and females (N=80) using a 2 x 2 cross-sectional study design,
      stratified by body weight (normal vs overweight/obese) and physical activity level (sedentary
      vs. active).
    

Detailed description: 
      The investigators hypothesize that low levels of fitness and MVPA result in impaired
      metabolic function in adolescents. For this pilot study, the investigators will quantify
      variations in metabolic characteristics using a 2 x 2 cross-sectional study design,
      stratified by body weight (normal vs overweight/obese) and physical activity (sedentary vs.
      active). The goal is to identify metabolic factors that influence the energy balance system
      to directly inform interventions designed to prevent or reduce the prevalence of pediatric
      obesity.
    

Intervention name(s): Data Collection Procedures
Intervention type(s): Diagnostic Test
Intervention description(s): Orientation (Consent, Screening Questionnaires) Clinic Measurements Body composition, via dual energy X-ray absorptiometry (DXA) Resting metabolic rate (RMR), via indirect calorimetry; Metabolic responses to a meal, via thermic effect of feeding (TEF) Subjective aspects of eating behavior using the Three Factor Eating Questionnaire (TFEQ) and Control of Eating Questionnaire (CEQ) Appetite, via visual analogue scales (VAS) pre- and post a prepared fixed meal and hormones related to satiety and hunger (insulin, leptin, ghrelin, peptide YY, glucagon-like peptide-1) obtained during blood samples (BLOOD) from an indwelling catheter.
Home assessments - Data collected at home during a 14 day window Fitness Test (VO2submax and VO2max) and DXA functional magnetic resonance imaging (fMRI)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will include 60 adolescent males (aged 14-18 years, Tanner stages III- IV),
        equally enrolled based on physical activity and body weight status.
      
Biospecimen description: 
      hormones related to satiety and hunger (insulin, leptin, ghrelin, peptide YY, glucagon-like
      peptide-1) obtained during blood samples (BLOOD) from an indwelling catheter.