bioihbjkbjnl/mcl2 huggingface dataset:
Low Intensity Blood Flow Restriction Training Study
Condition: Muscle Mass
Study type: Interventional

Summary: 
      The particpant will complete baseline testing by measuring subjects' quadriceps muscle
      thickness (cm) via ultrasound technology, as well as have them complete a one repetition
      maximum (1RM) test on the leg press machine and an isometric knee extension using a
      dynamometer - strength measures will be calculated for both right and left legs. After
      baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of
      leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a cuff
      that partially restricts blood flow to the limb (Study Group), or to wear a cuff that does
      not restrict blood flow (Control Group). Exercises will be completed 2x/week and will take
      approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. After 6
      weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be re-tested
      and compared to the initial measurements.
    

Detailed description: 
      Session 1 - baseline testing

        -  5-minute warm-up; 1RM calculation for both right and left legs using a supine leg press
           machine; isometric quadriceps strength measurement using a dynamometer; muscle thickness
           measurements of both right and left quadriceps muscle using ultrasound technology.

        -  After day 1 testing; randomly allocate subjects to either control group or experimental
           group

      Sessions 2-13 - 6 weeks of exercise protocol, 2x/per week

      Both the experimental and control groups will complete the same protocol for the entirety of
      the study:

        -  5- minute warm up

        -  Using a single-leg press exercise machine: Subjects complete the testing protocol with
           either partial blood flow restriction (cuff inflated to 100-250 mmhg depending on size
           of person) or no blood flow restriction (placebo inflation) on right limb.

             -  Protocol: 30 repetitions - 15 repetitions - 15 repetitions - 15 repetitions with
                each set separated by ~30-90 seconds.

             -  Right and left legs will be alternating, but only one leg will have the occlusion
                cuff

      Session 14 - Re-test

      - Re-check 1RM, isometric quad strength, as well as muscle thickness of quadriceps with
      ultrasound
    

Intervention name(s): Blood flow restriction cuff; Blood Flow restriction Cuff-Placebo
Intervention type(s): Device; Device
Intervention description(s): The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.; The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Glycemic Effect of Added Sugar on Bake Beans
Condition: Diabetes Mellitus, Type 2; Obesity; PreDiabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To investigate the effect of added sugar to bake beans on glycemic and insulinemic response.
    

Detailed description: 
      There will be a total of 7 test session. Each session will last for 3 hours. At each test
      session, volunteers will be served with 7 test meals and blood will be collected. After an
      overnight fast, subjects will visit the research center. Two fasting capillary blood samples
      will be collected via fingerpick. Following the fasting samples, volunteers will consume the
      test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180
      minutes after the ingestion of test meal. These samples will be used to analyses for whole
      capillary blood glucose. At every 30 minute interval, samples will be collected for analysis
      of capillary plasma insulin.
    

Intervention name(s): Glucose Reference 1; Glucose Reference 2; Glucose reference 3; Sucrose; Regular Bake beans in tomato sauce; Bake beans in tomato sauce, reduced sugar; Bake beans in tomato sauce, low GI
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 30 g of glucose dissolved in 250 ml of water; 30 g of glucose dissolved in 250 ml of water; 30 g of glucose dissolved in 250 ml of water; 30 g of Sucrose dissolved in 250 ml of water; Bake beans in tomato sauce containing 14 g of sugar; Bake beans in tomato sauce containing 12.2 g of sugar; Bake beans in tomato sauce containing 7.2 g of sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover randomized controlled Trials
Masking: None (Open Label)
Primary purpose: Other
Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France
Condition: Enterobacteriaceae
MeSH terms: Disease Susceptibility
Study type: Observational

Summary: 
      Enterobacteria constitute a family of Gram negative bacilli of the gastrointestinal flora.
      These micro-organisms are frequently responsible for nosocomial or community-acquired
      infections, for which treatment is essentially based on the use of beta-lactam antibiotics.
      This class of antibiotics comprises penicillins, cephalosporins, monobactams and carbapenems.
      Carbapenems have the advantage of possessing a broad antibacterial spectrum and the capacity
      to resist the hydrolytic action of a large number of beta-lactamases, widespread inactivating
      enzymes.

      However, new enzymes, called carbapenemases, able to confer resistance to carbapenems either
      alone or in combination with additional resistance mechanisms such as loss of membrane
      permeability or overexpression of efflux systems, are currently emerging all over the world.
      Carbapenemases represent a major public health problem because of the risk of therapeutic
      impasse and their high epidemic potential.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing bacteriological samples as part of routine clinical practice during
        their hospital stay in one of the 6 participating centres. Patients in whom the results of
        bacteriological examinations reveal the presence of an Enterobacteria strain with reduced
        susceptibility to carbapenems will be included in this project
      
Keywords: carbapenems
Motivational Interviewing and Vaccine Hesitancy in Children
Condition: Vaccine Hesitancy
Study type: Observational

Summary: 
      This study will assess the effectiveness of a motivational interviewing-based tool in
      addressing vaccine hesitancy expressed by parents or caregivers of children.
    

Detailed description: 
      In order for vaccines to be effective and protect communities from diseases, a large majority
      of individuals need to be vaccinated to protect those who do not respond to the vaccine and
      those who cannot be vaccinated. While vaccine hesitancy has been noted as a growing problem
      among parents, there are few evidence-based strategies for providers to utilize to discuss
      vaccination with these parents. Therefore, there is a critical need to develop effective
      communication tools to increase parental confidence in vaccines. A tool based on the
      principles of motivational interviewing (a goal-oriented, collaborative counseling style) may
      be effective in addressing this need. Thus, the aim of this study is to determine the impact
      of a motivational interviewing-based (MI-based) tool on pediatric vaccination rates through
      assessment of changes in the percentage of patients achieving the goal of completion of all
      recommended doses in children 6 years of age and younger. Secondary aims include determining
      the impact of the motivational-interviewing based tool on parental health beliefs regarding
      vaccines and the impact of the training on provider knowledge and confidence in using
      motivational interviewing.
    

Intervention name(s): MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)
Intervention type(s): Other
Intervention description(s): The MOTIVE tool incorporates the principles of motivational interviewing (MI) and provides a flowchart approach in which parental health beliefs have a corresponding MI-based strategy to further explore and/or address the hesitancy. The tool was developed from interviews with pediatricians and pediatric pharmacists, a review of the literature focusing on vaccine health beliefs, and the Parent Attitudes about Childhood Vaccines (PACV) Survey Tool. The tool was reviewed by multiple providers and feedback was provided on its usability in clinical practice when interacting with vaccine-hesitant parents and/or caregivers. The tool was then modified based on this feedback. Pediatric providers will complete four educational sessions on vaccine hesitancy, MI, and the use of the MOTIVE tool in clinical practice prior implementation.
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients, parents/caregivers, and providers at the Rocking Horse Community Center
      
Keywords: Motivational Interviewing; Pediatrics
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on
      irritable bowel syndrome.
    


Intervention name(s): Lactichoc; Stool sampling
Intervention type(s): Dietary Supplement; Other
Intervention description(s): dosage form: mix of 8 strains containing 1.2x10^11 CFU frequency, and duration: 2 capsules/day during 10 days; 3 stool samples are taken during the study (D0, D10 and D30)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
Condition: Early Pregnancy
Study type: Observational

Summary: 
      This clinical trial consisted of lay user study and method comparison study. Method
      comparison study: evaluate the clinical performance by comparing the results of new device
      and FDA cleared device (the comparator) tested on the same sample by professionals.

      Lay user study: evaluate the usability of by comparing the results of new device on the same
      sample tested by professionals and lay user, and by lay users complete the questionnaire.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 502 subjects with ages from 18-55 years old were enrolled . Among the 502 total
        subjects, 369 subjects aged between 18 and 55 years old voluntarily participated in the Lay
        User Study.
Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The investigators will investigate

        1. the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA
           copy numbers and the clinical psychopathology of schizophrenia, including severity of
           positive and negative symptoms, obesity and metabolic syndrome.

        2. the relationships between aberrant mitochondria genes (single nucleotide polymorphism of
           D-loop region-related genes and haplogroup N9a), DISC1 gene polymorphism, and clinical
           phenotypes in Taiwanese populations.

        3. whether these biological markers could be as clinical markers in schizophrenia for a
           long-term follow-up study.
    

Detailed description: 
      In past study, we had shown that there were significant differences in serum Lpo (lipid
      peroxidation) and Thiol levels between patients with schizophrenia and healthy controls. For
      patients taking risperidone, there were significant decreases in serum Thiol levels. In
      addition, there were also significant differences in age of onset of PPAR gamma coactivator
      1α (PGC-1α) polymorphism for schizophrenia patients. Therefore, we want to know the
      relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA copy
      numbers and the clinical psychopathology of schizophrenia, including severity of positive and
      negative symptoms, obesity and metabolic syndrome.

      In past study, we also found that there were significant differences in 10 SNPs located in
      the D-loop region-related genes between patients and healthy controls. Three SNPs could be
      found in Mitomap data, but another seven SNPs not been found in the Mitomap and they could be
      more confirmed. In addition, Tanaka et al. found that haplogroup N9a was related to diabetes
      and metabolic syndrome in Asia. Therefore, we were interested to clarify the relationships
      between above related mitochondria genes and clinical phenotypes in Taiwanese populations,.

      In addition, we also want to see whether these biological markers could be as clinical
      markers in schizophrenia for a long-term follow-up study.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will be conducted in our clinical setting. By a semi-structured interview for
        DSM-IV criteria, about 300 schizophrenic patients will be recruited in this study.
      
Biospecimen description: 
      Blood
    
Keywords: Schizophrenia; Oxidative stress; Mitochondria
Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance
Condition: Class III Malocclusion
MeSH terms: Prognathism; Malocclusion; Malocclusion, Angle Class III
Study type: Interventional

Summary: 
      This experimental study aims to evaluate the efficiency of the orthodontic removable traction
      appliance in the treatment of skeletal class III malocclusion. The study sample will consist
      of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly
      into two groups: experimental group and control group. The dentoskeletal changes will be
      assessed by using lateral cephalometric radiographs before treatment and after obtaining 3mm
      positive overjet.
    

Detailed description: 
      Treatment of class III malocclusion is a major challenge in orthodontic contemporary
      practice, Several appliance have suggested for the treatment of class III malocclusion, such
      as the facial mask and chin cup.

      Despite of the efficiency of this extraoral appliance, its external appearance and its big
      size reduce patients' cooperation which decrease its clinical effects.

      Another Class III treatment modality is the Orthodontic Removable Traction Appliance (ORTA).
      It is a removable appliance that can be used in conjunction with rapid palatal expansion or
      fixed appliances, It was developed in the 1980's by Dr. David Musich who developed this
      appliance in order to overcome issues of compliance that Dr. Musich experienced with use of
      the protraction facemask.

      There is only one study that evaluated this appliance which is a retrospective study compared
      the treatment effects of the ORTA and protraction facemask in treatment of Class III
      malocclusions. However, this study has a lot of limitations which made it difficult to
      accurately evaluate the efficiency of this device.

      The aim of this study is studying the dentoskeletal changes that result from treatment by
      this device, by comparing them to the changes in matched untreated group,by studying the
      cephalometric x-rays.
    

Intervention name(s): Vacuum plate; Rapid maxillary expander; Class III elastics
Intervention type(s): Device; Device; Device
Intervention description(s): Vacuum plate with two hooks between lateral incisor and canine in each side will be applied on the lower arch.; Rapid maxillary expander will be applied in the maxilla to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla.; Class III elastic traction from upper first molar to the hook in both side will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomly assigned to one of the two groups, case or control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Class III treatment; orthodontic removable traction appliance; RCT
Reinforcing Effects of Brief Exposures to Nitrous Oxide - 8
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. Comparisons
      between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine
      reinforcing effects of brief exposures to nitrous oxide in healthy volunteers.
    


Intervention name(s): 20% N2O; 40% N2O; 60% N2O; 80% N2O
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Nitrous Oxide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: nitrous oxide; reinforcer; subjective effects; healthy volunteer
Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers
Condition: Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis)
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Primary objectives:

        1. To comprehensively characterize steady state stereoselective pharmacokinetics of
           bupropion and its primary and secondary metabolites in healthy volunteers

        2. To prospectively determine the time course (onset), extent and offset of CYP2D6
           inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.
    


Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention description(s): Phase 1: Baseline CYP2D6 activity, using dextromethorphan (30 mg single dose PO) as a probe drug Phase 2: Single dose bupropion pharmacokinetics and its effect on CYP2D6 activity (determined by dextromethorphan 30 mg single dose PO) Phase 3: Steady state disposition of bupropion and its interaction with CYP2D6 activity (30 mg single dose PO)
Intervention MeSH terms: Bupropion
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This is an open-label, four-phases, fixed sequence healthy volunteers study investigating: the steady state stereoselective disposition of bupropion and metabolites; and effect of multiple doses of bupropion on CYP2D6 activity, as measured by the metabolism and pharmacokinetics of a single dose of dextromethorphan
Masking: None (Open Label)
Primary purpose: Basic Science
Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty
Condition: Degenerative Arthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Aspiration of gastric contents during perioperative period is a grave complication with
      significant morbidity and mortality. Diabetic patients have a higher incidence of autonomic
      dysfunction, causing gastropathy. They are known to have gastroparesis and the consequent
      delayed gastric emptying which predisposes them to an increased risk of aspiration than the
      general population. Furthermore, other common factors can influence the gastric emptying
      rate, as for example, old age, pain, and the use of opioid analgesics.

      In the previous study, evidence of increased pain was reported in patients undergoing staged
      bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity
      (tertiary hyperalgesia) due to the surgical injury to the first operated knee.

      In the present study, we will evaluate the effect of old age, diabetes, surgical stress,
      pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing
      staged-bilateral total knee arthroplasty.
    


Intervention name(s): Ultrasonic measurement of antral area
Intervention type(s): Procedure
Intervention description(s): Ultrasound exam is done before the induction of spinal anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed.
The cross-sectional area (CSA) of antrum is shown by the following formula: CSA = AP x CC x ㅠ/4.
Antral area will correspond to the average of the three measures.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be patients whom are scheduled to undergo staged bilateral total
        knee arthroplasty requiring preoperative fasting period of at least 8 hours. 40 patients
        will be recruited in total. One cohort consisting 20 patients will be diabetic. The other
        cohort consisting of 20 patients will be non-diabetic.
Perioperative Cardiac Troponin Levels in Healthy Adults
Condition: Extremity Orthopedic Surgery
Study type: Observational

Summary: 
      This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in
      patients without cardiac risk factors undergoing extremity orthopedic surgery. This study
      will provide important evidence on how to interpret postoperative cardiac troponin
      elevations.
    


Intervention name(s): Extremity orthopedic or trauma surgery
Intervention type(s): Procedure
Intervention description(s): hip, leg, shoulder, arm
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing extremity surgery without history of cardiovascular disease
      
Biospecimen description: 
      Plasma
    
Keywords: Cardiac Troponin; Perioperative Period; surgery
A Three-Part Study Of GSK580416 In Healthy Subjects
Condition: Respiratory Tract Infection; Infections, Bacterial
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in
      animals affected the digestive system and blood cells. Study OPS106400 will be the first
      administration of GSK580416 in humans. Parts A and B of this study will examine the safety,
      tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to
      placebo. Part C of the study will assess the effect of food on the safety, tolerability, and
      pharmacokinetics of a single dose of GSK580416 in healthy subjects.
    


Intervention name(s): GSK580416
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: tolerability,; pharmacokinetics,; first time in human,; food effect; safety,