bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe
Condition: Dentine Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      Subjects with at least two teeth with dentinal hypersensitivity and who meet the study
      criteria will be enrolled onto this double blind, randomised, parallel, controlled clinical
      trial. After enrolment, suitable subjects will use a fluoride toothpaste for 4 weeks (wash
      out period). Baseline dentine hypersensitivity assessments will be conducted using tactile
      stimuli, air blast, and VAS methods. Tactile methods of assessment will include use of the
      Yeaple Probe and the Jay Sensitivity Sensor probe. Air blast assessments will be conducted
      using the Schiff cold air sensitivity scale. The Oral Health Impact Profile (OHIP)
      questionnaire will be completed at four defined time points during the study. The baseline
      assessments will be conducted on the two teeth identified during the screening visit.

      On completion of the baseline assessments, subjects will be randomly assigned to product.
      Dentinal hypersensitivity assessments will be repeated after 18, 28 and 56 days of product
      use.
    


Intervention name(s): A01; B99; M89
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The gel will be applied in the evening of three consecutive days during the study time period; Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The bonding agent will be professional applied immediately prior to the clinical assessments.; Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
Condition: Ventricular Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of eleclazine (GS-6615)
      compared to placebo on the overall occurrence of appropriate implantable
      cardioverter-defibrillator (ICD) interventions (antitachycardia pacing [ATP] or shock) in
      adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).
    


Intervention name(s): Eleclazine; Placebo to match eleclazine
Intervention type(s): Drug; Drug
Intervention description(s): Eleclazine tablets administered orally; Placebo to match eleclazine tablets administered orally
Other intervention name(s): GS-6615
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: VT; VF; Ventricular Tachycardia; Ventricular Fibrillation; shock; ATP
Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis; Arthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The goal of this study is to explore the effectiveness of a commercially available,
      over-the-counter knee brace in the conservative treatment of knee osteoarthritis.
      Participants will either be fitted with a brace and told to wear it every day during normal
      activities, fitted with the brace and given instructions on a set of quadriceps strengthening
      exercises to complete twice daily, every day, or be given the exercise instructions, but not
      fitted with a brace. Functional and subjective outcomes will be collected preoperatively and
      at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing
      alone versus a home exercise program, and whether the combination of those provides the most
      therapeutic benefit to participants.
    


Intervention name(s): Exercise Only; Brace Only; Bracing + Exercises
Intervention type(s): Other; Device; Other
Intervention description(s): This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.; This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.; This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficiency, Safety and Portability of Neovasculgen
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic
      lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V.
      Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This
      study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165
      gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The
      study was conducted under the control of the Russian Ministry of Health and was completed in
      2011. Patients enrolled in the study were subjected to a 6-month
    

Detailed description: 
      We conducted a phase 2b/3 multicenter randomized controlled clinical trial of the
      intramuscular transfer of a plasmid DNA encoding vascular endothelial growth factor (VEGF)
      165 with cytomegalovirus promotor (CMV) in patients with atherosclerotic lower limb ischemia.
      A total of 100 patients were enrolled in the study, that is, 75 patients were randomized into
      the test group and received 2 intramuscular injections of 1.2 mg of pCMV- vegf165, 14 days
      apart together with standard pharmacological treatment. In all, 25 patients were randomized
      into the control group and received standard treatment only. The following end points were
      evaluated within the first 6 months of the study and during a 1.5-year additional follow-up
      period: pain-free walking distance (PWD), ankle-brachial index (ABI), and blood flow velocity
      (BFV).
    

Intervention name(s): Neovasculgen (Cambiogeneplasmid)
Intervention type(s): Drug
Intervention description(s): treatment
Other intervention name(s): Neovasculgen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAD; CLI; stage 2a-3 of Pokrovsky-Fonteine
The Burden of Pediatric Surgical Conditions in Rural Kenya
Condition: Burden of Surgical Disease in Western Kenya
Study type: Observational

Summary: 
      PURPOSE OF THE STUDY

      The main purpose of this study is to find out what is the true burden of surgical conditions
      in pediatric population in a well defined geographical rural area in western Kenya.
    

Detailed description: 
      MATERIAL This research will be conducted in the Homa Bay county in western Kenya in
      previously selected locations around the county in rural area. An estimated 800 children and
      youth under the age of 18 will be selected for this study. This study will take place between
      October and November 2015. The investigators hypothesis, based on prior survey studies done
      in Sub-Saharan Africa, is that roughly 6% of the people under 18 are suffering from a
      surgical condition. In a sample size of 800 people the margin of error is 1,65%.

      People who are currently being treated in a hospital will be excluded from the study. Also
      the people who decline from the study will be excluded. The number of declinations will be
      recorded.

      METHODS The people will receive a written and a verbal information regarding the study and
      its purposes from the primary research assistant. If they decide to participate in the study
      they or their parent/guardian will be asked to sign an informed consent. Local interpreter
      will be available to help with possible questions.

      The primary research assistant will conduct a short interview. Prior medical history will be
      taken. The participants will be asked their age. If age is not known the primary research
      assistant will estimate it. The height, weight and sex will be registered. A full physical
      examination will then be conducted. In this examination the participants will be assessed for
      visible deformations i.e. masses, scars, limb deformities. It will be determined whether the
      deformation is congenital or acquired. If the deformity is acquired the cause will be asked
      from the subject. The range of major joints will be registered. In case of palpable masses
      the possible diagnosis will be figured out using basic clinical skills. A structured survey
      sheet will be used collect the information. No other forms of diagnostic measures will be
      used. No blood or microbial culture samples will be collected and no x-ray imaging will be
      done.

      If a surgical condition is diagnosed the participant will be informed about the nature and
      possible cause of this condition. No treatment procedures will be done on site.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        800 children and youth under the age of 18 in a well defined area in rural Western Kenya
        (Kabondo city in Homa Bay County).
Run, Recovery, Repeat, Always Healthy ("Corre, Recupera, Repite, Siempre Saludable")
Condition: Physical Exertion
Study type: Interventional

Summary: 
      This study has as main objective to know how the processes of recovery are realized after a
      race of marathon. For this, the participants of a marathon race are divided into three work
      groups during the 9 days post-marathon, one with rest in the recovery period, another with
      continuous race three sessions every 48h and another with three sessions of elliptical every
      48h .
    

Detailed description: 
      The marathon runners suffer a high fatigue, as has been studied by different investigations,
      the proposal of this study is to know how the recovery processes are produced in runners who
      have completed a 42km test.

      To do this, baseline measurements of the runners have been made through stress tests and
      determinations of biomarkers in blood and urine. Subsequently blood and urine samples were
      taken the day before the marathon test and blood and urine samples were then taken again on
      arrival at 24h, 48h, 96h, 144h, and 196h.

      At the same time, an intervention was carried out in the recovery phase, with the runners in
      three groups. The first one performed rests during the 9 days after the race, the second
      performed continuous race monitored every 48h from the end of the race, and the third group
      performed aerobic work on an elliptical machine under the same conditions as the group of
      Continuous race
    

Intervention name(s): Athletics track; Elliptical machine
Intervention type(s): Other; Other
Intervention description(s): Running at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race. Control heart devices; Running at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race. Control heart devices
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The first one performed rests during the 9 days after the race, the second performed continuous race monitored every 48h from the end of the race, and the third group performed aerobic work on an elliptical machine under the same conditions as the group of Continuous race
Masking: None (Open Label)
Primary purpose: Other
Keywords: Marathon, runners, biomarkers, recovery
Simple Suppers Scale-up (S3)
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine effectiveness of a family meals intervention,
      Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight
      status.
    


Intervention name(s): Simple Suppers
Intervention type(s): Behavioral
Intervention description(s): Theory-based 10-week family meals program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults
Condition: Frail Elderly Syndrome; Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      To explore the effect of "Lactobacillus plantarum TWK10 (hereinafter referred to as TWK10)"
      produced by synbiotech Biotechnology Co., Ltd. on alleviating and improving the aging and
      debilitating diseases of the elderly. Methods: It is expected to recruit 55-85-year-old
      senior citizens, who are assessed by the Clinical Frailty Scale (CFS) as debilitating disease
      grades 1 to 4 as the experimental subjects of this study. All subjects were divided into
      three groups according to the principle of balance order of frailty grades, namely (1)
      placebo group (Placebo group, average 77.4 years old), (2) supplement TWK10 probiotic 2x1010
      CFU/day dose group (TWK10-L) Group, average 77.1 years old), (3) supplemented with TWK10
      probiotic 6x1010 CFU/day dose group (TWK10-H group, average 79.0 years old). The experiment
      was supplemented for 24 consecutive weeks, and before supplementation, 6 weeks, 12 weeks, 18
      weeks, the whole body composition and bone density test, as well as the functional fitness
      test were carried out in sequence. The items include: 3 meters walking ( Balance and gait
      assessment), 10-meter walking, 30-second sit-ups, and changes in the maximum grip strength of
      the left and right hands. Results: The experimental data showed that in the functional test,
      supplementing the TWK10-H group significantly improved the 3m gait balance, 10m walking, and
      lower limb muscle strength (30-second sit-ups) in the functional test. In terms of body
      composition and bone density, TWK10-H can significantly increase relative muscle mass after
      18 weeks of supplementation. Conclusion: This study confirmed that supplementation of
      Lactobacillus plantarum TWK10 for 18 consecutive weeks can significantly promote the
      improvement of functional tests for the elderly, such as: 3m gait balance, 10m walking, lower
      limb muscle strength and grip strength, and can maintain and improve muscle mass. It has the
      effect of improving the frailty and muscle loss of the elderly.
    


Intervention name(s): Lactobacillus plantarum TWK10-L; Maltodextrin; Lactobacillus plantarum TWK10-H
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Low dose: 2x1010 CFU/day; 0x1010 CFU/day; High dose: 6x1010 CFU/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Mitochondria and Muscle Health in Elderly
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Observational

Summary: 
      The aim of this study is to characterize the relation between skeletal muscle mitochondrial
      metabolism and muscle health in elderly, physically compromised humans. To study this
      relation, a cross-sectional study will be performed in well-defined, distinct subject groups.
      Thus, to obtain insight in the relation between mitochondrial health and muscle function, not
      only subjects that differ in mitochondrial function (based on physical activity) will be
      compared but also subjects with high- versus low muscle function will be selected.
    

Detailed description: 
      Aging is associated with a decline of mitochondrial and skeletal muscle volume, -quality and
      -function. If a causal link exists between the loss of mitochondrial function and muscle
      health is unknown, however, both appear with advancing age and are associated with the loss
      of functional capacity, which increases comorbidities and annual healthcare costs. The aim is
      to test the hypothesis that a compromised muscle function in sedentary elderly is related to
      an impaired mitochondrial health. A detailed characterization of mitochondrial metabolism and
      muscle function is performed in well-defined, (physically compromised) elderly humans, in a
      cross-sectional design. To obtain insight in the relation between mitochondrial health and
      muscle function, not only elderly subjects that differ in mitochondrial function (based on
      physical activity) will be compared but also elderly subjects with high versus low muscle
      physical function will be selected. Healthy, young (20-30 years,) individuals with normal
      physical activity levels will be included as absolute controls.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers between 20 and 30 years old and 65 and 80 years old
      
Biospecimen description: 
      Urine, blood, muscle tissue
    
Keywords: Mitochondrial health; Muscle function; Aging
Intralesional Bleomycin Versus Cryotherapy for Treatment of Cutaneous Warts
Condition: Cutaneous Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study was to determine the efficacy of intralesional bleomycin in
      comparison to cryotherapy on participants having cutaneous warts.
    

Detailed description: 
      This study was conducted in the Department of Dermatology of Jinnah Postgraduate Medical
      Centre, Karachi from January to June 2021 after receiving approval from the institutional
      ethical and research committee of hospital.

      Sample size was calculated through NCSS software. Total of one fifty four non-admitted
      patients were assigned two study groups with equal sample size of 77 randomly through lottery
      method. Those patients aged between 18 to 60 years of either gender with cutaneous warts for
      > 1 week to 48 weeks were included after written informed consent. Patients treated
      previously for warts by any methodology, with history of vascular disease, immunocompromised,
      hypertension, cardiovascular disorder, pregnancy, lactation and hypersensitivity to lidocaine
      were excluded.

      All demography, clinical history was recorded by a principal investigator on a predesigned
      Performa , informed written consent was taken before enrolment.

      Group A received intralesional bleomycin 0.1% therapy until the lesion blanched. It was
      prepared manually by diluting 15 mg powder in 5 ml distilled water and then each ml was
      further diluted by adding 2ml of 2% lignocaine, double the amount taken from the vial, so
      that concentration became 1mg/1ml (0.1%). Group B patients were treated with liquid nitrogen
      with the help of a cotton swab wrapped on a wooden stick and was applied firmly with 01 mm
      extra healthy skin margin until the lesion blanched.

      Follow-up was carried out at 02, 04 and 06 weeks. Both the groups were assessed and compared
      for efficacy after 6 weeks of therapy. SPSS 23 was used for analyzing data.
    

Intervention name(s): Bleomycin Injection; Cryotherapy
Intervention type(s): Drug; Procedure
Intervention description(s): Intralesional Bleomycin used for treatment of cutaneous warts.; Cryotherapy used for comparison of efficacy.
Other intervention name(s): Bleomycin Sulfate
Intervention MeSH terms: Bleomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cutaneous warts,intralesional bleomycin,cryotherapy,efficacy
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections; Otitis; Otitis Media
Study type: Observational

Summary: 
      The purpose of the study is to identify the bacterial aetiology of acute otitis media
      episodes in young children aged ≥ 3 months to < 5 years in Saudi Arabia.
    


Intervention name(s): Sample collection
Intervention type(s): Procedure
Intervention description(s): Middle ear fluid and urine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects aged ≥ 3 months and < 5 years of age, diagnosed as having AOM
      
Biospecimen description: 
      Middle ear fluid and urine
    
Keywords: Non-typeable Haemophilus Influenzae; Acute Otitis Media; Streptococcus Pneumoniae; etiology
Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To evaluate the potential of hydratation and renewal of the mucosa, through corneometry
      measurement and individual questionnaire perception.

      Secondary Objective:

      To evaluate the safety in normal condition of use.
    


Intervention name(s): Dermacid Silver (Lactic acid); Glycerine Vegetal Soap Granado Traditional
Intervention type(s): Drug; Drug
Intervention description(s): Liquid soap, daily use; Vegetal soap, daily use
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an
      important role in mediating neuroanatomical plasticity and functional recovery following
      traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin
      and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h
      posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma
      Score and prognosis of such patients with traumatic brain injury.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patient group comprised 21 male and 13 female. Their age ranged from 19 to 68 years,
        with mean age of 45.1 years. The mechanisms of trauma included motor vehicle collisions,
        falls, heavy strikes (patients who were hit by heavy objects such as bricks, sticks, or
        falling objects) and assaults. Types of lesions, as evidenced by radiologic and neurologic
        symptoms or signs, included cerebral contusions/lacerations, intracranial hematomas, brain
        stem injury and diffuse axonal injury.
      
Biospecimen description: 
      Serum samples
    
Keywords: Traumatic brain injury; Neuroglobin; Nogo-A; Prognosis