bioihbjkbjnl/mcl2 huggingface dataset:
Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
Condition: Unilateral Primary Osteoarthritis of Knee; Osteoarthritis Knee; Degeneration; Articular Cartilage, Knee; Degenerative Lesion of Articular Cartilage of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the
      knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative
      intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma
      (PRP) and hyaluronic acid (HA).
    


Intervention name(s): Microdrilling Surgery; Injections of BMAC + PRP + HA
Intervention type(s): Procedure; Procedure
Intervention description(s): All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care); All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
Condition: Localized Low-Intermediate Risk Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the
      potential to be a safe and effective non-invasive treatment for low to intermediate risk,
      organ-confined prostate cancer involving low incidence of morbidity. The study hypothesis
      will be tested by measuring treatment-related safety and initial effectiveness parameters in
      the ExAblate MRgFUS treated patients, as described above.

      Based on the result of this study, InSightec will initiate a larger study in an effort to
      approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS
      device.
    

Detailed description: 
      Objective of this feasibility trial is to assess safety and initial effectiveness of ExAblate
      MRgFUS in the treatment of low to intermediate risk, localized (organ confined) prostate
      cancer tumors.

      ExAblate treatment will be implemented as a focal tumor-selective therapy, directed at
      pre-defined volume(s)/sector(s) in the prostate, (identified as cancerous by mapping biopsy
      with or without multi-parametric MRI), rather than a whole gland or hemi-ablation treatment.

      Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS
      focal treatment of low risk organ confined prostate cancer. The risk of ExAblate
      treatment-related incontinence and impotence will also be assessed in this study.

      Effectiveness: determine the tumor control effect of ExAblate's MRgFUS focal treatment of low
      risk organ-confined prostate cancer (confirmed by TRUS-guided Transperineal Mapping Biopsy
      results).
    

Intervention name(s): MRgFUS Treatment
Intervention type(s): Device
Intervention description(s): Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy
Other intervention name(s): ExAblate 2100 Prostate system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRgFUS; Prostate Cancer; Low-Intermediate Risk Prostate Cancer; Localized Prostate Cancer; InSightec; ExAblate
Accommodation Disorders
Condition: Accommodative Insufficiency; Ill-sustained Accommodation
Study type: Observational

Summary: 
      This project will develop clinically useful, objective measurements of accommodative
      insufficiency and fatigue using continuous autorefraction recordings. The development of
      these procedures will help vision care professionals diagnose and treat accommodative
      anomalies.
    

Detailed description: 
      This project studies accommodative function, the ability to focus while doing near work.
      Visual discomfort symptoms, such as headaches, sore eyes, and blurred vision are commonly
      associated with prolonged reading or other near work. Researchers have long suspected
      accommodative dysfunction was involved but most clinical studies have failed to establish a
      relationship between weak accommodation and symptoms or reading impairments. Recent research,
      however, has found that clinical measure overestimate accommodative function and encourage
      the use of objective, autorefraction methods to measure and study accommodative weakness.
      This project will accomplish three goals. First, using autorefraction objective reliable
      procedures will be developed for measuring accommodative lag, the difference between the
      target location and where the eye is focused. Second, experiments will measure in real-time
      the impact of accommodative lag on reading fluency and visual discomfort systems. Third,
      studies will explore the role of the slow adaptive component in accommodative weakness. This
      work will lead to better methods for diagnosing and treating accommodative disorders.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Graduate students from Western University of Health Sciences
      
Keywords: Accommodation; Reading; Autorefraction
Effect of GEMS-H on Locomotor Function in Adults
Condition: Adults; Middle Age; Aged; Aged, 80 and Over
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of training with the Gait Enhancing
      and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in
      adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor
      function. Specifically, individuals in the GEMS-H group will show faster gait speed compared
      to those in the control group.
    

Detailed description: 
      The GEMS-H is a hip-type assist device developed by Samsung Electronics. The GEMS-H is worn
      around the waist and fastened at the waist and thighs by a set of belts with velcro to assist
      motion at the hip joints. The device weighs 2.1kg, and has 2 brushless direct current motors
      running on a rechargeable lithium ion battery. The normal operation time for the device is 2
      hours. It is controlled through a custom built application on a hand held tablet.

      The purpose of this study is to investigate the effect of training with the Gait Enhancing
      and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in
      adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor
      function. Specifically, individuals in the GEMS-H group will show faster gait speed compared
      to those in the control group.

      Participants will be scheduled for 18 sessions of training (randomly placed either in GEMS-H
      training group or traditional training group without the GEM-H) plus 5 sessions of testing
      (pre-training, mid-test after the 9 sessions of training, post-training, 1 month follow-up
      and 3 month follow-up after the 18 sessions training completed).
    

Intervention name(s): with Gait Enhancing and Motivating System-Hip (GEMS-H); without Gait Enhancing and Motivating System-Hip (GEMS-H)
Intervention type(s): Device; Other
Intervention description(s): The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale.
Assessments consist of gait function, cardiopulmonary metabolic energy cost, physical performance, balance, physical level, pain, fall efficacy, depression, quality of life and activities of daily living.; The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Training in the GEMS-H group consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device, whereas training in the control group consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments without device.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Determination of ClotPro Paediatric Reference Range Study
Condition: Clotting and Bleeding Disorders; Child Development; Infant Development; Coagulopathy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

Summary: 
      A new thromboelastometry analyser (ClotPro, Enicor GmbH, Munich, Germany) with improved
      technology was developed. This device has an improved new-generation viscoelastometric
      testing technique and enables the detection and assessment of factor deficiencies, low
      fibrinogen, platelet contribution (to whole blood coagulation), heparin and direct oral
      anticoagulants effects, fibrinolysis and antifibrinolytic drugs. This study aims to determine
      reference ranges for the ClotPro device for all paediatric age groups.
    

Detailed description: 
      Viscoelastic testing as a relatively novel method to assess coagulation status appears
      favourable in reducing blood product transfusions. The tests are performed on whole blood
      instead of plasma, which saves time and gives a quick sight at the interaction between
      cellular and plasmatic clotting factors.

      Reviews of the literature suggest that transfusions of packed red blood cells (pRBC), plasma,
      and platelets are all decreased in patients whose transfusions were guided by viscoelastic
      tests rather than by clinical judgement or conventional laboratory tests.

      The benefits of viscoelastic coagulation monitoring have been described in many fields of
      surgery and intensive care. Current literature and a guideline for the treatment of massive
      haemorrhage in perioperative bleeding and trauma patients recommend the use of viscoelastic
      tests to guide haemostatic resuscitation.
    

Intervention name(s): thromboelastometry test (TEM test)
Intervention type(s): Diagnostic Test
Intervention description(s): TEM test from the whole blood sample
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        6 Individual age categories are determined to monitor: ASA physical status I-II

          1. 0 (full term) to 3 months

          2. 4 to12 months

          3. 13 to 24 months

          4. 2 to 5 years

          5. 6 to10 years

          6. 11 to 16 years Demographic data to be recorded: age, gender, weight, height.
      
Biospecimen description: 
      whole blood
    
Keywords: thromboelastometry; viscoelastic testing; reference ranges
Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults
Condition: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to demonstrate the equivalence, in terms of
      immunogenicity, of three different industrial lots of the investigational vaccine thereby
      supporting consistency of the manufacturing process.

      Secondary Objectives:

      Immunogenicity

      To demonstrate that the investigational vaccine induces an immune response at least as good
      as the one induced by the reference vaccine, in terms of antibody titers.

      To assess the immunogenicity of the investigational vaccine using parameters defined in the
      European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).

      Safety:

      To demonstrate that the investigational vaccine is at least as well tolerated as the
      reference vaccine, in terms of defined safety profile.

      To describe the safety profile after vaccination.

      Comfort of the vaccination assessment:

      To assess the pain immediately after the injection using a Verbal Rating Scale. To describe
      the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire:
      the Vaccination Comfort Questionnaire.
    


Intervention name(s): Inactivated Split-virion influenza vaccine; Inactivated Split-virion influenza vaccine; Inactivated Split-virion influenza vaccine; Inactivated Split-virion influenza vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Vaccine Lot 1; Vaccine Lot 2; Vaccine Lot 3; Control Vaccine
Other intervention name(s): Vaxigrip
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Adults
A Study To Investigate The Absorption, Distribution, Metabolism, And Excretion Of [14c]PF-06463922 In Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to understand, using radiolabelled PF-06463922, how this compound is modified
      by the body once it is absorbed. The study also aims to understand how much of the compound
      is broken down and how much leaves the body unchanged.
    


Intervention name(s): [14C] PF-06463922
Intervention type(s): Drug
Intervention description(s): Single oral dose of 100mg PF-06463922 + [14C] PF-06463922
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06463922; [14C]PF-06463922; Human ADME; Radiolabel; Mass Balance; Pharmacokinetics
Hypoxic Pulmonary Vasoconstriction Pilot Study
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the events leading to smoking-associated
      centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent
      mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced
      inflammation.
    

Detailed description: 
      Overall goals of this study are to 1) determine the effects on sildenafil on the
      heterogeneity perfused blood volume in smokers susceptible to emphysema using dual energy CT
      2) utilize pulmonary blood volume heterogeneity as an image-based biomarker to differentiate
      normal and susceptible smokers.
    

Intervention name(s): Sildenafil study group
Intervention type(s): Drug
Intervention description(s): One dose of 20 mg Sildenafil will be given one hour before CT imaging.
Other intervention name(s): Revatio
Intervention MeSH terms: Sildenafil Citrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate
Condition: Vitamin B12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      Folic acid, a form of the vitamin folate, is added to grain products in Canada to help reduce
      birth defects. Folic acid is the synthetic form of folate and is very stable (doesn't break
      down) when added to foods. There are emerging health concerns about chronic folic acid
      consumption. Recently another more natural form of folate, L-5-methyltetrahydrofolate
      (L-MTHF) has become available. The investigators plan to conduct a randomized trial in women
      to determine if supplements containing L-MTHF consumed over three months raises blood folate
      levels as much as supplements containing folic acid. The investigators hypothesize that
      L-MTHF will increase red cell folate over 12 weeks to same extent as equimolar folic acid.
    

Detailed description: 
      The proposed study is a twelve week, cross-sectional, double blind, randomized controlled
      trial. The sample population will consist of one-hundred fifty healthy adult volunteers. All
      participants will be Malaysian women between eighteen and forty-two years of age. Study
      participants will be recruited by word of mouth and through advertisements placed in
      hospitals and universities starting in January 2011. Study participants will be randomly
      assigned to 1 of 3 treatment groups: 1) 1000ug L-MTHF 2) 1000ug folic acid 3) placebo (methyl
      cellulose). All treatments will be given in capsule form. Blood samples will be collected at
      baseline, 6 and 12 weeks.

      The primary outcome measure is red cell folate. A sample size of 45 subjects per group will
      allow us to detect a minimum difference of 100 nmol/L red cell folate assuming an alpha 0.05,
      a beta of 0.8 a SD of 183 nmol/L. Accounting for a 10% attrition rate we will enroll 50 women
      per group. The study will be analyzed as intent to treat. Baseline characteristics and
      compliance between treatment groups will be compared using a one-way ANOVA for continuous
      variables and chi-square analyses for categorical variables. The difference in measurements
      between the treatment groups at week 12 will be determined by regression analysis,
      controlling for baseline values.
    

Intervention name(s): L-5-methyltetrahydrofolate (Metafolin ®); folic acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): dosage: 1000 μg, frequency: once daily, duration: 12 weeks; dosage: 1000 μg, frequency: once daily, duration: 12 weeks; frequency: once daily, duration: 12 weeks
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)
Condition: Prostate Cancer; Urinary Incontinence; Beta-Alanine; Pelvic Floor Muscle Training; Radical Prostatectomy
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of beta-alanine in combination
      with pelvic floor muscle training (PFMT) compared to PFMT plus placebo in men undergoing
      radical prostatectomy.
    

Detailed description: 
      This study will assess efficacy of beta-alanine in combination with PFMT for the treatment of
      participants with urinary incontinence after radical prostatectomy. B-alanine is a component
      of L-carnosine (with L-histidine), which is needed for its synthesis. Βeta-alanine, thanks to
      its bioavailability) is a commonly used supplement that can improve exercise performance by
      increasing the amount of carnosine in striated muscle tissues. Supplementation of
      beta-alanine in elderly patients has resulted in an increase in physical activity, less
      fatigue and overall increase in L-carnosine concentration in muscles. PFMT utilization is
      considered a strong predictor of early return of urinary continence after radical
      prostatectomy (RP). We hypothesize, that combination of PFMT with beta-alanine could result
      in improved urinary continence after RP. The intervention will start 30 days before the
      surgery and will continue until primary outcome is met. Beta-alanine/placebo will be given
      daily. Efficacy, pharmacokinetics, biomarkers, tissue histology, participants reported
      outcomes and safety will be assessed. The total duration of study will be approximately 6
      months.
    

Intervention name(s): Beta-Alanine; Placebo; Pelvic floor muscle training (PFMT)
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Participants will receive 1150mg of beta-alanine three times a day; Participants will receive matching placebo three times a day; Participants in both groups will undergo PFMT training program
Other intervention name(s): Intervention group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The study was planned in a randomized controlled manner in order to evaluate the effect of
      mother's voice and lullaby on stress and sleep-wake situations of premature babies.
    

Detailed description: 
      Objective:This randomized controlled study was carried out to evaluate the effect of mother's
      voice and lullaby on preterm infants' stress and sleeping-waking states.

      Study design:The study was carried out in a newborn unit in a public hospital in Turkey. In
      this study, 90 preterm newborn were divided into three groups equally as mother's voice
      (n=30), lullaby (n=30) and control groups (n=30). Data were obtained by Mother and Newborn
      Identification Form, Newborn Stress Evaluation Form (NSEF) and Newborn Sleepıng-Wakıng State
      Evaluation Form (NSWEF). On the 1st, 3rd and 5th days of the study; Newborns' NSEF and NSWEF
      scores at pre-, post-study and on the fifth minutes were evaluated. Data were evaluated by
      using descriptive statistics, homogeneity tests, chi-square, intra-class correlation
      coefficent, two way of analysis on repeated measures, generalized linear model, pearson
      correlation analysis.
    

Intervention name(s): Music Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be conducted in a randomized controlled manner.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mother's voice; lullaby; preterm newborn; stress; sleep-wakefulness state