bioihbjkbjnl/mcl2 huggingface dataset:
Urdu Version of Tinetti Balance and Gait Assessment Scale,(POMA),Reliability and Validity Study
Condition: Balance; Distorted
Study type: Observational

Summary: 
      In this study we will observe the reliability and validity of Tinetti Balance assessment
      scale,(POMA) in Urdu language in Pakistani geriatric population with balance impairment.
      Also, check the improvement in assessment and rehabilitation in geriatrics with balance
      problem.
    

Detailed description: 
      The aim of study is to translate and culturally adapt Tinetti balance assessment scale (POMA)
      into Urdu language and secondly to investigate the reliability and validity of Tinetti
      Balance assessment scale (POMA) in geriatrics Pakistani population.This study will be cross
      sectional survey study in which convenience sampling technique will be used. Two scales will
      be performed by patient Tinetti Balance assessment scale and Berg Balance Scale (evaluate
      balance), Timed Up and Go Test (TUGT) (measure functional mobility) for comparison and data
      will be collected. The results of study will help to know the validity and reliability of
      Tinetti Balance assessment scale (POMA) in Urdu version with balance impairments in geriatric
      population.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        older people,especially age-related impairments in balance and postural control that effect
        the performance of everyday activities, which are primary reasons for falls. about 28-35%
        of older people (65 years) are experiencing falls. the prevalence increases to 50%up to 80
        years of age
      
Keywords: Assessment,balance ,older people, reliability,validity
BP PAL - Hypertension Chat Bot Pilot
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      A 2-arm randomized pilot trial aimed at evaluating the effectiveness of a 6-month remote
      monitoring program for the management of hypertension (HTN). 300 eligible patients will be
      randomized in a 1:1 ratio into two recruitment arms: A) Control (usual care), or B) Remote
      monitoring via automated messaging program. The target population are patients at the Penn
      Family Medicine University City and Westtown primary care practices with baseline poor blood
      pressure control as indicated by two blood pressures greater than 140/90 within the past
      twelve month including the most recent measurement and on at least one anti-hypertensive
      agent.
    

Detailed description: 
      STUDY DESIGN:

      Pragmatic, non-blinded, randomized controlled trial.

      Randomization and enrollment:

        -  Randomization will be at the patient level (stratified/balanced randomization by PCP)

        -  Enrollment will take place over short time period based off of lists of eligible
           patients pulled from the EMR

        -  Lists of eligible patients sent to PCPs with opportunity to opt patients out. Patients
           will be contacted via text followed by phone call to introduce them to the program.

      We expect recruitment to take approximately 1 month to reach a target sample size of 300. The
      program itself will be 6 months from the date of randomization. Total study duration should
      be approximately 7 months. Data analyses will take an additional 3 months.

      The control group will receive usual care as determined by PCP (control arm will not receive
      BP cuffs).The Intervention Group will receive the BP cuff and weekly SMS messages asking for
      the BP reading. The methods section below will outline the details for both groups.
    

Intervention name(s): HTN Chat bot
Intervention type(s): Behavioral
Intervention description(s): Remote monitoring via automated messaging program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: remote monitoring
Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study is conducted to evaluate the clinical performance of class I reinforced glass
      ionomer restorations (Zirconomer Improved and Equia Forte Fil)
    


Intervention name(s): Equia Forte Fil; Zirconomer Improved
Intervention type(s): Other; Other
Intervention description(s): Glass hybrid innovation achieved through the introduction of ultrafine, highly reactive glass particles dispersed with conventional GI. The restoration is coated with Equia Forte coat which incorporates multi-functional monomer producing a tougher resin matrix. This system is designed as alternative of amalgam in posterior teeth.; Zirconia reinforced GI, Glass Polyalkenoate restoration; it is designed to exhibit high strength where the glass component of this GI undergoes finely controlled micronization to achieve optimum particle size and characteristics .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Drug-drug Interaction Study With GLPG3667 and Midazolam in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers to look at the effect of the test medicine, GLPG3667, on how
      midazolam (MDZ) is taken up and eliminated by the body.
    


Intervention name(s): GLPG3667; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): From Day 3 to Day 8, GLPG3667 capsules q.d. orally in fed state.; On Day 1 and Day 7 as liquid formulation, orally in fed state.
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      This is a prospective randomized controlled trail to assess early urinary continence recovery
      rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter
      reconstruction is performed or not. A hundred forty-six patients with clinically localized
      and histological confirmed prostate cancer will be enrolled. Continence recovery is defined
      in the present study as declared urinary continence (absence of incontinence episodes) in the
      physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF,
      IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the
      secondary objective will be assessed by SHIM questionnaire.
    


Intervention name(s): Radical prostatectomy with posterior rhabdosphincter reconstruction; Radical prostatectomy without posterior rhabdosphincter reconstruction
Intervention type(s): Procedure; Procedure
Intervention description(s): To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.; Standard technique with a running suture to perform the urethrovesical anastomosis
Other intervention name(s): Rocco reconstruction technique; Posterior reconstruction; Rocco Stitch
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a prospective randomized controlled trial to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Prostate Cancer; Urinary incontinence; Radical prostatectomy; Rhabdosphincter; Robotic Surgery
"Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients"
Condition: Shoulder Impingement; Shoulder Pain; Shoulder Injury
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Injuries
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study was to translate and culturally adapt the MSQ to Turkish language
      and test the validity and reliability of Turkish version of MSQ in shoulder dysfunction
      patients. And also, the ultimate goal was to facilitate international researches in shoulder
      problems as well as to serve the physicians for their clinical practice.
    

Detailed description: 
      Munich Shoulder Questionnaire (MSQ) is an innovative tool for self-assessment of shoulder
      function. It was especially designed for an effective follow-up of shoulder patients which
      were also allowing for a quantitative assessment of the Constant, Shoulder Pain and
      Disability Index (SPADI) and DASH score consisting of a 30-items questionnaire. It based on
      subjective and objective parameters of shoulder function.

      Standart questionnaire enable to follow patients on a close and regular base with manageable
      effort for both the disability and the patients.an optimal instrument for outcome measurement
      of shoulder problems should meet the following requirments: a) the instrument should be a
      self-assmment patient reporting tool, b) the questions must be easily comprensible, c)
      filling in should be finished less than 30 minutes, d) the results should provide calculation
      of several well established scoring system. MSQ can be completed at home and typical
      functional abilities about evaluation are explained with pictures so these can make it easy.
      As a result, we choose to translate the MSQ into Turkish as it is less costly, practical and
      time consuming than developing a new tool. In addition, objective (normal joint movement and
      muscle strength) and subjective (pain, daily life activity, sport and leisure time
      activities) parameters in a single form to create the advantage in terms of ease of use and
      time. With these properties, MSQ may be preferred during follow-up of the results of
      conservative and / or surgical treatment.
    

Intervention name(s): Munich Shoulder Questionnaire
Intervention type(s): Other
Intervention description(s): Validation and Reability study
Other intervention name(s): Disability of arm, shoulder and hand; shoulder pain and disability index
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        shoulder dysfunction
      
Keywords: Cultural adaptation; validation; responsibility; shoulder
Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke
Condition: Ischemic Stricture of Intestine
MeSH terms: Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      The primary objective of this pilot study is the assessment of the safety of the ISS500
      System in patients who have experienced an acute ischemic stroke within the anterior
      circulation.

      The secondary objectives of this study are to examine the effectiveness of the ISS500 System
      implantation in the treatment of acute ischemic stroke.
    

Detailed description: 
      The study is an open label study in which a comparative group of patients will be
      prospectively selected from a resource of clinical trial data, the Virtual International
      Stroke Trials Archive (VISTA), on the basis of similar eligibility criteria and match for
      principal prognostic variables available at trial entry. Data from patients will be
      transferred to VISTA in a real time or at most, weekly basis and comparative group patients
      will be prospectively matched throughout the recruitment period. The VISTA investigators will
      be blinded to treatment group when receiving data from BrainsGate. The VISTA investigators
      will match each recruited BrainsGate patient with 3 patients from the VISTA archive. The
      matching criteria will include age ± 4 years; baseline NIH score matched exactly, and side of
      infarct.

      In addition, to the end of treatment visit, in which implanted patients will undergo a device
      removal procedure, two follow-up visits will be performed. The visits should be performed at
      30±5, and at 90±5 post enrollment. Aggregate trial duration will be ~100 days per patient,
      and the overall study duration will be up to 18 months.
    

Intervention name(s): ISS Active Stimulation
Intervention type(s): Device
Intervention description(s): ISS SPG stimulation and standard of care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic Stroke; Treatment; ISS; ImpACT; clinical trial
Functional Manifestations of Pressure Changes in the Middle Ear System
Condition: Middle-ear Function
Study type: Interventional

Summary: 
      This study is looking at whether functional magnetic resonance imaging (fMRI) can see if and
      when the brain responds to pressure stimulations of the eardrum. The study requires 2 visits,
      1 for screening to determine eligibility and 1 for the fMRI. This study will help to
      understand how the middle ear system is controlled, which may have an impact on how people
      with middle ear disease are treated.
    

Detailed description: 
      Otitis media is a ubiquitous disease in young children which can persist through adolescence,
      and arise or recur in adults. A consequence of an infection and/or Eustachian tube
      dysfunction, it manifests as an effusion that disrupts the normal impedance matching function
      of tympanic membrane-ossicular chain system. Eustachian tube dysfunction prevents the
      equilibration of middle ear pressures and drainage of the accumulated effusion. It is thought
      that middle ear status modulates the function of the Eustachian tube via afferent signals
      processed centrally resulting in changes in its tonus or muscular function. This pilot study
      of right-handed 21-35 year olds of either sex will validate a published fMRI method for
      visualizing cortical brain activation in response to external ear canal pressure changes
      (N=5). The outcome measure is intensity changes of the cortex associated with applied
      stimuli.
    

Intervention name(s): changing ear canal pressure
Intervention type(s): Other
Intervention description(s): ear canal pressure changes: pressure varied from +/-40 decapascals
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: middle ear; Eustachian tube; fMRI
Gastric Emptying and Gallbladder Motility Study
Condition: Gastric Emptying
Study type: Interventional

Summary: 
      Background of the study:

      Plant sterols can play an important role in lowering plasma cholesterol. The extent to which
      plant sterols can reduce plasma cholesterol levels depends on the intake scenario. We suggest
      that the difference in these effects depends on gastric emptying and bile secretion.

      Objective of the study:

      The aim of this study is to gain insight in the mechanisms that may be involved in the
      effects of plant sterol drinks on gastric emptying and gallbladder motility. In order to test
      this, we compare the different effects of the consumption of a plant sterol containing drink
      prior to, during and after a standardized meal.
    


Intervention name(s): Plant sterol containing drink; Standard macaroni meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal; The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Apixaban + DAPT in Lowering Platelet Reactivity and Thrombin Generation
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Observational

Summary: 
      Investigating Synergistic Effects of Apixaban with Dual Anti-Platelet Therapy (DAPT) in
      Lowering Platelet Reactivity and Thrombin Generation
    

Detailed description: 
      Combination anti-platelet therapies particularly those combining aspirin with a P2Y12
      antagonist (DAPT) are regarded as the current standard of care therapy for patients with
      Acute Coronary Syndrome (ACS). As thrombin potently induces platelet dense granular release
      and causes secondary adenosine 5'-diphosphate (ADP)-mediated P2Y12 receptor activation,
      apixaban via inhibition of thrombin generation may exhibit synergistic activity with direct
      P2Y12 receptor blockers such as clopidogrel or ticagrelor. The results from the study will
      provide a clearer understanding of how these antithrombotic agents work in combination and
      how the anti-Xa, apixaban, may reduce the contribution of thrombin and general platelet
      reactivity when used alone and in combination with antiplatelet agents. This study does NOT
      involve administration of medication to subjects. Experiments will be performed on donated
      blood samples from participants.
    

Intervention name(s): Flow Cytrometry; Thrombin Generation Assay
Intervention type(s): Diagnostic Test
Intervention description(s): Apixaban combined with blood specimens (in vitro) of study participants
Intervention MeSH terms: Thrombin
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        30 subjects with ACS diagnosis and dual anti-platelet therapy requirements and 10 healthy
        subjects; no restrictions on gender, race or ethnicity; ages 18-74, non-childbearing
        potential for females.
      
Keywords: Dual Anti-Platelet Therapy
Safety of and Immune Response to the Experimental Preventive HIV Vaccine, EP HIV-1090, in Healthy, HIV-1 Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the safety of and immune response to the
      investigational HIV vaccine, EP HIV-1090, in HIV uninfected adults.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and
      effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct,
      readily produced in large quantities, and stable for long periods of time. EP HIV-1090 is a
      DNA HIV CTL vaccine; the proteins for which its genes code are designed to interact with CD8
      cells (CTL) and cause CD8 cell proliferation. The DNA plasmids in EP HIV-1090 code for
      proteins conserved among HIV subtypes A, B, C, D, F, and G, which encompass the HLA subtypes
      of 85% of the worldwide general population.

      Participants will be enrolled in this study for 1 year. Group 4 participants will receive EP
      HIV-1090 or placebo at study entry and Months 1, 3, and 6. There will be 11 study visits that
      will occur at screening; study entry; and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. A
      physical exam and risk reduction/pregnancy prevention counseling will occur at each visit.
      Participants will be asked about their adverse experiences from vaccination at each visit.
      Blood and urine collection will occur at selected visits.
    

Intervention name(s): EP HIV-1043; EP HIV-1090
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant protein vaccine containing the 18 HIV proteins from HIV genes Pol, Vpu, and Gag.
The vaccine is provided in single-use 1.1-mL vials.; DNA plasmid vaccine containing the genes Gag, Pol, Vpr, Nef, Rev, and Env. The vaccine is provided in single-use 1.1-mL vials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF
      combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or
      tacrolimus, in participants who have undergone kidney transplantation. Participants will be
      randomized to one of three dosing regimens to receive concentration-controlled MMF with
      reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard
      CNI. Participants will be followed for 20-24 months after randomization.
    


Intervention name(s): Mycophenolate mofetil; Cyclosporine; Tacrolimus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The initial dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. In Groups A and B, subsequent doses will be adjusted to maintain blood MPA levels ≥1.3 μg/mL with cyclosporine or ≥1.9 μg/mL with tacrolimus. In Group C, subsequent doses are not to be adjusted, except in the case of unacceptable toxicity.; Cyclosporine will be given as 100-mg soft gelatin capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 125-165 ng/mL (reduced) or 250-270 ng/mL (full); Days 90 through end of study, 95-145 ng/mL (reduced) or 190-220 ng/mL (full).; Tacrolimus will be given as 1-mg and 5-mg capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 4-6 ng/mL (reduced), 8-10 ng/mL (full); Days 90 through end of study, 3-5 ng/mL (reduced), 6-8 ng/mL (full).
Other intervention name(s): CellCept; Neoral; Prograf
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment