bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Inhibitory Kinesio-tape of the Upper Trapezius on Lower Trapezius Muscle Excitation
Condition: Scapular Dyskinesis
MeSH terms: Dyskinesias
Study type: Interventional

Summary: 
      Shoulder pain increases excitation (or activity) of the upper trapezius (UT) and reduces
      excitation in lower trapezius (LT). Despite inconclusive evidence, kinesio-tape (KT) is often
      used to modify muscular excitation within the UT and/or LT to help correct alterations in
      scapular position and motion associated with shoulder pain/injury. The objectives of the
      current study were to determine if: 1) inhibitory KT to the UT acutely increases muscle
      excitation (whole-muscle and spatial distribution) within the LT in healthy individuals; and
      2) if loading the limb alters the magnitude of change in muscle excitation of the LT. We
      hypothesize that: 1) inhibitory KT application to the UT will immediately increase
      whole-muscle LT excitation, and result in an inferior shift in the distribution of excitation
      within the LT compared to no tape and sham-KT tape conditions; and 2) the magnitude of
      immediate increase in LT excitation with KT would be greater in the loaded condition. A
      repeated-measures, crossover design was used to determine the impact of KT applied to UT and
      load on muscle excitation of the LT. Participants were asked to perform a repeated arm
      elevation task during three different taping conditions: no KT, experimental KT and sham KT.
      Each taping condition performed the repeated arm elevation task during two loading
      conditions: no load and loaded with 2.3 kilograms. All six conditions were tested during one
      visit with the no load condition preceding the loaded condition for each taping condition. A
      baseline trial (no KT; N-KT) was performed first, followed by both an experimental-KT (E-KT)
      and sham-KT (S-KT) condition. The order of the E-KT and S-KT conditions were randomized and
      the order was counterbalanced. Testing for each tape condition lasted approximately
      10-minutes for a total of 45-minutes per participant including screening, EMG set-up and
      clean-up. KT was applied to the UT and muscle excitation (EMG amplitude) was measured in the
      LT using one single 32-grid high-density surface electromyography (HD-sEMG) electrode during
      a repeated arm elevation task.
    


Intervention name(s): kinesio-tape
Intervention type(s): Device
Intervention description(s): Twenty-one individuals with healthy shoulders completed 10 repetitions of an arm elevation task during three taping conditions (no-tape, experimental KT, sham KT) and 2 loading conditions (no-load and loaded).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: keniso tape (KT); Shoulder; upper trapezius; lower trapezius
Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases
Condition: Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, double blind and positive-controlled clinical trial to assess the efficacy and
      safety of Fuke Qianjin Capsule compared to Doxycycline Hyclate Tablet in patients with mild
      to medium PID and its sequalae.
    

Detailed description: 
      Study participants will be randomly assigned to Test or Control group and the following
      schedule will be followed

      Test group: metronidazole tablets + doxycycline hyclate tablets simulant are consecutively
      taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.

      Control group: metronidazole tablets + doxycycline hyclate tablets, are consecutively taken
      for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.

      Fuke Qianjin Capsules and their simulants are taken as 2 capsules at a time, 3 times a day,
      orally after breakfast, lunch and dinner, respectively; Metronidazole Tablets are taken as 2
      tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner,
      respectively; Doxycycline Hyclate Tablet and their simulants are taken as 1 tablet (0.1
      g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the
      same time as breakfast and dinner, respectively.

      Scoring pain, symptoms, local signs, routine leucorrhea, cervical secretions, gynaecological
      B-ultrasound will be examined before the enrollment and after study completion.
    

Intervention name(s): Control Group; Test Group
Intervention type(s): Drug; Drug
Intervention description(s): metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.; metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.
Other intervention name(s): Traditional Chinese Medicine (TCM)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, positive control
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Triditional Chinese Medicine; Pelvic Inflammatory Disease (PID); Doxycycline Hyclate; Metronidazole
Locating Nociceptive Stimuli on Digital Body Chart
Condition: Low Back Pain; Healthy Volunteers
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Digital body charts are used to assess the pain experience in people with pain. People are
      asked to report their pain by shading a human body template on a digital tablet. The aim of
      this study is to investigate whether people with chronic low back pain, compared to healthy
      volunteers, consistently locate on a digital body chart all nociceptive stimuli induced in
      the lumbar region.
    

Detailed description: 
      Healthy volunteers and people presenting chronic low back pain, will be recruited. A
      standardized grid will be drawn over the participants' lumbar region. Circular electrodes,
      connected to a constant current stimulator, will be applied at points on the grid. All
      participants will be blinded to the electrode locations. Painful electrocutaneous stimuli
      will be randomly delivered for each electrode. Participants will be instructed to draw with a
      stylus pen on a digital body chart displayed on a tablet where they will perceive each
      painful stimulation.

      The body chart will be centred on a canvas 768x1024 pixels (pxl), and pain location will be
      defined by X and Y coordinates. The consistency in reporting the location of each painful
      stimulation will be described through coordinates.

      In addition, only people presenting chronic low back pain will be asked to provide
      information about their lifestyle, level of disability, actual pain and general pain,
      assessment of kinesiophobia and health status.
    

Intervention name(s): Electrocutaneous stimulation; Assessment + Electrocutaneous stimulation
Intervention type(s): Other; Other
Intervention description(s): Painful electrocutaneous stimuli will be randomly delivered to electrodes positioned in a random order on the participants' back. Participants will be instructed to draw with a stylus pen on a digital body chart displayed on a tablet where they will perceive each painful stimulation.; Patients will be asked to provide information about their lifestyle, level of disability, actual pain and general pain, assessment of kinesiophobia and health status.
Subsequently, painful electrocutaneous stimuli will be randomly delivered to electrodes positioned in a random order on the patients' back. Patients will be instructed to draw with a stylus pen on a digital body chart displayed on a tablet where they will perceive each painful stimulation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The same procedure will be used for people with chronic low back pain and for healthy volunteers.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Chronic low back pain
Intervention With n3 LC-PUFA-supplemented Yogurt
Condition: Moderate Hypertriacylglycerolemic Subjects
Study type: Interventional

Summary: 
      The effective dosage of a n3-LC-PUFA intervention (with n3 LC-PUFA-enriched yoghurt) on the
      modulation of cardiovascular risk factors and inflammatory biomarkers were determined.
    

Detailed description: 
      Fifty three mildly hypertriacylglycerolemic subjects (TAG ≥ 150 mg/dL (1.7 mmol/L))
      participated on the placebo-controlled, double-blind, parallel designed study.

      The subjects consumed placebo yoghurt (1), or n3 LC-PUFA-enriched yoghurt (0.8 g n3 LC-PUFA/d
      (2), 3 g n3 LC-PUFA/d (3)) for 10 weeks.

      Blood samples were taken at the beginning and at the end of the period.

      Parameters:

        -  Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)

        -  Fatty acid distribution of plasma lipids (PL) and erythrocyte membranes (EM)

        -  Concentrations of eicosanoids (PGs, HETEs)

        -  Production of ex vivo stimulated cytokines by T cells

        -  SNPs in the CD36 genotype
    

Intervention name(s): n3 long chain polyunsaturated fatty acids
Intervention type(s): Dietary Supplement
Intervention description(s): Group 1 (placebo) Group 2 (0.8 g n3 LC-PUFA/d in 125 g yoghurt) Group 3 (3 g n3 LC-PUFA/d in 200 g yoghurt)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: n3 LC-PUFA, yoghurt, inflammatory markers
Cut-off Values of Muscle Thickness Ratio for Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The loss of muscle mass is one of the major diagnostic criteria for sarcopenia. Many methods
      are also used for the definition of sarcopenia. However there is no information about cut-off
      values in this respect in the literature. Therefore, the aim of this study is to determine
      the cut-off values of this ratio for confirming the diagnosis of sarcopenia.
    

Detailed description: 
      Decreases in total skeletal muscle mass are accepted to be necessary for confirming the
      diagnosis of sarcopenia. Many methods are also used for the definition of sarcopenia.

      However, ultrasound measurements has a high sensitivity and specify for confirming the
      diagnosis of sarcopenia. However there is no information about cut-off values in this respect
      in the literature. Therefore, the aim of this study is to determine the cut-off values of
      this ratio for confirming the diagnosis of sarcopenia.
    

Intervention name(s): Ultrasonographic evaluation
Intervention type(s): Other
Intervention description(s): Ultrasonographic measurement is assessment method to diagnosis of sarcopenia
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: older people; muscle; ultrasound
Study of Skin and Muscle Parameters Using a Skin Sensor
Condition: Skin Wounds
Study type: Interventional

Summary: 
      The aim of this study is to assess the role of skin sensors in obtaining reliable and
      accurate serial measurements of skin parameters in the context of cutaneous skin wound
      healing.
    


Intervention name(s): Skin sensor
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms "surgery side" and "non-surgery side" in parallel.
Masking: None (Open Label)
Primary purpose: Diagnostic
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions
Condition: To Determine Bioequivalence Under Fasting Conditions
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl
      Tablets
    

Detailed description: 
      To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg
      Buspirone HCl Tablets under fasting conditions, following administration of a 30 mg dose
    

Intervention name(s): buspirone HCl; Buspar
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 30 mg, single-dose; Tablets, 30 mg, single-dose
Other intervention name(s): Buspar; buspirone HCl
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; buspirone HCl; fasting
Optimizing Physical Activity Outcomes After Total Knee Arthroplasty
Condition: Total Knee Arthroplasty; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Although total knee arthroplasty is an effective intervention for decreasing knee pain and
      improving physical function, physical activity levels remain low up to a year after surgery.
      This study will use mobile-health technology to deliver an intervention designed to improve
      physical activity behavior for Veterans recovering from total knee arthroplasty. The study
      will assess the effectiveness of using behavior-change intervention as a supplement to
      conventional rehabilitation to improve physical activity. The intervention will be delivered
      using home-based tablet computers for Veterans to have remote interaction with the researcher
      and real-time physical activity feedback from a wrist-worn activity sensor.
    

Detailed description: 
      This randomized clinical trial will assess the efficacy of using physical activity behavior
      change intervention for Veterans recovering from total knee arthroplasty. Testing will occur
      at baseline (before surgery), at intervention midpoint (8 weeks after surgery), end of
      intervention (14 weeks after surgery), and 24 weeks after intervention. The primary outcome
      is accelerometer-assessed daily step count. Secondary outcomes include the percent time
      engaged in standing and walking activity and physical function (Six-Minute Walk, 30-Second
      Chair-Stand Test, Timed Up-and-Go, Western Ontario and McMaster Universities Osteoarthritis
      Index, and the Veterans RAND 12-Item Health Survey.
    

Intervention name(s): Physical Activity Behavior Intervention; Attention Control
Intervention type(s): Behavioral; Other
Intervention description(s): Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.; Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial; Two groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Total Knee Arthroplasty; Telemedicine; Physical Activity
A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the VisAbility Micro
      Insert System for the improvement of near visual acuity in presbyopic patients.
    

Detailed description: 
      The objective of this study is to evaluate the safety and effectiveness of the VisAbility
      Implant System (VIS) for the improvement of near visual acuity in presbyopic patients. This
      is a prospective clinical study that enrolled a total of 360 subjects ranging in age between
      45 and 60 years of age at 13 clinical sites. Subjects were implanted with the VisAbility
      Implant model SGP-046 in the primary eye and then in the fellow eye no sooner than 14 days
      later. Subjects were examined at one day, one week and at 1, 2, 3, 6, 12, 18 and 24 months
      post-operatively.

      The study also included a 60 subject randomized controlled sub-study at 3 investigation
      sites. Sub-study subjects were randomized (1:1 ratio) to a surgery group or a control group.
      Subjects randomized to the surgery group underwent surgery and were followed for 24 months in
      the same manner as the larger non-randomized surgical group. Subjects randomized to the
      control group were observed for 6 months, and were then eligible to undergo surgery after
      completion of this 6-month observation period.

      The primary endpoint is the achievement of distance corrected near visual acuity (DCNVA) of
      Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in
      DCNVA in the primary eye.

      This endpoint is evaluated against two objectives, a) 75% or more of primary eyes achieve the
      effectiveness endpoint at 12 months postoperative and b) the percentage of primary eyes
      achieving the effectiveness endpoint at 6 months postoperative (6-month responder rate) is
      higher than the percentage in the randomized control group.

      Safety data analyses were performed and separate summaries are provided for primary and all
      eyes. Descriptive statistics on the following attributes are provided for; BCDVA, IOP, Slit
      lamp findings, Fundus exam findings, and Adverse events.
    

Intervention name(s): VisAbility Micro Insert
Intervention type(s): Device
Intervention description(s): Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Near Vision; Reading Vision; Reading Glasses; Reading; Readers; Presbyopic; Presbyopia
Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.
Condition: Cataract
MeSH terms: Cataract; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This controlled, randomized, double blind, multicenter study will be carried out to
      demonstrate that the topical ophthalmic nanoemulsion of difluprednate 0.05% (Tolf®, Poen
      Laboratories), has a high anti-inflammatory efficacy, which would allow it to be administered
      after cataract surgery 1 drop, twice a day , starting the day before surgery and continuing
      for 14 days and 1 drop, once a day for the following 2 weeks, achieving an adequate
      anti-inflammatory activity, with the benefit of reducing the toxicity on the ocular surface,
      improving the dosage and adherence to treatment.

      The follow-up time will be 28 days and the outcome measures will be evaluated in a baseline
      (time 0), on day 1, on day 4 and on day 28 after surgery. The active control will be
      prednisolone acetate 1% + phenylephrine hydrochloride 0.12% topical ophthalmic suspension
      (Prednefrin® Forte, Allergan Argentina) given 1 drop, 4 times a days and 1 drop, twice a day
      for the next 2 weeks. Corneal thickness, central macula thickness, endothelial cell count,
      intraocular pressure, visual acuity, anterior chamber clearance and lacrimal film recovery
      will be evaluated.
    


Intervention name(s): Difluprednate Ophthalmic Emulsion 0.05%; Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution
Intervention type(s): Drug; Drug
Intervention description(s): 1 drop, 2 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, once a day for the next 2 weeks.; 1 drop, 4 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, twice a day for the next 2 weeks.
Other intervention name(s): Tolf®
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Phenylephrine; Oxymetazoline; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate; Difluprednate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Several prognostic predictors, including baseline ALL features and response to initial
      therapy, have been described in adult ALL raising the issue of whether these predictors might
      be redundant and which must be considered for treatment stratification. In the GRAALL-2003
      prospective Phase 2 study, we aim to hierarchize the following high-risk factors in
      Ph-negative ALL patients.
    

Detailed description: 
      1) baseline (BL) : WBC30G/L in B-lineage, CNS involvement, MLL-AF4 and E2A-PBX fusions,
      haploidy/near-triploidy; 2) early response (ER) : corticoresistance after prophase (CsR),
      chemoresistance at Day 8 (ChR); all CsR and/or ChR patients are planned to receive higher
      doses of cyclophosphamide (HyperC) at Day 15 of induction; 3) induction response (IR) : no CR
      or Ig-TCR minimal residual disease (MRD) 10-2 after standard or HyperC induction. Allogeneic
      stem cell transplantation is proposed to patients with a donor and at least one BL, ER, or IR
      factor.
    

Intervention name(s): Collection of treatment-stratefying prognostic factors
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute lymphoblastic leukemia; adult patient; chemotherapy; stem cell transplantation; Young adult patients