bioihbjkbjnl/mcl2 huggingface dataset:
Manual Therapy, Kinesiotape and Strength Training in Soccer Players With Recurrent Ankle Sprains
Condition: Ankle Sprains
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      Introduction. The ankle sprain is one of the most prevalent injuries in soccer players. The
      muscle strength deficit is one of the variables that can most influence the development of a
      sprain. It has been indicated how the Kinesiotape and the myofascial direct induction
      technique can improve functionality.

      Aim. To verify the effectiveness of the KinesioTape and the myofascial technique combined
      with strength training, in the reduction of pain, Rom increase, stability and strength in
      subjects who suffered ankle sprains.

      Study design. Randomized, multicentric clinical study with follow-up. Methods. A random
      assignment of the subjects recruited in two study groups will be carried out: experimental
      and control group. The treatment will last 4 weeks, with 2 weekly sessions, of 50-60 minutes.
      The intervention includes the application of kinesiotape and myofascial treatment with
      strength training. The study variables will be pain (VAS), mobility (goniometer), stability
      (ProKin balance) and strength (MicroFet). A descriptive statistical analysis will be carried
      out calculating the main statistical characteristics. By means of the Kolmogorov-Smirnov test
      the distribution of the normality of the sample will be assessed. With the t-student test for
      related samples we will calculate the difference of means between the evaluations made in
      both groups. With an ANOVA of repeated measures we will calculate the intra and intersubject
      effect. The calculation of the effect size will be done with the Cohen formula.

      Expected results. Improvement in stability, increase in range of motion, decrease in pain and
      increase in strength.
    


Intervention name(s): Experimental; Manual therapy group
Intervention type(s): Other; Other
Intervention description(s): Myofascial technique intervention of the subastragalar joint, kinesiotape and eccentric training with isoinercial machine. The intervention lasted 4 weeks. Each treatment session lasted 50 minutes, with 2 sessions a week. Between training sessions, the indicated break was 48 hours.; Myofascial technique of the subastragalar joint and eccentric training with isoinercial machine. The intervention lasted 4 weeks. Each treatment session lasted 50 minutes, with 2 sessions a week. Between training sessions, the indicated break was 48 hours.
Other intervention name(s): kinesio group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kinesiotape; Myofascial; Ankle sprain; Pain; Stability
Addressing Mental Health in African American Job Training Adolescents and Young Adults
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      This project's focus is twofold-to change the culture of an employment training program for
      adolescents and young adults (Youth Opportunities, or "YO") to more fully address the many
      mental health issues faced by its participants and to expand and improve the quantity and
      quality of mental health services for YO members. Four project components have been carefully
      selected to address the mental health issues of YO members: (1) Mental health
      education/training for YO staff and peer leaders, (2) Mental health education activities for
      YO members, (3) mental health screening on all newly enrolling YO members, and (4)
      comprehensive mental health services for YO members. These project components will be
      implemented at the HEBCAC YO Program (subsequently referred to as "Eastside" YO), with the
      Westside YO Program initially participating as a control site. Researchers at the Johns
      Hopkins University Center for Adolescent Health, led by Dr. Darius Tandon of the Department
      of Pediatrics, will conduct the research examining the effectiveness of these mental health
      services and supports.

      There are four project objectives. First, the proposed activities will increase YO members'
      knowledge of mental health resources and decrease stigma associated with seeking mental
      health services. Second, the investigators will see an increase in YO members' receipt of
      needed mental health services. Third, the investigators will see improvement in YO members'
      mental health. Fourth, as a result of their improved mental health, YO members will more
      actively engage in YO program activities and achieve more key program milestones (e.g., GED
      completion). These objectives are sequential, with later objectives predicated on the
      achievement of earlier ones.
    


Intervention name(s): Comprehensive Mental Health Services and Supports
Intervention type(s): Behavioral
Intervention description(s): This study uses a quasi-experimental design to test the efficacy of a comprehensive mental health intervention to improve the mental health and employment outcomes of young adults (18-24) enrolling in the Eastside YO Program. Newly enrolling Eastside YO members will receive an array of mental health education and services based on level of need and serve as this study's intervention group. Newly enrolling Westside YO members will receive "usual care" services delivered by the staff at the Westside YO Program and serve as this study's comparison group.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Depressive symptoms; Mental health services; Adolescents; Young adults; African-American
Laquinimod Phase IIa Study in Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to evaluate the safety and clinical effect of daily oral treatment of
      Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess
      Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is
      a novel immunomodulating drug which is currently in advanced stages of development by Teva
      Pharmaceuticals Ltd. for Multiple Sclerosis.
    


Intervention name(s): Laquinimod; placebo
Intervention type(s): Drug; Other
Intervention description(s): Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment; Matching placebo for 8 weeks of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Norspan Efficacy and Safety Among Elderly Subjects
Condition: Osteoarthritis Pain of the Hip and or Knee
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and
      safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe
      osteoarthritis pain of the hip and/or knee.
    


Intervention name(s): Buprenorphine transdermal patch
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Inflammation; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent
      published works pointed out that urine and serum markers could be used for detection of
      prostatic inflammation.

      The aim of the study is to assess the activity on inflammation biomarkers (serum and urine
      inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the
      treatment of urinary symptoms related to BPH.

      The potential links between serum and urinary markers of inflammation and BPH clinical
      symptoms at baseline and on treatment will be explored.
    


Intervention name(s): Permixon® 160 mg; Tamsulosine Arrow LP; Placebo matching Permixon® 160 mg; Placebo matching Tamsulosine Arrow LP
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration - 160 mg twice daily.; Oral administration - 0.4 mg daily.; Oral administration - twice daily.; Oral administration - daily.
Intervention MeSH terms: Saw palmetto extract; Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)
Condition: C.Surgical Procedure; Cardiac
Study type: Interventional

Summary: 
      The primary purpose of this study is to assess the effects of the use of EVADO with respect
      to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality.
      As secondary aim this study wants to conduct appropriate laboratory investigations in order
      to detect the major biological mechanisms potentially responsible for the beneficial effects
      of the EVADO system on the coagulation cascade and inflammatory activation.
    

Detailed description: 
      The present study is designed as a prospective, multicentre, randomized, open label,
      controlled, 2-arm parallel group, superiority trial.

      Participating centres are selected based on previous experience with the use of the EVADO
      system.

      Patients elected to open heart surgery for a variety of cardiac conditions related to
      coronary, valvular or aortic disease or their combination in the participating centers will
      be screened.

      This study as secondary aim wants to confirm the results of earlier investigation by a
      multicentre trial conducted on a larger population of patients undergoing a wide spectrum of
      open heart cardiac operations and either assess a number of cost-efficacy-efficiency
      indicators.
    

Intervention name(s): EVADO; Conventional CPB
Intervention type(s): Device; Device
Intervention description(s): EVADO (Extracorporeal Vacuum-Assisted Device Optimized) device enables separation of cardiotomy suction blood, which is stored in a separate reservoir, and, if re-infusion into the CPB circuit is required, this is performed only after selective filtering and by cell saver procedures. Moreover, by using a vacuum-assisted system for blood aspiration, EVADO allows complete elimination of roller pumps, therefore reducing the extent of mechanical cellular trauma. EVADO contains a phosphorylcholine-coated oxygenator, that confers superior biocompatibility. Finally, by requiring relatively limited priming volumes, it allows reducing haemodilution.; conventional miniature cardiopulmonary bypass technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extracorporeal Vacuum Assisted Device Optimised (EVADO)
Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to examine the changes of factors including Vascular Endothelial
      Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α),
      measurements of oxygen saturation in peripheral blood and wound surface area and
      ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser
      Therapy(LLLT).
    

Detailed description: 
      Defects in vessels and neovascularization makes diabetic chronic wounds difficult to treat, A
      decrease of angiogenic factor expression such as Vascular Endothelial Growth Factor(VEGF) and
      its receptors is involved in angiogenesis inhibition in diabetic ulcers. LLLT as a
      therapeutic treatment modality can effect on release of these factors and angiogenesis in
      wound site.

      The purpose of this study is to examine the changes of factors including VEGF,
      VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen
      saturation in peripheral blood and wound surface area in ischemic diabetic foot ulcers after
      LLLT, Therefore, the investigators can evaluate molecular process of angiogenesis, as a
      mechanism of useful effects of LLLT.

      In order to patients with ischemic diabetic foot ulcers(DFU) assigned into LLLT with
      Ga-As(904 nm) laser and placebo groups and will be treated for 12 sessions, every other day.
      On the first and last (twelfth) treatment session, before and after intervention, Blood
      sample are taken from all patients in the both groups for VEGF, VEGFreceptor-2, NO and HIF-1α
      measurement. Wound surface area and oxygen saturation of peripheral blood and ankle-brachial
      index (ABI) are measured at first and twelfth treatment.
    

Intervention name(s): Low Level Laser(Ga-As); Placebo
Intervention type(s): Device; Procedure
Intervention description(s): Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2; LLLT with zero intensity
Other intervention name(s): LLLT; Placebo low level laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study Evaluating Prevenar Vaccine in Healthy Infants
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age.
      To determine the antibody responses to the seven pneumococcal vaccine serotypes one month
      after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6
      months of age.
    


Intervention name(s): Prevenar
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Healthy Infants
Bioequivalence Study of Tacrolimus in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an in-vivo study to investigate the bioequivalence of generic tacrolimus and its
      reference listed drug (RLD). The objective of this study is to investigate the bioequivalence
      of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female
      volunteers under fasting conditions. The outcome of this study will help further
      understanding about pharmacokinetic (PK) performance of tacrolimus in a healthy volunteer
      population and improve review standards for bioequivalence of narrow therapeutic index (NTI)
      drugs.
    

Detailed description: 
      This is a single-dose, randomized, open-label, fully replicate crossover, four-period, two-
      treatment, two-sequence, bioequivalence study to investigate the bioequivalence of generic
      tacrolimus and its reference listed drug (RLD).

      Tacrolimus, a calcineurin inhibitor (CNI), has been widely used in solid organ and bone
      marrow transplants for more than two decades. Calcineurin, a calcium-dependent phosphatase,
      is instrumental for signal transduction for activation of T cell and B cell, which in turn
      cause production of autoinflammatory cytokines such as such as interleukin 2 (IL- 2), tumor
      necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ). CNIs prevents the
      dephosphorylation and translocation of various factors such as the nuclear factor of
      activated T-cells (NF-AT), and nuclear factor kappa-light-chain enhancer of activated B-cells
      (NF-κB), thereby inhibiting the signal transduction responsible for growth and proliferation
      of activated T cells and expression of autoinflammatory cytokines. This mechanism of action
      results in immunosuppression and prevents organ rejection.

      However, therapeutic drug monitoring is required for tacrolimus since the range between
      tacrolimus therapeutic and toxic tacrolimus whole blood concentrations is narrow and some
      toxicities are serious and/or irreversible. The objective of this study is to investigate the
      bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating
      female volunteers under fasting conditions.

      The outcome of this study will help further understanding about pharmacokinetic (PK)
      performance of tacrolimus in a healthy volunteer population and improve review standards for
      bioequivalence of narrow therapeutic index (NTI) drugs.
    

Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): a single dose of 1 mg capsule per period
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: a single-dose, randomized, open-label, four-period, two-sequence, two- treatment, single-center, crossover, bioequivalence study
Masking: None (Open Label)
Primary purpose: Other
Keywords: generic drug; tacrolimus; bioequivalence; reference listed drug; fasting condition
Vitamin D Deficiency and Low Bone Mineral Content in Children
Condition: Vitamin D Deficiency; Obesity
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      The Vitamin D study is designed to investigate the effect of body fat mass on vitamin D
      levels in children. Earlier studies have shown that individuals with increased fat mass may
      have low vitamin D levels.

      Our specific hypothesis states that children with increased fat mass will have lower blood
      levels of vitamin D when compared to non-obese children.Since vitamin D is the primary
      hormone for bone mineralization in humans, low levels of vitamin D could lead to decreased
      bone mineral content in these children.
    

Detailed description: 
      Fifty prepubertal male and female children of ages between 3-12 years will participate in
      this study. Of these, 25 obese children will be enrolled in the study group, and 25 non-obese
      children will serve as controls.

      All subjects will fill out a comprehensive mineral intake questionnaire as part of the study
      to ensure adequate calcium intake prior to the study.

      All subjects will collect a first morning urine sample for calcium, creatinine, and NTX.

      Fasting blood samples will be drawn for the following analytes: 25-hydroxyvitamin D, 1,
      25-dihydroxyvitamin D, intact PTH, calcium, phosphorus, magnesium, osteocalcin, insulin,
      c-peptide, fasting blood glucose, leptin, and adiponectin.

      Bone Mineral Content will be evaluated in 16 obese subjects with vitamin D level of < 30
      nmol/L.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prepubertal children
      
Keywords: Vitamin D deficiency, insulin resistance, obesity, bone
Prayer as a Possible Adjuvant Treatment for Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The goal of this study is to help determine the biochemical mechanisms underlying previously
      demonstrated health benefits of prayer, and to track humoral changes in various prayer
      activities.
    

Detailed description: 
      The purpose of this pilot study is to investigate certain biological mechanisms that may
      underlie the beneficial effects seen among cancer patients who pray. It will evaluate the
      effect of prayer on humoral (including biochemical/physiological inflammatory/immune)
      parameters, monitor changes in cancer related biomarkers and evaluate the effect of prayer on
      blood pressure, quality of life, health and dietary habits in relation to prayer activities,
      using validated questionnaires.
    

Intervention name(s): Prayer
Intervention type(s): Behavioral
Intervention description(s): Data collection on physiological biomarkers
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: breast; cancer; stage; one; four
Pedal@Work: A Worksite Wellness Program
Condition: Physical Activity
Study type: Interventional

Summary: 
      The primary aim of this pilot study is to test the efficacy of a worksite intervention for
      reducing daily sedentary time and improving risk factors for cardiometabolic disease (e.g.,
      measures of adiposity, anthropometrics, cardiorespiratory fitness) among sedentary,
      overweight, full-time working adults as compared to a waitlist control. A secondary aim will
      be to test pedal time at work as a measure of compliance with the intervention.
    

Detailed description: 
      Recent research indicates prolonged sedentary behaviors such as computer use and workplace
      sitting are particularly damaging resulting in increased risk for chronic diseases such as
      cardiovascular disease, type 2 diabetes and obesity. Few interventions have been tested with
      the specific purpose of reducing sedentary time to improve risk factors for cardiometabolic
      diseases. The primary aim of this pilot study is to test the efficacy of a worksite
      intervention for reducing daily sedentary time and improving risk factors for cardiometabolic
      disease (e.g., measures of adiposity, anthropometrics, cardiorespiratory fitness) among
      sedentary, overweight, full-time working adults as compared to a waitlist control. A
      secondary aim will be to test pedal time at work as a measure of compliance with the
      intervention. Participants will be followed for 12 weeks and randomized to either a treatment
      or wait list control group which will have the option to crossover into the intervention
      after 12 weeks.
    

Intervention name(s): Pedal@Work Worksite Wellness; Pedal@Work
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomized to the intervention group will be provided access to a portable pedal exercise machine, a pedometer and a worksite wellness motivational website for 12 weeks. As part of this website, participants will be emailed behavioral intervention materials a maximum of three times per week targeted at reducing sedentary time.; Worksite wellness program.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention