bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Three Warm-up Interventions at the Workplace Among Vineyard Workers - a Protocol Study
Condition: Pain; Injuries
Study type: Interventional

Summary: 
      Background:

      Physical activity programs at the workplace have shown positive results on physical
      capacities and pain for several years. Due to the duration of the training session, the need
      of instructor, and the need of a place to practice, these programs are commonly complex to
      implement. For this reason, many of companies, especially companies in manual sectors are
      turning to another solution, i.e warm-up intervention before work shift. These interventions
      present on paper numerous advantages such as short duration, no need to specifically allocate
      a place in companies and the possibility to perform exercises in working clothes…
      Surprisingly, while positive effects of warm-up interventions on pain, performance physical
      and psychological capacities, are expansively reported in sport context, effects of workplace
      warm-up intervention are lacking. Therefore, the aims of this study are (1) to implement such
      intervention among vineyard-workers, workers highly exposed to heavy physical workload and
      pain and (2) to assess their effects on physical (pain, strength, flexibility) and
      psychological (workload) functions and also on work-related outcomes (work performance,
      readiness to work)

      Methods:

      A cluster randomized study will be implemented among French vineyard workers. Four groups of
      30 participants will be constituted; corresponding to four different conditions: (1) hybrid
      warm-up intervention (HWU); (2) dynamic warm-up intervention (DWU); (3) stretching warm-up
      intervention (SWU); (4) no warm-up intervention (NWU). A total of 120 vineyard-workers will
      be recruited to participate in the study.

      Discussion:

      The results will provide more evidence about the short-term effects of warm-up interventions
      at the workplace, and will provide more evidence on which warm-up modality is the most
      effective on pain, performance, physical and psychological capacities among vineyard workers.
    


Intervention name(s): Hybrid Warm-up; Dynamic Warm-up; Stretching Warm-up
Intervention type(s): Other; Other; Other
Intervention description(s): Dynamic + stretching exercises; Dynamic exercises; Stretching exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A cluster randomized study will be implemented among French vineyard workers. Four groups of 30 participants will be constituted; corresponding to four different conditions: (1) hybrid warm-up intervention (HWU); (2) dynamic warm-up intervention (DWU); (3) stretching warm-up intervention (SWU); (4) no warm-up intervention (NWU). A total of 120 vineyard-workers will be recruited to participate in the study.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pain / injuries / warm-up intervention / vineyard workers / physical activity
Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults
Condition: Tick Born Encephalitis
MeSH terms: Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5
      years after first TBE booster
    


Intervention name(s): TBE vaccine for adults
Intervention type(s): Biological
Intervention description(s): Serology blood draw.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: tick born encephalitis, TBE, adults
Sex Hormones & Serum Sclerostin Level
Condition: Bony Sclerosis; Testicular; Hormone, C
Study type: Observational

Summary: 
      The aim of this study is to determine whether plasma sclerostin levels is affected by sex
      hormones during menstrual cycle. Blood samples will be obtained at the beginning (between
      2-5th day), mid (between 11-13th day) and end (between 21-23th day) of menstrual cycle. Serum
      sclerostin, estradiol, progesterone and testosteron levels will be measured blindly by only
      one investigator
    

Detailed description: 
      This study is a prospective, observational, single-center study. Ethical approval was
      obtained from the Institutional Review Board.

      This study will be completed with 40 premenopausal healthy volunteer women. An intravenous
      cannula will be inserted into the antecubital vein. Blood samples will be obtained at the
      beginning (between 2-5th day), mid (between 11-13th day) and end (between 21-23th day) of
      menstrual cycle.

      Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of
      collection. Aliquots of plasma will be added to Ependorf tubes and stored at -20°C.

      Plasma sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio,
      Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the
      manufacturer's instructions. The minimum detectable concentration of human sclerostin is
      typically <0.012 ng/ml. Intra-assay precision is less than 8%.

      Estradiol and progesterone levels will be analyzed in serum samples using an
      electrochemiluminescence immunoassay (Elecsys PTH, Elecsys-estradiol II; Roche Diagnostics,
      Mannheim, Germany) and the Cobas 601 analyzing system (Roche Diagnostics).

      Free testosteron levels will be analyzed in serum samples using an RIA (radio immun assay)
      (DSL 4900 Testosterone, Free, Active® RIA Assay kit, Beckman Coulter) and the DSL 4900
      Berthold Technologies Multi Crystal LB 2111 model gama counter.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premenopausal healthy women
      
Keywords: sclerostin; estradiol; progesterone; testosteron; sex hormones
Analysis of Cell-free DNA (cfDNA) During Periodontitis
Condition: Periodontal Diseases; Cardiovascular Diseases
MeSH terms: Periodontitis; Periodontal Diseases; Cardiovascular Diseases
Study type: Observational

Summary: 
      The purpose of this study was to examine the association between circulating cfDNA
      concentration and CVD risk in patients with periodontitis, CVD, and periodontitis plus CVD.
      In addition, the secondary objective was to identify, among other confounders, the impact of
      periodontitis and cardiovascular disease as potential significant predictors of circulating
      cfDNA levels in the enrolled population.
    

Detailed description: 
      Recent emerging evidence has shown that circulating cell-free (cf) DNA are involved in in
      several epigenetic processes linked with periodontitis, coronary stenosis and systemic
      inflammation. The present study was aimed at assessing the impact of periodontitis on
      circulating cfDNA levels and evaluating possible confounders that influenced this
      association. Healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and
      periodontitis+CVD (n=30) were enrolled. All subjects underwent regular periodontal
      examination and blood sampling. The analysis of the plasma cfDNA concentrations was performed
      using a dsDNA Assay Kit.
    

Intervention name(s): Clinical Attachment level
Intervention type(s): Other
Intervention description(s): 1-year
Other intervention name(s): Evaluation of changes (in millimeters) of Clinical attachment level loss
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and
        periodontitis+CVD (n=30) were enrolled.
Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients with Multiple myeloma who have undergone non-myeloablative allogeneic stem cell
      transplant will receive 6 vaccinations of donor derived dendritic cells combined with
      specific protein produced by multiple myeloma.
    

Detailed description: 
      To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic
      cells following mixed chimeric allogeneic transplantation for multiple myeloma.
    

Intervention name(s): Idiotype-pulsed allogeneic dendritic cells
Intervention type(s): Biological
Intervention MeSH terms: Immunoglobulin Idiotypes
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees
Condition: Unilateral Trans Tibial Amputation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this work was to test the Echelon foot efficiency to offer enhanced safety,
      comfort and function over a wide range of walking surfaces, inclines and stairs, thereby
      improving the quality of life for amputees.

      Ten individuals with a unilateral trans- tibial amputation will participate in two test
      sessions- one while using their own prosthetic foot, the other while using the Echelon foot.
    


Intervention name(s): Echelon foot
Intervention type(s): Device
Intervention description(s): One Echelon foot for each subject, for a period of a month.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unilateral trans-tibial amputees
Improving Adherence in Adolescents and Young Adults With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Although poor medication adherence occurs in more than 65% of adolescent and young adults
      (AYA) with bipolar disorder (BD) and is associated with poor recovery, high rates of relapse,
      and a 5.2 fold increased suicide risk, there have been no interventions that specifically
      target adherence in AYA with BD. This proposal will modify and test a customized adherence
      enhancement (CAE) intervention developed by the investigative team and found to be effective
      in BD adults in a high-risk, high-need group: AYAs with BD who are poorly adherent with
      prescribed BD medications. The project addresses the critical need for evidence-based
      interventions to improve adherence in AYAs with BD and has the potential to change outcome
      trajectories in high-risk young people with BD as they transition to adulthood.
    


Intervention name(s): Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA); Enhanced Treatment as Usual (ETAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA): CAE-AYA participants will have 4 core in-person sessions (45-60 minutes each) spaced about 1 week apart over a period of approximately 4 weeks and one "booster" in-person session approximately 4 weeks after completion of the 4 core sessions (total of up to 5 in-person sessions spaced out over 8 weeks). There will be one follow-up phone call with a study interventionist, approximately 6 weeks post-baseline (timed half-way between completion of the core sessions and the "booster" session). All AYAs assigned to the CAE-AYA arm will receive all 4 modules (Psychoeducation on BD Medications; Communication with Providers & Caregivers; Medication Routines; and Targeting Risky Behavior via Modified Motivational Enhancement Therapy (MET)), with the content within each module being customized to developmental stage and behavioral experience.; Enhanced Treatment as Usual (ETAU): ETAU will consist of usual clinical care with prescribing clinicians and therapists, augmented by written materials specific to BD for AYAs and 6 follow-up telephone calls to briefly review the materials and be available for questions by social workers with mental health experience and at least some experience in working with AYA with BD. In order to ensure that there is not treatment contamination, different trained interventionists will be used for CAE and eTAU. Therapists will briefly review the materials and be available for questions during the phone calls. Materials will cover general self-management in BD. The calls will be relatively brief (maximum of 20-30 minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty
Condition: Postoperative Pain; Knee Arthroplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and
      morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor
      -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total
      knee arthroplasty.
    


Intervention name(s): Adductor-Canal-Blockade with Ropivacaine; Adductor-Canal-blockade with saline
Intervention type(s): Procedure; Procedure
Intervention description(s): US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml; US-guided Adductor-Canal-blockade with saline
Other intervention name(s): Naropine; Postoperative pain; US-guided nerve block; Sham block
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor-Canal-Blockade; postoperative pain; US-guided nerve block; total knee arthroplasty
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to evaluate the effect of treatment with evolocumab, compared with
      placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization
      for unstable angina, or coronary revascularization, whichever occurs first, in patients with
      clinically evident cardiovascular disease.
    


Intervention name(s): Evolocumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.; Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High cholesterol; Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia
IdB 1016 Treatment for Hepatitis C Disease
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will measure the safety and tolerability of three different doses of IdB 1016 in
      patients with hepatitis C disease who have not responded to or are poor candidates for
      interferon-based therapies.

      NOTE: THE STUDY WILL ONLY RECRUIT STUDY PARTICIPANTS AT UNIVERSITY OF WASHINGTON MEDICAL
      CENTER IN SEATTLE
    

Detailed description: 
      Results from two open label and four randomized placebo-controlled studies in patients with
      liver disease of diverse etiology suggest that IdB 1016 (oral silybin-phosphatidylcholine
      phytosome) is well tolerated and significantly improves serum liver enzyme levels. However,
      IdB 1016 dosing in these studies ranged from 314 mg bid to 314 mg tid, which is below Phase I
      doses that were well tolerated in healthy volunteers. None of the studies tested the safety
      and efficacy of IdB 1016 strictly in patients with chronic hepatitis C disease or measured
      post-treatment histologic changes.

      This study will be an open label, randomized, dose-finding study. There will be three arms
      corresponding to three different IdB 1016 doses: 314 mg, 624 mg, and 942 mg tid. Each arm
      will have 15 patients diagnosed with chronic hepatitis C and will be stratified to five
      patients with fibrosis stage II (periportal fibrosis), five patients with fibrosis stage III
      (bridging fibrosis), and five patients with fibrosis stage IV (compensated cirrhosis). The
      treatment duration will be 12 weeks. Patients will be followed for an additional 4 weeks
      after treatment cessation to assess residual effects of measured parameters. Patients will
      have clinic visits on Day -21 (screening), Day 1 (treatment initiation), Day 29, Day 57, Day
      85 (end of treatment), and Day 113 (follow-up after washout).
    

Intervention name(s): IdB 1016
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Complementary Therapies; IdB 1016; Silybin; Antioxidant; Hepatitis C Virus; Phosphatidylcholine
Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This research is being done to determine whether transcranial direct current stimulation
      (tDCS) can improve certain mental abilities and alter functional connectivity in individuals
      with Schizophrenia. In this research, a 9 volt battery is used to deliver very weak
      electrical current to the surface of the scalp while participants complete cognitive tasks.
      Participants also receive a brain scan before and after stimulation. Our aim is to determine
      if tDCS can improve mental abilities in individuals with schizophrenia.
    

Detailed description: 
      Participants enrolled into this study may be asked to do the following:

      Grant permission for the researchers to view medical records associated with their
      language/cognitive difficulties

      Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of
      problem-solving and memory in order to verify eligibility to participate and to able to
      safely undergo the experimental procedures.

      Complete several tasks (e.g., saying words out loud, naming objects, drawing designs,
      remembering lists of words, searching for images or letters, and/or completing puzzles) based
      upon a number of cognitive functions such as language, memory, vision, processing, and
      perception.

      Wear electrodes that will be placed on the scalp with a large rubberized band. These
      electrodes will administer very weak electrical current (tDCS) from a 9 volt battery for 20
      to 60 minutes.

      Participation in several study conditions. The exact conditions and their order will be
      randomized. Under some conditions, participants may receive active stimulation (tDCS) and
      under other conditions, they may receive sham stimulation.

      The experimental sessions will last approximately 2 hours and participants may be asked to
      have more than one testing session in a day or to return for additional sessions.

      Have a Magnetic Resonance Imaging (MRI) brain scan.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Procedure
Intervention description(s): delivery of transcranial direct current stimulation or sham for 20 to 60 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognitive Improvement; tDCS; stimulation
Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
Condition: Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 2

Summary: 
      To study the efficacy & safety of Houtou Jianweiling tablet through the non-inferiority
      clinical trial of Houtou Jianweiling tablet with Omeprazole Enteric-coated tablet in patients
      with chronic non-atrophic gastritis.
    

Detailed description: 
      This is a Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the
      Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic
      Gastritis.
    

Intervention name(s): Houtou Jianweiling tablet; Omeprazole Tablet
Intervention type(s): Other; Drug
Intervention description(s): Houtou Jianweiling tablet (0.38 g), 4 tablets taken orally at a time, 3 times a day and Omeprazole Enteric-coated placebo tablet, taken 1 tablet orally once a day before breakfast.; Omeprazole Enteric-coated tablet (20 mg), 1 tablet taken orally once a day before breakfast and Houtou Jianweiling placebo tablets, taken orally, 4 tablets at a time, 3 times a day.
Other intervention name(s): Traditional Chinese Medicine (TCM); Active comparator
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prefrontal iTBS on Working Memory
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators previous pilot study showed that the brain remained activated after 3
      minutes of intermittent theta burst stimulation (iTBS). Therefore, an open question remains
      that how long the effects will last and when the maximum effects will be achieved. In
      addition, many pioneering works showed the positive effects of repetitive transcranial
      magnetic stimulation (rTMS) on working memory. Intermittent theta burst stimulation (iTBS) is
      a patterned form of rTMS, it has shown a non-inferior efficacy in depression but with a much
      shorter time (approximately 3 mins) than traditional rTMS (approximately 40 mins).

      As discussed above, this study aims to investigate the effects of prefrontal iTBS on working
      memory using concurrent iTBS/fNIRS and to explore the duration of the effects.
    


Intervention name(s): Transcranial magnetic stimulation (TMS)-active; Transcranial magnetic stimulation (TMS)-sham
Intervention type(s): Device; Device
Intervention description(s): Active intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).; Sham intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). The coil will be placed perpendicular to the left DLPFC. A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Healthy volunteers will receive iTBS two times with active or sham stimulation separated by one week to investigate the effect duration of iTBS on working memory
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Theta-Burst stimulation (iTBS); Functional near-infrared spectroscopy (fNIRS); Concurrent TMS/fNIRS; Working memory