bioihbjkbjnl/mcl2 huggingface dataset:
Examining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      We aimed to investigate the effect of scapular exercises on pain and functioning in patients
      with lateral epicondylitis to achieve a more accurate result by using little-used EMG between
      scapula and elbow muscles in the literature besides ongoing classical measurements and
      evaluations.
    

Detailed description: 
      Thirty patients who participated in the study were randomly divided into two groups. First
      group (n=15), conventional physiotherapy program and exercise, second group (n=15), in
      addition to the conventional physiotherapy program and exercises, scapula exercises were
      applied. Patients were evaluated before and after treatment by VAS, algometer, hand
      dynamometer, EMG, UEFS, PRTEE and DASH questionnaires.
    

Intervention name(s): experimantal group
Intervention type(s): Other
Intervention description(s): Control Group
Other intervention name(s): Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lateral Epicondylitis; electromyography; pain; scapula
SB-773812 Administered In Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two part study designed to evaluate the safety and efficacy of SB-773812 in the
      treatment of acute schizophrenia. Subjects with acute schizophrenia will be randomized in an
      adaptive design study to receive placebo, SB-773812 60mg or olanzapine 15mg for 12 weeks in
      Part A. An interim analysis will be conducted to assess the efficacy and safety of the
      SB-773812 60mg dose compared with placebo. Based on these data, up to two further doses of
      SB-773812 will be added to the randomization for Part B.
    


Intervention name(s): SB-773812; Olanzapine
Intervention type(s): Drug; Drug
Other intervention name(s): SB-773812
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; PANSS; Acute; Cognition
Norspan Transdermal Patches Study in Osteoarthritis Patients
Condition: Osteoarthritis Disorders
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open label, randomized, parallel group single dose pharmacokinetic
      (PK) study.
    

Detailed description: 
      After up to 7-day screening period, Eligible Patients will be randomized to 1 of 3 treatment
      groups, and begin treatment with BTDS 5mg, 10mg,20mg for 7 days.Venous blood will be
      collected at 0, 6, 12, 24, 36, 48, 60, 72, 96,120, 144,168,169,170,171,172,174,180,192,216,
      240 h postdose respectively.Plasma concentrations of buprenorphine and norbuprenorphine will
      be analyzed to determine the following pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax,
      Tmax, t½.
    

Intervention name(s): buprenorphine
Intervention type(s): Drug
Intervention description(s): The subjects will be randomized to receive either a single dose of BTDS 5, or BTDS 10, or BTDS 20 for 7 days. Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t:pg•hr/ml-Area under the plasma concentration-time curve frame: predose,6,12,24,36,48,60,72,96,120,144,168,169,170,171,172,174,180,192,216,240 hours post-dose.AUC0-inf:pg•hr/ml-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: pg/ml-Maximum observed plasma buprenorphine concentration. Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of buprenorphine elimination.
Other intervention name(s): Norspan
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoarthritis disorders
A Study to Demonstrate Pharmacokinetic and Pharmacodynamic Biosimilarity Between HEC-Glargine and US-Lantus® in Healthy Male Volunteers
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between
      HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult
      volunteers.
    

Detailed description: 
      This will be a double-blind, single-dose, randomized, two-period, two-treatment, two-sequence
      crossover clamp study performed at a single study center. The study population consists of
      healthy adult male subjects.

      The study will comprise of:

        -  A screening period: maximum 28 days prior to first dose administration.

        -  Admission: Subjects will be admitted to the study center on Day -1

        -  Two Treatment Periods (Treatment Periods 1 and 2): Subjects will be randomized to either
           of the 2 treatment sequences (AB or BA) on Day 1 of Treatment Period 1 to receive either
           test or reference product as per randomization schedule in a 1:1 ratio.

             -  Treatment A (Test Formulation): HEC-Glargine

             -  Treatment B (Reference Formulation): US-Lantus®

      On Day 1 of each Treatment Period, the study drug or reference product will be administered
      as a single morning dose to subjects in a fasting state. There will be a wash-out period of
      at least 7 calendar days. Each subject will receive both test and reference products in a
      crossover pattern over Treatment Periods 1 and 2.
    

Intervention name(s): HEC-Glargine; US-Lantus
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive 0.5 IU/kg of HEC-Glargine subcutaneously as a single morning dose on Day 1.; Subjects will receive 0.5 IU/kg of Lantus subcutaneously as a single morning dose on Day 1.
Other intervention name(s): Insulin glargine
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetic; pharmacodynamic; euglycemic clamp technique; insulin glargine; biosimilarity study
Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele
Condition: Varicocele; Male Infertility; Hypospermatogenesis; Non-Obstructive Azoospermia
MeSH terms: Infertility; Infertility, Male; Azoospermia; Varicocele; Oligospermia
Study type: Observational

Summary: 
      Varicose veins in the scrotum (varicocele) are responsible for >20% of male infertility in
      the US. Varicocele are associated with decreased sperm number and markedly reduced sperm
      fertilizing ability. Surgical repair or removal of varicocele restores fertility in only 1/3
      of cases. The goal of this study is to identify markers that predict the outcome of variocele
      correction. This would offer considerable health cost savings.

      Based on preliminary findings, we will obtain testis biopsies and semen specimens from
      infertile men with varicocele and prospectively examining the levels of cadmium, a toxic
      metal, and expression of genes required for normal sperm function. The semen and biopsies
      will be obtained during clinically dictated procedures. Cadmium and gene expression will be
      compared with response to varicocele repair (i.e., increased sperm production; pregnancy).
    


Intervention name(s): Varicocele repair
Intervention type(s): Procedure
Observational model: Defined Population
Time perspective: Prospective
Keywords: Varicocele; environmental toxins; male infertility; cadmium
Systems Pharmacology Approach to Uncontrolled Pediatric Asthma
Condition: Pediatric Asthma; Uncontrolled Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Background:

      Asthma is a heterogeneous respiratory disease and the most common chronic disease in
      children. A small subset of children has continuous poor asthma control despite appropriate
      adherence to asthma medication. There is a clinical need to identify these children as early
      as possible to optimize treatment and/or to find therapeutic alternatives. Therefore, the
      "Systems Pharmacology approach to uncontrolled Pediatric Asthma" (SysPharmPediA) study was
      set up.

      Objective:

      To establish a cohort of pediatric moderate-to-severe uncontrolled and controlled patients
      with asthma in order to investigate pathophysiological mechanisms underlying uncontrolled
      moderate-to-severe asthma in children on maintenance treatment, using a multi-omics systems
      medicine approach.

      Methods:

      In this multicenter observational case-control study, moderate-to-severe asthmatic children
      (n=145, age 6-17 years), were included in specialized hospitals in four European countries
      (Netherlands, Germany, Spain and Slovenia). Recruited subjects were selected based on good
      asthma control (controlled asthmatics, n=54) or poor asthma control / recurrent exacerbations
      (uncontrolled asthmatics, n=91). Comprehensive details concerning demographics, current and
      past patient/family history and clinical characteristics were collected. In addition,
      systems-wide omics layers, including epi(genomics), transcriptomics, microbiome, proteomics
      and metabolomics will be evaluated from multiple collected, relatively non-invasive, samples
      of from the recruited individuals, such as: blood, feces, saliva, nasal swabs and exhaled
      breath. Follow-up visits were performed 6 and 12 months after inclusion.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Four tertiary care centers from four European countries (the Netherlands, Germany, Spain,
        and Slovenia) recruited 145 asthmatic children and adolescents (6-17 years old). All
        centers obtained approval from their local medical ethics committee (ethics committee of
        University Regensburg, Germany (18-1034-101); Clinical Research Ethics Committee of the
        Basque Country, Spain (PI2015075 (SO)); Medical Ethics Committee of the University Medical
        Center Utrecht (UMC Utrecht), Utrecht, the Netherlands (NL55788.041.15); National Medical
        Ethics Committee, Slovenia (0120-569/2017/4)) and written informed consents were collected
        from the parents/caregivers and/or the recruited children when appropriate.
      
Biospecimen description: 
      blood, feces, saliva, nasal swabs and exhaled breath.
    
Keywords: Systems Pharmacology; Omics
Pain Assessment During General Anesthesia
Condition: Pain
Study type: Interventional

Summary: 
      During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid
      treatment is used for pain assessment.

      The change in haemodynamic variables and clinical sign are evaluated during anesthesia for
      pain assessment but these changes are not specific every time.

      The main of this study is to investigate the relationship between calculated compartment
      concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability)
      and APV (Arterial Pressure Variability) before a standard noxious stimulation during general
      anesthesia at calibrated hypnosis level.

      Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and
      that these effects would be blunted or abolished by by adequate analgesia. The current study
      is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during
      nociceptive surgical stimulation, at different levels of analgesia.
    


Intervention name(s): opioid (remifentanyl)
Intervention type(s): Drug
Intervention description(s): Infusion of remifentanyl (opioid) will be started at different levels for each group of the randomized study : 0 ng/ml (group 0), 1 ng/ml (group 1), 3 ng/ml (group 3) or 4 ng/ml (group 4)
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: pain assessment; anesthesia; analgesia; opioid; HRV; APV; autonomic nervous system (ANS); pupil size
Preemptive Analgesia for Postlaminectomy
Condition: Laminectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      To relieve post laminectomy pain, we have tried intraoperative perineural injection of
      lidocaine right after the exposure in expecting that this would be preemptive analgesia by
      blocking the nerve transmission so that postoperative pain starts later and lighter.
    

Detailed description: 
      A randomized double-blind 40 patients aged 18-50 of ASA I and II undergoing laminectomy were
      included in the study. All the patients were followed for their heart rate, arterial pressure
      , respiratory rate, oxygen saturation, end tidal CO2 and postoperative VAS scores.

      All the patients were premedicated with midazolam 0.1 mg/kg intramuscularly 40 minutes prior
      to surgery. The induction was made 2 mg/kg propofol, 1 ug/kg remifentanyl, 0.5mg/kg
      rocuronium. After the orotracheal intubation anesthesia was maintained with isoflurane
      (%0.5-2.0) and 0.1 mg/kg rocuronium.Just before the exposure of dorsal root, 0.5 cc %2
      lidocaine was injected on the dorsal root.The patients postoperative analgesic period, VAS
      scores and additional analgesic need was recorded. For the postoperative analgesia tramadol 1
      mg/kg tramadol was used.
    

Intervention name(s): Lidocaine, perineural injection, intraoperatively; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 cc lidocaine, one single injection over the dorsal root.; 0.5 cc %2 lidocaine,single injection
Other intervention name(s): lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: analgesia, postlaminectomy , lidocaine, dorsal root
Cardiac Energetics and Function in Normal Human Ageing
Condition: Left Ventricular Function Systolic Dysfunction; Left Ventricular Function Diastolic Dysfunction; Ageing
MeSH terms: Systolic Murmurs
Study type: Interventional

Summary: 
      Normal aging is characterized by altered cardiovascular function. Our preliminary data with
      MR imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension
      show that age-related cardiac dysfunction is characterized initially by impaired relaxation
      of the heart (40 - 60 years), and then at > 60 years altered contraction and impaired
      myocardial energetics. For the first time, the investigators will test whether the functional
      and energetic effects of normal aging can be reversed by acutely reducing stiffness of
      peripheral blood vessels using an ACE inhibitor. This will potentially have important
      insights into how normal aging affects the heart, and how potential treatments could be used
      to attenuate this process.
    

Detailed description: 
      Normal aging is characterized by altered cardiovascular function. Our preliminary data with
      MR imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension
      show that age-related cardiac dysfunction is characterized initially by diastolic dysfunction
      (40 - 60 years), and then at > 60 years altered systolic strains and impaired myocardial
      energetics. The investigators propose to study the mechanism of these findings in subjects
      with normal aging without any cardiovascular disease, hypothesizing that increased vascular
      stiffening contributes to impaired energetics and left ventricular function. For the first
      time, the investigators will test whether the functional and energetic effects of normal
      aging can be reversed by acutely reducing afterload using an ACE inhibitor. This will be
      tested at 2 ages (40-60 and > 60 years), so that the intervention tests the hypothesis soon
      after the abnormalities develop (40-60 years - diastolic dysfunction; > 60 years energetics
      and altered strains). This will potentially have important insights into how normal aging
      affects the heart, and how potential treatments could be used to attenuate this process.
    

Intervention name(s): Ramipril
Intervention type(s): Drug
Intervention description(s): Ramipril in one dose to reduce vascular stiffness to determine effects of this on left ventricular function and energetics
Intervention MeSH terms: Ramipril
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Energy Metabolism; Ageing; left ventricle; energetics; function
Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.
Condition: Hemodynamics Instability; Anesthesia, General; Anesthesia, Intravenous
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective is to examine if a high propofol dose is non-inferior to a low dose in
      respect to hemodynamic stability in healthy patients during induction of general anesthesia
      with propofol and remifentanil.
    

Detailed description: 
      Typically, one or more adjuvant medications are administered to supplement induction of
      general anesthesia. When combining anesthetic drugs, the hypnotic effects are often
      synergistic. Propofol is associated with hypotension and bradycardia and used together with
      remifentanil or sedative agents it may give synergistic or additive sedative and hemodynamic
      effects.

      Claeys (1988) and Fairfield (1991) examined the cardiovascular effects of propofol 2-2.5
      mg/kg induction dose and found significant reductions i SBP and SVR and small changes in CO,
      SV and HR. De Wit (2016) examined hemodynamic changes in different steady state propofol
      serum concentrations, and found a dose dependent SBP reduction, reduction in resistance of
      arterial and systemic circulation and a reduction in mean systemic filling pressures (MSFP)
      indicative of a reduction in "stressed volumes". The effective dose (ED) 95% for loss of
      consciousness for propofol was determined to 1.75 mg/kg when used alone, and 1.38 mg/kg when
      used together with remifentanil 0.25 microg/kg/min (total induction dose 1.75 microg/kg
      remifentanil) in a study by Koh et al. We want to examine the hemodynamic effects of giving a
      low (1.4 mg/kg) vs a high (2.4 mg/kg) propofol dose combined with a moderate remifentanil
      dose (about 1.5 microg/kg).
    

Intervention name(s): Propofol; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): 2,4 mg/kg; 1,4 mg/kg
Other intervention name(s): Propolipid; Propolipid
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, double blind.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cardiac Output (CO); Systolic Blood Pressure (SBP); Systemic Vascular Resistance (SVR); Heart Rate (HR); Stroke Volume (SV); Lithium Dilutional Cardiac Output (LiDCO); Minimal Invasive Hemodynamic Monitor; Propofol; Propolipid
Safety and Efficacy of a Combination Product for the Prevention of Veisalgia
Condition: Veisalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of a combination product
      for the prevention of veisalgia. Common symptoms of veisalgia following the moderate
      consumption of alcohol includes headache, fatigue, and thirst. It is the investigators
      hypothesis that a combination of two drugs can alleviate or significantly reduce these
      symptoms when taken before the start of moderate alcohol consumption.
    

Detailed description: 
      Some people who consume alcohol in moderation experience veisalgia. These symptoms include a
      long list of adverse effects that include headache, fatigue and thirst. The mechanism by
      which these effects occur has not been fully elucidated. Although, it has been documented
      that alcohol causes the release of a large number of substances into the blood stream that
      cause a number of physiologic changes.

      A 4-arm study will help to determine the effect each agent contributes to decreasing the
      alcohol induces physiologic changes and the effect when the two agents are delivered
      concurrently.
    

Intervention name(s): JMI-001 (SJP-304 and SJP-223); SJP-304; SJP-223; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Observational Study of the Incidence of Pressure Ulcers on the Help Support of Prevention of Bedsores POLYAIR®
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer
Study type: Observational

Summary: 
      The support of help to the prevention of sores include a big diversity of devices. The
      clinical experiment of these support comes up against the problem of the large number of
      factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to
      estimate the incidence of bedsores in these supports, with control of other factors
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons who are hospitalized in CHU of Nîmes with high risk of sores (Norton <9)