bioihbjkbjnl/mcl2 huggingface dataset:
Vibration Induced Reflex Responses and Estimation of TVR
Condition: Muscle; Physiology
Study type: Interventional

Summary: 
      The aim of this study is to estimate tonic vibration latency and whole body vibration reflex
      latency
    

Detailed description: 
      This study was included 17 patients with spastic spinal cord lesions and 23 healthy control.

      Soleus T-reflex, soleus H-reflex, soleus tonic vibration reflex (TVR), and reflex muscle
      response induced by whole body vibration was evaluated this study. To obtain the H-reflex
      response, the tibial nerve in the popliteal region was stimulated by using a stimulator
      (FE155 Stimulator HC ADInstrument, Oxford UK) with 1 ms-pulse current. The records was taken
      with the Ag / AgCl electrodes (Kendall ®Coviden, self-adhesive electrodes) placed on skin
      according to the SENIAM protocol. To obtain T-reflex response, an electronic reflex hammer
      (Elcon 100-150 Germany) was used. After H-reflex and T reflex records at rest, to obtain
      Tonic vibration reflex, local vibration was applied to the Achilles tendon at 50, 85, 140,
      185, 235 and 265 Hz. To obtain the reflex response induced by Whole body vibration, vibration
      was applied at 35, 37, 39, 41, 43 and 45 Hz. Tibial nerve stimulation was performed again to
      determine Hmax during whole body vibration and local vibration.H-reflex records was taken
      while the subject is sitting on a chair.

      The data was recorded with the PowerLab data acquisition device (ADInstrument Oxford UK). For
      Whole-body vibration, PowerPlate Pro5 (London UK) was used.
    

Intervention name(s): vibrator
Intervention type(s): Device
Intervention description(s): Local or whole body vibration was applied at six different frequencies
Other intervention name(s): cyclic mechanical loading
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vibration; muscle spindle; H reflex; tonic vibration reflex
Subcutaneous EEG: Forecasting of Epileptic Seizures
Condition: Epilepsies, Focal
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Observational

Summary: 
      Protocol Summary

      Population - Target population is 10 adults (18 to 75 years of age) with a diagnosis of
      treatment-resistant epilepsy with at least 20 seizures per year, and whose seizure onset
      recorded from scalp EEG is localized to a brain region accessible by the subcutaneous EEG
      electrodes

      Number of sites - Three sites; King's College Hospital NHS Foundation Trust, University
      College London Hospital NHS Foundation Trust, St George's University Hospital NHS Foundation
      Trust

      Study design - This study is an observational, non-randomised, non-interventional study. It
      is not intended as a device trial. It is not intended to assess the device performance,
      rather the usefulness of bio-signals in seizure prediction and in detecting
      seizure-associated phenomena. There will be no change to usual care as a result of taking
      part.

      A subcutaneous EEG device will be implanted under local anaesthesia to record continuous EEG
      and a non-invasive wrist-worn sensor will be used to acquire non-EEG bio-signals (eg. heart
      activity and rate, movements, muscle activity, electrodermal activity, body temperature)

      Objectives - The association will be investigated between non-invasive measurable variables
      related to stress and sleep, semi-invasive subcutaneous EEG phenomena, and the occurrence of
      seizures. The predictive value of change in non-invasive variables semi-invasive subcutaneous
      EEG phenomena for the occurrence of seizures will be assessed.

      Study Duration - Up to one year for each patient. Participants may be approached during or
      after this study to participate in related studies.

      Funding - This study receives funding from the Epilepsy Foundation of America, Innovative
      Medicines Institute (IMI) and UNEEG medical A/S.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit 10 suitable people with epilepsy referred, as part of their routine
        conventional care, to the Epilepsy Clinics at King's College Hospital (KCH), University
        College London Hospital NHS Foundation Trust (National Hospital for Neurology and
        Neurosurgery - NHNN), or St George's University Hospital NHS Foundation Trust (SGH).
      
Keywords: Focal Epilepsy; Longterm EEG Monitoring; Wearable Devices; mHealth; Seizure Forecasting
Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation
Condition: Polycystic Ovary Syndrome; Inflammation Gum; Cytokines
MeSH terms: Gingivitis; Polycystic Ovary Syndrome; Syndrome; Inflammation
Study type: Observational [Patient Registry]

Summary: 
      Periodontal diseases are chronic inflammatory disease occurred by the interaction between
      pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a
      reproductive and metabolic disease associated with increased risk of cardiovascular events.
      Endocan is a proteoglycan secreted mainly by endothelial cells under the control of
      inflammatory cytokines.

      Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by
      predominantly pathogenic microorganisms that colonize the subgingival area and cause local
      and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).

      Several lines of evidence established the association between periodontal and systemic
      diseases, including metabolic syndrome, diabetes, and cardiovascular disease.

      Because of the fact that both periodontal disease and PCOS are associated with systemic
      inflammation and insulin resistance, these two disorders may be linked through a common
      pathophysiologic pathway.

      A number of studies have indicated a possible relationship between PCOS and periodontal
      inflammation. Despite common risk factors, including oxidative stress, the relationship
      between chronic periodontitis (CP) and PCOS remains unclear.

      The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to
      evaluate the correlation between these two biomarker in women with periodontal disease and
      PCOS.
    


Intervention name(s): Collection of Serum and Saliva Samples
Intervention type(s): Diagnostic Test
Intervention description(s): Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants were included among women at the Department of Obstetrics and Gynecology,
        School of Medicine and Department of Periodontology, Faculty of Dentistry , Ataturk
        University
      
Biospecimen description: 
      Serum and Saliva
Using Health Information Technology to Improve Health Behaviors and Promote Cardiovascular Health Among Adolescent and Young Adult Cancer Survivors
Condition: Cardiovascular Disease; Young Adult Cancer Survivors
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Health information technology (HIT) has the potential to improve the quality, efficiency,
      consistency, and availability of cancer survivor care. PREVENT is a novel HIT tool designed
      by our team for adolescents (12-19 years). PREVENT aggregates and displays the American Heart
      Association's (AHA) Life Simple 7 cardiovascular health (CVH) risk factors and provides
      tailored, evidence-based, behavior change recommendations inclusive of community resources
      that are delivered to overweight/obese adolescents at the point-of-care to improve CVH. The
      investigators seek to expand this tool for patients beyond 19 years of age to increase this
      tool's reach to the entire adolescent and young adult (AYA) age range and then evaluate its
      effectiveness among AYA cancer survivors.
    


Intervention name(s): Wait-List Control; PREVENT tool
Intervention type(s): Behavioral; Behavioral
Intervention description(s): -Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool; -PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Thrombocytopenia Induced by Chemotherapy
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional

Summary: 
      Single blind, randomized, multicentric placebo controlled study to evaluate the efficacy of
      Study product in patient with Chemotherapy induced thrombocytopenia. The Study is divided
      into [screening visit (visit 1) > baseline and treatment allocation visit (visit 2) >blood
      collection (visit 3); treatment compliance visit (visit 4) > blood collection (visit 5)
      >blood collection (visit 6)>end of study visit (visit 7)].
    

Detailed description: 
      UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract), is an orally administered
      dietary supplement for management of thrombocytopenia. Manufactured bySanat Products Ltd.

      Throughout study, it will be designated as product A to maintain study blindness at subject
      end.

      Placebo Throughout study, it will be designated as product B to maintain study blindness at
      subject end.

      Single blind, randomized, multicentric placebo controlled study to evaluate the efficacy of
      Study product in patient with Chemotherapy induced thrombocytopenia. The Study is divided
      into [screening visit (visit 1) > baseline and treatment allocation visit (visit 2) >blood
      collection (visit 3); treatment compliance visit (visit 4) > blood collection (visit 5)
      >blood collection (visit 6)>end of study visit (visit 7)].

      Dose regimen After meeting the inclusion criteria subject will take 4 units daily (2 in
      morning and 2 in evening) for 10 days. Patients will be called on Day5th, 10th and 15thfor
      the Complete blood count (Central lab).

      Total blood loss Approximately 8-12 mL
    

Intervention name(s): UPLAT; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Carica papaya leaf Extract + Tinospora cardifolia Extract; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind, randomized, multicentric placebo controlled study
Masking: Single (Participant)
Primary purpose: Treatment
Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, randomized, three-period, three-treatment [Treatment A (test product
      administered without water), Treatment B (test product administered with water) and Treatment
      C (Reference product administered with water)], six-sequence, crossover, balanced, single
      dose oral bioequivalence study.
    

Detailed description: 
      Single dose oral bioequivalence study of Vortioxetine Hemihydrobromide Orally Disintegrating
      Tablets 20 mg and 'Trintellix' (Vortioxetine) Tablets 20 mg in healthy adult human subjects
      under fasting conditions.

        -  To compare and evaluate the oral bioavailability of Vortioxetine Hemihydrobromide Orally
           Disintegrating Tablets 20 mg (administered without water and with water) with that of
           'Trintellix' (Vortioxetine) Tablets 20 mg in healthy, adult, human subjects under
           fasting conditions.

        -  To monitor the safety and tolerability of the subjects.

      An open label, randomized, three-period, three-treatment [Treatment A (test product
      administered without water), Treatment B (test product administered with water) and Treatment
      C (Reference product administered with water)], six-sequence, crossover, balanced, single
      dose oral bioequivalence study.
    

Intervention name(s): Vortioxetine Hemihydrobromide Orally Disintegrating Tablets; Vortioxetine Hydrobromide Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg equivalent to 20 mg of Vortioxetine; Vortioxetine Hydrobromide Tablets 20mg
Other intervention name(s): SF001 ODT; Trintellix
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy
Condition: Visual Acuity; Geographic Atrophy; Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and performance profile of the
      suprachoroidal surgical approach and the Delivery System.
    

Detailed description: 
      This is a multicenter (when more than one hospital or medical school team work on a medical
      research study) study which includes an initial unmasked safety phase. The duration of
      participation in the study for each participant is approximately 3 years. Efficacy will be
      evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): CNTO 2476 3.0 x 10^5 cells; Subretinal Delivery System
Intervention type(s): Drug; Device
Intervention description(s): Participants will receive a single subretinal administration of CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL) given by subretinal Delivery System.; Participants will receive CNTO 2476 by using the Delivery System.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Best Corrected Visual Acuity; Geographic Atrophy; Macular Degeneration; CNTO 2476
UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study
Condition: Unconsciousness; Consciousness
MeSH terms: Unconsciousness
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be a single-site, controlled, unblinded study at the University of Wisconsin
      to examine changes in the electroencephalogram during anesthesia and waking.
    

Detailed description: 
      * 20 subjects will be recruited per drug, and subjects can be recruited to undergo multiple
      sedation protocols.

      Screening:

      Subjects will respond to the volunteer posts for the study by calling into a study specific
      phone number. They will complete a phone screening to determine basic eligibility for the
      study. At the beginning of the sedation session, participants will affirm that in the
      interval since their baseline visit, they have not acquired any of the cited exclusion
      criteria that would preclude participation. A review of these exclusion criteria will be
      completed by the Anesthesiologist. A standard pre-anesthetic assessment will be performed,
      including confirmation of NPO status, and documented using the standard Department of
      Anesthesiology pre-operative evaluation form.

      The first sedative will be dexmedetomidine followed by ketamine, propofol and then midazolam
      (dependent on the availability of the drugs). Total enrollment in the study will be up to 80
      subjects. Each sedation experiment will occur on separate days at least 28 days apart, if the
      subject chooses to participate in more than one session.
    

Intervention name(s): Dexmedetomidine; Ketamine; Propofol; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20 participants will be administered Dexmedetomidine.; 20 participants will be administered Ketamine.; 20 participants will be administered Propofol.; 20 participants will be administered Midazolam.
Intervention MeSH terms: Midazolam; Dexmedetomidine; Ketamine; Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sedation; Propofol; Dexmedetomidine; Ketamine; Sevoflurane; Electroencephalogram
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x
      200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an
      auto-injection device (test).
    


Intervention name(s): Certolizumab pegol; Certolizumab pegol
Intervention type(s): Drug; Drug
Intervention description(s): Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections; Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Other intervention name(s): Cimzia®; CDP870; CZP; Cimzia®; CDP870; CZP
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: certolizumab pegol; Cimzia; bioequivalence; Comparison Bioequivalence Study
Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a prospective consecutive double-blinded randomized study on the effect of
      PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe
      traumatic brain injury. All patients with severe traumatic brain injury were eligible for
      inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at
      intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure
      (CPP) of > 10 mm Hg, and arrival within 24 hours after trauma.

      Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a
      lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.

      A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers,
      measured by different cytokines.
    


Intervention name(s): epoprostenol versus normal saline; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 ng/kilogram/minute during 4 days; 0.5-1.5 ml/hour during 4 days
Other intervention name(s): Flolan®; Normal saline
Intervention MeSH terms: Epoprostenol; Tezosentan
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: traumatic brain injury
Sun Protection Factor (SPF) Assay
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection
      Factor (SPF) on the skin of human subjects.
    


Intervention name(s): BAY 987517; SPF 15 Control
Intervention type(s): Drug; Drug
Intervention description(s): Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.; Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Iron Absorption From Encapsulated Iron Sulphate in Microspheres
Condition: Iron-deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Food fortification has shown to be efficacious to alleviate the burden of micronutrient
      deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and
      stability of the fortified food and other added micronutrients remains a challenge. Soluble
      iron compounds cause minor organoleptic changes in foods but their bioavailability in man is
      rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds
      in which the iron is most bioavailable; however, they often cause unfavorable sensory
      changes.

      Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and
      iodine losses in salt, while maintaining acceptable bioavailability. In the present project,
      we would like to investigate the iron bioavailability from a new formulation of encapsulated
      iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.
    


Intervention name(s): free FeSO4; free FeSO4 and empty microspheres; free FeSO4 and hylauronic acid; free FeSO4 and eudragit polymer; encapsulated FeSO4 3.2%; encapsulated FeSO4 20%; encapsulated FeSO4 3.2%, encapsulated Vitamin A; encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid; FeSO4 embedded in Hyaluronic acid
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Testmeal with free FeSO4; Testmeal with free FeSO4 and empty micropsheres; Testmeal with free FeSO4 and hyaluronic acid; Testmeal with free FeSO4 and eudragit polymer; Testmeal with encapsulated FeSO4 with 3.2% Fe loading; Testmeal with encapsulated FeSO4 with 20% Fe loading; Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A; Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.; Testmeal with FeSO4 embedded in Hyaluronic acid
Intervention MeSH terms: Vitamins; Folic Acid; Vitamin A; Retinol palmitate; Fesoterodine; Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Iron deficiency; Iron fortification; Iron encapsulation