bioihbjkbjnl/mcl2 huggingface dataset:
Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis
Condition: Pregnancy Anemia; Newborn; Anemia
MeSH terms: Anemia
Study type: Observational

Summary: 
      Erythroferrone (ERFE) is a recently identified iron-regulatory hormone that couples iron
      homeostasis to erythropoiesis but at this time there are no human data on this hormone in
      pregnant women and their neonates. The investigators hypothesize that ERFE is a sensitive
      biomarker of iron deficiency and anemia in pregnancy and neonates, and that it mediates the
      feedback mechanism to correct iron deficiency and anemia. To address this research gap, the
      investigators will measure ERFE in maternal serum, umbilical cord serum and placental tissue
      using an existing biospecimen archive.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women carrying multiple fetuses (twins, triplets and quadruplets) or pregnant
        adolescents carrying a single fetus
      
Biospecimen description: 
      During pregnancy 15 mL maternal blood sample collected. At delivery 15 mL maternal blood
      sample, 20 mL umbilical cord blood sample and the placenta are collected.
Comparison of Desensitizing Materials
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      To compare the efficacy of two commercially available in-office desensitizing agents
      (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.
    

Detailed description: 
      Dentine hypersensitivity (DH) is a condition that occurs in non-pathological, non-defective
      teeth and is defined as "a short, sharp pain in response to stimuli, typically thermal,
      evaporative, tactile, osmotic or chemical and which cannot be attributed to any other dental
      defect or pathology". The incidence of DH ranges from 4% to 74% in several studies.
      Mandibular first molars, canines and premolars of both jaws are most commonly affected by DH.

      The pathogenesis of DH is linked to exposure of dentinal tubules that can occur in the oral
      cavity due to dental erosion from acidogenic diets, aggressive tooth-brushing, injudicious
      use of whitening products, gingival recession, periodontal debridement or surgery. The most
      commonly reported initiating factor is cold drinks. Management usually involves methods that
      can achieve one or both of the following objectives; i) alteration of fluid flow in the
      dentinal tubules and ii) modification or blocking of the pulpal nerve response.

      A broad range of products that achieve these objectives have been developed after rigorous
      trials and can be used in-office or at home depending on the severity of the condition. These
      products are commonly referred to as desensitizing agents. Grossman suggested that an ideal
      desensitizing agent should be non-irritating to the pulp, relatively painless on application,
      easy to apply, rapid in action, effective for long periods of time and should not stain the
      teeth.

      The use of dentine desensitizers has become one of the most common methods in managing DH.
      The most commonly used desensitizers contain components such as fluoride, triclosan,
      benzalkonium chloride, ethylene diaminetetraacetic acid and glutaraldehyde. Fluoraphat Pro
      (Neumunster, Germany) and VivaSens® (Ivoclar Vivadent, Schaan, Liechtenstein, Switzerland)
      are two agents that have been tested for use as dentine desensitizers and are currently
      available for commercial use. In the present study, two such varnishes VivaSens (Ivoclar
      Vivadent, Schaan, Liechtenstein, and Switzerland) and Fluoraphat (Promedical Neumunster,
      Germany) have been used. The present study aims to establish which of the two desensitizing
      agents has better efficacy in reducing hypersensitivity in patients who have been previously
      diagnosed with DH.
    

Intervention name(s): Fluoraphat Pro / VivaSens
Intervention type(s): Drug
Intervention description(s): desensitizing agents for treatment of dentinal hypersensitivity
Other intervention name(s): VivaSens
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetic interactions and safety between
      fimasartan and linagliptin in healthy male volunteers.
    

Detailed description: 
      This is an open-label, randomized, multiple-dose, two-period and single-sequence study to
      evaluate the pharmacokinetics and safety.
    

Intervention name(s): (fimasartan or linagliptin) x 7days; (fimasartan and linagliptin) x 7days
Intervention type(s): Drug; Drug
Intervention description(s): Part A: fimasartan, Part B: linagliptin; Part A & Part B: Co-administration of fimasartan and linagliptin
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fimasartan
Validity of Perfusion Index to Evaluate the Level of General Anaesthesia in Children.
Condition: Awareness, Anesthesia
MeSH terms: Intraoperative Awareness
Study type: Observational

Summary: 
      The aim of this study is to evaluate the validity of perfusion index to determine the level
      of anesthesia in comparison with auditory evoked potential in children undergoing
      tonsillectomy.
    

Detailed description: 
      The use of the perfusion index as an added monitoring tool during anesthesia provides the
      anesthetist with a number of benefits. It is a useful tool to forewarn the clinician of
      possible light planes of anesthesia, allowing for agent dose adjustment. It is a preexisting
      technology that is already widely available and used in most urban, regional,and rural
      centers, in both developed and developing countries, is noninvasive, continuous, and
      inexpensive.

      The AEP Monitor/2 (Danmeter A/S, Odense, Denmark), a commercialized system for depth of
      anesthesia monitoring, extracts the middle latency auditory evoked potentials (MLAEP) from
      the EEG-signal by using an autoregressive model with an exogenous input adaptive method
    

Intervention name(s): Perfusion index detected by pulse oximeter; AAI
Intervention type(s): Device; Device
Intervention description(s): Perfusion index detected by pulse oximeter; The AEP Monitor/2 (Danmeter A/S, Odense, Denmark), a commercialized system for depth of anesthesia monitoring, extracts the middle latency auditory evoked potentials (MLAEP) from the EEG-signal by using an autoregressive model with an exogenous input adaptive method.
Other intervention name(s): PI; AAI index detected by AEP monitor.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA physical status I-II patients aged 4-12 years and scheduled for elective tonsillectomy
        due to recurrent or chronic tonsillitis will be included in the study. Excluded from the
        study will be patients with significant cardiac, renal, pulmonary or hepatic disease.
Effects of Unilateral WBV on Muscleactivity of Contralateral Hip Adductor
Condition: Bone Mass; Effects of Vibration
Study type: Interventional

Summary: 
      The aim of this study is to investigate effects of femur exposed to unilateral vibration on
      the rest muscle electrical activity of contralateral hip adductors and contralateral soleus
      H-reflex in young adult men.

      This study hypothesize that femur exposed to unilateral vibration may affect the rest muscle
      electrical activity of contralateral hip adductors. Vibration can effectively enhance muscle
      strength and power. Previous studies have shown that vibration increases muscle
      electromyographic (EMG) activity. It has been showed that bone has an effect on the increase
      in muscle EMG activity caused by vibration in healthy young adults in a study. In this study,
      it was reported that vibrations-induced increases in muscle electrical activity of flexor
      carpi radialis (FCR) was related to ultradistal radius bone mineral content (BMC) and the FCR
      H-reflex was suppressed or depressed during vibration. This findings were reported to support
      the assumption that the bone exposed to cyclic mechanical loading may neuronally regulate
      muscle activity.
    

Detailed description: 
      A total of 20 voluntaries are planned to include in this study.

      Vibration will be applied the right lower extremity by whole-body vibration (PowerPlate Pro).
      Cases will stand on vibration plate. WBV will be applied at a frequency of 40 Hz and
      amplitude of 2 mm for 60 seconds. WBV will be applied one session only.

      The rest muscle electrical activity of ipsilateral and contralateral hip adductor muscles at
      rest will be measured by PowerLab (data acquisition system, ADInstruments, Australia)
      device.The rest-EMGrms will be measured at before and during vibration. We also evaluate a
      change in contralateral soleus H reflex during vibration.

      Effects of bone on the rest muscle electrical activity will be assessed by hip bone mineral
      density, bone mineral content and serum sclerostin level. The right hip bone mineral density
      (BMD) and BMC will be evaluated by bone densitometer (Norland). Plasma sclerostin level will
      be measured by using Human Sclerostin ELISA kıt before and after vibration.
    

Intervention name(s): Whole-body vibration
Intervention type(s): Other
Intervention description(s): Frequency: 40 Hz, vibration amplitude: 2 mm, duration: 60 sec
Other intervention name(s): Cyclic mechanical loading
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: bone; osteocyte; rest muscle electrical activity; whole-body vibration; sclerostin
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Condition: Femoral Artery Stenosis; Popliteal Artery Stenosis; Femoral Artery Occlusion; Popliteal Artery Occlusion
MeSH terms: Arterial Occlusive Diseases; Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral
      drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral
      arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.
    

Detailed description: 
      The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient
      IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with
      congruent design and protocol. Aggregate data from the two phases is intended to provide
      statistical power for the 12-month primary safety and effectiveness endpoints.
    

Intervention name(s): Drug-Coated Balloon (DCB); PTA Balloon: Balloon Angioplasty
Intervention type(s): Device; Device
Intervention description(s): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm; Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Drug-Coated Angioplasty Balloon; Drug Coated Angioplasty Balloon; Peripheral Artery Disease; Experimental; Percutaneous Transluminal Angioplasty (PTA)
Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effect of multiple intravenous infusions of S95011
      compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.
    


Intervention name(s): S95011 concentrate for solution for infusion; Placebo concentrate for solution for infusion
Intervention type(s): Drug; Drug
Intervention description(s): IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.; IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sjögren; Sjögren's Syndrome; Autoimmune disease; Systemic; Xerostomia; xerophthalmia; Salivary gland disease; Arthritis; Joint disease; Monoclonal antibody
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of
      trough FEV1 over time as the primary endpoint.
    


Intervention name(s): tetomilast (OPC-6535); tetomilast (OPC-6535); tetomilast (OPC-6535); placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral administration of 12.5mg OPC-6535, once daily for 24months; oral administration of 25mg OPC-6535, once daily for 24months; oral administration of 50 mg OPC-6535, once daily for 24months; oral administration of placebo, once daily for 24months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic obstructive pulmonary disease; COPD; emphysema
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Hungarian, Multicentre, Observational Study to study Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects
      will provide their Informed Consent/assent to upload their data for population-based analyses
      and, ultimately, clinical outcomes. Adherence data will be primarily derived from the
      easypod™ device combined with physician data entry of outcome measures. Data will be
      collected retrospectively and prospectively. This will allow the establishment of adherence
      profiles and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™.

      Secondary Objective:

        -  To identify adherence subject profiling

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To asses the impact of adherence on Insulin-like Growth Factor-1 (IGF-1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
ABT-348 as Monotherapy and in Combination With Azacitidine to Treat Advanced Hematologic Malignancies
Condition: Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; B-cell Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Myelodysplasia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated
      dose of ABT-348 as monotherapy and when given in combination with azacitidine.
    

Detailed description: 
      The primary objectives of this study are to determine safety and pharmacokinetics of ABT-348
      as monotherapy and when given in combination with azacitidine. The secondary objectives are
      to determine the maximum tolerated dose and recommended Phase 2 dose of ABT-348 when
      administered as monotherapy and when given in combination with azacitidine in subjects with
      advanced hematologic malignancies.
    

Intervention name(s): ABT-348; ABT-348; ABT-348 and azacitidine; ABT-348
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): An oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.; An oral dose of ABT-348, twice daily on Day 1, Day 8, and Day 15 of each 28 day cycle; An oral dose of ABT-348 on Day 1, Day 8, and Day 15 of each 28 day cycle. An IV or injection of azacitidine on Days 1-7 of each 28 day cycle.; An intravenous dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
Intervention MeSH terms: Azacitidine; Ilorasertib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-labeled (laboratory blinded), randomized, two period, single-center,
      crossover, comparative study, where each participant will be randomly assigned to the
      reference (Zestril®, 20 mg) or the test (Lisinopril, 20 mg) formulation in each period of
      study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both
      formulations are bioequivalent
    


Intervention name(s): Lisinopril tablet 20 mg; Zestril® tablet 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): Lisinopril is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 20 mg of lisinopril.; Zestril® is manufactured by Avara Reims Pharmaceutical Services, France. Each tablet contains 20 mg of lisinopril.
Other intervention name(s): The test product; The reference product
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Human Cytochrome P450 4F Enzymes and Drug Interactions
Condition: Healthy Volunteers; Drug Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-drug interactions play an important role in clinical adverse events due to the
      prevalence of multi-drug therapy. Co-administration of warfarin and a statin has expanded
      substantially in the US over the last decades. The purpose of this study is to develop a
      mechanistic understanding of the role of a drug-metabolizing enzyme, CYP4F2, in the
      interaction between warfarin and statins. This study will test the hypothesis that lovastatin
      potentiates the anticoagulant effect of warfarin by inducing vitamin K-metabolizing enzyme
      CYP4F2 in humans, thus increasing warfarin's anticoagulant effect.
    


Intervention name(s): Warfarin; Placebo; Lovastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg, po, single dose on day 7; po, once a day, days 1 through 14; 40 mg, po, once a day, days 1 through 14
Other intervention name(s): Coumadin; Mevacor
Intervention MeSH terms: Warfarin; Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Drug drug interactions; Warfarin; Anticoagulants; Lovastatin; Statins; CYP4F2; Vitamin K
Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy
Condition: Cardiovascular Prevention
Study type: Observational

Summary: 
      This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained
      .The aims of the post hoc analyses are:

      To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI
      concomitant use versus non-use, crude and adjusted by confounding.

      To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI
      concomitant use stratified by age and sex.

      To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA
      therapy.
    

Detailed description: 
      Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during
      the first year of ASA therapy for secondary prevention
    

Intervention name(s): Risk of low dose aspirin discontinuation
Intervention type(s): Drug
Intervention description(s): PPI continuous use; No PPI usePPI
Intervention MeSH terms: Aspirin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a pharmacoepidemiology study using data from The Health Improvement Network (THIN)
        primary care database in the UK. Patients aged 50-84 years with evidence of ischemic heart
        disease or cerebrovascular disease, who were new users of low-dose ASA (75-300 mg/day) and
        who had received at least two low-dose ASA prescriptions for the secondary prevention of
        cardiovascular disease or cerebrovascular disease between 2000 and 2007 were identified
        from THIN. .
      
Keywords: Discontinuation of low dose ASA,; Secondary cardiovascular prevention,; Acid-suppressing drugs,; Gastrointestinal risk,; Epidemiology