bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Netrin-1 in the Pathophysiology of Placenta Accreta Spectrum
Condition: Pathophysiology of Placenta Accreta
MeSH terms: Placenta Accreta
Study type: Observational

Summary: 
      The main goal of this study the possible involvement of netrin-1 into the pathophysiology of
      placenta accrete spectrum.

      To delineate the role of netrin-1, neogenin - zeb1 signaling pathway in mechanism of morbidly
      adherent placenta.
    

Detailed description: 
      The main goal of this study is:

        -  To shed light on the possible involvement of netrin-1 into the pathophysiology of
           placenta accrete spectrum.

        -  To study the role of netrin-1 in Epithelial to mesenchymal transition as a possible
           pathophysiological mechanism of placenta accrete spectrum.

        -  To delineate the role of netrin-1, neogenin - zeb1 signaling pathway in the progression
           of invasion of placenta accrete spectrum.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1. Full history taking including currant age, age of marriage, parity, history of
             abortion , history of dilation and endometrial curettage(D&C), number of previous
             caesarian section, history of uterine congenital anomaly, postpartum endometritis,
             hysteroscopic surgery, previous abnormal placentation, and similar condition in the
             family.

          2. Estimation of body mass index (BMI). 3- placental tissue obtained after delivery for
             immunohistochemistry and tissue homogenate analysis
      
Keywords: Netrin-1, neogenin,PAS, zeb-1
The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean Medicine
Condition: Respiratory Tract Diseases; Nose Diseases; Rhinitis
MeSH terms: Rhinitis; Respiratory Tract Diseases; Nose Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of
      Hyeonggaeyeongyo-Tang for chronic rhinitis according to pattern identification in Korean
      medicine.
    


Intervention name(s): Hyeonggaeyeongyo-tang
Intervention type(s): Drug
Other intervention name(s): Hyenggaelong Granule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyeonggaeyeongyo-tang; Chronic rhinitis; Pattern identification; Korean medicine
The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      To examine whether starting an exercise program with or without education can influence
      dietary choices in previously sedentary of 20-40 years.
    

Detailed description: 
      Subjects will complete an InBody test, demographic and physical activity survey, and
      food-frequency questionnaire via Qualtrics. Also, subjects may participate in a focus group
      and an individual interview.

      A minimum of 150 minutes of moderate exercise required each week and must be spread out in at
      least 2 days.

      Over the course of the study, subjects will complete InBody assessments, Food Frequency
      Questionnaire (items subjects are eating before, during, and after the investigator's study),
      and possible focus group questions (open-ended questions about thoughts and perceptions on
      exercise, nutrition knowledge, and health and nutrition history).
    

Intervention name(s): nutrition education; no nutrition education
Intervention type(s): Other; Other
Intervention description(s): The experimental group will receive nutrition education once during the study. It will occur at the beginning of the second week. This will consist of a 30-minute interactive lecture and a 15-minute question-and-answer session. The information covered will be basic nutrition principles for good health and to support regular exercise.; This group will not receive nutrition education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Strength Training for Elderlies and Their Effects on Muscle Fatigue and Microcirculation - Randomized Clinical Trial
Condition: Aging
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effects of a strength training program on
      functional capacity, muscle performance and microcirculation in the elderly.
    

Detailed description: 
      Purpose

      The primary research question is:

      Do muscular strength training programs can improve functional capacity, muscle performance
      and microcirculation in the elderly? Hypothesis: Strength training program will promote
      electromyographic changes during the development of peripheral muscle fatigue and
      microcirculatory blood flow contributing to functional autonomy.

      Secondary Research Questions

        1. Does the strength training program in the elderly improve the standard of
           electromyographic fatigue? Hypothesis: Elderly practitioners of strength exercise
           program showed increased neuromuscular efficiency and electromyographic fatigue index.

        2. Do the strength training program in the elderly improve peripheral microcirculation?
           Hypothesis: A regular program of strength exercise in the elderly increases the blood
           flow in peripheral microcirculation changing the process of muscle fatigue. These
           biomechanical and physiological changes contribute to increased functional autonomy and
           reducing the risk of falls in the elderly.
    

Intervention name(s): Strength training program
Intervention type(s): Other
Intervention description(s): Strength Training program applied twice a week for sixteen weeks. Each training exercises has a total time of 50 minutes. Warm-up: 5 minutes of stretching. Training: Leg press; Leg Curl; Vertical traction; Chest press; Abdominal crunch; Lower back. Gametherapy.
Relaxation: 5 minutes of stretching.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Basic Science
Keywords: Microcirculation; Electromyography; Motor Activity
The Effects of Spasticity on Glucose Metabolism in Individuals With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      Muscle atrophy may occur in individuals with spinal cord injury (SCI) as a result of
      diminished physical activity and alterations in glucose metabolism and body composition may
      be seen. In a few studies, it has been suggested that spasticity may have a positive impact
      on glucose metabolism by preventing muscle atrophy and alterations in body composition in
      individuals with motor complete SCI. Investigators aimed to assess the effects of spasticity
      on glucose metabolism and body composition in participants with complete and incomplete SCI.
    

Detailed description: 
      Investigators plan a prospective clinical trial. Participants with SCI were included to study
      if times from injury were at least one year. Participants had an AIS grades of A-D with
      spasticity. We evaluated that participants with AIS A and B SCI were motor complete group,
      AIS C and D SCI were motor incomplete group. Spasticity was assessed with Modified Ashworth
      Scale (MAS) and spasms were assessed with Penn Spasm Frequency Scale (PSFS). Hip adductor and
      extensor spasticity, knee extensor and flexor spasticity and ankle plantar flexor spasticity
      were assessed by using MAS. Body composition was measured by dual-energy x-ray
      absorptiometry. All participants underwent a 75 gram (g) oral glucose tolerance test (OGTT).
      Insulin sensitivity was assessed by calculating Matsuda index and HOMA-IR. Investigators
      assessed the effects of spasticity on glucose metabolism and body composition in participants
      with SCI.
    

Intervention name(s): body composition; glucose, insulin, glycohemoglobin
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): fat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body; In the morning after 12 hours overnight fast, all individuals underwent a 75 gram (g) oral glucose tolerance test (OGTT). Blood samples were taken before loading glucose and then 30, 60, 90 and 120 minutes after taking glucose solution in order to measure serum glucose and insulin levels. Glycohemoglobin (HbA1c) was measured in blood samples taken before the OGTT. We calculated the Matsuda index and Homeostasis model assessment index (HOMA-IR) using glucose and insulin levels.
Other intervention name(s): dual-energy absorptiometry (DXA),; fasting blood glucose, insulin, glycohemoglobin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Individuals with SCI were included to study if they were 18-65 years old and times from
        injury were at least one year.
      
Keywords: Body composition; glucose; spasticity; spinal cord injury
A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared
      to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled
      with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg
      once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or
      placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment.
      After 24 weeks of treatment, patients on active treatment will continue on the same treatment
      and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide
      20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on
      study treatment is 2+ years, and the target sample size is 500+ individuals.
    


Intervention name(s): Metformin; Placebo (matching sitagliptin); Placebo (matching taspoglutide); Sitagliptin; Taspoglutide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): As prescribed; Once daily oral administration of placebo (matching sitagliptin).; Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).; Once daily oral administration of 100 mg of sitagliptin.; Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Short Message Service (SMS) Impact on Patient Compliance Receiving Long Term Lipid Lowering Therapy With Statins
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The objective of the study is to determine whether short text massages could be used
      successfully as a compliance aid and improve clinical outcomes in long term lipid lowering
      therapy.
    

Detailed description: 
      Indication: Patients discharged from the Intensive Cardiac Care Unit or the Internal Medicine
      Department following acute coronary syndrome (ACS) events such as unstable angina or acute
      myocardial infarction who will be prescribed a statin for the first time for preventing
      further coronary episodes.

      Drug(s) and Dose/Regimen: Regular or aggressive Simvastatin therapy (dose will be adjusted
      according to LDL and Total Cholesterol levels). Treatment period 6 months.

      Objectives: To determine whether using SMS technology can improve compliance and hence
      clinical outcomes in patients with long-term lipid lowering therapy.

      Primary outcome: number of patients who achieve target LDL goals. Secondary outcomes:
      reductions of total cholesterol, LDL, LDL/HDL and CRP; increase of HDL; Readmissions due to
      ACS.

      Study Background/Rationale/Purpose: Long-term lipid lowering therapy is the cornerstone of
      preventing recurrent cardiac events in patients that have experienced such episodes. Numerous
      studies have demonstrated the efficacy of statins in the treatment of hyperlipidemia and
      reduction of total mortality, vascular mortality and coronary adverse events1.

      One of the main concerns affecting the success of long-term chronic drug treatments is
      patients' compliance and adherence to the prescribed regimen. Till date there is no gold
      standard system that will assure complete patient compliance.

      It has been suggested to explore the possibility of using short messages service (SMS)
      technology to improve patients' compliance 2-18. Such technology may be effective in
      targeting this problem; however, no controlled trials have been conducted to validate this
      method in long-term lipid lowering treatments. Furthermore, Israel is one of the leading
      countries in terms of expansion of the mobile phone services market, making SMS a feasible
      and effective form of communication with patients.
    

Intervention name(s): No intervention; Short Message Service (SMS)
Intervention type(s): Other; Behavioral
Intervention description(s): 60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge - control group; 60 patients post ACS receiving the study medication + doctor/pharmacist explanation at discharge + daily SMS reminder service (8 PM) - study group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: Compliance; Chronic; Pharmacotherapy; Statins
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
Condition: Insomnia Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of
      JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset
      and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant)
      upon multiple (14 days) dose administration in participants with insomnia disorder.
    


Intervention name(s): Placebo; JNJ-42847922, 5 mg; JNJ-42847922, 10 mg; JNJ-42847922, 20 mg; Zolpidem
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Matching placebo will be administered once daily based upon dosing group.; JNJ-42847922 will be administered as 5 mg (2*2.5 mg capsule) oral capsules once daily.; JNJ-42847922 will be administered as 10 mg oral capsule once daily.; JNJ-42847922 will be administered as 20 mg oral capsule once daily.; Zolpidem will be administered as 5 mg or 10 mg (2*5mg capsule) oral capsule once daily based upon the local labeling information.
Other intervention name(s): MIN-202;; Seltorexant; MIN-202;; Seltorexant; MIN-202;; Seltorexant
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Mexiletine on Colonic Transit in a Patient With Irritable Bowel Syndrome - Constipation (IBS-C)
Condition: IBS
Study type: Interventional
Phase: Phase 1

Summary: 
      To understand if Mexiletine will restores normal colonic motility in a patient with irritable
      bowel syndrome - constipation (IBS-C) and a genetic mutation in SCN5A.
    

Detailed description: 
      To understand if Mexiletine will restore normal colonic motility in a patient with a missense
      mutation in SCN5A, which encodes a voltage-sensitive sodium channel NaV1.5 as it is known to
      rescue certain expression defects of NaV1.5 in vitro.
    

Intervention name(s): Mexiletine
Intervention type(s): Drug
Intervention description(s): 6-day treatment period during which the medication will be taken orally with an initial dose of: 200 mg every 8 hours for 3 doses on day 3, increasing to 300 mg every 8 hours on days 4 and 5 (6 doses), and increasing further to 400 mg every 8 hours on days 6-8 if no telemetry changes and no dose limiting side effects
Intervention MeSH terms: Mexiletine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IBS
Assessment of Viral Shedding Week Following Administration of Live Attenuated Influenza Vaccine in Children
Condition: Influenza Vaccines
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      LAIV shedding studies in children could be an important way to confirm whether impediments to
      viral replication do indeed explain these observed reductions in vaccine effectiveness (VE),
      whether prior vaccination has any influence on replication and what future implications (if
      any) this might have for the UK paediatric LAIV programme. LAIV virus replication in children
      will be dependent on virological and host factors. The virus factors include replicative
      fitness of individual strains and the susceptibility to inhibition by other replicating
      strains (ability to compete). Host factors which may influence this include pre-existing
      specific immunity as a result of prior infection or previous vaccination (with either LAIV or
      IIV), and innate immune factors including mucosal immunity.

      There is significant variability in shedding across viral subtypes in studies done to date,
      so there is a need to obtain local data in a small pilot observational study which will look
      in detail at virus shedding by sequential daily virus samples, something not possible on a
      larger scale. The data generated will inform future LAIV studies in the UK in terms of
      optimum time of sample collection for viral shedding studies, which are likely to be required
      on a regular basis, to supplement field studies of vaccine effectiveness.

      This study will enrol up to 30 children that will allow these factors to be assessed. Both
      written informed consent from parent/ guardian and written assent from the child will be in
      place prior to any study procedure. All participants will have a baseline assessment of
      pre--existing influenza immunity (blood test, oral fluid collection and nasal swabs),
      followed by a single dose of LAIV. Parents will then be asked to take nasal swabs at home on
      days 1, 2, 3, 4, 5, 6, 7, 8, with further nasal swab, blood test and oral fluid collection in
      hospital 4 weeks later, in order to assess for immune responses to LAIV.
    


Intervention name(s): Live attenuated influenza vaccine (LAIV)
Intervention type(s): Biological
Intervention description(s): Single dose of LAIV
Other intervention name(s): Fluenz Tetra
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of Stent Implantation in Symptomatic Extra- and Intracranial Artery Stenosis
Condition: Stroke; Transient Ischemic Attack; Atherosclerosis; Stenosis; Stents
MeSH terms: Ischemic Attack, Transient; Atherosclerosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of stent implantation in
      patients with symptomatic extra- and intracranial artery stenosis and to determine its role
      in secondary prevention of ischemic stroke.
    


Intervention name(s): Stent implantation (Wingspan, Coroflex, and TiTAN2); Standard medical treatment
Intervention type(s): Device; Drug
Intervention description(s): Stent Implantation:
Wingspan intracranial stent with Gateway PTA balloon Catheter; Coroflex&reg - balloon expandable stent system and Coroflex Blue - Coronary Stent System; TiTAN2 Bio-active coating stent
Standard Medical Management:including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide) .
Arms: 1; Standard Medical Management:including antiplatelet agents(Aspirin 75~150mg/day or Clopidogrel 75mg/day),statins(Atorvastatin 20mg/day or Simvastatin 20mg/day),risk factor lowering agents (antihypertension agents:Amlodipine 5mg/day or Benazepril 10mg/day or Valsartan 80mg/day or Nifedipine 30mg/day or Indapamide 2.5mg/day,antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid )if necessary,interactive education program (Online medical education program, health behavior guide)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Stroke; Transietn Ischemic Attack; Stents; Stenosis
Bioequivalence Study Of Verapamil
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil
      formulations
    


Intervention name(s): verapamil; verapamil
Intervention type(s): Drug; Drug
Intervention description(s): 240 mg extended release tablets once daily at bedtime for 28 days; 240 mg extended release tablets once daily at bedtime for 28 days
Other intervention name(s): Covera HS; Covera HS
Intervention MeSH terms: Verapamil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular Diseases; Hypertension
Accuracy of Pulse Oximeters With Profound Hypoxia During Motion
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The aim of this study is to determine the accuracy of devices called pulse oximeters, which
      measure blood oxygen by shining light through fingers, ears or other skin, without requiring
      blood sampling. Study will be used with patients during controlled motion.
    

Detailed description: 
      This study is intended to evaluate performance of a new design pulse oximeter (test device)
      manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an
      FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be
      assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled
      setting of varying levels of inhaled oxygen concentration levels for patients during
      controlled motion.
    

Intervention name(s): Pulse oximeter
Intervention type(s): Device
Intervention description(s): OLV-4202 pulse oximeter (SW version: 01-11)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers. At least 5 subjects will be recruited to complete the study. Of
        these, 2 will be dark pigmented.