bioihbjkbjnl/mcl2 huggingface dataset:
Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis
Condition: Cirrhosis, Liver; Portal Hypertension; Varice Bleed
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Fibrosis
Study type: Observational

Summary: 
      Cirrhotic patients with AVB across 34 university medical centers in 30 cities in China from
      February 2013 to May 2020 who underwent endoscopy within 24 hours were included in this
      study. Patients were divided into an urgent endoscopy group (endoscopy <6h after admission)
      and an early endoscopy group (endoscopy 6-24h after admission). Outcomes included the
      incidence of 5-day rebleeding, in-hospital mortality, need for intensive care unit (ICU) and
      the length of hospital stay after the endoscopy management. Multivariable analysis was
      performed to identify risk factors for rebleeding. A propensity score matching (PSM) analysis
      was performed to achieve a balance at baseline between the urgent and early groups.
    


Intervention name(s): emergency endoscopic therapy
Intervention type(s): Device
Intervention description(s): When cirrhotic patients presented with AVB to the emergency department, emergency physicians consulted gastroenterologists on duty to assess the patient for suitability for endoscopy, usually after initial stabilization. Performance of endoscopy and its timing was at the discretion of the gastroenterologist on call. Therapeutic endoscopy for AVB was performed within 24 hours after consultation by an experienced attending endoscopist, using standard forward-viewing upper gastrointestinal video endoscopes at individual centers. Written informed consent for endoscopy was obtained before each procedure. The standard of care at all hospitals was to administer a vasoactive agent and antibiotics upon the patient's presentation. Packed red blood cells were transfused at the discretion of the attending gastroenterologist.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Complete demographic and clinical data of patients with cirrhosis associated with AVB who
        underwent emergency endoscopy within 24 hours between February 2013 and May 2020 across 34
        university hospitals from 30 cities in China was retrospectively reviewed. Two independent
        investigators (Liu C and Huang Y) reviewed the medical records, including demographic,
        laboratory, clinical and endoscopic data.
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction
Condition: Liver Dysfunction
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the pharmacokinetics profiles and safety of
      Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral
      dose of Evogliptin
    

Detailed description: 
      When the future evogliptin be administered to liver dysfunction patients, to investgate
      whether dose adjustment is necessary.
    

Intervention name(s): Evogliptin
Intervention type(s): Drug
Intervention description(s): DPP4-inhibitor, Evogliptin
Other intervention name(s): DA-1229
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type II
Interactive Exoskeleton Robot for Walking - Knee Joint
Condition: Stroke
Study type: Interventional

Summary: 
      An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This
      robotic system has been developed to facilitate functional motor recovery by practices
      walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank
      and reduce the hyperextension in the knee joint. The robotic knee system is able to sense the
      gait pattern from the stroke patients and assist the walking and control the knee angle. The
      clinical trial will use repeated measurements to evaluate the effectiveness of the robotic
      knee system in gait rehabilitation post stroke.
    


Intervention name(s): Knee robot
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Identifying Biomarkers of Parkinson's Disease Using Magnetic Resonance Imaging (MRI)
Condition: Parkinson's Disease (PD); Parkinsonism; Progressive Supranuclear Palsy (PSP); Multiple System Atrophy (MSA)
MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Parkinsonian Disorders; Supranuclear Palsy, Progressive
Study type: Observational

Summary: 
      This study is designed to determine if magnetic resonance imaging (MRI) measures can be used
      to diagnose and monitor the progression of Parkinson's disease (PD) while distinguishing
      between PD and parkinsonisms [conditions that are PD look-a-like diseases such as progressive
      supranuclear palsy (PSP) or multiple system atrophy (MSA)] when combined with changes in
      certain proteins in body fluids that are related to iron (Fe).
    

Detailed description: 
      The lack of in vivo biomarker(s) reflecting Parkinson's disease (PD)-related cell loss and
      associated pathoetiological/physiological processes in nigrostriatal structures has hindered
      discovery research and limited the ability to evaluate disease-modifying therapies. Recent
      research has generated excitement for using DTI and R2* MRI measures as biomarker(s) for
      PD-related pathology in nigrostriatal pathways, but they fall short by the lack of
      understanding of their clinical implications and biological/pathological underpinnings.
      Working closely with the National Institute of Neurological Disorders and Stroke (NINDS)
      Parkinson's Disease Biomarkers Program (PDBP), the proposed work will investigate multimodal
      MRI techniques in combination with fluid-based iron (Fe) protein profiles to serve as in vivo
      markers for PD-related nigrostriatal pathology that can be used as biomarkers for diagnosing
      PD, following its progression, and gaining mechanistic understanding of PD pathoetiology and
      pathophysiology.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinical patients and community volunteers
      
Biospecimen description: 
      Whole blood, serum, plasma, white blood cells, urine, cerebral spinal fluid (CSF), tissue
    
Keywords: Parkinson's; PD; nigrostriatal; substantia nigra; MRI; DTI; FA; R2*; Parkinson's Disease Biomarkers Program; PDBP; ferritin; transferrin; Fe; iron protein; PSP; MSA
The Role of Progesterone and PIF for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The aim of this study is to achieve a more profound understanding of the endocrine alteration
      in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore
      the optimal progesterone level needed for securing implantation and development of early
      pregnancy.

      The second part of the project will determine the value of Preimplantation Factor (PIF)
      measurement in embryo culture medium as a possible tool for improved embryo selection and the
      use of PIF as an early pregnancy serum marker for healthy implantation and embryo
      development.

      IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.
    


Intervention name(s): IVF/ICSI treatment
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing IVF/ICSI treatment at 4 Danish Fertility Centres.
      
Biospecimen description: 
      Serum, Embryo culture media
    
Keywords: Infertility; IVF/ICSI; Progesterone; Preimplantation Factor (PIF)
The Effect Of Olive Oil on Diaper Rash
Condition: Diaper Rash; Olive Oil
MeSH terms: Diaper Rash
Study type: Interventional

Summary: 
      Objective: Diaper rash is an irritating, common skin problem in newborns and young children
      and occurs in the skin rubbed by wet diapers and in the armpits due to heat, moisture and
      irritation. This experimental study was planned to investigate the effect of olive oil use on
      the healing of diaper rash in infants with first-degree diaper rash undergoing treatment in
      an infant ward.

      Methods: The study conducted between September 2020 and December 2020 included 37 infants
      aged 0-24 months who were treated for any reason in the Infant Clinic of a medical school and
      had first-degree rash. The infants in the experimental and control groups were "treated with
      olive oil and X brand cream" respectively. The X brand cream and the effects of olive oil and
      X brand cream use on the improvement of diaper rash were compared.
    


Intervention name(s): Olive oil
Intervention type(s): Other
Intervention description(s): The parents of the babies included in the experimental group were asked to fill in the questionnaires. The infant's skin condition was assessed using the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants. Each time the diaper was changed, the diaper area was cleaned with water and cotton wool and dried, 1-2 cc of natural extra virgin olive oil was applied, and the new diaper was fastened. At the end of each day, the diaper area was evaluated by the researcher and a nurse by using the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow up
Condition: Type 2 Diabetes; Overweight; Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      the present study aimed to follow up our participants in order to consider the changes in
      weight and anthropometric measurements after the 12-month weight maintenance as well as the
      total of 18 months, consisting of the previously described 24 weeks active weight loss and a
      further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal
      adiposity, carbohydrate, and lipid metabolism during these periods.
    


Intervention name(s): DBs at the end of the main meal + weight control program; Water at the end of the main meal+ weight control program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan.; Subjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diet beverages; water; diabetes; weight loss; insulin sensitivity
Overactive Bladder in Elderly Patients- An Early Warning of Coronary Artery Disease
Condition: Overactive Bladder Syndrome; Coronary Artery Disease
MeSH terms: Urinary Bladder, Overactive; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational [Patient Registry]

Summary: 
      Investigators aimed to investigate the association between over active bladder and coronary
      artery disease as demonstrated on coronary angiography.
    

Detailed description: 
      The close relationship has been demonstrated between pelvic ischemia and overactive bladder
      (OAB) in a study involving elderly patients. In this study, it has been found that pelvic
      ischemia has triggered OAB and it has been related with cardiac ischemia. The aim of this
      study was to delineate the correlation between OAB and the degree of coronary artery stenosis
      as demonstrated on coronary angiography.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients, whom were diagnosed to undergo coronary angiography in a center of cardiology
        between January 2016 and January 2017 were evaluated prospectively.
      
Keywords: overactive bladder; coronary artery disease; gensini score
Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment
Condition: Femoral Acetabular Impingement
MeSH terms: Femoracetabular Impingement
Study type: Interventional

Summary: 
      Since last past decade, arthroscopic hip surgery proved its efficacy in femoroacetabular
      impingement treatment. However, no consensus exist concerning capsular suture or not.
      According to capsular incision size, articular instability can persist if no suture is
      performed. In contrast, tightly suture can cause post-operative joint stiffness.

      This study aims to evaluate the non inferiority of non capsular suture after hip arthroscopy
      treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2
      years follow-up.
    

Detailed description: 
      Main Objective :

      Non inferiority evaluation of non capsular suture after hip arthroscopy treatment of cam or
      mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.

      The primary study endpoint is the patient reported outcomes (HAGOS score; iHOT-12 and MHHS)
      at 2 years follow-up.

      Secundary objectives :

        -  Clinical results at 6 month and 1 year follow-up

        -  Specific complications occuring and frequences

        -  Patient quality of life,

        -  The return to sport,

        -  Sport level after surgery compare to sport level before surgery

        -  Pain
    

Intervention name(s): Hip arthroscopy
Intervention type(s): Procedure
Intervention description(s): Suture will be realized with two simple suture knots (non resorbable suture material). These suture knots will be performed at the end of hip arthroscopy. Correct capsular suture will be controlled under arthroscopy video.
Patients randomized in control arm will not received capsular suture at the end of the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, monocentric, randomized, double blind study
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Hip arthroscopy; capsular suture; Femoral Acetabular Impingement
Study on Regenerative Treatment of Intra-bony Defects
Condition: Periodontal Disease; Periodontal Attachment Loss
MeSH terms: Periodontal Diseases; Periodontal Attachment Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this investigation is to determine whether a synthetic hydroxyapatite is as
      effective as an enamel matrix protein for periodontal regeneration in patients who have
      intra-bony periodontal defects.
    

Detailed description: 
      Regeneration of periodontal tissues that have been diminished by periodontal disease is the
      main goal of periodontal therapy. While conventional surgical therapy only offers limited
      potential towards recovering tooth-supporting tissues, more recently developed techniques
      lead to a greater and more predictable regeneration of the periodontal structures. Among
      these techniques, application of enamel matrix proteins or bone grafts can promote
      periodontal regeneration.

      The study is a prospective, controlled, mono-center, randomized, clinical trial, that is open
      to the operator, blinded to the examiner. It will be conducted in a parallel group design.
      Participants who have at least 1 intra-bony periodontal defect will receive regenerative
      surgery at baseline with the randomly selected devices. A newly developed synthetically
      manufactured bone grafting material made of hydroxyapatite (Ostim) will be the product under
      investigation. An enamel matrix protein derivative (Emdogain) will act as control device.
      Both materials will be applied in intra-bony defects during periodontal flap surgery.
      Follow-ups will take place at 7 and 14 days post surgery, and at 3, 6, 9, and 12 months.

      The primary aim is to compare the effectiveness of the test product with the control in the
      treatment of 1- and 2-wall intrabony periodontal defects on the amount of bone fill 12 months
      after surgery. Secondary parameters will be the clinical attachment level gain and reduction
      of probing pocket depth at 6 and 12 months.
    

Intervention name(s): Ostim; Emdogain
Intervention type(s): Device; Device
Intervention description(s): Ostim® is synthetically manufactured and comprises nanocrystalline hydroxyapatite. The small particle size facilitates resorption. Ostim is an aqueous watery paste and can be used to fill bone defects or to build up bony structures in the region of the jaws. Ostim is osteoconductive, facilitating bone growth. It will act as a scaffolding for the new bone. Ostim is absorbed during the healing process, in the beginning it is osseously interweaved and finally replaced by natural bone.; Emdogain® consists of sterile lyophilised Enamel Matrix Derivative with sterile aqueous solution of Propylene Glycol Alginate, 30 mg/ml.
Other intervention name(s): synthetic hydroxyapatite; enamel matrix protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Periodontal disease; Hydroxyapatite; Enamel matrix protein; Regeneration; Human
Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
Condition: Influenza; Fever
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents
      4 to 17 years of age.
    


Intervention name(s): Mammalian cell based flu vaccine; Egg based flu vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; children and adolescents; trivalent vaccine; cell culture; embryonated chicken eggs
An Association Between Asthma Severity and Capnography Parameters
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is a common chronic disorder of the airways characterized by periods of reversible
      airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by
      chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed
      airways, leading to airflow obstruction, and may be mild, moderate, or severe enough to
      become life-threatening events. Severity of asthma exacerbation is assessed through medical
      history and lung function measurements with Spirometer and requires full cooperation of the
      patient. Thus, in uncooperative populations or during emergency medical situations the
      spirometer cannot be used. As an alternative, capnography data has been proposed as an
      indicator of bronchospasm in asthma. Previous studies found correlations between the
      capnography parameters and methacholine challenge in asthma patients. However, the
      relationship between capnography parameters and severity of asthma or severity of asthma
      exacerbation have not been well characterized. The study hypothesis is that within the
      clinical population that is invited to do the methacholine challenge, a different waveform
      pattern in asthma patients will be detected and possibly a correlation between the severity
      of obstruction and pattern of waveform during the methacholine challenge. In this proposed
      feasibility observational study, sixty subjects, both men and women, who will be invited to
      participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin
      Medical Center, will be recruited to the study. Respiratory information will be recorded
      using the CapnostreamTM20p while the subjects will wear the non-invasive Smart CapnoLine®
      Plus sampling line. Additionally, FeNO will be measured using a DENOX 88 device during the
      methacholine challenge.
    


Intervention name(s): Capnostream20p
Intervention type(s): Device
Intervention description(s): The device will be used to monitor respiratory co2 values during the methacholine challenge, a well known diagnostic procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sixty subjects, both men and women, who will be invited to participate in the methacholine
        challenge in the Institute of Pulmonary Medicine at Rabin Medical Center, regardless to the
        study, will be recruitment to the study.
Mental Training for CFS Following EBV Infection in Adolescents
Condition: Fatigue Syndrome, Chronic; Epstein-Barr Virus Infection
MeSH terms: Infections; Communicable Diseases; Epstein-Barr Virus Infections; Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      The general aim of this study is to investigate the effect of an individually tailored mental
      training program in adolescents developing chronic fatigue syndrome (CFS) after an acute
      Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary endpoint),
      symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and markers of
      disease mechanisms (autonomic, endocrine, and immune responses).
    

Detailed description: 
      EBV-infection is a well-known trigger of CFS. A closely related research project (Chronic
      fatigue following acute Epstein-Barr virus infection in Adolescents; ClinicalTrials
      ID:NCT02335437) is a combined prospective and cross-sectional study of 200 adolescents
      suffering from acute EBV infection. The primary aim of that study is to identify factors that
      predispose to CFS 6 months after the acute infection. Thus, that project will provide a
      sample of thoroughly characterized CFS patients, all having the same precipitation factor
      (EBV-infection).

      The present project is an intervention trial in the subgroup of patients that actually did
      develop CFS 6 months after the acute EBV infection. Patients will be randomised 1:1 to either
      a mental training program (10 sessions) combining elements from cognitive behavioral therapy
      and music therapy, or routine follow-up from the general practitioner. By its nature,
      treatment group allocation cannot be blinded; however, both patients and therapists will be
      blinded for end-point evaluation. An extensive investigational program will be carried out at
      three time points: Prior to the intervention, immediately after the intervention, and 1 year
      after the intervention. The program includes: Clinical examination; Pain threshold
      assessment; Cardiovascular assessment; Cognitive assessment; Sampling of biological material
      (blood and urine); Questionnaire; Brain fMRI; Qualitative interview; Monitoring of physical
      activity (accelerometer)
    

Intervention name(s): Mental training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment