bioihbjkbjnl/mcl2 huggingface dataset:
Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors
Condition: Early Gastric Cancer; Barrett Esophagus
MeSH terms: Stomach Neoplasms; Barrett Esophagus
Study type: Interventional

Summary: 
      This study aims to examine the use of Linked Color Imaging in detection of gastric cancer
      precursors, as well as oesophageal and duodenal lesions.
    

Detailed description: 
      Gastric cancer is the fifth most common cause of death worldwide. Early detection and removal
      of gastric cancer precursors and early gastric cancer is crucial for good outcomes. However,
      these lesions are subtle and often missed by conventional white light imaging (WLI)
      endoscopy. Image enhanced endoscopy techniques have been developed to enhance the detection
      and characterization of gastrointestinal lesions. Narrow band imaging (NBI) is one such
      technique. Though widely used, its drawbacks include a limited far view as a result of the
      optical filter causing a dark endoscopic view. Linked color imaging (LCI) is a more recent
      image enhanced endoscopy technique that acquires images by using both narrow-band wavelength
      light and white light in an appropriate balance, enhancing slight color differences in the
      red region of mucosa. It has been proven to improve detection of H pylori gastritis and
      colorectal neoplasms. Thus far, there has been no study to determine whether the use of LCI
      will increase the detection rate of gastric cancer precursors and early gastric cancer
      compared to WLI. This study aims to determine whether LCI can increase the detection rate of
      gastric cancer precursors and early gastric cancer when compared to white light endoscopy,
      with the null hypothesis being no difference in detection rates. This study will also examine
      the use of LCI with magnification to predict histology findings for focal lesions seen on
      endoscopy, as well as the use of LCI in identifying esophageal lesions (such as Barett's
      esophagus) and duodenal lesions.
    

Intervention name(s): Linked Color Imaging; White Light Imaging
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Linked Color Imaging (LCI) is a form of image enhanced endoscopy that uses a laser endoscopic system that acquires images by simultaneously using narrow-band wavelength light and white light in an appropriate balance. This enhances slight color differences in the red region of the mucosa.; White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome
Condition: Obstructive Sleep Apnoea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Observational

Summary: 
      Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely
      metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no
      molecular markers for this physiopathological connection have been identified.

      This project aims to determine non-invasive biomarkers that may allow better comprehension of
      the metabolic consequences of OSAS, as well as assess the effect of Continuous positive
      airway pressure (CPAP) on these metabolic parameters.

      This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems
      to further explore the mechanisms behind OSAS, as well as the effect of the treatment with
      CPAP.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Obstructive Sleep Apnoea Syndrome Males 25-60 years
      
Keywords: CPAP; OSAS; CEDOC (Centro de Estudos de Doenças Crónicas); FCM (Faculdade de Ciências Médicas); UNL (Universidade Nova de Lisboa; NOVA MEDICAL SCHOOL; FCT (Fundação para a Ciência e Tecnologia)
Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate
      lactation in breastfeeding women. The intranasal administration of OT has recently attracted
      attention as a potential novel treatment in several psychiatric disorders in autism. However,
      given the anatomy of the nasal cavity, the current design of nasal sprays would be expected
      to provide an inadequate delivery of medication to the areas of the nasal cavity where direct
      transport into the brain via the olfactory nerve could potentially occur. OptiNose has
      developed an intranasal delivery device that provides improved reproducibility of nasal
      delivery, improved deposition to the upper posterior regions of the nasal cavity where the
      olfactory nerve innervates the nasal cavity.

      The primary objective of this study is to identify any differences between a single dose of 8
      international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with
      the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be
      measured in terms of performance on cognitive tests and physiological markers.
    


Intervention name(s): 8IU intranasal oxytocin; 24IU intranasal oxytocin; Placebo; OptiNose Breath Powered Bi
Intervention type(s): Drug; Drug; Drug; Device
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: oxytocin; social cognition
Evaluation of Liver Fibrosis Following Surgical-induced Weight Loss
Condition: Obesity
MeSH terms: Obesity; Fibrosis; Weight Loss
Study type: Observational

Summary: 
      Obesity is a frequent disease with an increased prevalence, estimated to 12.4% in France
      (OBEPI study 2006). Non alcoholic fatty liver disease (NAFLD) and non alcoholic
      steatohepatitis (NASH) both complicate morbid obesity and could be responsible for the
      development of liver fibrosis and consequently of liver cirrhosis. Bariatric surgery has been
      widely used in obese patients to reduce their weight but also to decrease morbidity
      conditions related to obesity. It could be involved in an improvement in liver lesions
      observed in obese patients. To evaluate the severity of liver lesions, the gold standard is
      pathological examination of the liver using percutaneous or surgical biopsies, with a scoring
      called Fibrosis score stage. Alternative less invasive techniques have been developed to
      evaluate liver lesions. These tests are commonly used in clinical hepatology and consisted of
      serum levels determination of fibrosis markers (Fibrotest, Transthyretin).

      The aim of this study is to evaluate the evolution of fibrosis scores during weight loss in a
      population of patients operated on for morbid obesity ( BMI > 40kg/m2 or BMI> 35kg/m2 with
      comorbidity). The primary end point is to evaluate the concordance between Fibrotest and
      transthyretin serum levels. The number of patients has been calculated on the basis of a
      concordance ( Kendall test) superior to 70% in patients with grade F1 fibrosis that
      represents about 40% of morbid obese patients. A total of 255 patients has to be enrolled in
      this study. According to the number of patients operated on in the 3 centres (>150/year), the
      time for recruitment is 12 months. Secondary end points will evaluate in these patients the
      excess weight loss, the improvement in fibrosis liver tests and the correlation with
      improvement in other obesity- related conditions, according to surgical procedures.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        obese patients
      
Keywords: morbid obesity; bariatric surgery; NASH; Liver fibrosis; Fibrotest
Multidetector Raw CT as a Single Tool in the Setting of Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      This is a prospective study including acute ischemic stroke patients aged 18 to 90.
      Multidetector raw CT is performed in acute ischemic stroke patients. Heart, neck vessels and
      brain arteries are studied during the same acquisition. Results are compared with the
      standard methods including transesophageal echocardiography (TEE), Doppler ultrasound (DUS)
      and MR angiography (MRA) of neck vessels. The main criteria is the ability of CT to classify
      the stroke etiology correctly according to the TOAST classification in comparison with the
      standard methods.
    


Intervention name(s): Multidetector raw CT
Intervention type(s): Device
Intervention description(s): Multidetector raw CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Stroke, ischemic, etiology, TOAST, CT, multidetector
Brain Stimulation and Cognitive Training - Efficacy
Condition: Schizophrenia; Schizo Affective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Mood Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      People with serious mental illness often experience difficulties with thinking skills like
      memory. These difficulties can make it harder to perform day-to-day activities. The purpose
      of this study is to test whether combining a type of non-invasive brain stimulation with
      computerized cognitive exercises is helpful in improving a specific type of memory skill in
      people who have mental health conditions.

      The study is a randomized clinical trial, meaning that participants will be randomly assigned
      to receive either 'active' or 'inactive' brain stimulation. All participants will complete
      computerized cognitive exercises, also known as cognitive training.

      Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the
      clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation.
      Participants will also complete paper-and-pencil assessments at the beginning and end of
      treatment, and one month after treatment ends.
    


Intervention name(s): tDCS (Active); BrainHQ; tDCS (Inactive)
Intervention type(s): Device; Behavioral; Device
Intervention description(s): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.; BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory; tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
Other intervention name(s): transcranial direct current stimulation; cognitive training; computerized cognitive exercises; transcranial direct current stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
the Effect of Different Wound Dressing on Prevention of Pressure ınjury Related to NIMV Mask
Condition: Pressure Injury
MeSH terms: Wounds and Injuries; Crush Injuries
Study type: Interventional

Summary: 
      This study is aimed to examine the effect of different wound dressings on the prevention of
      pressure injury in the face area related to noninvasive mechanical ventilation mask. The
      study was completed out with 102 patients who were followed up in Chest Diseases and Thoracic
      Surgery Hospital between October 2019 and August 2020 and met the inclusion criteria of the
      study. In the study, hydrocellular and hydrocolloid wound dressing was applied to the
      pressure areas under the mask of noninvasive mechanical ventilation in the intervention
      groups, while the routine treatment process was followed in the control group. Wound
      dressings were obtained from HARTMANN. Study data were collected with the "Individual
      Characteristics Form" and "Pressure Injury Rating Scale".
    

Detailed description: 
      In the hospital where the study was conducted, patients with respiratory failure receive NIMV
      treatment with an oro-nasal mask. In the study, hydrocolloid and hydrocellular wound
      dressings were placed on the pressure areas under the mask of the patients in the
      intervention group. NIMV treatment was applied to the face area of the patients in the
      control group with an oronasal mask without using any barrier cover. The pressure areas of
      the patients in the intervention and control groups were evaluated with the pressure injury
      scale before and after the NIMV treatment. Follow-up was carried out twice a day for 7 days.
    

Intervention name(s): wound dressing under the NIMV mask
Intervention type(s): Other
Intervention description(s): wound dressing under the NIMV mask
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: semi-experimental study with post test, control group
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: noninvasive mechanical ventilation; pressure injury; wound dressing
Robot-Aided Neurorehabilitation of the Upper Extremities
Condition: Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living
MeSH terms: Brain Injuries
Study type: Observational

Summary: 
      Task-oriented repetitive movement can improve movement performance in patients with
      neurological or orthopedic lesions. The application of robotics can serve to assist, enhance,
      evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy
      is used in neurological rehabilitation for patients with paralyzed upper extremities due to
      lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury.
      The goal of the therapy is to recover motor function, improve movement coordination, learn
      new motion strategies ("trick movements"), and/or prevent secondary complications such as
      muscle atrophy, osteoporosis, and spasticity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects and neurological patients after stoke or spinal cord injury
Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia
Condition: Breast Cancer; Precancerous Condition
MeSH terms: Carcinoma in Situ; Precancerous Conditions
Study type: Interventional

Summary: 
      RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One
      type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect
      the growth of abnormal breast cells.

      PURPOSE: This randomized pilot trial is studying how well omega-3 fatty acids work in
      treating women with newly diagnosed ductal carcinoma in situ and/or atypical ductal
      hyperplasia.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the effect of omega-3 fatty acids on markers of breast cancer progression
           in women with newly diagnosed ductal carcinoma in situ and/or atypical ductal
           hyperplasia.

        -  To determine the effect of omega-3 fatty acids on specific targets identified by
           microarray in breast cancer cells and in primary cultures from benign and malignant
           breast tissue biopsies.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8
           weeks.

        -  Arm II: Patients receive oral placebo olive oil capsules 3 times daily for up to 8
           weeks.

      Patients complete questionnaires at baseline, weekly during study treatment, at the
      completion of study treatment, and then at 30 days after completion of study treatment. These
      questionnaires include the Fish Oil Adverse Event Questionnaire, the Diet and Family History
      Questionnaire, the Changes to Diet and Medications Questionnaire, and the Post-Intervention
      Questionnaire.

      Patients undergo blood, urine, nipple aspirate, and tissue sample collection at baseline and
      after completion of study treatment for translational research studies. Blood samples are
      analyzed for genetic markers for breast cancer risk and progression by microarray analysis
      and red blood cell (RBC) fatty acids. Nipple aspirate samples are analyzed for fatty acids to
      determine the extent to which omega-3 fatty acid supplementation alters the fatty acid
      profile of breast tissue. Tissue samples are analyzed for the presence of ductal carcinoma in
      situ and/or atypical ductal hyperplasia or invasive cancer. Leftover blood, urine, nipple
      aspirate, and tissue samples are stored for future research studies.

      After completion of study treatment, patients are followed at 30 days.
    

Intervention name(s): omega-3 fatty acid; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Oral, 3 times daily; Oral, 3 times daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ductal breast carcinoma in situ; atypical ductal breast hyperplasia
A Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults.
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to compare the possible health benefits of intake of proteins
      from salmon, herring, cod and milk on glucose tolerance in overweight and obese adults.
      Overweight and obese subjects often have reduced glucose tolerance, and previous findings
      from a study on cod proteins suggested that glucose tolerance was improved.
    

Detailed description: 
      Participants receive 2.5g protein per day for 8 weeks as tablets.
    

Intervention name(s): Salmon protein hydrolysate; Herring protein hydrolysate; Cod protein; Milk protein
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2.5g salmon protein hydrolysate per day for 8wk.; 2.5g herring protein hydrolysate per day for 8wk.; 2.5g cod protein per day for 8wk.; 2.5g milk protein per day for 8wk.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics
      of multiple rising doses of BI 113608 in healthy male volunteers
    


Intervention name(s): BI 113608 PIB bid; Placebo to BI 113608 PIB bid; Placebo to BI 113608 PIB bid; Placebo to BI 113608 PIB qd; Placebo to BI 113608 PIB bid; BI 113608 PIB bid; BI 113608 PIB bid; BI 113608 PIB qd
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and reactogenicity of
      escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular
      injection in nucleos(t)ide analogs (NA)-treated chronic hepatitis B (CHB) participants.
    


Intervention name(s): JNJ-64300535; Placebo; Nucleos(t)ide Analogs (NA)
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Participants will receive JNJ-64300535 vaccine by electroporation-mediated IM injection on Day 1, Week 4, and Week 12.; Participants will receive 1 mL (0.9 percent [%] sodium chloride [NaCl]) of placebo solution matching to JNJ-64300535 electroporation-mediated IM injection on Day 1, Week 4, and Week 12.; Participants will receive NA as a standard of care treatment.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Acute Myocardial Infarction in Native Versus Non-native Young Population in Saudi Arabia
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      A retrospective study collecting the data of young patients admitted with diagnosis of Acute
      Myocardial Infarction.
    

Detailed description: 
      A retrospective study investigating young adults aged <45 years for males and <55 years for
      females admitted at Saud Al Babtain Cardiac Center with diagnosis of Acute Myocardial
      Infarction, determining its risk factors for Coronary Artery Disease (CAD) related to
      cultural characteristics and common positive consanguinity of parents as well as the
      prevalent diabetes and smoking.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Young adults, saudi or non-saudi, with Acute Myocardial Infarction.
      
Keywords: Young; Saudi