bioihbjkbjnl/mcl2 huggingface dataset:
A Prospective Study of Brain Network Activation (BNA) Changes in High School Athletes Following Concussion
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      The main purpose of this study is to prospectively examine changes in Brain Network
      Activation(BNA)following concussion in high school athletes. In addition, the study will
      examine the relationship between changes in BNA to symptoms, cognitive performance and
      vestibular function from baseline to 1-7, 8-14 and 15-21 day post injury intervals in high
      school athletes with concussion.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        High school (13-18 yrs) athletes from American football, soccer, and lacrosse who meet the
        inclusion/exclusion criteria will be recruited into the study. We expect that between 10-20
        participants will sustain a concussion during the period of the study and complete the
        post-concussion protocol.
      
Keywords: mild Traumatic Brain Injury; mTBI; Concussion
Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a clinical study that aims to investigate and compare the efficacy of transbuccal
      paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with
      acute pain of moderate intensity accepted to emergency room following a minor trauma of the
      lower limbs and/or superiors. To this end, several pain scoring will be performed using a
      visual analogue scale (VAS) at various times after drug administration.
    

Detailed description: 
      This is a clinical study that aims to investigate and compare the efficacy of transbuccal
      paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with
      acute pain of moderate intensity accepted to emergency room following a minor trauma of the
      lower limbs and/or superiors. To this end, several pain scoring will be performed using a
      visual analogue scale (VAS) at various times after drug administration.
    

Intervention name(s): paracetamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Paracetamol by permucosal route,; Paracetamol by intraveinous route,; Pain.; Patient with minor trauma of lower limb and/or superior limb (sprains, muscle contusions, …).
Coil Embolization of Coronary Artery Fistulas
Condition: C14; C14907933; C14907933125; G09330582163324; C14280647250
MeSH terms: Fistula
Study type: Observational

Summary: 
      Background and Purpose: Congenital coronary artery fistula (CAF) is an uncommon anomaly. In
      some patients they can became symptomatic, associated with significant morbidity and
      mortality. We report our experience in percutaneous treatment of CAF.
    

Detailed description: 
      Congenital coronary artery fistula (CAF) can be defined as a direct communication of a
      coronary artery with a cardiac chamber, great vessel, or other vascular structure, bypassing
      the myocardial capillary bed.

      CAF is an uncommon anomaly, occurring as an incidental finding in 0.1% to 0.2% of coronary
      angiograms. They are not gender specific. Many patients have symptoms like congestive heart
      failure, infective endocarditis, myocardial ischemia, or rupture of an aneurismal fistula.
      Surgical closure of coronary artery fistula was initially reported in 1983 with low rates of
      morbidity and mortality.

      Percutaneous treatment appeared as an alternative to surgery. Transcatheter closure of CAF
      was first utilized in 1983. Along this years, with experience and improvements in
      catheterization equipment and occlusion devices, CAF occlusion have been successfully
      performed using microcoils.

      We report our experience in using microcoils to percutaneous treatment of coronary fistulas.
    

Intervention name(s): Coil
Intervention type(s): Device
Keywords: coronary fistulas.; coils embolization.
Clinical Performance Evaluation of Two Silicone Hydrogel Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a randomized, double-masked dispensing study where subjects will randomized into one
      of two lens sequences to wear each of two contact lens types for a 4-week period with each
      lens type.
    


Intervention name(s): TEST Contact Lens; CONTROL Contact Lens
Intervention type(s): Device; Device
Other intervention name(s): senofilcon A; samfilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Virus Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and immunogenicity of VN-0200 after
      intramuscular injections in Japanese healthy adults and elderly subjects.
    


Intervention name(s): VN-0200; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total; Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus Infections; VN0200
Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT)
      based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck
      squamous cell carcinoma.
    

Detailed description: 
      Current guidelines define that pre-IC target volumes must be used for radiotherapy (RT)
      planning. This prospective, phase II trial assessed the results of patients with locally
      advanced squamous cell carcinoma of head and neck treatment with IC following by
      chemoradiotherapy (CRT), using post-IC PET/CT images for IMRT planning.
    

Intervention name(s): IMRT; PET/CT; Docetaxel; Fluorouracil; Cisplatin
Intervention type(s): Radiation; Radiation; Drug; Drug; Drug
Intervention description(s): IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).; Assessing tumor response using FDG-PET/CT.; 75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.; 750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.; 75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
Other intervention name(s): intensity-modulated radiation therapy; Positron emission tomography-computed tomography; Taxotere, Docefrez; 5-Fluorouracil, Adrucil; Platinol
Intervention MeSH terms: Docetaxel; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and neck cancer; PET/CT; induction chemotherapy; IMRT
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the safety and clinical effect of treatment with methylphenidate under
      different breakfast conditions (minimal breakfast versus standard continental breakfast) in
      children with Attention-Deficit Hyperactivity Disorder (ADHD).
    


Intervention name(s): Methylphenidate 20 mg long-acting capsules
Intervention type(s): Drug
Other intervention name(s): Ritalin LA
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; methylphenidate; children; food effect; Attention-Deficit Hyperactivity Disorder (ADHD) in children
Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients
Condition: Dental Carie; Orthodontics
Study type: Observational

Summary: 
      The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric
      Dental Patients. The investigators performed a multicenter observational study. The
      investigators included patients aged 1 to 18 years and who have already failed dental care
      because of non-cooperation; they could be with mental or cognitive disabilities and could
      have sedative premedication. The investigators performed any type of dental care With the Use
      of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after
      dental care.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Patients under 18 years

          -  Patients who have already failed dental care because of non-cooperation

          -  Patients with or without mental or cognitive disabilities (regardless of type)

          -  Patients with or without sedative premedication
A Multi-Center Study of Detection of Low Ventricular Ejection Fraction
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      This is a multi-site, retrospective study to evaluate the performance of a locked AI-based
      algorithm for detection of left ventricular systolic dysfunction. A prerequisite for
      inclusion of subjects from each institution will be the availability of at least one digital
      12-lead ECG paired with an echocardiogram with LVEF information within 30 days of the date of
      the ECG. The AI-ECG LVSD algorithm will be applied on all ECGs and diagnostic performance
      features for the detection of LVSD will be estimated using the provided paired LVEF value
      (Low LVEF as the reference label). Performance will also be assessed in subgroups of subjects
      determined by demographic and clinical factors.
    

Detailed description: 
      Following institutional review board approval, 12,000 12-lead ECG's paired with an
      echocardiogram with LVEF information within 30 days of the date of the ECG will be collected
      across three enrolled sites. Each site will provide data from up to 4000 enrolled subjects
      that meet the inclusion criteria. No other demographic characteristics or enrichment will be
      considered in the selection of subjects in order to best represent the general population for
      that site. Sites will securely transfer the data to a centralized repository for processing.

      Once data is collected, the device will be used to analyze the ECG data for all enrolled
      subjects without reference or access to the echocardiogram data. The device will display a
      binary 36 prediction of the likelihood of LVEF less than or equal to 40%. Results will be
      compared to the echocardiogram reference standard in accordance with the statistical analysis
      plan.
    

Intervention name(s): AI Algorithm to detect LVEF in ECG
Intervention type(s): Diagnostic Test
Intervention description(s): A clinical decision support software as a medical device that detects whether a patient has LVEF less than or equal to 40% based upon the input of one or more ECG vectors at the point-of-care.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adult subjects with or without known cardiac disease who are either inpatients or
        outpatients with ECGs and an echocardiogram within 30-days of the ECG date.
Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity
Condition: Hypersensitivity Dentin; Tooth Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Will the use of Bioactive glass with air abrasion technology (Sylc) compared to Fluoride
      Varnish (Biflourid 10) affects the degree of pain in patients complaining from
      hypersensitivity due to non-carious lesions?
    

Detailed description: 
      -  Population: Patients complaining from Dentin Hypersensitivity due to non-carious
           lesions.

        -  Intervention: Sylc, Air Abrasion Bioactive glass (Denfotex Research Ltd.)

        -  Comparison: BiFlourid 10, Fluoride Varnish (VOCO, Germany)

        -  Outcome measures: Dentin Hypersensitivity

      Outcome name Measuring device Measuring unit Dentin Hypersensitivity

        -  Thermal

        -  Tactile

        -  Evaporative
    

Intervention name(s): Sylc; fluoride varnish (Bifluorid 10)
Intervention type(s): Combination Product; Combination Product
Intervention description(s): a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment; It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.
Other intervention name(s): Sylc bioactive glass; Bifluorid 10
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dentin Hypersensitivity
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bifluoride, sylc, hypersensitivity,
Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms
Condition: Postmenopause
MeSH terms: Depression
Study type: Interventional

Summary: 
      The specific aims of this study are:

        1. To develop a breathing training protocol specifically designed to improve HRV and
           psychosocial functioning for postmenopausal women with depressive symptoms,

        2. To examine the immediate effects of an 8-week breathing training program on HRV and
           psychosocial end points in postmenopausal women with depressive symptoms,

        3. To examine the intermediate-term effects of an 8-week breathing training program on HRV
           and psychosocial end points in postmenopausal women with depressive symptoms, and

        4. To determine whether the change in depressive symptoms with breathing training in
           postmenopausal women is associated with the change in HRV.
    

Detailed description: 
      Postmenopausal women without hormone replacement therapy are associated with higher risk of
      cardiac morbidity and mortality. They are likely to experience depressive symptoms after
      menopause, and the comorbidity of depression are related to altered autonomic function. We
      expect that postmenopausal women with depressive symptoms who receive breathing training will
      demonstrate decreased depressive symptoms and increased heart rate variability immediately
      upon and later after completion of training, and optimally contributing to improve autonomic
      nervous regulation in their later life to prevent undesired cardiac outcomes.
    

Intervention name(s): Breathing training; Stress management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Respiratory sinus arrhythmia biofeedback-assisted deep breathing training; Cognitive reconstructive strategies for stress management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Depressive Symptoms; postmenopause; RSA biofeedback
A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy and tolerability of Faslodex
      (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor
      positive advanced breast cancer.
    


Intervention name(s): fulvestrant; anastrozole
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg intramuscular injection; 1 mg oral tablet
Other intervention name(s): Faslodex; ZD9238; Arimidex; ZD1033
Intervention MeSH terms: Fulvestrant; Anastrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oncology; cancer; breast cancer
Role of Respiratory Rate Derived From Capnography in Sedated Patients
Condition: Sedation Problems
Study type: Interventional

Summary: 
      Although appropriate sedation is recommended during colonoscopy, patients are at risk for
      adverse events e.g hypoventilation and hypoxemia due to inadvertent oversedation. The aim of
      this study was to evaluate the benefit of additional quantitative capnography monitoring (
      respiratory rate )in management of patient undergoing colonoscopy under sedation in
      preventing or reducing the incidence of adverse events and also determine when to start the
      procedure and when to give and not to give increments of sedative drugs during the procedure.
    


Intervention name(s): Standard capnography; Modified capnography
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients undergoing colonoscopy under sedation were randomly assigned to receive standard capnography monitoring or modified capnography monitoring which can be achieved by tucking capnography probe under the face mask.74 patients were enrolled. Patient characteristics were well balanced between the two groups 37 patients in each group.; If Respiratory rate below 14 b/m: more sedation isn't not advised and the patient may develop airway obstruction and needs airway intervention ( like jaw thrust or oral airway) If respiratory rate more than 20 b/m it means this patient is prone to awake or to move and this patient in need for incremental dose of sedative drug ( e.g 20 to 30 mg propofol) Also roughly speaking respiratory rate from 16 to 18 b/m is the target
Other intervention name(s): Qualitative capnograpyhy; Quantitative capnography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sedation; capnography; Respiratory rate; colonoscopy
Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics
Condition: Undernutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      In current practice, there are various nutritional risk scores and diagnostic tools which are
      used in both inpatient and outpatient settings,however, in some cases, these tools cannot be
      used due to lack of data.

      That's why a tool that doesn't require any anthropometric parameters, such as a visual food
      intake scale, could be useful to for medical and paramedical staff. In this way, a larger
      proportion of the paediatric population could benefit from nutritional screening.
    

Detailed description: 
      HAS defines undernutrition as a state of nutritional imbalance, characterized by a negative
      energy and/or protein balance. This negative balance may be linked to a deficit in isolated
      intake and/or an increase in energy and/or protein expenditure.

      In current practice, there are various nutritional risk scores and diagnostic tools which are
      used in both inpatient and outpatient settings. Practitioners can use discs to quickly and
      easily determine BMI, which corresponds to the ratio of Weight (Kg) / Height² (m). However,
      in some cases, these tools cannot be used due to lack of data.

      That's why a tool that doesn't require any anthropometric parameters could be useful to for
      medical and paramedical staff. In this way, a larger proportion of the paediatric population
      could benefit from nutritional screening.

      In adults, a visual food intake scale exists and has been validated for screening for
      nutritional risk. The hypothesis of this study is that the visual food intake scale could be
      a good tool for screening for nutritional risk in paediatrics
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a scheduled hospitalization, according to the day hospital scheduling list,
        will be proposed to participate in the study
      
Keywords: undernutrition; diagnostic; screening
A Phase I Study to Evaluate LSALT Peptide
Condition: None - Study is to Determine Safety in Healthy Participants
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose
      finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy
      participants
    


Intervention name(s): LSALT peptide; 0.9% Saline
Intervention type(s): Drug; Other
Intervention description(s): novel 16 amino acid peptide; saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science