bioihbjkbjnl/mcl2 huggingface dataset:
Diagnosis and Management of Enhanced Myometrial Vascularity Associated With Retained Products of Conception
Condition: Hypervascularized Uterine Retentions
Study type: Observational

Summary: 
      Background:

      Hypervascularized products of conception remain a topic debated in terms of definitions
      (ultrasound criteria, need complement by angio MRI) and management. The different uterine
      vascular lesions are often confused. This is a recurrent problem and care are heterogeneous.
      The aim of the study is to evaluate the management of these entities in CHU of Montpellier
      and determine more homogeneous care. The investigators further aimed to evaluate clinical
      presentation, ultrasound criteria, complications and the gynaecological and obstetrical
      outcomes of patients •Methods: This study will be conducted in compliance of ethic comitee.
      The investigators will collect data from 64 individuals, aged 18 to 50, suffering from
      uterine vascular lesions associated or not with products of conception between 2013 and 2019.
      Caracterisitics of the population, ultrasound and angio MRI data will be collected.
      Management wll be described as expectative, surgery or embolization of uterine arteries and
      the success or not will be noted. The investigators will question patients on their
      gynaecologic and obstetrical outcomes by telephone.

      •Discussion: The investigators aim to define and characterize the different lesions,
      establish ultrasound criteria that would guide treatments. Describe the current treatments
      and compare them in terms of efficiency and safety in order to establish a homogeneous
      treatment protocol in our center
    

Detailed description: 
      -  data are collected by computer software and patient phone calls

        -  ultrasounds criteria are reviewed by two clinicians

        -  statistical analysis is realized by a independent clinician

        -  the consent and agreement of the ethics committee has been sought
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women Aged between 18 and 50 years, and diagnosis of hypervascularized products of
        conception
      
Keywords: Women; Retained Products of conception, Arterio venous malformation; color doppler ultrasound; embolization; fertility
Auricular Acupuncture for Analgesia During Total Hip Arthroplasty
Condition: Acute Pain; Total Hip Arthroplasty
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in
      relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty
    


Intervention name(s): Auricular acupuncture (procedure)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Peri-device Leakage Closure After LAAO
Condition: Atrial Fibrillation; Stroke; Bleeding; Leakage of Cardiac Device
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The investigators thought to evaluate the safety and feasibility of peri-device leakage
      closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with
      different devices.
    

Detailed description: 
      The global burden of atrial fibrillation (AF) is high and thromboembolic stroke may be one of
      the fatal complications. Oral anticoagulation has been the mainstay therapy for decades to
      mitigate stroke risk. However, in poor candidates for long-term anticoagulation
      non-pharmacological stroke prevention with percutaneous left atrial appendage occlusion
      (LAAO) is a considerable treatment option. LAA shape and size varies widely and incomplete
      LAA closure or new leaks, due to LAA remodeling after the procedure, are observed in up to
      30% of patients. Those leaks may cause turbulent flow and increase the risk for thrombus
      formation and subsequent thromboembolic events. However, the clinical significance after
      percutaneous LAAO has yet to be determined.

      If significant leaks are present, patients usually remain on oral anticoagulation. In very
      few cases, an interventional approach is used to close peri-device leaks.

      This is the first systematic study, trying to include a respectable number of patients who
      underwent peri-device leakage closure after LAAO. In this multi-center, collaborative study
      the investigators aim to identify different peri-device leak closure strategies with
      associated clinical outcomes and evaluate safety and feasibility of the procedure.
    

Intervention name(s): Peri-device leakage closure after left atrial appendage occlusion
Intervention type(s): Device
Intervention description(s): Peri-device leakage closure after left atrial appendage occlusion
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients after interventional or surgical left atrial appendage occlusion with severe
        leakage, who underwent interventional peri-device leakage closure
      
Keywords: left atrial appendage occlusion; peri-device leakage; stroke
Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double blind, vehicle controlled Phase 2 study with a 4-week open label
      extension in adolescent and adult participants with atopic dermatitis and head and/or neck
      involvement. It is intended to compare the efficacy and safety of ruxolitinib cream 1.5% BID
      versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open
      label extension period.
    


Intervention name(s): Ruxolitinib cream; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Ruxolitinib cream 1.5% applied twice a day (BID)"; Vehicle cream applied twice a day (BID) to affected areas
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is 2:1 assignment to rux and vehicle creams.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatiits; adolescent; adults; in-home; telemedicine
A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease
Condition: Crohn's Disease; Colitis; Intestinal Disease; Gastrointestinal Disease; Digestive System Disease
MeSH terms: Crohn Disease; Colitis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the HARMONY study is to assess the safety and efficacy of an investigational
      drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a
      humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks
      IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are
      proteins normally produced by our immune system to help fight off foreign substances.
      Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the
      antibodies in our bodies, to target diseases.
    

Detailed description: 
      Participants will be randomized, assigned by chance, to one of five treatment groups
      consisting of: four groups differing in the amount of study drug given and one placebo group.
      The initial dose of study drug will be given intravenously, injected into a vein in the arm.
      Four weeks later, three subsequent doses of study drug will be given subcutaneously, through
      the skin, every four weeks for three doses. Patients will be followed for approximately six
      months after receiving their final dose.
    

Intervention name(s): anti-Interferon-gamma monoclonal antibody
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Interferon-gamma; Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Crohn's Disease; Colitis; Monoclonal antibody therapy; anti-interferon gamma
Standardizing Method and Development of Normal Values to Measure Human Small Intestinal and Colonic Permeability
Condition: Healthy
Study type: Observational

Summary: 
      To develop a test to measure small bowel and colonic permeability.
    

Detailed description: 
      The study consists of a physical examination, standardized meals and 3 oral sugar tests with
      24 hour urine collections. It requires the participants to visit the Clinical Research Trials
      Unit in the Charlton Building and Domitilla Building. Remuneration will be offered.
    

Intervention name(s): Small Bowel and Colonic Permeability Test
Intervention type(s): Other
Intervention description(s): small bowel and colonic permeability based on oral probe molecules and urine excretion in 60 healthy white, female and male adults aged 18-70y
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Biospecimen description: 
      urine samples for permeability measurements
A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475
      in healthy subjects
    


Intervention name(s): Saline; ACT-246475; Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single i.v. infusion of 100 mL saline 0.9% for 30 min; Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions; Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min
Other intervention name(s): Selatogrel
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Mycoprotein and Pea Protein Blend and Muscle Protein Synthetic Response
Condition: Muscle Protein Synthesis
Study type: Interventional

Summary: 
      Dietary protein is vital for the preservation of health and optimal adaptation to training.
      Plant proteins are considered inferior to animal proteins with respect to their ability to
      stimulate an acute muscle building response and therefore support long-term muscle
      reconditioning. Pea protein is a highly commercially available plant proteins source
      (available as supplements, food ingredients etc.), yet there is no research investigating its
      ability to stimulate a muscle building response. The investigators aim to assess the effect
      of consuming pea protein on muscle protein synthesis rates and compare these results to
      mycoprotein, a source known to elicit a robust anabolic response.

      Pea protein is lower in some of the essential amino acids, namely methionine, which could
      mean it is less effective compared with mycoprotein which has a more complete amino acid
      profile. So in addition to comparing pea with mycoprotein, the investigators also want to
      compare to a blend of pea and mycoprotein to see if replenishing the amino acid content in
      pea 'rescues' the anabolic response.
    


Intervention name(s): Bolus ingestion of protein
Intervention type(s): Dietary Supplement
Intervention description(s): Ingestion of 25g of protein
Other intervention name(s): Protein ingestion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if treatment with BG00012 can decrease the number of MS relapses during a
      certain time period. To determine if, over time, BG00012 treatment can decrease the number of
      certain types of brain lesions commonly seen in MS patients and slow down the time it takes
      for the disease to get worse.

      The purpose of this study is also to determine the safety of BG00012 and how well it is
      tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used
      to assess MS.
    


Intervention name(s): BG00012; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): dimethyl fumarate; Tecfidera®
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: relapsing; oral; remitting; multiple sclerosis
Evaluation of the Modified Early Warning Scoring System
Condition: Clinical Deterioration; Postoperative Complications; Nurse's Role
MeSH terms: Postoperative Complications; Clinical Deterioration
Study type: Interventional

Summary: 
      In this study, it was aimed to determine the effect of HRU and HG on patient outcomes in the
      care process in surgical patients followed according to MEUSS.

      The sample of the study, which was conducted as a randomized-controlled clinical trial,
      consisted of 252 patients who underwent surgical intervention under general anesthesia in a
      university hospital between 29 July 2022 and 31 October 2022.
    

Detailed description: 
      Postoperative patients are at risk of clinical worsening and minimizing this is vital. Nurses
      play a vital role in the early detection and management of clinical deterioration as they are
      the group of professionals with the highest patient contact. MEUSS is stated as a simple risk
      management tool based on physiological parameters that can allow early detection of clinical
      deterioration and initiation of the relevant intervention, improving the quality of care and
      patient safety provided to surgical patients.

      In this study, with a larger sample, patients will be followed up with MEUSS and a nursing
      guide for 2 hours in the clinic where they are transferred both after and after ASBU. Our
      study is a research with the highest sample in this field, in which patients are followed for
      the longest period of time, and it is thought that MEUSS and nursing guide applications can
      identify risky patients in the postoperative period and reduce postoperative complications
      with strict follow-up applied to these patients. The aim of this study; To determine the
      effect of Nursing Guide Practice (HRU) and Nursing Interventions (HG) on patient outcomes in
      the care process in surgical patients followed according to MEUSS.
    

Intervention name(s): MEWSS and Nursing Guide Application
Intervention type(s): Other
Intervention description(s): MEWSS and Nursing Guide application will be used for the patients in the experimental group. According to the Nursing Guide application, patients with MEWS above 4 will be monitored every 5 minutes, while those with a score below 4 will be monitored for 10 minutes. will be followed intermittently. Nursing interventions will be made in accordance with the problems experienced by patients with a score above 4.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized-controlled clinical trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Clinical deterioration; early warning score; nursing assessment; postoperative care; surgical nursing
Combination of Chest Scanography and Nasal Viral Detection Test to Detect COVID-19 Positive Patients Before Surgical Intervention in a University Hospital During Coronavirus Pandemia
Condition: COVID 19; SARS-Cov-2
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This research aims to improve the screening for COVID-19 upon admission to the Montpellier
      University Hospital for an act under general anesthesia or at high risk of transmission of
      the virus. Indeed, routine nasal swabs present many false negatives (60 to 70%) and many
      patients with the coronavirus have little or no symptoms. Performing a chest CT scan can
      reveal early signs very suggestive of viral pneumoniae due to the new coronavirus without
      additional risk compared to a simple chest X-ray (no injection of contrast medium, low
      exposure).

      The objective is to assess the sensitivity of the diagnosis of COVID-19 by carrying out a
      nasopharyngeal RT-PCR and a low dose thoracic scanography at the hospital admission of
      patients scheduled to a procedure under general anesthesia or at risk of aerosolization
      (surgery, endoscopy, procedures involving risk of interventional radiology) in order to limit
      the risks of transmission to healthcare professionals or other patients and to rationalize
      the use of protective equipment.

      This is an observational research without modification of care in the setting of COVID-19
      pandemia. All clinical and biological data will be issued from routine care and medical
      charts. Routine use of CT scan and nasal swabs is an institutional approved strategy.
      Serologic tests will be performed as soon as available from serum collection collected after
      routine blood analysis. All data will be anonymously recorded after information and
      non-opposition of the patient.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to hospital for a surgical or interventional procedure under general
        anesthesia or at risk of aerosolization during the COVID-19 outbreak and screened with
        chest CT-scan and nasopharyngeal RT-PCR to detect SARS-Cov-2 infection or carriage
      
Biospecimen description: 
      Plasma: preoperative, ICU admission at POD0 and POD1 samples
    
Keywords: COVID-19 infection or paucy-symptomatic carriage; In-hospital screening; Chest CT-scan
Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?
Condition: Knee Osteoarthritis; Knee Rheumatism
MeSH terms: Rheumatic Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      One common anesthetic that is performed for total knee replacement surgery is spinal
      anesthesia with an adductor canal regional block, which involves injecting numbing medication
      in the thigh region for pain control after surgery. The aim of this study is to determine
      whether the addition of another regional block called obturator nerve block, which involves
      injecting numbing medication in the upper thigh region, will improve pain control after
      surgery while not sacrificing mobility after surgery.
    

Detailed description: 
      There is currently no consensus on the optimal strategy that provides the most effective
      postoperative analgesia while preserving ambulation and limiting side effects such as nausea
      and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to
      adductor canal block can target both the anterior and posterior distribution of nerves to the
      knee to provide superior analgesia while not limiting ambulation. To test this hypothesis,
      the clinical team will compare the rate of IV opioid consumption in patients who receive a
      combination of adductor canal block and obturator nerve block at the surgical site versus
      patients who receive adductor canal block alone.
    

Intervention name(s): Obturator nerve regional block; Adductor canal regional block; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.; Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.; Saline as placebo comparator
Other intervention name(s): bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adductor canal regional block; obturator nerve regional block; total knee arthroplasty; knee replacement surgery; Knee rheumatoid arthritis
Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery
Condition: Healthy Volunteers; Recovery; Endothelial Function
Study type: Interventional

Summary: 
      Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and
      parameters of recovery after physical exertion.
    


Intervention name(s): L-Carnitine; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate; 1000mg cellulose + 475mg L-tartaric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Efficacy Study of Stearidonic Acid (SDA) Soybean Oil-containing Foods on Red Blood Cell Fatty Acid Content
Condition: Healthy Volunteers; Markers of Cardiovascular Risk
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to evaluate whether the omega-3 fatty acid stearidonic
      acid (SDA), when used as a food ingredient, increases the level of the long-chain omega-3
      fatty acid eicosapentaenoic acid (EPA) in red blood cell (RBC) membranes in men and women.
    


Intervention name(s): SDA soybean oil-containing foods; High-oleic sunflower oil containing foods; Eicosapentaenoic acid
Intervention type(s): Other; Other; Other
Intervention description(s): 3 servings per day of foods containing 500 mg each SDA soybean oil plus 3 x 500 mg high-oleic sunflower oil in softgels per day.; 3 servings per day of foods containing 500 mg high-oleic sunflower oil plus 3 x 500 mg high-oleic sunflower oil in softgels per day; 3 x 500 mg per day of Eicosapentaenoic acid as an ethyl ester in softgels plus 3 servings per day of high-oleic sunflower oil-containing foods
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety Study of an Oral Vaccine to Prevent Avian Influenza
Condition: Avian Influenza; Bird Flu
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine
      to prevent avian influenza. Volunteers will receive either one or two doses of research
      vaccine or placebo as part of this study.
    


Intervention name(s): ND1.1; Placebo control
Intervention type(s): Biological; Biological
Intervention description(s): adenovirus with the dsRNA adjuvant, dried and put into capsules; Capsules of the same size and shape as experimental groups
Other intervention name(s): Ad-HA-dsRNA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; pandemic; avian influenza; H5N1; flu