bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults
Condition: Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Influenza
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; RNA Virus Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza
      Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One
      dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered
      to approximately 10,000 participants
    

Detailed description: 
      This randomized, observer-blind, placebo-controlled multicenter, Phase 3 study will be
      conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine to be
      used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins
      expressed as VLPs for the 2017-2018 influenza virus strains.

      Approximately 10,000 healthy male and female participants aged 18 to 64 years will be
      randomized in a 1:1 ratio into one of two parallel treatment groups, such that approximately
      5,000 participants will receive the Quadrivalent VLP Influenza Vaccine at a dose of 30
      μg/strain and approximately 5,000 participants will receive the placebo. Within the two
      treatment groups, participants will be stratified by site and two age groups (18-49 years of
      age and 50-64 years of age in a 1:1 ratio).

      Participants will participate in this study for approximately eight to ten months, during
      which a first visit will be scheduled on Day 0 for screening and vaccine administration.
    

Intervention name(s): Quadrivalent VLP Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine; Single dose of a Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Human; RNA Virus Infections; Efficacy; Immunologic; Immunogenic Factors; Physiological Effects of Drug; Virus Diseases; Orthomyxoviridae Infections; Infection; Vaccine; Safety; Plant-made; Virus-like Particle; Hemagglutinin; Quadrivalent Influenza Vaccine
The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
Condition: Ischaemic Heart Diseases
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the
      heart. Current treatments are designed to relieve this blockage as quickly as possible to
      minimize damage to the heart muscle. However in restoring the supply of blood local damage
      known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how
      clot forming and clot dissolving pathways are affected during this process, and examine the
      role of a natural inflammatory hormone, bradykinin. This will help the investigators to
      understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new
      treatments for heart attacks.
    


Intervention name(s): Forearm vascular study; bradykinin receptor antagonist (HOE-140); Placebo (saline)
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.; Systemic infusion of bradykinin receptor antagonist (HOE-140).; Systemic infusion of placebo (saline).
Intervention MeSH terms: Bradykinin; Kininogens; Bradykinin Receptor Antagonists
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ischaemia reperfusion; Bradykinin; Platelet activation; Endothelial function
Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery
Condition: Drug Safety; Self Efficacy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the efficacy and safety of dexmedetomidine added to
      ropivacaine in patients undergoing shoulder surgery.
    

Detailed description: 
      Peripheral nerve blocks are used throughout the world in lieu of general anesthesia and, more
      commonly, to provide analgesia and opioid sparing in the postoperative course. Long acting
      local anesthetics, such as ropivacaine, can provide analgesia for 11.5 ± 5 hours. This leads
      to many patients reporting their first pain in the evening and nighttime hours when access to
      healthcare providers and support is most limited. A number of additives to local anesthetics
      have been studied in humans with limited success. Recent work by a group in Michigan found a
      dose dependent increase in the duration of analgesia to a thermal stimulus when
      dexmedetomidine was added to ropivacaine for sciatic nerve blocks in rat.

      The goal of the study is to investigate the safety and efficacy of dexmedetomidine added to
      ropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans.
      Provided the initial safety can be established, the trial will continue to evaluate secondary
      goals including the duration of analgesia, onset of sensory and motor blockade, and
      opioid-induced side effects. Tertiary outcomes will include subject satisfaction.
    

Intervention name(s): dexmedetomidine; saline
Intervention type(s): Drug; Drug
Intervention description(s): ropivacaine 100 mg + 150 mcg dexmedetomidine, single shot perineural application; ropivacaine + saline placebo, single shot perineural application
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Acetaminophen's Efficacy For Post-operative Pain
Condition: Tonsillitis; Airway Obstruction; Difficulty Swallowing
MeSH terms: Tonsillitis; Deglutition Disorders; Airway Obstruction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain
      control in children undergoing tonsillectomy with or without adenoidectomy.
    

Detailed description: 
      Tonsillectomy with or without adenoidectomy is a common surgical procedure in children and
      adolescents. Usually performed for recurrent tonsillitis or symptoms of airway obstruction,
      the procedure can result in significant post-operative pain. Common analgesic techniques
      include the use of oral acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), such
      as ibuprofen by mouth (PO) or ketorolac intravenous (IV), and narcotics. Acetaminophen has
      been shown to be effective in reducing pain and post-operative opioid requirements. Its
      administration can be oral, rectal, or intravenous. NSAIDs, though effective for pain
      control, have been shown to increase bleeding risk and disrupt hemostasis. Narcotics are
      effective for pain control but increase the risk of nausea and vomiting. They also have the
      potential to cause respiratory depression.

      IV acetaminophen (OFIRMEV) is indicated for management of mild to moderate pain, and as an
      adjunct to opioids for severe pain. Several studies have examined the efficacy of IV
      acetaminophen vs placebo and/or active controls (meperidine, rectal acetaminophen (PR),
      tramadol). IV acetaminophen has been shown to be superior to placebo for pain control. Though
      there is data regarding peak plasma and Cerebral Spinal Fluid (CSF) concentration of
      acetaminophen when given by different routes (PO vs IV vs PR), there is no data comparing the
      efficacy of oral vs IV administration for pain control post-tonsillectomy in children.
    

Intervention name(s): IV acetaminophen; PO acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .; PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
Other intervention name(s): Ofirmev; Acetaminophen Elixir
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: tonsillitis; recurrent tonsillitis; obstructed air passages; swallowing difficulties
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety,
      tolerability and pharmacokinetics, pharmacodynamics of SHR2150.

      will consist of 50 healthy subjects, 5 groups. The purpose of this part is to explore the
      safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150
      capsule in healthy subjects.
    


Intervention name(s): SHR2150；Placebo; SHR2150；Placebo; SHR2150；Placebo; SHR2150；Placebo; SHR2150；Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose；SHR2150-dose 1 or Placebo-dose 1; Single dose；SHR2150-dose 2 or Placebo-dose 2; Single dose；SHR2150-dose 3 or Placebo-dose 3; Single dose；SHR2150-dose 4 or Placebo-dose 4; Single dose；SHR2150-dose 5 or Placebo-dose 5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Women who are overweight or do not exercise are at higher risk for breast cancer after
      menopause. This study will test a new electronic device that measures the body's movement and
      works alongside a website to help women increase their physical activity level. If effective,
      this system could be tested in larger studies aiming to reduce breast cancer risk by reducing
      or preventing obesity.
    


Intervention name(s): Technology-Based Physical Activity Promotion; Pedometer Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants assigned to this group will use a web-integrated physical activity monitor, and accompanying website, to improve their physical activity levels.; Participants assigned to this group will receive a pedometer and be trained in its use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: primary prevention; sedentary; overweight; obesity; breast cancer; post-menopausal; women
Videoscope Guided Flexible LMA Insertion
Condition: Ideal Position of LMA Flexible
Study type: Interventional

Summary: 
      Laryngeal Mask Airway Flexible (LMA Flexible) is useful in various surgery because of its
      unique design. The flexometallic tube allows it could be used in head and neck related
      surgery but also make insertion more difficult. The ideal position of LMA Flexible is
      important because in most case, the surgery requiring LMA Flexible allows movements of the
      stem or patient's head during operation without dislodgement of LMA Flexible. Several studies
      have examined different techniques like assisting LMA Flexible with rigid introducers or
      lifting epiglottis with direct laryngoscope. But there is no study using videolaryngoscope
      (VL) for LMA Flexible insertion. The investigator hypothesized that McGrath(McGRATH™ MAC
      video laryngoscope;Aircraft Medical Ltd, UK.), one kind of the VL, assisted insertion would
      increase the success rate of LMA Flexible insertion by lifting epiglottis and securing a view
      while LMA Flexible is seated. The aim of this study was to investigate the efficacy of the
      McGrath VL assisted insertion of LMA Flexible compared with the standard method of digital
      manipulation technique in regard to the ideal anatomical position and sealing pressure in
      anesthetized adult patients.
    


Intervention name(s): Mcgrath; Control
Intervention type(s): Device; Device
Intervention description(s): McGrath assisted insertion of LMA flexible; Digital manipulation technique of LMA flexible insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Influence of Meal Skipping on Macronutrient Oxidation and Glucose Metabolism Under Isocaloric Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      Aim of the study is to investigate the impact of meal skipping (breakfast or dinner skipping)
      on the regulation of glucose metabolism and macronutrient balance (protein/fat/carbohydrate
      intake vs. -oxidation). An isoenergetic diet with 3 conventional meals (breakfast, lunch,
      dinner) serves as a control.
    

Detailed description: 
      The duration of the study is 7 days including 3 days with controlled diet and 4 days
      (including 5 nights) in a metabolic chamber at the Institute of Nutritional Medicine at the
      University of Hohenheim.

      The study phase in the metabolic chamber consists of (i) 1 day with 3 meals/day = baseline
      day, (ii) 1 day with breakfast skipping, (iii) 1 day with dinner skipping, (iv) 1 washout day
      where the subjects leave the chamber between 7 a.m. until 7 p.m..

      Beginning on the 3rd study day macronutrient and energy intake as well as the fasting periods
      are kept constant. To achieve comparable conditions the washout day is setted before the
      baseline day.
    

Intervention name(s): Breakfast skipping; Dinner skipping
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 18h fasting period in the morning; 18h fasting period in the evening
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: meal skipping; isocaloric diet; macronutrient oxidation; glucose homeostasis; arterial stiffness
Sensors for HEalth Recording and Physical Activity Monitoring
Condition: Physical Activity
Study type: Interventional

Summary: 
      The SHERPAM project is part of a scientific and technological context which aim is to record,
      transmit, analyse the physiological parameters of a patient, as well as to record the
      feedback to the patient and health professional to suggest the best individualised attitude.
      The questions of SHERPAM are generic. However, two specific applications will be addressed,
      in which the partners have already acquired some expertise: the recognition and
      quantification of physical activity with energy expenditure estimation, and the assessment of
      walking ability in patients with obliterative vascular disease in the lower limbs. Another
      application concerns the monitoring of the practice of physical activity and some biological
      signs in subjects with cardiovascular risk and in cardiac patients (arrhythmogenic diseases).
      Despite various clinical contexts and health goals, a common approach will be developed.
    

Detailed description: 
      To assess the SHERPAM Device (DS) by the continuous acquisition and transmission of data
      (accelerations, rotations, alterations in thoracic volume, heart rate, electrocardiogram) in
      a real life physical activity practice (subjects in their living environment and during their
      usual physical practices) using the DS's real-time communication tools, automatic data
      processing, and the DS's ability to produce information.
    

Intervention name(s): sensors
Intervention type(s): Device
Intervention description(s): Acquisition and transmission of exploitable recordings in the public targeted by the DS, that is to say which allow to draw clinical information in relation to the objectives of the DS (detection of the cardiac rhythm): data without artefact (saturation), in a good signal to noise ratio.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, monocentric, with healthy volunteers and patients
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Sensors; Health Recording
A Study of LY3461767 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study in healthy participants is to learn more about the safety of
      LY3461767 and any side effects that might be associated with it. The study will also measure
      how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it.
      For each participant, the study will last about 11 weeks, including screening.
    


Intervention name(s): LY3461767 - SC; LY3461767 - IV; Placebo - SC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC.; Administered IV.; Administered SC.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study
Condition: Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect
MeSH terms: Cholesteatoma
Study type: Observational

Summary: 
      Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes
      hearing loss, ear discharge, and ear pain, and serious complications. For the past several
      decades, most studies of cholesteatoma have been restricted to microscopic ear surgery.
      However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally
      invasive approach for cholesteatoma management. This thesis aim to investigate and compare
      the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma.

      Materials and methods: The retrospective study included 186 patients with cholesteatoma who
      received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between
      November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry
      improvement, treatment cost, time, graft success rate and recurrence rate were assessed after
      surgery.
    


Intervention name(s): endoscopic ear surgery; microscopic ear surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): a ear surgery via endoscopic; a ear surgery via microscopic
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        1. Patients who postoperative pathologically were confirmed cholesteatoma with or without
             mastoid involvement. The extent of disease was confirmed by preoperative HRCT temporal
             bone.

          2. The patients undergoed microscopic and/or endoscopic surgery for cholesteatoma
             including primary or revision surgery.

          3. have completely clinical characteristics, follow-up data and/or postoperative
             audiometric data
Functional Goat Cheese Effect in Lipid Profile Change
Condition: Obesity and Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose this study was to evaluate the therapeutic effect of a functional goat cheese on
      obese and overweight people with altered lipid profile. The functional goat cheese containing
      polyunsaturated fatty acid, in amounts exceeding other cheese, was developed to benefit
      cardiovascular health of people who need to normalize lipid profile; which in the long term
      can contribute to the prevention of cardiovascular diseases.
    

Detailed description: 
      A randomized, parallel, double-blind, controlled is being performing to evaluate the effect
      of a functional goat cheese on lipid profile in overweight or obese volunteers who need a
      special diet.

      Were included 60 volunteers (men and women) aged between 18 and 65 years (IMC ≥27<40 Kg/m2)
      with a cardiovascular risk (<10%). The volunteers are being followed at La Paz University
      Hospital of Madrid. For 12 weeks, the volunteers should consume 60 g of cheese daily
      (functional cheese or control cheese) and to receive advice to follow a balanced and
      individualized hypocaloric diet as well as physical activity.
    

Intervention name(s): Functional goat cheese; Control cheese
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 60 g per day during 12 weeks; 60 g per day during 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of insulin delivered in the
      peritoneum (abdomen)by an implantable pump in Type 1 diabetics.
    

Detailed description: 
      Implantable insulin delivery pumps have been shown to reduce the occurrence of severe
      hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic
      control is difficult to attain in subjects using exogenous insulin due to the risk of severe
      hypoglycemia. This study is aimed at comparing the efficacy of intraperitoneal (IP) insulin
      therapy to intensive subcutaneous insulin therapy over a period of 12 months.
    

Intervention name(s): Medtronic MiniMed Implantable Pump Human Recombinant Insulin; Medtronic MiniMed Implantable Pump System; Aventis HOE21PH U400
Intervention type(s): Drug; Device; Drug
Intervention description(s): 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.; The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.; 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
Other intervention name(s): Human insulin injection (rDNA origin); IP insulin pump system; Aventis U400 insulin; Aventis ETP Insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Implantable Insulin Pump; Intraperitoneal Insulin Delivery