bioihbjkbjnl/mcl2 huggingface dataset:
Immunologic Response to Influenza Vaccination in Children and Adolescents
Condition: Influenza, Human; Immune Response
MeSH terms: Influenza, Human
Intervention: Flucelvax inactivated influenza vaccine; Fluzone inactivated influenza vaccine
Intervention description: Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.); Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 4 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: inactivated; influenza; vaccine

Summary:

      The purpose of this study is to evaluate immunologic response to different types of influenza
      vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized
      controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine
      arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone
      (egg-based inactivated flu shot).
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 4-20 years;

          -  has prior vaccination history available (which can be determined based either on
             medical record review or through state registry review;

          -  plans to receive the current seasonal influenza vaccination at one of the recruiting
             sites

        Exclusion Criteria:

          -  unable or unwilling to completed required study activities, including informed
             consent, randomization to vaccine, and bloodwork;

          -  has already received influenza vaccine for the current season;

          -  has a known immunocompromising condition or is on an immunosuppressing medication
             (e.g., high dose steroids >10 days);

          -  is known to be pregnant;

          -  has a history of severe allergy to eggs or to influenza vaccine or any of its
             components
Belimumab Assessment of Safety in SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo plus standard therapy; Belimumab 10 mg/kg plus standard therapy; Standard therapy
Intervention description: Placebo plus standard therapy; Belimumab 10 mg/kg plus standard therapy; Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.
Intervention MeSH terms: Belimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4019.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies; Lupus; SLE; Systemic Lupus Erythematosus; Autoimmune Disease; Belimumab

Summary:

      The purpose of this study is to further enhance the existing knowledge regarding the side
      effects of belimumab when given with other lupus medicines to adults with active systemic
      lupus erythematosus (SLE). This study mainly focuses on collecting information on serious
      events that are not that common or may only be seen with long-term treatment. These events
      include death, serious infections and other infections of interest, cancers, serious mental
      health problems, including depression and suicide, and serious infusion and hypersensitivity
      reactions. This study is being done to help understand if treatment with belimumab increases
      the risk for these types of events. This study will also see if patients receiving belimumab
      with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.

          -  Active SLE disease.

          -  Autoantibody-positive.

          -  On stable SLE treatment regimen which may include corticosteroids (for example,
             prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants
             (for example, azathioprine, methotrexate, mycophenolate).

        Key Exclusion Criteria:

          -  Pregnant or nursing.

          -  Have received treatment with any of the following: belimumab, either as a marketed
             product or as an investigational agent; any B cell targeted therapy (for example,
             rituximab) in the past year; or any biological agent (for example, adalimumab,
             etanercept, infliximab, or anakinra) in the past 90 days.

          -  Have received a live vaccine within the past 30 days.

          -  Have severe active lupus kidney disease.

          -  Have severe active central nervous system (CNS) lupus.

          -  Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C.
Efficacy Study of Vaginal Mesh for Anterior Prolapse
Condition: Vaginal Prolapse; Uterine Prolapse; Cystocele; Pelvic Organ Prolapse
MeSH terms: Cystocele; Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Intervention: synthetic polypropylene mesh
Intervention description: Mesh used will be synthetic monofilament polypropylene. In this trial, patients in the experimental group will undergo interpositional multi-armed mesh placement using trocars for transobturator +/- ischioanal fossa placement at the level of the ischial spine.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 65.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: prolapse; uterus; mesh; bladder

Summary:

      The primary aim of this double-blind, randomized clinical trial (RCT) is to test the
      hypothesis that the addition of a standardized technique of interpositional synthetic
      polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery
      for anterior prolapse compared to traditional vaginal reconstructive surgery without mesh.
    

Eligibility criteria:

        Inclusion Criteria:

          1. women age > 21

          2. diagnosed with stage II-IV vaginal prolapse who desire reconstructive surgery

          3. available for 12 months of follow-up

          4. able to complete study questionnaires and assessments.

          5. available for 12 months follow-up

        Exclusion Criteria:

          1. Uterus in place.

          2. No anterior vaginal prolapse.

          3. Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection,
             history of pelvic irradiation, history of lower urinary tract malignancy, chronic
             steroid use or a compromised immune system.

          4. Current intermittent self catheterization.

          5. Pregnancy or desire for future fertility.

          6. Presence of an adnexal or ovarian mass.

          7. Shortened vagina.

          8. Other laparoscopic or abdominal/pelvic surgery in the past 3 months.*

          9. Known neurologic or medical condition affecting bladder function, e.g. multiple
             sclerosis, spinal cord injury.

         10. Need for surgery requiring an abdominal incision.

         11. <12 months post-partum. (Enrollment can be deferred until time requirement has been
             met).
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
Condition: Vaccines, Combined; Hexavalent Vaccine
Intervention: Vaxelis™
Intervention description: Vaxelis™ 0.5 mL sterile suspension in prefilled syringe for intramuscular administration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 11 Months
Maximum age: 13 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objectives of this study are to evaluate the safety, tolerability, and
      immunogenicity of a booster dose of Vaxelis™ (V419) given at ~11 to 13 months of age in
      healthy participants who were previously vaccinated with a 2-dose primary infant series of
      either Vaxelis™ or Hexyon™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at
             approximately 2 and 4 months of age

        Exclusion Criteria:

          -  Has known or suspected impaired immunological function

          -  Has known or history of functional or anatomic asplenia.

          -  Has a known hypersensitivity to any component of the study vaccine.

          -  Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other
             malignant neoplasm affecting the hematopoietic and lymphatic system

          -  Has a bleeding disorder contraindicating intramuscular vaccination

          -  Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus
             infection

          -  Was born to a mother with a known history of hepatitis B infection

          -  Had a recent febrile illness (defined as rectal temperature ≥38.1°C [≥100.5°F] or
             axillary temperature ≥37.8°C [≥100.0°F]) occurring at or within 72 hours prior to
             receipt of study vaccine

          -  Has encephalopathy of unknown etiology, occurring within 7 days following prior
             vaccination with a pertussis containing vaccine

          -  Has an uncontrolled neurologic disorder or uncontrolled epilepsy.

          -  Has a health or developmental disorder that, based on the clinical judgment of the
             investigator, could affect evaluation of the vaccine

          -  Has received or is expected to receive an immunosuppressive agent

          -  Meets corticosteroid use criteria

          -  Has received any licensed, non-live vaccine within 14 days of study vaccine

          -  Has received any license live vaccine within 30 days of study vaccine

          -  Has received a blood transfusion or blood product within 6 months of study vaccine
Vapocoolant Spray Used Prior to Intravenous (IV) Insertions
Condition: Pain
Intervention: Gebauer Ethyl Chloride; Nature's Tears
Intervention description: Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.; Sterile water mist will be administered 1-2 sprays prior to intravenous access
Intervention MeSH terms: Ethyl Chloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vapocoolant applied prior to IV access

Summary:

      The primary purpose of this study is to determine if by offering a vapocoolant (cold spray)
      to hospital outpatients prior to an intravenous catheter (IV) insertion will increase patient
      satisfaction of IV insertion as well as determine if pain of insertion is decreased.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to
             have IV access for injection of Radiopharmaceuticals

        Exclusion Criteria:

          -  If it is the first time the patient has had an intravenous catheter inserted

          -  Any patient who is or may be pregnant

          -  Any patient who is breast-feeding

          -  Any patient who has taken a narcotic, sedative and/or anti-anxiety medication within 8
             hours of intervention time.

          -  Any patient who has a known diagnosis of Raynaud's Syndrome or Carpal Tunnel Syndrome.

          -  Any patient who has an allergy or hypersensitivity to Ethyl Chloride.

          -  Any patient under the age of 18 and/or any patient over the age of 85

          -  Any patient who is illiterate

          -  Any patient who is non-English speaking

          -  Any patient with prior experience with a vapocoolant spray.
Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Ticagrelor; Clopidogrel
Intervention description: Comparison of ticagrelor with another antiplatelet drug (clopidogrel); Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: extracellular vesicles; inflammation; thrombosis; antiplatelet drugs

Summary:

      Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors
      are essential for platelet activation. Antagonists against the P2Y12 receptor, which are
      established in secondary prevention of myocardial infarction, have unexplained
      anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced
      infection-related mortality compared to clopidogrel, previous standard treatment for patients
      with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant
      platelet extracellular vesicles. The investigators assume that decrease in infection-related
      mortality in patients treated with ticagrelor may be explained by greater inhibition of the
      release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected
      to identify an additional mechanism of action of ticagrelor, which might contribute to the
      observed clinical benefits in patients treated with ticagrelor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Informed consent to participate in the study

          -  Percutaneous coronary intervention with stent implantation due to first S T elevation
             myocardial infarction, or first non S T -elevation myocardial infarction

          -  Administration of a loading dose of clopidogrel

        Exclusion Criteria:

          -  Known coagulopathy

          -  Known history of bleeding disorder

          -  Suspicion of intracranial haemorrhage

          -  Need for oral anticoagulation therapy

          -  Administration of glycoprotein (GP) II b - III a antagonists

          -  Cardiogenic shock

          -  Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)

          -  Severe liver insufficiency

          -  Chronic dyspnea

          -  Increased risk of bradycardia

          -  Autoimmune disease

          -  Infectious disease

          -  Neoplasms

          -  Pregnancy

          -  Study drug intolerance

          -  Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors

          -  Participation in any previous study with ticagrelor or clopidogrel
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Hot Flashes
Intervention: suvorexant; placebo
Intervention description: 10-20 mg taken at bedtime for four weeks; placebo taken at bedtime for four weeks
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; hot flashes; menopause; suvorexant; belsomra

Summary:

      The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri-
      and postmenopausal women who are experiencing sleep difficulties related to nighttime hot
      flashes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peri- or postmenopausal women

          -  DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes

          -  Some awakenings co-occur with a hot flash

          -  Score on the Insomnia Severity Index (ISI) measure ≥15

          -  Hot flashes present, including at night

        Exclusion Criteria:

          -  Diagnosis of other primary sleep disorders

          -  Shift workers

          -  Current or expected use of hypnotic medications

          -  Current major depressive episode

          -  Lifetime history of bipolar disorder, psychosis, or other serious mental health
             problem

          -  Current alcohol/substance use disorder

          -  Obesity

          -  Renal or hepatic disease

          -  Pregnancy or breastfeeding

          -  Recent malignancy

          -  Recent surgery

          -  Neurological disorder or cardiovascular disease raising safety concerns

          -  Medical instability considered to interfere with study procedures

          -  Concomitant medications with drug interaction or co-administration concerns

          -  Contraindications or allergic responses to suvorexant

          -  Recent or planned travel across time zones

          -  Excessive coffee or cigarette use
Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: Carboxymethylcellulose (CMC) Artificial Tears; Preservative-free, CMC-free Artificial Tears (control)
Intervention description: A pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group.; A pack of 21 vials of artificial tears containing 0.4% polyethylene glycol 400 and 0.3% propylene glycol will be given to subjects in the control group.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Carboxymethylcellulose (CMC), a common component in artificial tears, has been shown to
      modify the gut microbiome. The study is examining its effects on the eye microbiome, which
      may have implications on ocular disease and artificial tear choice. The study will administer
      artificial tears containing CMC to the treatment group and artificial tears without CMC to
      the control group. Surveys and conjunctival swabs will be collected before and after
      treatment for bacterial genome sequencing and analyzed by R statistical packages.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults above age 18 of either sex who can self-administer artificial tears and return
             for follow-up at the UF Oaks Eye Clinic.

        Exclusion Criteria:

          -  Individuals with active eye infections or have prosthetic eyes.

          -  Are immunocompromised, or are diagnosed with autoimmune diseases or malignant
             neoplasms about the eye.

          -  Individuals who take immunomodulatory therapy, steroids, antibiotics, medicated
             eyedrops, or are already using CMC eyedrops within 1 week of the study will also be
             excluded.
Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Propanolol; Placebo; Cognitive therapy workbook
Intervention description: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.; Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.; Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Propanolol; Beta Blockers; Reconsolidation; Cognitive Therapy; PTSD

Summary:

      This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in
      people with post-traumatic stress disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of PTSD or meets the five of the six diagnostic criteria for PTSD
             (event, hyperarousal, re-experiencing, duration, and distress/impaired functioning
             symptom criteria), but not the avoidance/numbing symptom criteria

        Exclusion Criteria:

          -  Past or current asthma

          -  Diabetes or heart disease

          -  Currently pregnant or breastfeeding

          -  Concurrent use of daily benzodiazepine; daily use of antidepressant medication allowed
             if dose has been stable for the 3 months before study entry

          -  Exposure therapy or additional cognitive therapy during the course of the study
             (supportive psychotherapy is allowed if ongoing for at least 3 months before study
             entry)

          -  Substance abuse

          -  Current use of beta blockers, amiodarone, chlorpromazine, cimetidine, clonidine, or
             digoxin