bioihbjkbjnl/mcl2 huggingface dataset:
Test-and-treat for Influenza in Homeless Shelters
Condition: Influenza; Respiratory Viral Infection
MeSH terms: Influenza, Human; Virus Diseases
Intervention: Point-of-care molecular testing and treatment of influenza
Intervention description: Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 1618.0
Sex: All
Minimum age: 3 Months
Healthy volunteers: No
Keywords: Tamiflu; Oseltamivir; Baloxavir; Influenza; Flu; Rapid Test; Xofluza

Summary:

      This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment
      for influenza in homeless shelters within the Seattle area to determine whether this strategy
      reduced the incidence of influenza in the shelter environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Resident for 1 or more days at a participating shelter

          -  ≥2 ARI symptoms or acute cough alone

          -  Willing to take study medication

          -  Willing to comply with all study procedures, including weekly surveillance and repeat
             nasal swab at day 2/3 and day 5/6/7 post-treatment

          -  Able to provide written, informed consent and/or assent

        Exclusion Criteria:

          -  Any serious or uncontrolled medical disorder or active infection that, in the opinion
             of the investigator, may increase the risk associated with study participation or
             study drug administration

          -  Inability to consent and/or comply with study protocol

          -  Individuals who have received oseltamivir or baloxavir within past 7 days for
             treatment of influenza

          -  Individuals with known hypersensitivity to baloxavir marboxil or oseltamivir

          -  Individuals with chronic kidney disease
Spinal Anesthesia in Total Hip Arthroplasty
Condition: Total Hip Arthroplasty
Intervention: Lidocaine; Bupivacaine
Intervention description: Spinal anesthesia administered prior to participant's THA; Spinal anesthesia administered prior to participant's THA
Intervention MeSH terms: Lidocaine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Hip replacement; Total hip arthroplasty; Anterior total hip replacement; Transient neurological symptoms; Spinal anesthesia

Summary:

      Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose
      of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a
      total hip arthroplasty (THA). The objective of this study is to compare the two spinal
      anesthesia treatments in regards to transient neurological symptoms (TNS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Radiographic evidence of symptomatic osteoarthritis in one or bilateral hips.
             Osteoarthritis will be defined as pain with weight-bearing at the hip articulation
             together with radiographic findings

          -  Indicated for total hip arthroplasty

          -  Agreement to undergo spinal anesthesia for surgery

        Exclusion Criteria:

          -  Patient refusal to undergo spinal anesthesia

          -  Patients with a known history of lumbar or sacral spinal fusion.

          -  Patients with a known history of prostate, urological, or kidney surgery.

          -  Patients who need monitoring of urine output during surgery (including patients with
             confirmed renal disease, renal failure, chronic renal insufficiency, or an indwelling
             catheter at the time of surgery).

          -  Current infection at site of injection

          -  Women of child-bearing potential who are on Medicare (child-bearing potential will be
             determined prior to surgery per Anesthesia standard of care)

          -  Hypovolemia

          -  Indeterminate neurologic disease

          -  Allergy or hypersensitivity to the study medications

          -  Currently taking any anti-coagulation medications or coagulopathic

          -  Increased intracranial pressure

          -  Subject is unable to make his/her own decision regarding the informed consent

          -  Subject is unable to read/understand English
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
Condition: Back Pain Without Radiation; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Ketorolac; Ibuprofen; Diclofenac; Educational Intervention
Intervention description: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed; Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed; Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed; Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
Intervention MeSH terms: Ibuprofen; Diclofenac; Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: ketorolac; diclofenac; ibuprofen; low back pain; back pain

Summary:

      Purpose: This is a randomized clinical trial comparing the effects of three different
      medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac

      Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or
      diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris
      Disability Questionnaire (RMQ)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age 18-64.

          -  Present to ED primary for management of Low Back Pain (LBP)

          -  Functionally impairing back pain: A baseline score of greater than 5 on the
             Roland-Morris Disability Questionnaire

          -  Musculoskeletal etiology of low back.

          -  Non-radicular pain.

          -  Pain duration <2 weeks (336 hours).

          -  Non-traumatic LBP

          -  Participant is to be discharged home.

        Exclusion Criteria:

          -  Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.

          -  Not available for follow-up

          -  Pregnant

          -  Chronic pain syndrome

          -  Allergic to or intolerant of investigational medications

          -  Contra-indications to investigational medications
Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean
Condition: Nausea; Vomiting; Satisfaction
MeSH terms: Nausea; Vomiting
Intervention: Acupressure Point P6 stimulator; Metoclopramide; Ondansetron
Intervention description: This device stimulates the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device is placed on patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device is removed from the patient in the operating room, before the patient is transported to the recovery room. Patients receive continuous stimulation at a level that is comfortable for the patient prior to administration of the standardized regional anesthesia.; 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.; 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.
Intervention MeSH terms: Ondansetron; Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the effectiveness of acupressure point P6 stimulation
      versus intravenous ondansetron plus metoclopramide versus no antiemetic prophylaxis during
      elective cesarean section under regional anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female subjects ages 18 to 45

          2. Subjects with American Society of Anesthesiologists (ASA) Class I or II

          3. Subjects with elective primary or repeat cesarean delivery

          4. Subjects who receive combined spinal epidural anesthesia

          5. English and non-English speaking subjects will be included in the study

        Exclusion Criteria:

          1. Female subjects <18 years of age

          2. Subjects requiring emergent cesarean delivery

          3. History of placenta accrete

          4. Multiple gestation pregnancy

          5. ASA status III or higher

          6. Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia

          7. History of any chronic medication use (other than prenatal vitamins), including
             inhaler medications

          8. Current urinary tract infection, pneumonia, or otitis media
Normoglycemia and Neurological Outcome
Condition: Acute, Non-traumatic Subarachnoid Hemorrhage; Intraparenchymal Hemorrhage; Brain Injuries
MeSH terms: Brain Injuries; Subarachnoid Hemorrhage; Hemorrhage
Intervention: Insulin; Conventional insulin treatment
Intervention description: All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.; All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: SAH (Subarachnoid Hemorrhage); Brain Hemorrhage; Traumatic Brain Injury; SAH; ICH

Summary:

      Brain injury patients who meet defined criteria will be assigned to intensive insulin
      treatment (target blood glucose levels of 10-110 mg/dl) or conventional IV insulin treatment
      (target glucose of 150-170 mg/dl). Follow up will occur at 3, 6 and 12 months. The primary
      outcome measure will be neurological outcome at 12 months according to Karnofsky Performance
      Scale (KPS). A general view of outcome will also be presented as favorable (good recovery+
      moderate disability), unfavorable (severely disabled+ vegetative state), and dead.

      Secondary outcome measures will be blood glucose levels and death.The investigators will also
      record systemic complications like pulmonary emboli, pulmonary edema, myocardial infarction,
      ventricular arrhythmias, and pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-traumatic SAH, ICH, or TBI

          -  Glasgow Coma Scale between 6 and 14

          -  admitted to an ICU of University of Louisville Hospital

        Exclusion Criteria:

          -  Patients <18 and >80 years

          -  GCS Motor score <4 or an overall GCS score of 15

          -  diabetic patients who suffer from dialysis-dependent diabetic nephropathy

          -  patients with multiple injuries

          -  patients who would have been classified as ASA 3 status prior to their acute
             neurological event
Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
Condition: Onychomycosis of Toenail
MeSH terms: Onychomycosis
Intervention: Efinaconazole 10% Topical Application Solution [JUBLIA]; Application of Nail Polish
Intervention description: Topical efinaconazole 10% solution (Jublia); Application of Nail Polish
Intervention MeSH terms: Efinaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Minimum age: 19 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal
      infections in patients who wear polish compared to those who do not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female age 19-70, as 19 is the legal age in Alabama

          -  DLSO affecting at least 1 great toenail diagnosed with positive potassium hydroxide
             microscopy and culture of a dermatophyte

          -  Suitable for application of topical antifungal therapy, in the opinion of the
             investigator

          -  Target toenail thickness of 3 mm or less as measured by digital caliper, as thickness
             greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this
             was the criteria used in the pivotal trial using topical efinaconazole for
             onychomycosis

          -  Women of childbearing potential will be required to use birth control and a negative
             urine pregnancy test must be documented prior to initiating treatment

        Exclusion Criteria:

          -  History of immunosuppression or concurrent use of immunosuppressant drugs

          -  History of uncontrolled diabetes mellitus

          -  History of psoriasis or any other condition that might interfere with the toenail
             evaluation

          -  Three or more dermatophytomas (streaks) on the target nail

          -  Severe DLSO of the target nail

          -  Patients who cannot refrain from wearing gel or plastic based polishes that are used
             in salons and that require curing
SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Brinz/brim vehicle; Prostaglandin analogue
Intervention description: Inactive ingredients used as a placebo for masking purposes
Intervention MeSH terms: Brimonidine Tartrate; Bimatoprost; Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 290.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering
      effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a
      prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of either open-angle glaucoma or ocular hypertension;

          -  Must sign an informed consent form;

          -  Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the
             same eye[s]) ≥ 19 and < 32 mmHg at 09:00.

          -  Willing and able to attend all study visits;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential who are pregnant, breast-feeding, intend to become
             pregnant during the study, or not using adequate birth control methods to prevent
             pregnancy throughout the study;

          -  Any form of glaucoma other than open-angle glaucoma or ocular hypertension;

          -  Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in
             the protocol;

          -  Any other conditions including severe illness which would make the subject, in the
             opinion of the Investigator, unsuitable for the study;

          -  Other protocol-specified exclusion criteria may apply.
A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD
Condition: Influenza; Influenza-like Illness; Influenza Vaccines
MeSH terms: Influenza, Human
Intervention: Egg based influenza vaccines; Recombinant influenza vaccines; Cell-culture based influenza vaccines
Intervention description: Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.; Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.; Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019,2019-2020, 2020-2021, and 2021-2022).
Masking: None (Open Label)
Enrollment: 15449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine

Summary:

      A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study
      arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based
      vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons
      (2018-2019, 2019-2020, 2020-2021, and 2021-2022).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Eligible for care in Department of Defense medical facilities (Defense Enrollment
             Eligibility Reporting System eligible)

          2. ≥18 years of age.

          3. At a participating Military Treatment Facility site for the purpose of receiving a
             seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.

          4. Able to speak English and able to provide informed consent

          5. Able to receive and respond to texts and/or emails, or a military recruit

        Exclusion Criteria:

          1. Adults intending to receive or who have received the current seasons FluMist Vaccine
             (LAIV)

          2. Adults who have already received a flu vaccine within the current season

          3. Individual who cannot receive a flu vaccine or standard dosing due to another medical
             condition

          4. Allergic to gentamicin, polymyxin and/or neomycin

          5. Individuals who fail to meet the inclusion criteria
Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide
Condition: Healthy Volunteers; Endotoxemia
MeSH terms: Endotoxemia
Intervention: Defibrotide; Placebo (0.9% sodium chloride); Lipopolysaccharide; Placebo (0.9% sodium chloride bolus)
Intervention description: 6.25mg/kg bodyweight over 2h infusion; (0.9% sodium chloride) infusion over 2h infusion; bolus infusion of 2ng/kg bodyweight lps; (0.9% sodium chloride) bolus infusion
Intervention MeSH terms: Defibrotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized to receive LPS (n=16) or placebo (n=4) first. In each group they will undergo two study periods (crossover trial): a placebo period and a defibrotide period. The placebo group (n=4) will only be analyzed descriptively.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Coagulation; Inflammation; Defibrotide; Fibrinolysis

Summary:

      Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of
      veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact
      mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will be
      investigated in the human endotoxemia model in order to gather further information on its
      actions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years of age

          -  <90kg body weight

          -  Normal findings in medical history and physical examination unless the investigator
             considers the abnormality to be clinically irrelevant

          -  Normal laboratory values unless the investigator considers abnormalities to be
             clinically irrelevant

          -  Ability to understand the purpose and nature of the study, as well as the associated
             risks

        Exclusion Criteria:

          -  Intake of any drugs that may interfere with the trial's endpoints or drugs (i.e.
             platelet inhibitors, anticoagulants, etc.)

          -  Positive results of HIV or hepatitis virology

          -  Acute illness with systemic inflammatory reactions

          -  Known allergies, hypersensitivities or intolerances to any of the used substances

          -  Acute or recent bleeding episodes, increased risk of bleeding at the discretion of the
             investigator

          -  Participation in an LPS trial within 6 weeks of the first study day

          -  Pregnancy or breastfeeding