bioihbjkbjnl/mcl2 huggingface dataset:
Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Condition: Heart Disease
MeSH terms: Heart Diseases
Intervention: Dexmedetomidine; Placebo
Intervention description: Dexmedetomidine; Normal saline administration matching dexmedetomidine rate of infusion
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 798.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-85 years old;

          2. Scheduled for cardiac surgery with bypass (CABG, valve, or combined);

          3. Able to provide a written informed consent;

          4. Hemodynamically stable (heart rate>= 55).

        Exclusion Criteria:

          1. Sick sinus syndrome or Wolff-Parkinson-White syndrome

          2. Atrio-ventricular block

          3. Hypersensitivity or known allergy to dexmedetomidine

          4. Hepatic disease, e.g. twice the normal level of liver enzymes

          5. Atrial fibrillation within 1 preoperative month;

          6. Permanent pacemaker;

          7. Use of amiodarone or dexmedetomidine within the last 30 days;

          8. Patients with an ejection fraction under 30% or who had severe heart failure

          9. Myocardial infarction in the previ¬ous 7 days;

         10. Body mass index =< 40 (BMI= mass (kg) / height (m)2);

         11. Those taking clonidine within last 48 hours.
Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV
Condition: Genital Herpes; HIV Infection
MeSH terms: Herpes Simplex; Herpes Genitalis
Intervention: valacyclovir; acyclovir
Intervention description: valacyclovir 1000 mg orally twice daily for 12 weeks.; acyclovir 400 mg orally twice daily for 12 weeks.
Intervention MeSH terms: Valacyclovir; Acyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Herpes Simplex Virus Type 2; Human Immunodeficiency Virus; Treatment Naive

Summary:

      To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus
      standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV
      reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The
      investigators hypothesize that high-dose valacyclovir will result in greater reduction in
      plasma HIV-1 and genital HSV reactivation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Documented HIV-1 seropositive

          -  Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy
             during the study period

          -  Detectable HIV-1 plasma viral load

          -  HSV-2 seropositive as determined by western blot

          -  Not intending to move out of the area for the duration of study participation

          -  Willing and able to provide independent written informed consent

          -  Willing and able to undergo clinical evaluations

          -  Willing and able to take study drug as directed

          -  Willing and able to adhere to follow-up schedule

        Exclusion Criteria:

          -  Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir

          -  Planned open label use of acyclovir, valacyclovir, or famciclovir

          -  History of evidence of CMV disease

          -  Known medical history of seizures

          -  Known renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl

          -  AST or ALT greater than 3 times upper limit of normal

          -  Hematocrit less than 30 %

          -  Neutropenia, defined as absolute neutrophil count less than 1000

          -  Thrombocytopenia, defined as platelet count less than 75,000

          -  History of thrombotic microangiopathy

          -  For women, pregnancy as confirmed by a urine pregnancy test

          -  Any other condition which, in the opinion of the principal investigator, may
             compromise the ability to follow study procedures and complete the study
Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: Doxycycline; Azithromycin; Augmentin
Intervention description: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.; Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.; If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
Intervention MeSH terms: Azithromycin; Doxycycline; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics
      as part of maximal medical therapy for treating chronic sinusitis and thus preventing
      patients from having to have sinus surgery. The hypothesis is that in the context of maximal
      medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at
      successfully treating chronic sinusitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic rhinosinusitis

          -  18 years of age or older

          -  English speaking

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  vasculitis

          -  cystic fibrosis

          -  primary ciliary dyskinesia

          -  allergic fungal sinusitis

          -  gross immunodeficiency

          -  current use of chemotherapy

          -  insulin-dependent diabetes mellitus

          -  recent trial of maximal medical therapy
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery
Condition: Cesarean Section Complications; Wound Breakdown; Wound Infection; Satisfaction; Surgical Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Surgical Wound Dehiscence; Wounds and Injuries; Surgical Wound
Intervention: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG); Standard Wound Care
Intervention description: Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7; Wound care will be administered as standard protocol in our institution
Intervention MeSH terms: Disinfectants
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label randomized control trial
Masking: None (Open Label)
Masking description: Data analysis will be blinded to assignment including the principal investigator.
Enrollment: 154.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cesarean; Wound care; Wound complication; Surgical site infection

Summary:

      This will be an open label pilot randomized controlled clinical trial. Women undergoing
      cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine
      gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-50 years of age.

          -  Women ≥ 24 weeks' viable gestation.

          -  To undergo cesarean delivery.

          -  Admission BMI ≥ 35.

        Exclusion Criteria:

          -  Patient unwilling or unable to provide consent.

          -  No prenatal care or a non-resident patient who is unlikely to be followed-up after
             delivery.

          -  Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g.
             transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or
             other.

          -  Decision not to have skin closure (e.g. secondary wound closure, mesh closure).

          -  Current skin infection.

          -  Coagulopathy.

          -  High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled
             hysterectomy, bowel or adnexal surgery).

          -  Known allergy to CHG.

          -  Incarcerated individuals.

          -  Chorioamnionitis.

          -  Subjects participating on other treatment trials or studies that would interfere with
             the current study's primary outcome.
A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery
Condition: Thoracolumbar Scoliosis
MeSH terms: Scoliosis
Intervention: Methadone; Normal Saline
Intervention description: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes; the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Intervention MeSH terms: Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can
      affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which
      is a measurement used for evaluation of curves in scoliosis on an anterior-posterior
      radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40
      degrees in the lumbar region) or when the curvature causes significant pain, or respiratory
      and cardiovascular restriction. Patient undergoing this surgical correction experience severe
      pain in the postoperative period and the management includes the use of opioid-based
      patient-controlled analgesia (PCA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient age 10 - 17 years

          2. Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and
             fusion

        Exclusion Criteria:

          1. Preoperative methadone therapy

          2. Inability to use the PCA

          3. Allergy to methadone or morphine

          4. Morbid obesity with a body mass index >36.0 kg/m2

          5. Patients with chronic renal failure defined by serum creatinine >2.0 mg/dL

          6. Liver failure defined as a history of cirrhosis or fulminant hepatic failure

          7. Preoperative congenital heart disease or arrhythmias

          8. Patient refusal to participate in study

          9. Pregnancy (It is standard of care for all post menarche female patients to undergo a
             urine pregnancy test prior to surgery).
Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C
Condition: Chronic Kidney Disease; Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Viekira Pak ± ribavirin; Mavyret
Intervention description: 12 weeks treatment with AbbVie Viekira Pak ± ribavirin; 8 or 12 weeks treatment with AbbVie Mavyret
Intervention MeSH terms: Ribavirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This a single-arm study. Initially, Viekira Pak was available through Abbvie. However, once Mavyret became available, it supplanted Viekira Pak as the study medication.
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD; HCV

Summary:

      Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for
      adults with chronic kidney disease and hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥ 18 year of age

          2. HCV genotype 1 ≥ 1000 IU/mL

          3. 6. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi
             equation

        Exclusion Criteria:

          1. Pregnant or lactating females

          2. Uncontrolled depression or psychiatric disease

          3. History or presence of any form of cancer within 3 years of enrollment

          4. Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of
             rituximab, steroids or plasmapheresis.

          5. Uncontrolled cardiovascular or pulmonary disease

          6. Experiencing symptoms attributed to uremia

          7. Anticipated need to begin renal replacement therapy in the next 6 months

          8. History of kidney transplant
Pharmacogenomics and Post-Operative Nausea and Vomiting
Condition: Postoperative Nausea
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Granisetron; Ondansetron
Intervention description: Rapid metabolizer will receive 1mg IV Granisetron; Poor or normal metabolizers will receive 4mg Ondansetron IV
Intervention MeSH terms: Ondansetron; Granisetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacogenetics; CYP2D6; Ondansetron; Granisetron; Bariatric surgery

Summary:

      The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic
      data to guide post-operative nausea and vomiting treatment in the bariatric surgical
      population. The hypothesis is that using genotypic variation in CYP2D6 to select the
      appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in
      the bariatric surgical population.
    

Eligibility criteria:

        Inclusion Criteria

          -  A Mayo Clinic patient scheduled to undergo any bariatric surgical procedure, including
             Roux-en-Y gastric bypass, sleeve gastrectomy, or duodenal switch.

          -  Patient age 18 or above.

          -  Patients must understand and provide written informed consent and HIPAA authorization
             prior to initiation of any study-specific procedures.

          -  Patient is willing to engage in a medication adjustment as part of their clinical
             visit (when needed).

        Exclusion Criteria

          -  Patient with uncontrolled concurrent illness including psychiatric illness, or
             situations that would limit compliance with the study requirements or the ability to
             willingly give written informed consent.

          -  Patients that deny access to their medical records for research purposes will not be
             included in this study. Also any patient who will be unable to have genetic testing at
             minimum of 1 week prior to scheduled surgery or with allergies to ondansetron or
             granisetron.

          -  Any patient with prior genetic testing that is readily available in the medical record
             will be excluded from this study.

          -  Any patient that is pregnant
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Sodium fluoride / silica and carbopol, 0.5g; Sodium fluoride / silica and carbopol, 1.5g; Sodium fluoride / silica and carbopol, 1.5g; Fluoride free dentifrice
Intervention description: Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol; Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol; Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol; A non fluoride dentifrice was given to participants of each arm at washout period
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate and compare the effect of the amount of toothpaste used and brushing
      time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel
      fluoride uptake (EFU).
    

Eligibility criteria:

        Inclusion Criteria:

        General and Dental Health

          -  Good general and dental health with (in the opinion of the investigator) no clinically
             significant and relevant abnormalities of medical history or oral examination

          -  Have no current active caries or periodontal disease that may compromise the study or
             the health of the subjects

          -  Residency: Currently living in the Indianapolis, Indiana area

        Dentures:

          -  Currently wearing a removable mandibular partial denture with sufficient room in the
             posterior buccal flange area to accommodate two enamel specimens (required dimensions
             12 mm x 7 mm)

          -  Willing to have their denture modified to accommodate enamel test specimens and
             willing and capable of wearing their removable mandibular partial dentures 24 hours
             per day during the experimental periods

          -  All restorations in a good state of repair

          -  Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated
             whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥
             0.8 mL/minute)

        Exclusion Criteria:

          -  Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated
             use during the study treatment periods

          -  Study Scale Use: Subjects unable to measure product weights accurately using the
             assigned study scale as determined by the study staff (as demonstrated on or before
             Visit 4)

          -  A member of the site study staff who is directly working on the project or living in
             that staff's household

          -  Any employee of any toothpaste manufacturer or their spouse or family member
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Intervention: Interlaminar Decompression
Intervention description: The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spinal Stenosis; Lumbar Spinal Stenosis

Summary:

      This is a multi-center, prospective, clinical study to assess the clinical application and
      outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal
      stenosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element
             hypertrophy.

          -  Prior failure of conservative therapy.

          -  Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5mm, confirmed by pre-op MRI
             and/or CT.

          -  Central canal cross sectional area ≤ 100 square mm.

          -  Anterior listhesis ≤ 5.0mm.

          -  Able to walk at least 10 feet unaided before being limited by pain.

          -  Available to complete 12 weeks of follow-up.

          -  Consistent with the intended labeling statement for use.

          -  Able to use all package components to perform the procedure.

          -  A signed Informed Consent Form is obtained from the patient.

        Exclusion Criteria:

          -  Prior surgery at intended treatment level.

          -  History of recent spinal fractures with concurrent pain symptoms.

          -  Disabling back or leg pain from causes other than LSS (e.g. acute compression
             fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).

          -  Significant / symptomatic disk protrusion or osteophyte formation.

          -  Excessive / symptomatic facet hypertrophy.

          -  Bleeding disorders and/or current use of anti-coagulants.

          -  Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID)
             within 5 days of treatment.

          -  Epidural steroids within prior three weeks.

          -  Inability of the patient to lie prone for any reason with anesthesia support (e.g.
             chronic obstructive pulmonary disease (COPD), obesity, etc.).

          -  Any potential wound healing pathologies that may compromise outcomes, including
             diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine
             radiation and severe COPD.

          -  Dementia and/or inability to give informed consent.

          -  Pregnancy.

          -  Intended treatment that is defined by the product labeling contraindications.

          -  On Workman's Compensation or considering litigation associated with back pain.