bioihbjkbjnl/mcl2 huggingface dataset:
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
Condition: Hepatitis C, Chronic; HIV Infection
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Raltegravir; Efavirenz
Intervention description: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily; Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Intervention MeSH terms: Efavirenz; Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV/HCV co-infection; Antiretroviral therapy

Summary:

      The main objective is to evaluate the hepatic safety of raltegravir when compared to
      efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment
      in patients with HIV and hepatitis C coinfection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count <
             350 cells/mm3 and/or WHO stage III or IV disease)

          -  Hepatitis C infection as documented by positive HCV antibodies and a detectable serum
             HCV RNA level

          -  AST and ALT ≤ 2 x ULN (≤ 80 U/L)

          -  Estimated creatinine clearance ≥ 60 mL/min

        Exclusion Criteria:

          -  Any prior ART

          -  Positive Hepatitis B surface antigen

          -  Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal
             bleeding)

          -  Requirement for acute therapy for other AIDS-defining illness within 14 days prior to
             study entry

          -  Currently on rifampicin therapy

          -  In the first trimester of pregnancy, intent to become pregnant, or breast feeding
             during the study period
Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia
Condition: Surgery
Intervention: Propofol 2mg/kg; Etomidate 0.3 mg/kg; Propofol 1 mg/kg; Etomidate 0.15 mg/kg
Intervention description: 2 mg/kg; 0.3 mg/kg; 1 mg/kg Propofol; 0.15 mg/kg Etomidate
Intervention MeSH terms: Propofol; Etomidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients in 3 cohorts will be administered 30 second bolus by manual hand push
Masking: Single (Participant)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Etomidate; Propofol

Summary:

      Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of
      anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for elective non-cardiac surgery

          -  ASA physical status of 2 or 3

          -  Age equal to or greater than 18 years old

        Exclusion Criteria:

          -  Adults unable to provide consent

          -  Age less than 18 years old

          -  Pregnant women

          -  Prisoners

          -  Difficult airway

          -  Morbid Obesity

          -  Preoperative sedation use

          -  Severe Cardiac, pulmonary and liver disease

          -  Hypotension and shock

          -  Emergency surgeries

          -  Allergy to propofol or etomidate
Predictors of Lorcaserin-Induced Weight Loss
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Intervention: Belviq; Placebo
Intervention description: Belviq is an oral drug; The placebo is made to mimic Belviq, but does not contain any active drug
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Overweight; Obesity; Weight Loss; Lorcaserin; Healthy Volunteers

Summary:

      This two-phase study aims to explore ways to predict who will respond well to the weight loss
      drug lorcaserin and to understand the mechanisms that develop which limit drug efficacy.
      Subjects will be recruited for a 5-week crossover study (phase 1) with lorcaserin and placebo
      followed by treatment with lorcaserin for 24 weeks (phase 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) 28-40

        Exclusion Criteria:

          -  Any clinically significant or relevant medical condition, including:

          -  Diabetes

          -  Uncontrolled Hypertension

          -  Heart disease

          -  Bleeding disorder

          -  Kidney or liver dysfunction

          -  Neurologic disease

          -  Psychiatric or eating disorders

          -  Pregnancy or breastfeeding

          -  Use of tobacco or opiates

          -  History of alcohol or drug abuse

          -  Recent weight change +/- 5%

          -  Medications that affect body weight
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal; Neonatal Opioid Withdrawal Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome; Substance Withdrawal Syndrome
Intervention: Morphine PRN; Morphine scheduled
Intervention description: Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.; Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Maximum age: 28 Days
Healthy volunteers: No
Keywords: morphine; Finnegan

Summary:

      Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to
      intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  newborn greater than or equal to 35 weeks gestation

          -  intrauterine opioid exposure

          -  signs and symptoms of opioid withdrawal

        Exclusion Criteria:

          -  congenital anomalies or suspected genetic condition

          -  co-morbid conditions that require sedation or analgesia due to clinical condition

          -  ongoing need for respiratory support
Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients
Condition: Otolaryngeal Cancer
MeSH terms: Delirium
Intervention: Ketamine; Placebo; Electroencephalogram (EEG)
Intervention description: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.; Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.; A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anesthesiology

Summary:

      The goal of this prospective randomized double blinded placebo controlled study is to
      investigate if a single dose of ketamine in addition to standard anesthesia will reduce the
      risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on
      post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will
      be utilized during the surgical procedure to evaluate its potential as a possible predictive
      device for delirium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current diagnosis of otolaryngeal cancer and undergoing surgery with general
             anesthesia

          -  Competent to provide informed consent

        Exclusion Criteria:

          -  Emergency surgery

          -  Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general
             anesthesia)

          -  Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor
             placement

          -  Poor health literacy

          -  Allergy, or have experienced any drug reaction to ketamine

          -  Pregnant or lactating

          -  Currently in active alcohol withdrawal

          -  Taking buprenorphine for chronic pain
ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
Condition: Shingles
MeSH terms: Herpes Zoster
Intervention: ZOSTAVAX
Intervention description: Shingles vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: solid tumor; chemotherapy; vaccine

Summary:

      This study evaluates if the shingles vaccine works in those persons that receive it before
      they receive chemotherapy for solid organ tumors. Half of the participants will receive the
      ZOSTAVAX shingle vaccine and half of the participants will not received anything.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Solid organ tumor patients that have at least 14 days between entry into the study
             with ZOSTAVAX vaccination and initial therapy for their malignancy that will include
             chemotherapy alone or surgery with subsequent chemotherapy plus or minus radiation
             therapy

          -  A plan for chemotherapy that at the onset at least an anticipated stop date within 3-6
             months of our sample collection phase of the study

        Exclusion Criteria:

          -  Prior history of HZ or shingles vaccine

          -  Systemic chemotherapy < 3 months prior to enrollment

          -  Any history of hematologic malignancy, HIV/AIDS, hematopoietic stem cell transplant,
             or other cellular immunodeficiency state

          -  Those receiving immunomodulating drugs at the time of vaccination such as prednisone
             methotrexate, azathioprine, mercaptopurine, or other biologics including TNF-alpha
             inhibitors

          -  Widespread metastatic tumor with bone marrow involvement

          -  Indefinite duration palliative chemotherapy subjects

               -  Inability to communicate with the study staff or bring unable to consent for
                  themselves

               -  History of anaphylactic/anaphylactiod reaction to gelatin, neomycin, or other
                  components of the vaccine
Total Intravenous Anesthesia in Sinus Surgery
Condition: Advanced Chronic Rhinosinusitis
Intervention: Propofol; Sevoflurane
Intervention MeSH terms: Propofol; Sevoflurane; Isoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve
      visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease
      in cardiac output without the peripheral smooth muscle relaxation and resultant vasodilation
      associated with inhaled anesthetics. This may be especially important in cases of advanced
      inflammatory sinus disease, when visualization may be most compromised. The goal of this
      study is to improve clinical practice paradigms by evaluating the use of TIVA versus inhaled
      anesthetic for maintenance of anesthesia in ESS for advanced paranasal sinus disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing endoscopic sinus surgery

          -  Advanced inflammatory sinus disease, defined as allergic fungal sinusitis, chronic
             rhinosinusitis with nasal polyposis, chronic rhinosinusitis with eosinophilia, or
             rhinosinusitis with pan-sinus opacification (Lund-Mackay score >12).

        Exclusion Criteria:

          -  Noninflammatory sinonasal disease

          -  Disease extending through the skull base or orbital wall

          -  American Society of Anesthesiologists Preoperative Health Status >II

          -  Known non-pharmacologic coagulopathy (platelet < 50000/mL, international normalized
             ratio > 1.2)

          -  Preoperative anticoagulants within 7 days of surgery

          -  Allergy to one of the study medications

          -  Age under 18 years

          -  Non-English-speaking
Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Condition: COPD; Chronic Bronchitis; Emphysema
MeSH terms: Bronchitis; Bronchitis, Chronic; Emphysema
Intervention: pneumatic vest; placebo pneumatic vest
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to show that one form of mechanical airway clearance techniques,
      High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish
      exacerbations of COPD which will improve respiratory health status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician Diagnosis of COPD,chronic bronchitis and/or emphysema

          -  Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) < or = 70%

          -  FEV1 < or = 65%

          -  Current or former smoker > or = 20 pack years

          -  History of 1 or more COPD exacerbations in past 6 months necessitation
             hospitalization, Emergency Department (ED) visit, antibiotic or steroid prescription

        Exclusion Criteria:

          -  Other lung diseases

          -  Co-morbid illnesses such as cancer, liver disease, cardiomyopathy

          -  Recent chest wall or abdominal trauma or surgery that would preclude using the vest
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: methotrexate (MTX); adalimumab (ADA)
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis

Summary:

      An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country
      study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up
      to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between
      participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX
      alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week
      32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment
      regimens using adalimumab and/or MTX, with participant allocation based on the initial
      randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.
    

Eligibility criteria:

        Inclusion Criteria:

          1. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit
             and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria

          2. Not in MDA at the time of screening

          3. Has 3 or more tender and 3 or more swollen joints

          4. Treated with methotrexate 15 mg (weekly) for at least 4 weeks

        Exclusion Criteria:

          1. Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or
             its excipients

          2. History of methotrexate intolerance/toxicity

          3. Medical conditions(s) precluding methotrexate dose increase above 15 mg

          4. Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of
             action biologic DMARD (bDMARD) or any systemic biologic agent in general
Effect of Cequa™ in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: CequaTM (Cyclosporine 0.09%) ophthalmic solution
Intervention description: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Intervention MeSH terms: Cyclosporine; Ophthalmic Solutions; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Keratoconjunctivitis Sicca; KCS; Dry eye

Summary:

      This is a Phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease,
      which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects with a history of bilateral dry eye disease for a period of at
             least 3 months.

          2. Aged of at least 18 years.

          3. Subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in
             an individual zone ≥2 as per National Eye Institute Grading Scale.

          4. Subjects with modified symptom assessment in dry eye global symptom score, ≥40 using
             visual analogue scale.

          5. Subjects with best-corrected visual acuity 20/200 or better in both eyes at the
             Screening/Baseline visit

        Exclusion Criteria:

          1. Subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less
             than 3 months prior to the Screening/Baseline visit.

          2. Subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion.

          3. Subjects who have active seasonal and/or perennial allergic conjunctivitis in either
             eye.

          4. Subjects who had already Use initiated any systemic or topical ocular medication.
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Intervention: Povidone-Iodine; Normal Saline
Intervention description: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine; Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 173.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Scoliosis; Spine fusion; 0.35% povidone-iodine

Summary:

      This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal
      patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of
      povidone-iodine and normal saline irrigation at reducing bacterial contamination of the
      surgical wound will be measured by collecting cultures before and after irrigation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 3 to 18 years on day of surgery

          2. diagnosis of spinal deformity

          3. undergoing elective posterior spine multi-level instrumentation surgery

        Exclusion Criteria:

          1. Documented renal failure

          2. documented allergy to iodine or shellfish

          3. previous spine fusion surgery

          4. undergoing elective posterior spine single-level instrumentation surgery

          5. undergoing anterior spine multi-level instrumentation surgery

          6. current antibiotic use.
Triple Combination Therapy in High Risk Crohn's Disease (CD)
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: Vedolizumab; Adalimumab; Methotrexate
Intervention description: Vedolizumab intravenous infusion.; Adalimumab injection for subcutaneous use.; Methotrexate oral tablets.
Intervention MeSH terms: Adalimumab; Methotrexate; Vedolizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine the effect of triple combination therapy with an
      anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist
      (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic
      remission in participants with newly-diagnosed CD stratified at higher risk for
      complications.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has an initial diagnosis of CD established within 24 months prior to screening with
             involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.

          2. Has moderate to severely active CD during Screening defined by a centrally assessed
             simple endoscopic score for Crohn disease (SES-CD) score >=7 (or >=4 if isolated ileal
             disease).

        Exclusion Criteria:

        Gastrointestinal (GI) Exclusion Criteria

          1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.

          2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal
             abscess.

          3. Has a known perianal fistula with abscess. (The participant may have a perianal
             fistula without abscess.)

          4. Has a known fistula (other than perianal fistula).