bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Entecavir; Lamivudine Placebo; Lamivudine; Entecavir Placebo
Intervention description: Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks); Capsules, Oral, 0 mg, once daily (0-96 weeks); Capsules, Oral, 100 mg, once daily (0-96 weeks)
Tablets, Oral, 100 mg, once daily (96-240 weeks); Tablets, Oral, 0 mg, once daily (0-96 weeks)
Intervention MeSH terms: Lamivudine; Entecavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B
      DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain
      reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100
      mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus
      infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nucleoside and nucleotide-naive subjects with chronic HBV infection

          -  Hepatitis B Surface antigen(HBsAg)-positive ≥6 months

          -  Detectable HBsAg

          -  HBV DNA ≥ 105 copies/mL by PCR

          -  ALT 1.3 to 10 x the ULN

          -  HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status
PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone
Intervention description: Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 491.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Paliperidone; R076477; Schizophrenia

Summary:

      The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER)
      in participants with schizophrenia (psychiatric disorder with symptoms of emotional
      instability, detachment from reality, often with delusions and hallucinations, and withdrawal
      into the self).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Clinical Global Impression-Severity (CGI-S) score greater than or
             equal to 4 points (moderately ill) at Screening

          -  Childbearing potential women who consent to the consistent use of the acceptable
             contraception (oral contraceptive, contraceptive injection, intrauterine device,
             double barrier method and contraceptive patch)

          -  Participants who are capable of and willing to fill out the questionnaire for
             themselves

          -  Participants who are compliant with self-medication or can receive consistent help or
             support

          -  Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders,
             fourth edition (DSM-IV)

        Exclusion Criteria:

          -  Participants with the past history of neuroleptic malignant syndrome (NMS)

          -  Participants with Treatment Resistance history who have failed to be properly treated
             with more than two other kinds of antipsychotic agents (at least 4 weeks of the
             therapeutic dose administration)

          -  Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or
             participants who can not swallow the drug whole (The study drug must not be chewed,
             divided, melted or grinded because it can impact the study drug release profile.)

          -  Participants who have been exposed to the study drug within one month before screening

          -  Participants with significant risk including suicide or aggressive behavior
Tobacco Use Treatment in Cancer Patients
Condition: Smoking, Cigarette
Intervention: Nicotine Replacement Therapy; Referral to AHEC/Quitline
Intervention description: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.; Participants will be referred to local AHEC/Quitline for treatment
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking, Cancer, Treatment

Summary:

      Tobacco use among cancer survivors reduces the effectiveness of cancer treatments, increases
      the risk for additional primary cancers, and increases mortality. Implementation of tobacco
      treatment for cancer patients is challenging, but may be improved substantially with
      clinically-efficient and sustainable solutions to accurately identify tobacco users, direct
      them to evidence-based treatment, and provide demonstrable outcomes for stakeholders.

      At UF Health Cancer Center (UFHCC), patient access and utilization of tobacco use treatment
      are sub optimal. Further, UFHCC has a largely rural catchment area with a high burden of
      tobacco-related disease and mortality. To address this research-to-practice gap using a
      mixed-methods approach to assess the relevant contextual factors at UFHCC and evaluate the
      feasibility of implementing a multi-level intervention to increase tobacco treatment
      utilization and improve health outcomes.

      This study uses a mixed methods approach and will inform the design of a pragmatic clinical
      trial to improve the delivery of tobacco use treatment services to cancer patients. Guided by
      a conceptual model that emphasizes patient, provider, and organizational characteristics, the
      study team will identify factors that influence the implementation process at the UFHCC. The
      ultimate goal of the proposed research is to provide new knowledge to facilitate the
      widespread adoption, implementation, and dissemination and sustained utilization of
      evidence-based tobacco use treatments in cancer care settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  UF Health cancer patients, 18 years and older, who are current smokers.

        Exclusion Criteria:

          -  Patients with unstable medical or psychiatric illness or

          -  Patients with a use disorder for illicit drugs.
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide; Placebo
Intervention description: Oral, once daily; Oral, one daily
Intervention MeSH terms: Linaclotide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to determine the effect of linaclotide on abdominal girth in
      IBS-C participants with the baseline symptoms of abdominal bloating and an increased
      abdominal girth.
    

Eligibility criteria:

        Inclusion Criteria:

        • Patient meets protocol criteria for diagnosis of IBS-C, abdominal pain, abdominal
        bloating and abdominal girth

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has both clinically significant findings and unexplained clinically
             significant alarm symptoms

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Doxycycline; Metronidazole; Placebo
Intervention description: During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads), oral, one capsule daily in the morning; During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area; During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning
Intervention MeSH terms: Metronidazole; Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea
      during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen
      of Oracea® and MetroGel® 1%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female aged 18 to 80 years inclusive.

          -  Subject with papulopustular rosacea (11 to 40 papules or pustules) and an IGA of
             moderate or severe.

          -  For subjects using medications to treat a concurrent medical condition, type and dose
             must have been stable for at least 90 days prior to study entry.

        Exclusion Criteria:

          -  Female subjects who are pregnant, nursing or planning a pregnancy during the study.

          -  Subject has any other active dermatological condition on the face that may interfere
             with the conduct of the study.

          -  Subject uses or has recently used any medication which may interfere with the
             absorption, distribution, or elimination of study medications, or may interfere with
             the assessments of efficacy or safety of the study medications.

          -  Subject has a known allergy to any of the components of the study products, and/or a
             known hypersensitivity to tetracyclines or metronidazole.
Endotracheal Tube Holder and Bite Guard Research
Condition: Surgery; Anesthesia
Intervention: Haider ETT Tube Holder and Bite Guard; Tape
Intervention description: Surgery patients will have endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard change in ETT tip position caused by traction up to 15N was measured prior to surgery.; Surgery patients will have endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ETT Holder, bite guard, airway, endotracheal tube

Summary:

      This study aims to test the effectiveness of a novel combined endotracheal tube holder and
      bite guard when compared with the current standard of care, tape and an oral airway.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  General anesthesia requiring oral endotracheal intubation in the prone position for
             the duration of surgery (head secured in a foam head holder, horseshoe frame, or
             Mayfield pins).

          -  General anesthesia for neurosurgery requiring oral endotracheal intubation, supine or
             slight lateral bump position for the duration of surgery. (Special emphasis will be
             placed on including patients who will undergo motor evoked potentials, and thus will
             not be paralyzed during the surgery).

          -  General anesthesia requiring oral endotracheal intubation with a left sided
             double-lumen endotracheal tube for lung isolation, lateral position for the duration
             of surgery.

        Exclusion Criteria:

          -  Dentition issues (loose teeth, missing teeth)

          -  Temporomandibular joint disease

          -  Maxillofacial abnormalities (deformities of the jaw, lips, tongue)

          -  Surgical procedures involving the teeth, lips, jaw

          -  History of asthma or bronchospasm

          -  Immunosuppression.
Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine; liposomal bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Randomized controlled trial; anesthetics-local; bupivacaine; analgesia; Pain, Postoperative

Summary:

      A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local
      injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic
      urologic surgeries in an effort to determine which method reduced postoperative opioid use
      the most.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18-years-old, undergoing laparoscopic urologic surgery.

        Exclusion Criteria:

          -  Pregnant and/or nursing mothers.

          -  Allergy to bupivacaine.
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
Condition: Hypercholesterolemia With Type2DM
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Intervention: Pitavastatin; Atorvastatin
Intervention description: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks; Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
Intervention MeSH terms: Atorvastatin; Pitavastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: pitavastatin; PWV; ESPRIT; Pitavastatin and Atorvastatin; Adiponectin; fasting insulin; hs-CRP; baPWV

Summary:

      A randomized, open label, dose titration study to evaluate the efficacy and safety of
      Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 25yrs~75yrs

          -  Fasting TG <400mg/dL, LDL-C ≥130mg/dL

          -  3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM,
             6.5%≤HbA1c≤10.0%

        Exclusion Criteria:

          -  Type1 DM, Gestational diabetes

          -  Patient need to treat with Insulin

          -  Patient with operational treatment for severe diabetic complication

          -  Uncontrolled Hypothyroidism

          -  Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within
             3 months (NYHA class4)

          -  Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)

          -  Renal disorder (Serum creatinine ≥ 2.0mg/dL)

          -  Hepatic disorder (AST or ALT ≥ 2.5 X UNL)

          -  Creatinine Kinase > 2.5 X UNL

          -  Gravida or lactation phase

          -  Administration of Atorvastatin, Rosuvastatin, Pitavastatin
Symptom Control Satisfaction With Proton Pump Inhibitor Regimen
Condition: Heartburn
MeSH terms: Heartburn
Intervention: Optimal Dosing of Omeprazole
Intervention description: Omeprazole 20 mg
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The overall aim of this study is to assess if patients with persistent gastroesophageal
      reflux disease (GERD) symptoms receiving sub-optimal omeprazole dosing experience improvement
      in GERD symptoms when prescribed an optimal dosing regimen. The optimal dosing regimen is
      defined as taking omeprazole 30 minutes prior to the first meal of the day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years old

          -  taking omeprazole 20 mg

          -  episodic heartburn at least 3 times per week

          -  provides consent and be willing to complete study questionnaires

          -  read, speak and write English

        Exclusion Criteria:

          -  weight loss (alarm symptom)

          -  normal esophagogastroduodenoscopy (EGD) in last one year

          -  pregnant or women planning on becoming pregnant at any time during the study

          -  history of Barrett's esophagus

          -  prior esophageal strictures

          -  intolerance/allergy to study medications

          -  patients on plavix or a history of upper gastrointestinal surgery

          -  investigators or their immediate family (spouse, children, sibling)
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
Condition: Intraoperative Bleeding
MeSH terms: Blood Loss, Surgical
Intervention: Epinephrin; 1% lidocaine with epinephrin 1:100,000; Saline
Intervention description: Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity; 4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site); 4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      In endoscopic sinus surgery a clear surgical field of view is a very important aspect for
      good surgical outcome. This study is to evaluate the preoperative preparation to acquire best
      surgical field of view by comparing between the use of topical adrenaline and the use of
      combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in
      patients scheduled for endoscopic sinus surgery for rhinosinusitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical
             treatment and scheduled for endoscopic sinus surgery

        Exclusion Criteria:

          -  Patients who have asymetrical disease on the two sides (Lund Mackay score difference
             more than 2)

          -  Patients who have endoscopic sinus surgery for treatment of tumor or disease other
             than sinusitis

          -  Patients with underlying uncontrolled hypertension

          -  Patients with bleeding disorder or are unable to discontinue antiplatelet or
             anticoagulant before the surgery

          -  Patients who are allergic to adrenaline or to xylocaine
Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty
Condition: Osteoarthritis; Acetaminophen; Arthroplasty, Hip Replacement
MeSH terms: Osteoarthritis
Intervention: Intravenous acetaminophen; Oral acetaminophen
Intervention description: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.; Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 56 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if intravenous acetaminophen is superior to oral
      acetaminophen when used as part of a multimodal pathway for primary total hip arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for elective, primary total hip replacement for osteoarthritis

          -  American Society of Anesthesiologists (ASA) Physical Classification I-III

          -  Weight 50 kg or greater

          -  Body mass index 18-40 kg/m2

        Exclusion Criteria:

          -  Inability to consent to study

          -  Inability to speak English

          -  Pregnancy

          -  Weight <50 kg

          -  Revision hip replacement or emergency surgery

          -  Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local
             infection, allergy to local anesthetics

          -  Allergies/intolerances/contraindications to any of the multimodal agents:
             acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone

          -  Chronic pain from a separate source other than operative hip

          -  Daily opioid equivalent use of 30 mg of morphine or greater at time of consent

          -  History of heart failure

          -  History of drug or alcohol abuse

          -  Rheumatoid arthritis

          -  Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion
             of the investigator, may interfere with the study assessments

          -  Chronic malnutrition, renal or liver impairment

          -  Hypersensitivity to acetaminophen or any of its excipients