bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
Condition: Post Operative Pain (Post Laparoscopic Hernia Repair)
MeSH terms: Hernia; Pain, Postoperative; Hernia, Inguinal
Intervention: 0.5% Bupivicaine
Intervention description: Local anesthetic
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post Operative Pain; hernia repair

Summary:

      To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia
      repair on post-operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair

          -  American Society of Anesthesiology (ASA) Class I and II

        Exclusion Criteria:

          -  Conversion from laparoscopic to open surgery

          -  History of Chronic pain or ongoing treatment for chronic pain

          -  Age less than 18 yrs

          -  Allergy to local anesthetics
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
Condition: Healthy Subjects
Intervention: 7-pneumococcal conjugate vaccine (7vPnC); diphtheria, tetanus, and acellular pertussis vaccine (DTaP); DTaP
Intervention description: 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 321.0
Sex: All
Minimum age: 3 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; pneumococcal conjugate

Summary:

      Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group
      1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular
      pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up
      doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to
      demonstrate that the immune responses as measured by serum antibody responses to diphtheria
      toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by
      DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP
      given alone. In addition, the study aims to evaluate the side effects (safety profile) after
      vaccination of 7vPnC when given with DTaP in healthy Japanese infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the
             last day the subject is 6 months of age) at time of enrollment.

          -  Available for entire study period and whose parent/legal guardian can be reached by
             telephone.

          -  Healthy infant as determined by medical history, physical examination, and judgment of
             the investigator.

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal, diphtheria,
             tetanus, or pertussis vaccines.

          -  A previous anaphylactic reaction to any vaccine or vaccine-related component.

          -  Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate any type of injection.

          -  History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis,
             bacteremia, osteomyelitis, arthritis).

          -  Subjects who are direct descendants (child, grandchild) of investigational site staff
             members or subjects who are direct descendants (child, grandchild) of Pfizer employees
             directly involved in the conduct of the trial.
Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation
Condition: Renal Transplant
Intervention: Enteric-Coated Mycophenolate Sodium (EC-MPS); Mycophenolate Mofetil (MMF)
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: QoL; GI Side Effects; MPA

Summary:

      This open, multi-center randomized controlled study is designed to investigate the quality of
      life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse
      events after converting to enteric-coated mycophenolate sodium (EC-MPS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Received kidney transplant

          2. Receiving immunosuppressive regimen that includes MMF

          3. Patients with GI side effects on standard MMF doses or patients on reduced dose MMF
             with existing but tolerated/controlled GI side effects.

          4. At least 18 years of age

          5. Willing to provide written informed consent

          6. Able to meet all study requirements including completing questionnaires and completing
             four study visits.

        Exclusion Criteria:

          1. Patients with GI symptoms assumed or known not to be caused by medroxyprogesterone
             acetate (MPA) therapy (e.g. oral bisphosphonate induced, infectious diarrhea)

          2. Acute rejection < 1 week prior to study enrollment

          3. Woman of child-bearing potential who is planning to become pregnant or is pregnant
             and/or lactating and who is unwilling to use effective means of contraception

          4. Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the
             opinion of the site investigator, would interfere with study requirements

          5. Undergoing acute medical intervention or hospitalization

          6. Any other medical condition that, in the opinion of the site investigator based on
             recall or chart review, would interfere with completing the study, including, but not
             limited to, visual problems or cognitive impairment.

          7. Receiving any investigational drug or have received any investigational drug within 30
             days prior to study enrollment.

        Additional protocol-defined inclusion/exclusion criteria may apply.
Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj
Condition: Arthroplasty, Replacement, Knee
Intervention: (Bupivacaine Liposome Injectable Suspension); Standard Preparation
Intervention description: Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.; A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Knee Arthroplasty, Total; Liposomal Bupivicaine

Summary:

      This study seeks to determine whether a new sustained-release local anesthetic solution
      (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after
      surgery will decrease opioid consumption and adverse events in opioid-tolerant patients
      presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study)
      group will use less opioid in the first 48 hours post-operatively than the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females age 18+ years old having total knee arthroplasty at UCI

          -  Meet at least one of the following criteria "opioid tolerant":

          -  Taking 50mg oral morphine equivalent or more per day

          -  On long-acting opioids (fentanyl pathc, oxycontin, methadone, etc.)

          -  Being followed by a chronic pain physician

          -  All subjects must be free of renal or hepatic dysfunction; defined as:

          -  Glomerular filtration rate >60 mL/min/1.73m^2

          -  AST & ALT <150, total bilirubin <1.0, INR <1.3 (if not taking anticoagulants)

          -  No active hepatitis, no jaundice

        Control group- received standard periarticular injection Research group- receives Exparel
        injection

        Exclusion Criteria:

          -  Allergy to local Anesthetic

          -  Pregnancy

          -  Nursing mothers

          -  Children<18 years of age

          -  Renal impairment (GFR<60 mL/min/1.73 m^2

          -  Hepatic impairment (active hepatitis, elevated AST or ALT, jaundice)

          -  Any history of ventricular arrhythmia or supraventricular tachycardia, or myocardial
             infarction within the last six months.
Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Adapalene/BPO Gel; Moisturizer SPF 30; Foam Wash
Intervention description: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily); Moisturizer SPF 30 (once daily); Foam Wash (twice daily)
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      This is an open-label, multi-center study to be conducted in the United States. The study
      will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in
      conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once
      daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for
      treatment with Epiduo® in accordance with the currently approved product labeling and who
      meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study
      products for 8 weeks. Efficacy and safety assessments include: complete lesion counts,
      cutaneous irritation assessment, end of study treatment questionnaire, photographic
      evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function
      assessment, treatment compliance, and adverse event assessment.
    

Eligibility criteria:

        Inclusion Criteria:

        - Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne,
        who are eligible for treatment with adapalene BPO gel in accordance with the currently
        approved product labeling.

        Exclusion Criteria:

        - Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or
        dermatological disorder, or topical condition or facial hair that could interfere with
        evaluations.
Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma
Condition: Hematoma, Subdural, Chronic
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Intervention: Dexamethasone; Placebo
Intervention description: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).; Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
Intervention MeSH terms: Dexamethasone
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
Keywords: [C10.228.140.300.535.450.400.120]

Summary:

      Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas
      are mostly based on observational studies. Here we present data from a prospective randomized
      pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or
      placebo for 30 days.

      Twenty patients with computed tomography (CT)- or magnetic resonance imaging (MRI)-confirmed
      CSDH were recruited from a single center and randomized in order to receive dexamethasone or
      placebo as a conservative treatment. Patients affected to the treatment group received oral
      dexamethasone 12mg/day for three weeks followed by tapering. These patients were followed for
      6 months and the rate of success of conservative treatment versus placebo was measured.
      Parameters such as hematoma thickness and global impression of change were also compared
      before and after treatment with chi-square tests. Adverse events and complications were
      documented.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years and older

          -  evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized
             tomography) scan or MRI (magnetic resonance imaging)

          -  classified between 0 and 2 using the Markwalder grading scale

        Exclusion Criteria:

          -  contraindications or intolerance to corticosteroid therapy

          -  patients already undergoing steroid treatment for any other indication

          -  previous neurological surgery up to one year prior to being considered for the study

          -  concomitant cerebral pathology of neoplastic or presumed infectious origin

          -  anticoagulant therapy that could not be stopped for 6 months

          -  refusal to participate in the study
Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
Condition: Endoscopic Sinus Surgery; Nasal Polyps
MeSH terms: Nasal Polyps
Intervention: Oxymetazoline; Epinephrine
Intervention description: Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.; Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
Intervention MeSH terms: Phenylephrine; Epinephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which
      are 2 different nasal decongestants both of which are routinely used before sinus surgery) on
      blood loss and the surgeon's view of the surgical field during sinus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery
             (ESS) in which the same sinuses and procedures on both sides are the same for CRS with
             or without nasal polyposis.

        Exclusion Criteria:

          -  pregnancy

          -  known coagulopathy

          -  an international normalized ratio greater than 1.3

          -  a partial thromboplastin time greater than 50 seconds

          -  use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)

          -  use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)

          -  poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg
             or greater or a diastolic blood pressure of 90mm Hg or greater

          -  having any adverse reaction to topical epinephrine or oxymetazoline.
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
Condition: Proteinuria; Transplant Glomerulopathy
MeSH terms: Proteinuria
Intervention: Acthar
Intervention description: Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.
Intervention MeSH terms: Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria
      associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant recipients with confirmed transplant glomerulopathy on kidney
             biopsy.

          -  Failed standard therapy (>25% reduction in proteinuria) including maximum use of an
             ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80
             and optimization of their immunosuppression

        Exclusion Criteria:

          -  Diabetes
Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: suvorexant; placebo
Intervention description: First in class orexin antagonist approved by the FDA for the treatment of insomnia; Pill with inactive ingredients
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine effects of blocking the orexin system with suvorexant
      after exposure-based intervention for posttraumatic stress disorder (PTSD) on sleep, PTSD
      symptoms, and intersession habituation.
    

Eligibility criteria:

        Inclusion Criteria:

        - Adult men and women (age 18 or older) who meet the Diagnostic and Statistical Manual of
        Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD.

        Exclusion Criteria:

          -  Medical or psychiatric conditions that require consistent use of medication that
             affects sleep or psychiatric symptoms, except for hormonal contraceptives

          -  Any persistent medical condition that affects sleep

          -  Inability to remember most details of the index event

          -  Diagnosis of a sleep disorder other than insomnia including polysomnography findings
             of apnea/hypopnea index > 10/hour

          -  Consumption of more caffeine than 5 cups of coffee/day equivalent

          -  Smoking > 20 cigarettes/day

          -  Habitual bedtimes after 3AM, habitual rise times after 10AM, or average napping > 2
             hour/day in a given week

          -  Moderate or severe alcohol use disorder within the past 6 months or moderate or severe
             drug use disorder within the past year

          -  Positive urine toxicology for illicit drugs including cannabis

          -  A history of psychotic disorders or bipolar disorder

          -  Current depression with history of recurrent depression that precedes exposure to a
             traumatic event

          -  Suicidal ideation with intent to act or with specific plan and intent in the past 6
             months [Type 4 - 5 ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)] or
             history of a suicide attempt

          -  Completion of exposure-based therapy targeting the index trauma

          -  Pregnancy or breast feeding

          -  Known sensitivity or allergy to an orexin receptor antagonist

          -  Limited ability to read or write English.
Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
Condition: Intraocular Pressure
MeSH terms: Glaucoma; Glaucoma, Angle-Closure
Intervention: Travoprost 0.004% + Brinzolamide 1.0%; Travoprost 0.004% + Tears Natural
Intervention description: Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily); Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Intervention MeSH terms: Travoprost; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IOP lowering efficacy and safety of Azopt plus Travatan

Summary:

      To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0%
      (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004%
      (Travatan) once daily. The study is double masked. The patients will receive either treatment
      for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years;

          -  CACG (Chronic Angle Closure Glaucoma) ≥ 1eye

          -  have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the
             screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32
             mmHg in both eyes

          -  clinical stability of VA (Visual Acuity) and optic nerve throughout the study

        Exclusion Criteria:

          -  Abnormality restricts exam of the fundus or anderior chamber

          -  conjunctivitis, keratitis or uveitis

          -  unable to be discontinued from using all ocular hypotensive medication(s) except
             Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks

          -  ocular surgery prior to the study