bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Cyclosporine; Loteprednol Etabonate; Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Intervention description: Used to increase tear production in patients who have dry eye caused by inflammation; Used to treat inflammation of the eye; Used to treat inflammation of the eye
Intervention MeSH terms: Loteprednol Etabonate; Cyclosporine; Dexamethasone; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction
      with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of
      dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic
      suspension 0.5%) and Restasis monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Signs and symptoms of Dry Eye Disease

          -  Consent to treat with topical immunomodulator

          -  Willing and able to comply with clinic visits and study related procedures

          -  Willing and able to sign the informed consent form

        Exclusion Criteria:

          -  Patients under the age of 18.

          -  Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)

          -  Active infectious systemic disease

          -  Active infectious ocular or extraocular disease

          -  Altered nasolacrimal flow of either acquired, induced, or congenital origin

          -  Hypersensitivity to dexamethasone

          -  Patients who have been on topical immunomodulating agents in the previous 3 months to
             their baseline visit

          -  Patient being treated with either topical, oral, or intravenous immunosuppressive
             agents, immunomodulating agents, or steroid (including NSAIDS)

          -  Patients with severe disease that warrants critical attention, deemed unsafe for the
             study by the investigator
The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty
Condition: Total Knee Replacement
Intervention: Fondaparinux Sodium (Arixtra)
Intervention description: 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The investigators hypothesize that Arixtra patients will be less likely to experience wound
      infection than patients who have received low-molecular weight heparin, coumadin or aspirin
      with mechanical compression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All primary unilateral TKA and THA cases will be included.

        Exclusion Criteria:

          -  Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral
             procedures will be excluded.
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?
Condition: Sickle Cell Anemia Crisis
MeSH terms: Anemia, Sickle Cell
Intervention: Acetaminophen; Normal saline
Intervention description: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen; Normal saline volume equivalent
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: 71.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sickle cell; acetaminophen in pain crises; opioid-sparing

Summary:

      The purpose of this study is to determine whether IV acetaminophen can decrease the need for
      subsequent opioid administration in the acute management of sickle cell crisis pain in the
      pediatric emergency room.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with
             acute sickle cell pain crisis with a pain of 6/10 or higher

        Exclusion Criteria:

          -  Patient with fever (38C or 100.4F)

          -  Patient less than age 4 years

          -  Patient greater than age 16 years

          -  Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen

          -  Patient received acetaminophen within the past 4 hours

          -  Patient with known liver disease or renal disease

          -  Patient not requiring IV morphine (pain score 5/10 or less)

          -  Patient enrolled in the study within the past 72 hours
Brain Effects of Opiate Agonist and Antagonist
Condition: Chronic Low-back Pain
MeSH terms: Low Back Pain
Intervention: Morphine
Intervention description: 30 mg oral tablet
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will look at the short-term effect of morphine on brain response to food.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants

          -  Patients in pain: suffering from persistent pain more days than not, 3/10 in intensity
             on a numerical rating scale, for at least 6 weeks or more.

        Exclusion Criteria:

          -  Any DSM diagnosis

          -  diabetes

          -  food allergies

          -  lactose intolerance

          -  participants seeking to quit smoking or to lose weight

          -  participants on any psychotropic medication including opiate based analgesics (e.g.
             oxycodone, methadone, suboxone)

          -  pregnant or nursing women

          -  pacemaker or other implanted electrical devices

          -  Participants with a past history of head trauma or seizures

          -  Any past history of illegal drug or alcohol misuse

          -  Participants who cannot undergo an MRI scan.
Attention & Memory Impairments in Menopausal Women
Condition: Symptomatic Menopause; Cognitive Impairments
Intervention: Lisdexamfetamine; Placebo
Intervention description: In a counterbalanced fashion, participants would receive titrated doses of LDX 20 to 60 mg/d for 4 weeks followed by a 2-week washout and then crossed over to the placebo tablets for another 4 weeks. All women will start with LDX 20 mg/d and then be titrated to 40 mg/d after 1 week and 60 mg/d after 2 weeks (as tolerated).; In a counterbalanced fashion, participants would receive placebo tablets for 4 weeks followed by a 2 week washout, then will receive titrated doses of LDX 20 to 60 mg/d for 4 weeks.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: Female
Minimum age: 45 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menopause; Aging; Memory; Women

Summary:

      The purpose of this study is to determine whether a medication called Vyvanse®
      (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of
      sustained attention, verbal encoding and recall and working memory, in menopausal aged women.
      LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The
      cognitive difficulties that menopausal women report experiencing are typical of adults who
      are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in
      alleviating those cognitive disruptions when compared to a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        Women ages 45 to 60 will be eligible for this study if they:

          -  Are within 5 years of their last menstrual period;

          -  Are able to give written informed consent;

          -  Must have clear urine toxicology screen upon recruitment;

          -  Are fluent in written and spoken English;

          -  Must have negative urine pregnancy test if still menstruating.

        Exclusion Criteria:

          -  History of seizures;

          -  History of cardiac disease including known cardiac defect or conduction abnormality;

          -  Abnormal electrocardiogram during screening;

          -  Use of estrogen therapy within previous 6 months;

          -  Current pregnancy or planning to become pregnant.

          -  Presence of a contraindication to treatment with stimulant medication; this would
             include the presence of hypertension, coronary disease, atrial fibrillation, and
             arrhythmia.
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
Condition: Smoking Cessation
Intervention: Integrated Smoking Cessation and Financial Counseling; Waitlist Integrated Smoking Cessation and Financial Counseling; Nicotine Replacement Therapy (NRT)
Intervention description: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.; Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.; Participants in both arms will be eligible to receive a free four-week supply of NRT.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 410.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking Cassation; Immigrants; Economic Disparity

Summary:

      This is a 24 month pilot project that will implement and evaluate an innovative program that
      integrates financial counseling with smoking cessation counseling for low-income immigrants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smokes ≥5 cigarettes per day

          -  Born outside the U.S.

          -  Interested in receiving smoking and financial counseling

          -  Self-reported income below 200% of the current federal poverty level for a given
             household composition

          -  New York City resident

          -  English or Spanish language

          -  Able to provide informed consent, and

          -  Does not have a representative who manages his/her funds (to ensure the participant
             has the ability to manage household money). We will exclude participants who report
             being pregnant or breastfeeding (unable to receive NRT).

        Hospital staff participants:

          -  Must be current medical or non-medical provider or administrator at Bellevue Hospital
             or New York University Lutheran Medical Center

        Exclusion Criteria:

          -  We will exclude participants who report being pregnant or breastfeeding.
Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery
Condition: Laparoscopic Sleeve Gastrectomy; Subcostal Transversus Abdominis Plane Block
Intervention: Saline; Bupivacaine
Intervention description: 40 mL sterile normal saline; 40 mL 0.25% bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consists of two study arms. Patients will be getting a subcostal transversus abdominis plane block with either bupivacaine or saline.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Group allocation and instructions on preparing the injectate solution for the subcostal TAP block will be included in a sealed envelope. On the day of the surgery, the group allocation will be revealed to an anesthesiologist not involved with the research study. The anesthesiologist not involved in the study or the care of the patient will prepare the solution to be used for the subcostal TAP block.
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Randomized control trial; Subcostal transversus abdominis plane block; Laparoscopic sleeve gastrectomy; Regional anesthesia; Opioid consumption; Bariatrics

Summary:

      The study team will be assessing if the unilateral subcostal transversus abdominis plane
      (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy
      surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18-80 years old

          -  Candidate for general anesthesia

          -  Undergoing laparoscopic sleeve gastrectomy

          -  Patients of participating surgeons

        Exclusion Criteria:

          -  Prior bariatric surgery of any kind

          -  Previous abdominoplasty

          -  Allergy or intolerance to one of the study medications

          -  ASA > 4

          -  Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine
             equivalent of >5mg/day for one month)

          -  History of alcohol/drug abuse

          -  History of hepatic or renal insufficiency

          -  Patient refusal
Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study
Condition: Verruca, Warts
MeSH terms: Warts
Intervention: Veregen only; Cryotherapy and Veregen
Intervention description: Topical application of Veregen 15% ointment on affected areas twice daily; Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a
      single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment
      and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the
      pediatric population. This novel treatment modality may be useful in the pediatric
      dermatology community offering a less invasive, painless option for treatment of non-facial
      verruca vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of any ethnic background

          -  Age between 6 years old and 16 years old

          -  A clinical diagnosis of non-facial verruca vulgaris

          -  Able to adhere to study visit schedule, Veregen ™ treatment requirements, and baseline
             cryotherapy treatment in half of patients

          -  Verruca size greater than 5 mm

        Exclusion Criteria:

          -  Medically unstable patients

          -  Patients with immunosuppression

          -  Families who decline participation

          -  Verruca may not have been treated in preceding 4 weeks prior to enrollment

          -  Verruca may not be located on the face or genitalia

          -  Verruca size less than 5 mm
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention description: three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis B, Vaccine; Immunogenicity; methadone maintenance treatment; Randomized Controlled Trial

Summary:

      This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune
      persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three
      injections at months 0, 1, and 6 in methadone maintenance treatment patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 18 and 70 years at the enrolment

          -  Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface
             antibody (anti-HBs) at enrollment

          -  Willing to adhere to the study protocol

        Exclusion Criteria:

          -  Being pregnant

          -  Intolerance or allergy to any component of the vaccine

          -  Any vaccination during the month preceding enrollment

          -  Ongoing opportunistic infection

          -  Liver disease

          -  Hematological disorder

          -  Cancer

          -  Unexplained fever the week before enrollment
MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
Condition: Stiffness Following Total Knee Arthroplasty
Intervention: Dexamethasone; Celecoxib
Intervention description: 8 mg of IV dexamethasone immediately before MUA.; 2 weeks per mouth of celecoxib (200 mg daily)
Intervention MeSH terms: Dexamethasone; Celecoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Compare the outcome following manipulation under anesthesia for stiffness in a randomized
      controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time
      of manipulation to a control group receiving manipulation alone.

      Outcomes will include pain, range of motion, as well as subjective outcome scores.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who have received a primary unilateral TKA for a diagnosis of osteoarthritis.

          2. MUA's scheduled between 6-10 weeks postoperatively

        Exclusion Criteria:

          1. Intolerance to NSAIDs

          2. Renal dysfunction

          3. Age < 18 or > 90 years

          4. Primary diagnosis of rheumatoid arthritis

          5. Patients with a Glomerular Filtration Rate (GFR) <60 as the cut off for Chronic Kidney
             Disease (CKD) (stage 3 CKD)
Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy
Condition: Cardiac Allograft Vasculopathy
MeSH terms: Vascular Diseases
Intervention: Perflutren Lipid Microsphere; RTMPE
Intervention description: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.; Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective
      non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and
      adult cardiac transplant recipients? Will perfusion deficits correlate with significant
      coronary artery stenosis identified by standard stress echocardiography and Invasive Coronary
      Angiography (ICA), and identify diffuse small vessel disease more effectively than current
      non-invasive techniques?
    

Eligibility criteria:

        Inclusion:

          -  Cardiac transplant recipients (> or equal to 10 months post transplant)

          -  Clinically followed at Mayo Clinic, Rochester Minnesota

        Exclusion:

          -  Standard contraindications to the use of ultrasound contrast and pharmacologic stress

          -  Recent (< 3 months) hospitalization for heart failure, acute coronary syndrome or
             allograft rejection

          -  Multi-organ transplant Known or suspected right-to-left, bi-directional, or transient
             right-to-left cardiac shunts

          -  Hypersensitivity to perflutren