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
Quality of Life Intermittent Catheter Study
Condition: Neurogenic Bladder Dysfunction Nos
MeSH terms: Urinary Bladder, Neurogenic
Intervention: SpeediCath Compact; Standard care
Intervention description: The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.; The coated intermittent catheter normally used by subject
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare compact intermittent catheters with standard coated
      intermittent catheters with regard to quality of life, using the Intermittent
      Self-Catheterisation Quality of life Measure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is at least 18 years of age

          -  Has given written informed consent

          -  Has neurogenic bladder dysfunction

          -  Has used coated intermittent catheter as primarily bladder emptying method for at
             least 6 months

          -  Is able to self-catheterise

          -  Is able to use SpeediCath® compact catheters

          -  If spinal cord injury subject, injury must have occurred more than 12 months ago

          -  Covered by Social security system

        Exclusion Criteria:

          -  Has used SpeediCath® compact catheters (not including screening for this
             investigation)

          -  Is admitted to rehabilitation centre

          -  Subjects using primarily catheter sets

          -  Is pregnant or breast-feeding
Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Ribavirin; Peginterferon alfa-2b (PEG-Intron); Ribavirin; Peginterferon alfa-2a [Pegasys]
Intervention description: 1000/1200mg/day po; 1.5 micrograms/kg sc weekly; 1000/1200mg/day po; 180 micrograms sc weekly
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Peginterferon alfa-2b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and
      PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on
      study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients at least 18 years of age

          -  CHC infection, genotype 1

          -  use of 2 forms of contraception during study in both men and women

        Exclusion Criteria:

          -  previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents

          -  medical condition associated with chronic liver disease (e.g., hemochromatosis,
             autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin
             exposure)

          -  decompensated liver disease

          -  women who are pregnant or breastfeeding
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis
Intervention: NexStent Carotid Stent System (Monorail Delivery System); FilterWire EZ™ Embolic Protection System
Intervention description: Self-expanding carotid stent for treating patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.; Used as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NexStent; FilterWire EZ; Boston Scientific; Carotid Artery; Carotid Endarterectomy; Carotid Revascularization

Summary:

      The primary objective of the SONOMA Registry is to confirm the safety of the NexStent®
      Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical
      practice and to identify rare or unanticipated device-related events that might occur.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Candidates must be indicated for carotid stent placement as per NexStent Carotid Stent
             labeling located in the Directions for Use (DFU).

        Exclusion Criteria:

          -  Subjects with contraindications as outlined in the DFU should be excluded from this
             registry.
Ranolazine and Microvascular Angina by PET in the Emergency Department
Condition: Microvascular Angina
MeSH terms: Angina Pectoris; Microvascular Angina; Emergencies
Intervention: Ranolazine; Placebo
Intervention description: Subjects will take the extended-release Ranolazine for a total of 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
Intervention MeSH terms: Ranolazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Chest Pain; Microvascular Angina; Ranolazine; Emergency department; PET

Summary:

      The purpose of this study is to determine the effectiveness of Ranolazine for the treatment
      chest pain from disease of small vessels of the heart also known as 'microvascular angina'.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients admitted to the Yale ED CPC

          -  ≥ 30 years age

          -  chest pain or angina equivalent as their chief complaint within 24 hours of enrollment

          -  Coronary Flow Reserve(CFR) <2.5 on PET scan in the ED.

        Exclusion Criteria:

          -  Acute coronary syndrome

          -  Prior evidence of obstructive heart disease (history of Percutaneous Transluminal
             Coronary Angioplasty (PTCA), Coronary Artery Bypass Grafting (CABG) or calcium score >
             10 on PET scan)

          -  Resting blood pressure of systolic >180/110 mm Hg or <100/40

          -  known cardiomyopathy or heart failure

          -  currently on dialysis

          -  creatinine clearance <30 ml/min

          -  liver cirrhosis

          -  significant aortic stenosis (murmur on exam)

          -  active use of cocaine or amphetamine

          -  current use of potent CYP3A4 inducers or inhibitors (such as ketoconazole,
             clarithromycin, HIV protease inhibitors)

          -  baseline QTc > 580 msec

          -  use of drugs that prolong QTc (Haldol, erythromycin)

          -  pregnancy

          -  inability to read or understand English

          -  suffering from a condition that precludes interview (i.e. cognitive or communication
             impairment).
Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis
Condition: Plaque Psoriasis; Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept; Etanercept
Intervention description: ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.; ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Enbrel; Psoriasis; Topical Psoriasis; Wyeth Psoriasis; Active Psoriasis

Summary:

      The purpose of this study is to compare the safety and efficacy of different doses of
      etanercept for the treatment of moderate to severe psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older at time of consent.

          -  Active, moderate to severe chronic plaque psoriasis defined by the following criteria:
             Clinically stable, plaque psoriasis involving greater than or equal to 10% body
             surface area (BSA) or PASI greater than or equal to 10.

          -  In the opinion of the investigator, failure, intolerance, contraindication or not a
             candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus
             ultraviolet A radiation (PUVA) therapy.

        Exclusion Criteria:

          -  Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere
             with evaluations of the effect of study medication on psoriasis.

          -  Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous,
             systemic vasculitis, scleroderma and polymyositis, or associated syndromes.

          -  Active or recent (within 2 years) tuberculosis (TB) infection.
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium; Combivent (Ipratropium/Albuterol)
Intervention MeSH terms: Albuterol; Tiotropium Bromide; Ipratropium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 349.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with
      tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler
      (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic
      Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.
    

Eligibility criteria:

        Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater
        than or equal to 40 years

          -  Current or ex-smoker with a >= 10 pack-year smoking history

          -  Use of Combivent® Metered Dose Inhaler (MDI)for >= 1 month prior to Visit 1

        Spirometric criteria (determined at study visits):

          -  Post-bronchodilator Forced Expiratory Volume in one second (FEV1) <= 70% (Visit 1)

          -  Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/Forced Vital Capacity (FVC) <=
             70% (Visit 2)

        Exclusion Criteria:

        Clinical history of asthma

          -  History of thoracotomy with pulmonary resection

          -  History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung
             disease

          -  Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain fr om using
             oxygen during Pulmonary Function Tests

          -  Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1

          -  Recent history 6 months or less of Myocardial Infarction

          -  Unstable or life-threatening cardiac arrhythmias

          -  Hospitalization for Congestive Heart Failure during past year

          -  Malignancy for which patient is receiving chemo or radiation therapy

          -  Pregnant or nursing women

          -  Known hypersensitivity to ipratropium or carrier substances, including related food
             products such as soybean, peanuts, or lactose

          -  Use of SPIRIVA® 3 months prior to Visit 1

          -  Symptomatic of prostatic hypertrophy or bladder neck obstruction

          -  Known narrow- angle glaucoma

          -  Participating in a pulmonary rehab program within 4 weeks of Visit 1
US Guided GNB vs Saline Injection for TKA
Condition: Postoperative Pain; Total Knee Arthroplasty; Nerve Block
MeSH terms: Pain, Postoperative
Intervention: bupivacaine; saline
Intervention description: Group 1 will receive genicular nerve block using bupivacaine; Group 2 will receive genicular nerve block using normal saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: anesthesiology; pain; arthroplasty

Summary:

      Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee
      analgesia for patients recovering from total knee replacement surgery compared to saline
      injection?

      Hypotheses:

      The investigators hypothesize that the combination of ultrasound-guided adductor canal block
      (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to
      decreased systemic side effects and improved overall satisfaction compared to
      ultrasound-guided saline injection for patients undergoing minimally invasive elective total
      knee arthroplasty (TKA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants 40 to 85 years old who are presenting for minimally invasive total knee
             arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks.

          -  Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing
             arthrotomy that does not extend beyond 1cm proximal to the patella and surgical
             techniques that focus on soft tissue protection.

        Exclusion Criteria:

          -  Patient refusal

          -  American Society of Anesthesiologists physical status classification of 4 or higher

          -  Pre-existing neuropathy in the femoral or sciatic distribution

          -  Coagulopathy

          -  Infection at the site

          -  Chronic opioid use (greater than 3 months)

          -  Pregnancy

          -  Medical conditions limiting physical therapy participation

          -  Any other contra-indication to regional anesthesia
Normoglycemia and Neurological Outcome
Condition: Acute, Non-traumatic Subarachnoid Hemorrhage; Intraparenchymal Hemorrhage; Brain Injuries
MeSH terms: Brain Injuries; Subarachnoid Hemorrhage; Hemorrhage
Intervention: Insulin; Conventional insulin treatment
Intervention description: All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.; All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: SAH (Subarachnoid Hemorrhage); Brain Hemorrhage; Traumatic Brain Injury; SAH; ICH

Summary:

      Brain injury patients who meet defined criteria will be assigned to intensive insulin
      treatment (target blood glucose levels of 10-110 mg/dl) or conventional IV insulin treatment
      (target glucose of 150-170 mg/dl). Follow up will occur at 3, 6 and 12 months. The primary
      outcome measure will be neurological outcome at 12 months according to Karnofsky Performance
      Scale (KPS). A general view of outcome will also be presented as favorable (good recovery+
      moderate disability), unfavorable (severely disabled+ vegetative state), and dead.

      Secondary outcome measures will be blood glucose levels and death.The investigators will also
      record systemic complications like pulmonary emboli, pulmonary edema, myocardial infarction,
      ventricular arrhythmias, and pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-traumatic SAH, ICH, or TBI

          -  Glasgow Coma Scale between 6 and 14

          -  admitted to an ICU of University of Louisville Hospital

        Exclusion Criteria:

          -  Patients <18 and >80 years

          -  GCS Motor score <4 or an overall GCS score of 15

          -  diabetic patients who suffer from dialysis-dependent diabetic nephropathy

          -  patients with multiple injuries

          -  patients who would have been classified as ASA 3 status prior to their acute
             neurological event
Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Autoimmune Diseases
Intervention: Rituximab Infusion
Intervention description: Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion.
Intervention MeSH terms: Rituximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rapid Infusion Rituximab

Summary:

      The purpose of this study is to evaluate the impact of rapid infusion rituximab on the
      incidence of infusion-related reactions in patients with Autoimmune Diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autoimmune patient at Wake Forest Baptist Health that is eligible for rituximab
             therapy

          -  Tolerate the standard infusion rituximab with ≤ grade 2 hypersensitivity reaction

          -  Consent to participate in the rapid infusion study

          -  Age ≥ 18 years ≤ 80 years

        Exclusion Criteria:

          -  Tolerate the standard infusion rituximab with ≥ grade 3 hypersensitivity reaction

          -  Neurocognitive impairment (i.e. dementia, Alzheimers, et al)
Post-Discharge Smoking Cessation Strategies: Helping HAND 4
Condition: Smoking Cessation
Intervention: Transitional Tobacco Care Management (TTCM); eReferral to State Tobacco Quitline (QL); Nicotine replacement therapy
Intervention description: PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.; Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.; Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1416.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tobacco; Cessation; Hospitalization; eReferral; Interactive Voice Response; Tobacco Quitline

Summary:

      This randomized controlled trial will compare the effectiveness of two models of
      post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Current cigarette smoker (>=1 cigarette in the week before admission and >=1
             cigarette/day when smoking at a baseline rate in the month prior to admission)

          -  Admitted to a study hospital

          -  Seen by hospital smoking counselor during inpatient stay

          -  Plans to try to quit smoking after hospital discharge

        Exclusion Criteria:

          -  Inability to give informed consent or participate in counseling due to serious
             cognitive or psychiatric disorder (e.g., dementia, psychosis)

          -  Life expectancy <12 months

          -  Medical instability

          -  No reliable telephone access or inability to use telephone

          -  Non-English speaking

          -  Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.