bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Written education material (basic); Additional education material; PELICAN-Proactive; PELICAN-Reactive
Intervention description: Education material on COPD distributed to all participants.; Additional education material sent to participants in the proactive and reactive arms.; In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy.; Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 444.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic obstructive pulmonary disease (COPD); Supplemental oxygen; Adherence; Telephonic education; Peer coaching

Summary:

      About 1 million individuals in the US have a prescription for supplemental oxygen (O2). Using
      O2 can prolong life and increase quality of life. Patients often do not use their oxygen as
      prescribed, which means that they are not benefiting as much as they could be from this
      therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for patients
      and CAregivers (PELICAN) will increase adherence to supplemental oxygen prescription and
      improve health in patients with chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or older.

          2. Physician diagnosis of COPD

          3. Physician prescription for home O2 for 24hrs/day, 7 days/week

          4. Willing to use home O2.

          5. Working telephone number.

        Exclusion Criteria:

          1. Unable to read and speak English.

          2. Discharge to home hospice or expected survival less than 6 months.
Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL
Condition: Cataracts
MeSH terms: Cataract
Intervention: AcrySof ReSTOR Aspheric IOL
Intervention description: Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cataract; visual acuity; AcrySof ReSTOR Aspheric Intraoculare Lens; Bilateral cataract

Summary:

      The objective of this study is to evaluate postoperative visual function in patients
      implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bilateral cataract patients who require natural crystalline lens removal and bilateral
             Intraocular Lens (IOL) implantation.

          -  50~75 years of age

          -  <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry
             readings.

        Exclusion Criteria:

          -  Patients with pre-existing conditions that could skew the results.

          -  Any of conditions before and during surgery specified in the product information.
Effect of Bupropion on Seizure Threshold in Depressed Patients
Condition: MDD
MeSH terms: Seizures
Intervention: Wellbutrin SR 300Mg Extended-Release Tablet
Intervention description: Wellbutrin SR 300Mg Extended-Release Tablet
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 Arms of randomization - one wherein patients get Wellbutrin in first ECT and another arm wherein patients get it with second ECT. Counterbalanced randomization
Masking: Double (Care Provider, Outcomes Assessor)
Masking description: Blinding to be done - Outcome assessor and care provider will be blinded to randomization arm of subject
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Wellbutrin; Electroconvulsive therapy; Right Unilateral Ultra Brief

Summary:

      The purpose of the study is to examine the effect of bupropion on seizure threshold and
      duration in depressed patients receiving right unilateral ultra-brief electroconvulsive
      therapy (ECT). The investigators plan to recruit 10 patients into the study, administer
      sustained release (SR) bupropion 4 hours prior to receiving ECT. The investigators plan to
      compare the seizure threshold and seizure durations between ECT sessions with and without
      bupropion administration. The study's implication is to examine how ECT can be optimized by
      rational combination with medications that lower seizure threshold.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects, age >18.

          2. Meeting diagnostic criteria for major depressive disorder or bipolar disorder per
             DSM5.

          3. Referred for ultra brief RUL ECT.

          4. Right motor dominant.

          5. Competent to provide informed consent.

          6. Able to read or comprehend English.

          7. H/O treatment with bupropion.

          8. Concomitant treatment with benzodiazepines, dosing of which has remained stable for a
             week prior to study ECT session.

        Exclusion Criteria:

          1. Lifetime history of schizophrenia, schizoaffective disorder, mental retardation,
             seizure disorder.

          2. Current alcohol abuse or dependence within past 6 months.

          3. Current substance abuse or dependence within past 6 months.

          4. Recently received ECT within preceding 3-6 months.

          5. Currently on any formulation of bupropion.

          6. Currently on any anticonvulsants or clozapine.
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo
Intervention description: 5 mg or 2.5 mg once daily
Intervention MeSH terms: Saxagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18206.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Risk of cardiovascular disease and death in patients with type 2 diabetes mellitus

Summary:

      The purpose of this study is to determine whether saxagliptin can reduce the risk of
      cardiovascular events when used alone or added to other diabetes medications
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes mellitus

          -  HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within
             6 months)

          -  High risk for CV events -Established cardiovascular disease and/or multiple risk
             factors

        Exclusion Criteria:

          -  Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1
             mimetics

          -  Acute vascular event <2months prior to randomisation
Sinusitis and Facial Pain Disorders Anti-Depression Trial
Condition: Chronic Sinusitis; Facial Pain Disorder; Depression
MeSH terms: Sinusitis; Facies; Facial Pain; Depression; Depressive Disorder; Somatoform Disorders
Intervention: escitalopram; placebo
Intervention description: 10mg - 30mg daily titrated as tolerated over 12 weeks; inactive comparator; titrated as per protocol over 12 weeks
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study hypothesis is that the addition of an antidepressant to the standard treatment
      regimen in patients with both chronic sinusitis and depression or facial pain disorders and
      depression will decrease the report of chronic sinusitis or facial pain symptom severity.

      This is a stratified, randomized, double-blind, placebo-controlled study using the drug
      escitalopram for the treatment of depression in patients experiencing depression and chronic
      sinusitis or depression and facial pain disorders.

      It is a 12-week study. Subjects will have a screening visit and then be followed up by phone
      weekly for four weeks and bi-weekly for 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meet diagnostic criteria for chronic sinusitis

          -  meet diagnostic criteria for facial pain disorder

          -  meet criteria for major depressive disorder on the PHQ-9

          -  18 years of age or older

          -  established primary care provider

          -  able to read and speak English

        Exclusion Criteria:

          -  unable to give informed consent of unable to complete self-administered questionnaires
             due to cognitive impairment, language barriers or severe medical condition

          -  terminal illness or significantly immunocompromized

          -  complications from chronic rhinosinusitis

          -  presence of sinus tumor

          -  isolated sphenoid disease

          -  immotile cilia syndrome

          -  currently on anti-depressant or mood stabilizer med.

          -  diagnosis of bipolar disorder, schizophrenic disorders, paranoid disorders, or
             psychotic disorders NOS

          -  significant suicide risk

          -  history of hospitalization for mental disorders including psychosis or depression

          -  history of drug abuse within prev. 6 months or dependency on any drug, including
             alcohol

          -  pregnant or breast feeding

          -  women of child-bearing potential not currently using an approved method of birth
             control
Pectoralis and Serratus Muscle Blocks
Condition: Post Operative Pain Control
MeSH terms: Pain, Postoperative
Intervention: Exparel 266 MG Per 20 ML Injection; Placebo
Intervention description: The local anesthetic (LA) used for the PECS II or serratus plane blocks will be a 0.5% bupivacaine HCL, not to exceed 2.5mg/kg or up to 150mg. The LA solution can be diluted with preservative free normal saline for smaller patients to allow for appropriate volume of injection. Treatment patients will also be given liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc. San Diego, CA) in a dose of 266 mg in 20 ml can be safely combined with bupivacaine HCL at a ratio not exceeding 2:1, but cannot be combined with other local anesthetics due to the concern of rapid release of encapsulated bupivacaine and subsequent local anesthetic toxicity.; Patients randomized to standard analgesia technique will be given pain medications.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The overall research plan is PECS/SAP blocks with liposomal bupivacaine improve the Overall
      Benefit Analgesia Score averaged over the postoperative days 1, 2, and 3. A 20% reduction on
      geometric means (i.e., true ratio of geometric means of 0.80) in OBAS will be considered the
      minimal clinically important benefit.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-85 years old;

          2. Elective minimally invasive robotically-assisted mitral valve repair via anterolateral
             thoracotomy

        Exclusion Criteria:

          1. Weight less than 50 kg;

          2. Pregnancy or lactation;

          3. Emergency surgery and patients transferred from the ICU to the operating room;

          4. Redo cardiothoracic surgery or post-operative reoperation within 72 hours of index
             procedure (including minor chest wall procedures including tube thoracostomy,
             thoracentesis or percutaneous drain placement);

          5. Anticipated endotracheal intubation > 24 hours;

          6. Anticipated non-study nerve block that provides analgesia to the intercostal nerves;

          7. Active systemic or cardiopulmonary infection;

          8. Mechanical circulatory support;

          9. Allergy or contraindication to study local anesthetics;

         10. Current chronic pain or routine opioid use (patients on chronic enteral opioids like
             Percocet or Vicodin) in a dose of > 30 mg of morphine-milligram-equivalents for at
             least 10 days in last 30 days;

         11. Poorly controlled psychiatric disorders;

         12. Clinically important current neurologic deficit;

         13. Active liver disease or cirrhosis;

         14. Pacemaker generator or breast implants ipsilateral to surgery;

         15. Previous participation in this study.
An Advanced Echocardiographic Evaluation of Nebivolol
Condition: Hypertension
MeSH terms: Hypertension
Intervention: nebivolol
Intervention description: nebivolol 5 or 10 mg oral, daily
Intervention MeSH terms: Nebivolol
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: 20 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if Nebivolol has any effect on heart function
      determined by changes in echocardiographic data or exercise tolerance.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of hypertension

          2. Written informed consent before initiation of any study related procedure

          3. Baseline Blood pressure > 140 systolic or >90 diastolic if on no antihypertensive
             therapy.

          4. Currently taking one antihypertensive or one antihypertensive and one diuretic for the
             treatment of hypertension.

        Exclusion Criteria:

          1. Physical limitations resulting in a limited ability to walk on treadmill for stress
             echo

          2. Intolerance to beta blockers

          3. On more than one medication for the treatment of hypertension unless the second
             medication is a diuretic.

          4. Currently pregnant or breast feeding.

          5. LFT > 3 X ULN

          6. HgA1C > 7

          7. Participation in other clinical research studies involving the evaluation of other
             investigational drugs or devices within past 30 days of enrollment

          8. Unwilling to follow protocol or return for study related procedures.

          9. Any of the following conditions:

             Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease
             Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia
             COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid
             dysfunction

         10. Any other medical condition that in the PI's opinion could affect myocardial function.

         11. Current ETOH or illicit drug abuse -
Overcome Biochemical Aspirin Resistance Through Cilostazol Combination
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Intervention: Cilostazol; placebo
Intervention description: cilostazol 100mg twice a day for 4 weeks; placebo 1 tablet twice a day matching for cilostazol
Intervention MeSH terms: Cilostazol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Infarction, Cerebral; Cilostazol; Aspirin Resistance

Summary:

      This study will recruit 316 ischemic stroke patients taking aspirin.

      They will be randomly assigned into cilostazol group or placebo group. Every patients will
      take 200mg of cilostazol a day or placebo for 1 month.

      The primary outcome variable of this study is rate of biochemical aspirin resistance on the
      Ultra Rapid Platelet Function Assay-ASA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic cerebral infarction documented on MRI or CT

          -  More than 35 years of age

          -  Patients taking aspirin 100mg a day for 2 weeks or more before randomization

        Exclusion Criteria:

          -  Patients taking any antiplatelets other than aspirin within 2 weeks before
             randomization

          -  Patients taking any anticoagulants within 2 weeks before randomization

          -  Patients taking thrombolytic therapy within 2 weeks before randomization

          -  Patients taking any NSAIDs within 2 weeks before randomization

          -  Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).

          -  Bleeding diathesis

          -  Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine >
             3.0mg/dl)

          -  Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than
             100,000/mm3)

          -  Pregnant or lactating patients

          -  Patients scheduled for angioplasty or revascularization procedures within 4 weeks

          -  Patients scheduled for any surgery or invasive procedures within 4 weeks

          -  Patients having acute coronary syndrome
Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine
Condition: Depression; Bipolar Disorder; Bipolar Depression; Melancholia; Lamotrigine
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lamotrigine; Placebos
Intervention description: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.; Placebo tablets
Intervention MeSH terms: Lamotrigine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if patients with melancholic bipolar II depression
      are more responsive to lamotrigine than patients with non-melancholic bipolar II depression.
      To do this, the investigators will re-analyze a previous clinical trial that evaluated
      lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must provide written and informed consent.

          2. Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8
             weeks, with a HAMD-17 score of at least 18 with scores of 3 or more on Items 1 or 7.

          3. For females, be of non-childbearing potential, or of childbearing potential with a
             negative pregnancy test at screening and agrees to one of (a) abstinence from sex two
             weeks prior and five days after drug continuation/discontinuation, (b) personal or
             partner sterilization, (c) one method of hormonal contraception, or (d) two barrier
             methods of contraception.

          4. Acceptable results (within two times the normal limit) on laboratory screening tests
             (e.g., thyroid function).

        Exclusion Criteria:

          1. Active suicidality.

          2. History of non-response to antidepressant treatment, or any previous treatment with
             lamotrigine.

          3. History of substance dependence in the past year, or abuse within the 4 weeks prior to
             study entry.

          4. Rapid cycling bipolar disorder.

          5. Receiving additional psychoactive medication (not including lorazepam for agitation),
             or has started a new course of psychotherapy within the last month.

          6. Received treatment for an anxiety or eating disorder within the last 12 months.

          7. Investigational drug use within the last month.

          8. History of epilepsy.
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling
Condition: Hypertension; Left Ventricle Hypertrophy
MeSH terms: Hypertension; Hypertrophy
Intervention: Aliskiren; Losartan; Amlodipine; Hydrochlorothiazide (HCTZ)
Intervention description: Aliskiren 300 mg film coated tablets; Losartan 100 mg tablets; Amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved.; HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (<140/90 mmHg) had not been reached.
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Aliskiren; hypertension; concentric LVH; LV remodeling; LVMI; biomarkers; PICP; CT-1; MMP-1; TIMP-1; AnxA5; Aldosterone; Essential hypertension with concentric left ventricle hypertrophy

Summary:

      The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels
      of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in
      hypertensive patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with hypertension

          -  Confirmed concentric left ventricular hypertrophy:

          -  LVMI > 49.2 g/m2.7 for men and >46.7 g/m2.7 for women

          -  Relative wall thickness > 0.42

        Exclusion Criteria:

          -  Sever or secondary HTN

          -  LV ejection fraction of <40%

          -  Patient with compelling indication to ACEIs or ARBs or BB

          -  History of myocardial infarction, coronary artery bypass surgery, PTC intervention,
             TIA or stroke within 6 months of study entry

          -  History of collagenopathies, osteopathy

          -  eGFR <30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L

          -  Morbid obesity (BMI ≥ 42 kg/m2

          -  Other protocol-defined inclusion/exclusion criteria may apply