bioihbjkbjnl/mcl2 huggingface dataset:
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
Condition: Chronic Sinusitis, Ethmoidal
MeSH terms: Sinusitis; Ethmoid Sinusitis
Intervention: Steroid-eluting sinus implant; Post-op standard of care
Intervention description: PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days; Post-op standard of care including debridement, irrigation, and/or topical steroids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients assigned to the treatment group underwent a bilateral in-office placement of a steroid-eluting sinus implant 7 days following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids. Patients randomized to the control group received same standard of care alone.
Masking: Double (Participant, Outcomes Assessor)
Masking description: Patients were wearing eye masked and noise-cancelling headsets during placement and follow-up endoscopies.
The primary outcome was assessed by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Steroid-eluting sinus implant; Mometasone furoate; Endoscopic sinus surgery

Summary:

      Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to
      either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid
      sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for
      6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of chronic rhinosinusitis, defined by the AAO-HNS 2015 guidelines,
             including presence of bilateral ethmoid disease.

          -  ESS including bilateral ethmoidectomy with middle meatal antrostomy within 7 days
             prior to scheduled implant placement. Concurrent septoplasty and surgical treatment of
             the other paranasal sinuses also permitted.

        Exclusion Criteria:

          -  Known history of intolerance to corticosteroids or an oral steroid-dependent
             condition.

          -  Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma
Exercise Pulmonary Transit Time
Condition: Heart Failure, Diastolic
MeSH terms: Heart Failure, Diastolic
Intervention: contrast echocardiography
Intervention description: giving echocardiographic contrast and taking echocardiographic images before and after exercise
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: small pilot study to test technical feasibility
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study seeks to measure pulmonary transit time via contrast-echocardiography before and
      after exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years old

          2. Able to give informed consent

        Exclusion Criteria:

          1. Known allergic reaction to Definity or Optison ultrasound contrast

          2. Pregnancy/Nursing - as assessed/disclosed by the participant
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inflexal V
Intervention description: Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
15 µg HA antigen of B/Brisbane/60/2008-like virus
Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Virus; Vaccination; Immunisation

Summary:

      This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine
      Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female and male adults

          -  Aged ≥18 to ≤60 years or >60 years on Day 1

          -  Written informed consent

        Exclusion criteria:

          -  Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or
             other acute disease

          -  Acute febrile illness (≥38.0 °C)

          -  Prior vaccination with an influenza vaccine in the past 330 days

          -  Known hypersensitivity to any vaccine component

          -  Previous history of a serious adverse reaction to influenza vaccine

          -  History of egg protein allergy or severe atopy

          -  Known blood coagulation disorder

          -  Chronic (longer than 14 days) administration of immunosuppressants or other
             immune-modifying drugs within 6 months before the first dose of study vaccine, incl.
             oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or
             topical steroids are allowed)

          -  Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)

          -  Investigational medicinal product received in the past 3 months (90 days)

          -  Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months
             (90 days)

          -  Pregnancy or lactation

          -  Participation in another clinical trial

          -  Employee at the investigational site, or relative or spouse of the investigator

          -  Suspected non-compliance
Ranolazine in Ischemic Cardiomyopathy
Condition: Cardiomyopathy; Chest Pain; Dyspnea
MeSH terms: Dyspnea; Cardiomyopathies; Chest Pain
Intervention: Ranexa; Placebo
Intervention description: 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.; 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Intervention MeSH terms: Ranolazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and
      shortness of breath despite conventional medical therapy and/or revascularization. The
      purpose of this study is to determine the efficacy of taking Ranexa versus placebo in
      patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional
      medical therapy and/or percutaneous revascularization.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical
             treatment is defined as the continued symptoms of chest pain or dyspnea despite
             treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless
             contraindicated, all cardiomyopathy patients should be treated with a beta blocker and
             an ACEI/ARB.

          2. Anginal chest pain or dyspnea

          3. Documentation of non treatable or optimally treated coronary artery disease

          4. Ejection Fraction of less than or equal to 40%

        Exclusion Criteria:

          1. Less than 18 years of age

          2. Pregnant or breast feeding

          3. Patients with non ischemic cardiomyopathy
Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER
Intervention description: Participants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 480.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone Extended Release

Summary:

      The purpose of this study is to explore the relationship between achieving symptomatic
      remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and
      personal and social functioning by means of the Personal and Social Performance (PSP) scale
      in participants treated with flexibly dosed paliperidone ER.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th
             edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of
             emotional instability, detachment from reality, often with delusions and
             hallucinations, and withdrawal into the self)

          -  Participant is drug naive or participant's previous treatment is considered
             unsuccessful due to one or more of the following reasons: lack of efficacy, lack of
             tolerability or safety, lack of compliance and/or other reasons

          -  Participants or their legally acceptable representatives had signed an informed
             consent document indicating that they understand the purpose of and procedures
             required for the study and were willing to participate in the study

          -  Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or,
             if sexually active, agree to practice an effective method of birth control before
             entry and throughout the study and must have a negative urine pregnancy test at
             screening

        Exclusion Criteria:

          -  Participants with use of clozapine, paliperidone extended release (ER), any
             conventional depot neuroleptic or Risperdal CONSTA during the last 3 months

          -  Participants with serious unstable medical condition, including known clinically
             relevant laboratory abnormalities

          -  Participants with history of neuroleptic malignant syndrome (high fever, rigid
             muscles, shaking, confusion, sweating more than usual, increased heart rate or blood
             pressure, or muscle pain or weakness)

          -  Participants with known hypersensitivity to paliperidone ER or risperidone

          -  Participants with inability to swallow the whole study medication tablet with aid of
             water
Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Intervention: lidocaine and prilocaine
Intervention description: Appropriate dose of Oraqix based on weight will be given before tooth extraction
Intervention MeSH terms: Lidocaine; Prilocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To establish Oraqix is safe when used on adolescent volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 and 17 and eleven twelfths

          -  requires tooth extraction

          -  healthy having not taken any prescription or over the counter medications within 60
             days of first visit

          -  must be a minimum of 15 kg

        Exclusion Criteria:

          -  anesthesia required for treatment other than study material

          -  given blood within 90 days of first visit

          -  pregnant

          -  allergic to local anesthetic

          -  documented history of glucose-6-phosphate dehydrogenase deficiency

          -  history of congenital idiopathic methemoglobinemia

          -  does not have a loose tooth easily extracted or who, in the opinion of the
             Investigator, is not suitable for tooth extraction using only topical anesthetic
Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: early initiation of treatment with Risperdal Consta; routine initiation of treatment with Risperdal Consta
Intervention description: 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.; 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; intramuscular injection; antipsychotic agents; long-acting risperidone

Summary:

      The primary objective of this randomized trial was to investigate whether early initiation of
      treatment with Risperdal Consta after an acute episode was not inferior to the routine
      approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental
             Diseases, Fourth Edition (DSM-IV)

          -  acute episode of schizophrenia within 2 weeks of study entry

          -  o subjects currently not treated or treated with oral antipsychotics or short-acting
             injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding
             the registered dose

          -  Positive And Negative Syndrome Scale (PANSS) score >=80

          -  Clinical Global Impression - Severity (CGI-S) score >=5

        Exclusion Criteria:

          -  DSM-IV axis I diagnosis other than schizophrenia

          -  known hypersensitivity or lack of response to risperidone

          -  pregnant or nursing females, or those without adequate contraception

          -  alcohol or drug abuse or dependence diagnosed in the last month prior to entry,
Smoking Cessation in Hospitalized Smokers
Condition: Smoking Cessation
Intervention: Nicotine Patches; Telephone Counseling; Brief Hospital Counseling
Intervention description: Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.; Up to 5 proactive counseling sessions from California Smokers' Helpline.; All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 1270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tobacco cessation; smoking cessation; telephone; self-help; smoking abstinence; tobacco use disorder; hospital; cardiopulmonary diseases; disparity

Summary:

      When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of
      them, however, go back to smoking soon after discharge. This study will test an innovative
      approach which includes dispensing nicotine patches at discharge, providing proactive
      telephone counseling post discharge, or giving a combination of the two. The interventions
      are aimed at increasing the long term quit rate of these patients.

      The specific aims of the study are to demonstrate the effects of two interventions,
      dispensing nicotine patches at discharge and providing proactive telephone counseling soon
      after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Smoke >=6 Cigarettes per day

          -  English or Spanish speaking

          -  Valid phone number

          -  Valid address

          -  Gave consent to participate in study and evaluation

        Exclusion Criteria:

          -  Hospital stay of less than 24 hours

          -  Inability to communicate orally

          -  Hypersensitivity to nicotine

          -  Pregnant

          -  Hospitalized for psychiatric treatment
Efficacy of Ketorolac 0.4% in Prostaglandin Suppression
Condition: Inflammation
MeSH terms: Inflammation
Intervention: Ketorolac 0.4%; Lubricating Eye Drop
Intervention description: One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days; One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation
Intervention MeSH terms: Ketorolac; Ophthalmic Solutions; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac
      0.04% following peripheral iridotomy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo phakic IOL implantation

        Exclusion Criteria:

          -  History of intraocular surgery in the operative eye
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Memantine; placebo
Intervention description: Memantine 20mg (10mg twice daily) oral administration for 12 weeks; Placebo oral administration twice daily for 12 weeks
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 265.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: memantine; Alzheimer's Disease; communication

Summary:

      The objective of this study is to evaluate the effect of memantine versus placebo on
      functional communication in patients with Alzheimer's Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients, 50 years or older, native English speakers, meeting
             National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's
             Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with
             a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline

        Exclusion Criteria:

          -  Current Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV)
             Axis I disorder other than AD

          -  Previous imaging results not consistent with the diagnosis of AD

          -  Modified Hachinski Ischemia Score greater than 4

          -  Evidence of other neurologic disorders

          -  Clinically significant systemic disease

          -  A known or suspected history of alcohol or drug abuse in the past 5 years

          -  Taking excluded medication

          -  Previous treatment with commercial memantine
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypercholesterolemia
Intervention: simvastatin (+) ezetimibe; Comparator: atorvastatin
Intervention description: simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks); atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypercholesterolaemia

Summary:

      Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving
      ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment
      panel (ATP) III guidelines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are naïve to lowering lipid agent

          -  Patients who are treated with lowering lipid agents and had a wash-out period for 4
             weeks.

        Exclusion Criteria:

          -  Impaired kidney function

          -  Increased liver enzyme levels

          -  Pregnant women

          -  Hypersensitivity to ezetimibe and other statin agents