bioihbjkbjnl/mcl2 huggingface dataset:
Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Dexamethasone 0.1% ophthalmic suspension; Olopatadine hydrochloride 0.1% ophthalmic solution; Inactive ingredients, used as placebo
Intervention description: Maxidex; Patanol; Tears Naturale II
Intervention MeSH terms: Olopatadine Hydrochloride; Dexamethasone; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Conjunctivitis; ocular allergy

Summary:

      The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to
      placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels
      in an Environmental Exposure Chamber (EEC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 1 year history of allergic conjunctivitis.

          -  Ability to self administer ophthalmic drops.

          -  Ability to avoid use of disallowed medications during the entire study period and
             specified period prior to visit 1.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Presence of any ocular infection.

          -  Confirmed diagnosis of dry eye.

          -  Presence of glaucoma or ocular hypertension.

          -  Moderate to severe asthma.

          -  Any severe, unstable, or uncontrolled systemic disease.

          -  Other protocol-defined exclusion criteria may apply.
Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™
Condition: Herpes Zoster; Fibrosis
MeSH terms: Herpes Zoster
Intervention: Zostavax; Placebo
Intervention description: Vaccination with one dose of Zostavax per Zostavax package insert; Injection of 0.65 mL of sterile normal saline
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 50 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Study Design:

      Double-blinded, placebo controlled study of the efficacy of Zostavax in cirrhosis.

      Subjects will receive either Zostavax or placebo and will be followed for four months.

      Hypothesis:

      The investigators hypothesize Zostavax would induce cell-based immunity in cirrhotic patients
      like that seen in elderly patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cirrhosis of any etiology diagnosed clinically by labs and imaging or by liver biopsy

          -  Male or Female age 50 to 70

        Exclusion Criteria:

          -  Active or history of Herpes Zoster

          -  Anaphylactic allergy to neomycin or gelatin

          -  Immunosuppressive medication use

          -  Antiviral medication use

          -  Known history of HIV

          -  Known immune deficiency disease

          -  Active on a liver transplant list

          -  Known malignancy other than non-melanomatous skin cancer within the past five years.

          -  History of vaccination with varicella or zoster vaccine

          -  Pregnant or lactating women

          -  Prisoners

          -  Post-transplant patient

          -  Acute illness
Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Hydrochlorothiazide
Intervention description: Nebivolol 5mg then nebivolol 10 mg; Hydrochlorothiazide 12.5 mg then hydrochlorothiazide 25 mg
Intervention MeSH terms: Hydrochlorothiazide; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Patients who have obstructive sleep apnea (OSA) frequently stop breathing while they sleep.
      They often develop high blood pressure. We are not sure what drug is best to treat the high
      blood pressure. This study will give the patients nebivolol or hydrochlorothiazide (HCTZ) for
      6 weeks after 2 weeks of placebo. The blood pressure response will be evaluated by 24 hour
      monitoring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ranging from 20 - 80 years

          -  Body mass index (BMI) of 20-38 to include the typical obese OSA patients

          -  Hypertension with blood pressures > 140/90 but less than 180/105 mmHg.

          -  Apnea-hypopnea index above 10

        Exclusion Criteria:

          -  Receiving sleep medicines (including heavy alcohol use) or drugs with adverse
             interactions with study medication.

          -  Women who have premenstrual syndrome, or those who are pregnant or capable of
             pregnancy and unwilling to use effective non-hormonal contraception

          -  Shift workers or have symptoms of narcolepsy, restless legs syndrome or insomnia, in
             order to minimize confounding effects of other sleep disorders

          -  Have apneas which are primarily central

          -  Have sleep fragmentation caused by syndromes such as chronic pain or movement
             disorders

          -  Have diseases such as asthma or chronic obstructive pulmonary disease that compromises
             respiration.

          -  Have known coronary or cerebral vascular disease, history of arrhythmias,
             cardiomyopathy, history of psychosis, current alcohol or drug abuse.

          -  Have any contraindications to any study materials, such as heart block.

          -  Have secondary hypertension

          -  Have creatinine levels above 2.5 mg %, more than 1+ proteinuria by dipstick, hematuria
             or electrolyte disorders.
Pre-medication With Alfentanil vs Placebo During ECT
Condition: Blood Pressure; Electroconvulsive Therapy
Intervention: Alfentanil; Placebos
Intervention description: Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed; Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
Intervention MeSH terms: Alfentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Masking description: study med prepared by a provider not involved in the anesthesia care of the subject
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anesthesia

Summary:

      Hemodynamic changes associated with the conduct of electroconvulsive therapy may be minimized
      with the administration of alfentanil as part of their anesthetic regimen. This study
      proposes to compare the effects in a blinded fashion. Currently alfentanil is an FDA approved
      drug used on a daily basis by anesthesiologists on other surgeries so this is not a new
      indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > /=18 years

          -  Males or females

          -  Anticipating electroconvulsive therapy to treat refractory depressive disorder

        Exclusion Criteria:

          -  Under the age of 18

          -  Allergy to alfentanil

          -  Allergy to other standard anesthetic medications utilized in the course of ECT
             (glycopyrrolate, methohexital, and succinylcholine)

          -  History of malignant hyperthermia

          -  History of severe airway obstruction, bronchospasm or laryngospasm

          -  History of recent myocardial infarction, ventricular arrhythmia

          -  Adverse reaction to ECT requiring premedication with lidocaine or atropine

          -  Non-English speaking

          -  Patients unable to consent for themselves

          -  Current pregnancy
Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: 6(S)-5-MTHF(Deplin); Placebo
Intervention description: Deplin is a medical food. Patients will take 15 mg/day of deplin.; Inactive substance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Medical food

Summary:

      The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective
      in relieving depression when it is added to standard kinds of antidepressants called
      serotonin reuptake inhibitors (SSRIs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years old

          -  Meet criteria for current Major Depressive Disorder

          -  Currently taking an SSRI

        Exclusion Criteria:

          -  Pregnant women

          -  Unstable medical illness including cardiovascular, hepatic, renal, respiratory,
             endocrine, neurological, or hematological disease

          -  Prior course of MTHF augmentation, or intolerance to MTHF at any dose

          -  Substance use disorders active within the last six months, any bipolar disorder
             (current or past), any psychotic disorder (current or past)

          -  Have failed more than 2 adequate antidepressant trials during the current Major
             Depressive Episode
Brilinta Taiwan Post Approval Safety Study
Condition: Non ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Infarction
Intervention: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Intervention description: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: NSTEMI

Summary:

      A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the
      cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with
      non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles
      are depolarized) elevation myocardial infarction
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures

          2. Female or male aged at least 20 years

          3. Patient who is considered as ethnic Taiwanese

          4. Index event of non-ST elevation myocardial infarction

        Exclusion Criteria:

          1. Contraindication or other reason that ticagrelor should not be administered

          2. Index event is an acute complication of Percutaneous coronary intervention (PCI)

          3. Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days
             from the enrolment

          4. Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped

          5. Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic
             treatment following enrolment
FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)
Condition: Infertility
MeSH terms: Infertility
Intervention: Urofollitrophin; Follitrophin alpha
Intervention MeSH terms: Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 710.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No
Keywords: In vitro fertilization (IVF); Assisted reproduction technologies (ART); GnRH-antagonist; Follicle stimulating hormone (FSH)

Summary:

      The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety
      of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled
      ovarian hyperstimulation in a GnRH-antagonist cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18-38 years old;

          -  BMI: 18-28 kg/m2;

          -  Less than 3 previously completed IVF cycles;

          -  Basal FSH <10 IU/L and E2 <80 pg/ml;

          -  TSH < 2.5 mIU/L

          -  >10 and <30 antral follicles 2-10 mm in size for both ovaries combined

          -  AMH: >1 ng/ml (7.15 pmol/l) and <5.6 ng/ml (40.0 pmol/l)

          -  Presence and adequate visualization of both ovaries;

          -  Within 12 months of the beginning of the study, uterine cavity consistent with
             expected normal function as assessed through transvaginal ultrasound,
             hysterosalpingogram, sonohysterogram or hysteroscopic examination;

        Exclusion Criteria:

          -  Primary ovarian failure or women known as poor responders;

          -  PCO and PCOS;

          -  Severe OHSS in a previous COH cycle;

          -  Uterine malformation that may impair the possibility to get pregnant;

          -  Ovarian cysts >10 mm;

          -  Hydrosalpinx that have not been surgically removed or ligated;

          -  Endometriosis stage 3 or 4;

          -  Oocyte donation;

          -  Severe male factor;

          -  Pathologies associated with any contraindication of being pregnant;

          -  History of recurrent miscarriage (more than 3 previous miscarriages);

          -  Hypersensitivity to the study medication;

          -  Abnormal bleeding of undetermined origin;

          -  Uncontrolled thyroid or adrenal dysfunction;

          -  Neoplasias;

          -  Severe impairment of renal and/or hepatic function.
Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Roflumilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 26.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Roflumilast; COPD

Summary:

      Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease
      surrogate markers of bone metabolism and early cardiovascular disease in individuals with
      moderate to severe airflow obstruction and a chronic bronchitis phenotype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco
             exposure, airflow obstruction (FEV1/FVC < 0.70) with an FEV1 < 70%

          -  baseline sputum production at least some of the time as reported on the Saint George's
             Respiratory Questionnaire, and at least one exacerbation within the past year

        Exclusion Criteria:

          -  Subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates,
             calcitonin, parathyroid hormone)

          -  Subjects with a body mass index less than 18 or greater than 34
Rejuvenation of the Lower Eyelid Using a Combination of Two Hyaluronic Acid Fillers - a Pilot Study
Condition: Infraorbital Hollows
Intervention: Restalyne; Perlane
Intervention description: one syringe of Restylane® (1.0cc) will be used total for both tear trough areas.; One syringe of Perlane® (1.0cc) will be used total for both tear trough areas.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to determine the efficacy and longevity of the use of
      Restylane® and Perlane® in combination for the rejuvenation of the infraorbital hollows and
      to measure patient satisfaction with this treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older

          -  No significant medical illness

          -  Subjects with the willingness and ability to understand and provide informed consent

        Exclusion Criteria:

          -  Under 18 years of age

          -  Pregnancy or Lactation

          -  Subjects who have had previous surgical treatment of the lower eyelid area or previous
             use of filling agents in the under eye area

          -  Subjects with a known allergy to the components in Restylane® or Perlane®

          -  Subjects currently taking blood thinners or who have had chemotherapy or radiation
             within the last 6 months

          -  Subjects with liver/kidney disease or compromise or who are immunocompromised

          -  Subjects with a known susceptibility to keloid formation or hypertrophic scarring

          -  Subjects with an open, non-healing sore or infection near the site of injections

          -  Subjects who are unable to understand the protocol or to give informed consent

          -  Subjects with mental illness
Aspirin Dosing in Diabetic Patients
Condition: Type 2 Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Aspirin
Intervention description: After having been on aspirin 81mg/daily for at least one-week, patients switched their aspirin regimen on a weekly basis according to the following scheme: aspirin 81mg twice daily (bid) for one week; aspirin 162 mg once daily (od) for one week; aspirin 162 mg bid for one week; aspirin 325 mg od for one week. Pharmacodynamic assessments were made after each sequence (5 time-points). Afterward, patients resumed the dose of aspirin that they were on prior to entering the study.
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes mellitus, coronary artery disease, aspirin therapy

Summary:

      Since diabetic platelets are characterized by an enhanced turnover rate, it may be
      hypothesized that an increase in the frequency, rather than the dose, of drug administration
      may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this
      may enable COX-1 blockade of newly generated platelets. However, how different dosing
      regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has
      been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate
      how increasing the frequency of aspirin administration, remaining within the daily
      recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with
      coronary artery disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically treated (taking oral hypoglycemic medication and/or insulin) type 2 diabetes
             mellitus patients between 18 to 75 years with stable coronary artery disease

        Exclusion Criteria:

          -  Blood dyscrasia or bleeding diathesis

          -  Oral anticoagulation therapy with a coumadin derivative

          -  Recent antiplatelet treatment (< 30 days) with a glycoprotein IIb/IIIa antagonist,
             thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole Platelet count <
             100 /microL

          -  History of gastrointestinal bleed within last 6 months

          -  History of cerebrovascular accident within last 3 months

          -  History of hospitalization for an acute coronary event or coronary revascularization
             (percutaneous or surgical) in the past 12 months

          -  Active bleeding or hemodynamic instability

          -  Any active malignancy

          -  Serum creatinine > 2 mg/dL

          -  Baseline ALT > 2.5 times the upper limit of normal

          -  Pregnant females

          -  HbA1C > 10%

          -  Use of nonsteroidal anti-inflammatory drugs past 10 days.
Chloroprocaine Spinal Anesthesia for Cervical Cerclage (CP Spinal)
Condition: Adverse Reaction to Spinal Anesthetic; Maternal Care for Cervical Incompetence
MeSH terms: Uterine Cervical Incompetence
Intervention: Chloroprocaine; Bupivacaine; Fentanyl; Saline
Intervention description: Administered as a single injection or continuously through an indwelling catheter - 50 mg; A dextrose Solution is usually given as an injection - 9 mg (1.4 ml); 15 mcg Fentanyl will be included int he spinal anesthetic in both groups; Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml
Intervention MeSH terms: Fentanyl; Bupivacaine; Chloroprocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chloroprocaine; cervical cerclage; spinal anesthesia; Bupivacaine

Summary:

      This study aims to determine whether or not spinal anesthesia with the local anesthetic drug,
      chloroprocaine, wears off faster than the local anesthetic drug, bupivacaine, and results in
      faster discharge from the post-anesthesia care unit after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I and II women

          -  18-45 yrs old

          -  Singleton pregnancy

          -  Cervical cerclage 1st or 2nd trimester of pregnancy undergoing with spinal anesthesia

          -  Height 150 - 180 cm

          -  BMI ≤ 40 kg/m2.

        Exclusion Criteria:

          -  Any contraindication to neuraxial anesthesia (history of neurologic disease (e.g.,
             multiple sclerosis, spinal stenosis, central or peripheral neuropathy)

          -  Pre-existing/chronic back pain

          -  Ester local anesthetic allergy, PABA allergy

          -  History of atypical cholinesterase (CP is metabolized by cholinesterase)