bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Brinzolamide 1% ophthalmic solution (Azopt); Placebo eye drops; Latanoprost 0.005% ophthalmic solution (Xalatan)
Intervention description: One drop three times a day in both eyes for 3 months; One drop three times a day in both eyes for 3 months; One drop once a day in both eyes for 3 months
Intervention MeSH terms: Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Glaucoma

Summary:

      The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day
      to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated
      intraocular pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral or bilateral primary open angle glaucoma, ocular hypertension or
             pseudoexfoliation syndrome.

          -  Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.

          -  Other protocol-defined inclusion criteria applied.

        Exclusion:

          -  Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or
             argon laser trabeculoplasty.

          -  Argon laser trabeculoplasty or phacoemulsification within the last 3 months.

          -  Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured
             by ultrasonic pachymetry.

          -  Ocular or periocular inflammation within 3 months prior to study (except blepharitis
             related or seasonal allergic conjunctivitis).

          -  History of uveitis or previous intraocular inflammation (other than post-operatively).

          -  Hypersensitivity to sulfa, or benzalkonium chloride.

          -  History of use of any steroids for over 1 week within 3 months of screening or likely
             need for any corticosteroids during the study (except inhaled, nasal or topical
             non-ocular).

          -  Other protocol-defined exclusion criteria applied.
NasoNeb Delivery of an Intranasal Steroid
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Budesonide; Placebo
Intervention description: Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily; Placebo delivered intranasally via NasoNeb nebulizer once daily
Intervention MeSH terms: Budesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: allergy

Summary:

      The purpose of this study is to see if a nasal steroid drug delivered to the nose with the
      NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round
      allergy symptoms).
    

Eligibility criteria:

        Inclusion Criteria

          1. Males and females between 18 and 55 years of age.

          2. History of perennial allergic rhinitis.

          3. Positive skin test to dust mite, dog, cat or indoor mold antigen.

          4. And a combined nasal AM and PM score of ≥4 for nasal congestion in the day preceding
             entry and total nasal symptom score greater than 8.

        Exclusion Criteria

          1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

          2. Pregnant or lactating women.

          3. Subjects treated with systemic steroids during the previous 30 days.

          4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom
             or Opticrom during the previous 30 days.

          5. Subjects treated with oral antihistamine/decongestants during the previous seven days.

          6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants
             during the previous 3 days.

          7. Subjects treated with immunotherapy and are escalating their dose.

          8. Subjects on chronic anti-asthma medications.

          9. Subjects with polyps in the nose or a significantly displaced septum.

         10. Upper respiratory infection within 14 days prior to study start.
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a; ribavirin [Copegus]
Intervention description: 180 mcg sc weekly, 48 weeks; 1'000 or 1'200 mg orally daily, 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      This multi-center, open-label study will evaluate the efficacy and safety of Pegasys
      (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in
      treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys
      (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated
      time of study treatment is 48 weeks, follow-up is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 and <70 years of age at initiation of treatment

          -  Body weight between 50 kg and 125 kg at baseline

          -  Chronic hepatitis C, genotype 1

          -  Chronic liver disease consistent with HCV infection

          -  Compensated liver disease (Child-Pugh Grade A)

        Exclusion Criteria:

          -  Pregnant or lactating women, and male partners of pregnant women

          -  Chronic hepatitis C, genotype 2, 3, 4, 5 or 6

          -  Previous treatment with interferon or ribavirin

          -  Positive for hepatitis A, hepatitis B or HIV infection

          -  History or evidence of a medical condition associated with liver disease other than
             chronic hepatitis C

          -  Decompensated liver disease and/or liver disease Child-Pugh classification >6

          -  Hepatocellular carcinoma

          -  History or evidence of esophageal bleeding

          -  Hemoglobinopathy, or any other cause for possible hemolysis

          -  Hb <11 g/dL in women, <12 g/L in males
Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures
Condition: Epilepsy, Idiopathic Generalized
MeSH terms: Seizures
Intervention: Levetiracetam; Valproate
Intervention description: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred; Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Intervention MeSH terms: Levetiracetam; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and
      safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age≥16

          -  At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least
             one in last 6 months

          -  Normal brain MRI or MRI without epileptogenic lesion

          -  Normal electroencephalography(EEG) or existence of generalized epileptiform discharges
             without any focal epileptiform discharges.

          -  Signing consent form

        Exclusion Criteria:

          -  History of treatment by sodium valproate or levetiracetam

          -  History of treatment by any anti-epileptic drug in last 6 months

          -  Plan for pregnancy

          -  Using no certain contraceptive method

          -  History of past or current hepatic disease

          -  History of past or current renal disease

          -  History of past or current hematologic disease

          -  History of known psychiatric disease

          -  History of status epilepticus
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
Condition: Liver Transplantation
Intervention: Everolimus; Tacrolimus; Corticosteroids
Intervention description: tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg; capsule containing 0.5, 1.0, or 5.0mg; For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.
Intervention MeSH terms: Everolimus; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 339.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Liver transplantation; Everolimus; Tacrolimus; Renal function

Summary:

      This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus
      versus a standard immunosuppressive regimen concerning kidney function in liver transplant
      recipients.
    

Eligibility criteria:

        Inclusion criteria:

        Male or female recipients of a full-size liver allograft, aged 18 to 65 years.

        Exclusion criteria:

        Patients with thrombocytopenia (platelets <50,000/mm³), with an absolute neutrophil count
        of <1,000/mm³ or leucopenia (leucocytes <2000/mm³), with anemia with Hb < 6g/dl at time of
        randomization

        Patients with uncontrolled hypercholesterolemia (>350mg/dL; >9mmol/L) or
        hypertriglyceridemia (>750 mg/dL; >8.5 mmol/L) at time of randomization

        History of malignancy of any organ system within the past 5 years whether or not there is
        evidence of local recurrence or metastases, other than non-metastatic basal or squamous
        cell carcinoma of the skin or HCC
Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus
Condition: Parkinson's Disease; Deep Brain Stimulation Surgery
MeSH terms: Parkinson Disease
Intervention: Dexmedetomidine
Intervention description: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: SubThalamic Nucleus; Microelectrode recording; Deep Brain Stimulation Electrode implantation

Summary:

      The purpose of this research study is to find out whether dexmedetomidine changes brain cell
      activity in the subthalamic nucleus (STN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo bilateral STN electrode implantation surgery with
             Micro-electrode recording for the treatment of Parkinson's disease.

        Exclusion Criteria:

          -  Hypersensitivity to dexmedetomidine

          -  Bradycardia: Sinus rhythm slower than 50 bpm

          -  Known or suspected obstructive sleep apnea

          -  Suspected difficult intubation

          -  Pregnancy

          -  Under 18 years of age or over 85 years of age

          -  Cognitive disability impairing understanding the experiment or signing the informed
             consent form
Effect of Single Dose Intranasal Insulin On Cognitive Function
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Placebo; Insulin (Humulin)
Intervention description: Placebo; 40 IU Intranasal Insulin will be administered once
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizophrenia; Memory; Concentration; Insulin

Summary:

      The purpose of the study is to find out how a small dose of insulin might affect memory, the
      ability to concentrate, and improve your daily functioning in patients with schizophrenia and
      schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The
      investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal
      insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's
      effect on cognition. The specific aims include:

        1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on
           cognitive functioning, including attention and memory.

        2. Examine whether single dose of intranasal insulin administration will raise serum
           insulin level and decrease plasma glucose level

      Insulin will be delivered through an air spray pump into your nose. The investigators will be
      comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years

          -  Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype

          -  Male or female

          -  Stable dose of the current antipsychotic drug for at least one month

          -  Well established compliance with out-patient treatment per treating clinician's
             judgement.

          -  Able to complete the cognitive assessment battery (must be English speaking)

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  Current substance abuse

          -  On clozapine or olanzapine

          -  Psychiatrically unstable per treating clinician's judgement.

          -  Significant medical illnesses including uncontrolled hypertension, diabetes, seizure
             disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases etc.

          -  Incapable to complete the cognitive battery assessment.
The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy
Condition: Neuromuscular Blockade
Intervention: deep block
Intervention description: sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Neuromuscular blockade; Sugammadex; Laparoscopic surgery; IL-6

Summary:

      This study is a multicenter, randomized, controlled, double-blinded, and parallel design
      study. A total of 96 patients were decided to be recruited considering a 10% dropout rate.
      Patients are randomized to receive a deep block or a moderate block. The randomization
      numbers are generated using a computer-generated randomization code (1) and are sealed in the
      opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia
      management after the induction of anesthesia. Patients, surgeons reporting the scale of
      surgical status, and another researcher analysing the cytokines levels are blinded to the
      patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective
      laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease,
      hepatic or renal function impairment, on medications affecting neuromuscular function, and
      with known allergy to the drugs to be used are excluded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists grade 1 or 2

          -  Scheduled for elective laparoscopic gastrectomy

        Exclusion Criteria:

          -  Severe respiratory or cardiac disease

          -  Severe hepatic or renal function impairment

          -  On medications affecting neuromuscular function

          -  Known allergy to the drugs to be used
A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Placebo
Intervention description: Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration; Matching placebo tablets, oral administration
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: nebivolol; Bystolic®; Hypertension; blood pressure; withdrawal

Summary:

      This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with
      stage 1 or stage 2 hypertension after the withdrawal of active medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and female outpatients 18 to 79 years of age

          -  Females must be post-menopausal, or not pregnant and using an approved contraceptive
             regimen

          -  meet criteria for stage I or II hypertension

          -  currently not treated, or being treated with no more than two anti-hypertensive
             medications

        Exclusion Criteria:

          -  type 1 or type 2 diabetes

          -  secondary hypertension

          -  evidence of other concurrent disease or conditions that might interfere with the
             conduct of the study

          -  treatment with any investigational study drug within 30 days of Screening (Visit 1)

          -  have a history of hypersensitivity to nebivolol or other β-blockers
Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
Condition: Chronic Sinusitis; Nasal Obstruction; Turbinate; Hypertrophy Mucous Membrane; Deviated Nasal Septum - Congenital; Deviated Nasal Septum Acquired
MeSH terms: Sinusitis; Nasal Obstruction; Hypertrophy; Postoperative Hemorrhage
Intervention: Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)
Intervention description: Medication administered 15 minutes prior to end of surgery.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the research is to assess the effectiveness of a dose of intravenous
      tranexamic acid (TXA) given intraoperatively to reduce postoperative bleeding after
      endoscopic sinus or nasal surgery (e.g. septoplasty, endoscopic sinus surgery, turbinate
      surgery). This medication has been shown to decrease blood loss during this type of surgery,
      but the implications for bleeding following surgery are unclear. Any impact on postoperative
      bleeding will be assessed over the first 7 days following surgery leading up to the first
      scheduled postoperative clinic visit. Patients will keep a standardized daily diary of their
      bleeding experience by indicating on a 0-10 visual analog scale (VAS) their impression of
      their bleeding.

      The primary outcome is the patient-reported visual analog scale (VAS) bleeding score on each
      day after surgery. The secondary outcomes include the the frequency with which the
      otolaryngology resident service is requested to evaluate patients in the recovery unit for
      postoperative bleeding concerns and the frequency of interventions such as application of
      hemostatic materials, packing, cautery, and/or return to the operating room.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to undergo elective sinus or nasal surgery (e.g. septoplasty, inferior
             turbinate reduction, endoscopic sinus surgery)

          -  Age 18 or greater

          -  English-speaking

          -  Able to provide consent

        Exclusion Criteria:

          -  Minors (age<18)

          -  Pregnant or may become pregnant by time of surgery

          -  Prisoners

          -  Non-English speaking

          -  Foreign citizens

          -  Unable to provide consent

          -  Known pro-thrombotic coagulation disorders

          -  Active intranasal drug use (e.g. cocaine)

          -  Surgery is for a sinonasal tumor or other sinus pathology not described in inclusion
             criteria

          -  Enrollment is in conflict with existing study participation