bioihbjkbjnl/mcl2 huggingface dataset:
Circadian Ocular Perfusion Pressure and Ocular Blood Flow
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension; Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution
Intervention description: Fixed combination ophthalmic suspension; Fixed combination ophthalmic solution
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Ophthalmic Solutions; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glaucoma; ocular perfusion pressure; ocular blood flow; open angle glaucoma requiring more than one IOP-lowering medication

Summary:

      The purpose of this study was to compare the short term effects of two intraocular pressure
      (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular
      pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is
      defined as the difference between arterial blood pressure (diastolic and systolic) and
      intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion
      pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign Informed Consent.

          -  Diagnosis of open-angle glaucoma in at least one eye.

          -  Requires more than one IOP-lowering medication.

          -  IOP measurements at Screening, Safety, and Eligibility/Period 1 Baseline Visits as
             specified in protocol.

          -  Able to discontinue all IOP-lowering medication prior to Eligibility Visit and for 4
             weeks between treatment periods.

          -  Willing to complete all required study visits.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Female of child-bearing potential if pregnant, lactating, or not using highly
             effective birth control measures.

          -  Severe central visual field loss in either eye.

          -  Previous glaucoma surgery in the study eye.

          -  Intraocular surgery in the study eye within 3 months prior to the Screening Visit.

          -  Wears contact lenses.

          -  Allergy/hypersensitivity to study medication.

          -  Cannot safely discontinue use of glucocorticoid medication.

          -  Uses medication that could affect IOP or blood pressure.

          -  Recent use of high-dose aspirin.

          -  Bronchial asthma or severe chronic obstructive pulmonary disease.

          -  Diabetic retinopathy.

          -  Any abnormality preventing reliable tonometry.

          -  Any severe illness or condition unsuitable for the study, in the opinion of the
             investigator.

          -  Other protocol-defined exclusion criteria may apply.
Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo
Condition: Smoking Cessation
Intervention: varenicline; placebo
Intervention description: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days); 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: nicotine withdrawal, smoking cessation, varenicline

Summary:

      Study objective is to compare neuropsychiatric adverse events in subjects treated with
      varenicline or placebo in a controlled setting where both groups are experiencing nicotine
      withdrawal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smokers who smoke >10 cigarettes/day and who have at least a moderate level of
             addiction as measured by the Fagerstrom Test for Nicotine Dependence (score >5)

        Exclusion Criteria:

          -  Any neuropsychiatric disease including depression, history of suicidal thoughts or
             behavior, bipolar disorder.

          -  Any unstable medical condition
Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
Condition: Workplace Migraine Treatment
MeSH terms: Migraine Disorders
Intervention: Triptan; Treximet 85Mg-500Mg Tablet
Intervention description: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan; Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium
Intervention MeSH terms: Naproxen; Sumatriptan; Naratriptan; Zolmitriptan; Rizatriptan; Eletriptan; Almotriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a randomized, open-label, 6-attack (3-attacks per arm) crossover design in which subjects were randomized to threat their first 3 workplace migraines with sumatriptan/naproxen sodium or with their usual triptan monotherapy before treating their subsequent 3 workplace migraines with the opposite medication.
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Productivity; Migraine; Treximet; Triptan

Summary:

      Researchers want to learn about work productivity after treatment of a migraine headache with
      your usual migraine medication as compared to your work productivity after treatment with
      Treximet.

      During this research subjects will take Treximet to treat 3 workday migraine attacks. For a
      second part of the research subjects will take their usual prescribed medication for 3
      workday migraine attacks. The subjects will complete questionnaires after treating each
      migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  episodic migraine diagnosis

          -  age 18 or older

          -  currently using a triptan as primary migraine monotherapy

          -  currently employed

          -  if of childbearing potential, willing to prevent pregnancy during study participation

          -  able to understand and consent to study participation

        Exclusion Criteria:

          -  younger than age 18

          -  not having episodic migraine diagnosis

          -  not using a triptan as primary migraine monotherapy

          -  not currently employed

          -  pregnant or nursing or unwilling to prevent pregnancy during study participation

          -  unable to understand and consent to study participation
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Intervention: doxycycline monohydrate tablet; doxycycline carragenate tablet
Intervention description: Tablet, 100 mg, Single dose; Tablet, 100 mg, Single dose
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence

Summary:

      The purpose of this protocol is to study if two different tablet formulations of doxycycline
      are bioequivalent to each other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects between the ages of 18 and 55 years.

          -  Body Mass Index (BMI) of 18 to 30 kg/m2.

        Exclusion Criteria:

          -  Evidence or history of clinically significant abnormality.

          -  Any condition possibly affecting drug absorption.

          -  A positive urine drug screen.
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
Condition: Opioid Use; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ibuprofen; Acetaminophen; Norco
Intervention description: NSAID; analgesic; acetaminophen plus opioid
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
Masking: None (Open Label)
Enrollment: 170.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postpartum

Summary:

      Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus
      opioid
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaker women who had a cesarean section

        Exclusion Criteria:

          -  Inability or refusal to provide informed consent.

          -  Reported current or prior opioid or benzodiazepine use disorder, including urine drug
             screen positive for a non prescribed opioid or benzodiazepine upon admission or during
             prenatal care.

          -  Current treatment with methadone, buprenorphine or buprenorphine plus naloxone.

          -  Known alcoholism disorder.

          -  Severe renal or hepatic impairment.

          -  Known creatinine > 1.5 at the time of delivery or severe proteinuria leading to
             diagnosis of renal disease prior to delivery.

          -  Severe peptic ulcer disease

          -  Severe asthma (if patient has asthma but has previously tolerated NSAIDS, she will be
             allowed to participate)

          -  Known CYP450/CY92D6 mutation conferring opioid ultra-rapid metabolizer status.

          -  Allergy to any of the study drugs (anaphylaxis).

          -  Incarcerated or institutionalized patients.

          -  Inability to follow up as outpatient in our outpatient clinic.

          -  wound dehiscence or infection diagnosed prior to discharge from the hospital

          -  wound vac placed prior to discharge from the hospital
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin glargine; Inhaled Insulin (Exubera)
Intervention description: Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.; Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 413.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Insulin Glargine Diabetes HbA1c

Summary:

      This study is to determine if inhaled insulin is effective in treating type 2 diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6
             months prior to study entry

          -  Screening HbA1c > 7.0%

          -  Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least
             3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a
             thiazolidinedione

        Exclusion Criteria:

        Smoking within last 6 months PFTs outside of range

          -  Type 1 diabetes mellitus

          -  Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen
             (alone or with Oral Antidiabetic Agents)

          -  Active liver disease; significantly-impaired hepatic function, as shown by, but not
             limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT)
             or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above
             2x the upper limit of normal as measured at visit 1. However, patients with elevated
             ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter
             the study.
Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity
Condition: Stroke; Brain Injuries; Spasticity
MeSH terms: Muscle Spasticity; Brain Injuries
Intervention: Botox
Intervention description: Botox 75-150 units, single treatment only
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Stroke; Brain Injuries; Spasticity; Botulinum Toxins

Summary:

      The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating
      muscle tightness and spasms in the feet and ankles of people with stroke.
    

Eligibility criteria:

        Inclusion Criteria -

          -  Spasticity resulting from ABI (stroke, including vascular malformations, traumatic
             brain injury)

          -  Ashworth Score (resting) of at least 2 of the primary ankle plantarflexor
             (gastrocnemius)

          -  Onset of primary illness at least six months prior to study inclusion

          -  At least 12 years of age

        Exclusion Criteria -

          -  Hypersensitivity or allergy to botulinum toxin

          -  History of myasthenia gravis or other neuromuscular disease

          -  Current use of aminoglycosides

          -  Botulinum toxin or phenol injection to study limb within six months prior to
             recruitment

          -  Current use of other spasmolytic drug, such as diazepam, baclofen, dantrolene,
             tizanidine

          -  Presence of contracture or significant muscle atrophy

          -  Pregnancy
Concentration of Ertapenem in Colorectal Tissue
Condition: Diverticulosis, Colonic; Rectal Neoplasms; Colonic Neoplasms
MeSH terms: Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic
Intervention: Ertapenem
Intervention description: powder for infusion, 1 gram I.V., single dose over 30 min.
Intervention MeSH terms: Ertapenem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue
      from three hours up to six hours (25% of dosing interval) after administration of ertapenem.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized patients 18 years or older requiring elective surgical intervention (open
             or laparoscopic surgery) at the colon will be eligible for this study.

          -  Patients with benignant disorders (e.g. colonic diverticulosis) will be preferred.

        Exclusion Criteria:

          -  Pregnancy or lactation in women

          -  Emergency surgery, history of serious allergy or intolerance to β-lactam antibiotics
             and other carbapenems

          -  Systemic antimicrobial therapy with ceftazidime (internal standard of high-performance
             liquid chromatography / mass spectrometry) within a 7 days period prior to study entry

          -  Ongoing intraabdominal infections

          -  Terminal illness

          -  Chronic immunosuppressive therapy

          -  Severe diseases of the liver, e.g. cirrhosis of the liver with ALT or AST > 6 x upper
             limit of normal (ULN) and bilirubin > 3 x ULN, severe renal insufficiency with a
             creatinine clearance ≤30 mL/min., neutrophil count < 1000 cells/mm3, platelets < 75000
             cells/mm3 and coagulation studies (INR) > 1.5 x ULN, ongoing therapy with valproin
             acid.
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Condition: Hyperopia; Myopia
MeSH terms: Hyperopia
Intervention: Lotrafilcon B; lotrafilcon B with Hydraluxe
Intervention description: commercially available contact lens; commercially available contact lens
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The current study aims to systematically investigate the diurnal variation in the optical
      quality of soft contact lenses on eye throughout the day. Subject reported quality of vision
      will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Habitual prescription +5.00 D to -6.00 D

          -  18-35 years of age

          -  The subject must appear able and willing to adhere to the instructions set forth in
             this clinical protocol.

          -  Vertex corrected refractive cylinder must be -0.75 or less.

          -  Visual acuity best correctable to 20/25 or better for each eye

          -  The subject must read and sign the Informed Consent form.

          -  Mesopic pupil size >5.00 mm.

        Exclusion Criteria:

          -  active condition that would prevent contact lens wear

          -  history of issues of eye alignment or binocularity by self-report

          -  doctor diagnosed, self-reported accommodative or binocular vision issues

          -  doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular,
             ongoing treatment
Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)
Condition: Aspergillosis
MeSH terms: Aspergillosis
Intervention: voriconazole; anidulafungin
Intervention description: Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).; Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy
Intervention MeSH terms: Voriconazole; Anidulafungin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: invasive aspergillosis, opportunistic mold infection

Summary:

      This study will test the effectiveness and the safety of giving two antifungal agents
      (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are
      unable to tolerate polyene therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.

        Exclusion Criteria:

        Patients with invasive aspergillosis for more than 30 days at the time of study entry.
        Patients with uncontrolled bacterial or viral infection at the time of study entry.
        Patients with significant liver dysfunction or who are taking certain medications which
        interact with voriconazole.
Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)
Condition: Hypertension; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Intervention: Candesartan; Candesartan; Felodipine; Felodipine
Intervention description: 16 mg once daily in oral tablet form; 32 mg once daily in oral tablet form; 5 mg once daily in oral tablet form; 10 mg once daily in oral tablet form
Intervention MeSH terms: Felodipine; Candesartan; Candesartan cilexetil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: LVH

Summary:

      The purpose of this study is to investigate effect of candesartan based therapy on percent
      change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left
      ventricular hypertrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood
             pressure within 160-200 mm/Hg

          -  Patients diagnosed as left ventricular hypertrophy by electrocardiogram

        Exclusion Criteria:

          -  Secondary hypertension

          -  History of myocardial infarction

          -  Stroke within the previous 6 months