bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis
Condition: Neurotrophic Keratitis
MeSH terms: Keratitis
Intervention: cenegermin-bkbj
Intervention description: Cenegermin-bkbj ophthalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage 1 Neurotrophic Keratitis; Corneal Disease; Ocular Disease

Summary:

      This study is to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL)
      cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged ≥ 18 years.

          2. Patients with Stage 1 NK defined by the Mackie criteria

        Exclusion Criteria:

          1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.

          2. Have current or history of conditions that may confound the study data including but
             not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD),
             neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome.

          3. History of severe systemic allergy or severe ocular allergy (including seasonal
             conjunctivitis expected during the subject's participation in the trial) or chronic
             conjunctivitis and/or keratitis other than dry eye disease.

          4. Patients with severe vision loss with no potential for visual improvement in the study
             eye, in the opinion of the investigator, or if the subject is deemed legally blind.

          5. Ocular surgery or elective ocular surgery expected during participation in the trial.

          6. Patients with eyelid abnormality that may alter eyelid function including but not
             limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid
             syndrome.
Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Intervention: Artificial tears
Intervention description: At random, subjects will receive isotonic artificial tear or a control (normal saline).
Intervention MeSH terms: Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dry eye; artificial tears; tear osmolarity; residence time

Summary:

      Background:

      Osmolarity is defined as the concentration of particles dissolved in a solution. Normal tears
      contain various dissolved particles including proteins, salts and other electrolytes. The
      investigators plan to investigate how osmolarity of the tear film changes over time after
      instillation of artificial tears containing hyaluronate. This is one kind of artificial tear
      that is used to treat dry eye.

      Dry eye and tear osmolarity:

      Dry eye is a significant health problem, but diagnosis and treatment are often ambiguous and
      ineffective. There has been a resurgence of interest and research in dry eye in the past 5
      years, and tear osmolarity has emerged as perhaps, one of the most effective ways to evaluate
      tear quality and dry eye status. Dry eye is usually treated with artificial tears, and many
      formulations are available. The investigators will test an isotonic solution that contains
      hyaluronate. Hyaluronate binds water and should help to maintain water on the eye.

      Objective:

      We plan to study the time course of possible changes in tear film osmolarity following
      instillation of an isotonic artificial tear containing hyaluronate. The investigators will
      use the TearLab, a new clinical instrument that has been developed to quickly and easily
      measure tear film osmolarity. Understanding how artificial tears affect tear film osmolarity
      over time can help doctors determine efficacy and dosing schedules. The investigators will
      test the isotonic hyaluronate (Blink Contacts) artificial tears relative to normal saline
      solution.

      Hypothesis:

      The investigators should be able to measure a decrease in tear osmolarity over time following
      instillation due to the water-binding effect of hyaluronate artificial tears relative to a
      control (normal saline solution).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age Normal vision in both eyes (20/30 best corrected) Preference
             for patient with dry eye symptoms

        Exclusion Criteria:

          -  No ocular disease other than dry eye Currently taking no ocular or systemic
             medications that might affect results
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis; Inflammation
Intervention: Secukinumab 300 mg; Placebo
Intervention description: Secukinumab 300 mg was provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab consisted of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 48 inclusive.
The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occurred on days of study visits.
The injections not occurring on days of study visits were done by the patients (or caregivers) at home.; Placebo was provided in 1 mL prefilled syringe. Each placebo dose consisted of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3, 4), then after four weeks at Week 8. At Week 12, patients were switched to receive 300 mg secukinumab once weekly for five weeks (Weeks 12, 13, 14, 15, 16) followed by monthly dosing through Week 48 inclusive.
The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occured on days of study visits.
The injections not occurring on days of study visits were done by the patients (or caregivers) at home.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; plaque psoriasis; secukinumab; AIN457; biologic; monoclonal antibody; aortic vascular inflammation

Summary:

      This study evaluated the effect of secukinumab compared to placebo on aortic vascular
      inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly
      controlled by current psoriasis treatments.
    

Eligibility criteria:

        Inclusion Criteria:

        - Males and females at least 18 years of age with moderate to severe plaque psoriasis

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque psoriasis

          -  Previous exposure to IL-17A or IL-17 receptor targeting agents.

          -  Other active or ongoing disease that may interfere with evaluation of psoriasis or
             places the patient at unacceptable risk

          -  Other protocol-defined inclusion/exclusion criteria may apply
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
Condition: Non-Cystic Fibrosis Bronchiectasis
MeSH terms: Bronchiectasis; Fibrosis
Intervention: Amikacin; Normal saline
Intervention description: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.; Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
Intervention MeSH terms: Amikacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Nebulized amikacin;; Non-Cystic Fibrosis Bronchiectasis;; Bacterial clearance rate of sputum；; Acute exacerbation.

Summary:

      This is a multi-centered, randomized, controlled study to assess the efficacy, indications
      and adverse reactions of combined administration of nebulized amikacin in patients with acute
      exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled
      antibiotics are more likely to cause bacterial resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female study subjects ≥18 years of age and ≤80 years of age;

          -  Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis;

          -  Confirmation of infection with Pseudomonas aeruginosa at screening;

          -  Are sensitive to amikacin;

          -  Acute exacerbation of bronchiectasis.

        Exclusion Criteria:

          -  Bronchiectasis due to special causes;

          -  Smokers;

          -  Are associated with bronchial asthma;

          -  Have any serious or active medical or psychiatric illness;

          -  Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces ≥15% after
             inhaling amikacin.
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Hyperkalemia
Intervention: Patiromer 25.2 g
Intervention description: Single dose of Patiromer 25.2 g
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Investigator hypothesize that a single dose of patiromer will lower serum potassium
      levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied
      in at least two multicenter randomized controlled trials, the Investigator further
      hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic
      patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate
      for this study because the research staff will enroll patients with moderate (K greater than
      6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this
      population for more effective control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ESRD patients with serum potassium greater than or equal to 6.0 mEq/L

          -  Emergent dialysis not expected to be available for 6 hours

        Exclusion Criteria:

          -  new clinically significant arrhythmia on initial ECG

          -  patiromer is contraindicated

          -  have received SPS
Sitagliptin and Glucagon Counterregulation
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Placebo
Intervention description: Sitagliptin 100 mg daily; Placebo one tablet daily
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 65 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at
      moderate hypoglycemia in metformin-treated subjects with T2DM
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written consent has been given.

          2. Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the
             preceding 3 months)

          3. Age >65 years.

          4. HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.

          5. Ability to complete the study

        Exclusion Criteria:

          1. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.

          2. Type 2 diabetes, positive GAD antibodies

          3. eGFR <60 ml/min

          4. Acute infections which may affect blood glucose control within 4 weeks prior to visit
             1

          5. Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.

          6. Liver disease such as cirrhosis or chronic active hepatitis

          7. History of coronary heart disease or heart failure class III or IV

          8. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at
             least one unit of blood within the past 2 weeks or a blood transfusion within the past
             8 weeks.

          9. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment
             (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.

         10. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable
             for the study
Bupropion for Smoking Cessation During Pregnancy
Condition: Pregnancy Related; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Bupropion SR; Smoking Cessation Counseling; Placebo
Intervention description: Bupropion SR 150 mg tablet; 35-min counseling by trained research nurse; Matching Bupropion SR placebo tablet
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregnancy; Tobacco use disorder; Smoking cessation; Bupropion SR; Zyban

Summary:

      This is a prospective, double-blind placebo-controlled randomized pilot trial of the
      preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for
      smoking cessation during pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days

          -  13-30 weeks gestation

          -  ≥18 years of age

          -  able to speak English or Spanish

          -  intent to carry pregnancy to term

          -  stable residence

        Exclusion Criteria:

          -  current illicit drug or alcohol abuse or dependence

          -  twins or other multiple gestation

          -  treatment for psychiatric disorder within the last 6 months

          -  unstable medical problems (eg, hypertension (BP>140/90), preeclampsia, threatened
             abortion, hyperemesis gravidarum)

          -  known congenital abnormality

          -  seizure disorder

          -  use of psychotropic medication

          -  use of medication known to lower the seizure threshold

          -  anorexia/bulimia

          -  a personal history of closed head trauma with > 30 minutes of loss of consciousness or
             amnesia or resulting in skull fracture or subdural hematoma/brain contusion

          -  use of any other smoking cessation treatment in the past 30 days

          -  current enrollment in methadone treatment program

          -  prior pregnancy with preeclampsia diagnosis

          -  chronic hypertension (past history or current diagnosis)
Treatment of Insomnia in Migraineurs
Condition: Insomnia; Migraine
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: eszopiclone; placebo
Intervention description: 3 mg tablet every night at bedtime; 1 tablet every night at bedtime
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; migraine; eszopiclone; insomnia in migraineurs

Summary:

      It is hypothesized that treating insomnia in migraineurs, many of whom also have tension
      headaches, prolongs total sleep time to the extent that it decreases overall headache
      frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly
      affecting daytime functioning, which is hypothesized to improve as well with prolonged total
      sleep time.
    

Eligibility criteria:

        Inclusion criteria:

          1. Men and women, 18 to 64 years of age (inclusive) with International Headache Society
             (IHS)-II migraine with/without aura and Diagnostic and Statistical Manual (DSM)-IV
             primary insomnia (sleep onset/sleep maintenance).

          2. Migraine frequency is 4-12 times per month, with a maximum of 20 days with headache
             per month, for 1 month or longer prior to screening.

          3. A usual, estimated total sleep time of 6½ hours per night or less, for 1 month or
             longer prior to screening, due to problems falling asleep, waking up during the night,
             or waking up early.

        Exclusion criteria:

          1. Abortive migraine treatment with schedule II-III opioids.

          2. Use of caffeine-containing medications, prescription and non-prescription, not
             exceeding 10 days per month.

          3. Preventive migraine treatment with tricyclics or anticonvulsants.

          4. Treatment of insomnia with non-prescription medications, such as diphenhydramine,
             melatonin, or valerian, and prescription medications, such as hypnotics, barbiturates,
             benzodiazepines, sedating antihistamines, antidepressants, and antipsychotics.
Stereotactic Body Radiotherapy for Head and Neck Tumors
Condition: Squamous Cell Carcinoma of the Head and Neck; Nasopharyngeal Carcinoma; Salivary Gland Cancer; Head and Neck Sarcoma; Paraganglioma of Head and Neck; Chordoma of Head and Neck; Chondrosarcoma of Head and Neck; Angiofibroma of Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Nasopharyngeal Carcinoma; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms; Chondrosarcoma; Paraganglioma; Chordoma; Head and Neck Neoplasms; Angiofibroma
Intervention: stereotactic body radiotherapy; Stereotactic body radiotherapy
Intervention description: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction); 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stereotactic radiosurgery; head and neck tumors; squamous cell carcinoma of head and neck

Summary:

      This study will evaluate the local control rates as well as acute and late toxicity rates of
      stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck
      tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient age > 18 years

          -  Zubrod performance status of 0-3

          -  Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma

          -  Malignant head and neck cancers such as invasive squamous cell carcinoma,
             adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma

          -  Signed study-specific consent form

        Exclusion Criteria:

          -  Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown
             effects of RT on lactating females

          -  Patients with psychiatric or addictive disorder that would preclude obtaining informed
             consent
Relapse Prevention With Varenicline
Condition: Recurrence; Smoking Cessation; Substance-Related Disorders
MeSH terms: Recurrence; Substance-Related Disorders
Intervention: Varenicline; Placebo
Intervention description: Varenicline given twice a day or five weeks.; Placebo given twice a day or five weeks.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Relapse; Smoking Cessation; Substance Abuse

Summary:

      This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation
      aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the
      laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking
      and will delay or prevent relapse compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years old

          -  Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests
             positive for nicotine metabolites at intake

          -  Contemplating a smoking cessation attempt in the near future

          -  Willing to engage in a practice quit attempt during which they will be asked to smoke
             on one occasion

          -  Able to give informed consent

        Exclusion Criteria:

          -  Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression,
             bi-polar disorder, or schizophrenia

          -  History of attempted suicide or expresses any current suicidal ideation

          -  Pregnant, breast feeding, or planning to become pregnant within the next 3 months

          -  Reports desire for immediate treatment of tobacco/nicotine dependence

          -  Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less
             than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma
             creatinine adjusted by weight, gender, and age)