bioihbjkbjnl/mcl2 huggingface dataset:
Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Condition: Bronchiectasis Adult; Mediastinal Lymphadenopathy; Pneumonia; Chest--Diseases; Infiltrates; Bronchopulmonary Disease; Cancer, Lung
MeSH terms: Lung Neoplasms; Bronchiectasis; Lymphadenopathy
Intervention: Topical lidocaine; Nebuliser solution; Nebuliser Suspension
Intervention description: 1% lidocaine topically applied in 4 mL aliquots; 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer; 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess if there is decrease in cough during flexible
      bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration
      are used. The modes of administration being evaluated are topical, nebulized and atomized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial
             ultrasound evaluation and transbronchial needle aspiration.

          -  Diagnosis of pulmonary disease requiring flexible bronchoscopy

          -  Greater than 18 years of age.

        Exclusion Criteria:

          -  Any intervention beyond flexible bronchoscopy and endobronchial ultrasound

          -  Inability to tolerate bronchoscopy.

          -  Patients that receive paralytics.

          -  Patients with neuromuscular diseases.

          -  Inability to consent for procedures.

          -  Allergies to lidocaine or any other drugs used in protocol.

          -  Existing renal insufficiency or liver disease
OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Condition: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: Dexamethasone; Placebo Vehicle
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of post-surgical inflammation and pain in subjects who had undergone cataract
      extraction with intraocular lens implantation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a cataract and is expected to undergo clear corneal cataract surgery with
             phacoemulsification and implantation of a posterior chamber lens

          -  Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or
             better in both eyes

        Exclusion Criteria:

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination

          -  Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening

          -  Any intraocular inflammation in the study eye present during the screening slit lamp
             examination
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
Condition: Vaccines, Pneumococcal
Intervention: 13-valent Pneumococcal Conjugate Vaccine; 7vPnC
Intervention description: 0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.; 0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1712.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Infants; Pneumococcal Conjugate Vaccines; Vaccines, Pneumococcal

Summary:

      The purpose of this study will be to evaluate safety, tolerability and immunogenicity of
      three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied
      for consistency of the immune response, as well as for non-inferiority and safety as compared
      to 7-valent Pneumococcal Conjugate Vaccine.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy 2 month old infants

          -  Available for the duration of the study and reachable by telephone

          -  Able to complete two blood drawing procedures during the study

        Exclusion criteria:

          -  Previous vaccination, contraindication or history of allergic reaction to vaccines or
             vaccine components

          -  Bleeding disorder, immune deficiency or significant chronic or congenital disease

          -  Previous receipt of blood products or immune globulin
Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
Condition: Castrate-resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Denosumab
Intervention description: Administered by subcutaneous injection
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-national, multi-center, open-label, single-arm extension study for the
      prolongation of bone metastasis-free survival in men with hormone-refractory (androgen
      independent) prostate cancer. Patients currently participating in the phase 3 study 20050147
      (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is
      determined in the 20050147 study. The primary endpoint of the 20050147 study is bone
      metastases-free survival determined by the time to first occurrence of bone metastases
      (either symptomatic or asymptomatic) or death from any cause. Participants will receive
      open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they
      developed a bone metastasis or for up to 3 years, whichever comes first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study
             20050147

          -  Subjects must sign the informed consent before any study specific procedures are
             performed

        Exclusion Criteria:

          -  Developed sensitivity to mammalian cell derived drug products during the 20050147
             study

          -  Currently receiving any unapproved investigational product other than denosumab

          -  Any disorder that, in the opinion of the investigator, may compromise the ability of
             the subject to give written informed consent and/or comply with study procedures
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
Condition: Hypercholesterolemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Intervention: Atorvastatin 10 mg; Ezetimibe 10 mg/simvastatin 20 mg; Atorvastatin 20 mg; Ezetimibe 10 mg/simvastatin 40 mg; Atorvastatin 40 mg
Intervention description: Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks; Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks; Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks; Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks; Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1289.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: High Cholesterol

Summary:

      A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus
      atorvastatin in elderly patients with high cholesterol at high or moderately high risk for
      coronary heart disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a cholesterol level of 130 mg/dL or greater

          -  Patient is willing to maintain a cholesterol lowering diet for as long as they are in
             the study

          -  Patient is at moderate high risk or high risk for coronary heart disease per the
             National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)
             guidelines

        Exclusion Criteria:

          -  Patient weighs less than 100 lbs

          -  Patient has an allergy to ezetimibe, simvastatin or atorvastatin
A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution
Condition: Healthy Subjects
Intervention: AC-170 0.24%; AC-170 Vehicle
Intervention MeSH terms: Cetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 516.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 2 years of age

          -  be able to self-administer eye drops or have a parent/legal guardian available for
             this purpose

          -  if less than 18 years old have a history or family history of atopic disease
             (including allergic conjunctivitis)

          -  have ocular health within normal limits

        Exclusion Criteria:

          -  known contraindications or sensitivities to the study medication or its components

          -  any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety trial parameters

          -  use of disallowed medication during the period indicated prior to the enrollment or
             during the study

          -  be pregnant, nursing, or planning a pregnancy
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Condition: Chronic Kidney Disease; Dialysis; Hyperphosphatemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: MCI-196
Intervention description: 3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Phosphate binder

Summary:

      The primary objective of this study is to demonstrate the long-term safety and tolerability
      of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with
      hyperphosphatemia.

      The secondary objective of this study is to assess the long-term efficacy of flexible doses
      of MCI-196.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, and is >=18 years old

          -  Stable hemodialysis or peritoneal dialysis

          -  Subjects have stable phosphate control

          -  Subjects on stabilized phosphorus diet

          -  Subjects undergoing regular dialysis treatment

          -  Females and of child-bearing potential have a negative serum pregnancy test

          -  Male subjects must agree to use appropriate contraception

        Exclusion Criteria:

          -  Current clinically significant medical comorbidities, which may substantially
             compromise subject safety, or expose him/her to undue risk, or interfere significantly
             with study procedures and which, in the opinion of the Investigator, makes the subject
             unsuitable for inclusion in the study

          -  serum albumin level < 3.0g/L

          -  PTH level > 1000pg/mL

          -  Hemoglobin level < 8mg/dL

          -  A History of significant gastrointestinal motility problems

          -  Biliary obstruction or proven liver dysfunction

          -  A positive test for HIV 1 and 2 antibodies

          -  A history of substance or alcohol abuse within the last year

          -  Seizure disorders

          -  A history of drug or other allergy

          -  using cholestyramine, colestipol or colesevelam

          -  Schedule to receive a kidney transplant within the next 6 months

          -  Participation in a clinical study with any experimental medication in the last 30 days
             or an experimental biological product within the last 90 days prior to signing of
             informed consent
Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: imiquimod cream; imiquimod cream; Placebo
Intervention description: cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.; cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.; cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
Intervention MeSH terms: Imiquimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 479.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic keratosis; Skin disease

Summary:

      The purpose of this study is to determine whether imiquimod creams are effective in treating
      Actinic Keratoses when applied to the face or balding scalp.

      Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the
      sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient
      contained in the study cream for this study is the same as that of the approved product
      Aldara, which has been shown to be safe and effective for the treatment of AKs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good general health

          -  Have 5 to 20 AKs on the face or balding scalp

          -  Negative urine pregnancy test (for women who are able to become pregnant)

          -  Willing to make frequent visits to the study center during treatment and follow-up
             periods.

        Exclusion Criteria:

          -  Women who are pregnant, lactating or planning to become pregnant during the study.

          -  Have had a medical event within 90 days of the first visit (such as; stroke, heart
             attack).

          -  Have any skin condition in the treatment area that may be made worse by treatment with
             imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).

          -  Have received specific treatments/medications in the treatment area(s) within the
             designated time period prior to study treatment initiation.
Lurasidone Extended Use Study
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Intervention: Lurasidone
Intervention description: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Healthy volunteers: No
Keywords: Schizophrenia; bipolar disorder; Lurasidone; Latuda

Summary:

      This is an open-label continuation study designed to monitor the safety, tolerability and
      effectiveness of lurasidone in subjects who have completed participation in a lurasidone
      extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment
      with lurasidone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject or legal guardian provides written informed consent. For eligible subjects
             under age 18, verbal assent is also required.

          -  The subject has completed the extension phase of a prior lurasidone clinical study.
             Eligible subjects may enroll into this continuation study directly (or within 10 days)
             after completing the extension phase of a prior lurasidone clinical study. Subjects
             that have completed an extension study prior to the initiation of this protocol at the
             study site, may participate in this study up to 3 months after completion of the
             extension phase of the prior lurasidone study.

          -  The subject is judged by the Investigator to be suitable for participation in a
             clinical study involving open-label lurasidone treatment and is able to comply with
             the protocol.

          -  The subject, in the Investigator's judgment, may benefit from continued treatment with
             lurasidone

        Exclusion Criteria:

          -  The subject is considered by the Investigator, to be at imminent risk for homicidal or
             suicidal behavior.

          -  The subject resides in a country where lurasidone has been approved for any
             indication.

          -  The subject is currently enrolled in any other investigational study.

          -  The subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide
             Severity Rating Scale (C-SSRS).
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Medigus SRS endoscopic stapling system
Intervention description: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GERD; Gastroesophageal Reflux; Fundoplication; Endoluminal; Gastroesophageal Flap Valve

Summary:

      The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling
      system for the treatment of GERD.

      The system allows the operator to staple the stomach to the esophagus,in order to restore the
      gastroesophageal flap valve. The effect of the stapling is similar to a common operation for
      GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is
      not needed.

      The hypothesis of the study is that the treatment will be effective in improving GERD related
      quality of life by 50% or more in the majority of the subjects, and that the procedure will
      be as safe as surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of GERD related symptoms for at least 2 years.

          -  Recent objective evidence of GERD, demonstrated by a 24h pH acid exposure test.

          -  History of daily intake of proton pump inhibitors (PPIs) for at least 6 months, with
             significant relief of symptoms (i.e., difference in GERD Health Related Quality of
             Life (GERD HRQL) scores on and off PPI > =6).

          -  GERD-HRQL ≥20 off of PPI's

        Exclusion Criteria:

          -  Hiatal hernia > 3 cm or a paraesophageal hernia

          -  Barrett's esophagus or grade IV esophagitis

          -  Esophageal stricture, ring or web causing symptoms of dysphagia

          -  Grade I Flap valve according Hill's classification

          -  History of co-morbidity