bioihbjkbjnl/mcl2 huggingface dataset:
Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Endoscopic Ablation System; Standard Anti-arrhythmic Drug (AAD) Therapy
Intervention description: Single ablation procedure with Endoscopic Ablation System; Medication as prescribed by physician.
Intervention MeSH terms: Anti-Arrhythmia Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: AF; PAF; paroxysmal atrial fibrillation; ablation; failed drugs

Summary:

      The purpose of the study is to compare two types of treatment for atrial fibrillation (AF)
      that are designed to treat the symptoms of atrial fibrillation. The treatments being compared
      are:

        -  A single catheter ablation procedure with the investigational EAS, a visually-guided,
           light-energy catheter

        -  Standard drug therapy (antiarrhythmic drugs)

      To learn more about the CardioFocus ENABLE investigational clinical study, please contact the
      study site closest to you.

      Eligibility Criteria

      Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study
      eligibility criteria include:

        -  18 to 80 years of age

        -  Frequent episodes of AF

        -  Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)

        -  Other criteria
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 80 years old

          -  Paroxysmal atrial fibrillation (AF)

          -  Frequent episodes of AF

          -  Failed at least 1 drug treatment

          -  Others

        Exclusion Criteria:

          -  Others
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: atorvastatin; atorvastatin; ezetimibe
Intervention description: Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks; Atorvastatin 40 mg by mouth, once a day for 6 weeks; Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.
Intervention MeSH terms: Atorvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 579.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus
      Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not
      Adequately Controlled on Atorvastatin 40 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg

        Exclusion Criteria:

          -  Pregnant or lactating women or intending to become pregnant

          -  Patient with sensitivity or intolerance to ezetimibe or atorvastatin
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: Efinaconazole Topical
Intervention description: Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
Intervention MeSH terms: Efinaconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic
      subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of
      subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the
      efficacy and safety of both topical and oral antifungal treatment options for onychomycosis
      in diabetic subjects. However, no study to date has specifically addressed the efficacy and
      safety of efinaconazole among diabetic subjects.

      The objective of this noncomparative, uncontrolled study is to determine the efficacy of
      topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus.
      Specific indicators to measure efficacy of treatment will be the mycological cure rate,
      complete cure rate, and treatment success. Furthermore, an additional goal of the study is to
      gain knowledge of safety in the setting of a cohort of diabetic subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive
             mycologic culture findings.

          -  Involvement of at minimum 20% of the target great toenail.

        Exclusion Criteria:

          -  Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual
             onychomycosis, diagnosis of superficial white onychomycosis

          -  Diagnosis of peripheral arterial disease or anatomic abnormalities of the target
             toenail

          -  Inability to follow through with all requisite office visits

          -  Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator,
             or history of systemic antifungals within the prior five years.

          -  Active interdigital tinea pedis refractory to topical antifungal treatments

          -  Known hypersensitivity to efinaconazole

          -  Use, within the month preceding screening, of: topical antifungal agents, topical
             anti-inflammatory agents to the toes

          -  Any history of oral systemic antifungal with known activity against dermatophytes
Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: omalizumab; Placebo
Intervention description: Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.; Placebo was supplied in vials with solution for subcutaneous injection.
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Severe asthma,; non-atopic,; omalizumab

Summary:

      This study will assess the change in the expression of FcεRI receptors of blood basophils and
      dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in
      adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Severe persistent asthma with the following characteristics:

          -  Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at
             least 2 exacerbations having required systemic corticosteroid and/or at least 1
             hospitalization or emergency room visit in the past year.

          -  Treated with high-dose inhaled corticosteroid (i.e. > 1,000 µg beclometasone
             dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without
             maintenance oral corticosteroid).

          -  Non-atopic, i.e. negative blood multiallergic testing and negative
             Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests
             to a battery of common aeroallergens

        Exclusion Criteria:

          -  Current smokers or smoking history stopped for less than 3 years or > 10 pack years.

          -  Asthma exacerbation during the 4 weeks prior to randomization.

          -  Active lung disease other than non-atopic asthma.

          -  Patients with an active cancer, a suspicion of cancer or any history of cancer with
             less than 5 disease free years.

          -  Pregnant or nursing (lactating) women.

          -  Treatment with omalizumab.

        Other protocol-defined inclusion/exclusion criteria may apply
RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
Condition: Sjogren-Larsson Syndrome
MeSH terms: Sjogren's Syndrome; Sjogren-Larsson Syndrome; Syndrome
Intervention: ADX-102 1% Topical Dermal Cream (reproxalap); Vehicle of ADX-102 Topical Dermal Cream
Intervention description: ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.; Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No
Keywords: ADX-102, Sjögren-Larsson Syndrome

Summary:

      A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the
      Safety and Efficacy of ADX-102 1% Topical Dermal Cream in Subjects with Sjögren-Larsson
      Syndrome (SLS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is aged 3 years or older

          -  Subject has a genetically-confirmed diagnosis of SLS.

          -  Subject has active ichthyosis that is Grade 2 or higher on the Visual Index Ichthyosis
             Severity (VIIS) score.

          -  Females of child-bearing potential: Negative pregnancy test at Screening and Baseline
             Visits.

        Exclusion Criteria:

          -  Subject has evidence of a serious active infection.

          -  Systemic or topical retinoids or other topical medications, not including emollients,
             within the past 30 days Baseline Visit 1.

          -  Subject has received an investigational systemic or topically administered drug within
             the past 30 days prior to Baseline Visit 1.

          -  Subject is currently receiving immunosuppressive therapy, including intermittent or
             low-dose systemic corticosteroids.

          -  Subject has a known allergic reaction to any ingredients of study drug formulation.

          -  Subject has any clinically significant laboratory test abnormalities or a history of
             any other condition that, in the opinion of the Investigator, could compromise the
             subject's ability to comply with the protocol or that could compromise the subject's
             safety or the interpretation of the study results.
Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab pegol
Intervention description: Liquid certolizumab pegol administered every two weeks as a single injection (400 mg at Entry, Week 2 & Week 4, followed by 200 mg every 2 weeks).
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Joint Disease; Arthritis; Certolizumab pegol; Cimzia

Summary:

      The purpose of this study is to continue to assess the safety of certolizumab pegol in
      combination with methotrexate (MTX).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be able to understand the written Informed Consent Form (ICF)

          -  Patients must have achieved an ACR20 (American College of Rheumatology) response at
             Week 16 and completed the entire C87077 (NCT00580840) study or patients having been
             randomized at Week 18 and having met the pre-defined criteria for flare

          -  Patients must have complied with the protocol requirements during their participation
             in C87077 (NCT00580840)

          -  Female patients of childbearing potential must have a negative urine pregnancy test at
             Entry and must continue to have negative urine pregnancy tests throughout their study
             participation

          -  Patients must be willing to comply with protocol

        Exclusion Criteria:

          -  Patients must not have a diagnosis of any other inflammatory Arthritis

          -  Patients must not have a secondary, non-inflammatory type of Arthritis that in the
             investigator's opinion is symptomatic enough to interfere with the evaluation of the
             study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)

          -  Patients must not have a history of an infected joint prosthesis with that prosthesis
             still in situ

          -  Patients who do not meet the Medical History Exclusion criteria, as defined per
             protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic
             infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative
             Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus
             (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or
             uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary,
             Cardiac, Neurological or Cerebral Disease
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
Condition: Atrial Fibrillation; Cardiovascular Disease
MeSH terms: Atrial Fibrillation; Cardiovascular Diseases
Intervention: Irbesartan; placebo
Intervention description: oral administration (tablets) once daily; oral administration (tablets) once daily
Intervention MeSH terms: Irbesartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 9016.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; Cardiovascular disease; angiotensin II blocker

Summary:

      The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the
      risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and
      death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular
      events.
    

Eligibility criteria:

        Inclusion Criteria:

        Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:

          -  have a systolic blood pressure of at least 110 mmHg

          -  not already receiving an angiotensin receptor blocking agent, unless they are willing
             and able to be changed to another antihypertensive agent

          -  no previous intolerance to angiotensin receptor blocking agents

          -  no proven indication for angiotensin receptor blocking agents, unless an Angiotensin
             Converting Enzyme (ACE) inhibitor can be substituted

        Exclusion Criteria:

        Patients will be excluded from ACTIVE study if any of the following are present:

          -  requirement for clopidogrel (such as recent coronary stent procedure)

          -  requirement for oral anticoagulant (such as prosthetic mechanical heart valve)

          -  prior intolerance to acetylsalicyclic acid (ASA) or clopidogrel

          -  documented peptic ulcer disease within the previous 6 months

          -  prior intracerebral hemorrhage

          -  significant thrombocytopenia (platelet count <50 x 10(9)/L)

          -  psychosocial reason making study participation impractical

          -  geographic reason making study participation impractical

          -  ongoing alcohol abuse

          -  mitral stenosis

          -  pregnant or nursing woman or woman of child bearing potential and not on effective
             birth control for at least one month prior to start of study or not willing to
             continue on birth control for duration of study

          -  severe comorbid condition such that the patient is not expected to survive 6 months

          -  patient currently receiving an investigational pharmacologic agent

          -  requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor
             nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE
             A
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Diclofenac HPBCD s.c. 75mg/ml; Voltarol 75mg/3ml i.m.
Intervention description: 1 single injection at day of dental surgical extraction; 1 single injection at day of dental surgical extraction
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD
      75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment
      of acute moderate-to-severe pain after dental impaction surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing surgical extraction of a single fully or partially impacted
             mandibular 3rd molar requiring bone removal.

          -  Patients experiencing moderate to severe post-operative pain within 6 hours from end
             of surgery.

          -  Pre-operative laboratory tests in the reference ranges or without clinically
             significant abnormalities as judged by the Investigator.

        Exclusion Criteria:

          -  Surgery performed under general anaesthesia, or sedation.

          -  Complications occurring during the surgical procedure or in the period before
             randomisation as judged by the investigator.

          -  Acute local or systemic infection at the time of surgery that could confound the
             post-surgical evaluation.

          -  Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other
             GI disturbances or disease that in the opinion of the investigator could be negatively
             affected by the administration of NSAIDs.

          -  Clinical signs or history of coagulation disorders that could be negatively affected
             by NSAIDs administration.

          -  Hepatic or renal impairment.

          -  Patients with significant cardiac impairment, history of cerebrovascular disease,
             history or peripheral arterial disease, uncontrolled hypertension.

          -  Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication
             components.

          -  Patients under chronic treatment with topical or systemic analgesics/NSAIDs.

          -  Patients under treatment with any medication that may affect the treatment efficacy
             evaluation.

          -  Patients under treatment with any medication whose concomitant use may be susceptible
             to interactions with diclofenac or may affect safety.
A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection
Condition: Helicobacter Pylori
MeSH terms: Infections
Intervention: Vonoprazan; Amoxicillin; Clarithromycin; Bismuth Potassium citrate; Esomeprazole
Intervention description: Vonoprazan Tablets; Amoxicillin Capsules; Clarithromycin Tablets; Bismuth Potassium citrate; Esomeprazole Tablets
Intervention MeSH terms: Amoxicillin; Clarithromycin; Potassium Citrate; Esomeprazole; Bismuth
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 510.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication
      with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all
      HP-positive participants.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Helicobacter pylori (HP)-positive participants as determined by ^13C-urea breath test
        (^13C-UBT) at the start of the study (Visit 1 [screening]) and who require HP eradication
        in Physician judgment.

        Exclusion Criteria:

          1. Participant had any of the following conditions at the start of the study (Visit 1,
             screening): acute upper gastrointestinal bleeding, active gastric ulcer (GU) or
             duodenal ulcer (DU) characterized by defective mucos with white coating (with or
             without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion
             (AGML), or acute duodenal mucosal lesion (ADML). However, participants with gastritis,
             gastric or duodenal erosion are permitted to participate.

          2. Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those
             with a history of gastric acid hypersecretion.

          3. Participant has a history of malignancy or was treated for malignancy within 5 years
             before the start of the screening visit (the participant may be included in the study
             if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).

          4. Participant has a known acquired immunodeficiency syndrome or hepatitis infection,
             including hepatitis virus carriers (hepatitis B surface antigen [HBsAg] or hepatitis C
             virus [HCV]- antibody-positive).