bioihbjkbjnl/mcl2 huggingface dataset:
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
Condition: COPD Asthma
MeSH terms: Asthma
Intervention: Spirometry at initial visit; Albuterol; Spirometry at 12-month follow-up
Intervention description: Initial visit for the intervention group, an initial demographics form and health questionnaires. To evaluate the breathing, a pre and post broncho dilator will be performed as well as a spirometry test.; The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.; At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry test and undergo the same spirometry protocol as the intervention group.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic
      Error in COPD and Asthma patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1.Age >40 years of age

          -  2. Use of a maintenance respiratory medication and one of the following in the past
             year:

          -  3. Diagnosis of asthma and/or COPD

          -  4. No spirometry test performed in the past 3 years

          -  5. Past or current smoker or is exposed to tobacco

        Exclusion Criteria:

          -  Unable to perform adequate spirometry

          -  Non-English speaking

          -  Pregnancy

          -  Plans to move from the Chicago Area within the next year

          -  Seen by pulmonary specialist in the past 3 years

          -  Any terminal illness with a life expectancy of <6 months

          -  Life threatening (e.g. intensive care admission and/or use of mechanical ventilation)
             respiratory failure event in the past year.
Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat
Condition: Pharyngitis
MeSH terms: Pharyngitis
Intervention: Ambroxol; Placebo
Intervention MeSH terms: Ambroxol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg
      in the treatment of sore throat in patients with acute viral pharyngitis.
    

Eligibility criteria:

        1. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant
        patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least
        severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance
        by the patient seems guaranteed.

          1. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary
             infection (clinical findings; inter alia assessment of exudate).

          2. First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more
             than 3 days ago already.

          3. Counting of white blood cell in blood routine examination exceeds 10?109/L.

          4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.

          5. Broncho-motor disorders or concomitant diseases with relatively large quantities of
             secretion (danger of secretion blockage).

          6. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.

          7. Previous and/or existing tumour condition.

          8. Pregnancy and/or breast-feeding.

          9. Alcohol, and/or drug abuse.

         10. Simultaneous participation in another clinical trial.
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
Condition: Lung Disease
MeSH terms: Lung Diseases
Intervention: Nitric oxide; Placebo
Intervention description: Nitric Oxide vapour (gas) for inhalation (400 ppm); Placebo gas for inhalation
Intervention MeSH terms: Nitric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 800.0
Sex: All
Maximum age: 26 Hours
Healthy volunteers: No
Keywords: Preemie, Inhaled Nitric Oxide

Summary:

      The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to
      reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to
      assess the long-term effects of the therapy on the development of these children over 7 years
      of clinical follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inborn preterm infants 24+0 weeks-28+6 days weeks gestational age (defined by first
             trimester ultrasound or if not available based on the last menstrual period) who
             requires the use of surfactant within 24 hours of birth (either prophylactically, or
             for signs of developing respiratory distress), or who requires the use of continuous
             positive airway pressure (CPAP) (fraction of inspired oxygen concentration (FiO2) ≥
             0.30 on a mean airway pressure ≥ 4cm water (H2O)) within 24 hours of birth in order to
             maintain an oxygen saturation (SpO2) ≥ 85%.

          -  Informed consent of the guardian.

        Exclusion Criteria:

          -  Outborn infants.

          -  Infants ≥ 29 weeks gestational age.

          -  Infants requiring FiO2 >0.5 to maintain SpO2 >85%, on a sufficient mean airway
             pressure (e.g., > 8 cm H2O on controlled mechanical ventilation (CMV)) in order to
             achieve adequate chest inflation (8-9 ribs on Chest X-ray) two hours after the proper
             administration of exogenous surfactant.

          -  Any suspected congenital heart disease other than patent ductus arteriosus or atrial
             septal defect.

          -  Any infant with severe bleeding or coagulation abnormalities at high-risk of
             diathesis, e.g., platelet <50,000 per millimeter cube (mm³), fibrinogen <0.5 gram per
             liter (g/L), other clotting factors <10%.

          -  Any infant in whom a decision has been made not to provide full treatment, e.g.,
             chromosomal abnormalities, severe multiple abnormalities, severe birth asphyxia, etc.

          -  Use of another investigational drug or device before or during the active study
             period.
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Edoxaban-based Regimen; VKA-based Regimen
Intervention description: 15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed); Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).
Intervention MeSH terms: Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transcatheter Aortic Valve Implantation -- TAVI; Anticoagulation; Atrial Fibrillation; ENVISAGE-TAVI-AF

Summary:

      When the upper chambers of a person's heart receive or generate irregular electrical signals,
      it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.

      Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often
      other diseases, such as a heart attack. Some patients with atrial fibrillation have other
      heart disease, such as heart valves that may need to be replaced using catheters.

      Often doctors give patients drugs that reduce those blood clots. These are either vitamin K
      antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear
      which of the drugs is better for reducing stroke without increasing severe bleedings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification and contraception

          -  Is willing and able to comply with any restrictions related food, drink and
             medications

          -  Voluntarily consents to participate and provides written informed consent prior to any
             protocol-specific procedures

        Exclusion Criteria:

          -  Has history or current use of over-the-counter medications, dietary supplements, or
             drugs (including nicotine and alcohol) outside protocol-specified parameters

          -  Has signs, symptoms or history of any condition that, per protocol or in the opinion
             of the investigator, might compromise:

               1. the safety or well-being of the participant or study staff

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding)

               3. the analysis of results
Clobetasol Propionate Versus Fractionated Carbon Dioxide Laser for the Treatment of Lichen Sclerosus
Condition: Vulvar Lichen Sclerosus
MeSH terms: Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
Intervention: Fractionated Carbon Dioxide Laser; Clobetasol Propionate 0.05% ointment
Intervention description: Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart.; Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment.
Intervention MeSH terms: Clobetasol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vulva; Lichen Sclerosus; Fractionated Carbon Dioxide Laser; Mona Lisa Laser; Clobetasol Propionate; Vulvodynia

Summary:

      This study is being done to compare the effects, good and bad, of fractionated CO2 laser
      treatment and clobetasol propionate .05% ointment on vulvar lichen sclerosus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven symptomatic vulvar lichen sclerosus

          -  Ability to understand the study, accept randomization and logistically follow-up with
             scheduled visits

          -  English Speaking

        Exclusion Criteria:

          -  Known vulvar malignancy

          -  Pregnancy or planning pregnancy or less than 3 months postpartum

          -  Premenopausal

          -  Current or prior diagnosis of any gynecologic malignancy

          -  Previous pelvic radiation therapy

          -  Allergy to topical steroid

          -  Active Urinary Tract Infection (UTI), vulvar infection (candida, herpes, bacterial
             vaginosis, trichomoniasis or other infection)

          -  Pelvic organ prolapse > than Stage 2

          -  Treatment with systemic immunomodulators, topical calcineurin inhibitors (tacrolimus,
             pimecrolimus), or vaginal hormonal or vulvar topical steroid use within 2 months of
             enrollment

          -  History of transvaginal mesh implant (excluding sling or sacrocolpopexy mesh)

          -  IUD (Intrauterine Device)

          -  Skindex-29 overall score <21, below mildly impaired health related quality of life
             threshold
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
Condition: Recurrent Glioblastoma
MeSH terms: Glioblastoma
Intervention: Nivolumab; Bevacizumab; Ipilimumab
Intervention description: specified dose on specified days; specified dose on specified days; specified dose on specified days
Intervention MeSH terms: Bevacizumab; Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 529.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the efficacy and safety of nivolumab administered
      alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain
      cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab
      administered alone or in combination with ipilimumab in patients with different lines of GBM
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with histologically confirmed Grade IV malignant glioma

          -  Previous treatment with radiotherapy and temozolomide (Cohorts 1, 1b and 2 only)

          -  First recurrence of GBM (Cohorts 1, 1b and 2 only)

          -  First diagnosis of GBM with resectable disease (Cohorts 1c Part A only)

          -  First diagnosis of unmethylated MGMT GBM (Cohort 1d and Cohort 1c Part B only)

          -  Karnofsky performance score of 70 or higher

        Exclusion Criteria:

          -  More than 1 recurrence of GBM (Cohorts 1, 1b and 2 only)

          -  Any recurrence of GBM (Cohorts 1c and 1d only)

          -  Presence of extracranial metastatic or leptomeningeal disease

          -  Active, known or suspected autoimmune disease

          -  Clinically significant cardiovascular disease

          -  Prior bevacizumab or other Vascular Endothelial Growth Factor (VEGF) or
             anti-angiogenic treatment (Cohort 2 only)
SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer
Condition: Sentinel Lymph Node; Melanoma (Skin); Breast Cancer
MeSH terms: Breast Neoplasms; Melanoma
Intervention: IC-Green KIT
Intervention description: fluorescence lymphangiography with the use of IC-Green
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to determine if fluorescence lymphangiography can be used
      alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis
      is that sentinel nodes can be identified using only indocyanine green (ICG) and fluorescence
      lymphangiography, without the need for technetium99 and a gamma probe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with melanoma or breast cancer who meet criteria for and consent to sentinel
             node biopsy.The melanoma should be located on the upper extremity between and
             including the wrist and shoulder, or the lower extremity between and including the
             ankle and groin.

        Exclusion Criteria:

          -  Melanoma located on the trunk, head or neck. Patients with an allergy to indocyanine
             green or sodium iodide. Pregnant and nursing women. Patients who have had a prior
             sentinel node biopsy in the same nodal basin.
AR101 Real-World Open-Label Extension Study
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101
Intervention description: AR101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; Food Allergy

Summary:

      This study is enrolling participants by invitation only. This is an open-label, safety
      extension study for subjects who participated in the ARC007 study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Received AR101 in study ARC007

          -  Completed the ARC007 study

          -  Use of effective birth control by sexually active female subjects of childbearing
             potential

        Key Exclusion Criteria:

          -  Developed a clinically significant change in health status during the ARC007 study
             which in the opinion of the investigator would make the subject unsuitable for
             participation in this study.

          -  Receiving a prohibited medication or anticipated use of a prohibited medication [e.g.,
             angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium
             channel blockers], any monoclonal antibody, any investigational peanut immunotherapy,
             or any other immunomodulatory therapy.

          -  Currently in the build-up phase of immunotherapy for any nonfood allergen.

          -  Currently participating in any other interventional clinical study outside of the
             ARC007 study that was just completed.
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo for Upadacitinib; Upadacitinib
Intervention description: Tablets taken orally once a day; Tablets taken orally once a day
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 912.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Upadacitinib

Summary:

      The objective of this study is to assess the efficacy and safety of upadacitinib for the
      treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD)
      who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and < 18 years
             of age

          -  Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline
             Visit and subject meets Hanifin and Rajka criteria.

          -  Active moderate to severe AD defined by:

               -  Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline
                  Visits;

               -  Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and
                  Baseline Visits;

               -  ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline
                  Visits;

               -  Baseline weekly average of daily Worst Pruritus NRS ≥ 4.

          -  Candidate for systemic therapy or have recently required systemic therapy for AD

          -  Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days
             before the Baseline Visit.

          -  Documented history of inadequate response to topical corticosteroids (TCS) or topical
             calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months
             before Baseline Visit

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor

          -  Unable or unwilling to discontinue current atopic dermatitis treatments prior to the
             study

          -  Requirement of prohibited medications during the study

          -  Other active skin diseases or skin infections requiring systemic treatment or would
             interfere with appropriate assessment of atopic dermatitis lesions

          -  Female subject who is pregnant, breastfeeding, or considering pregnancy during the
             study
Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: AbobotulinumtoxinA; Placebo
Intervention description: Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA; Treatment of glabellar facial lines with placebo
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An interventional phase 3 study to evaluate efficacy and safety of a new dilution and
      injection volume of AbobotulinumtoxinA treatment for glabellar lines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe glabellar lines at maximum frown

          -  Understands the study requirements and signs an informed consent form

        Exclusion Criteria:

          -  Botulinum toxin treatment in the face within 6 months prior to study treatment
Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase
Condition: Macular Edema; Macular Degeneration; Diabetes
MeSH terms: Macular Degeneration; Macular Edema; Edema
Intervention: Ranibizumab 0.5mg
Intervention description: Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ranibizumab; Diabetic Macular Edema

Summary:

      The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in
      diabetic patients presenting with reduced visual acuity due to diabetic macular edema and
      evaluating spacing out of follow-up after initial intensive treatment phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type I or type II diabetes with HbA1c≤10%

          -  Visual impairment due to a diabetic macular edema

          -  Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary

        Exclusion Criteria:

          -  Inflammation or infection in one eye

          -  Women of childbearing potential without an efficient contraception, pregnant or
             breastfeeding

        Other protocol-defined inclusion/exclusion criteria may apply