bioihbjkbjnl/mcl2 huggingface dataset:
Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab pegol
Intervention description: certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12.
Treatment duration: 12 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: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab pegol; Cimzia; Crohn's disease; Greek patients

Summary:

      An open-label multi-center single-cohort study to assess the safety and efficacy of
      certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek
      patients who have previously responded to infliximab but who no longer have a sustained
      response or became intolerant to infliximab
    

Eligibility criteria:

        Inclusion Criteria:

        • Adult men and women with Crohn's disease previously responsive to infliximab who became
        non-responsive or intolerant

        Exclusion Criteria:

          -  Symptomatic obstructive intestinal strictures

          -  Bowel resection within 4 weeks

          -  Current total parenteral nutrition

          -  Short bowel syndrome

          -  Concomitant disease or pathological condition that could interfere with Crohn's
             disease or to be harmful for the well being of the patient.
Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal; Hemolysis
Intervention: Danicopan; Placebo; C5 Inhibitor
Intervention description: Oral tablet; Oral tablet; Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Paroxysmal Nocturnal Hemoglobinuria (PNH); Extravascular Hemolysis (EVH); Factor D inhibitor; Complement; Danicopan; C5 inhibitor

Summary:

      The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy
      to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with
      PNH who have clinically evident EVH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PNH

          -  Clinically Evident EVH defined by:

               -  Anemia (Hgb ≤9.5 gram/deciliter) with absolute reticulocyte count ≥120 x
                  10^9/liter

          -  Receiving an approved C5 inhibitor for at least 6 months prior to Day 1

          -  Platelet count ≥30,000/microliters (µL)

          -  Absolute neutrophil counts ≥500/μL

          -  Documentation of/or willingness to receive vaccinations for N. meningiditis and
             prophylactic antibiotics as required

        Exclusion Criteria:

          -  History of a major organ transplant or hematopoietic stem cell transplantation (HSCT)

          -  Participants with known aplastic anemia or other bone marrow failure that requires
             HSCT or other therapies including anti-thymocyte globulin and/or immunosuppressants

          -  Known or suspected complement deficiency

          -  Laboratory abnormalities at screening, including:

               -  Alanine aminotransferase >2 x ULN (>3 x ULN in case of patients with documented
                  liver iron overload defined by serum ferratin values

                    -  500 ng/ML)

               -  Direct bilirubin >2 x ULN (unless due to EVH or documented Gilbert's Syndrome)

          -  Current evidence of biliary cholestasis

          -  Estimated glomerular filtration rate of <30 milliliters/minute/1.73 meter squared
             and/or are on dialysis

          -  Evidence of human immunodeficiency virus, hepatitis B, or active hepatitis C infection
             at screening
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Comparator: atorvastatin; Comparator: Placebo; Comparator: ezetimibe; Comparator: Placebo.
Intervention description: Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks; Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks; Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.; Atorvastatin 40mg Pbo tablets po qd (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: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe
      plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high
      risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg

        Exclusion Criteria:

          -  Pregnant or lactating women or intending to become pregnant

          -  Patient with sensitivity or intolerance to ezetimibe or atorvastatin

          -  Patient with diabetes or coronary heart disease
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Condition: Cerebral Arterial Diseases
MeSH terms: Cerebral Arterial Diseases
Intervention: Dotarem; TOF MRA
Intervention description: Each subject will receive one injection of Dotarem 0.2ml/kg; Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: carotid or vertebral artery disease; Contrast agent; MRA

Summary:

      The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering
      from carotid or vertebral arterial disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged more than 18 years

          -  Strongly suspected of having carotid or vertebral arterial disease

          -  Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA)
             examination

        Exclusion Criteria:

          -  Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)

          -  Contraindication to MRI

          -  Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA
             examination
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
Condition: Neurogenic Detrusor Overactivity; Pediatric
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin succinate
Intervention description: Oral suspension
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 6 Months
Maximum age: 4 Years
Healthy volunteers: No
Keywords: Solifenacin succinate suspension; Efficacy; Safety

Summary:

      The purpose of this study was to evaluate long term efficacy and safety of treatment with
      solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity
      after multiple dose administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Myelomeningocoele

          -  Documented diagnosis of NDO, confirmed by urodynamics

          -  DSD (detrusor sphincter dyssynergia)

          -  Practicing clean intermittent catheterization (CIC)

        Exclusion Criteria:

          -  Know genitourinary condition (other than NDO) that may cause incontinence

          -  Bladder augmentation surgery

          -  Current faecal impaction

          -  Electro-stimulation therapy within 2 weeks prior to visit

          -  Subjects with the following gastro-intestinal problems: partial or complete
             obstructions, decreased motility like paralytic ileus, subjects at risk of gastric
             retention

          -  Reflux grade 3 to 5

          -  Current urinary tract infection
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: SPARC0913
Intervention description: One drop of SPARC0913 in affected eye once daily for 24 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Ocular hypertension

Summary:

      The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter,
      open label, non-randomized, uncontrolled, single group assignment, safety study of subjects
      with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive
      study medication for a period of 24-weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged ≥18 years

          -  Willing to participate and giving written informed consent

          -  Willing to commit to study medication-dosing, study visits and follow-up visits to
             complete evaluation

          -  Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma

        Exclusion Criteria:

          -  History of allergic hypersensitivity or poor tolerance to latanoprost

          -  History of Substance abuse or addiction (alcohol drugs) in the past 3 years

          -  History of chronic use of concomitant medications in neurologic or psychiatric illness
             that would affect assessment of safety and effectiveness of the study medication

          -  Any abnormality preventing IOP measurement
A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Condition: Chronic Renal Anemia
MeSH terms: Anemia
Intervention: Methoxy polyethylene glycol-epoetin beta
Intervention description: Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when
      administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal
      anemia. Individuals currently receiving maintenance treatment with epoetin alfa or
      darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120,
      200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or
      darbepoetin alfa they were receiving in the week preceding study start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to (≥) 18 years of age

          -  Chronic renal anemia

          -  Stable epoetin alfa or darbepoetin alfa therapy for past 2 months

          -  Hemodialysis therapy for ≥3 months

        Exclusion Criteria:

          -  Transfusion of red blood cells during previous 2 months

          -  Poorly controlled hypertension requiring hospitalization or interruption of ESA
             treatment in previous 6 months

          -  Acute or chronic bleeding
Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine; Olmesartan medoxomil; Amlodipine+valsartan; Hydrochlorothiazide
Intervention description: Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.; Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.; Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.; Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertension, valsartan, amlodipine

Summary:

      This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose
      combination in adults with moderate, inadequately controlled hypertension. There was an
      optional study extension for eligible patients who wanted to participate that contains the
      triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).
    

Eligibility criteria:

        Inclusion Criteria for Core study:

          -  Male or female patients (>=18 years)

          -  Females must be either post-menopausal for one year, surgically sterile or using
             effective contraceptive methods

          -  Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110
             mmHg)

        Inclusion Criteria for Extension:

        - Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of
        core study.

        Exclusion Criteria for Core study:

          -  Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >=
             180 mmHg)

          -  Pregnant or nursing women

          -  Treated hypertensive patients with controlled hypertension under current therapy

          -  A history of cardiovascular disease, including angina pectoris, myocardial infarction,
             coronary artery bypass graft, percutaneous transluminal coronary angioplasty,
             transient ischemic attack, stroke, and heart failure NYHA II - IV

        Exclusion Criteria for Extension:

          -  prematurely discontinued the core study

          -  failed to comply with the core study protocol

        Other protocol-defined inclusion/exclusion criteria applied to the study.
A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
Condition: Bilateral LASIK Surgery
Intervention: carboxymethylcellulose sodium based new eye drop formulation; carboxymethylcellulose sodium based eye drops
Intervention description: 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.; 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare the safety and efficacy of a new eye drop formulation with REFRESH
      PLUS® in participants following LASIK surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        -Patients scheduled for LASIK surgery in both eyes.

        Exclusion Criteria:

          -  Any systemic medication use within 3 months of screening (including over the counter,
             herbal, prescription, or nutritional supplement) which may affect dry eye or vision

          -  Use of topical eye medication other than prescribed for use in pre- or post-operative
             care

          -  Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months
             prior to Screening

          -  Eye infection, inflammation, or allergy

          -  Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30
             days prior to LASIK surgery.
Buspirone as a Potential Treatment for Recurrent Central Apnea
Condition: Central Apnea; Heart Failure
MeSH terms: Apnea; Sleep Apnea, Central
Intervention: Acetazolamide; Buspirone
Intervention description: Cabonic Anhydrase inhibitor; Agonist of a 5-HT1a receptor with some D2 agonist properties.
Intervention MeSH terms: Acetazolamide; Buspirone
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: buspirone; acetazolamide

Summary:

      The purpose of this study is to determine whether buspirone compared to acetazolamide and to
      placebo will reduce the number and/or severity of breathing pauses during sleep that occur in
      some patients with Heart Failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide informed consent,

          -  Ambulatory and in stable condition for the past 4 months,

          -  A diagnosis of heart failure with left ventricular systolic dysfunction as evidenced
             by an ejection fraction <35%,

          -  NYHA class II or III clinical status, and

          -  Diagnosis of dilated cardiomyopathy or ischemic cardiomyopathy.

        Exclusion Criteria:

          -  Unstable angina, unstable heart failure, acute pulmonary edema, congenital heart
             disease

          -  History of unstable and/or advanced hepatic disease

          -  History of renal failure, CrCL < 30

          -  Current use of an SSRI, or use within one month of testing

          -  Intrinsic pulmonary diseases: ILD and/or COPD (FEV1/FVC < 65%)

          -  Kyphoscoliosis or neuromuscular disease

          -  Suboptimally treated hypothyroidism

          -  Use of narcotics or benzodiazepines

          -  Use of theophylline or pseudoephedrine

          -  Use the following medications:

               -  MAO inhibitors

               -  diazepam

               -  haloperidol

               -  nefazodone

               -  trazodone

               -  erythromycin

               -  grapefruit juice

               -  itraconazole

               -  rifampin

               -  ketoconazole

               -  ritonavir,

               -  cimetidine

          -  Known allergy to buspirone or acetazolamide
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: LEO 43204 gel; Vehicle gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 437.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to compare the short term efficacy of LEO 43204 gel with
      vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days
      as field treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment
             area of sun-damaged skin on either the full face or a contiguous area of approximately
             250 cm2 (40 in2) on the chest

          -  Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking
             area of 50 cm2 (8 in2). The tracking area must be within the treatment area

        Exclusion Criteria:

          -  Location of the treatment area (full face or chest) within 5 cm of an incompletely
             healed wound or within 5 cm of a suspected BCC or SCC

          -  Treatment with ingenol mebutate gel in the treatment area within the last 12 months

          -  Lesions in the treatment area that have: atypical clinical appearance (e.g.
             hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g.
             did not respond to cryotherapy on two previous occasions)

          -  History or evidence of skin conditions other than the trial indication that would
             interfere with the evaluation of the trial medication (e.g., eczema, unstable
             psoriasis, xeroderma pigmentosum)
Multi-Center Study of New Medications to Treat Vaginal Infections
Condition: Vaginal Infection
MeSH terms: Infections
Intervention: Metronidazole; Gel vehicle
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the
      treatment of vaginal infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:

          -  Capable of providing written informed consent or assent

          -  Currently not menstruating and not anticipating menses during treatment

          -  If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically
             sterile, or practicing an acceptable form of birth control

          -  Negative pregnancy test

          -  Other criteria as identified in the protocol

        Exclusion Criteria:

          -  Other infectious causes of vulvovaginitis

          -  Subject has recently used, or is expected to require the concomitant use of prohibited
             medications/products

          -  Nursing mother

          -  Use of any investigational drug within 30 days of enrollment

          -  History of hypersensitivity to any ingredient/component of the formulations

          -  Other criteria as identified in the protocol