bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Leflunomide; Methotrexate; Ocrelizumab; Ocrelizumab; Placebo
Intervention description: Oral repeating dose; Oral or parenteral repeating dose; Intravenous repeating dose (200mg); Intravenous repeating dose (500mg); Intravenous repeating dose
Intervention MeSH terms: Methotrexate; Leflunomide; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 836.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RA; SCRIPT; anti-CD20; CD20

Summary:

      This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in
      patients with active rheumatoid arthritis who have an inadequate response to at least one
      anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous
      ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment
      will be administered at weeks 24 and 26. All patients will receive stable doses of either
      concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive
      additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and
      then participants will enter the open label phase until the drug is commercialized. Target
      sample size is 1000.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age

          -  Rheumatoid arthritis for at least 3 months

          -  Inadequate response to previous or current treatment with at least one anti-TNF-alpha
             agent

          -  Receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for
             the last 4 weeks

          -  Swollen joint count (SJC) ≥ 4 (66 joint count) and tender joint count (TJC) ≥ 4 (68
             joint count) at screening and baseline.

          -  CRP ≥ 0.6 mg/dL using a high-sensitivity assay.

          -  Positive rheumatoid factor or positive anti-CCP antibody or both.

        Exclusion Criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease, other than RA

          -  Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline
Phase III Study of ASP2151 in Herpes Zoster Patients
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: ASP2151; valaciclovir
Intervention description: 200 mg once daily or 400 mg once daily; 1000 mg three times daily
Intervention MeSH terms: Valacyclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 751.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with
      valaciclovir (VACV) 3000 mg in patients with herpes zoster.
    

Eligibility criteria:

        Inclusion Criteria:

        (1) Patients who have a rash associated with herpes zoster, and who can start receiving the
        study drug within 72 hours after onset of the rash

        Exclusion Criteria:

          1. Patients who are not expected to have an adequate response to oral antiviral
             medication

          2. An extreme decline in immune function

          3. Presence of serious complications

          4. Patients found to meet any of the following conditions based on laboratory tests
             performed within 14 days before informed consent:

               -  AST or ALT ≥ 2.5 x upper limit of normal

               -  Platelet count < lower limit of normal

               -  Serum creatinine ≥ 1.5 mg/dL

               -  Creatinine clearance < 50 mL/min

          5. Current or previous history of malignant tumor within 5 years before informed consent

          6. Diagnosis of autoimmune disease

          7. Evidence of bone marrow suppression
Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Condition: Fuchs' Endothelial Dystrophy; Bullous Keratopathy
MeSH terms: Fuchs' Endothelial Dystrophy
Intervention: Netarsudil; Placebo
Intervention description: netarsudil opthalmic solution 0.02%; Placebo eye drops
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Cornea transplant recipients who are using topical corticosteroids long-term to prevent
      transplant rejection will be randomized to use netarsudil or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age; male or female patient undergoing Descemet membrane
             endothelial keratoplasty; patient is able and willing to administer eye drops; patient
             is able to comprehend and has signed the Informed Consent form; patient is likely to
             complete the nine-month course of the study.

        Exclusion Criteria:

          -  A patient exhibiting pre-operative intraocular inflammation; a patient with a known
             sensitivity to any of the ingredients in the study medications; a patient who has a
             condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the
             investigator's opinion may put the patient at significant risk, may confound the study
             results, or may interfere significantly with the patient's participation in the study;
             a patient with abnormal eyelid function; a patient that is exhibiting active corneal
             ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis;
             a patient who has been diagnosed with uncontrolled glaucoma, prior aqueous shunt or
             trabeculectomy, or with preoperative intraocular pressure > 22 mm Hg in the potential
             study eye; presence of any ocular disease that would interfere with the evaluation of
             the study treatment (however, patients with a history of cystoid macular edema,
             age-related macular degeneration, corneal neovascularization, and other
             non-interfering comorbidities may be enrolled); a patient with a history of
             non-compliance with using prescribed medication; a patient who is concurrently
             involved in or participated in another randomized clinical trial within 30 days prior
             to enrollment in this study; patients who are pregnant or planning to become pregnant
             within the duration of the study.
Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination tablet orally once daily in the morning.; IVA tablet orally once daily in the evening.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and
      pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple
      combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF
      genotypes.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex,
             and height.

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary
             status.

          -  Solid organ or hematological transplantation.

        Other protocol defined Inclusion/Exclusion criteria may apply.
A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
Condition: Travelers' Diarrhea
MeSH terms: Dysentery; Diarrhea
Intervention: Rifaximin (Sandoz GmbH) tablet; Rifaximin (Xifaxan); Placebo
Intervention description: 200 mg tablet administered orally.; 200 mg tablet administered orally; Matching Placebo tablet administered orally
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Travelers; diarrhea; rifaximin; equivalence

Summary:

      This study compared safety and efficacy of a generic rifaximin tablet to the reference listed
      drug in the treatment of travelers' diarrhea. Additionally both the generic and reference
      formulations were tested for superiority against a placebo tablet.

      It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of
      these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The
      remaining 27 patients received study drug and 25 patients completed the study.

      The study was terminated due to slow enrolment. The final analysis included only safety
      analysis in the Safety population, due to the low number of randomized patients. No efficacy
      analysis was performed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is able to read and understood the language of the Informed Consent Form and
             Patient Information.

          -  International travelers with a duration of stay in host country long enough to attend
             schedules visits.

          -  Affected by naturally acquired acute diarrhea, defined as the passage of at least 3
             unformed stools within 24 hours immediately preceding randomization preceding
             randomization

        Exclusion Criteria:

          -  Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any
             of the excipients of the study drug.

          -  Pregnant, breast feeding or planning pregnancy

          -  Acute diarrhea for > 72 hours immediately prior to randomization.

          -  Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually)
             or clinical findings suggesting moderate or severe dehydration.
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: CT-P13 SC (Infliximab); Placebo SC
Intervention description: Subcutaneous injection of CT-P13 SC; Subcutaneous injection of Placebo SC
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 396.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC
      over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female aged 18 to 75 years, inclusive.

          -  Patient who has moderately to severely active CD with a score on the CDAI of 220 to
             450 points

        Exclusion Criteria:

          -  Patient who has previously received either a TNFα inhibitor or biological agent within
             5 half-lives

          -  Patient who has previously demonstrated inadequate response or intolerance to TNFα
             inhibitors for the treatment of CD.
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Condition: Vaginitis
MeSH terms: Vaginitis
Intervention: POLYGYNAX®; GYNODAKTARIN®; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 661.0
Sex: Female
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated
      for the local treatment of vaginitis due to sensitive germs and treatment of non specific
      vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.

      Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study
      supporting the interest of the combination of antifungal and antibiotics agents versus
      antifungal agent alone.

      The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole
      in the treatment of women experiencing symptoms of infectious vaginitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with an abnormal vaginal discharge associated with one (or more) functional
             vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation
             clinically evoking an infectious vaginitis:

               -  bacterial vaginitis

               -  non-specific vaginitis (atypical symptoms)

               -  mixed vaginitis (i.e. suprainfected fungal vaginitis) and able to receive an
                  empirical local treatment

        Exclusion Criteria:

          1. Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious
             vaginitis in the 12 months prior to inclusion

          2. Vaginal infection justifying systemic therapy

          3. History of atrophic vaginitis or suspected atrophic vaginitis at inclusion

          4. Patient presenting with signs of genital herpes or signs of non-infectious vulvar
             pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact
             dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))

          5. Patient with current Sexually Transmitted Infection (STI) and/or patients with
             clinical suspicion of STI

          6. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes
             mellitus, corticosteroids treatments)

          7. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to
             inclusion

          8. Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the
             time of inclusion

          9. Pregnant or lactating women or delivery within last 1 month
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Filgotinib; PTM filgotinib
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1351.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy of filgotinib in the
      induction and maintenance treatment of moderately to severely active ulcerative colitis (UC)
      in participants who are biologic-naive and biologic-experienced.

      Participants who complete the study, or met protocol specified efficacy discontinuation
      criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead
      Study GS-US-418-3899: NCT02914535).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
             the date of the screening visit

          -  Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of
             15 cm from the anal verge. Documentation should include endoscopic and histopathologic
             evidence of UC.

          -  A surveillance colonoscopy is required at screening in individuals with a history of
             UC for 8 or more years, if one was not performed in the prior 24 months

          -  Moderately to severely active UC

          -  Previously demonstrated an inadequate clinical response, loss of response to, or
             intolerance to at least 1 of the following agents (depending on current country
             treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor
             necrosis factor alpha (TNFa) antagonists, or vedolizumab

        Key Exclusion Criteria:

          -  Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant
             colitis, ulcerative proctitis, or toxic mega-colon

          -  Active tuberculosis (TB) or history of latent TB that has not been treated

          -  Use of any concomitant prohibited medications as described in the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe
Condition: Neovascular Age-related Macular Degeneration (nAMD)
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: SOK583A1 (40 mg/mL); Prefilled Syringe (PFS)
Intervention description: SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration; Prefilled Syringe (PFS)
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Open label study,; intravitreal injection,; biosimilar,; aflibercept,; PFS

Summary:

      This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet)
      nAMD, eligible for IVT aflibercept treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥ 50 years of age at baseline

          -  Subjects diagnosed with nAMD (uni- or bilateral)

          -  Subjects already under IVT Eylea treatment (last injection of the induction period or
             maintenance phase)

        Exclusion Criteria:

          -  Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in
             the study eye at baseline, which is of clinical significance according to the
             investigator's judgment, such as active infections of the anterior segment; this
             includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or
             autoimmune associated uveitis or endophthalmitis

          -  Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as
             intraocular pressure (IOP) ≥ 26 mmHg, despite treatment with anti-glaucomatous
             medication)

          -  History of a medical, ocular or non-ocular condition, that in the judgment of the
             investigator, would preclude a safe administration of investigational product

          -  Visual Acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted
             level of legal blindness

          -  Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment

          -  Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥
             100 mmHg at Screening)

          -  Subjects who do not comply with the local COVID-19 regulations of the study site
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Intervention: G2-TR intraocular implant containing travoprost; Sham surgery + active-comparator eye drops
Intervention description: Provided in Arm/Group descriptions.; Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).
Intervention MeSH terms: Travoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 590.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase III study to compare the safety and efficacy of intraocular implants containing
      travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5%
      (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma
      (OAG) or ocular hypertension (OHT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open-angle glaucoma or ocular hypertension.

          -  C/D ratio ≤ 0.8

          -  Zero to three preoperative ocular hypotensive medications

        Exclusion Criteria:

          -  Active corneal inflammation or edema.

          -  Retinal disorders not associated with glaucoma.
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: turoctocog alfa pegol
Intervention description: Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Male
Minimum age: 0 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and
      pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP)
      in children with severe haemophilia A who have undergone treatment with previous factor VIII
      (FVIII) products.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients with severe congenital haemophilia A (FVIII activity level below 1%)

          -  Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII
             products for patients aged 6-11 years and above 50 ED to FVIII products for patients
             aged 0-5 years

        Exclusion Criteria:

        - Any history of FVIII inhibitors