bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
Condition: Encephalitis; Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: Blood sample; JE-CV administered in Study JEC02
Intervention description: Blood sample for immunogenicity assessment; Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 596.0
Sex: All
Minimum age: 2 Years
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Encephalitis; Japanese Encephalitis; Japanese Encephalitis Chimeric Virus Vaccine; Toddlers

Summary:

      This is a long-term follow-up of the persistence of immune response in participants who
      previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02
      (NCT00735644) . No vaccination was administered during the present long-term follow-up study.

      Primary Objective:

        -  To describe the yearly persistence of humoral immune response to Japanese encephalitis
           after a single dose of JE-CV
    

Eligibility criteria:

        Inclusion Criteria :

          -  Provision of Informed Consent Form signed by at least one parent or other legally
             acceptable representative, and by at least one independent witness if required by
             local regulations.

          -  Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination
             blood sample at baseline in JEC02 trial.

          -  Participant and parent/legally acceptable representative able to attend all scheduled
             visits and comply with all trial procedures.

        Exclusion Criteria :

          -  Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up
             to inclusion in JEC05 trial.

          -  Planned participation in another clinical trial up to the first year of the follow-up
             in the present trial.
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg tablet administered orally once daily; Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Intervention MeSH terms: Ribavirin; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the antiviral efficacy, safety, and
      tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC)
      and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV)
      infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Genotype 1 or 2 HCV infection

          -  Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical
             history or liver biopsy

          -  Previously treated with a DAA-containing regimen of at least 4 week duration

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
Condition: Chronic Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: ibrutinib; Placebo; Prednisone
Intervention description: Ibrutinib capsules administered orally daily; Placebo capsules administered orally daily; Prednisone administered daily
Intervention MeSH terms: Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 193.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: chronic graft versus host disease; PCYC1140; PCYC1140IM; 1140; Ibrutinib; GVHD; Steroid dependent; refractory; chronic; PCI32765; IMBRUVICA; Pharmacyclics; PCYC; graft versus host disease; immunology; new onset graft versus host disease; INTEGRATE; Corticosteroids; prednisone

Summary:

      To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects
      with newly diagnosed moderate to severe cGVHD.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  New onset moderate or severe cGVHD as defined by the 2014 National Institutes of
             Health (NIH) Consensus Development Project Criteria

          -  Need for systemic treatment with corticosteroids for cGVHD

          -  No previous systemic treatment for cGVHD (including extracorporeal photopheresis
             [ECP])

          -  Participants may be receiving other immunosuppressants for the prophylaxis or
             treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or
             treatment of acute GVHD it must be at or below 0.5 mg/kg/d

          -  Age ≥12 years old

          -  Karnofsky or Lansky (subjects <16 years) performance status ≥60

        Key Exclusion Criteria:

          -  Received any previous systemic treatment for cGVHD with the exception of
             corticosteroids administered for cGVHD within the 72 hours prior to signing the
             informed consent form.

          -  Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD

          -  Any uncontrolled infection or active infection requiring ongoing systemic treatment

          -  Progressive underlying malignant disease or any post-transplant lymphoproliferative
             disease

          -  Known bleeding disorders

          -  Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Brolucizumab 6 mg; Aflibercept 2 mg
Intervention description: Administered as opthalmic solution for an intravitreal injection to the study eye; Administered as an opthalmic solution for intravitreal injection to the study eye
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: double-masked, extension study; neovascular age-related macular degeneration; intravitreal injection; brolucizumab; aflibercept

Summary:

      The purpose of this extension study was to assess the safety and efficacy of the new
      formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who
      received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The
      medical condition treated in the core and extension trials was neo-vascular age-related
      macular degeneration (nAMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sign written informed consent

          -  Completed the core study, CRTH258A2301, also known as CRTH258-C002 as defined by
             assessments at Visit 26/Week 96 within ≤12 weeks of the baseline.

        Exclusion Criteria:

          -  Patient discontinued the treatment or the core study prematurely at any time

          -  Patient received standard of care treatment for nAMD after completion of the core
             study

          -  Pregnant or nursing women and women of child-bearing potential

          -  Stroke or MI (myocardial infarction) within 3 months of the baseline extension visit
Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
Condition: Retinal Vein Occlusion; Macular Edema
MeSH terms: Macular Edema; Retinal Vein Occlusion
Intervention: Ozurdex; Ozurdex
Intervention description: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies; 0.7 mg intravitreal DEX implant on first visit then every 16 weeks
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BRVO; CRVO; Macular Edema; Anti-VEGF; Ozurdex

Summary:

      To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular
      function and recalcitrant macular edema associated with retinal vein occlusion following
      treatment with 2 or more prior intravitreal anti-VEGF drug injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion
             (BRVO)

          -  Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last
             45 days.

          -  Age 18 years or older

          -  ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of
             20/25 to 20/800

          -  Central foveal thickness >275 microns or presence of cystic edema on OCT studies.

          -  For sexually active women of childbearing potential, agreement to the use of an
             appropriate form of contraception (or abstinence) for the duration of the study.

          -  Ability to provide written informed consent • Capable of complying with study protocol

        Exclusion Criteria:

          -  History of steroid-related glaucoma (steroid response) requiring more than one topical
             glaucoma medication.

          -  Intraocular injection of steroid medication within prior 4 months

          -  Evidence of significant retinal ischemia on fluorescein angiography in the opinion of
             the treating physician.

          -  Previous laser photocoagulation within 4 months of study

          -  Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy)
             that would limit visual acuity in the opinion of the treating physician

          -  Patients who are pregnant.

          -  Unwilling or unable to follow or comply with all study related procedures.
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Condition: Meniscus Tear, Tibial; Pain, Postoperative; Postoperative Complications; Ketorolac Adverse Reaction; Opioid Use
MeSH terms: Pain, Postoperative; Postoperative Complications; Tibial Meniscus Injuries
Intervention: Ketorolac; Oxycodone-Acetaminophen
Intervention description: Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.; Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.
Intervention MeSH terms: Acetaminophen; Ketorolac; Acetaminophen, hydrocodone drug combination; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ketorolac; meniscus tear; analgesics; pain

Summary:

      The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase
      in recent years, partly due to a younger, more active population, and improved technology and
      technique. However, pain management in the post-operative period is critical to the ability
      to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have
      been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents
      are associated with several side effects, including nausea/vomiting, constipation, and
      somnolence. In addition, opioid agents have a significant potential for abuse in comparison
      to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives
      to limit narcotic usage, surgeons must explore alternate pain modalities in the acute
      postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with
      analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the
      beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative
      period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this
      agent following arthroscopic meniscus surgery have not been extensively described.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 18 and 89 years of age

          -  Patients undergoing primary arthroscopic meniscus surgery

        Exclusion Criteria:

          -  Patients age less than 18 or greater than 89 years

          -  Illiterate or non-English speaking patients

          -  Patients with contraindications to ketorolac

          -  History of drug or alcohol abuse

          -  Chronic use of analgesic or psychotropic drugs
A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Condition: Hereditary Angioedema Types I and II
MeSH terms: Angioedema; Angioedemas, Hereditary; Hereditary Angioedema Types I and II
Intervention: C1-esterase inhibitor
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in
      preventing hereditary angioedema (HAE) attacks when it is administered under the skin of
      subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks.
      The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the
      treatment phase, wherein subjects will be randomized to treatment with either low- or
      medium-volume C1-INH. Subjects who have an insufficient treatment response during the study
      will be given an opportunity to undergo a dose increase. The study aims to enroll eligible
      subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in
      study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the
      United States (US) who complete Treatment Period 2 will be allowed to participate in an
      Extension Period. During the Extension Period participating US subjects will continue to
      receive treatment with open-label CSL830 for up to an additional 88 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 6 years or older.

          -  A confirmed diagnosis of HAE type I or II.

          -  HAE attacks over a consecutive 2-month period that required acute treatment, medical
             attention, or caused significant functional impairment.

          -  For subjects who have used oral therapy for prophylaxis against HAE attacks within 3
             months of first study visit: use of a stable regimen within 3 months of the first
             study visit.

        Exclusion Criteria:

          -  Incurable malignancies.

          -  Any clinical condition that will interfere with the evaluation of C1-INH therapy.

          -  Clinically significant history of poor response to C1-esterase therapy for the
             management of HAE.

          -  Suspected or confirmed diagnosis of acquired HAE or HAE with normal C1-INH.

          -  Inability to have HAE managed pharmacologically with on-demand treatment.
A Long-Term Safety Study of ALKS 5461
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461
Intervention description: Sublingual tablet, taken daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1485.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Agree to use an approved method of contraception for the duration of the study

          -  Have the potential to safely benefit from the administration of ALKS 5461

          -  Have a diagnosis of major depressive disorder (MDD)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Have a positive test for drugs of abuse

          -  Currently pregnant or breastfeeding

          -  Have a current primary Axis-I disorder other than MDD

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 2 years, or received
             more than 1 course of electroconvulsive treatment during their lifetime

          -  Have attempted suicide within the past 2 years

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation within the past 60 days

          -  Additional criteria may apply
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Oral Cavity and Oropharynx; Oral Mucositis
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Mucositis; Stomatitis
Intervention: SGX942; Placebo
Intervention description: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.; Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OM; Head and Neck Cancer; SGX942; Dusquetide; Squamous Cell Carcinoma

Summary:

      To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe
      oral mucositis in patients receiving chemoradiation treatment for the treatment of head and
      neck cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant
             organ metastases

          -  Scheduled to receive cisplatin chemotherapy of 80-100 mg/m²

          -  Scheduled to receive a continuous course of fractionated, conventional external beam
             with a cumulative radiation dose between 55 and 72 Gy at each site

        Exclusion Criteria:

          -  Current mucositis

          -  Current, clinically significant, active infection that in the opinion of the
             Investigator would make them an unfit participant in the trial

          -  Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline
             and 6 weeks post-RT

          -  Prior radiation to the head and neck

          -  Chemotherapy treatment within the previous 12 months

          -  Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx

          -  Evidence of significant renal, hepatic, hematologic, or immunologic disease determined
             by any one of the following: Estimated creatinine clearance <30 mL/min; ALT or AST
             level greater than 10-fold the upper limit of normal or total bilirubin greater than
             3-fold the upper limit of normal; Manifestations of end-stage liver disease, such as
             ascites or hepatic encephalopathy; Thrombocytopenia; or CD4+ T cell count below 200
             cells per μL

          -  Evidence of immediate life-threatening disease or a life expectancy of less than 3
             months

          -  Women who are pregnant or breast-feeding

          -  Participation in any study involving administration of an investigational agent within
             30 days of randomization into this study