bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
Condition: Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal ACWY Polysaccharide Vaccine; MenACWY CRM (19 to 55 years); Meningococcal ACWY Conjugate Vaccine; Novartis MenACWY Vaccine (56 to 65 Years)
Intervention description: One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.; One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.; One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.; One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2831.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; meningitis; vaccine; adolescents; adults

Summary:

      This study will evaluate the safety and immune response of Novartis Meningococcal ACWY
      conjugate vaccine in healthy adolescents and adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  individuals who are 19-65 years of age inclusive and who, after the nature of the
             study has been explained have provided written informed consent

          -  individuals who are available for all visits and telephone calls scheduled for the
             study;

          -  individuals who are in good health

        Exclusion Criteria:

          -  individuals with a previous or suspected disease caused by N. meningitidis

          -  individuals with previous immunization with a meningococcal vaccine or vaccine
             containing meningococcal antigen(s)

          -  individuals with previous or suspected disease caused by N. meningitidis

          -  individuals with any serious acute, chronic or progressive disease

          -  individuals who are pregnant or breastfeeding
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL/VOX; SOF/VEL
Intervention description: 400/100/100 mg FDC tablet administered orally once daily with food; 400/100 mg FDC tablet administered orally once daily without regard to food
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic

Summary:

      The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
      treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC)
      for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in
      participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C
      virus (HCV) infection and cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic genotype 3 HCV infection (≥ 6 months)

          -  Presence of cirrhosis

          -  HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen

          -  Use of protocol specified methods of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically significant illness that may interfere with
             participation in the study

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory parameters outside the acceptable range at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
Condition: Anemia; Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: HX575 epoetin alfa; US-licensed epoetin alfa
Intervention description: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.; Solution for subcutaneous injection.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: erythropoietin alfa; CKD 5d

Summary:

      The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed
      reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to
      generate data supporting that the efficacy and safety under treatment with HX575 and
      Epogen®/Procrit® are comparable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous
             maintenance therapy with Epogen® or Procrit® at least once per week

          -  Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period

          -  Adequate iron substitution

        Exclusion Criteria:

          -  Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy

          -  History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies

          -  Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection

          -  Hepatitis C infection on an active treatment

          -  Symptomatic congestive heart failure (New York Heart Association [NYHA] class III and
             IV)

          -  Unstable angina pectoris, or cardiac infarction during the last 6 months prior to
             randomization

          -  Percutaneous coronary intervention, or coronary artery bypass grafting during the last
             6 months prior to randomization

          -  History of malignancy of any organ system

          -  Systemic lupus erythematous

          -  Immunocompromized patients

        Other In-/Exclusion criteria may apply
Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study
Condition: Osteoarthritis; Arthritis; Pain
MeSH terms: Osteoarthritis
Intervention: Placebo IV; Placebo SC; Tanezumab SC; Placebo IV; Tanezumab SC; Placebo IV; Tanezumab SC; Placebo IV; Tanezumab IV; Placebo SC
Intervention description: 1 ml of placebo administered SC and IV once every 8 weeks.; 1 ml of placebo administered SC and IV once every 8 weeks.; 1 ml tanezumab injection SC administered every 8 weeks; 1 ml placebo administered IV every 8 weeks; 1 ml tanezumab injection SC administered every 8 weeks; 1ml placebo administered IV every 8 weeks; 1 ml tanezumab injection SC administered every 8 weeks; 1ml placebo administered IV every 8 weeks; 1 ml tanezumab injection IV administered every 8 weeks; 1ml placebo administered SC every 8 weeks
Intervention MeSH terms: Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: safety; efficacy; parallel group; double-blind; multicenter; injection; infusion; osteoarthritis; bridging; subcutaneous; intravenous; tanezumab

Summary:

      This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab
      administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC)
      administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of
      tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16
      weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of osteoarthritis (OA) of the knee according to American College of
             Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal
             to 2

          -  18 years of age or greater

          -  Two methods of birth control one of which must be barrier if of childbearing potential

          -  Willing to discontinue pain medication except as permitted per protocol

        Exclusion Criteria:

          -  Pregnancy or wishing to be pregnant during the course of the study, lactating women

          -  Body Mass Index (BMI) greater than 39

          -  Clinically significant cardiac, neurological, psychiatric conditions and other
             conditions that are excluded by the protocol.

          -  Previous exposure to a Nerve Growth Factor (NGF) antibody
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
Condition: Multiple Sclerosis, Primary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Intervention: Ocrelizumab; Placebo
Intervention description: Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.; Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.
Intervention MeSH terms: Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 735.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This randomized, parallel group, double-blind, placebo controlled study will evaluate the
      efficacy and safety of ocrelizumab in participants with primary progressive multiple
      sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary progressive multiple sclerosis (according to revised McDonald
             criteria)

          -  EDSS at screening from 3 to 6.5 points

          -  Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than
             (>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0

          -  Sexually active male and female participants of reproductive potential must use two
             methods of contraception throughout the study treatment phase and for 48 weeks after
             the last dose

        Exclusion Criteria:

          -  History of relapsing remitting MS, secondary progressive, or progressive relapsing MS
             at screening

          -  Inability to complete an MRI (contraindications for MRI)

          -  Known presence of other neurologic disorders

          -  Known active infection or history of or presence of recurrent or chronic infection

          -  History of cancer, including solid tumors and hematological malignancies (except for
             basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the
             cervix that have been excised and resolved)

          -  Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab,
             atacicept, belimumab, or ofatumumab)

          -  Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab,
             anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone,
             azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body
             irradiation, or bone marrow transplantation

          -  Any concomitant disease that may require chronic treatment with systemic
             corticosteroids or immunosuppressants during the course of the study
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
Condition: Coronary Artery Disease (CAD); Coronary Atherosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Intervention: Placebo; Aliskiren
Intervention description: Placebo; 300 mg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 613.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: CAD; coronary artery disease; coronary atherosclerosis; coronary angiography; IVUS; intravascular ultrasound; plasma renin activity; renin angiotensin aldosterone system,; direct renin inhibitors; coronary atheroma

Summary:

      The study will assess the change in coronary atherosclerotic disease as determined by
      intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to
      standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the
      pre-hypertensive range.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with CAD who have blood pressure in the pre-hypertensive range defined as a
             msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.

          -  Patients with or without current treatment for hypertension

          -  Angiographic evidence of coronary artery disease

          -  At least 2 qualifying Cardiovascular risk factors at Visit 1

        Exclusion Criteria:

          -  Baseline IVUS determined unacceptable

          -  Patients requiring treatment with disallowed study medications

          -  Patients with clinically significant heart disease

          -  Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left
             ventricular ejection fraction of < 25%

          -  Patients requiring treatment with any 2 of the following classes of medication at
             Visit 1 or Visit 2:

               -  Angiotensin converting enzyme inhibitors

               -  Angiotensin receptor blockers

               -  aldosterone receptor blockers or a direct renin inhibitor.

          -  Other conditions may apply
Abatacept Versus Adalimumab Head-to-Head
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Adalimumab
Intervention description: Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days); Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
Intervention MeSH terms: Adalimumab; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 869.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no
      worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis
      who are biologic naive
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe Rheumatoid arthritis (RA) according to American College of
             Rheumatology (ACR) criteria

          -  Methotrexate failure

          -  Naive to RA biologics

          -  ≤5 years duration of disease

          -  Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2

          -  Willingness to self-inject subcutaneous (SC) drug

        Exclusion Criteria:

          -  Previous or current medical conditions that are warnings against the use of tumor
             necrosis factor (TNF)-blocking agents

          -  History of active or chronic hepatitis

          -  Cancer in the last 5 years

          -  History of severe chronic or recurrent bacterial or viral infections

          -  Risk of tuberculosis

          -  Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic,
             Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease
Tanezumab In Osteoarthritis Of The Knee (2)
Condition: Arthritis; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: tanezumab 10 mg; tanezumab 5 mg; naproxen; placebo
Intervention description: tanezumab 10 mg one dose at weeks 0 and 8; tanezumab 5 mg one dose at weeks 0 and 8; naproxen 1000 mg daily for 16 weeks; placebo to match tanezumab and naproxen dosing
Intervention MeSH terms: Naproxen; Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 832.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: monoclonal antibody; RN624; PF-04383119; nerve growth factor; anti-nerve growth factor; OA; pain

Summary:

      The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared
      with naproxen and placebo in patients with osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2

        Exclusion Criteria:

          -  Pregnancy or intent to become pregnant

          -  BMI greater than 39

          -  other severe pain, significant cardiac, neurologic or cardiac disease
Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Carboxymethylcellulose Based Eye Drop Formulation A; Carboxymethylcellulose Based Eye Drop Formulation B; Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops; Carboxymethylcellulose Based Lubricant Eye Drops
Intervention description: Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.; Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.; Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.; Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Ophthalmic Solutions; Lubricant Eye Drops
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation
      in subjects with dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dry eyes

          -  Current use of eye drops for dry eye at least twice daily, on average for at least 3
             months

        Exclusion Criteria:

          -  Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive
             keratectomy (PRK) surgery in the last 12 months

          -  Need to wear contact lenses during the study, or has worn contact lenses in the last 6
             months

          -  Active ocular allergy
Prospective Study of Patients With Thrombocytopenia Following HSCT
Condition: Thrombocytopenia; Hematologic Diseases
MeSH terms: Thrombocytopenia; Hematologic Diseases
Intervention: Decitabine; rhTPO; Conventional Treatment
Intervention description: Decitabine; rhTPO; immunoglobulin, glucocorticoid etc
Intervention MeSH terms: Decitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Healthy volunteers: No
Keywords: Isolated thrombocytopenia; decitabine; rhTPO

Summary:

      Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to
      an increased risk of life-threatening hemorrhage, frequent requirement of platelet
      transfusions and extended hospital stays, representing a challenging clinical problem.
      Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet
      recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent
      to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT.
      Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce
      platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted
      an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine
      in the treatment of thrombocytopenia following HSCT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;

          2. Neutrophil and hemoglobin were well recovered;

          3. Full donor chimerism was achieved;

          4. No response to conventional treatments (e.g. thrombopoietin, immunoglobulin,
             glucocorticoid alone or in combination) for a duration of at least 4 weeks;

        Exclusion Criteria:

          1. Patients with malignancy relapse;

          2. Active infections;

          3. Grade Ⅲ-Ⅳ acute GVHD or severe chronic GVHD according to National Institute of Health
             criteria;

          4. Severe organ damage;

          5. Thrombosis requiring treatment;

          6. Received decitabine following the current transplantation.