bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
Condition: Chronic Hepatitis C; HCV; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: glecaprevir/pibrentasvir
Intervention description: Tablet; glecaprevir coformulated with pibrentasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV Treatment Experienced; Hepatitis C; HCV Genotype 3; Without cirrhosis; Non-cirrhotic; HCV Genotype 2; Renal Transplant; HCV Treatment Naive; Post transplant; HCV Genotype 6; Liver Transplant; HCV Genotype 5; HCV Genotype 4; Kidney Transplant; HCV Genotype 1

Summary:

      The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of
      ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or
      renal transplant with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age at time of screening.

          -  Screening laboratory result indicating hepatitis C virus (HCV) genotype 1-6 (GT1-6)
             infection.

          -  Subject is a recipient of a cadaveric or living donor liver transplant which was a
             consequence of HCV infection at least 3 months prior to screening Or subject received
             a cadaveric or living donor kidney at least 3 months before screening.

          -  Subjects must be documented as non-cirrhotic.

          -  Subject is currently taking a stable immunosuppression regimen based on tacrolimus,
             sirolimus, everolimus, mycophenolate mofetil (MMF), mycophenolic acid, azathioprine,
             and/or cyclosporine.

        Exclusion Criteria:

          -  Female subject who is pregnant, breastfeeding or is considering becoming pregnant
             during the study or for approximately 30 days after the last dose of study drug.

          -  Clinical history of fibrosing cholestatic hepatitis post-transplant.

          -  Re-transplantation of the liver or kidney.

          -  Steroid resistant rejection of the transplanted liver or kidney, or a history of
             rejection treated with high dose steroid within 3 months of screening.

          -  History of post-transplant complications related to hepatic or renal vasculature.
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Mesalamine; Placebo
Intervention description: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo; This is an inactive pill
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; Diarrhea; Mesalamine; Gastroenteritis; abdominal pain; hypersensitivity

Summary:

      The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in
      patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will
      evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma
      cytokines before and after treatment with Lialda.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria

          1. Men and women age 18-75 years

          2. Rome III criteria for IBS

          3. Symptom onset after apparent acute gastroenteritis

          4. Symptoms of 6 months or greater duration

          5. Normal gross appearance of the colonic mucosa other than erythema

          6. Negative markers for celiac disease and inflammatory bowel disease

          7. Normal thyroid function and serum calcium

          8. Stable medication regimens for other medical conditions.

        Exclusion Criteria:

          1. Age <18 or >75 years

          2. Previous diagnosis of or history compatible with IBS

          3. Constipation-predominant IBS.

          4. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV

          5. History of/or presence of malignancy

          6. Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory
             bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic
             resection, paraplegia or quadriplegia. .

          7. Current evidence of drug or alcohol abuse as judged by the investigator

          8. Allergy to mesalamine or aspirin

          9. Investigator perception of patient's inability to comply with the study protocol

         10. Unstable psychiatric disease

         11. Recent change in gastrointestinal medications
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Adalimumab; ABP 501
Intervention description: Participants will receive subcutaneous (SC) injection of adalimumab; Participants will receive SC injection of ABP 501
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Study is double-blind.
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Adalimumab; Biosimilars; Tumor necrosis factor; Psoriasis Area and Severity Index

Summary:

      Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches
      between Humira® and ABP 501 (new high concentration formulation) compared with continued use
      of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study
      is composed of two periods: A lead-in period of treatment with Humira® followed by a
      randomized two parallel arm period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants has moderate to severe plaque psoriasis (with or without psoriatic
             arthritis) for at least 6 months and has stable disease for at least 2 months

          -  Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA)
             and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline

          -  Participant has no known history of latent or active tuberculosis

        Exclusion Criteria:

          -  Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication induced psoriasis, or other skin conditions at the time of screening (eg,
             eczema) that would interfere with evaluations of the effect of investigational product
             of psoriasis

          -  Participant has an active infection or history of infections

          -  Participant has received biologic treatment for psoriasis within the previous month or
             5 drug half-lives (whichever is longer) prior to enrollment

          -  Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior
             to enrollment

          -  Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or
             excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks
             prior to enrollment

          -  Participant has received topical psoriasis treatment within 2 weeks prior to
             enrollment
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: risankizumab; secukinumab
Intervention description: Subcutaneous (SC) injection; Subcutaneous (SC) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque Psoriasis

Summary:

      The main objective of this study is to evaluate the efficacy and safety of risankizumab
      compared with secukinumab for the treatment of adult subjects with moderate to severe plaque
      psoriasis who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least
             6 months before the Baseline Visit

          -  Subject has stable moderate to severe chronic plaque psoriasis with or without
             psoriatic arthritis

          -  Subject must be a candidate for systemic therapy as assessed by the investigator;

          -  Subject must be an acceptable candidate to receive secukinumab according to the local
             label for this compound.

        Exclusion Criteria:

          -  History of erythrodermic psoriasis, generalized or localized pustular psoriasis,
             medication-induced or medication-exacerbated psoriasis, or new onset guttate
             psoriasis; or active skin disease other than psoriasis that could interfere with the
             assessment of psoriasis;

          -  Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or
             active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein
             derivative (PPD) test result may participate in the study if further work up
             (according to local practice/guidelines) establishes conclusively that the subject has
             no evidence of active tuberculosis. If presence of latent tuberculosis is established,
             then treatment must have been initiated and maintained according to local country
             guidelines.

          -  Active systemic infection during the last 2 weeks prior to Baseline Visit (exception:
             common cold)

          -  History of any documented active or suspected malignancy or history of any malignancy
             within the last 5 years except for successfully treated non-melanoma skin cancer
             (NMSC) or localized carcinoma in situ of the cervix

          -  Previous exposure to risankizumab

          -  Previous exposure to secukinumab
Convalescent Plasma in Outpatients With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: Convalescent Plasma; Saline
Intervention description: SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.; Saline with multivitamin administered via intravenous (IV) infusion..
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The overarching goal of this project is to confirm or refute the role of passive immunization
      as a safe and efficacious therapy in preventing the progression from mild to severe/critical
      COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies
      after passive immunization.The primary objective is to determine the efficacy and safety of a
      single dose of convalescent plasma (CP) for preventing the progression from mild to severe
      COVID-19 illness. The secondary objective is to characterize the immunologic response to CP
      administration.

      This study will enroll adults presenting to the emergency department (ED) with mild,
      symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to
      severe/critical illness, but who are clinically stable for outpatient management at
      randomization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection

          -  Has at least one study defined risk factor for severe COVID-19 illness

          -  Clinical team deems stable for outpatient management without supplemental oxygen

          -  CP available at the site at the time of enrollment

          -  Duration of symptoms ≤ 7 days at ED presentation

          -  Informed consent from subject

        Exclusion Criteria:

          -  Age less than 18 years

          -  Prisoner or ward of the state

          -  Presumed unable to complete follow-up assessments

          -  Prior adverse reaction(s) from blood product transfusion

          -  Receipt of any blood product within the past 120 days

          -  Treating clinical team unwilling to administer 300 ml fluid

          -  Enrollment in another interventional trial for COVID-19 illness
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
Condition: Chronic Hepatitis B Virus, Pediatric
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Entecavir; Placebo
Intervention description: Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response; Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response
Intervention MeSH terms: Entecavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric
      patients with chronic hepatitis B virus infection
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Males and females, aged 2 to <18 years

          -  Hepatitis B surface antigen-positive

          -  Detectable hepatitis B e (HBe) antigen, and no detectable anti-HBe antibodies

          -  Alanine aminotransferase (ALT) 1.5 to <10 times the upper limit of normal at screening
             and within 8 to 24 weeks prior to screening

          -  Evidence of the presence of hepatitis B virus DNA at least 4 weeks before screening
             and >100,000 copies/mL at screening

        Key Exclusion Criteria

          -  Any prior therapy with entecavir

          -  At least 12 weeks of prior therapy with any nucleoside or nucleotide antiviral agent

          -  Therapy with interferon alpha, thymosin alpha, or nucleototide antiviral agents within
             24 weeks of screening

          -  Coinfection with HIV, hepatitis C virus, or hepatitis D virus

          -  Decompensated liver disease

          -  Liver transplant recipients

          -  Other forms of acute and chronic conditions which may cause increased ALT levels

          -  Children who were breastfed while their mothers received lamivudine or whose mothers
             received lamivudine during pregnancy
Open Label Extension to Bridging Study CTBM100C2303
Condition: Pseudomonas Aeruginosa; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tobramycin inhalation powder
Intervention description: Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d.
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 6 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Tobramycin Inhalation Powder; Cystic fibrosis; Lung diseases; Anti-Bacterial Agents

Summary:

      This was an open-label, single arm (uncontrolled) study in participants suffering from cystic
      fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who
      were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into
      CTBM100C2303.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5
             days before enrollment into this study.

          -  Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.

          -  Forced Expiratory Volume in One Second (FEV1) at screening (study CTBM100C2303) must
             be between 25% and 80% of normal predicted values.

        Exclusion Criteria:

          -  Any use of inhaled anti-pseudomonal antibiotics between the termination of the core
             trial CTMB100C2303 and the enrollment into this study.

          -  Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost SR; Sham: Applicator Without Needle; Active Comparator: Timolol 0.5%; Timolol Vehicle (placebo)
Intervention description: Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.; Sham administered on Day 1, Week 16, and Week 32.; Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.; Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Intervention MeSH terms: Timolol; Bimatoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in
      patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month
      treatment period with an 8-month extended follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes
        require IOP-lowering treatment.

        Exclusion Criteria:

          -  Previous enrollment in another Allergan Bimatoprost SR Study

          -  Eye surgery (including cataract surgery) and/or any eye laser surgery within the past
             6 months in the study eye

          -  Anticipated need for laser eye surgery within the first 52 weeks of the study duration

          -  History of glaucoma surgery
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