bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Administration of Peginterferon Alfa-2a [Pegasys] by Autoinjector Versus Pre-filled Syringe in Patients With Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Autoinjector; Pre-filled syringe
Intervention description: Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.; Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, cross-over, open label study will compare the tolerability and handling of
      application of peginterferon alfa-2a [Pegasys] by autoinjector versus pre-filled syringe in
      patients with chronic hepatitis C, either on treatment with peginterferon alfa-2a for at
      least 12 weeks or treatment-naïve for peginterferon alfa-2a. Patients will be randomized to
      self-injection of 180mcg peginterferon alfa-2a once a week using either an autoinjector or a
      prefilled syringe for 3 weeks, then switch to use the other method of injection for another 3
      weeks. Anticipated time on study treatment is 6 weeks. Target sample size is <100 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/=18 years of age

          -  chronic hepatitis C

          -  on treatment with peginterferon alfa-2a for >/= 12 weeks at baseline, or
             treatment-naïve for peginterferon alfa-2a

        Exclusion Criteria:

          -  history or evidence of decompensated liver disease

          -  autoimmune hepatitis

          -  hypersensitivity to peginterferon alfa-2a or any of its components

          -  concomitant treatment that requires administration by self-injection, or prior use of
             an autoinjector
Safety and Dialysability of Dotarem® in Dialysed Patients
Condition: End-stage Renal Failure
MeSH terms: Kidney Failure, Chronic
Intervention: Dotarem® IV injection at 0.1 mmol/kg
Intervention description: Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Dotarem; Dialyses; Dialysed; Safety; Safety and dialysability of Dotarem in dialysed patients

Summary:

      To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients
      with chronic renal failure who require hemodialysis treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female, aged ≥18 years

          -  Subjects suffering from end-stage renal failure who require hemodialysis treatment for
             3 times per week (or equivalent to allow overnight dialysis being rescheduled as
             appropriate per protocol)

          -  Female Subjects with effective contraception (contraceptive pill or Intra-Uterine
             Device), or surgically sterilized or post-menopausal (minimum 12 months amenorrhea)

          -  Subjects having provided their written informed consent to participate in the trial

        Exclusion Criteria:

          -  Known allergy to gadolinium chelates

          -  Pregnant, breast feeding, or planning to become pregnant during the trial

          -  Having received or scheduled to be injected with any contrast agent within 7 days
             before or after the Dotarem® injection

          -  Schedule to receive erythropoietin (EPO) or iron therapy during 1 week after the
             Dotarem® injection

          -  Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV
             antibodies

          -  Evidence of hepatitis C and/or positive hepatitis C antibody and/or positive hepatitis
             B surface antigen

          -  History of hypersensitivity to drugs with a similar chemical structure
Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation
Condition: Kidney; Complications, Allograft
Intervention: eculizumab
Intervention description: Eculizumab Induction 600mg IV every 7 days for 4 doses
Eculizumab 900mg IV 7 days later
Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks
Intervention MeSH terms: Eculizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: chronic kidney allograft injury; complement protein; eculizumab; Kidney transplantation

Summary:

      This study is designed to assess the effectiveness of eculizumab in recipients of kidney
      transplantation with donor-specific antibodies (DSA) and worsening kidney function and to
      assess if eculizumab improves endothelial cell injury in the kidney.

      The investigators hypothesize that complement inhibition with eculizumab will reduce
      allograft injury, resulting from less complement-mediated injury of endothelial cells and
      less endothelial cell activation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant recipients greater than 6 months from the date of transplant

          -  Must be on standard immunosuppression: tacrolimus, mycophenolate mofetil, prednisone
             and have stable tacrolimus trough levels over past 3 months

          -  Deteriorating renal function, as defined by 20% reduction in GFR (MDRD calculation)

          -  Presence of DSA, as defined as MFI > 1100

          -  Renal biopsy demonstrating no diffuse, irreversible end-stage organ injury (i.e. stage
             IV Fibrosis)

          -  Renal biopsy demonstrating C4d deposition (stratum 1) or no C4d deposition (stratum 2)

        Exclusion Criteria:

          -  History of CMV, BK, HSV or other viral infections

          -  History of chronic, recurrent bacterial infections

          -  Evidence of tubulitis on renal biopsy or other morphological features of acute
             cellular rejection or acute humoral rejection

          -  Renal biopsy demonstrating diffuse, irreversible end-stage organ injury

          -  Absolute GFR < 25 (MDRD calculation)

          -  Inability to provide informed consent

          -  History of poor vascular access

          -  Refusal to use double barrier contraception during study participation

          -  Patients actively enrolled in other clinical trials
Drug-Drug Interaction Between Colchicine and Ritonavir
Condition: Pharmacokinetics
Intervention: Colchicine; Ritonavir; Colchicine
Intervention description: A single dose of colchicine 0.6 mg administered alone at 7:00 a.m. on Day 1 after an overnight fast of at least 10 hours.; One 100 mg ritonavir capsule administered twice daily at 7:00 a.m. and 7:00 p.m. on Days 15 to 18 without regard to meals, then along with colchicine at 7:00 a.m. on Day 19 after an overnight fast of at least 10 hours; final dose of 100 mg ritonavir administered at 7:00 p.m. on Day 19; A single dose of colchicine 0.6 mg administered along with ritonavir at 7:00 a.m. on Day 19
Intervention MeSH terms: Ritonavir; Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism
      of colchicine. This study will evaluate the effect of multiple doses of ritonavir on the
      pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to
      evaluate the safety and tolerability of this regimen in healthy volunteers. All study
      subjects will be monitored for adverse events throughout the study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, hyperlipidemia, pulmonary, hepatic,
             gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine,
             immunologic, dermatologic, neurological, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Intervention: EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic
      Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects,
      immediately after bilateral tympanostomy tube surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and
             eligible for bilateral myringotomy and tympanostomy tube insertion;

          -  Legally Authorized Representative (LAR) must read and sign the informed consent;

          -  Parent or caregiver must agree to complete the required study visits and comply with
             the requirements of the study;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Menarcheal females;

          -  Previous otologic or otologic-related surgery within the past 30 days or ongoing
             complications;

          -  Existing perforation of the eardrum;

          -  Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions
             which could interfere with evaluation of the study drug;

          -  Any systemic disease or disorder, complicating factor or structural abnormality that
             would negatively affect the conduct or outcome of the study;

          -  Use of prohibited medications or inadequate washout of any medication including
             systemic and topical antibiotics, steroids and/or analgesics;

          -  Weighs less than 8 kg;

          -  Other protocol-specified exclusion criteria may apply.
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Infliximab (BCD-055); Infliximab (Remicade)
Intervention description: infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
Intervention MeSH terms: Infliximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic
      equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD,
      Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing
      spondylitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  signed informed consent

          -  active ankylosing spondylitis, which exists in patient within last 3 months

          -  BASDAI score > or equal to 4 points, spinal pain (by VAS) > or equal to 4 points

          -  history of NSAID use for the treatment of AS within last 3 months

          -  adequate renal and liver function

          -  absence of severe abnormalities in complete blood count

          -  consent to use adequate contraception

          -  ability to follow Protocol procedures

        Exclusion Criteria:

          -  previously use of any biologic for AS treatment

          -  total ankylosing of the spine

          -  known allergy to chimeric proteins or any excipients of BCD-055/Remicade

          -  hepatitis B, active hepatitis C, HIV, syphilis

          -  known tuberculosis

          -  latent forms of tuberculosis

          -  any bacterial infection diagnosed within last month which required oral antibiotics
             (within last 2 weeks) or parenteral antibiotics (within last 4 weeks)

          -  drug or alcohol abuse

          -  any other disease which can affect assessments or masking some symptoms of AS (severe
             osteoarthrosis, nervous disorders with impairment of sensory or motor functions,
             another inflammatory joint disease apart from AS, etc.)

          -  severe uncontrolled hypertension

          -  chronic heart failure

          -  decompensated renal or liver disorders

          -  severe uncontrolled diabetes mellitus

          -  chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis

          -  any mental disorder, incl. severe depression or/and suicide thoughts/actions in
             anamnesis

          -  unstable angina pectoris

          -  myocardial infarction within last 12 months

        Other exclusion criteria could be found in the Full Study Protocol
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840; Celecoxib
Intervention description: ALXN1840 was administered orally as a single dose as 4 x 15 milligram (mg) enteric-coated tablets with 240 milliliters (mL) of water (fasting), for a total dose of 60 mg.; Celecoxib was administered orally as a single dose as one 200-mg tablet with 240 mL of water (fasting).
Intervention MeSH terms: Celecoxib; Tetrathiomolybdate; Choline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomized to 1 of 2 treatment sequences: A-B or B-A.
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cytochrome P450; Healthy; ALXN1840; Celecoxib; CYP2C9

Summary:

      This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine
      the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9
      (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of
      ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via
      total molybdenum with the coadministration of celecoxib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adequate venous access in the left or right arm to allow the collection of blood
             samples.

          -  Bodyweight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to
             < 30 kg/meter squared.

          -  Willing and able to follow protocol-specified contraception requirements.

          -  Capable of giving signed informed consent.

        Exclusion Criteria:

          -  History or presence of/significant medical history.

          -  Clinically significant multiple or severe allergies.

          -  Lymphoma, leukemia, or any malignancy within 5 years.

          -  Breast cancer within the past 10 years.

          -  Serum creatinine > upper limit of normal (ULN) of the reference range.

          -  Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > ULN.

          -  Current or chronic history of liver disease or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  QTc > 450 milliseconds (msec) for male participants or > 470 msec for female
             participants.
Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Condition: Healthy Participants
Intervention: Rosuvastatin; Sotorasib
Intervention description: Oral dose; Oral dose
Intervention MeSH terms: Sotorasib; Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AMG 510; Sotorasib; Rosuvastatin; Healthy participants

Summary:

      A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin,
      and to assess the PK of rosuvastatin when administered alone, in healthy participants.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive),
             at the time of Screening.

          -  Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.

          -  Females of nonchildbearing potential

        Exclusion criteria:

          -  Inability to swallow oral medication or history of malabsorption syndrome.

          -  History of hypersensitivity, intolerance, or allergy to any drug compound, food, or
             other substance, unless approved by the Investigator (or designee) and in consultation
             with the Sponsor.

          -  Poor peripheral venous access.

          -  History or evidence, at Screening or Check in, of clinically significant disorder,
             condition, or disease, including history of myolysis, not otherwise excluded that, in
             the opinion of the Investigator (or designee), would pose a risk to subject safety or
             interfere with the study evaluation, procedures, or completion.
A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: OCV-103 and OCV-104; OCV-103 and OCV-104; OCV-103 and OCV-104; OCV-103 and OCV-104
Intervention description: 0.3 mg of each; 1 mg of each; 3 mg of each; 6 mg of each
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: OCV-C02; Colorectal Cancer; Antigen specific cancer immunotherapeutic

Summary:

      To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed
      Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have human leukocyte antigen (HLA)-A*24:02

          -  Patients who have histologically-confirmed colorectal cancer (adenocarcinoma)

          -  Patients with advanced or relapsed colorectal cancer who are refractory or intolerant
             to standard chemotherapy

          -  Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
             0 to 1 at the time of enrollment in the trial.

        Exclusion Criteria:

          -  Patients who are HIV antibody test positive

          -  Patients with an active infection

          -  Patients who have or are suspected to have CNS metastasis of colon cancer (such as
             metastatis of the brain)
Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma
Condition: Advanced Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab
Intervention description: Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks
Intervention MeSH terms: Ipilimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab
      manufactured by two different processes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of malignant melanoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Measurable/evaluable disease per modified World Health Organization (mWHO) criteria

        Exclusion Criteria:

          -  Active Brain Metastasis

          -  Primary ocular or mucosal melanoma

          -  Prior Autoimmune disease

          -  Inadequate hematologic, hepatic or renal function

          -  Use of immunosuppressants

          -  Prior treatment with a CD137 agonist or cytotoxic T lymphocyte antigen 4 (CTLA-4)
             inhibitor