bioihbjkbjnl/mcl2 huggingface dataset:
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Voclosporin; Placebo Oral Capsule
Intervention description: Calcineurin inhibitor, oral, 23.7 mg twice daily (BID); Voclosporin placebo, oral, 3 capsules twice daily (BID)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: lupus nephritis; calcineurin inhibitors; voclosporin

Summary:

      The purpose of this study is assess the long-term safety and tolerability of voclosporin
      compared with placebo for up to an additional 24 months following completion of treatment in
      the AURORA 1 study in subjects with lupus nephritis (LN).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1
             study. Subjects who had a temporary interruption and successfully restarted study drug
             during the AURORA 1 study will be allowed with Medical Monitor approval.

          2. Written informed consent before any study-specific procedures were performed.

          3. In the opinion of the investigator, subject required continued immunosuppressive
             therapy.

          4. Women of childbearing potential must continue to use effective contraception and have
             a negative urine pregnancy test at Month 12.

          5. Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the
             duration of the study.

        Exclusion Criteria:

          1. Currently taking or known need for any of the medications or food items listed in
             Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.

          2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or
             expected to require dialysis during the study period.

          3. A planned kidney transplant within study treatment period.

          4. Subjects with any medical condition which, in the Investigator's judgment, may be
             associated with increased risk to the subject or may interfere with study assessments
             or outcomes.

          5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using
             adequate contraceptive precautions.

          6. Vaccines using live organisms, virus or bacterial, while taking the study treatment.
A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: TRV130
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 768.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with moderate to severe pain caused by medical conditions or surgery, who require IV
      opioid therapy may be enrolled in this open label safety study. Patients will be treated with
      TRV130 by IV bolus, PCA (patient-controlled analgesia) administration, or both, as determined
      by the investigator, for a duration not to exceed 14 days.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  Moderate to severe acute pain for which parenteral opioid therapy is warranted

          -  Able to understand and comply with the procedures and study requirements, and to
             provide written informed consent before any study procedure.

        Exclusion Criteria include:

          -  Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse
             condition or history of such condition that would confound the interpretation of
             safety, tolerability, or efficacy data in the study.

          -  Hemodynamic instability or respiratory insufficiency.

          -  Advanced cancer in palliative or end-of-life care.

          -  Another current painful condition (other than acute pain for which parenteral opioid
             therapy is warranted) that would confound the interpretation of safety, tolerability,
             or efficacy data in the study.

          -  Clinically significant, immune-mediated hypersensitivity reaction to opioids.
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: brentuximab vedotin; doxorubicin; bleomycin; vinblastine; dacarbazine
Intervention description: Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.; Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.; Bleomycin: 10 units/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.; Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle; Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Intervention MeSH terms: Doxorubicin; Bleomycin; Dacarbazine; Brentuximab Vedotin; Vinblastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1334.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hodgkin Lymphoma; Hodgkins Lymphoma; Antibody, Monoclonal; Antibody-Drug Conjugate; Antigens, CD-30; Immunotherapy; Lymphoma; Lymphoma, Classical; ECHELON-1

Summary:

      This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of
      comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin
      (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated
      A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and
      dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Treatment-naïve participants with Ann Arbor Stage III or IV HL.

          2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current
             World Health Organization (WHO) classification.

          3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
             (<=) 2.

          4. Bidimensional measurable disease as documented by radiographic technique per the
             International Working Group Revised Criteria for Response Assessment for Malignant
             Lymphoma.

        Exclusion Criteria:

          1. Nodular lymphocyte predominant Hodgkin lymphoma.

          2. Cerebral/meningeal disease, including signs and symptoms of progressive
             multifocalleukoencephalopathy (PML).

          3. Sensory or motor peripheral neuropathy.

          4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy
             within 12 weeks of first study drug dose.

          5. Known human immunodeficiency virus (HIV) positive.

          6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
             infection.

        Please note that there are additional exclusion criteria. The study center will determine
        if you meet all of the criteria.
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Emicizumab
Intervention description: Emicizumab will be administered as per the schedule specified in the respective arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the
      efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially
      once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This
      study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W)
      and once every 4 weeks (Q4W) regimens in pediatric participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children less than (<) 12 years of age, with allowance for participants 12 to 17 years
             of age who weigh <40 kilograms (kg) (Cohort A only); and participants <2 years of age
             will be allowed to participate only after the protocol-defined interim data review
             criteria are met (Cohort A only)

          -  Diagnosis of congenital hemophilia A of any severity and documented history of
             high-titer inhibitor (that is [i.e.], greater than or equal to [>/=] 5 bethesda units
             [BU])

          -  Requires treatment with bypassing agents

          -  Adequate hematologic, hepatic, and renal function

        Exclusion Criteria:

          -  Inherited or acquired bleeding disorder other than hemophilia A

          -  Ongoing (or planning to receive during the study) immune tolerance induction (ITI)
             therapy or prophylaxis treatment with FVIII

          -  Previous (in the past 12 months) or current treatment for thromboembolic disease or
             signs of thromboembolic disease

          -  Other disease that may increase risk of bleeding or thrombosis

          -  History of clinically significant hypersensitivity associated with monoclonal antibody
             therapy or components of the emicizumab injection

          -  Known infection with human immunodeficiency virus (HIV) or hepatitis B or C virus

          -  Use of systemic immunomodulators at enrollment or planned use during the study period

          -  Planned surgery (excluding minor procedures such as tooth extraction or incision and
             drainage) during the study

          -  Inability (or unwillingness by caregiver) to receive (allow receipt of) blood or blood
             products (or any standard-of-care treatment for a life-threatening condition)

          -  Participants who are at high risk for thrombotic microangiopathy (TMA) (e.g., have a
             previous medical or family history of TMA), in the investigator's judgement
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM/IVA; LUM/IVA
Intervention description: Lumacaftor (LUM) 200 mg every 12 hours (q12h)/ivacaftor (IVA) 250 mg q12h (for 6 through 11 years of age).
LUM 400 mg q12h/IVA 250 mg q12h (for 12 years and older).; LUM 200 mg q12h/IVA 250 mg q12h (for 6 through 11 years of age).
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic
      fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator
      (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233).
      Study 110 is designed to evaluate the safety and efficacy of long term treatment of
      lumacaftor in combination with ivacaftor.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects entering the Treatment Cohort must meet both of the following criteria:

          -  Completed study visits up to Week 24 of Study 109 or Week 26 of Study 011B and did not
             permanently discontinue treatment

          -  Willing to remain on a stable CF medication through the Safety Follow-up Visit.

        Subjects entering the Observational Cohort must meet 1 of the following criteria:

          -  Completed 24 weeks of study drug treatment in Study 109 or completed 24 weeks of study
             drug treatment and the Week 26 Safety Follow up in Study 011B.

          -  Received at least 4 weeks of study drug and completed visits up to Week 24 of Study
             109 or Week 26 of Study 011B.

        Exclusion Criteria (Treatment Cohort Only):

          -  History of any comorbidity or laboratory abnormality that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject (e.g., cirrhosis with portal hypertension).

          -  Pregnant and nursing females.

          -  Sexually active subjects of reproductive potential who are not willing to follow the
             contraception requirements.

          -  History of drug intolerance in the prior study that would pose an additional risk to
             the subject in the opinion of investigator

          -  History of poor compliance with study drug and/or procedure in the previous study as
             deemed by the investigator.

          -  Participation in an investigational drug trial (including studies investigating
             lumacaftor and/or ivacaftor).
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants 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; Active Comparator: Timolol 0.5%; Sham: Applicator Without Needle; Timolol Vehicle (placebo)
Intervention description: Bimatoprost SR administered in the study eye 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.; Sham administered on Day 1, Week 16, and Week 32.; 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 594.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of bimatoprost SR in participants 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 in either eye within the first 52 weeks of the
             study duration

          -  History of glaucoma surgery
Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
Condition: Glabellar Lines; Lateral Canthal Lines
Intervention: botulinum toxin neuromodulator
Intervention description: A dose of QM1114-DP will be injected in the GL area and in the LCL area.
Intervention MeSH terms: Botulinum Toxins; Neurotransmitter Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the
      long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal
      Lines (Crow's Feet and LCL).
    

Eligibility criteria:

        Inclusion Criteria:

        - Male or female at least 18 years of age.

        Exclusion Criteria:

          -  Previous use of any Botulinum toxin in facial areas within 9 months prior to study
             treatment.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than the investigational product).

          -  Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          -  Known allergy or hypersensitivity to any component of the investigational product
             (QM1114-DP) or any botulinum toxin serotype.
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: CP-690,550; CP-690,550
Intervention description: 5 mg tablets, BID, for at least 12 months; 10 mg tablets, BID, for at least 12 months
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 944.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ulcerative colitis; open-label; long term treatment

Summary:

      This study is an open label, long-term extension study for subjects with moderate to severe
      ulcerative colitis designed to evaluate long term therapy of CP-690,550.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who completed induction studies A3921094 or A3921095 and were classified as
             not meeting clinical response criteria; OR

          -  Subjects who completed maintenance study A3921096 or who discontinued treatment early
             in Study A3921096 due to treatment failure.

        Exclusion Criteria:

          -  Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.

          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
             colitis, or clinical findings suggestive of Crohn's disease.

          -  Subjects who have had surgery for ulcerative colitis or in the opinion of the
             investigator, are likely to require surgery for ulcerative colitis during the study
             period.
Study of SkQ1 as Treatment for Dry-eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: Low Dose - SkQ1; High dose - SkQ1; SkQ1 (Vehicle)
Intervention description: SkQ1 Low dose ophthalmic solution; SkQ1 High Dose ophthalmic solution; Vehicle for SkQ1 ophthalmic solution
Intervention MeSH terms: Benzalkonium Compounds
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-group study of two strengths of ophthalmic solution versus placebo solution
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Dry Eye Syndrome; SkQ1; KCS; Keratoconjunctivitis

Summary:

      The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and
      effective compared to placebo for the treatment of the signs and symptoms of dry eye
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age;

          -  Provide written informed consent;

          -  Have a subject reported history of dry eye;

          -  Have a history of use of eye drops for dry eye symptoms ;

          -  Ocular Discomfort;

          -  Schirmer's Test score;

          -  Have corneal fluorescein staining ;

          -  Have lissamine green conjunctival Staining ;

          -  Have a conjunctival redness;

        Exclusion Criteria:

          -  Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;

          -  Have any clinically significant slit lamp findings at Visit 1;

          -  Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit
             1;

          -  Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned
             over the study period;

          -  Have an uncontrolled systemic disease;

          -  Be a woman who is pregnant, nursing or planning a pregnancy;

          -  Be a woman of childbearing potential who is not using an acceptable means of birth
             control;

          -  Have a known allergy and/or sensitivity to the study drug or its components ;

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study;

          -  Be currently enrolled in an investigational drug or device study or have used an
             investigational drug or device within 30 days of Visit 1;
An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma
Condition: Melanoma; Skin Cancer
MeSH terms: Melanoma
Intervention: BMS-986205; Nivolumab; Placebo
Intervention description: specified dose on specified day; Specified dose on specified day; Specified dose on specified day
Intervention MeSH terms: Nivolumab; Linrodostat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to
      nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to
      be removed by surgery, and has not previously been treated
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  12 years and older unless not permitted by local regulations; in that case 18 years
             old and older

          -  Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
             1

          -  Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the
             American Joint Committee on Cancer (AJCC) Staging Manual (8th edition)

          -  Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or
             metastatic melanoma)

          -  Measurable disease per RECIST v1.1

        Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases

          -  Uveal or ocular melanoma

          -  Participants with active, known, or suspected autoimmune disease

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured

        Other protocol defined inclusion/exclusion criteria could apply