bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution
Condition: Glaucoma Open-angle
MeSH terms: Glaucoma, Open-Angle
Intervention: Travoprost Intraocular Implant, high elution; Travoprost Intraocular Implant, low elution; Timolol Maleate Ophthalmic Solution, 0.5%
Intervention description: Surgical implant placed within the eye to elute travoprost.; Surgical implant placed within the eye to elute travoprost; Instillation of one drop of timolol in the study eye twice daily
Intervention MeSH terms: Timolol; Travoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant
      to timolol ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open angle glaucoma

        Exclusion Criteria:

          -  Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular
             disorders.

          -  Functionally significant visual field loss, including severe nerve fiber bundle
             defects.

          -  Prior glaucoma surgery.

          -  Uncontrolled systemic disease, pregnant females or those planning a pregnancy.

          -  Other ocular status conditions, etc.
A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo Q2W; Tralokinumab 300 mg, Q2W; Placebo, Q2/4W; Tralokinumab 300 mg, Q2/4W
Intervention description: Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.; Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.; Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.; Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 689.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Tralokinumab; CAT-354

Summary:

      The purpose of this study is to determine whether the addition of tralokinumab to standard
      asthma medication is effective in the treatment of adults with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years

          -  Body mass index (BMI) between 16-40 kilogram per square meter (kg/m^2) at Visit 1

          -  Uncontrolled severe asthma

          -  A chest x-ray with no abnormality

          -  Females of childbearing potential who are sexually active with a non-sterilized male
             partner must use highly effective contraception from Day 1

          -  Non-sterilized males or sterilized males who are less than or equal to (=<) 1 year
             post-vasectomy who are sexually active with a female partner of childbearing potential
             must use a highly effective method of contraception

        Exclusion Criteria:

          -  Employee of the clinical study site or any other individuals directly involved with
             the conduct of the study, or immediate family members of such individuals

          -  Pregnant or breastfeeding women

          -  Any other respiratory disease

          -  Previously taken tralokinumab (the study drug)

          -  Current smoker or a history of smoking which would be more than 1 pack per day for 10
             years

          -  Known immune deficiency

          -  History of cancer

          -  Hepatitis B, C or Human Immuno-deficiency Virus (HIV)

          -  Any disease which may cause complications whilst taking the study drug.
A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
Condition: Adenoid Cystic Carcinoma
MeSH terms: Carcinoma; Carcinoma, Adenoid Cystic
Intervention: AL101
Intervention description: AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane.
In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenously
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with
      recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that
             is recurrent or metastatic, not amenable to potentially curative surgery or
             radiotherapy.

          2. Evidence of radiographic or clinical disease progression within 6-months of signing
             informed consent; newly diagnosed metastatic patients will be allowed.

          3. Patients must have Formalin-fixed, Paraffin-embedded tissue available .

          4. Must have at least 1 target lesion that is measurable for patients with nodal or
             visceral metastasis.

        Exclusion Criteria:

          1. Diagnosed with a malignancy other than ACC in the past 2 years.

          2. Uncontrolled, Active Infection

          3. Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel
             disease (IBD)]

          4. Symptomatic central nervous system (CNS) metastases.

          5. Unstable or severe uncontrolled medical condition

          6. Eastern Cooperative Oncology Group (ECOG) performance status ≥2.

          7. Abnormal organ and marrow function
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Niraparib
Intervention description: Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily.
Intervention MeSH terms: Niraparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 289.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; CRPC; Metastatic castrate-resistant prostate cancer; Prostate neoplasm; Galahad; Niraparib; DNA anomalies; DNA defect; PARP inhibitor; PARPi

Summary:

      The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of
      niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and
      deoxyribonucleic acid (DNA) repair anomalies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed prostate cancer (mixed histology is acceptable, with the
             exception of the small cell pure phenotype, which is excluded)

          -  Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer
             with evidence of disease progression on or after treatment, or discontinued from a
             taxane-based chemotherapy due to an adverse event

          -  Received a second-generation or later androgen receptor (AR)-targeted therapy (for
             example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the
             treatment of metastatic prostate cancer with evidence of disease progression or
             non-metastatic castration-resistant prostate cancer with evidence of subsequent
             metastasis

          -  Biomarker-positive by at least one of the following criteria: (a) Biallelic
             deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or
             tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test
             (somatic local results must be confirmed as positive by the sponsor-validated assay
             before dosing)

          -  Progression of metastatic prostate cancer in the setting of castrate levels of
             testosterone or history of bilateral orchiectomy at study entry

        Exclusion Criteria:

          -  Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP)
             inhibitor

          -  Prior platinum-based chemotherapy for the treatment of prostate cancer

          -  Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid
             leukemia (AML)

          -  Symptomatic or impending cord compression

          -  Symptomatic brain metastases
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
Condition: Acute Pyelonephritis
MeSH terms: Pyelonephritis
Intervention: Omadacycline; Levofloxacin; Omadacycline
Intervention description: po tablets; iv solution/po tablets; iv solution
Intervention MeSH terms: Levofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or
      iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of
      female adults with acute pyelonephritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants, age 18-65 years who have signed the informed consent form

          -  Must have a qualifying acute pyelonephritis

          -  Participants must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

          -  Must be able to comply with all of the requirements of the study

        Exclusion Criteria:

          -  Males

          -  Symptoms of acute pyelonephritis present for longer 7 days prior to randomization

          -  Infections that require antibacterial treatment for greater than 14 days

          -  Evidence of suspected non-renal source of infections, vaginitis, or sexually
             transmitted infection

          -  Evidence of significant immunological disease

          -  Evidence of liver impairment or disease

          -  Evidence of unstable cardiac disease

          -  Severe renal disease or requirement for dialysis

          -  Evidence of septic shock

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to
             levofloxacin

          -  Has received an investigational drug within the past 30 days

          -  Participants who are pregnant or nursing

          -  Unable or unwilling to comply with the protocol requirements
Plerixafor for Stem Cell Mobilization in Normal Donors
Condition: Blood And Marrow Transplantation
Intervention: Filgrastim; Plerixafor; Apheresis Procedure
Intervention description: 5 µg/kg in the morning daily for 4 days.; 240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization.; The apheresis procedure will start in the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor.
The apheresis procedure may continue beyond day 1 until the target dose of 4x106 CD34+ cells/kg (recipient's weight) is obtained.
Intervention MeSH terms: Plerixafor; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Blood And Marrow Transplantation; Normal allogeneic donors; Stem cell mobilization; peripheral blood progenitor cells; PBPC; Allogeneic hematopoietic stem cell transplantation; HSCT; Donating blood stem cells; C-CSF; Neupogen; Filgrastim; Plerixafor; Mobozil; Apheresis

Summary:

      The goal of this clinical research study is to learn if treating stem cell donors with
      filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of
      blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of
      these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs
      to be performed.

      Researchers will study if using both drugs lowers the risk of the stem cell transplant
      recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in
      which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's
      body.

      The safety and effectiveness of this drug combination will also be studied.

      Filgrastim and plerixafor are both designed to help move or "mobilize" the stem cells from
      the bone marrow to the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Donor eligibility: Age >/= 10 years.

          2. Donor eligibility: Related donors who met standard eligibility criteria and are
             willing to participate in this study.

          3. Donor eligibility: Able to provide informed consent.

          4. Recipient Eligibility: Patients who are scheduled to undergo an allogeneic related
             transplant and whose donors consented to participate in this study.

          5. Recipient Eligibility: Able to provide informed consent.

        Exclusion Criteria:

        1) Donors who are on anti-coagulation or anti-platelet agents are not eligible.
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
Condition: Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Alirocumab; Placebo Matched to Alirocumab
Intervention description: Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody; Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to assess the long-term safety and tolerability of
      alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl
      glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other
      lipid-modifying therapies (LMTs).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Prior participation in and the successful completion of the R727-CL-1003 study
             (NCT01266876).

          2. Patients must be on a stable daily statin regimen for at least 3 weeks before prior to
             entry into the study

          3. A negative urine pregnancy at the screening/baseline visit for women of childbearing
             potential

        Key Exclusion Criteria:

          1. Reported a drug-related serious adverse event (SAE) or drug-related clinical or
             laboratory adverse event (AE) in the R727-CL-1003 study that resulted in early
             termination or withdrawal

          2. Significant protocol deviation in R727-CL-1003, such as non-compliance by the
             investigator or patient

          3. Low-density lipoprotein (LDL) apheresis within 12 months before the screening/baseline
             visit

        Note: Other exclusion criteria applied
Study to Evaluate an Influenza Vaccine Candidate
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Candidate Influenza Vaccine GSK1247446A - 2 different formulations; FluarixTM
Intervention description: Single dose, Intramuscular injection; Single dose, Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1220.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Influenza vaccine

Summary:

      The purpose of this study is to evaluate the immune response and safety of influenza vaccine
      candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in
      elderly aged 60 years old and above.
    

Eligibility criteria:

        Inclusion criteria:

          -  A male or female age 60 years or older at the time of the vaccination.

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  Written informed consent obtained from the subject.

          -  Free of an acute aggravation of the health status as established by clinical
             examination before entering into the study.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the administration of the study vaccine, or planned use during the study
             period.

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, as determined by physical examination or laboratory screening tests.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within three months prior to the first vaccine dose.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to enrolment in this study. Planned administration
             of a vaccine not foreseen by the study protocol up to 30 days after vaccination.

          -  History of hypersensivity to a previous dose of influenza vaccine.

          -  Previous vaccination against influenza within the 9 months prior to enrollment.

          -  History of confirmed influenza infection within the last 12 months.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine(s)

          -  Acute disease at the time of enrolment.
A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: CSL112; Placebo
Intervention description: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.; 0.9% weight/volume sodium chloride solution (ie, normal saline)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1267.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter randomized, double-blind, placebo-controlled, parallel-group,
      dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of
      multiple dose administration of two dose levels of CSL112 compared with placebo in subjects
      with acute myocardial infarction (AMI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women, at least 18 years of age, with evidence of myocardial necrosis in a
             clinical setting consistent with a type I (spontaneous) acute myocardial infarction
             (AMI), in the last week.

        Exclusion Criteria:

          -  Ongoing hemodynamic instability

          -  Evidence of hepatobiliary disease

          -  Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or
             severe renal impairment or if subject is receiving dialysis

          -  Evidence of unstable renal function

          -  History of acute kidney injury after previous exposure to an intravenous contrast
             agent.

          -  Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its
             components

          -  Other severe comorbid condition, concurrent medication, or other issue that renders
             the subject unsuitable for participation in the study