bioihbjkbjnl/mcl2 huggingface dataset:
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
Condition: Congenital Heart Disease in Children; Inflammatory Response
MeSH terms: Heart Diseases; Heart Defects, Congenital; Inflammation
Intervention: Methylprednisolone; Isotonic saline
Intervention description: IV Steroid pre-operative and intra-operative; Isotonic saline pre-operative and intra-operative
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1263.0
Sex: All
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD),
      safety and efficacy of methylprednisolone in infants undergoing heart surgery with
      cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled
      safety and efficacy study. Blood samples will be collected from a subset of enrolled study
      participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be
      randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study
      drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery
      and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will
      be followed for primary and secondary outcomes for the duration of their hospitalization.
      Serious study drug-related adverse events will be collected for 7 days after the last dose of
      study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 1 year at the time of surgery

          -  Undergoing heart surgery with CPB as part of standard clinical care

          -  Availability and willingness of the parent/legally authorized representative to
             provide written informed consent

        Exclusion Criteria:

          -  < 37 weeks adjusted gestational age at time of surgery

          -  Any oral or intravenous steroid treatment within two days of surgery

          -  Any patient receiving any of the following medications within 2 days of surgery:

        Amphotericin B, aminoglutethimide, anticholinesterases, warfarin, P450 3A4 inducers
        including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan
        and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin,
        voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole,
        erythromycin and verapamil.

          -  Infection contraindicating steroid use

          -  Preoperative mechanical circulatory support or active resuscitation at the time of
             randomization

          -  Emergent surgery precluding steroid administration 8-12 hours before surgery
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed
Condition: HIV-1-infection
Intervention: B/F/TAF; F/TAF; DTG; DTG Placebo; F/TAF Placebo; B/F/TAF Placebo
Intervention description: 50/200/25 mg FDC tablet(s) administered orally once daily; 200/25 mg FDC tablet(s) administered orally once daily; 50 mg tablet(s) administered orally once daily; Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Intervention MeSH terms: Dolutegravir; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of switching from a regimen
      of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and
      emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of
      bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically
      suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum
             time periods:

               -  ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse
                  transcriptase inhibitor (NRTI) resistance prior to the screening visit)

               -  ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the
                  screening visit)

          -  Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with
             DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable)
             preceding the screening visit

          -  Plasma HIV-1 RNA levels < 50 copies/mL at screening visit

          -  Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the
             Cockcroft-Gault formula for creatinine clearance

          -  No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed
             virologic failure

          -  Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
             infection are permitted to enroll

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Belimumab in Remission of VASculitis
Condition: Vasculitis
MeSH terms: Microscopic Polyangiitis; Vasculitis
Intervention: Placebo; Belimumab 10 mg/kg; Azathioprine
Intervention description: Placebo; Belimumab 10 mg/kg; Azathioprine
Intervention MeSH terms: Azathioprine; Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Wegener's Granulomatosis; anti-MPO; WG; Belimumab; GPA; anti-proteinase 3; anti-neutrophil cytoplasmic antibody; anti-myeloperoxidase; Granulomatosis with polyangiitis; Vasculitis; Autoimmune Diseases; Microscopic Polyangiitis; anti-PR3; ANCA; MPA; Systemic Vasculitis

Summary:

      The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination
      with azathioprine, for the maintenance of remission following a standard induction regimen in
      patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in
      this study is "1 to 1" which means that participants have an equal chance of receiving
      belimumab or placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill
             criteria.

          -  Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids
             and 1 of the following medications: rituximab, oral cyclophosphamide OR IV
             cyclophosphamide.

          -  Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO)
             antibodies at any time prior to enrollment.

          -  Achieve remission no more than 26 weeks after first dose of induction treatment.
             Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and
             receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive
             visits 21 to 35 days apart.

          -  Maintenance therapy on this study must start no more than 2 weeks after confirmation
             of remission.

        Key Exclusion Criteria:

          -  Pregnant or nursing.

          -  Receipt of a B cell targeted therapy (other than rituximab) at anytime

          -  Receipt of an investigational biological agent within the past 60 days.

          -  Required management of acute or chronic infections within the past 60 days.

          -  Current drug or alcohol abuse or dependence.

          -  Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C.

          -  History of severe allergic reaction to contrast agents or biological medicines.
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
Condition: Malaria
MeSH terms: Malaria
Intervention: Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy; Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy
Intervention MeSH terms: Pyrimethamine; Piperaquine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Artenimol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 782.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chemoprevention; Malaria; Sulfadoxine-Pyrimethamine; Dihydroartemisinin-Piperaquine

Summary:

      This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected
      pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation
      will be randomized in equal proportions to one of two intermittent preventive treatment in
      pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly
      dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP
      placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant
      women will end approximately 6 weeks after giving birth. All children born to mothers
      enrolled in the study will be followed from birth until they reach 12 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by
             ultrasound

          -  Estimated gestational age between 12-20 weeks

          -  Confirmed to be HIV uninfected by rapid test

          -  16 years of age or older

          -  Resident of Busia District, Uganda

          -  Provision of informed consent by the pregnant woman for herself and her unborn child

          -  Agreement to come to the study clinic for any febrile episode or other illness and
             avoid medications given outside the study protocol

          -  Plan to deliver in the hospital

        Exclusion Criteria:

          -  History of serious adverse event to SP or DP

          -  Active medical problem requiring inpatient evaluation at the time of screening

          -  Intention of moving outside of Busia District, Uganda

          -  Chronic medical condition requiring frequent medical attention

          -  Prior SP preventive therapy or any other antimalarial therapy during this pregnancy

          -  Early or active labor (documented by cervical change with uterine contractions)
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Condition: Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary; Bone Neoplasms; Bone Marrow Diseases
Intervention: Denosumab
Intervention description: Administered by subcutaneous injection every 4 weeks (Q4W)
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; bone metastases; breast cancer; prostate cancer

Summary:

      This trial will facilitate access to denosumab for adults with advanced cancer who have
      participated in a denosumab phase 3 study until denosumab is approved and available for sale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject was previously enrolled in a denosumab phase 3 study and participated in the
             Open-label Extension portion of that study.

          -  Subject or subject's legally acceptable representative has provided informed consent.

        Exclusion Criteria:

          -  Subject is of child bearing potential and planning to become pregnant within 7 months
             after the end of treatment.

          -  Subject is of child bearing potential and is not willing to use, in combination with
             her partner, two highly effective methods of contraception during treatment and for 7
             months after the end of treatment.

          -  Subject has known sensitivity to any of the products to be administered during dosing.

          -  Subject will not be available for protocol required study visits or procedures, to the
             best of the subject and investigator's knowledge.

          -  Subject has any kind of disorder that, in the opinion of the investigator, may
             compromise the ability of the subject to give written informed consent and/or to
             comply with all required study procedures.
DE-117 Spectrum 5 Study
Condition: Primary Open-angle Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-117 Ophthalmic Solution
Intervention description: Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117
      ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or
      OHT
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.

          -  Provide signed written informed consent.

          -  Diagnosis of POAG or OHT in both eyes.

          -  Qualifying corrected visual acuity in each eye.

          -  Qualifying central corneal thickness in each eye.

          -  Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost
             Run-in Period.

          -  Qualifying Anterior chamber angle.

          -  Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

        Exclusion Criteria:

          -  Patients who cannot safely discontinue use of Ocular Hypotensive Medications during
             Washout.

          -  Patients with prior exposure to DE-117.

          -  History of ocular surgery specifically intended to lower IOP

          -  Advanced glaucoma in either eye.

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             Goldmann applanation tonometry.

          -  Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1
             (Screening) and throughout the study in either eye.

          -  Females who are pregnant, nursing, or planning a pregnancy.
Early Treatment of Cytokine Storm Syndrome in Covid-19
Condition: Cytokine Storm; COVID-19
MeSH terms: COVID-19; Cytokine Release Syndrome
Intervention: Anakinra; Normal saline
Intervention description: The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days; The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel treatment arms
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Investigator, care provider, and participant blinded
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This proposal addresses the problem of preventing the very high mortality and morbidity
      associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory
      failure in Covid-19 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years old or older

          2. Molecular (pcRNA) diagnosis of SARS-CoV-2 infection

          3. Chest imaging studies consistent with Covid-19 pneumonia

          4. Hyperferritinemia (>700 ng/ml)

          5. History of fever >38 degrees C

          6. Any three of the following:

               1. Elevated d-dimer (> 500 ng/ml)

               2. thrombocytopenia (< 130,000/mm3)

               3. leucopenia (WBC <3500/mm3) or lymphopenia (<1000/mm3)

               4. elevated AST or ALT (> 2X ULN)

               5. elevated LDH (> 2X ULN)

               6. CRP > 100 mg/L

        Exclusion Criteria:

          1. Participation in other investigational treatment protocols for Covid-19 infection

          2. Culture confirmed active bacterial infection requiring antibiotic therapy

          3. On mechanical ventilation

          4. Previous known hypersensitivity reaction to anakinra

          5. Previous known hypersensitivity reaction to E Coli derived proteins

          6. Pregnant or breast-feeding females
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
Condition: Urologic Diseases; Hypospadias; Undescended Testes; Chordee; Hydrocele; Orchiectomy
MeSH terms: Hypospadias; Urologic Diseases; Cryptorchidism
Intervention: Exparel 133 miligrams per 10 milliliter injection; Bupivacaine Hydrochloride
Intervention description: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection; Local wound infiltration with 0.25% bupivacaine.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 104.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in
      improving pain scores and reducing narcotic pain requirements in pediatric patients following
      minor urologic procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric patients 6 years and older undergoing minor pediatric urologic surgery

          -  Patients who are otherwise eligible to receive routine care following minor urologic
             surgery

        Exclusion Criteria:

          -  Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal,
             hepatic dysfunction)

          -  Pediatric patients younger than 6 years of age

          -  Pediatric patients with a history of pain syndromes or are unable to tolerate opiate
             medication

          -  Unwilling to participate in 48 hours and 10-14 day follow-up phone calls
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: AXS-07
Intervention description: AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 706.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Axsome; AXS-07; MoSEIC™ meloxicam; rizatriptan

Summary:

      MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to
      evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect
      of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has participated in a prior study with AXS-07 for the treatment of migraine

        Exclusion Criteria:

          -  Has previously received any investigational drug or device or investigational therapy
             within 30 days before Screening, other than AXS-07

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Condition: Choroidal Neovascularization; Macular Edema; Glaucoma, Neovascular; Diabetic Retinopathy
MeSH terms: Macular Edema; Diabetic Retinopathy; Choroidal Neovascularization; Glaucoma, Neovascular; Neovascularization, Pathologic
Intervention: ranibizumab
Intervention description: One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare
      VEGF driven ocular diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active choroidal neovascularization (CNV)

          -  Active macular edema (ME)

          -  Rubeosis iridis/neovascular glaucoma.

          -  Proliferative diabetic retinopathy requiring vitrectomy.

        Exclusion Criteria:

          -  wet Age-related macular degeneration

          -  pathologic myopia

          -  pseudoxanthoma elasticum

          -  diabetic macular edema

          -  retinal vein occlusion

          -  < 18 years of age

          -  History of hypersensitivity to ranibizumab

          -  Use of any systemic anti-angiogenic drugs 3 months before inclusion

          -  Women of child-bearing potential and Pregnant or nursing (lactating) women.

          -  Active or suspected ocular infection