bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
Condition: HCMV Reactivation or HCMV End-Organ Disease
Intervention: 60 mg AIC246; 120 mg AIC246; 240 mg AIC246; Placebo
Intervention description: Oral administration; Oral administration; Oral administration; Oral administration
Intervention MeSH terms: Letermovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCMV

Summary:

      The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the
      chances of the cytomegalovirus becoming active again and causing illness after an HBPC
      transplant (allogeneic stem cell transplant).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seropositive for HCMV IgG antibodies before transplantation

          -  First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of
             the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's
             lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder

          -  Evidence of post transplantation engraftment

          -  Able to swallow tablets.

        Exclusion Criteria:

          -  Previous anti-HCMV therapy after this allogeneic HBPC transplantation

          -  Mismatched or cord blood transplant recipients

          -  Current or history of end-organ HCMV disease

          -  Graft versus host disease (GVHD)

          -  Impaired liver function

          -  Reduced renal function
Dexamethasone Solution for the Treatment of Oral Lichen Planus
Condition: Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Intervention: Dexamethasone
Intervention description: Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral lichen planus; Dexamethasone solution

Summary:

      The objective of this single center, 4-week, open label randomized, phase II study is to
      evaluate and characterize the tolerability and clinical effectiveness of dexamethasone
      0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen
      planus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and older.

          -  Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the
             last week).

        Exclusion Criteria:

          -  Patients already on topical or systemic steroids.

          -  Inability to comply with study instructions.

          -  Uncontrolled intercurrent illness or psychiatric illness/social situations that would
             limit compliance with study requirements.

          -  VAS sensitivity score < 7.
Blood Pressure After Endovascular Stroke Therapy-II
Condition: Acute Stroke; Endovascular Thrombectomy
MeSH terms: Stroke
Intervention: Nicardipine; Labetalol; Hydralazine
Intervention description: In the event where SBP values are above the randomly assigned target, intravenous nicardipine will be initiated at 2.5 mg/hr to lower the SBP. If SBP is still not reduced to below assigned target after 15 minutes, nicardipine dose will be increased by 2.5 mg/hr every 15 minutes until the target SBP or a maximum dose of 15 mg/hr is reached.; If SBP is above target despite maximum nicardipine infusion for 30 minutes, 10-20 mg of intravenous labetalol will be added every 15 minutes.; If SBP remains unresponsive for 1 hr despite the use of maximum doses of nicardipine and labetalol, a Hydralazine will be added at the treating physician's discretion. Incidence of the latter scenario is anticipated to be exceedingly rare.
Intervention MeSH terms: Labetalol; Hydralazine; Nicardipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blood Pressure Control

Summary:

      The purpose of this study is to assess the safety of lowering blood pressure in acute stroke
      patients that are successfully treated with a mechanical thrombectomy procedure. The
      investogators will evaluate the hypothesis that lower blood pressure management strategies do
      not result in larger volume of stroke or worse 3-month clinical outcome in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (≥18 years)

          -  Undergoing successful EVT (defined as modified Thrombolysis in Cerebral Ischemia
             Score, mTICI, ≥2b) for an occlusion in the anterior cerebral circulation large vessel
             (internal carotid artery and M1 or M2 segments of the middle cerebral artery).

          -  Intervention will be initiated only for those with a successful recanalization
             (modified Thrombolysis in Cerebral Ischemia Score ≥ 2b).

          -  Undergoing a baseline CT or MR perfusion study

          -  Those with unsuccessful recanalization (mTICI 0-2a) will be not intervened upon.

        Exclusion Criteria:

          -  Known heart failure with ejection fraction <30%

          -  Presence of a left ventricular assist device

          -  Patients undergoing extracorporeal membrane oxygenation

          -  Pregnancy

          -  Enrollment in any other clinical trial
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis
Condition: Nasal Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Nasal Polyps
Intervention: AK001 low dose; AK001 high dose; Placebo
Intervention description: 25 mg AK001 will be administered as multiple doses; 250 mg AK001 will be administered as multiple doses; Placebo will be administered as multiple doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses.
      Pharmacodynamic activity will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in
             each nostril according to the polyp grading scale

          -  History of sinusitis symptoms

          -  SNOT-22 ≥30

          -  No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or
             urinalysis findings

        Exclusion Criteria:

          -  Use of systemic corticosteroids within 6 weeks of screening

          -  Chronic use of antibiotic therapy within 3 months prior to Screening

          -  Nasal surgery (including polypectomy) within 6 months prior to Screening

          -  Use of investigational drugs or participation in another clinical trial within 30 days
             prior to Screening or 5 half-lives, whichever is longer
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenABCWY; Placebo; MenACWY
Intervention description: Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.; 0.5 mL saline solution (IM); Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 305.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis ABCWY; Adolescents; Vaccination; Meningococcal disease

Summary:

      Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single
      dose of MenACWY vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescents from 10-18 years of age, generally in good health, and available for all
             study visits, who/whose legally acceptable representative has given written informed
             consent at the time of enrollment.

          -  Female subjects of childbearing potential must have a negative urine pregnancy test.

        Exclusion Criteria:

          -  Serious, acute, or chronic illnesses. Previous or suspected disease caused by N.
             meningitidis. Previous immunization with any meningococcal vaccine.

          -  Exposure to individuals with clinically proven meningococcal disease or clinical
             bacterial meningitis without further microbiologic characterization.
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Calcitriol 3mcg/g
Intervention description: Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.
Intervention MeSH terms: Calcitriol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Calcitriol; Psoriasis; PK; Adolescents

Summary:

      This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the
      adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied
      twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous
      areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will
      be collected during the first 3 weeks of the study; safety and efficacy data will be
      collected for the 8 weeks of the treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic plaque psoriasis

          -  10 - 35% BSA of involved skin

          -  Age 12 - 17

        Exclusion Criteria:

          -  Other type of psoriasis (other than plaque)

          -  Significant abnormal lab findings

          -  Vit D insufficiency
Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: bromfenac ophthalmic solution 0.06%
Intervention description: bromfenac ophthalmic solution 0.06% bilaterally twice a day
Intervention MeSH terms: Bromfenac; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution
      in dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 years of age or older

        Exclusion Criteria:

          -  No active ocular conditions of disease
Control of Major Bleeding After Trauma Study
Condition: Trauma; Hemorrhagic Shock
MeSH terms: Shock, Hemorrhagic
Intervention: Type AB plasma; Crystalloid fluid (standard of care for resuscitation)
Intervention description: The plasma is thawed and administered to subjects in the experimental (plasma) arm.; Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coagulopathy; hemorrhagic shock; plasma; blood product transfusion

Summary:

      Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely
      injured trauma patients are found to be coagulopathic and forty percent of the mortality
      following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy.
      It has been established that early administration of fresh frozen plasma decreases mortality
      following severe injury, replacing lost coagulation factors, improving the coagulopathy and
      restoring blood volume. This study will determine if giving plasma to severely injured trauma
      patients during ambulance transport versus after arrival to the hospital will help reduce
      hemorrhage, thus decreasing both total blood product administration and mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age>=18 years

          -  Acutely injured

          -  SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute.

        Exclusion Criteria:

          -  Visibly or verbally reported pregnant women

          -  known prisoners

          -  unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to
             randomization)

          -  known objection to blood products

          -  the patient has an opt-out bracelet or, necklace or wallet card

          -  a family member present at the scene objects to the patient's enrollment in research.
Erenumab For Treatment of Hemicrania Continua
Condition: Hemicrania Continua
MeSH terms: Anencephaly; Headache
Intervention: Erenumab
Intervention description: 140 mg of erenumab via subcutaneous injection
Intervention MeSH terms: Erenumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: No

Summary:

      This research is being conducting to learn if the study drug erenumab is successful in
      treating hemicrania continua. The study is also evaluating the safety and tolerability of
      erenumab in individuals being treated for hemicrania continua.
    

Eligibility criteria:

        Inclusion Criteria

          -  Adults over the age of 18-66

          -  At least a 12 month history of hemicrania continua (unremitting subtype) according to
             International Classification of Headache Disorders, 3rd Edition (ICHD-3)1

          -  Previous or current complete response to indomethacin

          -  Stable preventive treatment for at least 2 months and no anticipated need to
             adjust/add current headache prevention treatment

        Exclusion Criteria

          -  Nonresponse to a therapeutic dose of indomethacin for hemicrania continua when used
             for at least 1 week

          -  Pregnant or lactating subjects

          -  Use of barbiturate or opioid >6 days per month; history of chronic migraine

          -  History of previous trigeminal-autonomic cephalalgia

          -  History within previous 2 months of interventional procedure for headache (occipital
             or other extracranial nerve block, sphenopalatine ganglion block, cervical facet
             block, facet rhizotomy)

          -  History of cranial nerve/rhizolysis

          -  Botulinumtoxin injection with previous 4 months

          -  Parenteral infusion of or oral corticosteroid use for more than 3 days within 4 weeks
             prior to screening phase
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Condition: Diabetic Kidney Disease (DKD)
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: CSL346; Placebo
Intervention description: VEGF-B antagonist monoclonal antibody; Normal saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No

Summary:

      This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy,
      safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with
      diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ≥ 25 years of age with a diagnosis of type 2 diabetes
             mellitus (T2DM)

          -  Urinary ACR ≥ 150 mg/g

          -  eGFR > 20 mL/min/1.73m2

          -  Glycosylated HbA1c < 12%

        Exclusion Criteria:

          -  Current diagnosis of type 1 diabetes mellitus

          -  History of acute kidney injury or chronic dialysis/renal transplant

          -  Uncontrolled hypertension or class III / IV heart failure

          -  Left ventricular ejection fraction < 50% by echocardiogram

          -  Troponin-I > the upper reference limit

          -  b-type natriuretic peptide > 200 pg/mL

          -  ALT > 2x the upper limit of normal
An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread
Condition: Cancer
Intervention: Nivolumab
Intervention description: Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether nivolumab is an effective treatment for
      cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with advanced or metastatic malignancy

          -  Received standard of care treatment for primary malignancy and standard of care
             treatment for relapsed cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody,
             or any other antibody or drug specifically targeting Tcell co-stimulation or
             checkpoint pathways.

          -  Subjects previously treated with investigational anticancer therapies less than 6
             weeks prior to the first dose of Nivolumab

          -  Subjects with an active, known, or suspected autoimmune disease

        Other protocol-defined inclusion/exclusion criteria apply
Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: BeneFIX
Intervention description: BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Factor IX (FIX)

Summary:

      The goal of this non-randomized, multi-center study in subjects with severe hereditary
      haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX
      in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participated in the previous study "Efficacy and safety of factor IX (FIX) contained
             in Alphananine in patients with severe hereditary haemophilia B":

          -  Congenital deficiency in Factor IX (FIX)

          -  FIX residual activity of ≤2% of normal

          -  Had required FIX-containing products in the past and in clinical records that were
             collected data to assess a reliable estimation of at least 150 treatment exposure days
             to previous products

          -  Was able to receive treatment for more than 10 days for a 6-month period

        Key Exclusion Criteria:

          -  Received a dose of FIX in the 7 days prior to the infusion

          -  FIX inhibitor level of >0.5 Bethesda units (BU) or clinically relevant presence in the
             past (≥5 BU)

          -  Active bleeding at the moment of infusion

          -  Had a known allergic reaction to any BeneFIX component

          -  Exhibited symptoms of any intercurrent infection (ie, fever, chills, nausea) at the
             time of the first infusion

          -  Had any disease that might affect the distribution or metabolism of FIX and which
             could affect interpretation of the study (such as non-controlled diabetes mellitus)

          -  Had non-controlled arterial hypertension

          -  Had abnormal renal function (creatinine >1.5 mg/dL)

          -  Had documented liver cirrhosis or any hepatic disorder with alanine aminotransferase
             (ALT) levels 2.5x upper limit of normal (ULN )

          -  Prevision to be concomitantly treated with other FIX-containing products

          -  Had conditions that might affect subject compliance (survival-limiting [in 2 year
             time] diseases, alcohol or other drug abuse, etc.)

          -  Unable to provide a storage plasma sample before the first dose of BeneFIX
Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: BI 695501 Autoinjector; BI 695501 Prefilled syringe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is an open-label, phase II study of BI 695501 to assess handling experience of patients
      with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients
      with additional exposure to BI 695501 and to enhance the safety database for this compound.
    

Eligibility criteria:

        Inclusion criteria:

          -  Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which
             is not adequately controlled by non-biologics DMARDs.

          -  No contraindications to anti-Tumor necrosis factor (TNF) agents.

          -  Either biologics naive or biologics-experienced but with no experience of
             self-administration medication using autoinjector or pen.

          -  Patients must be able and willing to self-inject BI 695501. Further inclusion criteria
             apply.

        Exclusion criteria:

          -  Experience with self-administration of medication using an autoinjector or pen.

          -  American College of Rheumatology functional Class IV or wheelchair/ bed bound.

          -  Primary or secondary immunodeficiency.

          -  History of tuberculosis (TB). Further exclusion criteria apply.