bioihbjkbjnl/mcl2 huggingface dataset:
A Gene Therapy Study for Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: SPK-9001
Intervention description: A novel, bioengineered adeno-associated viral vector carrying human factor IX variant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemophilia B; Blood Coagulation Disorders; Gene Therapy; Gene Transfer; Factor IX Deficiency; Factor IX Gene; Factor IX Protein; Vector; AAV

Summary:

      A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with
      Hemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent and comply with requirements of the study

          -  Males ≥18 y.o. with confirmed diagnosis of hemophilia B (≤2 IU/dL or ≤2% endogenous
             factor IX)

          -  Received ≥50 exposure days to factor IX products

          -  A minimum average of 4 bleeding events per year requiring episodic treatment of factor
             IX infusions or prophylactic factor IX infusions

          -  No measurable factor IX inhibitor as assessed by the central laboratory and have no
             prior history of inhibitors to factor IX protein

          -  Agree to use reliable barrier contraception until 3 consecutive samples are negative
             for vector sequences

        Exclusion Criteria:

          -  Evidence of active hepatitis B or C

          -  Currently on antiviral therapy for hepatitis B or C

          -  Have significant underlying liver disease

          -  Have serological evidence* of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 (* subjects who
             are HIV+ and stable with CD4 count >200/mm3 and undetectable viral load are eligible
             to enroll)

          -  Neutralizing antibodies reactive with AAV-Spark100 above and/or below a defined titre

          -  Participated in a gene transfer trial within the last 52 weeks or in a clinical trial
             with an investigational drug within the last 12 weeks

          -  Unable or unwilling to comply with study assessments
One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: abiraterone acetate with Methylprednisolone
Intervention description: YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Abiraterone Acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, single-arm, multi-center extension study to evaluate safety in
      patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid).
      Patients will have successfully completed an 84-day treatment with abiraterone acetate in a
      previous trial. Results from the final visit of the previous study will be used to determine
      patient's eligibility for this study. Patients in this study will be eligible to receive
      open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of
      serum testosterone and PSA levels will be monitored. Disease progression will be assessed by
      PCWG2 criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of 84 days of treatment with YONSA in Churchill Pharmaceuticals
             clinical trial, CHL-AA-201

          -  Last dose of YONSA or Zytiga within 45 days prior to treatment in this study

          -  Written informed consent obtained prior to any study-related procedure being performed

          -  Has in the investigator's opinion, the potential to gain clinical benefit with YONSA
             treatment

          -  Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50
             ng/dL at screening

          -  Life expectancy of at least 9 months at screening

          -  Subject is willing and able to comply with all protocol requirements assessments

          -  Agrees to protocol-defined use of effective contraception.

        Exclusion Criteria:

          -  Serious concurrent illness, including psychiatric illness, that would interfere with
             study participation

          -  Inability to swallow tablets whole

          -  Known hypersensitivity to YONSA, methylprednisolone, or any excipients in study
             medications

          -  Moderate to severe hepatic impairment (Child-Pugh Classes B and C)
Long-Term Assessment of Remyelinating Therapy
Condition: Acute Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Intervention: Placebo; BIIB033 100mg/Kg
Intervention description: Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: This was a follow-up study with no investigational product; however, the allocation method in RENEW Study (NCT01721161) was randomised-controlled and to maintain the blind from RENEW, the treatment disclosure for RENEW was not shared with study sites or participants until the end of this study.
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FF-VEP; mfVEP; Human anti-LINGO-1; BIIB033; AON

Summary:

      The primary objective of the study is to assess full-field visual evoked potential (FF-VEP)
      latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after
      the last study visit. The secondary objective is to assess clinical progression and severity
      of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study
      NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was
      administered in the previous study. The participants, investigator and outcome assessors
      remain blinded in this follow-up study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or
             placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2
             years from Week 32 or projected Week 32 visit, if the subject did not complete all
             visits in Study NCT01721161).

        Key Exclusion Criteria:

          -  Not previously enrolled in Study NCT01721161

          -  Subjects with recent kidney function, such as serum creatinine above upper limit of
             normal range, will not be allowed to receive administration of Gd but will otherwise
             be allowed to participate in the study, including magnetic resonance imaging (MRI)
             assessments not requiring the use of Gd.

          -  Female subjects must have had a recent pregnancy test and must not be breastfeeding
             prior to MRI assessments with Gd.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Disease Progression
Intervention: LY3202626; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 316.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: BACE inhibitor

Summary:

      The main purpose of this study is to evaluate the safety and the effect on brain tau of the
      study drug LY3202626 in participants with mild Alzheimer's disease (AD) dementia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with mild AD dementia based on the National Institute on Aging (NIA) and the
             Alzheimer's Association (AA) disease diagnostic criteria as determined by a qualified
             clinician approved by the Sponsor or designee.

          -  Mini-Mental State Examination score of 20 to 26 inclusive at screening visit.

          -  Has a florbetapir PET scan consistent with the presence of amyloid pathology at
             screening.

        Exclusion Criteria:

          -  Significant neurological disease affecting the central nervous system (CNS), other
             than AD, that may affect cognition or ability to complete the study, including but not
             limited to, other dementias, serious infection of the brain, Parkinson's disease,
             multiple concussions, or epilepsy or recurrent seizures (except febrile childhood
             seizures).

          -  Ocular pathology that significantly limits ability to reliably evaluate vision or the
             retina.

          -  Use of strong inducers of cytochrome P450 3A (CYP3A).

          -  Sensitivity to florbetapir or ¹⁸F-AV-1451.

          -  Contraindication to MRI or PET or poor venous access for blood draws.
Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Simvastatin; Placebo
Intervention description: 40 mg Simvastatin/day; Matching Placebo
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 40 Years
Maximum age: 72 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the research is to see how simvastatin affects a substance in the body called
      beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and
      spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting
      Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid
      in the spinal fluid. This study will also see if simvastatin affects memory and thinking,
      blood flow in the brain, and blood vessel function. The investigators hope that future
      studies show whether simvastatin might prevent memory loss and decrease the chance of
      developing Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent diagnosed with Alzheimer's disease

          -  Age 40-72

        Exclusion Criteria:

          -  Active liver disease

          -  History of adverse reaction to statins

          -  Contraindication to lumbar puncture

          -  Elevated creatine kinase and creatinine lab values

          -  Use of medications known to interact with statins

          -  History of dementia or mild cognitive impairment

          -  Currently pregnant or planning to become pregnant

          -  Use of large quantities of grapefruit juice (more than 1 quart per day)

          -  Contraindications to MRI (for MRI sub-study)

          -  Currently on cholesterol-lowering medication or use in past 4 months

          -  History of heart attack, heart problems, stroke and/or diabetes

          -  Drinking more than a quart of grapefruit juice per day

          -  Metal implants, or metal debris in body (MRI)

          -  List of medications that interact with simvastatin
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
Condition: Indolent Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Duvelisib
Intervention description: Phosphoinositide-3-kinase (PI3K) inhibitor
Phase: Phase 2
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: PI3K Inhibitor

Summary:

      This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a
      monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma
      [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab
      and to either chemotherapy or radioimmunotherapy (RIT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who had been diagnosed with iNHL that had progressed.

          -  Participants must have exhibited lack of CR or progressive disease (PR) or progression
             within 6 months after the last dose of a chemotherapy induction regimen or RIT.

          -  Participants must have had rituximab-refractory disease, defined as lack of CR or PR
             or PD within 6 months of last dose.

          -  Measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one
             dimension by computed tomography (CT), positron emission tomography/CT or magnetic
             resonance imaging.

          -  Adequate renal and hepatic function.

        Exclusion Criteria:

          -  Candidate for potentially curative therapies in the opinion of the investigator.

          -  Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor.

          -  Prior history of allogeneic hematopoietic stem cell transplant.

          -  Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents
             within 4 weeks before first dose of study drug.

          -  Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of
             lymphoma.

          -  Symptomatic central nervous system NHL.

          -  Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of
             study treatment.

          -  Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for
             hepatitis C virus antibodies, hepatitis B surface antigen, or hepatitis B core
             antibodies.

          -  History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
             requiring medication or mechanical control within the last 6 months prior to first
             dose of study drug.
Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine
Condition: Eastern Equine Encephalitis
MeSH terms: Encephalomyelitis, Equine; Encephalomyelitis, Eastern Equine; Encephalitis
Intervention: Inactivated, Dried, TSI-GSD 104, EEE
Intervention description: Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is < 1:40 after day 28. Up to four booster doses may be given in any 1-year period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: EEE

Summary:

      This study is designed to determine the safety and immunogenicity of Eastern Equine
      Encephalitis (EEE) Vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old.

          -  EEE PRNT80 ≤ 1:20.

          -  EEE PRNT80 ≤ 1:40 for booster series

          -  (females) Negative pregnancy test on the same day before vaccination.

          -  Not planning pregnancy for 3 months.

          -  At risk for exposure to virulent EEE virus (with up-to-date risk assessment).

          -  Up-to-date (within 1 year) physical examination/tests.

          -  Sign and date the approved informed consent.

          -  Willing to return for all follow-up visits.

          -  Agree to report adverse events (AE) up to 28 days after each vaccination.

        Exclusion Criteria:

          -  Over 65 years of age (for Primary Immunization).

          -  Clinically significant abnormal lab results including evidence of Hepatitis C,
             Hepatitis B carrier state, or elevated (2X normal) liver function tests.

          -  History of immunodeficiency or current treatment with immunosuppressive medication.

          -  (females) Currently breastfeeding.

          -  Confirmed human immunodeficiency virus (HIV) titer.

          -  Any known allergies to components of the vaccine.

          -  A medical condition that, in the judgment of the Principal Investigator (PI), would
             impact subject safety (i.e.-vaccination or exposure to another Alphavirus).

          -  Administration of any IND product or live vaccine within 28 days of EEE.

          -  Any unresolved AEs resulting from a previous immunization.
Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: oral delivery mucosal stain
Intervention description: 200mg methylene blue MMX tablet taken prior to colonoscopy
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluation of the intraepithelial neoplasia detection rate in patients with long standing
      ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to
      colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  endoscopically verified UC signed written informed consent

        Exclusion Criteria:

          -  Known or suspected GI obstruction or perforation Liver or renal impairment,
             malignancy, pregnancy or lactation, suppressed PT.
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: AbobotulinumtoxinA dose level 1 or 2; placebo; AbobotulinumtoxinA dose 3; AbobotulinumtoxinA dose 4
Intervention description: Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA
      treatment for glabellar lines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe glabellar lines at maximum frown as assessed by the Investigator
             using a photographic scale

          -  Moderate to severe glabellar lines at maximum frown as assessed by the subject using a
             static categorical scale

        Exclusion Criteria:

          -  Botulinum toxin treatment in the face within 9 months prior to study treatment
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Mirikizumab; Placebo
Intervention MeSH terms: Mirikizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: inflammatory bowel disease; IL-23; biologic

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of the study drug
      Mirikizumab in participants with active Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported
             stool frequency and abdominal pain.

          -  Inadequate response or failure to tolerate at least one of the following:
             aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg,
             azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for
             the treatment of CD.

        Exclusion Criteria:

          -  Have complications of CD such as strictures, stenoses, or any other manifestation for
             which surgery might be indicated, or that could confound the evaluation of efficacy.

          -  Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis,
             indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous
             colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.

          -  Have had any kind of bowel resection, diversion, or placement of a stoma within 6
             months or any other intra-abdominal surgery within 3 months prior to screening.

          -  Are unsuitable for inclusion in the study in the opinion of the investigator or
             sponsor for any reason that may compromise the subject's safety or confound data
             interpretation.