bioihbjkbjnl/mcl2 huggingface dataset:
Leukemia Stem Cell Detection in Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia (AML)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Allogeneic HCT; Consolidation chemotherapy
Intervention description: Allogeneic HCT; Cytarabine-based consolidation chemotherapy
Intervention MeSH terms: Cytarabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following
      induction chemotherapy. However, a large majority subsequently relapse and succumb to the
      disease. Currently, cytogenetics and molecular aberrations are the best prognostic
      indicators; however, these factors cannot prognosticate accurately for individual patients.
      Overall, the majority of patients with favorable or intermediate-risk AML will experience
      relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less
      than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably
      translate into cure. This study is undertaken to determine whether the presence of LSCs has
      prognostic value as well as to determine whether the presence of LSCs has predictive value.
      This study has an observational component, whereby we intent evaluate whether the presence or
      absence of LSCs is prognostic. This study also has an interventional component in which it
      uses LSC status to determine whether favorable and intermediate risk AML patients in CR
      receive consolidation with chemotherapy or allogeneic HCT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must have previously signed the specimen procurement protocol consent associated with
             the leukemia stem cell assay ("Step 1 informed consent") prior to starting AML
             therapy.

          2. Age 18 years and older

          3. New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy and
             reviewed by an institutional hematopathologist

          4. Completion of induction therapy, as defined by the Investigator and post-induction
             bone marrow biopsy.

        Exclusion Criteria:

          1. Any debilitating medical or psychiatric illness that would preclude ability to follow
             study procedures.

          2. Indeterminate leukemia stem cell assay results at diagnosis.
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Omiganan
Intervention description: Topical gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the long-term safety of once-daily application of Omiganan topical gel
      in subjects with severe papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, male and nonpregnant female subjects, 18 years of age or older.

          2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment
             grading scale at baseline

          3. Subjects with the presence of telangiectasia at Baseline

          4. Subjects with the presence of facial erythema associated with their rosacea at
             Baseline

        Exclusion Criteria:

          1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

          2. Subjects with nodular rosacea

          3. Standard exclusion criteria.
A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ankylosing; nonradiographic spondyloarthritis

Summary:

      The main purpose of this study is to evaluate the safety and efficacy of the study drug known
      as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants
      with nonradiographic axial spondyloarthritis (nonrad-axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are ambulatory.

          -  Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the
             2009 Assessment of Spondyloarthritis International Society (ASAS) classification
             criteria.

          -  Have a history of back pain ≥3 months with age at onset <45 years.

          -  Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating
             scale (NRS) at screening and baseline.

          -  Have objective signs of inflammation by presence of sacroiliitis on MRI and/or
             presence of elevated C-reactive protein (CRP).

          -  In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory
             drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.

          -  If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.

          -  Have a history of prior therapy for axSpA for at least 12 weeks prior to screening.

        Exclusion Criteria:

          -  Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria.

          -  Have received any prior, or are currently receiving treatment with biologics, tumor
             necrosis factor inhibitors or other immunomodulatory agents.

          -  Have received a live vaccine within 12 weeks or have had a vaccination with Bacillus
             Calmette-Guerin (BCG) within the past year.

          -  Have an ongoing or serious infection within the last 12 weeks or evidence of active
             tuberculosis.

          -  Have a compromised immune system.

          -  Have any other serious and/or uncontrolled diseases.

          -  Have either a current diagnosis or a recent history of malignant disease.

          -  Have had major surgery within 8 weeks of baseline, or will require surgery during the
             study.

          -  Are pregnant or breastfeeding.

          -  Have evidence of active anterior uveitis (an acute episode) within the last 42 days
             prior to baseline randomization.
Short Course Vaginal Cuff Brachytherapy in Treating Patients With Stage I-II Endometrial Cancer
Condition: Endometrial Clear Cell Adenocarcinoma; Endometrial Endometrioid Adenocarcinoma; Endometrial Serous Adenocarcinoma; Stage I Uterine Corpus Cancer; Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Uterine Corpus Carcinosarcoma; Uterine Corpus Sarcoma
MeSH terms: Adenocarcinoma; Endometrial Neoplasms; Cystadenocarcinoma, Serous; Carcinoma, Endometrioid; Carcinosarcoma; Adenocarcinoma, Clear Cell
Intervention: Vaginal Cuff Brachytherapy; Short course vaginal cuff brachytherapy
Intervention description: Undergo standard of care vaginal cuff brachytherapy; Undergo short course vaginal cuff brachytherapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Healthy volunteers: No

Summary:

      This randomized phase III trial studies short course vaginal cuff brachytherapy to see how
      well it works compared with standard of care vaginal cuff brachytherapy in treating patients
      with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as
      internal radiation therapy, uses (over a shorter period) radioactive material placed directly
      into or near a tumor in the upper portion of the vagina to kill tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear
             cell, to include tumors originating in the cervix, but are primarily located in the
             uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other
             sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I, with
             one of the following combinations of stage and grade:

               -  Stage IA, grade 2, 3

               -  Stage IB, grades 1-3

               -  Stage II, grades 1-3

          -  Patients post hysterectomy and free from residual disease

          -  World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance
             status 0-2

          -  Able to provide informed consent and willing to sign an approved consent form that
             conforms to federal and institutional guidelines

          -  Life expectancy of >2 years.

        Exclusion Criteria:

          -  Stages of endometrial carcinoma other than described

          -  Previous pelvic radiotherapy

          -  Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Condition: Cytomegalovirus (CMV)-Positive Recipients; Allogeneic, Hematopoietic Cell Transplant (HCT)
MeSH terms: Cytomegalovirus Infections
Intervention: ASP0113; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASP0113; Cytomegalovirus (CMV); Hematopoietic Cell Transplant (HCT)

Summary:

      The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as
      measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD)
      through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT
      will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a CMV-seropositive HCT recipient

          -  Participant is planned to undergo either of the following:

               -  Sibling Donor Transplant

               -  Unrelated Donor Transplant

          -  Participant has one of the following underlying diseases:

               -  Acute myeloid leukemia (AML)

               -  Acute lymphoblastic leukemia (ALL)

               -  Acute undifferentiated leukemia (AUL)

               -  Acute biphenotypic leukemia

               -  Chronic myelogenous leukemia (CML)

               -  Chronic lymphocytic leukemia (CLL).

               -  A defined myelodysplastic syndrome(s) (MDS)

               -  Primary or secondary myelofibrosis

               -  Lymphoma (including Hodgkin's)

        Exclusion Criteria:

          -  Participant has active CMV disease or infection or has received treatment for active
             CMV disease or infection within 3 months (90 days) prior to transplant

          -  Participant has a modified hematopoietic cell transplant comorbidity index (HCT-CI)
             score ≥ 4

          -  Participant has received a prior HCT and has residual Chronic Graft-versus-host
             Disease (cGVHD)

          -  Participant who is scheduled to have a cord blood transplant or a haploidentical
             transplant

          -  Participant has a platelet count of less than 50,000 mm3 within 3 days prior to
             randomization (platelet transfusions are allowed)

          -  Participant has aplastic anemia or multiple myeloma
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Condition: Chorea, Huntington
MeSH terms: Huntington Disease; Chorea
Intervention: Valbenazine; Placebo
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Huntington's; Huntington; Chorea; Movement disorder; Valbenazine; HD; Tetrabenazine; VMAT2-Inhibitor

Summary:

      This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the
      efficacy, safety, and tolerability of valbenazine to treat chorea in participants with
      Huntington disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a clinical diagnosis of Huntington Disease (HD) with chorea

          2. Be able to walk, with or without the assistance of a person or device

          3. Participants of childbearing potential who do not practice total abstinence must agree
             to use hormonal or two forms of nonhormonal contraception (dual contraception)
             consistently while participating in the study until 30 days (females) or 90 days
             (males) after the last dose of the study drug

          4. Be able to read and understand English

        Exclusion Criteria:

          1. Have a history of previously established therapy with a VMAT2 inhibitor, in the
             judgement of the investigator

          2. Have difficulty swallowing

          3. Are currently pregnant or breastfeeding

          4. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch
             block, atrioventricular block, uncontrolled bradyarrhythmia, or heart failure

          5. Have an unstable or serious medical or psychiatric illness

          6. Have a significant risk of suicidal behavior

          7. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1
             year of screening

          8. If taking antidepressant therapy, be on a stable regimen

          9. Have received gene therapy at any time

         10. Have received an investigational drug in a clinical study within 30 days of the
             baseline visit or plan to use such investigational drug (other than valbenazine)
             during the study

         11. Have had a blood loss ≥550 milliliters (mL) or donated blood within 30 days before the
             baseline visit

         12. Had a medically significant illness within 30 days before baseline, or any history of
             neuroleptic malignant syndrome
Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
Condition: Dyslipidemia
MeSH terms: Cardiovascular Diseases; Dyslipidemias
Intervention: Evolocumab
Intervention description: Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 1600.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label extension (OLE) study designed to assess the extended
      long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study
      20110118). Approximately 1600 subjects will be enrolled in this study. This study will
      continue for 260 weeks (approximately 5 years).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent prior to initiation of any study-specific
             activities/procedures.

          -  Subject had completed FOURIER (Study 20110118) while still receiving assigned
             Investigational Product.

        Exclusion Criteria:

          -  Permanent discontinuation of Investigational Product during FOURIER for any reason
             including an adverse event or serious adverse event.

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 4 weeks since ending treatment on another investigational device or drug
             study(ies). Other investigational procedures while participating in this study are
             excluded.

          -  Subject likely to not be available to complete all protocol-required study visits or
             procedures, and/or to comply with all required study procedures to the best of the
             subject and investigator's knowledge.

          -  History or evidence of any other clinically significant disorder, condition or disease
             that, in the opinion of the investigator or Amgen physician, if consulted, would pose
             a risk to subject safety or interfere with the study evaluation, procedures or
             completion.

          -  Subject has known sensitivity to any of the active substances or excipients (eg,
             sodium acetate) to be administered during dosing.

          -  Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed
             during treatment with evolocumab and for an additional 15 weeks after treatment with
             evolocumab discontinues.

          -  Female subjects of childbearing potential unwilling to use an acceptable method of
             effective contraception during treatment and for an additional 15 weeks after the last
             dose of protocol-required therapies.
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
Condition: Anogenital Human Papilloma Virus Infection; Condyloma Acuminata
MeSH terms: Papillomavirus Infections; Papilloma
Intervention: V501; Placebo
Intervention description: Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant; Formulated with AAHS adjuvant
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1124.0
Sex: Male
Minimum age: 16 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus
      [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to
      26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence
      of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501
      reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection,
      condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal,
      or perineal cancer compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese

          -  No clinical evidence of gross genital lesion suggesting sexually-transmitted disease
             and no clinically present external genital warts

          -  Other inclusion criteria will be discussed with the investigator during screening

        Exclusion Criteria:

          -  History of known prior vaccination with an HPV vaccine or plans to receive one outside
             the study

          -  History of external genital warts

          -  History of severe allergic reaction that required medical intervention

          -  Received immune globulin or blood-derived products in the past 6 months or plan to
             receive any before Month 7 of the study

          -  History of splenectomy, is currently immunocompromised, or has been diagnosed with
             immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic
             lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory
             bowel disease, or other autoimmune condition

          -  Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or
             topical corticosteroids and certain regimens of systemic corticosteroids

          -  Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular
             injections

          -  Ongoing alcohol or drug abuse within the past 12 months
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
Condition: Exertional Heat Stroke
MeSH terms: Heat Stroke; Sunstroke
Intervention: Ryanodex and Standard of Care; Standard of Care
Intervention description: Ryanodex to be administered as a rapid IV push; Body cooling measures and supportive measures
Intervention MeSH terms: Dantrolene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ryanodex (dantrolene sodium) for injectable suspension plus Standard of Care
Masking: Double (Participant, Care Provider)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat
      stroke (EHS) compared to current Standard of Care (SOC) for EHS.
    

Eligibility criteria:

        Inclusion Criteria: Core body temperature of greater than or equal to 40.0 degrees C (104
        degrees F); recent history of exertional activity; GCS score less than 13; tachycardia -

        Exclusion Criteria: clinical severe infection; hyperthermia secondary to another condition;
        endotracheal intubation;; sedative drugs administered prior to or at time of study entry;
        likelihood of head trauma within 6 months pre-study; positive pregnancy test; history of
        myocardial infection within 30 days; history of seizure disorder or epilepsy; concomitant
        or prior use of calcium channel blockers.

        -