bioihbjkbjnl/mcl2 huggingface dataset:
Contrast-enhanced Ultrasound Evaluation of Chemoembolization
Condition: Hepatocellular Carcinoma; Chemoembolization, Therapeutic
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Ultrasound contrast agent (Contrast-enhanced ultrasound); Logiq E9 Scanner (Contrast-enhanced ultrasound)
Intervention description: Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand.; Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to evaluate the sensitivity and specificity of 2D and
      4D contrast enhanced ultrasound for monitoring transarterial chemoembolization (TACE)
      response 1-2 weeks and 1 month post treatment as an alternative to contrast-enhanced magnetic
      resonance (MRI) or computed tomography (CT) imaging
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients >= 21 years of age

          -  Patient capable of making informed decisions regarding his/her treatment

          -  Scheduled for TACE treatment of a HCC mass (lesions reported as Liver Imaging
             Reporting and Data Systems 4B or 5 or Organ Procurement and Transplantation Network 5a
             or 5b)

          -  Negative pregnancy test in a female of child-bearing age.

          -  Have an HCC mass viewable on grayscale B-mode ultrasound.

        Exclusion Criteria:

          -  Females who are pregnant or nursing.

          -  Patients not eligible or scheduled for TACE of a HCC mass.

          -  Patients who have received an investigational drug in the 30 days before study drug
             administration, or will receive one within 72 h after their final CEUS exam.

          -  Patients who have received prior radioembolization (Y90) of the lesion of interest.

          -  Patients with known or suspected cardiac shunts.

          -  Patients with pulmonary hypertension or unstable cardiopulmonary conditions.

          -  Patients who are medically unstable, patients who are seriously or terminally ill, and
             patients whose clinical course is unpredictable. For example:

          -  Patients with unstable occlusive disease (e.g., crescendo angina)

          -  Patients with clinically unstable cardiac arrhythmias

          -  Patients with uncontrolled congestive heart failure (NYHA Class IV)
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Intervention: Vehicle; WC3011 Estradiol Vaginal Cream
Intervention description: Vehicle Cream applied to the vagina daily for 2 weeks followed by dosing 2 times a week for 10 weeks; WC3011 estradiol vaginal cream applied daily for 2 weeks followed by dosing 2 times a week for 10 weeks
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 576.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: vaginal dryness; vaginal atrophy; estrogen

Summary:

      The primary objective of this study is to compare the efficacy of WC3011 with placebo vaginal
      gel in postmenopausal women for the relief of vaginal dryness caused by vaginal atrophy as
      measured by self-assessment, vaginal pH and vaginal smear.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Moderate to severe vaginal dryness

          -  Postmenopausal meeting one of the following: 12 months spontaneous amenorrhea, 6
             months spontaneous amenorrhea with serum Follicle-stimulating hormone (FSH) > 40
             milli-International Unit (mIU)/mL, 6 weeks postsurgical bilateral oophorectomy
             confirmed by surgical report, ultrasound or serum FSH > 40 mIU/mL, 6 weeks
             postsurgical hysterectomy with ovary failure confirmed by serum FSH > 40 mIU/mL

          -  Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years

          -  Vaginal pH >5.0

          -  Less than or equal 5% superficial cells on vaginal wall cytologic smear

          -  Normal breast exam; if > 40 years, documentation of negative mammogram

        Exclusion Criteria:

          -  Randomization in PR-04409, participation in clinical trial or use of investigational
             drug within 30 days prior to screening

          -  Smokes ≥ 15 cigarettes/day

          -  Known or suspected premalignant or malignant disease

          -  Cardiovascular disease, insulin-dependent diabetes mellitus, congestive heart failure,
             stroke or ischemic attack, thrombophlebitis or thromboembolic disorder

          -  Increased frequency/severity headaches with estrogen therapy

          -  Drug addiction/alcohol abuse within last 2 years

          -  Currently taking St. John's Wort or anticoagulant

          -  Uncontrolled hypertension or thyroid disorder, clinically significant depression or
             untreated urinary tract infection
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
Condition: Knee Injury
MeSH terms: Knee Injuries
Intervention: CR Plug
Intervention description: CR Plug will be placed in the harvest site
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Cartilage injury; OATS; Knee injury; allograft; autograft

Summary:

      The main objective of this study is to test the ability of an allograft plug to provide a
      successful repair of an osteochondral defect left at the harvest site during OATS procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female at least 18 years of age and up to 55 years of age

          -  Must be skeletally mature

          -  Have a grade III or IV lesion in femoral condyle

        Exclusion Criteria:

          -  Skeletally immature

          -  Osteoarthritic knees, osteonecrotic knees, osteophyte formation

          -  Use of any investigational therapy within thirty (30) days prior to the first visit
Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: flortaucipir F18; Brain PET Scan
Intervention description: No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) at baseline will be read by independent, blinded readers. IV injection, 240 megabecquerel (MBq) (6.5 mCi), single dose in AZES; positron emission tomography (PET) scan of the brain
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Physician PET scan readers are participants, blinded to demographic and clinical data from the source PET scans.
Masking: None (Open Label)
Masking description: PET scans were obtained in an open-label fashion.
Enrollment: 205.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will evaluate whether visual interpretation of flortaucipir-PET (positron emission
      tomography) scans, examining patterns of tracer uptake at baseline, can predict the rate of
      clinically-meaningful cognitive decline due to AD after 18 months. All scans are acquired
      from cohorts of a previously completed study, I8D-MC-AZES (NCT02245737, lanabecestat, Eli
      Lilly and Company sponsor).
    

Eligibility criteria:

        Scan Reader Criteria (5 total readers):

          -  Board-certified in radiology or nuclear medicine

          -  Professional experience interpreting PET scans

        Scan Criteria (205 total scans):

          -  Former enrollment in AZES Study

          -  Flortaucipir scan at baseline

          -  clinical dementia rating - sum of boxes (CDR-SB) assessment at 18 months

        Scan Study Population (AZES Study):

          -  55 to 85 years

          -  MCI due to AD or probable AD by National Institute on Aging-Alzheimer's Association
             criteria (Albert 2011

          -  mini-mental status exam (MMSE) of 20 to 30 inclusive

          -  CDR global score of 0.5 (MCI), or 0.5 or 1 (AD) with a memory box score ≥ 0.5, and a
             score of ≤85 on the Delayed Memory Index of the Repeatable Battery for the Assessment
             of Neuropsychological Status.

          -  Amyloid positive status confirmed by florbetapir PET or lumbar puncture
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 24 mcg administered orally BID; 24 mcg administered orally BID
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 552.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule
      formulations of lubiprostone, as compared to placebo, when administered orally in
      participants with Chronic Idiopathic Constipation (CIC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or
             meets the diagnosis as confirmed using the Rome III constipation module questionnaire
             during the Screening period.

          -  Is male or female, 18 or older years of age

          -  Should be on stable dose of fiber supplement or a concomitant medication for the
             indication of lowering blood pressure

        Exclusion Criteria:

          -  Has any gastrointestinal (GI) condition, other than constipation, affecting GI
             motility or defecation

          -  Is unable to eat or drink, take oral medications, or to hold down oral medications due
             to vomiting
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes
Intervention: Glasdegib; Azacitidine
Intervention description: 25 mg or 100 mg tablet; 100 mg/vial powder for 25 mg/mL suspension for injection
Intervention MeSH terms: Azacitidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label study available to all eligible participants from Study B1371019 and
      participants originating from Study B1371012 continuing on study intervention with
      azacitidine with or without glasdegib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any participant who continues to demonstrate clinical benefit (as determined by the
             Principal Investigator) from study treatment with azacitidine with or without
             glasdegib in this Study or from Study B1371012.

          -  Capable of giving signed informed consent as described in Appendix 1, which includes
             compliance with the requirements and restrictions listed in the ICD and in this
             protocol.

        Exclusion Criteria:

          -  Other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk
             of study participation or, in the investigator's judgment, make the participant
             inappropriate for the study.

          -  Female participants who are pregnant or breastfeeding (if continuing to receive study
             intervention);

          -  Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason
             (including INT cohort participants required to end study treatment)
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: icatibant
Intervention description: Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg
Intervention MeSH terms: Icatibant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Efficacy; Hereditary angioedema; HAE; Pediatric; Children; Pharmacokinetics; Safety; Firazyr; icatibant

Summary:

      HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the
      Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single
      subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with
      Hereditary Angioedema (HAE) during an initial acute attack.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Two through <18 years of age at the time of first HAE attack.

               -  Prepubertal and pubertal/postpubertal subjects experiencing and acute cutaneous,
                  abdominal, or laryngeal HAE attack treated with icatibant as part of this study.

               -  Pubertal/postpubertal subjects with HAE who are treated with icatibant, but not
                  during an attack.

          2. Documented diagnosis of HAE Type I or II.

          3. Informed consent (and subject assent as appropriate) signed by the subject's
             parent(s)or legal guardian(s).

        Exclusion Criteria:

          1. Diagnosis of angioedema other than HAE.

          2. Participation in another clinical trial that involves the use of any investigational
             product (drug or device)within 30 days prior to study enrollment or at any time during
             the study.

          3. Any known factor/disease that might interfere with the treatment compliance, study
             conduct,or result interpretation.

          4. Congenital or acquired cardiac anomalies that interfere significantly with cardiac
             function.

          5. Treatment with ACE inhibitors within 7 days prior to treatment.

          6. Use of hormonal contraception within the 90 days prior to treatment.

          7. Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone)
             within the 90 days prior to treatment.

          8. Pregnancy or breastfeeding.

          9. A physical condition that interferes with pubertal status determination.
Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan; Enalapril
Intervention description: Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.; Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Intervention MeSH terms: Valsartan; Enalapril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Children; pediatrics; High Blood Pressure; Hypertension; Valsartan; enalapril

Summary:

      The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of
      valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight
      stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with
      hypertension (SSBP ≥ 95th percentile for age gender and height).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ages 6-17, with a documented history of hypertension

          -  Must be able to swallow a pill

          -  Must be ≥ 18 kg or ≤160 kg

          -  MSSBP (mean of 3 measurements) must be ≥ 95th percentile, for age, gender and height,
             at Visit 2 (randomization), by office blood pressure measurement

          -  Patients who are eligible and able to participate in the study and whose
             parent(s)/guardian(s) consent in writing (written informed consent) to their doing so
             after the purpose and nature of the investigation has been clearly explained to them.
             (An assent will be required for some patients depending upon their age and local
             requirements regarding assents)

        Exclusion Criteria:

          -  Renal artery stenosis

          -  Current diagnosis of heart failure (NYHA Class II-IV).

          -  MSSBP ≥ 25% above the 95th percentile

          -  Second or third degree heart block without a pacemaker.

          -  Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.

          -  Clinically significant valvular heart disease.

          -  Patient that demonstrates clinically significant ECG abnormalities other than those
             associated with left ventricular hypertrophy.

          -  Previous solid organ transplantation except renal, liver or heart transplantation.
             Renal, liver or heart transplant must have occurred at least 6 months prior to
             enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months
             and deemed clinically stable by the investigator.

        Other protocol-defined inclusion/exclusion criteria may apply
A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Condition: Hemodialysis Patients With Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: PA21
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hyperphosphatemia

Summary:

      The purpose of this study is to investigate the safety and efficacy for 52-week dosing in
      hemodialysis patients with hyperphosphatemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving stable maintenance hemodialysis 3 times a week.

          -  Dialysis patients with hyperphosphatemia

        Exclusion Criteria:

          -  Patients having history of a pronounced brain / cardiovascular disorder.

          -  Patients having severe gastrointestinal disorders.

          -  Patients having severe hepatic disorders.
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Condition: Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: imatinib mesilate; interferon-alpha (INF-a); cytarabine (ARA-C)
Intervention description: imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.; interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day.; cytarabine 20 mg/m^2/day (max 40 mg) SC for 10 days every month.
Intervention MeSH terms: Interferons; Cytarabine; Interferon-alpha; Interferon alpha-2; Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 1106.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: CML; STI571; imatinib; interferon; interferon alpha; cytosine arabinoside; chronic myeloid leukemia; Philadelphia chromosome positive

Summary:

      The purpose of this study is to evaluate and compare the side effects and anti-leukemic
      benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid
      leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to
      receive either interferon plus Ara-C or imatinib as initial treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Must have signed consent for Amendment 5

          -  Must have completed visit 62 of the core IRIS trial or be in follow-up

          -  Must be on STI571 treatment

          -  If on IFN treatment, must be willing to cross over to STI571 treatment

        Exclusion criteria:

          -  Patients who have discontinued from the study and are in follow-up

          -  Patients who are on IFN treatment and do not want to cross over to STI571 treatment

          -  Patients who have not consented to amendment 5

          -  Patients who did not complete the amendment 5 protocol

        Additional protocol-defined inclusion/exclusion criteria may apply