bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Rupture
Intervention: Contrast Ultrasound
Intervention description: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The goal is to non-invasively study the metabolic processes within the aortic wall that are
      thought to explain progression to clinical manifestations of an aortic aneurysm.

      Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast
      ultrasound, coupled with serum biomarker measurements will allow the identification of the
      vulnerable aortic wall and patients who are at risk of AAA growth or rupture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.

          -  21 years of age or older

          -  ability to give informed consent.

        Exclusion Criteria:

          -  Inability to provide an informed consent

          -  Known allergy to Definity

          -  Unstable cardiopulmonary conditions

          -  pregnancy
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Condition: Burns; Sedation
MeSH terms: Burns
Intervention: Dexmedetomidine
Intervention description: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine [in ug/kg/hr], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: pediatric; burn; sedation

Summary:

      Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care
      units. We are studying whether this drug is cardiovascularly safe in pediatric patients who
      have recently been burned.
    

Eligibility criteria:

        Inclusion Criteria:

          -  pediatric patient

          -  >25% total body surface area (tbsa) burn and < 90% tbsa

          -  opioid requirements > 0.1 mg/kg/hour of morphine (or equivalent)

          -  midazolam requirement > 0.1 mg/kg/hour

          -  treatment team determined that patient should be started on dexmedetomidine

        Exclusion Criteria:

          -  hemodynamically unstable patients (epinephrine > 1.0 ug/kg/min, levophed > 0.75
             ug/kg/min, dopamine > 10 ug/kg/min)

          -  pregnant patients

          -  patients with history of heart block

          -  patients with congenital heart disease

          -  patients with significant hepatic dysfunction

          -  patients with urine output < 0.5 ml/kg/hour [averaged] over past 24 hours
Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Intervention: Ubiquinol; Ensure
Intervention description: 300 mg Ubiquinol (3 mL liquid Ubiquinol).; 50 mL Ensure
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years)

          -  Cardiac arrest defined by cessation of pulse requiring chest compressions

          -  Not following commands after ROSC

          -  Admission to the ICU

          -  Naso/orogastric tube

          -  Ability to receive enteral medication

        Exclusion Criteria:

          -  Protected populations (pregnant women, prisoners, the intellectual disabled)

          -  Current CoQ10 supplementation

          -  Anticipated death within 24 hours

          -  > 12 hours from ROSC to estimated randomization

          -  Jejunostomy tube (J-tube)
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms
Intervention: lapatinib
Intervention description: tyrosine kinase inhibitor
Intervention MeSH terms: Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; brain metastases; ErbB2 positive; HER2 positive; neoplasms; cancer; lapatinib; LAP016A2202; LAP016A; CLAP016A2202; GW572016

Summary:

      Determine how safe and effective lapatinib is when used to treat patients with ErbB2
      overexpressing breast cancer that has spread to the brain and is still progressing there even
      after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic
      radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for
      safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during
      the course of the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed Informed Consent

          -  ErbB2(HER2)overexpressing breast cancer.

          -  Brain lesion(s) which are progressing.

          -  Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or
             Stereotactic Radiosurgery (SRS).

          -  Prior treatment with trastuzumab (Herceptin), either alone or in combination with
             chemotherapy.

          -  Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by
             Echocardiogram.

          -  Able to swallow an oral medication.

          -  Adequate kidney and liver function.

          -  Adequate bone marrow function.

        Exclusion criteria:

          -  Pregnant or lactating females.

          -  Conditions that would effect the absorption of an oral drug.

          -  History of immediate or delayed hypersensitivity reaction to gadolinium contrast
             agents.

          -  Pre-existing severe cerebral vascular disease, such as stroke involving a major
             vessel.

          -  Serious medical or psychiatric disorder that would interfere with the patient's safety
             or informed consent.
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Olpasiran; Placebo
Intervention description: Dose 1 Dose 2 Dose 3 Dose 4; Dose 5
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Olpasiran; AMG 890; siRNA; lipoprotein (a) Lp(a); Cardiovascular; Cardiovascular disease; Atherosclerotic cardiovascular disease; Cholesterol; Apolipoprotein (B); Hyperlipidemia; Dyslipidemia

Summary:

      Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on
      percent change from baseline in lipoprotein(a) (Lp[a]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 80 years

          -  Lipoprotein (a) > 150 nmol/L

          -  Evidence of atherosclerotic cardiovascular disease

        Exclusion Criteria:

          -  Severe renal dysfunction

          -  History or clinical evidence of hepatic dysfunction

          -  Malignancy within the last 5 years

          -  Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day
             Niacin
Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease
Condition: Cancer
MeSH terms: Prostatic Neoplasms
Intervention: FACBC PET-CT Imaging
Intervention description: Participants will fast for 4 hours to normalize their neutral amino acid levels. One hour prior to the scan, participants will drink up to 450ml of standard oral contrast. Participants will lie on the scanning bed while the bed moves through the PET/CT scanner for the CT portion of the exam. After completion of the CT scan, approximately 10 units of FACBC will be injected for the PET scan portion of the exam. The bed will move through the scanner again and the PET portion of the exam will take 30 minutes. The entire visit will take about two hours.
Standard of care procedures include conventional imaging (CT and/or MRI; bone scan and/or NaF PET per institutional standards) and radical prostatectomy with extended pelvic lymph node dissection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: All participants will have the same intervention
Masking: None (Open Label)
Enrollment: 61.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; Metastatic cancer; Urogenital disorders; Oncology; Radiology

Summary:

      This study is for patients who have a high risk of metastatic prostate cancer (cancer that
      has spread outside of the prostate) who are going to have radical prostatectomy. The
      Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron
      emission tomography (PET) scan is a new imaging approach that has promising results in
      showing progression of cancer. The goal of this study is to determine if FACBC PET imaging
      will detect metastatic disease in patients with high risk prostate cancer who have negative
      conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic
      resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging
      may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary
      prostate cancer and potentially improve staging of the cancer. Additionally, the researchers
      will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis.
      They will also analyze and compare the prostate tissue, serum and urine parameters that are
      linked to higher rates of FACBC positivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High-risk prostate cancer patients eligible for standard of care surgery

               -  At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen
                  (PSA) >20, as per clinical assessment and routine guidelines

          -  Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or
             sodium fluoride (NaF) PET)

        Exclusion Criteria:

          -  Definitive findings of systemic metastasis on conventional imaging.
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Condition: Smoking Lapse Behavior
Intervention: varenicline; bupropion; Placebo
Intervention description: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).; 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).; Placebo
Intervention MeSH terms: Bupropion; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: smoking lapse behavior; smoking cessation; varenicline; bupropion; medication effect on smoking lapse behavior

Summary:

      The purpose of this study is to examine how smoking cessation medications (varenicline,
      bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in
      non-treatment seeking daily smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18-55

          -  able to read and write in English

          -  Smokers

        Exclusion Criteria:

          -  any significant current medical or psychiatric conditions that would contraindicate
             smoking

          -  current Diagnostic and Statistical Manual IV abuse or dependence of other substances,
             other than nicotine dependence or alcohol abuse

          -  positive test result at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  women who are pregnant or nursing

          -  suicidal, homicidal, or evidence of current severe mental illness

          -  participants prescribed any psychotropic drug in the 30 days prior to study enrollment

          -  blood donation within the past 6 weeks

          -  individuals seeking treatment for smoking cessation or have attempted to quit smoking
             within the past 3 months

          -  specific exclusions for bupropion administration not already specified, including:
             have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia;
             previous hypersensitivity to bupropion; history of alcohol or drug dependence in the
             past year; history of seizure disorder of any etiology

          -  known allergy to varenicline or taking H2blockers

          -  participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current study
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
Condition: Sickle Cell Anemia
MeSH terms: Anemia; Anemia, Sickle Cell
Intervention: ACZ885; Placebo
Intervention description: Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects; Monthly doses of placebo to match the administered dose of canakinumab s.c.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 8 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Sickle cell disease; hemoglobinopathy; pediatric

Summary:

      The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric
      and young adult patients with sickle cell anemia (SCA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ages 8-20 years of age (both inclusive) diagnosed with sickle
             cell anemia (HbSS) or sickle beta0 thalassemia (documented by family studies, or
             analysis of either hemoglobin or DNA).

          -  Patient's written informed consent from those ≥18 years of age must be obtained before
             any assessment is performed. Parent or legal guardian's written informed consent and
             child's assent, if appropriate, are required before any assessment is performed for
             patients < 18 years of age.

          -  Detectable baseline of background or episodic pain measured by daily e-diary over 1 to
             2 weeks during screening period as defined below: Average daily pain score ≥ 1 cm
             without analgesic use over a period of at least 7 days and/or, At least one episode of
             pain requiring analgesic use during a period of up to 14 days.

          -  History of ≥2 vaso-occlusive pain episodes in the past year, as defined as pain with
             no other, non-sickle cell identifiable cause that requires analgesia and interferes
             with the patient's normal daily routine.

        Exclusion Criteria:

          -  History of known hypersensitivity to canakinumab.

          -  Ongoing or treatment with the past 3 months with red blood cell transfusion therapy,
             or have evidence of iron overload requiring chelation therapy.

          -  Transcranial Doppler ultrasound in the past year or at screening in patients with an
             accessible transtemporal window, demonstrating velocity in middle or anterior cerebral
             or internal carotid artery ≥200 cm/sec.

          -  Administration of any other blood products within 3 weeks of screening visit.

        Other protocol-defined inclusion/exclusion criteria may apply.
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: CUROSURF® (poractant alfa)
Intervention description: Three administrations with a 24 hours dosing interval.
Each endotracheal (ET) administration 1, 2, and 3 consisted of poractant alfa bolus:
30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW, diluted with normal saline up to 2ml /kg LBW.
Intervention MeSH terms: Poractant alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Seventy patients will be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm).
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: acute respiratory distress syndrome; ARDS; Adults; Surfactant; Poractant alfa (porcine surfactant, Curosurf®),; Curosurf®; Coronavirus disease (COVID-19); Coronavirus 2019 Disease

Summary:

      The purpose of this study was to evaluate the efficacy and safety of poractant alfa
      (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients
      diagnosed with SARS-COV-19 acute respiratory distress syndrome (ARDS).
    

Eligibility criteria:

        Inclusion Criteria:

        Participants were eligible to be included in the study if the following criteria apply:

          1. Male or female ≥18 and ≤ 80 years of age

          2. Informed consent for participation in the study (refer to section 15 for detailed
             inform consent procedure)

          3. Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before
             randomisation

          4. Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio <
             150 mmHg

          5. Lung compliance ≤45 ml/cmH20

          6. Intubated and artificially ventilated less than 48 hours before the first poractant
             alfa administration

        Exclusion Criteria:

        Participants were excluded from the study if any of the following criteria apply:

          1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage and
             pneumothorax)

          2. Weight < 40kg

          3. Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate
             (eGFR) < 30)

          4. Pregnancy

          5. Administration of any nebulized surfactant in the 48 hours before the first poractant
             alfa administration

          6. Extracorporeal membrane oxygenation (ECMO)
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: GDC-0853
Intervention description: Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term
      safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU)
      who have completed the treatment period in a fenebrutinib CSU parent study. Participants may
      enroll in this OLE study at any time after completing the treatment period of the parent
      study. Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg)
      orally twice a day. Treatment may continue until the end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to comply with the study protocol, in the investigator's judgment

          -  Completion of the treatment period as specified in the parent study

          -  Acceptable demonstration of tolerance to study drug during the parent study as
             determined by the investigator or Medical Monitor

          -  For participants receiving treatment with proton-pump inhibitors (PPIs) or H2-receptor
             antagonists (H2RAs), agreement to maintain treatment at a stable dose for the first 12
             weeks of the study

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive measures, and agreement to refrain from
             donating eggs

          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             a condom, and agreement to refrain from donating sperm

        Exclusion Criteria

          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within
             4 weeks after the final dose of fenebrutinib

          -  Treatment with any investigational agent or live/attenuated vaccine in the preceding 6
             weeks

          -  Any signs or symptoms of infection judged by the investigator to be clinically
             significant since completing the treatment period of the parent study

          -  Any significant changes (e.g., events, changes in medication) occurring after
             completion of participation in the parent study that, in the investigator's judgment,
             would increase the risk of adverse events in this OLE study