araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo

Summary: Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for abdominal aortic aneurysm.

Detailed description: The invited population will be offered ultrasound investigation of their abdominal aorta. Further information regarding risk factors will be noted and measurement of ankle-brachial index will be measured/calculated. A further step in the future will be to sample blood with focus on different cytokines and genmediators.

Eligibility: Inclusion Criteria:
  -  Males aged 65 years
  Exclusion Criteria:
  -  None

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: A Study of ARQ 197 in Combination With Erlotinib

Summary: This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.


Eligibility: Inclusion Criteria:
  -  Voluntary written informed consent for study participation must be obtained
  -  A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
  -  History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
  -  ECOG PS of 0 or 1
  -  Life expectancy of ≥3 months
  -  Poor metabolizers as defined by CYP2C19 genotype
  Exclusion Criteria:
  -  Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
  -  Surgery for cancer within 28 days prior to ARQ 197 dose
  -  Active double cancer
  -  Known symptomatic brain metastases
  -  An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
  -  Pregnant or lactating
  -  Subjects who wish to have a child and who would not agree to use contraceptive measures

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Avastin for PDR (Proliferative Diabetic Retinopathy)

Summary: The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).

Detailed description: Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.

Eligibility: Inclusion Criteria:
  -  Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.
  Exclusion Criteria:
  -  Dense vitreous hemorrhage
  -  Inability to follow-up for surgery within 3-7 days after intravitreal injection
  -  History of stroke, thromboembolic event, or heart attack within the last 6 months
  -  Less than 18 years of age
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A

Summary: The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Detailed description: The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.
  To assure that patients with an STS score ≥ 4% have been selected.

Eligibility: Inclusion Criteria
  1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure.
  2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
  4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
  6. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.
  Exclusion Criteria
  1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).
  5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
  6. Heart team assessment of inoperability (including examining cardiac surgeon).

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions

Summary: The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). GenTAC established a registry of 3706 patients with genetic conditions that may be related to thoracic aortic aneurysms and collected medical data and biologic samples. The study ended in September 2016. Data and samples are available from NHLBI and requests should be made to BioLINCC. See the NHLBI website for more information: https://www.nhlbi.nih.gov/research/resources/gentac/.


Eligibility: Eligible subjects must have one of the conditions listed below and be enrolled in-person at one of the participating clinical centers.Contact the study coordinator at the location nearest you for more information about participation.
  -  Marfan syndrome
  -  Turner syndrome
  -  Ehlers-Danlos syndrome
  -  Loeys-Dietz syndrome
  -  FBN1, TGFBR1, TGFBR2, ACTA2 or MYH11 genetic mutation
  -  Bicuspid aortic valve without known family history
  -  Bicuspid aortic valve with family history
  -  Bicuspid aortic valve with coarctation
  -  Familial Thoracic Aortic Aneurysm and DissectionsYes
  -  Shprintzen-Goldberg syndrome
  -  Other aneurysms and dissections of the thoracic aorta not due to trauma, <50yo
  -  Other congenital heart disease (e.g., Tetralogy of Fallot, coarctation)
  Exclusion Criteria:
  -  Inability of the patient, parent or guardian to give consent.
  -  Unwillingness to provide a blood or buccal specimen.

Relevance to patient case: possibly relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Study of Post-operative Oxygen Consumption Following Vascular Surgery

Summary: To define any changes in whole body oxygen consumption that occur following major vascular surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and infra-inguinal lower limb revascularisation procedures).


Eligibility: Inclusion Criteria:
  -  Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh
  Exclusion Criteria:
  -  Patient refusal

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma

Summary: The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive GNAQ or GNA11 metastatic melanoma.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not previously treated with a MEK inhibitor.
  -  Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment.
  -  The patient has a radiographically measurable tumor.
  -  ECOG performance status 0, 1, or 2.
  -  The patient is able to swallow and retain oral medication.
  -  Life expectancy of at least 4 months.
  -  Toxicities from previous anti-cancer therapy (except alopecia) are recovered (Grade 1 or less) at the time of enrollment.
  -  The patient has adequate organ and bone marrow function.
  -  Sexually active patients must use medically acceptable methods of contraception during the course of the study.
  -  Female patients of childbearing potential must have a negative serum pregnancy test at screening.
  Exclusion Criteria:
  -  The patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization.
  -  The patient has received experimental therapy within 21 days of starting study drug.
  -  The patient has received nitrosourea or mitomycin C within 42 days of starting study drug.
  -  The patient has received any herbal medications or palliative radiotherapy within 14 days of starting study drug.
  -  The patient is currently receiving anticoagulation therapy that is not well controlled.
  -  Ongoing or newly diagnosed eye abnormality other than symptoms due to uveal melanoma.
  -  History of retinal vein occlusion or central serous retinopathy.
  -  Current severe, uncontrolled systemic disease.
  -  History of leptomeningeal disease or spinal cord compression secondary to metastasis.
  -  Brain metastasis, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery and the disease has been stable for at least 3 months without steroid use or on a stable dose of steroids for at least 1 month prior to starting study drug. Stability of brain metastases must be confirmed with imaging.
  -  The patient has a concurrent, active hematological malignancy or other solid tumor malignancy.
  -  History of clinically significant cardiac or pulmonary dysfunction.
  -  Allergy or hypersensitivity to components of the GSK1120212 formulation.
  -  The patient is pregnant or breastfeeding.

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair

Summary: To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.

Detailed description: Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.The primary outcomes included the biomarkers reflecting intestinal injury (serum intestinal fatty acid binding protein, endotoxin levels and diamine oxidase activity) and the variables reflecting pulmonary injury (arterial-alveolar oxygen tension ratio, alveolar-arterial oxygen tension difference and respiratory index). In addition, the severity of intestinal and pulmonary injury was assessed with different scoring methods, respectively. Markers of oxidative stress and systemic inflammation were measured as well.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of abdominal aortic aneurysm
  -  Must be received open abdominal aortic aneurysm repair
  Exclusion Criteria:
  -  age >80 years old
  -  Acute coronary syndrome or myocardial infraction within
  -  3 months
  -  Chronic obstructive pulmonary emphysema
  -  angina pain within 48 hours of repair procedure
  -  ejection fraction less than 40%
  -  poor pulmonary function (PaO2 <60mmHg)
  -  history of inflammatory bowel disease
  -  history of diarrhea (≥2 liquid stools per day for ≥2 days) within 1 week of surgery
  -  intestinal chronic inflammatory disease

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection

Summary: Background: Aortic stent-graft is useful to occlude intimal tear and prevent further dilatation of the false lumen in patients with aortic dissection. The long-term benefit of aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well demonstrated, especially in patients at high risk of aneurysmal change and death.
  Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft insertion performed just after the acute phase into the descending thoracic aorta in patients with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.


Eligibility: Inclusion Criteria:
  -  Uncomplicated distal aortic dissection
  -  Initial false lumen diameter >= 22 mm
  Exclusion Criteria:
  -  Old age (> 75 years old)
  -  Other comorbidity or malignancy with life expectancy < 5 years
  -  Complicated dissection requiring aortic surgery or intervention
  -  Sudden death in acute phase
  -  Marfan syndrome

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)

Summary: This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.


Eligibility: Inclusion Criteria:
  -  Infra-renal abdominal aortic aneurysm
  Exclusion Criteria:
  -  Previous infra-renal aortic surgery
  -  Known diabetes

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

Summary: The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.


Eligibility: Inclusion Criteria:
  -  Age > 18 years
  -  Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
  -  Patient able and willing to return to the implant center for follow-up visits
  -  Able and willing to give informed consent and follow protocol procedures.
  Exclusion Criteria:
  -  Inadequate echocardiographic window for transthoracic imaging
  -  Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
  -  Evolving endocarditis or active endocarditis in the last 3 months.
  -  Heavily calcified annulus or leaflets.
  -  Congenital malformation with limited valvular tissue
  -  Patient requires mitral valve replacement.
  -  Previously implanted annuloplasty ring/band.
  -  Patient requires aortic or pulmonic valve replacement or repair.
  -  Patient is pregnant (urine HCG test result positive) or lactating.
  -  Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
  -  Life expectancy of less than twelve months.
  -  Patient is participating in concomitant research studies of investigational products.

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial

Summary: A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.

Detailed description: Purpose: To evaluate the safety and efficacy of THV-9300 (20mm) for patients who have severe symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet and for whom undergoing a surgery safely would be difficult.
  Enrollment: 15 patients (No.of patients needed: 12)
  Follow-up: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 months and annually for 5 years.
  Clinical sites:
  1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4) Kokura Memorial Hospital

Eligibility: Inclusion Criteria:
  -  Patients who were judged difficult to safely undergo AVR
  -  Severe senile degenerative aortic valve stenosis
  -  NYHA Functional Class II or greater
  -  Signed Informed Consent
  Exclusion Criteria:
  -  Aortic valve is congenital unicuspid or bicuspid
  -  Annulus size between < 16 mm or > 19 mm
  -  LVEF < 20 %

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry

Summary: A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.


Eligibility: Inclusion Criteria:
  -  Patient is implanted with Zenith® Low Profile AAA Endovascular Graft
  Exclusion Criteria:
  -  Patients for whom this device would not normally be considered standard of care.

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Pilot Study of the Endologix Fenestrated Stent Graft System

Summary: The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.


Eligibility: Inclusion Criteria:
  -  Informed consent understood and signed and pt agrees to all follow-up visits;
  -  Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
  -  Adequate iliac/femoral access compatible with the required delivery systems
  -  Non-aneurysmal infrarenal aortic neck <15mm in length
  -  Most caudal renal artery to aortoiliac bifurcation length at least 70mm
  -  Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) <60° to the aneurysm sac;
  -  Angle <60° (clock face) between the SMA and celiac artery
  -  Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
  -  Iliac anatomy suitable for commercial bifurcated stent graft;
  -  Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts
  Exclusion Criteria:
  -  Life expectancy <1 year as judged by the investigator;
  -  Psychiatric or other condition that may interfere with the study;
  -  Participating in the enrollment or 30-day follow-up phase of another clinical study;
  -  Known allergy to any device component;
  -  Coagulopathy or uncontrolled bleeding disorder;
  -  Contraindication to contrast media or anticoagulants;
  -  Ruptured, leaking, dissecting, or mycotic aneurysm;
  -  Serum creatinine (S-Cr) level >2.0 mg/dL;
  -  Traumatic vascular injury;
  -  Active systemic or localized groin infection;
  -  Connective tissue disease (e.g., Marfan's Syndrome);
  -  Recent (within prior three months) cerebrovascular accident or myocardial infarction;
  -  Prior renal transplant;
  -  Length of either renal artery to be stented <13mm;
  -  Significant occlusive disease or calcification of either renal artery;
  -  An essential accessory renal artery;
  -  Indispensable inferior mesenteric artery;
  -  Untreated aneurysmal disease of the descending thoracic aorta;
  -  Clinically significant mural thrombus circumferentially in the suprarenal segment;
  -  Prior iliac artery stent implanted that may interfere with delivery system introduction;
  -  Unsuitable vascular anatomy
  -  Pregnancy (female patient of childbearing potential only)

Relevance to patient case: not relevant
Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: Endovascular Abdominal Aortic Aneurysm Repair by Interventional Cardiologists

Summary: Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by Interventional Cardiologists


Eligibility: Inclusion Criteria:
  -  Patients with abdominal aortic aneurysm amenable for endovascular repair
  Exclusion Criteria:
  -  Pregnant patients
  -  Patients less than 18 years old.

Relevance to patient case: not relevant