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

Clinical trial: Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

Summary: Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.

Detailed description: The study will include patients with small AAA (diameter 4.1 to 5.4 cm defined by Computed Tomographic scan) suitable for endovascular repair (EVAR).
  Randomization is designed with equal probability of assignment to each of the two groups (ie, immediate endovascular repair or surveillance group) by means of a computer-generated -random-number list . After eligibility is verified, assignment will be made using a computer database held at the Coordinating Centre.
  In the immediate repair group, endovascular repair with introduction of an aortic endograft (Cook Zenith) will be performed within six weeks from randomization.
  In the surveillance group, patients are followed without repair until the aneurysm reaches 5.5 cm in diameter, or enlarges at least 1.0 cm in one year, or until patient develops symptoms that are attributed to the aneurysm by the attending investigator. When one of these criteria is met, endovascular repair (if the patient remains a candidate for EVAR), or open repair will be carried out.

Eligibility: Inclusion Criteria:
  -  Patients of 50-80 years of age
  -  Non symptomatic infrarenal AAA of 4.1 to 5.4 cm in diameter measured by CT performed within 3 months before randomization
  -  Adequate infrarenal aortic neck (length > 15 mm diameter < 30 mm) and other anatomical configurations suitable for EVAR
  -  Patients have a life expectancy of at least 5 years
  -  Signed informed consent
  Exclusion Criteria:
  -  Ruptured or symptomatic AAA
  -  AAA maximum diameter >= 5.5 cm
  -  Suprarenal or thoracic aorta aneurysm of more than 4.0 cm
  -  Patient unsuitable for administration of contrast agent
  -  Severe heart, lung, liver or renal disease (serum creatinine >= 3mg/dl)
  -  Need for adjunctive major surgical or vascular procedures within 1 month
  -  High likelihood of non compliance with follow-up requirements

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

Clinical trial: RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve

Summary: The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.

Detailed description: Patient clinical evaluations will consist of 3-month, 6-month, and 12-month follow up of the primary endpoints. Additional follow up of 18-month, 24-month, and annually thereafter will also be included.

Eligibility: Inclusion Criteria:
  -  Grade 2, 3, or 4 functional mitral valve regurgitation per 2D echocardiography
  -  Patient undergoing concomitant coronary artery bypass graft surgery, either on-pump or off-pump
  -  Left ventricular ejection fraction greater than or equal to 25%
  -  Age between 18 and 80 years, inclusive
  -  Patient is willing and available to return for study follow up
  -  Ability of the patient or legal representative to understand and provide signed consent for participating in the study.
  Exclusion Criteria:
  -  Structural abnormality of the mitral valve (e.g. calcification or thickening of the valve leaflets, ruptured papillary muscle, ruptured chordae tendinae, mitral valve prolapse, mitral stenosis, etc.)
  -  Asymptomatic Grade 2 MR (those with NYHA Class < II AND LVEF > 40%)
  -  Organic valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring surgical intervention
  -  Transmural myocardial infarction within 30 day period prior to surgical placement of Coapsys
  -  NYHA class IV
  -  Left ventricular end diastolic diameter > 7.0 cm
  -  Cardiac surgery on an emergency or salvage basis
  -  Left atrial or left ventricular thrombus
  -  Left ventricular aneurysm
  -  Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the Coapsys
  -  Chronic renal failure requiring dialysis
  -  Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
  -  Active infection
  -  Life expectancy of less than 24 months due to conditions other than their cardiac status
  -  Participation in another investigational drug or device protocol
  -  Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures.

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

Clinical trial: Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

Summary: A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.


Eligibility: Inclusion Criteria:
  -  Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
  -  Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
  -  Subjects must be willing to and capable of participating in the study, and provided written informed consent.
  Exclusion Criteria:
  -  Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
  -  Subjects undergoing emergency surgery.
  -  Subjects with any intra-operative findings that may preclude conduct of the study procedure.
  -  Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
  -  Subjects unwilling to receive blood products.
  -  Subjects with autoimmune immunodeficiency diseases (including known HIV).
  -  Subjects who are known, current alcohol and / or drug abusers.
  -  Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
  -  Female subjects who are pregnant or nursing.

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

Clinical trial: Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters

Summary: This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.

Detailed description: Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.

Eligibility: Inclusion Criteria:
  -  Newly placed double-lumen hemodialysis catheter
  Exclusion Criteria:
  -  Major bleed within last 3 months
  -  Platelet count less than 50 x 10 9/L or current coagulopathy (most recent INR > 1.5, not due to warfarin)
  -  Active peptic ulcer disease
  -  Anticipated need for invasive intervention within next 2 weeks
  -  Taking warfarin for an indication other than access prophylaxis
  -  Allergic to, or intolerant of, warfarin
  -  Pregnant
  -  Woman of child-bearing age who has not agreed to use an adequate method of birth control for the duration of the study
  -  Catheter likely needed for 2 weeks or less
  -  Patient previously took part in the study
  -  Patient has known aortic aneurysm of 6cm or greater
  -  Patients nephrologist has refused consent
  -  Patient has refused consent

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

Clinical trial: Genetic Research of Bone Morphogenetic Protein Receptor-II Gene in Taiwanese Patient With Primary Pulmonary Hypertension

Summary: Primary pulmonary hypertension (PPH) is a rare lung disorder in which the blood pressure in the pulmonary artery rises far above normal levels for no apparent reason. The pulmonary artery is a blood vessel carrying oxygen-poor blood from the right ventricle (one of the heart's pumping chambers) to the lungs. In the lungs, the blood picks up oxygen, then flows to the heart's left side, where the left ventricle pumps it to the rest of the body through the aorta. In the United States, an estimated 500 to 1,000 new cases of primary pulmonary hypertension are diagnosed each year. The greatest number is reported in women between ages 20 and 40. However, men and women in all age ranges as well as very young children can develop PPH. Researchers have identified more than 40 BMPR2 mutations that can cause primary pulmonary hypertension. Many of these mutations introduce a stop signal that halts protein production prematurely, decreasing the amount of functional BMPR2 protein. Other mutations prevent the BMPR2 protein from reaching the cell surface, or alter its structure so it cannot form a complex with other proteins. It remains unclear how BMPR2 mutations cause primary pulmonary hypertension. Researchers suggest that a mutation in this gene prevents cell death or promotes cell proliferation, resulting in an overgrowth of cells in the blood vessels of the lungs. Cell overgrowth can narrow the diameter of the vessels, restricting blood flow and resulting in elevated blood pressure. However, it has not yet been reported regarding the genetic variants in Taiwan. Further details have been described in this project proposal.


Eligibility: Inclusion Criteria:
  -  diagnosed as idiopathic pulmonary artery hypertension and associated family
  Exclusion Criteria:
  -  none

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

Clinical trial: Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC

Summary: The purpose of this study is to compare the cost effectiveness, quality of life and outcomes of the endovascular stent graft repair with the open surgical repair of abdominal aortic aneurysms.

Detailed description: Abdominal Aortic Aneurysms have been traditionally repaired using the standard open surgical technique. The use of Endovascular stent grafts(EVAR) to treat aortic aneurysms has been ongoing for approximately 8-10 years. Use of EVAR to treat aortic aneurysms in high risk has been reported to be beneficial. However, the costs of this therapy are quite significant and therefore in order to best understand the cost effectiveness of this type of aneurysm treatment, an extensive prospective comparative evaluation is required. This study will compare outcomes and cost-effectiveness for patients receiving EVAR, with high surgical risk, and OSR, with low surgical risk, and OSR, where there is high surgical risk and not suitable for EVAR based on anatomical complexity. Demographic, medical, health care resource utilization, cost, and quality of life information is collected from participating patients over a period of a year following repair.

Eligibility: Inclusion Criteria:
  -  infrarenal abdominal aortic aneurysm,
  -  > 5.5 cm diameter
  -  scheduled for elective surgical repair
  Exclusion Criteria:
  -  previous repair of AAA

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

Clinical trial: Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)

Summary: The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.


Eligibility: Inclusion Criteria (Surgical Patients):
  1. Non-emergent surgical candidate (aneurysm has not ruptured)
  2. Patients 21 years of age or older
  3. Male or infertile Female
  4. Aneurysm >/=4.5 cm in diameter, or
  5. Aneurysm >/= twice the normal aortic diameter directly above the aneurysm, or
  6. Aneurysm >/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or
  7. Saccular aneurysm > 3.0 cm
  Inclusion Criteria (Stent Graft Patients)
  1. Patient meets all inclusion criteria for surgical candidate
  2. Aneurysm starts >/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable
  3. Diameter of aortic fixation zone (neck) >/= 22mm and </= 30 mm
  4. Supra renal aortic diameter </= 34 mm
  5. The required device coverage length >/= 13 cm extending from most distal main renal artery ostium to the distal anchoring site within the common iliac artery (or external iliac artery if planned occlusion of internal iliac artery)
  6. Aortic neck angulation < 60° as estimated from CT scan images or angiogram
  7. Iliac artery attachment zone diameter </= 20 mm
  8. Iliac arteries with a length of >/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites
  9. Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system
  10. Aortic bifurcation > 18 mm in diameter
  11. Creatinine level < 2.5 mg/dl
  Exclusion Criteria (Surgical and Stent Graft Patients):
  1. Weight > 350 lbs. (159 Kg)
  2. Mycotic, ruptured or traumatic aneurysm
  3. Life expectancy < 2 years
  4. MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months
  5. Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA
  Exclusion Criteria (Stent Graft Patients only)
  1. Aneurysm is symptomatic or tender
  2. Creatinine > 2.5 mg/dl or patient on dialysis
  3. Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface

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

Clinical trial: Moxonidine in Patients Undergoing Vascular Surgery

Summary: Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months


Eligibility: Inclusion Criteria:
  -  abdominal aortic or peripheral vascular surgery
  Exclusion Criteria:
  -  unstable angina,
  -  severe symptomatic heart failure (NYHA IV)
  -  systolic blood pressure at rest < 100 mmHg
  -  bradycardia (<50/min)
  -  higher grade AV heart block
  -  creatinine clearance < 30 ml/min
  -  pregnancy
  -  no consent

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

Clinical trial: Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial

Summary: After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm diameter and the presence of endoleaks is evaluated with CT angiography yearly after Endovascular Aneurysm Repair (EVAR).
  The aim of this study is to investigate the value of MRA examinations for the follow-up of these patients. The advantages of MRA with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.

Detailed description: The FEAT trial (Follow-up of Endovascular Aneurysm Treatment) is designed as a prospective, single-center, follow-up study. 100 Patients will be enrolled in this study. These patients will undergo additional MRA-examinations the day before EVAR, the day after EVAR, 6 months and 1 year after EVAR. These patients also participate in the conventional CTA follow-up scheme which comprises a pre- and post-operative CTA and a CTA yearly thereafter. Coagulation parameters in the blood will be measured before and 1 year after EVAR.

Eligibility: Inclusion Criteria:
  -  Patient is planned for endovascular abdominal aortic aneurysm repair
  Exclusion Criteria:
  -  contraindication for MRI examination
  -  claustrophobia
  -  pacemaker
  -  other non-MRI compatible implants

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

Clinical trial: A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis

Summary: The purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be randomized to receive either olmesartan medoxomil or placebo for one year.


Eligibility: Inclusion Criteria:
  -  Males or Females age less than or equal to 18
  -  TEE-defined Grade III or IV atherosclerotic disease of the thoracic aorta documented within the previous 90 days, or established atherosclerotic disease of the lower extremities as demonstrated by:
  -  a history of lower extremity peripheral vascular surgery for obstructive atherosclerotic disease, or
  -  a history of lower extremity peripheral arterial angioplasty for obstructive atherosclerotic disease, or
  -  a history of lower extremity amputation secondary to atherosclerotic disease, or
  -  an ABI <0.90 within the previous 90 days, or
  -  a history of claudication in patients with documented coronary artery disease (i.e., history of myocardial infarction, coronary revascularization, or coronary angiography demonstrating at least one obstructive coronary lesion with a 50% or greater stenosis).
  Exclusion Criteria:
  -  Women of childbearing age who do not agree to utilize protocol approved contraceptive methods.
  -  Average pre-dose SBP < 100 or DBP < 60.
  -  Patients with any serious disorder including cardiovascular (ventricular arrhythmias, valvular disease or implantable defibrillator), renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic (excluding patients with controlled diabetes mellitus), hematologic/oncologic (including an active malignancy other than basal cell carcinoma or non-metastatic prostate cancer), neurologic, and psychiatric diseases.
  -  Patients with a history of MI, PTCA, CABG, heart failure, CVA or TIA within the last 30 days.

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

Clinical trial: Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm

Summary: It has been estimated that 80% of deaths from abdominal aortic aneurysms results from rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal Aortic Aneurysm) patients with reports of improvements. Despite the use of EVAR, patients have developed complications with lung and kidney function. This study will investigate certain biochemical processes that will potentially reduce these complications. Knowledge gained from this study may also be used to further research in this field through larger studies.


Eligibility: Inclusion Criteria:
  -  Open/Elective EVAR patients
  Exclusion Criteria:
  -  Patients who do not present with abdominal aortic aneurysms or ruptured abdominal aortic aneurysm

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

Clinical trial: Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Summary: The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.

Detailed description: After the introduction of endovascular repair of abdominal aortic aneurysms (AAA), both benefits and drawbacks of this new technique have been reported. To assess whether the new technique is an adequate substitute of conventional AAA repair, a randomised study is required. The DREAM trial is a randomised multicenter trial enrolling patients eligible for elective treatment of infrarenal AAAs. The primary endpoint is combined operative mortality and morbidity. Secondary endpoints and additional assessments include event-free survival, quality of life,and costs.

Eligibility: Inclusion Criteria:
  -  Asymptomatic, infrarenal AAA that requires surgery
  -  Adequate infrarenal neck
  -  Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the device to be used
  -  Patient having a life expectation of at least 2 years and cleared for transabdominal intervention
  -  Signed informed consent
  Exclusion Criteria:
  -  ruptured AAA or symptomatic AAA, which requires emergency surgery
  -  maximum aneurysm diameter< 5.0 cm
  -  suprarenal AAA
  -  Inflammatory AAA (more than minimal wall thickening)
  -  infrarenal neck unsuitable for endovascular fixation or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
  -  bilateral retroperitoneal incision required for EVAR
  -  sacrifice of both hypogastric arteries required
  -  anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
  -  patient unsuitable for laparotomy
  -  administration of contrast agent not possible: proved, severe systemic reaction to contrast agent
  -  active infection present
  -  transplantation-patients
  -  limited life expectation due to other illness (< 2 year)
  -  non-iatrogenic bleeding diathesis
  -  connective tissue disease

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

Clinical trial: Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

Summary: To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.

Detailed description: This study will assess hemodynamic changes in aortas of patients after treatment of their abdominal aortic aneurysm (AAA) with an FDA approved stent-graft (Zenith). This study does not require any change in clinical protocol to the the way the AAA procedures are currently done. Utilizing the catheters already employed in this procedure, intravascular blood pressure measurements will be documented at various times and at various anatomic levels prior to and after deployment of the stent-graft.
  As the compliant aortic aneurysm acts as a capacitor, expanding during systole and contracting during diastole, it is our hypothesis that endovascular AAA repair using a non-compliant stent-graft changes the aortic pulse profile.

Eligibility: Inclusion Criteria:
  -  Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft

Relevance to patient case: not relevant