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

Clinical trial: Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)

Summary: The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.

Detailed description: A descending thoracic aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this clinical study the Talent Thoracic Stent Graft will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system.
  Medtronic Vascular submitted a Pre-Market Application (PMA P070007) to the FDA on February 28, 2007, and received market approval for the Talent Stent Graft System on June 5, 2008. As a condition of approval, the FDA has requested a post-market trial. In collaboration with the FDA, Medtronic has designed a post-approval study to document the long-term performance of the Talent Stent Graft System under post market conditions.
  This study will examine the post-market performance of the Talent Thoracic Stent Graft System. This study is a prospective, non-randomized five-year trial. Originally, a total of 451 subjects were going to be analyzed. That group consisted of 195 enrolled subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 planned "de novo" subjects enrolled after the PMA approval. However, Medtronic discontinued manufacturing of the study device for US commercialization, and as a result, enrollment was terminated in May 2014, when it was determined that no more proximal devices were available either in inventory or at the sites. A total of 349 subjects will be analyzed, based on 195 VALOR Test Group subjects and 154 "de novo" subjects.

Eligibility: Inclusion Criteria: appropriate anatomy for elective repair of the descending thoracic aortic aneurysm
  -  iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and or accessories
  -  non-aneurysmal aortic diameter in the range of 18-42mm; and
  -  non-aneurysmal aortic proximal and distal neck lengths equal to or greater than 20mm
  -  subject has a Descending Fusiform Thoracic Aneurysm = to or greater than 5cm in diameter OR is = to or greater than 2 times the diameter of the non-aneurysmal thoracic aorta and/or saccular aneurysms/penetrating ulcers
  -  Signed patient informed consent
  Exclusion Criteria:
  -  Less than 18 yrs old
  -  pregnant
  -  unable to comply w/follow-up
  -  participating in other drug or device trials;
  -  Subject has a co-morbidity causing expected survival to be less than 1 year

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

Clinical trial: Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

Summary: In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular approach can be chosen. Since open surgery is more durable in many countries a laparoscopic procedure using " key hole surgery " has gained wider acceptance. The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times.

Detailed description: In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular approach can be chosen. Since open surgery is more durable in many countries a laparoscopic procedure using " key hole surgery " has gained wider acceptance. The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times.
  Study design: Multi center prospective randomized study including patients with infra or juxtarenal aortic aneurysms ( AAA).
  In group I the AAA is resected using a conventional long incision and standard procedures for resecting the AAA. A Dacron graft is used in inlay technique to restore blood flow.
  In group II a total laparoscopic approach is chosen to exclude the AAA. Identical to open surgery a dacron graft is laparoscopically sawn in to exclude the AAA and to restore blood flow.
  In a subgroup II a the laparoscopic anastomosis is performed with a stapling device to simplify and to accelerate the procedure.
  Endpoints of the study:
  Total operating time, aortic crossclamping time, stay in ICU, return to a regular diet,postoperative ileus, total hospital stay, major and minor complications, blood loss, renal function in cases with juxtarenal AAA.Patients are evaluated for postoperative pain, wound related problems, hernias and time until full mobilisation is achieved.
  Hypothesis: The laparoscopic approach though associated with a longer operating time and longer clamping times is associated with a reduced recovery time, les pain and less wound related problems compared to a full length conventional incision.

Eligibility: Inclusion Criteria:
  -  patients with abdominal aortic aneurysms
  -  fit for open surgery
  Exclusion Criteria:
  -  patients unfit for open surgery
  -  patients with malignancies

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

Clinical trial: Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.
  PURPOSE: This phase I trial is studying chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.

Detailed description: OBJECTIVES:
  -  To determine and define the biological basis of different subtypes of chronic graft-vs-host disease using a targeted single nucleotide polymorphisms approach in patients who have undergone allogeneic stem cell transplantation.
  OUTLINE: Two important aspects of the methodologies that will be employed for the analysis of SNPs associated with GVHD are throughput efficiency to be able to perform the assays on a reasonable number of samples as well as having the ability to add or remove SNPs to the assay panel. While a genome-wide association study to identify variants associated with GVHD would offer an unbiased approach, our patient cohort size would not allow significant statistical power in the study. Therefore, a more targeted approach using two established technologies is proposed.
  The Sequenome assay uses the unique combination of a single-base primer extension assay incorporating one of four modified nucleotides. The four modified nucleotides each have a unique mass that allows them to be distinguished from one another using mass spectrometry. Each SNP is determined analyzing the primer extension product from a PCR amplicon that surrounds the SNP of interest. The development of each assay involves designing flanking PCR primers and an internal extension assay using web-based software provided by Sequenome. The assays can be designed to analyze up to 30 SNPs in a single reaction, providing a customizable, efficient and high-throughput assay for SNPs of interest.

Eligibility: DISEASE CHARACTERISTICS:
  -  Underwent prior matched related or unrelated allogeneic stem cell transplantation (SCT)
  -  Presence OR absence of chronic graft-vs-host disease after day 100 and alive after day 180 post-transplantation
  -  No T-cell depleted SCT, cord blood transplantation, mismatched allogeneic transplantation, or autologous transplantation
  -  Available recipient and donor DNA (samples collected from the Vanderbilt University or the Fred Hutchinson Cancer Center tissue bank)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

Summary: Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.

Detailed description: -  Subject is > 18 years of age.
  -  Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
  -  Subject is a candidate for endovascular thoracic aortic repair.
  -  Subject has a TAA that meets one of the following criteria:
  -  Is diagnosed with a Fusiform Focal TAA >5cm, or
  -  Is diagnosed with a Fusiform Focal TAA that has a diameter < 5 cm and has exhibited rapid expansion, or
  -  Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
  -  Is diagnosed with a saccular TAA of any size.

Eligibility: Inclusion Criteria:
  -  Subject is > 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening.
  Subject is a candidate for endovascular thoracic aortic repair.
  Subject has a TAA that meets one of the following criteria:
  1. Is diagnosed with a Fusiform Focal TAA ≥5cm, or
  2. Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or
  3. Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
  4. Is diagnosed with a saccular TAA of any size (where potential for rupture is increased*).
  -  Tortuosity and angulation do not exceed 90 degrees.
  -  Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.
  Exclusion Criteria:
  -  Subject has a life expectancy < 2 years.
  -  Subject has a lesion that prevents safe delivery or expansion of the device.
  -  Subject has concomitant ascending aortic aneurysm.
  -  Subject has known allergies to any of the device materials.
  -  Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
  -  Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.

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

Clinical trial: Association of AGTR1 and ACACB Gene Polymorphism and Diabetic Nephropathy in Type 2 Diabetes

Summary: India is the "Diabetes Capital of the World" with 41 million Indians having diabetes, with every fifth diabetic in the world being an Indian and type 2 Diabetes Mellitus (T2DM) constitutes the major chunk of diabetes. One of the most severe complications of diabetes is the development of diabetic nephropathy. Diabetic nephropathy (DN) is the leading cause of end-stage renal disease (ESRD) worldwide. There are many identifiable risk factors of diabetic nephropathy like hyperglycemia, hyperlipidemia, hypertension, and proteinuria, the genetic factor is the main among all. Long-term observational studies show that nearly 30-35% of type 2 diabetic patients develop nephropathy, irrespective of glycemic control. The regional variation in diabetes prevalence and in the proclivity for diabetes induced renal disease; along with reports of familial clustering of nephropathy suggest a possible genetic basis. The renin-angiotensin system (RAS) has been strongly implicated in the pathogenesis of progressive renal diseases. In addition, the blockage of angiotensin II with either ACE inhibitor or an angiotensin type-I receptor antagonist has been found to prevent or delay the progression of renal injury associated with diabetes 5 and now these drugs are first-choice drugs for the treatment of diabetic subjects with hypertension. The genes encoding the renin-angiotensin system (RAS), such as angiotensin-converting enzyme (ACE), angiotensinogen (AGT) and angiotensin II receptor type 1 (AGTR1), have been reported to be the most probable candidate genes for diabetic nephropathy. As there is no data available for AGTR1 polymorphism and DN in the north Indian T2DM, its out attempt to fill the scientific gap.


Eligibility: Group:-1: Patients with diabetic nephropathy
  Inclusion criteria:
  -  Type 2 Diabetes and duration of more than or equal to 5 years.
  -  Age between 30 to 85 years.
  -  Presence of both albuminuria and retinopathy.
  Exclusion criteria:
  -  Patients with diagnosis of type 1 diabetes
  -  Any known nondiabetic renal disease.
  -  Patients who had a MI or had undergone CABG within 3 month.
  -  Patients who had a CVA or had undergone PTCA in the previous 3 months.
  -  Patients who had had a transient ischemic attack within the previous 3 months.
  -  Patients who had any history of heart failure before enrollment.
  -  Patients with UTI.
  -  Pregnant patient.
  Group:-2: Patients without diabetic nephropathy Same characteristic as group 1 but no evidence of diabetic nephropathy.

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

Clinical trial: South American Thoracic Stent-Graft Study

Summary: A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).


Eligibility: Inclusion Criteria:
  -  The TriVascular Thoracic Stent Graft System is indicated in subjects diagnosed with an aneurysm in the descending thoracic aorta having vascular morphology suitable for endovascular repair, including:
  -  Adequate iliac/femoral access compatible with the required delivery systems,
  -  Non-aneurysmal aortic segments proximal and distal to the aneurysm.

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

Clinical trial: Cardiac Output Monitoring in Aortic Aneurysm Surgery

Summary: To compare CO values obtained by the lithium indicator dilution method and pulse power analysis before, during and after anaesthesia and surgery for the elective repair of abdominal aortic aneurysms. This will enable us to determine how often and when calibration of the pulse power analysis derived CO is required.


Eligibility: Inclusion Criteria:
  -  Patients presenting for elective abdominal aortic and extent 4 thoracoabdominal aortic aneurysm repair
  Exclusion Criteria:
  -  Patients not giving informed consent.
  -  Patients under the age of 18 years.
  -  Patients who may be pregnant
  -  Patients with learning disabilities.
  -  Rhythm other than sinus rhythm.
  -  Patients on oral lithium therapy.
  -  Patients less than 40kg
  -  Patients with severe mitral regurgitation

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

Clinical trial: The Link Between Human Cytomegalovirus (HCMV) and Hypertension

Summary: It has been reported that mouse cytomegalovirus infection alone can elevate the blood pressure in mice. Since HCMV has uniquely evolved with its human host, with little genetic similarity to the animal CMV counterparts, and it only replicates in human, an epidemiological study is required to define the relevance of HCMV infection and expression of hcmv-miRNA-UL112 to the pathogenesis of essential hypertension.
  The investigators found that hcmv-miR-UL112, a human cytomegalovirus (HCMV)-encoded miRNA, was highly expressed in the hypertensive patients. Among the top miRNA target predictions, the investigators demonstrate that IRF-1 is a direct target gene of hcmv-miR-UL112, along with MICB that has been previously reported. Both IRF-1 and MICB play critical roles in immuno/inflammatory and anti-infection response. Thus, the investigators speculated that IRF-1 and MICB repression by hcmv-miR-UL112 could be considered a unifying mechanism that evades the host response at several levels: antiviral, inflammatory, and immune. In addition, there is an increasing evidence that IRF-1 may be important in apoptosis, angiogenesis, neointima formation and the pathogenesis of vascular diseases. IRF-1 can up-regulate angiotensin II type 2 receptor (AGTR2) that exerts antiproliferative and proapoptotic actions and affects regulation of blood pressure. It has been reported that the targeted disruption of the mouse AGTR2 gene resulted in a significant increase in blood pressure and increased sensitivity to angiotensin II. The nitric oxide synthase expression and NO synthesis in macrophages and distinct cardiomyocytes are induced and controlled by IRF-1 in response to inflammation, important steps in vascular biology that may improve endothelial function and inhibit smooth muscle cell migration, and a key pathophysiological event in hypertension. Collectively, these reports support a strong relationship between IRF-1 regulation and hypertension, indicating a potential role of hcmv-miR-UL112 and HCMV infection in the pathogenesis of hypertension.Thus, the investigators want to investigate the potential link between HCMV infection and essential hypertension.


Eligibility: Inclusion Criteria:
  -  Patients with essential hypertension are assessed for potential secondary causes, for the severity of hypertension, other risk factors and for end-organ damage
  -  Aged between 30 to 60 years
  -  Untreated (whole day average > 140/90 mmHg) or treated hypertension whole-day average < 140/85), as determined by 24-hour blood pressure monitoring.
  Exclusion Criteria:
  -  Cancer
  -  Diabetes
  -  Smoking
  -  Renal failure
  -  Stroke
  -  Peripheral artery disease

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

Clinical trial: CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Summary: Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.


Eligibility: Inclusion Criteria:
  -  Patient is a candidate for mitral valve repair.
  -  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:
  -  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 prosthetic mitral valve or 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: The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian Population

Summary: Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third eventually rupture if left untreated.
  Several randomized trials showed that ultrasonographic screening for AAA could reduce the frequency of acute operations and AAA-related mortality.
  However, all of randomized trials were performed in Western countries. There was no randomized trials for AAA screening in Asian countries.
  This randomized, controlled trial is to analyze the benefits of screening old population for AAA in Korea.

Detailed description: Old population, aged from 60 to 85 years, are randomized into two groups; one group is invited for ultrasonographic screening for AAA, and the other acts as age- and sex-matched controls.
  For screening group, The anterioposterior and transverse diameter of the infrarenal aorta is measured at their maximal sizes. The subsequent surveillance of screened patients is done as follows
  -  Aortic diameter less than 3.0cm, no further testing
  -  AAA 3 to 4cm, ultrasonographic follow-up every year
  -  AAA 4 to 5cm, ultrasonographic follow-up every 6 months
  -  AAA greater than 5cm, referral to a vascular surgeon
  For control group, the information for any causes of death is collected every year.

Eligibility: Inclusion Criteria:
  -  all men aged 60 to 85 years
  -  women aged 60 to 85 years with cardiovascular risk factors such as hypertension, hyperlipidemia, peripheral arterial occlusive disease, coronary artery disease, cerebrovascular attack.
  -  men and women older than 50 years with a family history of AAA
  Exclusion Criteria:
  -  people who was diagnosed with AAA
  -  people who underwent aneurysm repair such as open aneurysm repair or endovascular aneurysm repair
  -  People who underwent abdominal aortic surgery such as aortobifemoral bypass
  -  People whose life expectancy is less than 2 years
  -  People who appear unfit for repair of AAA
  -  people who do not agree with this study

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

Clinical trial: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical)

Summary: A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.

Detailed description: Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.
  Follow-up Intervals: 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 month annually for 5 years.

Eligibility: Inclusion:
  1. EuroSCORE of ≥ 15 %
  2. Severe senile degenerative aortic valve stenosis
  3. Symptomatic aortic valve stenosis
  4. Informed consent
  5. Compliance
  Exclusion:
  1. Logistic Euroscore > 40 %
  2. Evidence of an acute myocardial infarction
  3. Congenital unicuspid or congenital bicuspid valve/ non-calcified
  4. Mixed aortic valve disease

Relevance to patient case: not relevant