araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Efficacy Observational Study of Candesartan Cilexetil on Hypertensive Patients

Summary: The purpose of this study is to observe treatment with candesartan cilexetil 16mg for 8 weeks, in uncontrolled hypertensive patients, in improvement of achieving of treatment goals and impact on blood pressure level in patients with uncontrolled hypertension treated with candesartan cilexetil.


Eligibility: Inclusion Criteria:
  -  diagnosis of essential hypertension (mild or moderate as defined in European Guidelines of Hypertension, 2003), that are treated already with candesartan cilexetil 16mg o.d. within last 2 weeks or more, according to Romanian approved Atacand SPC. Written informed consent to allow access and use(analysis) of data collected
  Exclusion Criteria:
  -  Patients not to be included in the programme: patients who have any contraindication to the product as detailed in Romanian approved Atacand SPC. Use of specific concomitant medication known to present a potential safety concern according to Romanian approved SPC

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.

Detailed description: The goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but infrequent responses. Mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most patients who have initial responses to EGFR-TKI eventually progress. The mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood.
  This is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.

Eligibility: Inclusion Criteria:
  Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and who fulfill the following eligibility criteria will be considered eligible for this study.
  -  Patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, EGFR patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy)
  -  Development of disease progression while actively receiving tyrosine kinase inhibitor
  -  Signed informed consent
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Genetic Studies in Breast Cancer

Summary: The purpose of this study is to determine the specific genetic alterations associated with breast cancer. This will leat to a better understanding of the genetic causes of breast cancer.

Detailed description: It is estimated that 175,000 new breast cancer cases and 44,5000 cancer deaths will result from female breast cancer in 1991. One of the most important risk factors is a family history of breast cancer. A susceptibility allele which accounts for a large proportion of familial breast cancer has been localized to chromosome 17q and attempts to clone the susceptibility are proceeding rapidly. The existence of recognized susceptibility loci and the awareness of a significan proportion of genetic predisposition and the associated penetrances remain unknown and are impossible to estimate without bias from previous studies. This study is designed to estimate heterogeniety and prenetrance in a series of unslected families, identify additional breast cancer susceptibility locs, as well as provide resources for gene isolation and mutation analysis studies.

Eligibility: Inclusion Criteria:
  -  patient with breast cancer under age 41
  -  patient with bilateral breast cancer 41-50 years old or 41-50 years old with a first degree relative (mother, sister, daughter) with breast cancer diagnosed under age 50
  -  patient with ovarian cancer with first degree relative with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 60
  -  patient any age with either ovarian or breast cancer who have 2 first degree rleatives with either ovarian cancer diagnosed at any age or breast cancer diagnosed under age 50
  -  relatives of any of the above patients will be included in this trial if a genetic abnormality is found in the patient's blood sample
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Molecular Markers in Treatment in Endometrial Cancer

Summary: The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.

Detailed description: This is a prospective multicenter study to investigate the predictive value of molecular markers in endometrial cancer for lymph node metastasis, prognosis and treatment. For the previously studied tumor markers p53, p16, ER, PR and HER2neu, we want to investigate the expression in curettage material in relation to lymph node metastasis and prognosis among endometrial carcinoma patients. We also want to investigate the distribution of genetic alterations in fresh frozen tumor tissue in order to design prospective randomized treatment trials of metastatic endometrial cancer based on molecular profile. There will be a special emphasis on disturbances in the pathways influenced by new targeted therapy, such as inhibitors of Her2/NEU, EGFR, receptor tyrosine kinase, mTOR, PTEN and hormone receptor pathways.

Eligibility: Inclusion Criteria:
  -  Women with endometrial carcinoma
  -  Available endometrial biopsy
  -  Informed consent
  Exclusion Criteria:
  -  No informed consent

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

Summary: This study will investigate whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer.


Eligibility: Inclusion Criteria:
  1. A female older than 21 years of age,
  2. Have suspicious imaging findings suggesting a possibility of breast cancer, or biopsy-proven breast cancer.
  Exclusion Criteria:
  1. Pregnant,
  2. Unwilling to give informed consent,
  3. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
  4. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
  5. Have received orthodontic work involving ferromagnetic materials,
  6. Claustrophobic,
  7. Have had allergic response to contrast agents (such as iodine or gadolinium) previously,
  8. Have known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders.

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Therapeutic Thoracentesis for Patients With Congestive Heart Failure and Large Pleural Effusion

Summary: Transudative pleural effusions are a common manifestation of patients with congestive heart failure. Severe dyspnea and respiratory failure may develop in those with large effusions, which in general show poor response to medical treatment. Therapeutic thoracenteses (TT) may be indicated in these patients and can produce marked relief of symptoms. However, the underlying effect of TT on gas exchange and respiratory mechanics in theses patients remains unclear. The researchers' hypothesis is that,TT may improve arterial oxygenation and respiratory mechanics in patients with congestive heart failure complicated by large pleural effusions.


Eligibility: Inclusion Criteria:
  -  transudative pleural effusion established by the criteria of Light
  -  the effusion occupying at least half of one hemithorax shown on chest radiography
  -  symptoms of respiratory distress
  -  diagnosis of congestive heart failure
  Exclusion Criteria:
  -  severe uncontrolled coagulopathy
  -  unstable hemodynamics
  -  diagnosis of liver cirrhosis, chronic obstructive pulmonary disease,asthma and/or any parenchymal lung disease, such as pneumonia, fibrosis or malignancy.

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Added)

Summary: A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function


Eligibility: Inclusion Criteria:
  -  Male or female aged 18 or above
  -  Congestive Heart Failure with symptoms for more than 4 weeks before starting study
  -  Provision of informed consent
  Exclusion Criteria:
  -  Current low blood pressure with symptoms
  -  Liver disease considered significant by the study doctor
  -  Pregnant or lactating females

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)

Summary: A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function


Eligibility: Inclusion Criteria:
  -  Male or female aged 18 or above
  -  Congestive Heart Failure with symptoms for more than 4 weeks before starting study
  -  Provision of informed consent
  Exclusion Criteria:
  -  Current low blood pressure with symptoms
  -  Liver disease considered significant by the study doctor
  -  Pregnant or lactating females

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Preserved)

Summary: A study to evaluate the effect of Atacand on patients with heart failure with preserved left ventricular function


Eligibility: Inclusion Criteria:
  -  Male or female aged 18 or above
  -  Congestive Heart Failure with symptoms for more than 4 weeks before starting study
  -  Provision of informed consent
  Exclusion Criteria:
  -  Current low blood pressure with symptoms
  -  Liver disease considered significant by the study doctor
  -  Pregnant or lactating females

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics

Summary: RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment.
  PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.

Detailed description: OBJECTIVES:
  -  To correlate data obtained by DCE-MRI and MRS in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology.
  -  To evaluate the impact of MRSI data on treatment planning for radiotherapy and/or surgery.
  OUTLINE: Healthy participants undergo dynamic contrast-enhanced (DCE)-MRI and magnetic resonance spectroscopic (MRS) for longitudinal studies of breast imaging and spectroscopy.
  Patients with breast cancers undergo DCE-MRI and MRS prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). After treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies.
  Breast tissue samples are collected from patients undergoing surgery. Samples are evaluated by histopathological and proteomic analysis for correlation with DCE-MRI and MRS findings.
  The study interventions are discontinued after definitive surgery is performed.
  PROJECTED ACCRUAL: A total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Women with breast tumors planning to undergo surgical resection
  -  Healthy volunteers, including any constitutionally healthy female with no history of breast cancer
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Female
  -  Menopausal status not specified
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  Not acutely ill
  -  No non-magnetic resonance-compatible ferromagnetic materials present in the body
  PRIOR CONCURRENT THERAPY:
  -  Prior chemotherapy and/or radiotherapy allowed

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Self-Care for Lymphedema in Patients With Breast Cancer

Summary: RATIONALE: Identifying why patients don't do self care for lymphedema may help doctors plan better at-home self-care treatment.
  PURPOSE: This research study is looking at self-care practices for lymphedema in patients with breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To systematically identify and describe the barriers to completing recommended at home self-care of lymphedema in patients with breast cancer.
  -  To identify patient recalled instructions as to at home self-care practices for lymphedema as told to them by healthcare professionals and others.
  -  To identify the current at home self-care practices of breast cancer survivors with treatment treated lymphedema.
  Secondary
  -  To examine the relationship between at home self-care activities and symptoms in breast cancer survivors with lymphedema.
  -  To examine the relationship between at home self-care activities and quality of life in breast cancer survivors with lymphedema.
  -  To identify patient-perceived benefits to at home self-care.
  OUTLINE: Patients complete questionnaires about their breast cancer diagnosis and treatment history, lymphedema history and problems, and years of education and income. Patients also complete surveys about home self-care practices for lymphedema and any benefits, burdens, or barriers of at home care.

Eligibility: DISEASE CHARACTERISTICS:
  -  History of breast cancer
  -  Lymphedema in one or both arms that occurred during or after breast cancer treatment
  -  Must have received prior lymphedema treatment by a healthcare professional
  -  Patients with self-reported arm swelling subsequent to breast cancer treatment that has not been treated by a healthcare professional are not eligible
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  English speaking
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Study to Demonstrate the Non-inferiority of Olmesartan Medoxomil Versus Candesartan Cilexetil in Reducing Blood B-type (or Brain) Natriuretic Peptide Levels at Week 24

Summary: This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24


Eligibility: Inclusion Criteria:
  -  Male or female, adult, out-patients aged between 18 and 85 years
  -  Patients with documented hospital admission within the previous 3 months before randomization with discharge diagnosis of CHF
  -  Patients with functional NYHA class II-IV with LVEF < 40% assessed within the last 3 months
  -  Patients with blood BNP levels > 400 pg/ml or NT-ProBNP levels > 1500 pg/ml
  -  Patients with CHF due to ischemic heart disease, idiopathic dilated cardiomyopathy (IDC), mitral or aortic insufficiency or hypertension
  -  Patients with stable conventional treatment with diuretics, ACEI and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance
  Exclusion Criteria:
  -  Females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. If a female becomes pregnant during the study, she has to be withdrawn immediately
  -  Patients with current hospitalisation due to heart failure
  -  Patients with stroke or transient ischemic attack (TIA) within the last 3 months
  -  Patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months
  -  Planned cardiac surgery, revascularization or resynchronization within the study period
  -  Patients with operable valvular disease or significant obstructive cardiomyopathy
  -  Patients with bradycardia [heart rate (HR) < 50 bpm]
  -  Patients with hypotension [systolic blood pressure (SBP) < 90 mmHg]
  -  Patients with obstructive pneumopathy
  -  Patients with clinical significant renal failure (creatininemia > 200 micromol/l)

Relevance to patient case: not relevant
Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)

Summary: The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without discontinuation due to a study drug-related AE and in the investigator's opinion, have an on-going clinical indication for an orally administered suspension of candesartan cilexetil to control blood pressure. Children will return to clinic every 3 months (more frequently at the investigator's discretion) for safety and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses, echocardiograms and by physical examinations at specified clinic visits. Blood pressure and heart rate will be measured at each clinic visit. Study drug is administered orally once a day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a vist-by-vist basis depending on the child's BP response. It is anticipated that study dose will align closely with the effective anti-hypertensive dose determined in Study 328. If the child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day and/or the addition of other antihypertensive medications are permitted, with the exception of other angiotensin receptor blockers. The HIP study offers eligible children up to two additional years of treatment with the liquid formulation of Atacand.


Eligibility: Inclusion Criteria:
  -  Must have participated in Protocol 328 (without discontinuation due to a study drug related AE).
  -  Must sign an informed consent prior to initiating any stus dy procedures.
  -  Have, in the opinion of the investigator, an on-going clinical indication for oral liquid formulation of candesartan cilexetil to control hypertension
  -  Weight ≥ 10 kg and ≤ 40 kg.
  Exclusion Criteria:
  -  Any situation, clinical condition (such as clinically significant declining renal function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study.
  -  Estimated glomerular filtration rate (GFR) <30 ml/min/1.73m2 for non-transplant patients and <40 ml/min/1.73m2 for transplant patients based on the Schwartz Formula (Schwartz et al 1987) as determined at enrollment into Study 328.
  -  Impaired liver function defined as either acute liver disease or chronic liver disease with persistently elevated liver enzyme values judged clinically significant by the investigator.
  -  Currently using any medications that, in the opinion of the investigator could negatively affect the subject when given together with candesartan cilexetil.

Relevance to patient case: not relevant