araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: VinCaT: Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer

Summary: The purpose of this study is to evaluate the activity and safety of the combination of vinorelbine, carboplatin and trastuzumab in HER2-positive metastatic breast cancer.

Detailed description: The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has improved survival in patients with Her-2 positive metastatic breast cancer, but newer combinations with less toxicity and cross resistance are needed. Early clinical studies have suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active against metastatic breast cancer, with less toxicity. In this phase II single center trial, 39 patients will be enrolled to evaluate the activity and safety of this combination.

Eligibility: Inclusion Criteria:
  -  Histological or cytological diagnosis of breast cancer
  -  Stage IV disease
  -  None or at most one prior treatment for metastatic disease (prior treatment with trastuzumab for metastatic disease is not permitted)
  -  Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of c-erbB2/neu (FISH+)
  -  ECOG Performance Status 0-2
  -  Age >18 and < 75 years
  -  Left Ventricular Ejection Fraction (LVEF) >50%
  -  Life expectancy >3 months
  -  Signed informed consent
  Exclusion Criteria:
  -  Absence of measurable or evaluable disease
  -  Life expectancy < 3 months
  -  ECOG performance status > 2
  -  History of prior malignancy in the last 5 years (other than adequately treated non-melanoma skin cancer or excised cervical carcinoma in situ).
  -  Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for metastatic disease)
  -  Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy with trastuzumab is permitted)
  -  Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl
  -  Creatinine > 1.5 x the upper normal limits
  -  GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper normal limits in absence of hepatic metastases
  -  GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper normal limits in presence of hepatic metastases
  -  Congestive hearth failure or history of congestive heart failure, unstable angina pectoris even if it is medically controlled, myocardial infarction, clinically significant valve disease, uncontrolled arrhythmia
  -  Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
  -  Male gender
  -  Pregnant or lactating women
  -  Refusal or incapacity to provide informed consent
  -  Inability to comply with follow up

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

Summary: RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.
  PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

Detailed description: OBJECTIVES:
  -  Characterize each woman's individual mammographic density (MD) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual MD longitudinal change and breast cancer risk.
  -  Examine whether these patients or healthy participants manifest different patterns of within-individual change in MD and evaluate predictors of across-individual differences.
  -  Determine whether the developmental profile of MD differs systematically between these patients and healthy participants.
  OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity.
  -  Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
  -  Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
  PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.

Eligibility: Inclusion Criteria:
  -  Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system
  -  Have at least 3 screening mammograms since 1994
  -  for cases, diagnosis with breast cancer between 2004-2006
  Exclusion criteria:
  -  having had irregular screening (less than 3 mammorgrams since 1994)
  -  Having breast implants
  -  Known carriers of BRCA1/BRCA2 genes
  -  Unable to give written consent

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters

Summary: RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.
  PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.

Detailed description: OBJECTIVES:
  -  Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.
  OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.
  Patients and their siblings are followed annually for 5 years.
  PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Pathologically confirmed invasive breast cancer (patient)
  -  No ductal carcinoma in situ
  -  Affected OR unaffected sibling
  -  Affected sibling must have had (or currently has) breast cancer only
  -  Unaffected sibling must be female
  -  No deceased siblings
  -  Must be a full-blood related sibling
  -  Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Acupuncture Treatment in Adults Undergoing Diagnostic OGD : A Double-Blind Placebo Controlled Randomized Trial

Summary: To find out how the application of acupuncture needles to the proposed acupuncture points: Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during Esophago-gastro-duodenoscopy (EGD)

Detailed description: Acupuncture is being used as one part of Chinese medicine for more than 2,500 years in treating diseases. Recent functional magnetic resonance imaging demonstrated that acupuncture can suppress the “pain” area in the brain so as to reduce the pain that felt by human subjects. Western medicine proposed the acupuncture mechanisms as to “provoke the release of endogenous substances” from central nervous system so in reducing pain. Many studies had been done using acupuncture in reducing pain for post-operation period, however, most of them were not very systematic and even some of them are leak of control group. Furthermore, to our knowledge, the use of acupuncture for reducing anxiety during EGD has not been previously investigated.

Eligibility: Inclusion Criteria:
  -  18-70 undergoing elective unsedatant diagnostic EGD
  -  belonging to American Society of Anesthesia (ASA) classes 1 to 2
  Exclusion Criteria:
  -  History of gastrectomy, esophagectomy, Whipple’s operation and other gastrointestinal operations
  -  ASA class 3 to 4
  -  Pregnancy
  -  Allergy to acupuncture needles
  -  Request sedation
  -  Previous experiences of EGD

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)

Summary: This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.


Eligibility: Inclusion Criteria:
  -  Male and female adults, 18 through 70 years of age, inclusive
  -  Diagnosis of Major Depressive Disorder according to DSM-IV criteria
  -  HAM-D17 total score > or = 22 at Screening and Baseline
  Exclusion Criteria:
  -  History of non-response to paroxetine
  -  Patients who have been previously treated with agomelatine
  -  History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
  -  Any current Axis I disorder other than major depressive disorder which is the focus of treatment
  -  Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
  -  Use of any psychoactive medication after the screening visit
  -  Female patients of childbearing potential who are not using effective contraception
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

Summary: The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.

Detailed description: Radiotherapy to Squamous Cell Carcinomas of the Head and Neck have been modified during the last decades by altered fractionation, the addition of concomitant chemotherapy or modification of hypoxia. By these modifications the locoregional control, disease-specific survival or overall survival have been increased but the price have been increased morbidity.
  The addition of antibodies against the Epidermal Growth Factor receptor (EGFR-I) may further increase the control and survival of patients with Squamous Cell Carcinomas of the Head and Neck when combined with radiotherapy and/or chemotherapy.
  The aim of the present study is to determine whether
  1. The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
  2. Whether disease-specific survival or overall survival is improved by addition of zalutumumab
  3. Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
  4. Acute and late toxicity to the treatment.

Eligibility: Inclusion Criteria:
  -  Histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx)
  -  Curative intent and no prior treatment
  -  Age > 18 years
  -  WHO performance 0-2 (incl.)
  -  No prior treatment with EGFr-I
  -  Informed consent according to local guidelines and national law
  -  The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
  -  Fertile women must use contraceptive devices (IUD or oral contraceptives)
  Exclusion Criteria:
  -  Rhinopharynx or carcinomas of unknown origin
  -  Distal metastases
  -  Other malignant diseases (prior or current) except from planocellular skin cancer

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: High Risk Breast Cancer Screening Program

Summary: Objectives:
  -  To screen population with high risk for breast cancer
  -  To promote the concept and importance of surveillance mammography
  -  To find out the incidence of breast cancer in population who are in high risk for breast cancer
  -  To collect blood samples for molecular analysis


Eligibility: Inclusion Criteria:
  -  Female
  -  > 40 years of age
  -  Women who have first-degree relative suffered from breast cancer
  -  Women who have first-degree relative suffered from ovarian cancer
  -  Family history of male breast cancer
  -  Family history of breast cancer (not necessarily first degree relatives) diagnosed before age of 40
  -  Family history of breast cancer (not necessarily first degree relatives) affecting 2 or more family members
  -  Personal history of ovarian cancer
  -  Personal history of premalignant conditions of breast and ovary
  Exclusion Criteria:
  -  Women with mammogram within one year

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Level of Physical Activities in Patients Before and After Breast Cancer Treatment

Summary: Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Detailed description: Introduction: Breast cancer is the most common malignant neoplasy in women. The risk for breast cancer in a lifetime is high among north-american women, about one out of eight, with 66% of the cases occurring after menopause and 15% when women are under 40 years old. Published cohort studies show clear evidences that women who practice intense physical activities have the risk for breast cancer reduced. The risk reduction for these women is 70%, and 10% for those who practice physical activities at a low level. During adolescence and adult age, moderate to intense physical activities may protect against a future breast cancer development. But some questions still need to be answered: Were women with a breast carcinoma diagnosis already physically active during life? Were there changes in these physical activities after treatment? Why? Objectives: The aim of this study was to identify the level of physical activities in patients before and after breast carcinoma treatment, and to observe if there were changes in the level of these activities. Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Eligibility: Inclusion Criteria:
  -  Patients whit diagnosis of breast cancer

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Prospective & Retrospective Data Collection of Breast Cancer Cases From 2000 to Present

Summary: Prospective & Retrospective data collection of breast cancer cases from 2000 to present


Eligibility: Inclusion Criteria:
  -  Patients with breast cancer

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Simvatstatin Used to Treat Pulmonary Hypertension

Summary: we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.

Detailed description: advanced pulmonary hypertension is refractory to the medication in use nowaday, especially pulmonary hypertension secondary to congenital heart disease or chronic pulmonary embolism.It is revealed that statins may intefere the pathogenisis of the pulmonary hypertension in many key poing, such as improving apotosis or inhiting the proliferation of pulmonary vascular smooth muscle cell. so we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.

Eligibility: Inclusion Criteria:
  -  pasp>50mmHg
  Exclusion Criteria:
  -  pasp<50mmhg

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 1)

Summary: The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion).


Eligibility: Inclusion Criteria:
  -  Advanced cancer, excluding cancer in the blood
  -  Availability of 10 tumor tissue slides
  Exclusion:
  -  Known brain metastases
  -  Severe nerve damage
  -  Significant cardiovascular disease
  -  Inadequate blood counts
  -  Inadequate liver or kidney function
  -  Inadequate thyroid function or uncontrolled thyroid disease

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Registry of Mastectomy for Breast Cancer Risk Reduction

Summary: This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.


Eligibility: Inclusion Criteria:
  -  Patients at an elevated risk for breast cancer.
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Local Surgery for Metastatic Breast Cancer

Summary: Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival

Detailed description: This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.
  In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.

Eligibility: Inclusion Criteria:
  -  Women with metastatic breast cancer at the initial diagnosis
  Exclusion Criteria:
  -  Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
  -  who have systemic morbidity that do not allows her to be in the trial,
  -  who have synchronous breast cancer at the contralateral breast,
  -  who have a previous cancer history or another primary cancer history and metastasis at the past,
  -  who have palpable lymph node/nodes at the contralateral axilla,
  -  who do not agree to participate the trial

Relevance to patient case: not relevant