araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

Summary: This study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs. The study method requires less time than the standard method.
  It is hypothesized that both methods would be suitable for use in egg donor cycles.

Detailed description: Currently a combination of medications is used to prepare the uterine lining of recipients for implantation in egg donor cycles. The protocol used most commonly is as follows: Initially the individual's own pituitary-ovarian system is suppressed using a GnRH agonist so there are not conflicting signals sent to the uterus. This is followed by hormonal medication identical to what is secreted by the ovaries to prepare the uterine lining for subsequent embryo transfer in donor egg cycles.This preparation typically takes a minimum of four weeks.
  This study will compare a different medication, a GnRh antagonist (which is commonly used in IVF) to suppress an individual's system during the preparation of the uterine lining. This protocol would generally take only two weeks to prepare the uterine lining.

Eligibility: Inclusion Criteria:
  -  recipients awaiting egg donation
  -  some ovarian function
  -  normal endometrial cavity
  Exclusion Criteria:
  -  submucosal myoma
  -  myoma(s) greater than 4 centimeters
  -  endometrial polyp
  -  DES exposure
  -  documented recalcitrant thin endometrium ( <7 mm)
  -  untreated vulvovaginitis
  -  active pelvic infection
  -  endometrial cancer or suspected/known hormonally sensitive cancers
  -  breast cancer
  -  thromboembolic disease
  -  cerebrovascular or coronary heart disease
  -  diabetes mellitus
  -  hepatic tumors or active liver disease
  -  severe hypertension
  -  headaches with neurologic disease
  -  cholestatic disease
  -  heavy smoking over age 35

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Eltrombopag for the Prevention of Chemotherapy Induced Thrombocytopenia

Summary: The purpose of this study is to study the effect of eltrombopag on chemotherapy induced thrombocytopenia. Thrombocytopenia is when there is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.

Detailed description: The combination chemotherapy regimen of gemcitabine and docetaxel has become an increasingly used treatment choice for subjects with advanced sarcomas. The regimen has shown activity in first and second line for subjects with metastatic uterine leiomyosarcoma, relapsed/refractory pediatric sarcomas, and improved progression-free survival and overall survival in persons with metastatic sarcoma when compared to gemcitabine alone. The regimen has additionally been recognized as a treatment option for subjects with advanced sarcoma.
  Chemotherapy-induced toxicity in the blood such as low platelet level is a common and often therapy-limiting side effect of treatment.
  There are two phases in this study. The purpose of the Phase I study is to determine the recommended dose of eltrombopag. The purpose of the Phase II study is to determine the safety, tolerability, and efficacy (how well the drug works) of eltrombopag in subjects who are receiving gemcitabine and docetaxel chemotherapy.
  Eltrombopag (Promacta) is an FDA approved drug for the treatment of chronic idiopathic thrombocytopenic purpura (ITP)- a condition of having an abnormally low platelet count. Eltrombopag is now being further investigated for other thrombocytopenic (low platelet)disorders.
  Participants will take the assigned dose of eltrombopag once a day starting five days before each cycle of chemotherapy and for 5 days after chemotherapy. Eltrombopag is not taken on the day of chemotherapy. Eltrombopag is taken orally.

Eligibility: Inclusion Criteria:
  -  Metastatic soft tissue or bone sarcoma
  -  18 years of age or older
  -  Adequate blood counts
  -  Adequate kidney and liver function
  -  At least 1 but no more than 3 prior systemic therapy regimens for this cancer
  -  Good performance status - able to carry out work of a light or sedentary nature
  Exclusion Criteria:
  -  Pre-existing hear disease such as congestive heart failure, or arrhythmia known to increase the risk of thromboembolic events (blood clots)
  -  Blood clot in the last 6 months, known clotting problem or platelet disorder
  -  History of brain cancer

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Retrospective Study to Evaluate the Feasibility of Ovarian Preservation in Patients With Endometrial Carcinoma

Summary: Endometrial cancer is one of the most common female malignancies in the United States, and has increased in incidence in Taiwan in recent decades.A recent population-based analysis noted that 4% of endometrial cancers occurred in women aged 40 years or younger, furthermore it is up to 15% in Taiwan according to the data of cancer registry. The standard treatment of endometrial cancer results in surgical menopause and places patients at risk for the long-term sequelae of estrogen deprivation. The goal of this study was to determine the frequency of a coexisting ovarian malignancy and to evaluate the outcome of ovarian preservation in women with treatment for endometrial cancer.

Detailed description: we reviewed the cases with early stage of endometrial cancer who have primary staging surgery between January 1989 to December 2009. The enrolled patients will be divided into two group (oophorectomy vs. ovary preservation) for analysis:the outcome and recurrence type.To evaluate the outcome of ovarian preservation in women with endometrial cancer .

Eligibility: Inclusion Criteria:
  -  early stage endometrial cancer after primary surgery exclusion criteria:
  -  MMMT, type 2 endometrial cancer

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

Summary: Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High prevalence in southeast and eastern Asia has been observed. At present, the cellular and molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.
  The RAS gene product has a key role in controlling cell growth and differentiation through its intrinsic GTPase activity. Point mutations that activate the RAS protein and its downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals. Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer and lung cancer. Studies from European and Japanese groups have recently described that activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF mutation in the same tumor as well as the results from Thailand. In this study, the investigators hypothesize copy number changes rather than genetic mutation of either KRAS or BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary tracts.


Eligibility: Inclusion Criteria:
  -  The patients diagnosed as biliary tact adenocarcinoma.

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Rubinstein-Taybi Syndrome: Functional Imaging and Therapeutic Trial

Summary: An exploratory phase 2 therapeutic trial in children from 6 to 21, RTS carriers, randomized to be treated either with sodium valproate with the usual pediatric dosage (30 mg/kg/j), or by placebo for one year.
  The investigator would like to include children because they could best profit from it due to their neuronal plasticity as CBP and EP300 take effect through neuronal and synaptic plasticity.
  The therapeutic effect of sodium valproate in RTS patients will be assessed thanks to a clinical approach (learning and memory neuropsychological evaluation, fine motor skills assessment by pointing), to a biological approach (histone acetylation functional tests), and to imaging (morphological and functional MRI).

Detailed description: Such a multidisciplinary approach has never been presented for this syndrome; it should enable us identifying specific cognitive and motor deficits and their association thanks to imaging markers. Assessing the various aspects of motor skills, i.e. primary (movements, standing at ease position, immobility) and complex motor skills (actions and behaviours, motor aspects of feelings and language expressions) is an integral part of the clinical examination in psychiatrics.
  The main interest of a functional capacity analysis is to be used as an index allowing the assessment of the nervous system's global capacities and the study of the connections between cognitive functions and motor skills Main objective: Evaluate long term memory with subtest "point location" - CMS and "image recognition" RBMT A patient is said to be responder if after one year his or her test result increase for one point at least one of the two tests : a increase of one point to "point location" or "image recognition".
  Double-blind phase 2 clinical trial, designed as a one-step Fleming design but with a control group. Rubival is a two-parallel group randomized trial:
  -  a placebo group of 20 patients
  -  a group of 40 patients taking sodium valproate (HDAC inhibitor) with an oral dosage of 30 mg/kg/jour

Eligibility: Inclusion Criteria:
  -  Children over 6 and under 21
  -  RTS confirmed by a genetic study with a CBP gene or EP300 gene mutation
  -  Sufficient cognitive capacities for neuropsychological evaluation
  -  Free and informed consent of the parents or guardians
  -  Children affiliated to or benefiting of the French social welfare system
  Exclusion Criteria:
  -  Contraindication to sodium valproate
  -  Women of reproductive age without effective contraception means
  -  Case history of sodium valproate treatment
  -  Monotherapy treatment for epilepsy with Lamictal with a dosage superior to 5 mg/kg/j
  -  Family history of severe hepatitis including drug
  -  Acute or chronic hepatitis
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Metformin for the Treatment of Endometrial Hyperplasia

Summary: The purpose of this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state.

Detailed description: This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH.

Eligibility: Inclusion Criteria:
  -  Be between the ages of 18-75 years old
  -  Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy
  -  Have no contraindications to short-term metformin therapy
  -  Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault formula
  -  Have normal serum transaminase values (AST and ALT)
  -  Need to be able to undergo metformin treatment for a duration of 12 weeks prior to repeat endometrial biopsy
  Exclusion Criteria:
  -  Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin
  -  Have a history of liver or renal dysfunction.
  -  Have a random glucose of ≤ 65 or ≥ 200
  -  Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol for 5 years or more may be enrolled in this study.
  -  Have a history of vitamin B12 deficiency
  -  Are pregnant
  -  Are currently taking insulin
  -  Are taking a drug that may significantly interact or influence the metabolism of metformin
  -  In the opinion of the investigator, the patient is felt not to be appropriate for the study

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health

Summary: The purpose of this study is to see whether it is feasible to conduct a study to determine if the use of hyaluronic acid (HLA) vaginal gel (HyaloGYN®) improves vulvovaginal health.
  This study aims to look at whether or not HyaloGYN® is effective in women with a history of hormone receptor positive cancer and experiencing vaginal and/or vulvar symptoms of estrogen deprivation following their breast and endometrial cancer treatment.


Eligibility: Inclusion Criteria:
  -  History of breast cancer or endometrial cancer confirmed at MSKCC or outside pathology report
  -  Breast cancer patients must be at least 3 months post-active treatment (including chemotherapy, radiation therapy, endocrine therapy, and/or maintenance therapy), but not greater than 5 years post-active treatment (exception: AIs are required, and monoclonal antibodies are allowed)
  -  Breast cancer patients must be currently on adjuvant aromatase inhibitors
  -  Endometrial cancer patients must be at least 3 months post-active chemotherapy and/or maintenance therapy treatment but not greater than 5 years post-active chemotherapy and/or maintenance therapy treatment. They must be at least 4 weeks post-radiation therapy (EBRT or IVRT) but not greater than 5 years post-radiation therapy.
  -  Endometrial cancer patients must have underwent surgical treatment (total abdominal hysterectomy ([TAH]/BSO)) and radiation therapy (external beam radiation therapy [EBRT] or IVRT)
  -  Currently have no clinical evidence of disease
  -  Menopausal at study entry as described by:
  -  Surgical menopause (TAH/BSO), or
  -  Age ≥ 50 years and cessation of menstruation for at least 1 year, or
  -  Age <50 years and cessation of menstruation for at least 1 year with estradiol level in post-menopausal range, or
  -  Rendered post-menopausal with the use of LHRH agonist
  -  Patients who are new visits to Female Sexual Medicine Program or patients are not consistently using any vulvovaginal health promotion strategies (e.g., pelvic floor exercises, dilator therapy, moisturizers) recommended by the Female Sexual Medicine Program Reporting being bothered by vulvovaginal symptoms of estrogen deprivation (i.e., vulvovaginal dryness or discomfort [pain with intercourse or examination])
  -  Without history of other cancers (excluding non-melanoma skin cancer)
  -  Women at least 18 years of age
  -  Able to read and speak English
  -  Able to participate in the informed consent process
  Exclusion Criteria:
  -  Inability to provide informed consent
  -  Vaginal bleeding of unknown etiology within 12 months of study entry
  -  Currently taking hormone replacement therapy [local or systemic] (Patients must discontinue for 2 weeks in order to be eligible prior to study enrollment)

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Epidemiological Analysis on Endometrial Cancer in Guangdong Province of China

Summary: Endometrial cancer is one of the most common gynecological cancers, and the incidence increasing in the world. However, there isn't any large sample data of endometrial cancer reported in China. Thus Endometrial cancer project of Guangdong province conduct a large multicentre clinical investigation about endometrial cancer.

Detailed description: Endometrial cancer project of Guangdong province is mainly conducted by the Department of Gynecology of the Third Affiliated Hospital of Sun Yet-sen University, and other 62 major hospitals in Guangdong province participate in this project. In this large multicentre clinical investigation, the endometrial cancer database including more than 10,000 cases has been established. Further the investigators will demonstrate the epidemiological characteristics, etiology, risk factors, clinical treatment and prognosis of endometrial cancer.

Eligibility: Inclusion Criteria:
  -  patients who was diagnosed with endometrial carcinoma from 2000 to 2010 in Guangdong province of China;
  -  patients with intact clinical and pathological information
  Exclusion Criteria:
  -  not included in the inclusion criteria

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Transvaginal Ultrasound in Women With Abnormal Uterine Bleeding

Summary: The objective of this study is to investigate the role of transvaginal ultrasound in detecting endometrial hyperplasia and endometrial cancer in women aged more than 35 presenting with abnormal uterine bleeding.


Eligibility: Inclusion Criteria:
  -  Premenopausal women aged over than 35
  -  Abnormal uterine bleeding (menorrhagia/menometrorrhagia/metrorrhagia)
  -  Accept transvaginal examination (pelvic examination and ultrasound)
  -  Informed consent
  Exclusion Criteria:
  -  Severe uterine bleeding resulting in unstable vital signs
  -  Pregnancy
  -  Current medications: anticoagulants, selective serotonin reuptake inhibitor (SSRI), antipsychotics, corticosteroids, hormones, herbs
  -  Intrauterine device
  -  Genital tract pathologies: infection, submucous myoma distorting uterine cavity
  -  Systemic diseases that may cause coagulopathies: Thyroid disease, liver disease, pituitary/ hypothalamus diseases
  -  Not able to retrieve endometrial tissue

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Myeloproliferative Neoplasms and Bone Structure

Summary: This is a clinical study to evaluate the effect of CMPN (Chronic myeloproliferative neoplasm) to the bone.
  The hypothesis is that patients with CMPN have a higher fracture-rate compared to the background population. We expect to find a lower BMD using conventional DXA scan (dual energy x-ray absorptiometry), and a change in other parameters using HR-pQCT (high-resolution peripheral quantitative computerized tomography).Biochemical bone markers is measured to support the hypothesis.

Detailed description: This is a clinical study to evaluate the effect of CMPN to the bone.
  Three individual cohorts are defined; a cohort consisting of 50 patients with Polycythemia Vera (PV), a cohort consisting of 50 patients with Essential Thrombocythemia (ET), and a cohort consisting of 25 patients with Primary Myelofibrosis (PMF).
  Patients are recruited from the Department of Hematology, Odense University Hospital.
  Interventions consist of:
  -  Conventional DXA scan to measure Bone Mineral Density (BMD).
  -  Experimental HR-pQCT to assess geometry, strength and microstructure of the bone in 3 dimension.
  -  Blood-samples are collected and frozen for later analyses of Biochemical Bone Markers: 1-CTP, Ctx, ALP (alkaline phosphatase)and P1NP.
  The outcome is compared to healthy control individuals.

Eligibility: Inclusion Criteria:
  -  Diagnosis of PV (according to WHO 2008 criteria), only JAK2-pos.(Janus kinase 2)
  -  Diagnosis of ET (according to WHO 2008 criteria), only JAK2-pos.
  -  Diagnosis of PMF (according to WHO 2008 criteria)independent of JAK2-status.
  Exclusion Criteria:
  -  Pregnancy
  -  Bone Diseases (Mb. Pagets, Myelomatosis, MGUS (monoclonal gammopathy of undetermined significance), osteogenesis imperfecta, Prim. hyperparathyroidism, osteomalacia.
  -  Drugs (Prednisone>3 mth, anti-osteoporotic drugs, anti-estrogen drugs.
  -  Presence of any psychologic condition or language barrier, which may interfere which a complete understanding, and arise ethnical considerations.

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: REM (Risk Of Endometrial Malignancy)

Summary: The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.

Detailed description: Objective: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help physician are needed, in order to triage patients into high and low risk of endometrial cancer (EC). The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account. Logistic regression algorithm was utilized to categorize patients into low and high risk groups for EC.

Eligibility: Inclusion Criteria:
  1. aged between 45 and 80 years;
  2. Eastern Cooperative Oncology Group performance status 0-2 according to World Health Organization (WHO) criteria;
  3. informed consent obtained from the patients.
  Exclusion Criteria:
  1. abnormal cardiac, haematological, renal, respiratory and/or hepatic functions;
  2. presence of a previous malignancy;
  3. presence of concomitant adnexal masses.

Relevance to patient case: not relevant
Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: BKM120 for Patients With PI3K-activated Tumors

Summary: The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility: Inclusion Criteria:
  -  Patient had a confirmed diagnosis of a solid tumor or hematological malignancy with the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer, prostate cancer or breast cancer.
  -  Patient's tumor was evaluated and pre-identified to have activation of the PI3K pathway, at a CLIA certified laboratory
  -  Patient must have received at least one prior treatment for recurrent metastatic and /or locally advanced disease and for whom no standard therapy options was anticipated to result in a durable remission.
  -  Patient must have had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines
  -  Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  Exclusion Criteria:
  Patient had received previous treatment with BKM120 Patient had symptomatic CNS metastases Patient had mood disorder as outlined in Section 5 Patient had received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

Relevance to patient case: not relevant