araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Clinical Evaluation of the HPV Assay on the BD Viper LT System With Cervical Specimens

Summary: The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.


Eligibility: Inclusion Criteria:
  -  Females who are >21 years of age
  -  Females who provide informed consent
  Exclusion Criteria:
  -  Known pregnant
  -  Cervical cytology specimen collected within the last 4 months
  -  Prior complete or partial hysterectomy involving removal of cervix
  -  Application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications
  -  Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
  -  Enrolled in a cervical disease diagnostic trial since 2007.

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study

Summary: This is a single-armed, open-labeled and single-centered study of everolimus in selective patients with metastatic melanoma for evaluation of the efficacy and safety. The study objective is to evaluate efficacy profile of everolimus.
  The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 18 months. Everolimus will be given in the dose of 10 mg orally each day at lease 6 months unless disease progression or intolerance. The follow-up is till death(at least 1 year).


Eligibility: Inclusion Criteria:
  Clinical diagnosis of metastases melanoma. Must have evidence of mutations(Kinase domain) of mTOR . Must be ECOG performance status 0,1, or 2 . Must be estimated life expectancy of 3 months or greater. Must be age 18 years or older, male or female. Must have at least one measurable site of disease as defined by at least 1 cm in greatest dimension.
  Adequate organ function. Must be willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  Exclusion Criteria:
  Prior systemic therapy for metastatic disease within 4 weeks. Second malignancy within the last 5 years. Severe and/or uncontrolled medical disease. Received RAD001 or other mTOR inhibitors previously . Hypersensitivity to everolimus Current treatment on another clinical trial. Pregnancy or breastfeeding.

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: The Kilimanjaro Cervical Screening Project

Summary: Although highly curable, cervical cancer kills thousands of women in developing countries annually. The investigators will pilot a project to improve detection of cervical cancer in Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise available in a large medical centre and remote use of a mobile phone camera application.


Eligibility: Inclusion Criteria:
  -  Female
  -  Over 18 years of age
  Exclusion Criteria:
  -  Previous removal of uterus

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)

Summary: This study is a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).


Eligibility: Inclusion Criteria:
  All Participants:
  -Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
  Boys and Girls 9 to 14 Years:
  -Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
  Women 16 to 26 Years:
  -  Has never had a Papanicolaou (Pap) test or only had normal Pap test results
  -  A lifetime history of 0 to 4 male and/or female sexual partners
  Exclusion Criteria:
  All Participants:
  -  Known allergy to any vaccine component
  -  History of severe allergic reaction that required medical intervention
  -  Thrombocytopenia or any coagulation disorder
  -  Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
  -  Currently immunocompromised, or been diagnosed with immunodeficiency
  -  Had a splenectomy
  -  Receiving or has received immunosuppressive therapies within the last year
  -  Received any immunoglobulin product or blood-derived product within 3 months
  -  Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: The Cancer of the Pancreas Screening-5 CAPS5)Study

Summary: Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.

Detailed description: The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.

Eligibility: Inclusion Criteria:
  -  Hereditary Pancreatitis or
  -  Peutz-Jeghers Syndrome or
  -  Strong family history of pancreas cancer on one side of the family tree or
  -  Confirmed germline mutation carrier (BRCA2, FAMMM, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC
  -  Endoscopic evaluation of pancreas scheduled
  Exclusion Criteria:
  -  Medical comorbidities or coagulopathy that contraindicate endoscopy
  -  Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis
  -  Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
  -  Poor performance status
  -  Inability to provide informed consent
  -  Pregnancy.

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity

Summary: This study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients. Such a study will allow the development of suitable immunological tools to be used in assessing response in a subsequent phase I study aiming at evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing tumors. In addition, this study will help defining the baseline cancer-associated immune responses in the selected patient population.
  Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this study.
  WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex vivo and cultured IFNg ELISpot as well as tetramer staining.


Eligibility: Inclusion Criteria:
  -  Specific Inclusion criteria
  -  For ovarian cancer patients: Histologically confirmed surgical diagnosis of high-grade serous (or undifferentiated) ovarian cancer
  -  For CIN3 and cervical cancer patients: Histologically confirmed diagnosis of CIN3 or cervical cancer
  -  For AML and CML patients: HLA-A2 positivity and diagnosis of AML or CML confirmed by bone marrow biopsy or peripheral blood
  -  Shared inclusion criteria
  -  No evidence of active progressive disease. For ovarian cancer patients, a woman with a rising CA125 and negative imaging is acceptable
  -  Age ≥ 18 yrs and < 70 yrs
  -  ECOG 0-2
  -  Adequate hematologic assessment (results from the previous standard of care visit):
  -  Absolute neutrophil count (ANC) greater than or equal to 1.0 x 109/L
  -  Platelets greater than or equal to 100 x 109/L.
  -  Written informed consent
  Exclusion Criteria:
  -  Treatment with chemotherapy, radiation therapy, other immunotherapy or non-topical steroids within the past 3 weeks prior to initiation of the study.
  -  Immunosuppressive therapy (excluding topical steroids) for any other condition.
  -  Recurrent/progressive disease confirmed clinically, radiologically or histologically before entry into the study. (exclude versus inclusion criteria)
  -  Persistent fever (>24 hours) documented by repeated measurement or active uncontrolled infection in the last 4 weeks.
  -  Active autoimmune disease, including, but not limited to, SLE, MS, ankylosing spondylitis.

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Outcome of Women With Cervical Cancer

Summary: Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed countries over the past 40 years, however, there has also been an increase in relative and absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix over the same period.
  Our understanding of the natural history and optimal management of AC is limited. It appears that AC and SCC of the cervix behave differently. They are different in epidemiology, prognostic factors, and patterns of failure after similar treatments. Available data suggest that they may also differ in their response to treatment. We postulate that new treatment strategies specifically tailored to AC should be explored.
  However, there is few data about outcome of cervical cancer in Taiwan. So we propose this proposal for retrospective analysis of clinicopathological parameters and outcomes in patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous carcinoma.


Eligibility: Inclusion Criteria:
  -  Time interval: from 1991 to date.
  -  Comprehensive surgical staging, debulking procedure, radiotherapy or chemotherapy.
  -  All female patients with cervical cancer who underwent treatment for cervical cancer at Far Eastern Memorial Hospital.
  -  All the patients diagnosed as cervical cancer, especially for women with adeno- and adenosquamous carcinoma.
  -  To review:
  1. Clinical data: including age at diagnosis, presenting symptoms, gravidity, parity, menstrual history, body mass index, history of diabetes, hypertension, personal history of cancer and staging.
  2. Pathologic information: deep stromal invasion, lymph-vascular space invasion, lymph node involvement, parametrium invasion, vaginal cut end and tumor size.
  3. Survival data: disease-free and overall survival.
  4. Radiation report, Chemotherapy treatment, operation, discharge and admission note.
  Exclusion Criteria:
  -  Not comprehensive staging/debulking procedure.
  -  Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.
  -  Female minors or disabled persons.

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Adjuvant Chemotherapy for Locally Advanced Cervical Cancer

Summary: Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.

Detailed description: Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%.
  This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.

Eligibility: Inclusion Criteria:
  -  Age 18-70 years
  -  Cervical cancer FIGO stage IIB-IVA
  -  Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
  -  ECOG performance status 0-2
  -  No history of other cancer except basal cell carcinoma
  -  Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3)
  -  Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl
  -  Consent to participate
  Exclusion Criteria:
  -  Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI
  -  Adnexal mass from physical examination or imaging study
  -  Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
  -  Pregnancy or lactation

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors

Summary: The project is a clinical behavioral research project based at University of Pennsylvania. The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and theory-based health promotion intervention to enhance cervical cancer prevention among young women ages 18-26 living in economically disadvantaged urban communities. The investigators will evaluate the intervention for feasibility, acceptability and preliminary efficacy.


Eligibility: Inclusion Criteria:
  -  Age 18-26 years
  -  Not yet received the HPV vaccine
  -  Speak, read, and understand 5th grade level of English;
  -  Had vaginal sex with a male partner in the past 2 months.
  Exclusion Criteria:
  • Currently pregnant and/or plan to be pregnant in next 6 months

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Cross-sectional and Questionnaire Study for Leg Lymphedema

Summary: The purpose of this study is to identify the incidence,feature,clinical significance for leg lymphedema after gynecologic cancer treatment.

Detailed description: Medical records will reviewed. And all patients who met the inclusion criteria will contacted by a telephone call by a clinical research coordinator. The telephone interview questionnaire for Lower Extremity Edema (LEE) and gynecologic cancer lymphedema questionnaire (GCLQ) will t take approximately 20-30 min to complete. The questionnaire for LEE included onset, severity, location, duration, and management. Patients will also questioned concerning deep vein thrombosis to exclude other causes of LEE. LEE is defined as subjective edema of lower extremity based on patients' complaint. LLL is defined based on a clinical diagnosis of lymphedema by a physician.

Eligibility: -  Inclusion criteria
  1. the patient who gynecologic cancer treatment at National Cancer Center , Korea(2001~2011)
  2. no active cancer treatment at the moment
  3. available telephone communication
  -  exclusion criteria 1. The patient unlikely to comply with the protocol
  <More information by cancer type>
  -  early ovarian cancer group Inclusion criteria were early stage epithelial ovarian cancer*, no active treatment, available telephone communication with patients, and ability and willingness to provide verbal informed consent.
  *early ovarian cancer (FIGO stage I and II) at National Cancer Center, Korea who underwent cytoreductive and staging surgery between January 2001 and December 2010
  -  locally advanced cervical cancer group patients with locally advanced cervical cancer who treatment at National Cancer Center, Korea between October 2001 and July 2007. Of 222 patients with locally advanced cervical cancer, 74 patients were underwent pretreatment laparoscopic surgical staging and 148 patients received radiotherapy . Women with locally advanced cervical cancer, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study.
  -  primary endometrial cancer group patients with endometrial cancer who underwent surgery, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Community Awareness, Resources and Education (CARE I): Project 3

Summary: Community Awareness, Resources and Education (CARE) Project - Project 3 will determine if Appalachian women have unique risk factors for an abnormal Pap smear that might contribute to the increased risk of cervical abnormalities, specifically cancer, in their communities.

Detailed description: The aim of CARE: Project 3 is to determine the social, behavioral, and biological variables that might contribute to increased risks of an abnormal Pap smear in Appalachian women in Ohio. To accomplish these aims, a case-control study was proposed. Women age 18 and older with an intact cervix, not pregnant, and no current or past history of invasive cervical cancer are recruited at the time of their scheduled Pap smear from clinics/physician practices in Appalachian region of Ohio. Women receiving Pap tests at participating medical clinics/physician practices are recruited for a case control epidemiologic study assessing HPV prevalence and its impact on cervical intraepithelial neoplasia (CIN). Cervical mucus will be collected for Human Papillomavirus (HPV) assays and stored for potential other assays related to HPV. Serum will be drawn for HPV serology and stored for future analysis. Controls are defined as women with a normal Pap smear. Cases are defined as women with abnormal Pap smear (from atypical squamous cells of uncertain significance (ASCUS) to cancer.

Eligibility: Inclusion Criteria:
  -  Female
  -  18 years or older
  -  Able to give informed consent
  -  Intact cervix
  -  No prior history of invasive cervical cancer
  -  English speaking
  -  Willing to have biological specimens stored for future studies
  -  Resident of Appalachian Ohio
  Exclusion Criteria:
  -  Pregnant
  -  Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance.
  -  Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Community-Driven Cervical Cancer Prevention in Western Kenya

Summary: There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will


Eligibility: Inclusion Criteria:
  -  Female, ages 25-65 Willing to sign informed consent Lives in community where randomization arm is
  Exclusion Criteria:
  -  Prior hysterectomy

Relevance to patient case: not relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Cervical Activation During Elastic and Manual Resistance

Summary: Cervical pain is a condition that affects 14.6% of all adults annually. Of this annual prevalence, 37.3% experience persistent neck pain with periodic recurring episodes. The purpose of this study is to compare muscle activation patterns of the cervical musculature during exercises with elastic versus manual resistance in a neck pain and asymptomatic populations. Methods: A convenience sample of 15 healthy, physically active participants and 15 current patients diagnosed with non-radicular cervical pain will be recruited. Exclusionary criteria will include: current cervical or upper extremity injury (healthy group), history of neck surgery, corticosteroid treatment within the last two weeks, and radicular signs or symptoms. Surface electromyography will be used to quantify the activity level of the bilateral SCM, AS, Cervical Paraspinal (CP), and the Upper Trapezius (UT) muscles while performing a series of 6 exercises with elastic resistance using Thera-Band® Resistance Bands and manual resistance. The area will be prepped and surface electrodes placed on the corresponding muscles. The movement will be standardized by using the peak activation (PA) of each muscle during full flexion-extension movement to create a percentage of peak activation (%PA). The testing battery will consist of 6 exercises with elastic resistance and manual resistance, totaling 12 different trials. Each trial will involve 5 repetitions, each held for 5 seconds. The exercises will include cervical: extension, flexion, left rotation, right rotation, left side bending, and right side bending. The men will use the green and women will use the red Thera-Band® Resistance Band. The order of exercises will be randomized in to two parts to minimize the effect of fatigue. First, cervical flexion and extension with manual and elastic resistance will be randomized. Secondly, the remaining 8 exercises will be randomized. Following each exercise, the patient will rate their perceived level of exertion on the Thera-band® Resistance Intensity Scale for Exercise (RISE).


Eligibility: Inclusion Criteria:
  -  healthy physically active subjects (healthy group)
  -  patients diagnosed with non-radicular cervical neck pain (neck pain group)
  -  18-65
  Exclusion Criteria:
  -  current cervical or upper extremity injury (healthy group)
  -  history of neck surgery
  -  corticosteroid treatment within the last two weeks
  -  radicular signs or symptoms

Relevance to patient case: not relevant