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

Clinical trial: Polycystic Ovary Syndrome Genetics and Treatment Response

Summary: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age women. Women with PCOS have a high risk of prediabetes, type 2 diabetes and heart disease. The investigators have found a possible change in the DNA (genes of the body that encode all of our traits) that seems to be related to insulin resistance. In this study, the investigators will try to determine whether the change in the gene affects a woman's ability to respond to a common treatment for PCOS, metformin.
  These studies will uncover the change in a gene that might be one of the causes of PCOS. Discovering this gene will help better understand the diabetes and insulin abnormalities that are common in PCOS and will help us to better diagnose and treat PCOS to prevent the diabetes in these women.

Detailed description: Polycystic ovary syndrome (PCOS), which affects 7-10% of reproductive aged women, has traditionally been classified as a reproductive and dermatologic syndrome because of its high rate of infertility and the cosmetic complications of hyperandrogenism. However, it has become increasingly clear that insulin resistance is important in the pathogenesis of the disorder.
  There are a number of variants that have been determined to be associated with PCOS risk. The investigators will determine the effect of these variants on the phenotype and response to treatment in PCOS. Subjects with PCOS will undergo extensive phenotyping including adipose tissue biopsy, dual energy X-ray absorptiometry (DXA, bone density) scan to examine adipose stores, an intravenous glucose tolerance test to study insulin sensitivity and beta cell function, androgen stimulation and inflammatory markers. The phenotyping will be repeated after 3 months of treatment with metformin. The studies will determine whether the genotype at PCOS risk variants dictates phenotype and response to treatment with metformin. Discovering genes involved in the etiology of PCOS will help pull us out of the endless circle that has characterized our understanding of PCOS pathophysiology for many years. The proposal also has the potential to illuminate one etiology of insulin resistance, which is present even in lean women with PCOS, and the impaired glucose tolerance and diabetes found in over 40% of PCOS patients.

Eligibility: Inclusion Criteria:
  -  Polycystic ovary syndrome
  -  No medications for 1 month
  -  Good general health
  Exclusion Criteria:
  -  Smoker
  -  Acute infection or chronic disease
  -  Diabetes
  -  Trying to get pregnant
  -  Bleeding disorders

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

Clinical trial: Clinical Study in Post-operation Treatment of Cervical Cancer

Summary: The purpose of the research is to evaluate the effect of additional chemotherapy in postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion or tumor thrombi in the vascular system).

Detailed description: Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.

Eligibility: Inclusion Criteria:
  1. patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion;
  2. squamous carcinoma;
  3. age＜70;
  4. Gynecologic Oncology Group (GOG):0-2.
  Exclusion Criteria:
  1. negative nodes,surgical margin,and/or parametrium;
  2. No serious damage to the liver and kidney function, no hypertension,diabetes and other effects of therapy complications.

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

Clinical trial: Efficacy and Safety Study of Concurrent Chemoradiation Therapy to Treat Locally Advanced Cervical Cancer

Summary: Concurrent chemoradiation therapy with weekly cisplatin is the current standard treatment for patients with locally advanced cervical cancer. However, weekly cisplatin is related to renal toxicity and not convenient regimen. Recently, carboplatin has proved to be a good radiosensitizer and less renal toxicity. Weekly carboplatin is more convenient regimen for both patients and physicians. Weekly carboplatin may have similar efficacy with weekly cisplatin and may have more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy and safety of concurrent chemoradiation with weekly carboplatin in patients with locally advanced cervical cancer.


Eligibility: Inclusion Criteria:
  -  Previously untreated, histologically confirmed cervical cancer
  -  One of following histologic types Squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
  -  Age: 20-75 years
  -  GOG performance status: 0-2
  -  Adequate organ function Bone marrow: WBC ≥ 3,000/mm3, ANC ≥ 1,500/mm3, Platelet ≥ 100X103/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine < 1.25 × UNL, Liver : AST, ALT < 3 × UNL, T- bilirubin < 1.5 mg/ mm3
  -  Contraception during study treatment
  -  Informed consent
  Exclusion Criteria:
  -  Previous chemotherapy or pelvic radiation therapy
  -  Hormone therapy within 4 weeks
  -  Concomitant malignancy within 5 years except cured basal cell carcinoma of skin
  -  Uncontrolled medical disease
  -  Pregnant or lactating woman
  -  Etc.

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

Clinical trial: Hyperthermia Combined Brachytherapy in CCU

Summary: The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer. Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG score. Following the completion of radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45 minutes before and during the HDR BT. Follow-up examinations were scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained from these patients.


Eligibility: Inclusion Criteria:
  -  patients with locally advanced cervical cancer FIGO stage II - III
  -  signed informed consent for participation in the study
  Exclusion Criteria:
  -  patients with FIGO stage I and IV
  -  patients with poor performance status with contraindications for radical treatments

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

Clinical trial: The Association of G9a Protein and the Outcome of Patients With Cervical Cancer

Summary: G9a protein was approved to be highly associated with recurrence of breast cancer, gastric cancer, hepatocellular cancer, prostate cancer and lung cancer. Therefore, the aim of this study was to clarify the association and G9a protein and cervical cancer by analyzing the immunohistochemical staining of G9a protein to the histopathologic specimen of cervical cancer and clinical data.


Eligibility: Inclusion Criteria:
  -  cases with cervical cancer

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

Clinical trial: Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm

Summary: The purpose is to evaluate whether implementation of primary human papillomavirus (HPV) screening in the screening programme for cervical cancer improves the programme in terms of better cancer protection and better cost efficiency.

Detailed description: Primary HPV screening is a method with higher sensitivity than cytology for detection of high-grade cervical intraepithelial neoplasia, which is the precursor of cervical cancer. In particular, HPV test is a better test for revealing adenocarcinomas, since these cancers often show a normal cytology.
  Cervical cancer screening at age 60:
  Cytology is less effective in older women, and screening with cytology in women over 60 has no documented effect. Today a large part of cervical cancer develop in women older than 60, to whom no screening is offered. The prevalence of HPV is around 4% in this age group. Since we know that testing negative for HPV gives a better long-term protection against cervical cancer compared to cytology, primary screening for HPV in 60-year old women would give a longer lasting protection in this high-risk group compared with today.
  Cervical cancer screening at age 30-40:
  HPV screening is most cost effective above 35 years of age. The reason for this is that HPV is less prevalent at age 35 than in younger women and also because cervical cancer seldom develops before this age. Since the HPV test has a negative predictive value (NPV) of almost 100% this could lead to longer screening intervals, which would be improve cost-effectiveness.

Eligibility: Inclusion Criteria:
  Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No exclusion criteria.

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

Clinical trial: V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

Summary: This study will evaluate the long term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.


Eligibility: Inclusion Criteria:
  -  Healthy Japanese females
  -  Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
  -  Lifetime history of 0 to 4 male or female sexual partners
  -  No oral temperature ≥37.5 centigrade within 24 hours prior to injection
  Exclusion Criteria:
  -  Received a marketed HPV vaccine
  -  Prior abnormal papanicolaou smear (PAP) or biopsy showing CIN
  -  Known history of positive test for HPV
  -  Known history of genital warts
  -  Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
  -  History of splenectomy, known immune disorders, or receiving immunosuppressives
  -  Immunocompromised or diagnosed as having human immunodeficiency virus

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

Clinical trial: Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

Summary: The purpose of this study is to measure the levels of serum proteins and other biomarkers in cervical cancer patients. We believe that some of these markers may be useful in selecting patients for specific types of cancer therapies. These markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.

Detailed description: SPECIFIC STUDY AIMS
  Specific Aim 1: To use gene expression analysis of primary cervical cancers to identify a gene expression signature that predicts for lymph node metastases in this disease.
  Specific Aim 2: To predict lymph node metastases by performing multiplex measurements of cancer-associated proteins and cytokines using proximity ligation assay (PLA) on plasma samples.
  Specific Aim 3: To measure circulating human papilloma virus (HPV) DNA in the plasma samples of cervical cancer patients using real-time quantitative polymerase chain reaction (qPCR) and determine its ability to predict for nodal metastases.
  Specific Aim 4: To use deep sequencing to evaluate gene and sequence differences between cervical cancer patients with and without lymph node metastasis.

Eligibility: Inclusion Criteria:
  -  Patients must have a known or suspected cervical cancer.
  -  Age >=18 years.
  -  Patients must have no other active cancer at the time of diagnosis.
  -  Patients must have no history of a hysterectomy.
  -  Patients must be able to give informed consent.
  -  Patients must be willing to undergo a biopsy of the cervical tumor to provide tissue for the study.
  -  Patients must have completed a standard-of-care FDG-PET/CT prior to initiation of therapy, for assessment of lymph nodes.
  Exclusion Criteria:
  - Pregnant women

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

Clinical trial: Cervix Hypoxia FAZA

Summary: The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have an effect on how cervix cancer grows and responds to treatments like radiotherapy and chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300 patients. The use of PET scans to measure hypoxia may be better and simpler than the methods used previously.


Eligibility: Inclusion Criteria:
  -  Age ≥18 years
  -  Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
  -  TNM (7th edition) cT1-4, N0-1, M0-1
  -  Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
  -  No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
  -  A negative urine or serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age
  -  Ability to provide written informed consent to participate in the study
  Exclusion Criteria:
  -  Prior complete or partial hysterectomy
  -  Carcinoma of the cervical stump
  -  Inability to lie supine for more than 30 minutes
  -  Patients taking the drug disulfuram (Antabuse)

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

Clinical trial: Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening

Summary: This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) of two screening approaches:
  -  Novel approach: every 3 years high risk-human papillomavirus (HR-HPV) testing of (at home) self-collected samples with in-clinic cytology of HR-HPV positive women and referral to colposcopy of women with cytology > atypical squamous cells of uncertain significance (ASCUS); repeat HPV testing of HR-HPV positive but cytology negative women at one year;
  -  Currently recommended approach: for women < 30: every 3 years in-clinic cytology screening, with HPV based triage of women with ASCUS and referral to colposcopy of all women with squamous intraepithelial lesion (SIL) and/or HPV+ ASCUS; for women 30+, screening by Papanicolaou (Pap) and HPV, every 2-3 year (depending on previous history) with referral to colposcopy of those who are HPV 16/18+ or with cytology > ASCUS; retesting of those who are positive for other HR-HPV at one year.
  II. Compare these two approaches with respect to overall cost-effectiveness and acceptability.
  III. Determine the performance and cost-effectiveness of each approach in vaccinated and unvaccinated women < 30.
  OUTLINE: Participants are randomized to 1 of 2 arms.
  GROUP I (home-based HPV screening): Participants collect 2 vaginal specimens using polyester swabs. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.
  GROUP II (clinic-based standard of care screening): Participants undergo Pap testing. Participants with a positive Pap test undergo standard of care, including colposcopy, HPV testing, cervical biopsy and/or endocervical curettage (ECC). Participants with cervical biopsies showing precancerous changes requiring treatment may undergo loop electrosurgical excision procedure (LEEP) or are referred to appropriate care.

Eligibility: Inclusion Criteria:
  -  Able to provide informed consent in English
  Exclusion Criteria:
  -  Have had hysterectomy
  -  Currently pregnant
  -  Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years
  -  Received colposcopy of cervix within TWO years
  -  Received Pap test within ONE year
  -  Immunocompromised (positive human immunodeficiency virus [HIV] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs)
  -  Decisionally impaired adults requiring a legally authorized representative

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

Clinical trial: Cervical Cancer Screening Project Part C

Summary: This proposal has been developed through collaboration between the University of Minnesota and New American Community Services (NACS), and the research design is based on a needs assessment conducted by the community partner. The investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based Pap test. All participants will be given identical education materials on cervical cancer screening and HPV, currently in use by the Minnesota Sage Program.

Detailed description: The trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (HPV) testing for cervical cancer screening. The main objective is to estimate the successful screening completion rate among a sample of Somali women who have not undergone cervical cancer screening for three or more years. Women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based Pap test.

Eligibility: Inclusion Criteria:
  -  Somali female age 25-70 years
  -  have lived in the U.S. 10 years or less
  -  have not had a Pap test (by self report) in the last 3 years
  Exclusion Criteria:
  -  Women with a self reported past history of any of the following will not be eligible:
  -  total hysterectomy
  -  cervical cancer
  -  active history of cervical dysplasia

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

Clinical trial: Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer

Summary: Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor positive breast cancer patients
  Phase II multicenter 1:1 randomized clinical trial Total 208 patients
  Primary endpoint Clinical response rate
  Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy Toxicity profile of neoadjuvant letrozole, metformin

Detailed description: To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients

Eligibility: Inclusion Criteria:
  -  Estrogen receptor positive breast cancer
  -  Clinically measurable tumor size(stage II/III)
  -  No evidence of distant metastasis
  -  Postmenopause women 'Age≥60yr' OR 'previous bilateral oophorectomy' OR 'FSH>30 with no bleeding history within 1yr'
  -  ECOG 0-2
  -  Adequate hepatorenal, bone marrow function 'serum Cr<1.4mg/dL' AND 'Bilirubin< upper limit of normal x 1.5 AND 'AST/ALT < upper limit of normal x 1.8 AND 'ALP < upper limit of normal x 1.8 AND 'Hemoglobin >10 g/dL' AND 'ANC >1,500/mm3' AND 'Platelet >100,000/mm3'
  -  Spontaneous signed into the written informed consent
  Exclusion Criteria:
  -  Who does not meet the above inclusion criteria
  -  History of other carcinoma
  -  Uncontrolled infection
  -  History of psychiatric, epileptic disease
  -  Male breast cancer
  -  Diabetes 'HbA1c≥6.5' OR 'FBS≥126mg/dL'
  -  Hypersensitivity or intolerance to metformin
  -  Risk of metformin associated lactic acidosis 'Congestive heart disease of NYHA Class llll/IV' OR 'History of other acidosis' OR 'Alcohol intake more than either 3 bottles beer OR 1 bottle Soju'
  -  During medication of metformin, sulfonylureas, thiazolidinediones, insulin
  -  Diffuse microcalcification in mammogram
  -  Multiple OR bilateral OR inflammatory breast cancer
  -  Chemotherapy or endocrine therapy within 2yr due to history of breast cancer

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

Clinical trial: Concurrent Chemoradiotherapy for Cervical Cancer in Elderly Women

Summary: The purpose of this study is to evaluate the efficiency and safety of weekly Cisplatin /Liposome paclitaxel concurrent chemoradiothrapy in the treatment of locally advanced cervical cancer in elderly women.

Detailed description: Concurrent radiotherapy is the standard treatment of inoperable cervical cancer .Due to the physical conditions, elderly patients usually associated with medical complications, so generally just receive radiotherapy alone. Recently, some retrospective studies have shown that the impact of chemotherapy did not cause an increase in the complication rate among elderly patients as compared to younger patients with cervical cancer, and may improve the survival when concurrent with radiotherapy. Cisplatin and paclitaxel are two effective drug in treating cervical cancer, but whether they are safe enough for elderly when concurrent with radiotherapy, there are no clearly reports. In this study ,we replace the conventional dose chemotherapy with weekly cisplatin or lipsome paclitaxel , to compare the efficiency and safety of weekly cisplatin / liposome paclitaxel concurrent chemoradiotherapy and radiotherapy alone in the treatment of cervical cancer in elderly patients.

Eligibility: Inclusion Criteria:
  1. Histologically proven squamous carcinoma of cervix
  2. FIGO stageⅡB and ⅢB
  3. Over 65 years
  4. Do not receive other treatment
  5. Performance index ECOG grade 0 to 2
  6. Normal ECG
  7. Normal hematological parameters
  8. Normal renal and liver function tests
  Exclusion Criteria:
  1. Concomitant disease which may adversely affect the outcome
  2. Poor nutritional status
  3. Medical or psychological condition precluding treatment
  4. Previous treatment
  5. Concurrent treatment for any cancer

Relevance to patient case: not relevant