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

Clinical trial: Comparison of Post-surgery Adjuvant Therapy for Cervical Carcinoma

Summary: Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive.
  In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.

Detailed description: After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles.
  We have recruited 800 patients till November 2014.

Eligibility: Inclusion Criteria:
  -  Patients with newly histologically confirmed cervical carcinoma
  -  Original clinical stage must be Ib~IIa （FIGO）
  -  Age between 18-65
  -  With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
  -  More than 3 months survival is to expect
  -  Patients must give signed informed consent
  Exclusion Criteria:
  -  The presence of uncontrolled life-threatening illness
  -  Receiving other ways of anti-cancer therapy
  -  Residual tumor which can not be removed in the surgery
  -  Investigator consider the patients can't finish the whole study
  -  With normal liver function test (ALT、AST>2.5×ULN)
  -  With normal renal function test (Creatinine>1.5×ULN)
  -  WBC<4,000/mm3 or PLT<100,000/mm3
  -  Receive the external pelvic irradiation before the surgery

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

Clinical trial: Prevention of HPV in 20 to 45 Year Old Chinese Women (V501-041)

Summary: A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.

Detailed description: The Base Study V501-041 had a planned duration of 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The total duration of the study extension is expected to be approximately 48 months, until the requisite number of primary efficacy endpoint cases (HPV 16/18-related CIN 2 or worse) has accrued over the total study period (base study and extension).

Eligibility: Inclusion Criteria:
  -  Healthy women between the ages of 20 and 45
  -  Have used effective contraception for 2 weeks prior to starting in the study
  -  Does not have a temperature within 24 hours before the first injection
  Exclusion Criteria:
  -  Prior history of genital warts
  -  More than 4 lifetime sexual partners
  -  Have undergone hysterectomy
  -  Have active cervical disease or history of cervical disease

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

Clinical trial: Investigation of the Uterine Cervix Using CervicalMD

Summary: The purpose of this study is to demonstrate the CervicalMD device's ability to collect digital imagery suitable for a colposcopy examination.


Eligibility: Inclusion Criteria:
  -  Female
  -  Negative Pregnancy test
  -  Abnormal Pap smear
  -  18 years and older
  -  Presence of a cervix
  Exclusion Criteria:
  -  Pregnant
  -  Absence of a cervix
  -  Less than 18 years old
  -  Male

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

Clinical trial: Can Alternative Treatment Have an Impact on Cervical Dysplasia?

Summary: In this study two questions will be answered:
  -  can mindfulness meditation help cell-changed on the cervix to disappear?
  -  can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results?

Detailed description: 200 women, who have participated in cervical cancer screening and have mild dysplasia, will be randomized into two groups; an intervention group and a control group. The intervention group will be asked to do mindfulness meditation twice a week listening to instructions from a CD. 200 additional women having normal cervical screening results will also be included in the project.

Eligibility: Inclusion Criteria:
  -  Women aged 23-29 years
  -  Participated in cervical cancer screening
  -  Having mild dysplasia and normal screening results
  Exclusion Criteria:
  -  Women who have previously had dysplasia

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

Clinical trial: Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

Summary: This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.

Detailed description: The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.

Eligibility: Inclusion Criteria:
  -  Participant is in good physical health
  -  Participant has had a lifetime history of 0 to 4 sexual partners
  -  Females between 18-to-24 years
  Exclusion Criteria:
  -  Participant has a history of abnormal Pap test
  -  Participant has a history of positive test for HPV
  -  Participant has a history of recent or ongoing alcohol or drug abuse
  -  Participant is immunocompromised or has an autoimmune condition
  -  Participant has received immunosuppressive therapy within a year of screening
  -  Participant has previously received an HPV vaccine
  -  Participant is pregnant
  -  Participant has a history of external genital/vaginal warts
  -  Participant is currently enrolled in a clinical trial
  -  Participant has a history of a severe allergic reaction that required medical attention

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

Clinical trial: Retrospective Study of the Relationship Between Human Papillomavirus Genotype and Cervical Epithelial Lesions

Summary: Human papillomavirus (HPV) infection plays a key role in the carcinogenesis of cervical cancer and pre-invasive lesions. There are hundred types of HPV, including high risk and low risk types, and it is proved the close association between the cervical cancer and high risk HPV. While HPV 16 and 18 are known to be the leading two genotypes detected in women with cervical neoplasm worldwide, there is considerable difference in the other prevalent high risk genotypes in different geographic areas. It is important to establish the local database about the cervical intraepithelial lesions and the related prevalent HPV genotypes. The investigators designed a retrospective study which included total 784 patients managed at our hospital from January 1, 2000 to December 31, 2007. The present study was to investigate the HPV genotypes in the Taiwanese female patients with abnormal cervical cytology and analyses the association between HPV types and cervical pre-invasive lesions. It could provide the guide for the clinicians in the management of patients with abnormal cytological change of Pap smear.


Eligibility: Inclusion Criteria:
  -  Healthy volunteers
  -  People infected with HPV type 16 but without CIN lesions
  -  Patients with CIN lesions
  -  Patients with cervical cancer from National Taiwan University Hospital
  -  Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards.
  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: Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis

Summary: The purpose of this study is to:
  1. make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer.
  2. reduce screening costs, screening and benefits into quantitative evaluation, for our country to develop cervical cancer prevention and control strategy to provide a reliable theoretical basis.

Detailed description: 1. To carry out large-scale prospective randomized controlled clinical study to evaluate the "cytological molecular markers Detect + P16INK4A" methods of screening accuracy and reliability, as well as the screening method of the biological effects.
  2. Markov set up mathematical model of screening tests to quantify the inputs and the evaluation proceeds. With a view to optimize and perfect a simple, convenient, practical and efficient program of cervical cancer screening.

Eligibility: Inclusion Criteria:
  -  Married women aged 25 to 65-year-old with risk factors
  -  No tumor and pelvic radiation therapy history
  -  Non-pregnant women at present

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

Clinical trial: Salt Loading and Thiazide Intervention Study

Summary: Although hypertension can be easily diagnosed and there are many medications available to treat hypertension, this condition is poorly managed in many patients and is a leading cause of morbidity and mortality worldwide. Because a newly identified hypertension susceptibility gene, STK39 (Serine Threonine Kinase 39), plays a central role in kidney sodium transport, the investigators propose a pharmacogenetics study to examine the relationships between STK39 genotypes and responses to salt loading and to thiazide diuretics, hydrochlorothiazide. The investigators hypothesize that STK39 genotypes will be associated with the outcome of both interventions and can contribute to personalized care for hypertension by predicting patients most likely to effectively control their blood pressure by adopting salt-reducing diet and taking thiazide diuretics.


Eligibility: Inclusion Criteria:
  -  Old Order Amish
  -  Age 18 to 65
  -  Have systolic blood pressure between 120 and 160 and diastolic blood pressure between 80 and 100
  Exclusion Criteria:
  -  History of myocardial infarction, stroke, congestive heart failure, liver disease
  -  Known cause of secondary hypertension
  -  Diabetes or Fasting glucose > 100 mg/dL
  -  Women who are pregnant, on oral contraceptives, or menstruating
  -  Used hydrochlorothiazide (HCTZ) in the last 8 weeks or known allergy to HCTZ
  -  Taking non-steroidal anti-inflammatory drugs
  -  Estimated glomerular filtration rate < 80 mL/m
  -  Intention to alter dietary habit during the study
  -  Abuse of alcohol or drug

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

Clinical trial: Cyclooxygenase-2 Expression in Tissue Samples From Patients With a Normal Cervix, Cervical Intraepithelial Neoplasia, or Early Invasive Cervical Cancer

Summary: RATIONALE: Studying samples of tissue from patients with or without cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at cyclooxygenase-2 expression in tissue samples from patients with a normal cervix, cervical intraepithelial neoplasia, or early invasive cervical cancer.

Detailed description: OBJECTIVES:
  -  Determine cyclooxygenase-2 (COX-2) levels in biopsy or surgical specimens from patients with normal cervical epithelium, cervical intraepithelial neoplasia, or microinvasive squamous cell carcinoma of the cervix.
  -  Correlate COX-2 levels with histological diagnosis and parameters of invasion (i.e., matrix metalloproteinase, microvessel count, and VEGF).
  OUTLINE: Paraffin-embedded tissue samples are analyzed by immunohistochemistry for evaluation of cyclooxygenase-2 levels, microvessel count, and matrix metalloproteinase and VEGF expression.
  Medical data for study analysis is obtained by retrospective review of patient charts.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets 1 of the following criteria:
  -  Underwent hysterectomy with removal of a normal cervix for diagnosis unrelated to cancer or cervical dysplasia
  -  Underwent cervical biopsy or removal of cervical tissue and diagnosed with cervical intraepithelial neoplasia (CIN) grades 1-3
  -  Underwent cervical biopsy and diagnosed with microinvasive squamous cell carcinoma of the cervix
  -  Paraffin-embedded tissue samples of normal cervical epithelium, CIN, or microinvasive squamous cell carcinoma of the cervix must be available for examination
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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 Detection Using Optical Spectroscopy

Summary: The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.


Eligibility: Inclusion Criteria:
  -  undergoing colposcopy for the diagnosis of cervical cancer
  -  LEEP for the treatment of cervical cancer in early stages.
  Exclusion Criteria:
  -  Women under the age of 18 (minors) will be excluded from this study.
  -  patients will be excluded if she has had a recent episode of bleeding or preterm labor.
  -  Subjects who are not competent to give consent will excluded

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

Clinical trial: DNA Cytometry for Cervical Cancer Screening in China

Summary: Very few screenings of any kind will be possible during a woman's lifetime in most low-resource regions, where 80% of the half-million global cases of cervical cancer occur every year. Although a single round of human papillomavirus (HPV) testing was associated with a significant decline in the rate of advanced cervical cancers and associated deaths, whether other methods like as DNA image cytometry can be used as an more accurate means than others in screening cervical cancer or not is yet to be verified. In addition, the accuracy of both DNA image cytometry and conventional cytology is not well known. The investigators hypothesized that DNA image cytometry was superior in screening cervical cancer than conventional cytology.


Eligibility: Inclusion Criteria:
  -  Currently or had been married
  -  Not pregnant
  -  Had an intact uterus with no prolapse
  -  Had no history of cervical cancer
  -  Living in China
  Exclusion Criteria:
  -  Not willing to participate or finish the study at any time
  -  History of cervical surgeries

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

Clinical trial: Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer

Summary: RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment.
  PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Measure quality of life (QLQ-C30) at week 18 in patients with metastatic gynecological cancer receiving systematic nutritional supplements during first-line chemotherapy.
  Secondary
  -  Study the maintenance or improvement of intake and nutritional status.
  -  Study the quality of life during chemotherapy.
  -  Evaluate tolerance and compliance to treatment with nutritional supplements.
  -  Evaluate the feasibility of and the tolerance to chemotherapy.
  -  Measure the overall survival over 18 weeks.
  -  Analyze the cost-effectiveness of different strategies of nutritional care.
  OUTLINE: Patients are randomized to 1 of 3 treatment arms.
  -  Arm I: Patients are monitored via standard follow-up assessments every 3 weeks.
  -  Arm II: Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
  -  Arm III: Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks with additional biweekly assessments completed at home by a service provider.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed gynecological cancer
  -  Currently receiving first-line chemotherapy for metastatic disease
  PATIENT CHARACTERISTICS:
  -  WHO performance status (PS) 0-2 or Karnofsky PS 70-100%
  -  Not pregnant or nursing
  -  Intake < 75% of theoretical need
  -  Weight loss ≥ 5% within the past 6 months
  -  No patients with dementia or altered mental status
  -  No psychological, familial, social, or geographic situations that preclude clinical follow up
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No concurrent radiotherapy

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

Clinical trial: Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study

Summary: Rationale: Diagnostic procedures, such as positron emission tomography (PET) using fluorodeoxyglucose (FDG), may help determine response to standard cancer therapy in patients with cervical cancer
  The purpose of this study is to evaluate the change in cervical tumor heterogenity as measured by FDG-PET/CT imaging.


Eligibility: Inclusion Criteria:
  1. Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa)
  2. Age ≥ 18
  3. Able to receive chemoradiation therapy with Cisplatin.
  4. Non-pregnant status in women of childbearing potential.
  5. No other active cancer at the time of diagnosis of cervical cancer Patients cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
  6. Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year.
  7. Scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging of cervical cancer at Barnes-Jewish Hospital Clinical PET Facility on a Biograph 40 PET/CT scanner
  8. Able to give informed consent
  Exclusion Criteria:
  1. Age < 18
  2. Patients with a known active malignancy other than cervical carcinoma.
  3. Pregnant and breastfeeding patients.
  4. Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging

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

Clinical trial: Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study

Summary: The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus erythematous and compare the antibody response with an equal number of age-matched healthy women.

Detailed description: Genital infection with human papillomavirus (HPV) is one of the most common sexually transmitted infections in Hong Kong. Most cases of HPV infection are asymptomatic. However, in some individuals, especially those patients who are immunocompromised, HPV infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (CIN) and rarely cervical cancer.
  Systemic lupus erythematosus (SLE) is a disease that predominantly affects women of the childbearing age. Patients with SLE are at risk of persistent HPV infection. This is because of the immunosuppressive state induced by various treatments. The prevalence of abnormal Pap smears and cervical squamous intraepithelial neoplasia (CIN) in SLE patients is higher than that in age-matched healthy women. Thus, prevention of HPV infection is important in patients with SLE to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.
  The quadrivalent HPV vaccine, GARDASIL is effective in reducing the occurrence of high-grade CIN lesions and anogenital disease elated to HPV-16 and HPV-18 infection. Vaccination of young women aged 16 to 23 years resulted in seroconversion rates of more than 99% for all the HPV types (6,11,16,18) and was well tolerated. There has been very little information regarding the efficacy of the quadrivalent HPV vaccine in immunocompromised hosts. The objectives of the current study are to evaluate the immunogenicity and safety of the quadrivalent HPV vaccine in a group of patients with SLE in terms of antibody conversion. Comparison will be made with an equal number of age-matched healthy women.

Eligibility: Inclusion Criteria:
  SLE patients
  -  Female patients aged ≤ 35 years
  -  Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
  -  Having received a stable dose of prednisolone and/or other immunosuppressive agents within 3 months of study entry
  -  Able to give written informed consent
  Controls
  -  Women aged ≤ 35 years, matched those of SLE patients recruited
  -  No known chronic medical diseases
  -  Not receiving any long-term medications including herbs
  Exclusion Criteria:
  -  History of allergy to HPV vaccines

Relevance to patient case: not relevant