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

Clinical trial: Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears

Summary: RATIONALE: Written educational materials and counseling by phone may help promote follow-up care in women with abnormal Pap smears.
  PURPOSE: This clinical trial is studying how well written educational information and phone calls work in increasing follow-up care in Hispanic women with abnormal Pap smears.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the reasons for nonadherence to follow-up in Hispanic women with abnormal Pap smear findings.
  -  Assess the effect of written educational information and phone calls on follow-up rate in these patients.
  OUTLINE: This is a pilot, cross-sectional, controlled, multicenter study. Patients are sequentially assigned to 1 of 3 intervention groups.
  -  Group 1 (control): Patients complete a standardized Spanish survey questionnaire, assessing their demographic information, knowledge, attitudes, behaviors, experiences with cervical screening, past medical history, and prior treatment, either in person (for those who kept their colposcopy appointment) or over the telephone (for those who did not keep their colposcopy appointment). Additional questions are added for patients who did not keep their colposcopy appointment to test for differences and to learn the reasons for not keeping their appointment.
  -  Group 2 (written educational information): Patients receive notification of their colposcopy appointment and an educational letter about Pap smears, cervical cancer risk, and the purpose and procedure of colposcopy. They complete the standardized Spanish survey questionnaire as in group 1.
  -  Group 3 (phone call): Patients receive notification of their colposcopy appointment and a personal telephone call educating them about Pap smears, cervical cancer risk, and the purpose and procedure of colposcopy. They complete the standardized Spanish survey questionnaire as in group 1.
  All patients are asked to agree to submit residual Pap smear fluid to the Comprehensive Cancer Center of Wake Forest University tumor bank, and be included in a tracking system to insure future follow-up communications.

Eligibility: DISEASE CHARACTERISTICS:
  -  Abnormal Pap smear findings indicating the need for further treatment at the colposcopy clinic
  -  Scheduled for colposcopy at the Comprehensive Cancer Center of Wake Forest University
  -  No history of invasive cervical cancer
  PATIENT CHARACTERISTICS:
  -  Must be of Hispanic background, including any of the following:
  -  Hispanic
  -  Latino
  -  Chicano
  -  Mexican American
  -  Puerto Rican
  -  Cuban American
  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: Simple Versus Radical Hysterectomy for Stage I Cervical Cancer

Summary: The primary objective of this study is to assess the preferences (values and utilities) of women for complications and recurrences associated with the surgical treatment of cervical cancer. A secondary objective of this study is to compare the preferences of women at high-risk for developing cervix cancer with the preferences of women who have already been diagnosed with cervix cancer.

Detailed description: You will be asked to undergo a face to face interview. During the interview, you will be asked questions about your values and feelings about your health status. You will be shown a "feeling thermometer" and asked to rate how your health condition makes you feel. You will also be asked to rate how some of the risks of treatment of cervix cancer make you feel. You will be shown a "chance board" and asked to consider some of the possible outcomes of the disease and possible risks associated with the treatment of cervix cancer. You will be asked to consider the likelihood of achieving certain outcomes and of developing certain side effects due to the disease and/or treatment. The interview will take place in a private room in the clinic and should take around 20 minutes to complete.
  This is an investigational study. As many as 96 women will participate in this study. Up to 48 women who are at high risk of developing cervix cancer and up to 48 women who have been diagnosed with cervix cancer will participate. All will be enrolled at M. D. Anderson.

Eligibility: Inclusion Criteria:
  1. Women who are at least 18 years of age.
  2. Women who speak English
  3. Women presenting to the Colposcopy Clinic in the Gynecologic Oncology Clinic at M.D. Anderson Cancer Center OR women with an established diagnosis of either Stage IA2 or IB1 cervix cancer treated with radical hysterectomy 3-24 months prior to presenting to the Gynecologic Oncology
  Exclusion Criteria:
  1. Women who are not 18 years of age.
  2. Women who are non-English speakers.
  3. Women with a diagnosis of any type of cancer other than cervical cancer.
  4. Women who are currently pregnant.

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

Clinical trial: DNA Array Analysis of Patients With Cervical Cancer

Summary: The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation. Researchers will study a large number of genes located in tumor material to learn this information.

Detailed description: Patients in this study are already scheduled to begin radiation therapy. Researchers will get tumor cells by taking two biopsies of the cervix. The first biopsy of the cervical tumor will be done before any treatment is given. The second biopsy will be performed about 48 hours after the radiation treatment has begun. They will then study the cells in the lab with a new technique for studying gene expression called DNA array, as well as HPV analysis, quantification of apoptosis levels, hematoxylin and eosin staining, and storage of tissue for future research..
  The patterns of gene expression in the biopsies will be compared with the success of radiation treatments.
  Some of the material will also be stored and used in the future for other research projects.
  This is an investigational study. A total of 18 patients will take part in this study. All will be enrolled at UTMDACC.

Eligibility: Inclusion Criteria:
  1. Newly diagnosed cervical cancer: clinical Stage IB -IIIB
  2. Invasive pure squamous cell carcinoma
  3. Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation
  Exclusion Criteria:
  1. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation

Relevance to patient case: definitely relevant
Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Summary: The primary purpose of the study is to test the safety of HPV Vaccine in Women


Eligibility: Inclusion Criteria:
  -  Females age 16 to 23 years old
  -  Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit
  Exclusion Criteria:
  -  History of vaccination with an HPV vaccine
  -  History of hepatitis B infection
  -  History of vaccination with hepatitis B vaccine
  -  History of genital warts or treatment for genital warts

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

Clinical trial: Perceptions of Cervical Cancer Among Asian Americans

Summary: The goal of this research study is to learn about the beliefs, practices, and knowledge about cervical cancer among Asian American young adults. Researchers want to develop materials that will educate Asian Americans about cervical cancer and encourage them to get screened for this disease.

Detailed description: Survey:
  If you agree to take part in this study, you will complete a survey about your health practices and knowledge about cervical cancer and HPV. You will also be asked to provide some personal history on yourself such as your age, gender, birthplace, ethnicity, relationship status and educational level. Female participants will be asked to indicate if they have received an HPV test (also called a "Pap" test) within the last 3 years. The survey will take about 5-10 minutes to complete and will be filled out on the same day as the focus group.
  Focus Group:
  You will also take part in a discussion group called a "focus group." A trained focus group leader will guide you and 8-10 others through a series of questions. He/she will lead a discussion to hear comments, opinions, and observations on a brochure and poster about cervical cancer and HPV. Groups will be made up of participants of the same gender (that is, all male or all female) and ethnic group (Filipino, Korean, or Vietnamese). Each discussion group will last about 2 hours and may be audiotaped so that the discussion may be transcribed and analyzed. You will only be called by your first name and you are not required to use your real name during the focus group discussion. You will not be identified by the audiotape recordings.
  Length of Study:
  When the focus group discussion is over, you will be off-study.
  This is an investigational study. Up to 60 participants will be enrolled on this study. All will be enrolled at M. D. Anderson.

Eligibility: Inclusion Criteria:
  1. Self identified as Korean, Filipino, or Vietnamese
  2. Individuals 18-29 years of age
  3. Have a high school education or less (but not less than 4th grade)
  4. Able to read and speak English and one of these languages: Korean, Vietnamese, or Tagalog
  5. Lower socioeconomic status, defined as: for a household of 1, not more than $18,620 annual income, for a household of 2, not more than $24,980, for a household of 3, not more than $31,340, for a household of 4, not more than $37,700, for a household of 5, not more than $44,060, for a household of 6,not more than $50,420, for a household of 7, not more than $56,780 NOTE: The CDC has granted some flexibility with these income guidelines
  6. Not currently pregnant
  Exclusion Criteria:
  1) Household income greater than 200% of the federal poverty level

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

Clinical trial: A Prospective Study Examining the Barriers to Care for Harris County Cervical Cancer Patients

Summary: The goal of this behavioral research study is to look at the reasons that may prevent women from getting early treatment for their cervical cancer.

Detailed description: Little is known about what prevents women with cervical cancer from getting early and possibly curative treatment. This study consists of a series of questionnaires that ask questions about religion; coping; access to health care; physical, emotional, and spiritual well-being; understanding of health questions; control; fear; anxiety; and other health beliefs to determine why some women delay coming in for check-ups and why some women do not complete their treatments. It is thought that health beliefs influence behavior practices and that by identifying these issues, things can be done to improve the health condition and results for these patients.
  You will be asked to complete a series of questionnaires at 2 specific time points: The first time point will be before treatment begins and the second time point will be within a month following completion of treatment.
  Filling out the questionnaires should take about 45 minutes each time. You should have adequate time to complete these questionnaires during your clinic appointment.
  If you want to take part but are too ill to complete the questionnaires, you will be provided a pre-addressed, stamped envelope, so that you can mail them back to the study staff at your earliest convenience.
  This is an investigational study. This is an investigational study. Up to 150 patients will be enrolled at Lyndon B. Johnson General Hospital.

Eligibility: Inclusion Criteria:
  1) All newly diagnosed cervical cancer patients through Stage IVB presenting to the Lyndon B. Johnson General Hospital (LBJ) Gynecologic Oncology Clinic.
  Exclusion Criteria:
  1) Patients who are not English or Spanish speaking.

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 (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

Summary: The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)


Eligibility: Inclusion Criteria:
  -  Female between 16 to 26 years old
  -  Has never had Pap testing or have only had normal Pap test results
  -  Lifetime history of 0 to 4 sexual partners
  Exclusion Criteria:
  -  History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
  -  History of severe allergic reaction that required medical attention
  -  Are pregnant
  -  Received a marketed HPV vaccine
  -  Currently enrolled in a clinical trial
  -  Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

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

Clinical trial: Hydralazine Valproate for Cervical Cancer

Summary: The current standard for recurrent, persistent or metastatic cervical cancer is palliative chemotherapy with cisplatin topotecan, however, the results need to be improved. Epigenetic aberrations play an important role in cancer progression by silencing growth regulatory genes and there is now evidence that inhibitors of DNA methylation and HDAC inhibition synergize the cytotoxicity of chemotherapy.
  Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate plus standard cisplatin topotecan against placebo plus cisplatin topotecan upon progression-free survival.
  Hypothesis. Hydralazine and magnesium valproate associated to cisplatin topotecan will increase progression-free survival from 4.6 to 7.6 months as compared with the same regimen of chemotherapy plus placebo.

Detailed description: Randomized, double-blind phase III trial. A total of 143 patients (alpha 0.5, power 0.8)with metastatic, persistent or recurrent cervical cancer without previous systemic treatment will be randomized to cisplatin topotecan + placebo or cisplatin topotecan hydralazine valproate for 6 courses every 3 weeks. Patients will receive an oral dose of hydralazine of 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/Kg t.i.d. Both drugs in a slow-release formulation. Experimental drugs or placebo will start from seven days before day 1 of chemotherapy until the end of the sixth course.

Eligibility: Inclusion Criteria:
  -  informed consent, histological diagnosis of persistent, recurrent or metastatic cervical carcinoma; measurable disease by physical examination, CT Scan, MRI or PET-CT. Biopsy is required for confirmation only if the lesion is unique, has less than 2cm in the longest diameter or has no clearly defined borders.
  -  Patients should have no previous systemic treatment (could have received chemotherapy as radiosensitization to the pelvis and or para-aortic field.
  -  Aged >18 years, performance status 0-2 according to ECOG classification, and adequate liver, hematological and renal function, as defined by: hemoglobin >10 g/L, leukocytes >4000/mm3, platelets >100 000mm3; normal creatinine value and creatinine clearance >60 mL/min; total bilirubin < 1.5 upper normal limit value.
  Exclusion Criteria:
  -  History of allergy to hydralazine or valproate; past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician; newly diagnosed hypertension patients with or without pharmacological treatment are allowed as long as their treatment do not include hydralazine.
  -  Previous use of the experimental drugs (hydralazine and magnesium valproate) as well as if patients were pregnant or breast-feeding. Other exclusion criteria are uncontrolled systemic disease or infection.

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 (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

Summary: The purpose of this study is to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study are 1) V503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503 reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type 6/11/16/18 antibodies compared with GARDASIL.

Detailed description: The study includes a double-blind, dose-finding evaluation of a 3-dose regimen of 3 dose formulations of V503 and GARDASIL (Base Study Part A), a double-blind, safety/efficacy evaluation of a 3-dose regimen of the V503 dose formulation selected in Part A and GARDASIL (Base Study Part B), and an open-label extension consisting of 2 substudies: an evaluation of immune memory in participants receiving a fourth vaccination with V503 (Extension Cohort 1) and an opportunity for participants who received GARDASIL in the base study to receive a 3-dose regimen of V503 (Extension Cohort 2).

Eligibility: Inclusion Criteria:
  -  Female between 16- to 26-years-old
  -  Has never had Pap testing or has only had normal Pap test results
  -  For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in Part B of the base study and was in the per-protocol immunogenicity population for ≥1 HPV type
  -  For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized to GARDASIL in either Part A or Part B of the base study and received ≥1 dose of GARDASIL
  Exclusion Criteria:
  -  History of an abnormal cervical biopsy result
  -  History of a positive test for HPV
  -  History of external genital/vaginal warts
  -  Currently a user of any illegal drugs or an alcohol abuser
  -  History of severe allergic reaction that required medical attention
  -  Are pregnant
  -  Received marketed HPV vaccine or participated in an HPV trial
  -  Currently enrolled in a clinical trial
  -  Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent.)

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

Clinical trial: A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)

Summary: The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.


Eligibility: Inclusion Criteria:
  -  Females between 16- to 26-years-old
  -  Has never had Pap testing or has only had normal Pap test results.
  -  Lifetime history of 0 to 4 sexual partners
  Exclusion Criteria:
  -  History of an abnormal cervical biopsy result
  -  History of a positive test for HPV; History of external genital/vaginal warts
  -  Currently a user of illegal drugs or an alcohol abuser
  -  History of severe allergic reaction that required medical attention
  -  Are pregnant
  -  Received a marketed HPV vaccine
  -  Currently enrolled in a clinical trial
  -  Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent)

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

Clinical trial: Second-Line Treatments for Anovulatory Infertility in PCOS Patients

Summary: To date, it is still unclear the potential role of laparoscopic ovarian diathermy (LOD) in the management of polycystic ovary syndrome (PCOS)-related anovulatory infertility. Metformin administration, alone or combined with clomiphene citrate (CC), has shown to be an effective and attractive second-line treatment for ovulation induction in women with polycystic ovary syndrome (PCOS) after failure of CC treatment. The aim of the present study will be to compare in a randomized controlled fashion the efficacy of LOD with metformin plus CC administration in the treatment of the CC-resistant PCOS patients.

Detailed description: A total of 50 primary infertile anovulatory PCOS patients with documented CC-resistance will be enrolled and randomized into two groups of treatment of 25 subjects each. Group A will undergo diagnostic laparoscopy followed by metformin plus CC, whereas group B will undergo LOD followed by observation. Anovulatory patients will receive IM progesterone. The treatment will be of six months followed by nine-month of observation for pregnant patients. The incidence of spontaneous menses, and the pregnancy, abortion, and live-birth rates will be recorded.

Eligibility: Inclusion Criteria:
  -  PCOS
  -  Clomiphene citrate-resistance
  -  Anovulation
  -  Infertility
  Exclusion Criteria:
  -  Age < 18 or > 35 years
  -  Body mass index >35
  -  Neoplastic, metabolic, endocrine, hepatic, renal, and cardiovascular disorders or other concurrent medical illnesses
  -  Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs affecting hormone levels, carbohydrate metabolism, or appetite
  -  Pelvic diseases
  -  Previous pelvic surgery
  -  Suspected peritoneal factor infertility/subfertility
  -  Tubal or male factor infertility or sub-fertility

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

Clinical trial: Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

Summary: The purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for any increase in disease activity following receipt of the vaccine.

Detailed description: Each individual subject's participation is scheduled to last approximately two years. Patients will be given Gardasil injections at months 0, 2, and 6. Patients will have geometric mean titers (GMT) measured at 7, 12, and 24 months. Questionnaires about health and function will also be completed at each visit.

Eligibility: Inclusion Criteria:
  -  Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and sero-negative arthritis.
  Exclusion Criteria:
  -  Pregnancy
  -  Known allergy/sensitivity or any hypersensitivity to yeast or components of study drug or their formulation
  -  Systemic onset JIA with active systemic symptoms (systemic onset JIA with polyarticular features but no fever or rash may be included).
  -  Prior vaccination against HPV
  -  Known HPV infection
  -  Current or history of cervical cancer or cervical intraepithelial neoplasia (CIN).
  Males are excluded from this study because Gardasil® is currently approved only for females.

Relevance to patient case: not relevant