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

Clinical trial: Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes

Summary: The purpose of this study is to understand the role bacteria that normally live in the colon may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer. The investigators will collect stool specimens as well as additional colon biopsy specimens during the patient's scheduled colonoscopy procedure. The investigators will also collect a questionnaire about diet and lifestyle. The samples will be used to study the impact of diet on naturally-occurring oral and gut bacteria and their influences on human health including risk of cancer.


Eligibility: Inclusion Criteria:
  -  Male or Female age 18 or older
  -  Hereditary colorectal cancer syndrome with one of the following:
  -  Lynch syndrome, as defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes
  -  Other hereditary colonic polyposis syndromes, as defined by the presence of a deleterious germline mutation in any one of the following polyposis genes (APC, biallelic MYH, STK11, SMAD4, BMPR1A, or other CRC-risk associated genes at discretion of PI)
  Exclusion Criteria:
  -  Unable to provide informed consent for testing
  -  Unable to complete English language questionnaire
  -  Receiving active chemotherapy
  -  Having completed active chemotherapy less then 12 months prior to day of scheduled lower endoscopy
  -  No infectious or drug induced colitis less then 12 months prior to day of scheduled lower endoscopy
  -  No history of inflammatory colitis (Crohn's disease or ulcerative colitis)

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

Clinical trial: Effect of Fee on Attendance in Cervical Cancer Screening

Summary: Several reasons can explain non-attendance in cervical cancer screening. In low resource settings the attendance is even lower. The effect of fee as contributing reason of non attendance has not been studied before why the investigators decided to study this in a low resource setting as a randomised trial.

Detailed description: Non-attendance in the cervical cancer screening programme is the most important factors why Swedish women contract the disease. Low attendance rate is observed in districts with low socioeconomic resources. Several reasons can explain this, including the existence of a fee. A low attendance rate in low resource districts is also noticed in Gothenburg, Sweden. After multiple interventions the coverage has slightly increased. None of the interventions included the aspect of the fee. The investigators decided to study the effect of fee abolishment in a randomized control trial emanating from the regular cervical cancer-screening program. Method: Randomized Control Trial (RCT). Women in low resource areas of Gothenburg, due for screening, January-July 2013, were randomised to receive an offer of a free test or receiving the regular invitation stating the regular fee of 100 Swedish kronor (SEK) (≈11 €). Power calculation has shown 80 % power to detect an increase in participation of 20% at 1972 participants.

Eligibility: Inclusion Criteria:
  -  All women in the designated geographical area, consecutively enrolled in planned screening according to standard routine. I.e women are invited if they are between 23 and 60 years of age and don't have a pap smear registered the last three or five years according to age.
  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: Two-dose Schedule of Quadrivalent HPV Recombinant Vaccine in 11-year-old Boys in Mexico City

Summary: In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most common oncogenic "high-risk" genotypes and cause approximately 70% of all cervical cancers despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are HPV associated. A large number of studies, including both adult and young females, have demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection against infection. Immunogenic vaccination results in young men and boys are equally satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men. The recommended vaccination scheme includes three shots giving the second at two months and the third at six months after the initial shot. Recently, it has been shown that the use of a two shot scheme (0 and 6 months) is equally effective among girls. The purpose of this study is to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared with young women and girls.


Eligibility: Inclusion Criteria:
  -  All those children whose parents accept their participation in the study.
  Exclusion Criteria:
  -  Fever,
  -  previous vaccination against HPV,
  -  allergy to vaccine components,
  -  thrombocytopenia,
  -  immunosuppression,
  -  diarrhea,
  -  vomiting,
  -  dyscrasia,
  -  administration of another anti-viral vaccine in the previous 15 days.

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

Clinical trial: NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Cervical Cancer FIGO Stage IB2 and IIB

Summary: Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in patients with cervical cancer FIGO IB2 and IIB.

Detailed description: The optimal treatment for patients with cervical cancer on FIGO stage IB2 and IIB is controversial. There is no randomized comparison of a dose-dense NACT (TP or TIP-schedule) followed by hysterectomy and LNE (investigational Arm A) versus primary chemo-radiation (standard arm B). Primary endpoint is the DFS at 5 years, secondary endpoints local control at 5 years, OS at 5 years, QOL, questionnaires on sexual activity/QOL.

Eligibility: Inclusion Criteria:
  -  >18 years
  -  cervical cancer FIGO IB2, IIB,
  -  squamous cell, adeno or adenosquamous cell carcinoma
  -  informed consent
  Exclusion Criteria:
  -  small cell/neuroendocrine component
  -  previous radiation, previous cancer
  -  pregnancy
  -  HIV
  -  severe co-morbidities

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

Clinical trial: Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Women

Summary: The purpose of this project is to determine whether outreach to HIV-negative women who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates among these women. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective.

Detailed description: To the investigators' knowledge, this study will be the first to assess the efficacy of email in cervical cancer screening outreach in a randomized controlled trial. It will also be one of the few randomized controlled trials to directly compare different outreach media directly, as opposed to different variations within a single medium (e.g. two different types of letters). Lastly, given the unique patient demographic makeup at Fenway, including a significant number of lesbian and bisexual women and transmen, secondary subanalyses have the potential to significantly add to the investigators' knowledge of what media work best in conducting cervical cancer screening outreach with sexual and gender minorities, who are disproportionately underscreened compared to heterosexual cis-gendered women.

Eligibility: Inclusion Criteria:
  -  Female or female-to-male transgender patients with a cervix
  -  HIV-negative
  -  Medical appointment at Fenway Community Health during calendar year 2012 who have not had a Pap smear in the past 3 years (since January 2010)
  Exclusion Criteria:
  -  HIV-positive (due to different Pap testing guidelines)
  -  Male-to-female transgender patients
  -  Patients with a history of a hysterectomy, unless specified as partial or supracervical
  -  Patients aged 30-64 who had a negative Pap test in the past 5 years with simultaneous negative Human papillomavirus infection (HPV) co-testing

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

Clinical trial: Irreversible Electroporation(IRE) For Uterine Cervical Neoplasms

Summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Uterine Cervical Neoplasms.

Detailed description: By enrolling patients with unresectable Uterine Cervical Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Uterine Cervical Neoplasms.

Eligibility: Inclusion Criteria:
  -  Uterine Cervical Neoplasms diagnosed by positive biopsy or non-invasive criteria,
  -  Not suitable for surgical resection,
  -  Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  -  A prothrombin time ratio > 50%,
  -  Platelet count > 80x10^9/L,
  -  Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
  -  Able to comprehend and willing to sign the written informed consent form (ICF),
  -  Have a life expectancy of at least 3 months.
  Exclusion Criteria:
  -  Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
  -  Any active implanted device (eg Pacemaker),
  -  Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  -  Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
  -  Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

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

Clinical trial: Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

Summary: Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and comparing the results to those acquired from a control cohort undergoing VCE for accepted indication at our centre.

Detailed description: Investigation for suspected SB tumors is an acceptable indication for VCE. SB polyps occur frequently in patients with FAP/PJS and in patients with FAP, they are significantly more common in patients with Duodenal/Ampullary polyps. Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps.
  The primary hypothesis is that patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas have a higher prevalence of small bowel polyps compared with patients undergoing VCE for various indications who have not had a duodenal polyp diagnosed or removed.
  Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital will receive VCE examination. Control population will consist of age matched controls having VCE for OGIB/IDA at Westmead hospital. Patients will be required to have had a documented colonoscopy within the previous three years. If colonoscopy was not performed within this time frame, the patient will have a colonoscopy as part of the study protocol.

Eligibility: Inclusion Criteria:
  -  Cases - Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014.
  -  Controls - Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA).
  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: A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck

Summary: BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree and squamous cell carcinoma of the head and neck.
  Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.


Eligibility: Inclusion Criteria:
  1. Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck.
  2. Progressive disease after ≥ 1 prior chemotherapy regimen.
  3. Patients with brain metastases are eligible if asymptomatic and neurologically stable for at least 4 weeks and are not taking any medications contraindicated
  4. Chemotherapy must have been completed at least 4 weeks prior to initiation of study medication
  5. ECOG performance status 0-1
  6. Tumors must have measurable disease as per RECIST (version 1.1);
  7. Female or male, 18 years of age or older
  8. Adequate organ function
  9. Life expectancy of > 3 months
  Exclusion Criteria:
  1. Current treatment on another therapeutic clinical trial
  2. Prior treatment with docetaxel within 6 months of enrollment
  3. Stage II, III or IV cardiac failure
  4. Carcinomatous meningitis
  5. Ongoing cardiac dysrhythmias
  6. Peripheral neuropathy
  7. Serious concomitant conditions
  8. Pregnant or breast feeding
  9. Known sensitivity to ferumoxytol
  10. Hypersensitivity to polysorbate 80

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

Clinical trial: Hemostatic Procedure After Biopsy of the Cervix

Summary: Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of Independent factors such as Age and Body mass index.


Eligibility: Inclusion Criteria:
  -  abnormal pap smear
  -  first colposcopy ever
  Exclusion Criteria:
  -  pregnancy
  -  bleeding disorder
  -  the use of blood thinner
  -  language barrier
  -  unwillingness to participate

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

Clinical trial: Connected to Care: Use of Mobile Short Message Services to Improve HPV Care

Summary: This study evaluates the effect of the mobile phone intervention 'Connected to Care' on the attendance rate to cervical cancer screening check-up appointments.

Detailed description: Connected to Care is a two-site RCT (Randomised Clinical Trial), in which the effect of an mHealth intervention is compared to standard of care in a group of women who are undergoing VIA (Visual Inspection with Acetic Acid) and are tested for HR (High-Risk) HPV (Human Papilomavirus). Post testing, HPV-positive women receive a home visit by a community health worker where they are informed about the result of their HPV-test and invited to a check-up appointment 12 months later. In the 12-month period that follows, the intervention group receives mHealth (Mobile Health) messages about cervical cancer and how it can be prevented by regular screening; quizzes based on the mHealth messages; and sms-reminders for the check-up appointment. The primary hypothesis is that the intervention increases the attendance rate with 15%. The effect of the intervention is 12-month check-up attendance rates for HR HPV-positive women (both intervention and control group).

Eligibility: Inclusion Criteria:
  -  HPV-positive
  -  Able to give informed consent
  Exclusion Criteria:
  -  Do not have access to a mobile phone/ cannot provide a phone number

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

Clinical trial: Recurrence in High-grade Lesions After Conization

Summary: Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ).
  Study Design: A case-control study that included 103 patients. Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III). Follow-up exams were conducted every six months with Pap smear collection and colposcopic examination with biopsy, when necessary, for a minimum period of twelve months. Cure was defined as a normal follow-up examination within 24 months. During follow-up, relapse occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at which time a new cervical conization by LLETZ was performed.


Eligibility: Inclusion Criteria:
  1. history of surgery for conization
  Exclusion Criteria:
  1. under 18 years of age,
  2. immunosuppressed,
  3. Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
  4. Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.

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

Clinical trial: Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer

Summary: Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.

Detailed description: Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).

Eligibility: Inclusion Criteria:
  -  Patients with newly histologically confirmed cervical carcinoma
  -  Original clinical stage must be IIB （FIGO 2009）
  -  Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
  -  Age between 18-65
  -  Patients must give signed informed consent
  Exclusion Criteria:
  -  The presence of uncontrolled life-threatening illness
  -  Receiving other ways of anti-cancer therapy
  -  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

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

Clinical trial: DNA Methylation Biomarkers for Cervical Cancer Screening

Summary: The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.


Eligibility: Inclusion Criteria:
  -  women with age ≥20 and sexual experience
  -  Agree to sign ICF
  Exclusion Criteria:
  -  women had received Hysterectomy
  -  women had destructive therapy for cervical lesions in 6 months, for examples: conization, Laser or cryotherapy, chemotherapy, and radiation therapy
  -  Women are at pregnancy or had baby delivery in 6 weeks

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

Clinical trial: LESs Surgical Radicality for EaRly Stage Cervical Cancer

Summary: This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.

Detailed description: The purpose of this study is to evaluate the safety and efficacy of extrafascial hysterectomy compared with modified radical hysterectomy, both plus level 1 pelvic lymph-node dissection, in patients with early stage IA2-IB1 cervical cancer ≤ 2cm. The experimental procedure will be considered to be promising for treatment of stage IA2-IB1 cervical cancer ≤ 2cm if the Bayesian posterior probability of "the difference of the 3-y DFS rate is less than the non-inferiority margin of 5%" is at least 50%. Thus, using this proof of concept design, the planned sample size is 40, with 20 cases per arm, which provides 72% chance of satisfying the above criteria, under the hypothesis that the lowest 3-y DFS rate in each arm is 90%. As required, adjuvant therapy will include cisplatin-based chemo-radiation or pelvic radiation alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109 criteria.

Eligibility: Inclusion Criteria:
  1. Patients with histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix by LEEP, cone or cervical biopsy;
  2. Aged between 18 and 70 years;
  3. performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
  4. FIGO early stage IA2-IB1 ≤ 2cm;
  5. Appropriated cardio-respiratory, hepato-renal and hematological reserves; and
  6. Signing of the Consent Form.
  Exclusion Criteria:
  1. Limiting systemic comorbidities including neuro-psychiatric disorders or obesity;
  2. Apparent or confirmed uncontrolled infections;
  3. Other malignancies in activity;
  4. Previous radiation or chemotherapy treatment or major pelvic surgery;
  5. History of drug allergies, and pregnancy or breast feeding; and
  6. Evidence of more extensive disease at the time of surgery.

Relevance to patient case: not relevant