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

Clinical trial: Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer

Summary: This study is to assess how patients respond to their treatment for cervical cancer. This research does not involve a specific treatment for the cancer that will be recommended by the doctor and may include radiation therapy and/or chemotherapy. This is a separate research imaging study designed to assess how patients respond to their treatment for cervical cancer.


Eligibility: Inclusion Criteria:
  -  Biopsy-documented, newly-diagnosed primary cervical cancer of all histopathology types.
  -  Clinically visible gross lesion (International Federation of Gynecology and Obstetrics (FIGO) stage IB1 and above).
  -  Treatment (chemoradiation), DCE-MRI and 18F-FMISO PET studies will be at MSKCC.
  -  Patients must be an adult female 18 years of age or older.
  Exclusion Criteria:
  -  Patients who because of general medical or psychiatric condition, or physiologic status cannot give an informed consent.
  -  Patients who received prior radiation treatment to pelvis.
  -  Patients with contraindications to DCE-MRI (non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium, end-stage renal disease) and/or 18F-FMISO PET.
  -  Patients who do not fulfill the screening criteria for safe DCE-MRI or 18F-FMISO PET as per the Department of Radiology guidelines.
  -  Pregnant patients; and or patients who are breast-feeding their babies.

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

Clinical trial: Cavitation Ultrasound in Treatment of Patients With PCOS

Summary: The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid profile.

Detailed description: Polycystic ovary syndrome (PCOS) affects 5 to 10% of women of childbearing age and is the most common cause of anovulatory infertility. Common clinical manifestations include menstrual irregularities and signs of androgen excess such as hirsutism, acne, and alopecia. Metformin, a biguanide, is the most widely used drug for the treatment of type 2 diabetes worldwide. Its primary action is to inhibit hepatic glucose production, but it also increases the sensitivity of peripheral tissues to insulin. The increase in insulin sensitivity, which contributes to the efficacy of metformin in the treatment of diabetes, has also been shown in non diabetic women with the polycystic ovary syndrome.In women with PCOS, long-term treatment with metformin may increase ovulation, improve menstrual cyclicity, and reduce serum androgen levels; the use of metformin may also improve hirsutism. If published data on the effects of metformin in the prevention of diabetes can be extrapolated to women with the PCOS, then the drug may actually retard progression to glucose intolerance in affected women, as reported in a small, retrospective study. Ultrasonic vibrations spread in the form of a wave in medium such as a liquid or a solid. When the particles of an elastic medium are under ultrasonic vibration, they act continuously in only one direction. The lipolytic range of ultrasounds is 30-70 Kilohertz (KHz), and the best effects are obtained in a range between30-35 KHz. The depth of the treatment in the tissues is generally2-3 cm, to avoid muscles involvement. Biological effects of ultrasounds on adipocytes are: micro-mechanical, thermal, micro-streaming and cavitation. Cavitation ultrasound means that ultrasounds produce an alternation of decompression and compression waves in a fluid media which progressively increase the tension of the adipocyte until it implodes and frees the emulsified fat. The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid profile.

Eligibility: Inclusion Criteria:
  -  Obese infertile polycystic ovarian syndrome (PCOS) women
  Exclusion Criteria:
  -  Women 40 years or older
  -  Women using fertility treatments, oral contraceptives or other confounding medications during the last 3 months
  -  Smokers or with history of general diseases like cardiovascular, liver, kidney or respiratory disease, diabetes, uncontrolled hypertension, or malignancy

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

Clinical trial: Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin

Summary: The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.


Eligibility: Inclusion Criteria:
  -  Women aged from 18 to 35
  -  Infertility for a period of a year or more or 6 month of irregular menstrual cycle
  -  PCOS under the Rotterdam criteria
  -  Insulin resistance HOMA-IR > 2.5
  -  Normal semen analysis values
  -  Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH, Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase, SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total cholesterol, Triglycerides, oral glucose tolerance test
  Exclusion Criteria:
  -  Tubular factor
  -  Normal ovarian reserve
  -  Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen, weight-loss agent or oral contraceptives in the past 6 months
  -  Neoplasia
  -  BMI > 35
  -  Renal, hepatic or cardiac failure
  -  Lactic, acidosis antecedent

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

Clinical trial: Study of a Predictor for Cervix Cancer

Summary: Non operated cervix cancer are usually treated by radio-chemotherapy. Non control local rate is inexplicably close to 30%. However, important volume of those tumors and their hypoxia degree induce phenomenon of pathologic angiogenesis, explaining these therapeutic failures.
  Persistence of tumor hypoxia could be a predictive factor of local control

Detailed description: HPV linked cervix cancer is the second most prevalent form of female cancer. It's also the leading cause of death by cancer in Asia, South America and Africa. Hopefully, screening program lead to a 50 % of mortality reduction during the past 40 years. Classic therapeutic strategy consists of external pelvic radiation therapy associated with chemotherapy and followed by brachytherapy. Curative surgical removal is realized 4 to 6 weeks after radiation therapy. However relapse rate is frequent (20 to 30%). Biological mechanisms involved in this high relapse rate are not understood.
  Nevertheless, it is suggest that initial hypoxia of cervix tumor during 20 Gy radiation therapy is a pejorative prognostic factor. At the opposite, the amelioration of tumor vascularisation during 20 Gy radiation therapy is a positive prognostic factor. It's possible that an amelioration of hypoxia lead to lesser tumor resistance to radiotherapy. However such possibility has to be test during clinical trial.
  Thus, the objective of ANOXICOL study is to evaluate the predictive value of persistent hypoxia, during 20 Gy radiation therapy associated with chemotherapy, for local control of cervix cancer.

Eligibility: Inclusion Criteria:
  -  cervix epidermoid cancer or adenocarcinoma : I to IIIB
  -  treatment by radiochemotherapy
  -  ECOG ≤ 1
  -  social and psychological compliance for standard treatment of radiochemotherapy for cervix carcinoma
  -  patient affiliated to health insurance system
  -  signed informed consent
  Exclusion Criteria :
  -  contraindication to chemoradiotherapy
  -  resequable cervical cancer
  -  para-aortic metastases histologically proven
  -  inability to perform an abdominal MRI or a PET Scan
  -  contraindications related to MRI: pacemaker, vascular clip, and all devices incompatible with the electromagnetic field generated by MRI
  -  unbalanced diabete
  -  administration of EPO
  -  transfusion within 3 days before the first biopsy
  -  creatinine clearance under 60 mL / min;
  -  ANC <1500 / mm3 and Platelets <120,000 / mm3
  -  neuropathy, diabetes (fasting glucose greater than 140 mg / l) or any other condition that strongly contraindicates concomitant chemotherapy with radiotherapy
  -  sigmoid diverticulitis, Crohn's disease or systemic disease, collagenose

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

Clinical trial: Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer

Summary: This study is being performed to investigate if the application of Arista absorbable hemostat (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection for cancer. These fluid collections can become symptomatic in some patients. Arista would be applied to one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after surgery

Detailed description: PRIMARY OBJECTIVES:
  I. To determine whether, if applied to the lymph node basins after pelvic lymph node dissection, Arista could potentially reduce the formation of lymphoceles and consequently the need for secondary interventions.
  OUTLINE:
  Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis.
  After completion of study treatment, patients are followed up at 3 months.

Eligibility: Inclusion Criteria:
  -  Patients with prostate cancer who are electing to undergo robotic radical prostatectomy with pelvic lymph node dissection at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center by Dr. Ronney Abaza

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

Clinical trial: Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

Summary: Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Detailed description: Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)

Eligibility: -  Inclusion Criteria:
  -  Patients whose treatment is provided to Centre Oscar Lambret
  -  With a corpus uteri adenocarcinoma, no metastatic, treated by:
  -  Surgery and observation without complementary treatment
  -  Or surgery and adjuvant radiotherapy
  -  Or Surgery and curietherapy of vaginal dome
  -  With a cervix carcinoma, stade IA2 to IIB proximal, treated by :
  -  External radiochemotherapy and curietherapy
  -  Or only surgery
  -  Or pre-surgical curietherapy and surgery
  -  Age > 18 years

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

Clinical trial: Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

Summary: This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

Detailed description: Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

Eligibility: Inclusion Criteria:
  -  Good physical health
  -  Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
  -  Other inclusion criteria will be discussed with the investigator
  Exclusion Criteria:
  -  History of severe allergic reaction that required medical intervention
  -  Currently enrolled in a clinical trial
  -  If participant is female, pregnant
  -  Currently immunocompromised or having received immunosuppressive therapy in the last year
  -  Positive test for HPV
  -  History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
  -  If participant is female, history of abnormal cervical biopsy results
  -  Other exclusion criteria will be discussed with the investigator

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

Clinical trial: Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy

Summary: Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases.
  Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances.
  Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery.
  Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.


Eligibility: Inclusion Criteria:
  -  Female patients 18 years of age or older
  -  Biopsy-confirmed cervical squamous-cell carcinomas
  -  Stage IB2, IIA ou IIB according to the FIGO staging of cervical carcinomas
  -  No spread to lumbo-aortic lymph nodes
  -  No prior pelvic radiotherapy
  -  No prior cancer treatment
  -  WHO Performance status less than or equal to 1
  -  Beneficiary of a health insurance
  -  Must provide her signed and informed consent
  Exclusion Criteria:
  -  Reccurent or Metastasized cancer
  -  History of uncontrolled cancer, or any cancer treated for less than 5 years (except basal cell carcinomas)
  -  Any contraindication to MRI
  -  Know hypersensitivity to Gadolinium, 18F-FDG or one of the excipients
  -  Pregnant or breast feeding patients
  -  Participation in any other clinical trial that could interfere with the study results
  -  Any geographical, social or psychical reasons that could prohibit the ability to return for follow-up assessment

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 of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer

Summary: Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis cervical cancer, to evaluate the efficacy and toxic reaction.

Detailed description: Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound nanoparticle form of paclitaxel designed to avoid problems associated with solvents used in Taxol. And albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy, and with greater concentration in tumor tissue compared with normal tissues. This is a single center, non-randomized, open-label Phase II clinical study to investigate the efficacy and tolerability of albumin-bound paclitaxel plus nedaplatin in patients with advanced, recurrent metastatic cervical cancer. About 30 patients will receive 175-200 mg/m2 albumin-bound paclitaxel, d 1 combined with 80- 100 mg/m2 nedaplatin, d 2, every 3 weeks. At least 2 cycles will be completed for each patient, for whom responded to the treatment, 4-6 cycles will be completed.

Eligibility: Inclusion Criteria:
  -  Cervical cancer, advanced or recurrent metastasis
  -  Measurable and assessible tumor lesions
  -  Used ordinary paclitaxel or platinum drugs, more than 28 days
  -  Aged 18-70
  -  KPS score> 60 points, expected to survive more than 3 months
  -  Normal bone marrow function
  -  The function of liver and kidney had no obvious damage
  -  Normal function of vital organs
  -  No brain metastases
  -  Patients or their agents to sign informed consent
  -  Compliance, and can be followed up regularly
  Exclusion Criteria:
  -  Brain metastases
  -  Serious complications
  -  Acute inflammatory response
  -  Combined with other tumor
  -  Pregnancy or breast-feeding women
  -  Vertebral metastasis with nerve compression symptoms
  -  Large volume of pleural effusion, pericardial effusion
  -  Other malignancy within five years
  -  Drug allergy
  -  Other chemotherapy contraindications
  -  The possibility of pregnancy, and not willing to contraception
  -  No measurement of lesion
  -  Mental illness which is difficult to control

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

Clinical trial: European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System

Summary: The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.

Detailed description: This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD Viper LT Systems.
  The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping Test results.

Eligibility: Inclusion Criteria:
  -  Referred to follow up due to one or more abnormal Pap or an HPV infection
  -  Subjects who have provided informed consent
  -  Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines.
  Exclusion Criteria:
  -  Known to be pregnant
  -  With prior complete or partial hysterectomy involving removal of cervix
  -  Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds.
  -  Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.

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

Clinical trial: Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)

Summary: To compare 5-year overall survival between patients who undergo radical hysterectomy followed by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO stage IB2 and IIA2 cervical cancer


Eligibility: Inclusion Criteria:
  -  Previously untreated, histologically confirmed cervical cancer
  -  FIGO stage IB2 and IIA2 disease
  -  One of following histologic types
  1. Squamous cell carcinoma
  2. Adenocarcinoma
  3. Adenosquamous carcinoma
  -  Gynecologic Oncology Group performance status: 0-2
  -  Adequate organ function
  1. Bone marrow: WBC > 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin ≥ 10g/dL
  2. Kidney: Creatine < 1.25 * upper normal limit
  3. Liver: AST, ANT < 3 * upper normal limit, Total bilirubin < 1.5 mg/mm3
  -  Patient who have Singed an approved informed consent
  Exclusion Criteria:
  -  Patients with cervical cancer who have received any previous radiation or chemotherapy
  -  Neuroendocrine carcinoma of uterine cervix
  -  Occult cervical cancer which was found after simple hysterectomy
  -  Para-aortic nodal involvement (> 10 mm short axis diameter on pretreatment imaging study)
  -  History of other invasive malignancies, with the exception of non-melanoma skin cancer, in situ melanoma and thyroid cancer, who had (or have) no evidence of the other cancer present within the last 5 years
  -  Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  -  Prior diagnosis of Crohn's disease or ulcerative colitis
  -  Neurologic or psychiatric disease
  -  Patients who are pregnant or lactating

Relevance to patient case: not relevant