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

Clinical trial: Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Summary: Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

Detailed description: PRIMARY OBJECTIVES:
  I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.
  II. Determine the toxicity of this drug in these patients.
  SECONDARY OBJECTIVES:
  I. Determine change in lesion size in these patients after treatment with this drug.
  II. Compare histologic response before and after treatment with this drug in these patients.
  OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
  Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.
  Arm II: Patients receive standard care.
  At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
  Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed grade III cervical intraepithelial neoplasia
  -  Confirmed by biopsy or colposcopy
  -  Positive for human papilloma virus 16
  -  No endocervical glandular dysplasia
  -  No adenocarcinoma in situ
  -  Performance status - GOG 0-2
  -  No life-threatening or serious hematological disorder
  -  No life-threatening or serious hepatic disorder
  -  No life-threatening or serious renal disorder
  -  No life-threatening or serious cardiac disorder
  -  No life-threatening or serious respiratory disorder
  -  HIV negative
  -  Must be immunocompetent
  -  No history of autoimmune disease
  -  No life-threatening or serious immunological disorder
  -  No prior or concurrent severe allergic disease
  -  No concurrent human papilloma viral infection other than type 16
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No life-threatening or serious gastrointestinal disorder
  -  No life-threatening or serious endocrine disorder
  -  No invasive malignancy within the past 5 years except nonmelanoma skin cancer
  -  No concurrent chronic or systemic steroids
  -  No prior organ transplantation
  -  No prior cancer therapy that would preclude study therapy

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

Clinical trial: Treatment of Infertility in Women With Polycystic Ovary Syndrome

Summary: Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women. The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair, acne, and infertility. This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility.

Detailed description: PCOS is characterized by excess circulating androgen levels and chronic anovulation. The fundamental pathophysiologic defect is unknown, but PCOS is characterized by insulin resistance and compensatory hyperinsulinemia. Improvements in insulin sensitivity in PCOS women, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. Resumption of ovulation occurs in up to 70% of women treated for PCOS. This study will evaluate the safety and effectiveness of clomiphene citrate and metformin XR in achieving a successful pregnancy in infertile PCOS women.
  Women with PCOS who are seeking pregnancy will be enrolled in this study. Women will be randomized to one of three different treatment arms: A) metformin XR 1000 mg twice/day; B) clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle); or C) metformin XR 1000 mg twice/day with clomiphene citrate 50 mg/day for 5 days (day 3-7 of cycle). Women will continue on study medications for 30 weeks, 6 treatment cycles, or until they become pregnant. Progesterone levels will be drawn weekly to monitor ovulation.

Eligibility: Inclusion Criteria
  -  Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer
  -  Elevated testosterone level
  -  Good general health
  -  Sperm concentration in partner of 20 million/ml or greater
  -  Ability to have intercourse 2-3 times per week
  -  One functional fallopian tube and normal uterine cavity

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

Clinical trial: Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer

Summary: This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.

Detailed description: OBJECTIVES:
  I. Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases, using preoperative or intraoperative lymphatic mapping, in patients with stage IB1 cervical cancer.
  II. Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.

Eligibility: Inclusion Criteria:
  -  Diagnosis of carcinoma of the cervix of 1 of the following cellular types:
  -  Squamous cell carcinoma
  -  Adenocarcinoma
  -  Adenosquamous cell carcinoma
  -  Stage IB1 disease (no greater than 4 cm)
  -  No unequivocal evidence of metastases
  -  Adequate surgical candidate
  -  No known allergy to triphenylmethane compounds
  -  No prior pelvic irradiation
  -  No prior retroperitoneal surgery
  -  More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy
  -  Prior cone biopsy allowed provided current disease is stage IB1

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

Clinical trial: Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults

Summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study.
  The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility: Inclusion Criteria:
  -  Participated in study 580299/001 and received all three doses of vaccine/placebo.
  -  Written informed consent obtained from the subject prior to enrollment
  Exclusion Criteria:
  -  Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.

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

Clinical trial: Irinotecan Study For Cervical Cancer

Summary: The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin as first-line chemotherapy for advanced or recurrent cervical cancer


Eligibility: Inclusion Criteria:
  -  Histologically documented, advanced or recurrent squamous cell carcinoma of uterine cervix. Patients may have received concurrent (with radiotherapy) or (neo)adjuvant (before or after local treatment) chemotherapy for primary tumor providing that at least 6 months have passed from the completion of previous therapy and the diagnosis of recurrent disease was documented
  -  Having measurable lesion(s), without previous radiation therapy.
  Exclusion Criteria:
  -  Patients had ever received primary chemotherapy for cervical cancer other than mentioned previously (in the inclusion criteria).
  -  Patients ever received cisplatin with total dose > 300 mg/m2 and received radiotherapy or local treatment delivered to the target lesion.

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

Clinical trial: A Phase Ⅲ Randomized Study of Mitomycin/Vindesine/Cisplatin Versus Irinotecan/Carboplatin Versus Paclitaxel/Carboplatin With Concurrent Thoracic Radiotherapy for Unresectable Stage Ⅲ Non-Small-Cell Lung Cancer

Summary: To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC.


Eligibility: Inclusion Criteria:
  All patients had histologically or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.
  Exclusion Criteria:
  The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection. -

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

Clinical trial: Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix

Summary: This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix cancer. In addition, we aim to determine the effect of celecoxib (Celebrex) on tumour oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis and apoptosis.


Eligibility: Inclusion Criteria:
  -  Biopsy-proven carcinoma of the cervix, with visible/palpable tumours; FIGO stage T1B-3B, NO/1, MO, to be treated with definitive radiotherapy and chemotherapy
  -  ECOG performance status of 0, 1, or 2
  -  Adequate hematologic function; Granulocyte count greater than 1.5 x 109/L, Platelet count greater than 100 x 109/L
  -  Adequate organ function; Serum creatinine £ 1.25 x ULN, or a calculated creatinine clearance ³ 50 mL/min, Serum bilirubin £ 1.25 x ULN and AST/ALT £ 3xULN
  -  No prior treatment for cervix cancer
  -  Informed consent
  Exclusion Criteria:
  -  Use of an NSAID in the 2 weeks prior to study enrollment
  -  Patients with an active malignancy at another site
  -  Patients with significant cardiac, renal, or pulmonary disease or any other medical conditions that may preclude radical therapy
  -  Patients who have significant history of ischaemic heart disease or stroke who would be deemed not suitable for cessation of their daily prophylactic aspirin
  -  Patients with history of peptic ulcer disease or previous NSAID related gastrointestinal bleeding
  -  Patients with hypersensitivity to NSAIDS or celecoxib, or sulfonamides
  -  Patients who unwilling or unable to give informed consent

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

Clinical trial: California WISEWOMAN Project

Summary: The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.


Eligibility: Inclusion Criteria:
  -  National Breast and Cervical Cancer Early Detection Program (NBCCEDP)

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

Clinical trial: Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

Summary: This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.


Eligibility: Inclusion Criteria:
  -  Girls ages 9 to 15 years (must not yet have had coitarche)
  -  Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)
  Exclusion Criteria:
  All Subjects:
  -  History of known prior vaccination with an HPV vaccine.
  Women Ages 16 to 23 Only:
  -  Individuals with any prior history of genital warts or treatment for genital warts.
  -  Individuals with > 3 lifetime male or female sexual partners.

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

Clinical trial: Metformin in Assisted Reproduction-MET-AR-study

Summary: Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index [BMI] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.

Detailed description: PCOS is an hormonal disease including hyperandrogenism, oligo-or anovulation and/or polycystic ovaries by ultrasound. PCOS women often suffer insulin resistance or even diabetes risk as well as a full blown metabolic disease.
  These women often suffer infertility due to their lack of regular ovulations. Metformin is a well known anti-diabetic drug, and in some PCOS women metformin might decrease the hyperandrogenism, improve insulin resistance and give more regular ovulations. Thereby increase chance of pregnancy. Our hypothesis is that metformin will increase clinical pregnancy rates both spontaneously and following IVF/ICSI.

Eligibility: Inclusion Criteria:
  -  Fulfilling Rotterdam criteria for PCOS
  -  Infertility more than 1 year
  -  First or second cycle of IVF/ICSI treatment
  -  Age below 38 years at inclusion
  -  BMI below 28 kg/m3 at inclusion
  -  Willing to be randomised to 4 months metformin or placebo
  -  Signed written informed consent
  Exclusion Criteria:
  -  Not suitable for starting dose 112.5 IE
  -  Basal FSH above 10 IU/L
  -  Known renal disease or s-creatinine above 110 umol/L
  -  Known liver disease or s-ALAT above 80 IU/L
  -  Known alcoholism or drug abuse
  -  Known diabetes mellitus or fasting plasma glucose above 7 mmol/L
  -  Corticosteroid treatment (oral)
  -  Treatment with cimetidine, anticoagulants, erythromycin or other macrolides
  -  Hyperprolactinemia (PRL above 700 mIU/L)
  -  Abnormal thyroid function tests
  -  Known congenital adrenal hyperplasia
  -  Androgen secreting tumours
  -  Cushing syndrome
  -  Metformin treatment within the last one month prior to screening
  -  Unfit to participate for any other reason

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

Clinical trial: Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

Summary: The aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an important factor that influences the effectiveness of radiotherapy and other treatments.


Eligibility: Inclusion Criteria:
  -  Newly diagnosed patients with carcinoma of the cervix ( 3 cm in size or larger) where an examination under anesthesia is to be performed for staging purposes
  -  Informed consent
  Exclusion Criteria:
  -  Patients with clinically occult cervix carcinoma

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

Clinical trial: A Trial for Patients With Advanced/Recurrent Cervical Cancer

Summary: This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.


Eligibility: Inclusion Criteria:
  -  Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression
  -  Measurable disease
  -  Gynecologic Oncology Group (GOG) performance status 0-2
  -  Patients must have received one prior systemic chemotherapy for persistent or recurrent disease
  -  Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
  -  All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
  -  Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
  -  Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy
  Exclusion Criteria:
  -  Prior Pemetrexed
  -  Patients who have received radiation to more than 25% of marrow bearing areas
  -  Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer

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

Clinical trial: CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto

Summary: Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.

Detailed description: To determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer, IIB-IVA FIGO stage.

Eligibility: Inclusion Criteria:
  -  Histologically proven primitive epidermoid or andenocarcinoma Cervix
  -  FIGO stage IIB (obviously parameter attack), III or IVA
  -  No previous chemotherapy nor radiotherapy
  -  Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma
  -  PS ECOG < 2
  -  Life expectancy > 12 weeks
  -  Written consent given
  Exclusion Criteria:
  -  Other malignant cervix tumor histology
  -  Visceral remotly metastasis
  -  Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer
  -  Anormal labs values
  -  Peripheric neuropathy CTC > 2
  -  Auditory loss > 2
  -  Cardiopathy
  -  Inflammatory digestive pathology
  -  Evolutive infection
  -  Other experimental concommitant treatment
  -  Lacting or pregnant women

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

Clinical trial: Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma

Summary: There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with improvements in durable remissions and overall survival. Though the incidence and mortality in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau, arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to local regional radiation, mortality from advanced cervical cancer in the United States is expected to further decrease. However, further advances in this disease are needed.


Eligibility: Inclusion Criteria:
  1. Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage I-2, II-B, III-B, IV-A.
  2. Patients with negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT, MRI or lymphadenectomy.
  3. Patients with adequate bone marrow function: ANC greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl, and Hemoglobin > 10 mg/dl.
  4. Patients with adequate renal function: Creatinine equal to or less than 1.5 mg%.
  5. Patients with adequate hepatic function: Bilirubin less than or equal to 1.5 x normal and SGOT and Alkaline phosphatase less than or equal to 3 x normal.
  6. Patients who have signed an approved informed consent.
  7. Patients with GOG Performance Status of 0, 1, 2, or 3.
  8. Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
  9. Patients who are suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation.
  Exclusion Criteria:
  1. Patients who cannot be or have not been adequately clinically staged.
  2. Patients with lower one-third vaginal involvement.
  3. Patients with septicemia or severe infection.
  4. Patients with circumstances that will not permit completion of the study or required follow-up.
  5. Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
  6. Patients with carcinoma of the cervical stump.
  7. Patients who are lactating or pregnant.

Relevance to patient case: not relevant