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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Uterine Cervical Neoplasms ≮ 18 years, cervical cancer verified by pathology， IIA stage, accepted the operation ( Piver III and pelvic lymph node dissection) as initial therapy， obtained the patient's agreement the patient had accepted chemotherapy or radiotherapy before operation
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-999.0, Spinal Cord Injury Bone Loss Osteoporosis Enrollment in, and completion of one year of treatment, in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury" Adherence rate for teriparatide use of ≥60% Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) Ability to understand and the willingness to sign a written informed consent Individuals who could not tolerate teriparatide treatment Individuals who will not be able to return for all study visits Patients may not be receiving any other investigational agents Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 20.0-69.0, Cervical Abnormalities Cervical Intraepithelial Neoplasia Grade 2/3 Cervical Cancer ASC-US cytology, living in metropolitan area of Medellin Previous abnormal cytology
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Colon Cancer Rectum Cancer Liver Metastases Patients with colon and rectum cancer without known metastasis Patients who gives informed consent Patients who are referral to laparoscopic surgery Patients who are not able to give informed consent Patients who are under 18 of age Patients with known metastasis Patients who are allergic to contrast agents Patients who are pregnant or lactating
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-999.0, Cervical Intraepithelial Neoplasia woman aged 30 or older lived in a household visited by one of study CHWs hysterectomy been treated for a precancerous lesion with previous HPV test pregnant mentally-disabled
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, BRAF V600E Mutation Present BRAF V600K Mutation Present Metastatic Malignant Solid Neoplasm Metastatic Melanoma Stage III Cutaneous Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Unresectable Solid Neoplasm Patients must have histologically confirmed, BRAF-mutant (V600E/K) solid tumor (molecularly confirmed using Cobas assay or a comparable Food and Drug Administration [FDA]-approved assay) that is metastatic or unresectable, have received and tolerated prior BRAF or BRAF and MEK inhibitor (BRAF targeted) therapy at full dose or not previously received BRAF targeted therapy, and for which standard curative measures do not exist or are no longer effective If test at Clinical Laboratory Improvement Act (CLIA)-certified laboratory (lab) used a non-FDA approved method, information about the assay must be provided; (FDA approved tests for BRAF V600 mutations in melanoma THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Prior therapy is allowed; patients may have received any number of prior lines of therapy, including treatment with a BRAF and/or MEK inhibitor All prior anti-cancer treatment-related toxicities must be less than or equal to grade 1 according to the Common Terminology for Adverse Events version 5 (CTCAE version 5.0; National Cancer Institute [NCI], 2017) at the time of enrollment; a notable exception are endocrinopathies caused by immune checkpoint inhibitors that are appropriately treated with medical management (e.g. hormone replacement therapy, anti-diabetic agents) Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Life expectancy of greater than 3 months Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,200/mcL Hemoglobin >= 9 g/dl (patients may be transfused to this level) Patients who received prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to day 1 of cycle 1; patients are permitted to be on dabrafenib and trametinib standard of care at start of therapy without wash-out period prior to day 1 of cycle 1; dosing will change to protocol determined dose levels on day 1 of cycle 1 Patients must not have received prior HSP90 inhibitor therapy Patients who are receiving any other investigational agents; patients who have taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to randomization Patients with history of activating RAS mutation positive tumors regardless of interval from current study; however, patients may have concurrent BRAFV600 and RAS mutations in the tumor to be treated with protocol therapy Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic or untreated or not stable for >= 4 weeks (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks History of known immediate or delayed hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to AT13387, dabrafenib, or trametinib, or excipients or to dimethyl sulfoxide (DMSO) Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued prior to the mother being treated with the study drugs Patients known to be human immunodeficiency virus (HIV)-positive patients and on combination antiretroviral therapy are ineligible History of another malignancy other than the study indication under this trial within 5 years of study enrollment; does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, in situ breast cancer, or other in situ cancers
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors Melanoma Subjects must have histologically or cytologically confirmed metastatic cutaneous or mucosal melanoma, Able to swallow and retain orally administered medication, Adequate hematological, renal, hepatic, and coagulation laboratory assessments Clinically significant bleeding within 4 weeks of screening, Current use of warfarin, factor Xa inhibitors, and direct thrombin inhibitors, Infection requiring anti-infective treatments within 1 week of study enrollment, Anti-tumor therapy, Major surgery within 28 days
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Abnormality Female years or older Able to give informed consent Intact cervix No prior history of invasive cervical cancer English speaking Willing to have biological specimens stored for future studies Resident of Appalachian Ohio Pregnant Medical or psychiatric illness that precludes research project requirements, ability to give informed consent, or protocol compliance Smokers (will be contacted by study team to see if they are eligible/willing to participate in CARE: Project 2
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-65.0, CIN Cervix Cancer Female between 30-65years of age 2. Not pregnant by menstrual history 3. No history of prior treatment for cancer of the cervix 4. No history of hysterectomy 5. Healthy enough to undergo a pelvic examination, i.e., not seriously ill with a debilitating condition Women below and above this age group 2. Women already screened and detected for cervical precencers and cancers 3. Women with debilitating condition 4. Women with Hysterectomy 5. Women whom are pregnant
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer Women ≥ 18 years of age. 2. Cervical cancer confirmed by histology. 3. Advanced or metastatic or recurrent cervical cancer confirmed by clinical and/or radiological proof with no curative treatment options. 4. For cohort 10 (and 12), i.e. patients eligible to receive bevacizumab at each site per standard of care, patients may be primary stage IVB (including persistent) or first recurrent carcinoma of the uterine cervix (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma). Prior treatment with chemotherapy for recurrent disease is not permitted. However, one prior line of chemotherapy with platinum during primary radio-chemotherapy or platinum-base chemotherapy as neoadjuvant chemotherapy prior to surgery is permitted 5. Tumour must be HPV16 positive. 6. Patients should be eligible for chemotherapy with carboplatin and paclitaxel, and have consented with chemotherapy with carboplatin and paclitaxel, before the start of the informed consent procedure for the study. 7. Performance status (WHO scale/ECOG) 1. 8. Written informed consent according to local guidelines. 9. Written approval by the treating physician/investigator of his/her clinical judgment that the patient has a reasonable life expectancy and is sufficiently fit and motivated to complete the study treatment and comply to all study procedures conform the protocol Treatment: 1. Prior treatment with anti-HPV agents. 2. Chronic systemic steroid use. Local application (i.e. stable doses of topical or inhaled corticosteroids) is allowed. 3. Less than 4 weeks since the last treatment with other cancer therapies, (i.e. endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc), less than 8 weeks for cranial radiotherapy, and less than 6 weeks for nitrosoureas and mitomycin C. 4. Toxicities resulting from previous anti-cancer therapy must be resolved to ≤ grade 2. 5. Recent treatment (within 30 days of first study treatment) with another investigational drug. 6. Patients with known hypersensitivity to any component of the Investigational Medicinal Product. 7. Any contraindication to the use of authorized applied products (i.e. paclitaxel, carboplatin or bevacizumab). Haematology and biochemistry: 8. Inadequate bone marrow function: Absolute Neutrophil Count (ANC) < 1.5 x 109/L, or platelet count < 100 x 109/L or hemoglobin < 6 mmol/L. 9. Inadequate liver function, defined as Serum (total) bilirubin > 2 x upper normal limit (ULN) Aspartate Aminotransferase (ASAT) or Alanine Aminotransferase (ALAT) > 2.5 x ULN (> 5 x ULN in patients with liver metastases) Alkaline phosphatase levels > 2.5 x ULN (> 5 x ULN in patients with liver metastases, or > 10 x ULN in patients with bone metastases). Other: 10. Clinical suspicion or radiological evidence of brain or leptomeningeal metastases. 11. Previous or current malignancies at other sites, with the exception of basal or squamous cell carcinoma of the skin and with the exception of other malignancies from which the patient may be considered cured as evidenced by complete regression of all lesions >10 years ago. 12. Active HIV, chronic hepatitis B or C infection. 13. Patients of childbearing potential not willing to consistently and correctly us a contraceptive method according to ICH (M3) resulting in low failure rate, i.e. less that 1% per year such as oral contraceptives or use of effective means of contraception. 14. Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to study treatment start in patients of childbearing potential. 15. Major surgical procedure within 28 days prior to the first study treatment. 16. Uncontrolled sustained hypertension (systolic > 180 mm Hg and/or diastolic > 110mm Hg). 17. Clinically significant (i.e. active) cardiovascular disease defined as Stroke within ≤ 6 months prior to day 1 Transient Ischemic Attack (TIA) within ≤ 6 months prior to day 1 Myocardial infarction within ≤ 6 months prior to day 1 Unstable angina New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure (CHF) Serious cardiac arrhythmia requiring medication; 18. History of severe bronchial asthma and/or severe allergy. 19. Evidence of any other medical conditions that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-999.0, Cervical Cancer Women sentenced or anticipate a sentence of one year or less Ability to follow participants post-jail release Able to read and understand English Women who have been treated for cervical cancer with procedures that would obviate the need for regular screening Exhibit severe psychological distress
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-999.0, Cervical Intraepithelial Neoplasia Healthy women older than age 21, military or civilian Negative pregnancy test results Confirmed CIN 2-3 on cervical biopsy with a negative endocervical curettage (ECC) and satisfactory colposcopy visualizing the complete transformation zone of the cervix The patient will be available and in the San Diego area for 6 months after enrollment to complete the clinic visits and follow up Positive CIN 2-3 on ECC Presence of cancer Pregnancy or lactation Immuno-compromised (systemic lupus erythematosus, kidney transplant) Hepatitis Hypersensitivity to Imiquimod Ulcerative colitis Crohn's disease Human Immunodeficiency virus
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Multiple Sclerosis Pain Depression Patient has a definitive diagnosis of MS confirmed by subjects' MS physician in the University of Washington (UW) MS Center Patient has received care and plans to continue to receive care at the UW MS Center during enrollment period Patient has access to and is able to communicate over the telephone (we will provide phone headsets if needed) to allow participation in the telehealth components of the study Patient can read, speak and understand English Patient is at least 18 years of age Patient reports a clinically significant problem with pain and/or depression Patient represents a high suicide risk Patient reports symptoms of a current psychotic disorder or diagnosis of bipolar disorder with current psychotic features at time of screening Subject attends appointments more than once per month with a psychiatrist for treatment of depression Patient reports planning major surgery in the next ten months Patient reports alcohol or psycho-active substance dependence within past month Patient has moderate to severe cognitive impairment
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer Written informed consent. 2. Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix. Not accepted are small cell, clear cell and other rare variants of the classical adenocarcinoma. 3. Histologically confirmed, Stage IB-IVB, invasive cervical carcinoma associated with HPV 16 and/or 18 and meet the following for either Cohort 1 or Cohort 2. 1. Cohort 1 Newly diagnosed inoperable cervical cancer treated with chemoradiation therapy with curative intent and life expectancy of at least 12 months as assessed by the investigator No CNS/spinal metastases Able to initiate study treatment within 2 weeks of completion of last chemoradiation treatment 2. Cohort 2 Persistent and/or recurrent cervical cancer No CNS/spinal metastases Able to initiate study treatment at least 2 weeks but no more than 4 weeks after completion of salvage therapy Life expectancy of at least 12 months as assessed by the investigator 4. Electrocardiogram (ECG) with no clinically significant findings. 5. Chemistry, liver function tests, renal function, total CPK and hematology lab results must be ≤ Grade 1 at the time of screening. 6. Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1. 7. Adequate venous access for repeated blood sampling according to the study schedule. 8. Women of child-bearing potential must have a negative serum pregnancy test and agree to remain sexually abstinent, have a partner who is sterile (i.e., vasectomy), or use two medically effective methods of contraception (e.g., oral contraception, barrier methods, spermicide, intrauterine device [IUD]). 9. Able and willing to comply with all study procedures Pregnancy or breastfeeding. 2. History of previous therapeutic HPV vaccination. 3. Prior exposure to an investigational agent or device within 30 days of signing the ICF. Of note, the participant may participate in observational studies. 4. Positive serological test for HIV, Hep B or Hep C or history of HIV infection, Hepatitis B or Hepatitis C (women with cured HCV will be allowed; participant must have had a serologic test performed within 12 months of informed consent). 5. Prior major surgery from which the participant has not yet recovered to baseline. 6. High medical risks because of non-malignant systemic disease or with active uncontrolled infection. 7. Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. 8. Congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease. 9. Use of topical corticosteroids at or near the intended administration site. 10. Any cardiac pre-excitation syndromes (such as Wolff-Parkinson-White). 11. History of seizures (unless seizure free for 5 years). 12. Tattoos or scars within 2 cm of the intended site of injection or if there is implanted metal within the same limb. Any device implanted in the chest (e.g., cardiac pacemaker or defibrillator) excludes the use of the deltoid muscle on the same side of the body. 13. Active drug or alcohol use or dependence. 14. Imprisonment or compulsory detainment for treatment of either a psychiatric or physical (i.e. infectious disease) illness. 15. History of immunosuppressive or autoimmune disease. 16. Any other illnesses or conditions that in the opinion of the investigator may affect the safety of the participant or limit the evaluation of a participant or any study endpoint
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-44.0, Contraceptive Usage Good general health 2. Aged 18-44 years, inclusive, at the enrollment visit 3. Intact uterus with at least one ovary 4. Serum progesterone value ≥ 3 ng/mL at the Screening Visit (V0-P) 5. Pap test within the last 12 months or undergo a Pap test at screening prior to enrollment. If a potential subject states that she has had a Pap test within the last 12 months, then she will need to provide documentation of acceptable test results 6. Cervical mucus score of >7, which is based on the modified Insler scoring system during the screening cycle. The cervical mucus is collected by aspiration and the assessment is based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible score of 12 (3, 4) 7. Regular menstrual cycles that occur every 24 days 1. If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles prior to screening 2. If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening 8. Heterosexually abstinent or, if heterosexually active, must have undergone previous tubal sterilization, be in monogamous relationship with a vasectomized partner, or only use male or female condoms (use of condoms that are pre-lubricated with or without spermicide is acceptable) for the entire duration of the study. Use of a spermicide applied separately is not allowed. Cervical caps or diaphragms are not allowed during study participation 9. In the opinion of the investigator, able to comply with the protocol, willing to record requested information in the daily diary, and live within the study site catchment area or within a reasonable distance from the site 10. Understand and sign an IRB approved informed consent form prior to screening activities (including fasting blood draw) 11. Willing to refrain from use of any vaginal creams, lubricants, gels, or spermicides for 3 days prior to study admission through to the end of the study 12. Agree not to participate in any other clinical trials during the course of this study Known hypersensitivity or contraindication to progestins 2. Known or suspected pregnancy 3. Prior hysterectomy or bilateral oophorectomy 4. Prior cervical surgery (LEEP, Cone biopsy) 5. A history (within prior 12 months) of drug or alcohol abuse 6. Undiagnosed abnormal genital bleeding 7. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects diagnosed at screening with a Chlamydia or gonococcus infection may not be included in the trial unless they are treated and proof of cure is documented after treatment (i.e. repeat test with negative results). In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent. Antiviral prophylactic therapy is permitted 8. Uncontrolled thyroid disorder 9. Any Pap test finding that would require additional workup or treatment during the study interval. HPV testing will not be done at screening for these subjects 10. Use of an injectable hormonal contraceptive (Depo-Provera®) within the past 10 months 11. Use of oral contraceptives, contraceptive implants, or other sex steroid hormones within 30 days prior to screening visit 12. Women who are breastfeeding or within 30 days of discontinuing breast feeding 13. Women planning to undergo major surgery within four months of study enrollment 14. Women planning pregnancy within their months of study enrollment 15. Smoking in women who are ages 18-44 years old that smoke 15 cigarettes or more per day must be evaluated by the PI for based on risk factors that would increase their risk for cardiovascular (CVD) and thromboembolism 16. Current or past deep vein thrombophlebitis or thromboembolic disorders 17. History of known thrombophilia in a first-degree relative <45 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk 18. Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis 19. History of retinal vascular lesions, unexplained partial or complete loss of vision 20. Known or suspected carcinoma of the breast, endometrium, or any other known or suspected progestin-dependent neoplasia 21. Past history of any other carcinoma (excluding basal cell carcinomas) unless in remission for more than 5 years 22. Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication 23. Headaches with focal neurological symptoms only in women over 35 years old 24. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use or other benign or malignant liver tumors; active liver disease 25. Systolic BP > 140 mm Hg and/or Diastolic blood pressure (BP) > 90 mm Hg after 5-10 minutes rest 26. Clinically significant abnormal serum chemistry values according to the Principal Investigator's judgment 27. Participation in another clinical trial involving an investigational drug or device within last 30 days (prior to screening) 28. Use of liver enzyme inducers within last 90 days (prior to screening) or intention to use liver enzyme inducers during the study 29. Known HIV infection 30. Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. Women enrolled in the study, who use condoms to protect against STIs or pregnancy, should be instructed that they can use condoms that are pre-lubricated with spermicide or lubricated, but they cannot use a spermicide applied separately and they should record all condom use in their diaries 31. Women who use any medications on the Exclusionary Medication List OR used any within the past three months prior to the screening visit 32. Women with BMI ≥40 kg/m2 are excluded 33. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-55.0, Bacterial Vaginosis For BV Subjects: (140 subjects) Premenopausal women over the age of 18 who have BV who are willing to sign informed consent Positive for all Amsel Vaginal pH > 4.5 Positive amine test > 20% clue cells on wet mount Grayish-white adherent discharge Subject is willing to refrain from using any vaginal medications, douches or spermicides except for the metronidazole suppositories that are given to her for the duration of the study Subject is willing to use supplied non-lubricated condoms when sexually active. But not to have sexual intercourse within 48 hours of any Study Visit Subject to refrain from alcohol for 24 hours prior to the first 7 days of the metronidazole treatment and for 48 hours after completion of this treatment. for Healthy control group Study for BV Study Subjects Mixed vaginal infection at time of enrollment Pregnancy, nursing or planning on getting pregnant Subject on anticoagulation therapy, lithium therapy or Antabuse therapy Vaginal bleeding at time of enrollment Allergy to metronidazole Use of any vaginal antibiotics or antifungals in the previous 10 days, from enrollment Must not require treatment for an abnormal Pap smear or genital cancer Must abstain from vaginal douching during enrolled period. Study for Control Subjects
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 4.0-18.0, Precocious Puberty Growth Hormone Tests Children older than 4 years. referred by the endocrine clinic to a decapeptyl treatment or growth hormone test none
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-65.0, Cervical Cancer Women Haitian, Hispanic, or African American Ages 30-65 years Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade Women who report having had a hysterectomy Women who have a history of cervical cancer Women who plan to move outside of Miami-Dade county during the next six months Women who are enrolled in any other cancer prevention/outreach related study Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Prader-Willi Syndrome Pediatric patients with PWS confirmed by methylation PCR genetic testing 2. Prepubertal pediatric patients (Tanner's Pubertal stage I) at screening 3. Pediatric patients who have never been treated with hGH prior to screening, or who had been treated with hGH for less than 6 months if they had a treatment history, and whose last administration was made 6 months prior to screening 4. Pediatric patients with normal thyroid function at screening (Those with normal function through a hormonal therapy were allowable.) 5. Pediatric patients whose parents or LARs signed the informed consent form in writing after receiving the explanation about the purpose, method, effects, etc. of the clinical study, and who also signed the informed consent form in writing if they are capable of reading and understanding writing Pediatric patients who are accompanied by other causes for growth retardation as follows except for PWS at screening : Chronic renal failure (including the case in which renal transplantation has been undergone), Silver-Russell syndrome, Turner's syndrome, Seckel syndrome, Down's syndrome, Noonan syndrome, Cushing's syndrome, congenital infections, psychiatric disorders, chronic debilitating diseases, etc. 2. Pediatric patients with malignancy or a history of malignancy at screening 3. Pediatric patients with severe respiratory disturbance, or sleep apnoea or a history of respiratory infections with an unknown cause at screening. However, those whose condition had been confirmed to be eligible to participate in the clinical study on investigator's judgment were allowed to participae in the study. 4. Pediatric patients with impaired fasting glucose, diabetes, and diabetic retinopathy at screening 5. Pediatric patients whose epiphyses are closed with a growth rate of ≤1 cm/year at screening 6. Pediatric patients who are being administered any drug that may have an effect on the secretion and actions of hGH (estrogen, androgen, anabolic steroids, corticosteroids, GnRH analogs, thyroxine, aromatase inhibitors, etc.) or anticonvulsants and cyclosporin at screening, and have been administered any of them for a long period of time within 6 months prior to screening (However, those who have been administered a thyroxine preparation for ≥4 weeks on a stable dose [allowable in case the investigator determines the dose is stable even though it is changeable based upon the weight of the pediatric patient] were allowed to participate in the clinical study.) 7. Pediatric patients who are being administered any drug (e.g. methylphenidate) for treatment of hyperactivity disorders including attention deficit hyperactivity disorder (ADHD) at screening 8. Pediatric patients who are hypersensitive to somatropin or any excipient of the investigational product (cresol or glycerol) or who have a relevant history of hypersensitivity 9. Pediatric patients who have participated in any other clinical studies after enrolled in this study or who had participated in any other clinical studies within 3 months prior to enrollment in this clinical study 10. Pediatric patients in whom this clinical study is considered to be difficult to be conducted for any other reasons on investigator's judgment
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, BRCA1 Mutation Carrier BRCA2 Mutation Carrier Endometrial Adenocarcinoma Estrogen Receptor Negative HER2/Neu Negative High Grade Ovarian Serous Adenocarcinoma Progesterone Receptor Negative Recurrent Breast Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Uterine Corpus Carcinoma Stage III Uterine Corpus Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Stage IV Uterine Corpus Cancer AJCC v7 Triple-Negative Breast Carcinoma Any histologically confirmed locally advanced recurrent endometrial adenocarcinoma (except for carcinosarcoma), recurrent high-grade serous ovarian/primary peritoneal/fallopian tube carcinoma, or deleterious BRCA mutant recurrent ovarian/primary peritoneal/fallopian tube cancer for whom no curative option is available will be eligible; any patient proven to have metastatic triple negative breast cancer, defined from standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) will be eligible Patients may have unlimited prior chemotherapeutic regimens for management of recurrent locally advanced endometrial carcinoma, recurrent ovarian carcinoma, or metastatic triple negative breast cancer; treatment as frontline therapy for metastatic disease is acceptable; patients who have received prior PARP inhibitors, MTOR inhibitors, and/or AKT inhibitors are allowed to participate; patients may have progressed on prior PARP inhibitor, MTOR inhibitor, or AKT inhibitor but they may not have discontinued drug for toxicity With the exception of alopecia, any unresolved toxicities from prior chemotherapy should be no greater than Common Terminology for Adverse Events (CTCAE) (version 4.0) grade 1 at the time of starting study treatment Patients should have measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) 1.1; if no measurable disease is present, patients should have assessable disease such as pleural effusion, ascites, with cancer antigen 125 (CA125) Gynecological Cancer Intergroup (GCIG) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Women of child-bearing potential and their partners must agree to use contraception (hormonal or barrier method of birth control; abstinence) from study entry until 30 days after last dose of study drug; male partners should be instructed to use contraception during the study period; women of child-bearing potential (intact uterus) should have a negative serum pregnancy test; if a woman becomes pregnant or suspects she is pregnant while on study, she should tell her treating physician immediately; female patients must have evidence of non-child-bearing potential by fulfilling 1 of the following at screening: a) post-menopausal defined as > 50 years old and amenorrheic for >= 12 consecutive months following cessation of all exogenous hormonal treatments; b) documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation Women must not breast-feed while taking the study medications Absolute neutrophil count >= 1,500/mcL (measured within 28 days prior to entry/randomization) Hemoglobin >= 10 gm/dL (measured within 28 days prior to entry/randomization) Platelets >= 100,000/mcL (measured within 28 days prior to entry/randomization) Patients receiving any other investigational agents or any additional anti-cancer agents Patients who have endometrial carcinosarcoma; patients with ovarian cancer who have histology other than high-grade serous in the absence of a deleterious BRCA mutation; if the patient has a deleterious BRCA mutation, any histology will be accepted Patients who have recurrences that are amenable to potentially curative treatment with radiation therapy or surgery Patients who have a history of other malignancies except for basal cell or squamous cell skin cancer, in situ cervical cancer, unless they have been disease-free for at least five years; patients may have dual primaries of endometrial, ovarian or breast cancer Patients who have a history of myelodysplastic syndrome Patients who have symptomatic, uncontrolled spinal cord compression and/or brain metastases; a scan to confirm absence of brain metastasis is not required; patients can receive a stable dose of corticosteroids (except those prohibited per protocol) before/during study if these were started at least 28 days prior to entry Patients who have had prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 28 days of starting study treatment (not including palliative radiotherapy at focal sites), or corticosteroids that are prohibited per protocol within 14 days of starting study treatment Patients who have had major surgery within 28 days prior to entry into the study or be recovering from any effects of surgery; patients who have had minor surgery within 2 weeks prior to entry into the study Patients who have a resting electrocardiogram (ECG) with a Fridericia corrected QT (QTcF) interval of >= 470 msec at 2 or more time points within a 24 hour period or a family history of long QT syndrome Patients who have required a blood transfusion within 28 days prior to study start
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Immediate Postpartum Hemorrhage The trial will women aged 18 years or older who have just had a vaginal delivery between 35 and 42 weeks of gestation with a PPH persisting 15 minutes after the injection of 5 UI or 10 IU of oxytocin by slow IV and uterine massage and who provided informed written consent. If her condition does not allow her consent to be obtained immediately in ethically acceptable conditions, it may be obtained from her healthcare agent, or if there is none, from a family member, if present. In case where neither a healthcare agent nor a family member is present on the day of the patient can nonetheless be included. She will be informed secondarily, and her consent will be requested for the potential continuation of the research and use of her data Patient beneficiary or affiliated to a health insurance The trial will not women who have just had a cesarean delivery with a contraindication to Sulprostone with clinical chorioamnionitis or an in utero fetal death or a medically-indicated termination of pregnancy with PPH secondary to cervicovaginal lacerations without any uterine hemorrhage, uterine rupture, or placenta accreta with arterial bleeding requiring embolization with a purulent infection of the cervix, vagina or uterus with symptoms indicating a hysterectomy with cervical cancer
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 12.0-21.0, Sexually Transmitted Diseases Depression Diagnosis Substance Use Disorders 21 years attending primary care clinic none
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-49.0, Cervical Neoplasia Cervical Cancer female, age 30-49, able to give informed consent pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-65.0, Cancer Cervix women from 30 to 65 years old women living in french territorial division 37 ("Indre-et-Loire") women having a reported general practitioner in french territorial division 37 ("Indre-et-Loire") pap smear made in the three last years
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-80.0, Cervical Cancer abnormal cervical cancer screening by pap smear of high risk HPV test - no consent -
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 14.0-19.0, Pregnancy Sexually Transmitted Diseases female self-identify as African American 19 years of age present to clinic on date of potential enrollment for clinical care has had vaginal sex with a male partner at least once in the past 6 months HIV-negative by self-report not currently pregnant (verified by urine pregnancy test) desire to avoid pregnancy for at least 12 months plan to be in the Atlanta area for the next 12 months competent to participate in consenting or assenting process per recruiter evaluation pregnant HIV positive
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cancer of Cervix Tumors Male or female subjects age >18 years at the time of informed consent Histologically/cytologically confirmed locally advanced or metastatic solid tumors for which no curable therapy exists. In dose expansion part of this study, only patients with stage IV or recurrent/persistent cervical cancer will be enrolled. Confirmation of FGF/FGFR aberration is not required Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Adequate marrow function as defined below: absolute neutrophil count ≥ 1.5 x 10 9/L platelets ≥ 100,000 x 10 9/L hemoglobin ≥ 9.0 g/dL Adequate liver function as evidenced by bilirubin <1.5 times the upper limit of normal (ULN); alanine aminotransferase (AL T) and aspartate aminotransferase (AST) <3 times the ULN Evidence of measurable or evaluable disease, as determined by v 1.1 Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 12 consecutive months (Le., has had menses at any time in the preceding 12 consecutive months). Oral contraceptives (OC), injected or implanted hormonal methods are not allowed as the sole method of contraception because BGJ398 has not been characterized with respect to its potential to interfere with PK and/or the effectiveness of OCs It is preferred that archival tumor sample is available for molecular testing, if not available, a newly obtained tumor biopsy may be submitted instead (not mandatory) For patients enrolled in dose escalation, any number of prior treatments allowed. For patients enrolled in dose expansion, no prior chemotherapy is allowed (previous single agent cisplatin concurrent with radiotherapy is accepted) No prior therapy with paclitaxel, BGJ398 or other FGFR targeting agents Preexisting> grade 2 peripheral neuropathy Patients with brain metastases are allowed provided that they are clinically stable for a period of 30 days prior to study entry and there is not a requirement for steroids or anti epileptics History of pancreatitis in last 6 months prior to enrollment History and/or current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, or patients with other phosphate regulating abnormalities. Because hyperphosphatemia is a frequent occurrence with BGJ398 treatment, pretreatment and concurrent treatment with phosphate regulating agents is allowed Current evidence of corneal or retinal disorder/ keratopathy such as bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivits, etc Since BGJ398 is a likely inhibitor of CYP3A4, patients who are currently receiving treatment with agents that are known sting inducers or inhibitors CYP3A4 are not allowed Treatment with any of the following anti-cancer therapies prior to the first dose of the of BGJ398 within the stated timeframes: intravenous chemotherapy within a period of 4 weeks ( 6 weeks for nitrosourea, mitomycin-C), biological therapy (e,g. antibodies) within a period of time that is ~ 5 t1/2 or less than 4 weeks, whichever is shorter, prior to starting study drug, any other investigational agents within a period of time that is < 5 tl/2 or 4 weeks (whichever is shortest) prior to starting study drug, wide field radiotherapy < 4 weeks or limited field radiation for palliation < 2 weeks prior to starting study drug Use of medications that increase serum levels of phosphorus and/or calcium
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-75.0, To Determine the Prevalence, Penetrance of BRCA1 and BRCA2 Mutations in Romanian Womens With Breast or Ovarian Cancer Categories of patients to be recruited for complete sequencing of all BRCA1 and BRCA2 exons are subjects who have been diagnosed with breast or ovarion cancer and who are: 1)40 years of age or younger 2)Triple negative breast cancer diagnosed before 50 years of age 3)Male with breast cancer 4)Bilateral breast cancer, first tumor diagnosed before 50 years of age 5)2) + 50 years of age or younger with at least one (first degree) relative diagnosed with breast cancer at 50 years of age or younger or a first degree relative with ovarian cancer 6)of any age with 2 or more relatives with breast cancer 7)of any age with 2 or more relatives with ovarian cancer 8)of any age with a personal history of ovarian cancer, tuba or peritoneal carcinoma 9)Two patients in same branch of the family, Prostate ca < 60 yr and 1st degree relative with BC < 50 yr 10)Two or more 1st and 2nd degree relatives of a patient with breast cancer, at least one of them <50 yr 11)of any age with a family history of male breast cancer or are at increased risk of having a BRCA mutation based on or Tyrer-Cuzick models
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-69.0, Cancer of the Cervix Cervical Intraepithelial Neoplasia Australian residents with a cervix, aged 25-69 years who are attending for routine cervical screening. (Note: since April 2016 recruitment has been confined to the younger strata, i.e. women age-eligible for HPV vaccination aged at least 25 and born on or after 1st July 1980, as the recruitment target of the older cohort was met) Participants may have been previously enrolled in the Compass Pilot but must have been discharged to routine screening. Women may also be in follow-up management for a previous abnormality or unsatisfactory cytology Previous total hysterectomy (uterus and cervix) The presence of symptoms or signs for which cervical cancer must be excluded Currently undergoing treatment for cervical cancer Currently enrolled in the Compass Pilot Study
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-60.0, CIN Married women attending the Preventive Oncology screening clinic women in age group 30 to 60 years Unmarried women married women in the age group less than 30 years and above 60 years pregnant women women with history of total hysterectomy women with cervical cancer
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Bilateral Laparoscopic Salpingectomy Woman aged 18 years or more All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers Informed and signed consent Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc Pregnancy, ongoing or planned during the study period Allergy to fluorescein Previous allergy or anaphylactic shock during an angiography Allergic or hypersensibility reactions Severe asthma, chronic cardiac or pulmonary diseases Restricted renal function Patient under a beta-blockers treatment Inability to understand information provided Not covered by a national health insurance scheme, prisoner or under administrative supervision
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-75.0, Uterine Cervical Neoplasms patients with squamous cell, adenosquamous or adenocarcinoma of the cervix Stage IB2-IIB according to the Inyernational Federation of Gynecology and Obstetrics (FIGO) age between 18 and 75 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 normal cardiac and respiratory functions absence of secondary malignancies no previous surgical, chemotherapic and/or radiotherapic treatment for secondary malignancies informed consent obtained from the patient histological confirmation of papillary serous, mucinous, clear cell, squamous cell, mixed and undifferentiated carcinoma of the uterus abnormal hepatic function (transaminases > 2.5 x upper limit, serum bilirubin > 1,5 x upper limit) abnormal renal function (creatinine clearance <60 mL/min and/or serum creatinine>2.0 mg/100 mL) function abnormal bone marrow function (absolute neutrophil count <1,5 x 109/L or platelet count < 100 x 109/L or hemoglobin < 9 g/dL severe or uncontrolled infection, other systemic diseases or mental illness; and pregnant women. Clinical staging was performed according to the NCCN and included pelvic examination, cervical biopsy, abdomen-pelvis Computed Tomography, chest X-ray; examination under anesthesia, cystoscopy and/or proctoscopy if clinically indicated (National Comprehensive Cancer Network, Clinical Practicw Guidelines in Oncology. Cervical Cancer, Version 2.2015)
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Ovarian Reserve Women undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Cervical Cancer Intraepithelial Neoplasia Women of all ages are eligible to the study if they have been referred to the participating colposcopy clinic because of an abnormal Pap test at the level of an atypical squamous cells of undetermined significance or worse squamous or glandular abnormality (i.e., ASCUS+) or an abnormal co-test (ASCUS+ and HPV-positive) result none
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-999.0, Cervical Cancer Cervical Precancer Adherence women who are at least 21 years old are seeking care for a Pap smear exam are seeking care for a colposcopy exam for the first time are not pregnant by self-report are able to provide informed consent women who do not meet the above women who have no prior history of a hysterectomy women who have previously participated in this study
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer No prior treatment for cervical cancer. 2. FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type). 3. Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and optional for IB1 stage 4. Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more). 5. Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment). 6. Age ≥ 18 years. 7. ECOG (Eastern Cooperative Oncology Group) 0-2. 8. Life expectancy > 6 months. 9. Patient eligible for standard treatment (according to standards of each center). 10. Patient having health care insurance. 11. Informed and signed consent by patient. (DICOM = Digital Imaging and Communications in Medicine) Patient enrolled in a clinical trial involving an investigative new agent. 2. Co morbidity, preventing patient to tolerate the proposed standard treatment. 3. Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix). 4. Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 . 5. Patient deprived from ability to decide on her own. 6. Patient unable to have a regular follow up for geographical, social or psychological reasons. 7. Pregnancy or patient old enough to procreate and not using effective contraceptive method
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-59.0, Compliance Cervical Cancer Women between 25-59 years-old Not pregnant Had held their last Pap smear for over a year Could read Women with previous hysterectomy History of cervical cancer or its precursors Bearers of some state of chronic immunosuppression (such as HIV ou autoimmune diseases) Those who underwent self-collection of their specimen during menstrual period
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 2.0-25.0, Tumors Solid Malignant Tumors Osteosarcoma Differentiated Thyroid Cancer (DTC) Histologically or cytologically confirmed diagnosis of solid malignant tumor. 1. Cohort 1: Any solid malignant tumor. 2. Cohort 2A: Differentiated Thyroid Cancer (DTC) with one of the following histological subtypes: i) Papillary thyroid cancer (PTC). i.a) Follicular variant. i.b) Other variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hurthle cell variant of papillary carcinoma, or poorly differentiated carcinomas). ii) Follicular thyroid cancer (FTC). ii.a) Hurthle cell. ii.b) Clear cell. ii.c) Insular. c) Cohort 2B, 3A, and 3B: Relapsed or refractory osteosarcoma. 2. Relapsed or refractory solid tumor malignancy that has progressed on standard anticancer therapy with no available curative options. (Note: Osteosarcoma participants must be in first or subsequent relapse [greater than or equal to first relapse]). Only the osteosarcoma participants enrolled to Cohorts 3A and 3B must be deemed candidates for ifosfamide and etoposide chemotherapy). 3. Evaluable or measurable disease that meets the following 1. Participants must have evaluable or measurable disease based on 1.1 using computed tomography (CT)/magnetic resonance imaging (MRI). 2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have subsequently grown unequivocally to be deemed a target lesion. 4. DTC participants must be 131 iodine-refractory/ relapsed as defined by at least one of the following: 1. One or more evaluable or measurable lesions that do not demonstrate iodine uptake on any radioiodine scan; or 2. One or more evaluable or measurable lesions that have progressed based on 1.1, within 12 months of 131 iodine therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre or post-treatment scanning. These participants must not be eligible for possible curative surgery; or 3. Cumulative activity of 131 iodine greater than 400 millicuries (mCi) or 14.8 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry. 5. Participants with DTC must be receiving thyroxine suppression therapy and levels of thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than or equal to 5.50 milliunits per liter (mU/L)). When tolerated by the participant, thyroxine dose should be changed to achieve TSH suppression (TSH less than 0.50 mU/L). 6. Participants with known central nervous system (CNS) primary tumors or metastases who have completed brain therapy (such as radiotherapy, stereotactic radiosurgery, or surgical resection) and have remained clinically stable, asymptomatic, and off of steroids for 2 weeks prior to Cycle 1 Day 1 will be eligible. 7. Male or female participants age 2 years to less than18 years and less than or equal to 25 years for osteosarcoma subjects at the time of informed consent. 8. Lansky play score greater than or equal to 50% or Karnofsky Performance Status score greater than or equal to 50%. Use Karnofsky for participants greater than or equal to 16 years of age and Lansky for participants less than 16 years of age. 9. Life expectancy greater than or equal to 3 months. 10. Adequate bone marrow function as evidenced by: 1. absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^9/L (for Cohorts 3A and 3B leucocyte count greater than or equal to 2 x 10^9/L; participants with bone marrow involvement should have ANC greater than or equal to 0.8 x 10^9/L and leucocyte count greater than or equal to 1 x 10^9/L). 2. hemoglobin greater than or equal to 8.0 grams/deciliter (g/dL) (a hemoglobin less than 8.0 g/dL is acceptable if it is corrected by growth factor or transfusion before starting lenvatinib). 3. platelet count greater than or equal to 75 x 10^9/L. 11. Adequate liver function as evidenced by: 1. bilirubin less than or equal 1.5 times the upper limit of normal (ULN). 2. alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN. 12. Adequate renal function as evidenced by: a) Serum creatinine based on age/gender as below. If serum creatinine is greater than maximum serum creatinine for age/gender as shown in the table below, then creatinine clearance (or radioisotope glomerular filtration rate [GFR]) must be greater than 70 milliliter/minute/1.73 square meter (mL/min/1.73 m2). Maximum Serum Creatinine in milligrams/deciliter (mg/dL) for male: i. Age 2 to less than 6 years = 0.8 ii. Age 6 to less than 10 years = 1.0 iii. Age 10 to less than 13 years = 1.2 iv. Age 13 to less than 16 years = 1.5 v. Age greater than or equal to 16 years = 1.7 Maximum Serum Creatinine (mg/dL) for Female: vi. Age 2 to less than 6 years = 0.8 vii. Age 6 to less than 10 years = 1.0 viii. Age 10 to less than 13 years = 1.2 ix. Age 13 to less than 16 years = 1.4 x. Age greater than or equal to 16 years = 1.4 The threshold creatinine values in this Table were derived from the Schwartz formula for estimating glomerular filtration rate using child length and stature data published by the CDC. b) Urine dipstick less than 2+ for proteinuria. Participants who have greater than or equal to 2+ proteinuria on dipstick urinalysis should undergo a spot protein-creatinine (P/C) ratio that should be Grade less than 2. c) No clinical evidence of nephrotic syndrome. 13. Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) greater than or equal to 50%) at baseline as determined by echocardiography. 14. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as: BP less than 95th percentile for sex, age, and height/length at screening (as per National Heart Lung and Blood Institute guidelines) and no change in antihypertensive medications within 1-week prior to Cycle 1/Day 1. Osteosarcoma subjects 18 to 25 years should have BP ≤150/90 mm Hg at screening and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1. 15. Washout of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas; 4 weeks for definitive radiotherapy, and 2 weeks for palliative radiotherapy; 3 months from high-dose chemotherapy and stem cell rescue; 3 weeks from major surgery. Participants must have recovered from the acute toxic effects of all prior anticancer therapy before enrollment into the study. 16. Written and signed informed consent from the parent(s) or legal representative (guardian) and assent from the minor participant. Written informed consent from subjects ≥18 years. 17. Willing and able to comply with the protocol, scheduled follow-up, and management of toxicity as judged by the Investigator. Cohort 3B (Combination Expansion): Osteosarcoma subjects who progressed in Cohorts 1 or 2B and opt to receive combination therapy. 18. Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet only Numbers 6 through 17 (after progression in Cohort 2B) Any active infection or infectious illness unless fully recovered prior to dosing. 2. Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study. 3. Other organ toxicity due to prior anticancer therapy (investigational agent, chemotherapy, or radiation therapy) except alopecia, and ototoxicity due to cisplatin not already covered in the inclusion/ which has not recovered to Grade less than 2 per Common Terminology for Adverse Events (CTCAE) v4.0. 4. Known hypersensitivity to any component of the product (lenvatinib or ingredients). 5. Concurrent administration of any other antitumor therapy. 6. Previous treatment with lenvatinib (except for participants previously enrolled into Cohorts 1 or 2B of this study). 7. Two or more prior vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted therapies. 8. Currently receiving any investigational drug or device in another clinical trial or within 30 days preceding informed consent. 9. A clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval greater than 480 msec). 10. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib. 11. Gastrointestinal bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 3 weeks prior to the first dose of study drug. 12. Active second malignancy within 2 years prior to enrollment ([in addition to the primary tumor types specified by cohort in Criterion Number 1], but not including definitively treated superficial melanoma, in-situ, basal or squamous cell carcinoma of the skin). 13. Previous treatment with ifosfamide and Grade greater than or equal to 3 nephrotoxicity or encephalopathy (Cohorts 3A and 3B). 14. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. Cohort 3B (Combination Expansion): Osteosarcoma participants who progressed in Cohorts 1 or 2B and opt to receive combination therapy. 15. Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet all the with the exception of Criterion Number 6
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Colorectal Cancer patients scheduled to robot-assisted CRC resection patients with histologically verified cancer i colon or rectum informed consent patients with minimum age of 18 patients without liver metastases patients who have not given informed consent patients with severe heart disease, lung hypertension, or had had a heart attack < 7 days patients with alcohol or drug abuse patients with liver metastases
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-65.0, Cervical Carcinoma Human Papillomavirus Infection Ages 30-65 No Pap test in the last 3 years Resident of an Ohio Appalachia county Not currently pregnant or was not pregnant in the last 3 months No history of invasive cervical cancer No history of hysterectomy; women will not be eligible for the pilot randomized controlled trial (RCT) if they participated in the focus groups that helped develop this study (focus groups were institutional review board [IRB] approved as Protocol 2014C0086) or the preliminary device test; we will also require women to read and understand English and have the ability to provide informed consent, which will be inferred upon completion and return of the study consent, and Health Insurance Portability and Accountability Act (HIPAA) forms
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-50.0, Cervical Intraepithelial Neoplasia Aged 18-50 years Had recent (≤ 60 days) Pap smear result consistent with high grade squamous intraepithelial lesion (HSIL) or "cannot rule out HSIL" or HSIL on colposcopy-guided biopsy Untreated for HSIL or "Cannot rule out HSIL" Able to provide informed consent Willingness and able to comply with the requirements of the protocol History of disease or treatment causing immunosuppression (e.g., cancer, human immunodeficiency virus, organ transplant, autoimmune disease) Being pregnant or attempting to be pregnant within the period of study participation Breast feeding or planning to breast feed within the period of study participation Allergy to Candida antigen History of severe asthma requiring emergency room visit or hospitalization within the past 5 years History of invasive squamous cell carcinoma of the cervix History of having received PepCan If in the opinion of the Principal Investigator or other Investigators, it is not in the best interest of the patient to enter this study
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Metastatic Lung Non-Small Cell Carcinoma Metastatic Lung Small Cell Carcinoma Metastatic Pancreatic Adenocarcinoma Metastatic Triple-Negative Breast Carcinoma Pancreatic Ductal Adenocarcinoma Stage III Breast Cancer AJCC v7 Stage III Lung Non-Small Cell Cancer AJCC v7 Stage III Lung Small Cell Carcinoma AJCC v7 Stage III Pancreatic Cancer AJCC v6 and v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIA Lung Non-Small Cell Cancer AJCC v7 Stage IIIA Lung Small Cell Carcinoma AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IIIB Lung Small Cell Carcinoma AJCC v7 Stage IIIC Breast Cancer AJCC v7 Stage IV Breast Cancer AJCC v6 and v7 Stage IV Lung Non-Small Cell Cancer AJCC v7 Stage IV Lung Small Cell Carcinoma AJCC v7 Stage IV Pancreatic Cancer AJCC v6 and v7 Triple-Negative Breast Carcinoma Unresectable Lung Small Cell Carcinoma Unresectable Pancreatic Adenocarcinoma Unresectable Pancreatic Carcinoma Unresectable Triple-Negative Breast Carcinoma Patients must have histologically confirmed, metastatic or unresectable malignancy of the following types: (a) non-small cell lung cancer (NSCLC), (b) triple-negative breast cancer (TNBC; defined by estrogen receptor [ER] < 1%, progesterone receptor [PR] < 1% and HER2 1+ or less by immunohistochemistry [IHC]; if HER-2 expression is 2+, a negative fluorescence in situ hybridization [FISH] testing is required) (c) pancreatic adenocarcinoma (PDAC), or (d) small cell lung cancer (SCLC) Must have received at least one line of standard systemic treatment for locally advanced or metastatic disease setting of the respective tumor type; for NSCLC, it is either PD-1/PD-L1 inhibitor, or platinum-containing chemotherapy, or an EGFR tyrosine kinase inhibitor or an ALK inhibitor if sensitizing mutation present; TNBC: platinum-containing chemotherapy; PDAC: fluorouracil (5-FU-), gemcitabine-, or taxane-containing chemotherapy either with or without radiation therapy; SCLC: platinum-containing chemotherapy for limited or extensive stage disease Patients must have measurable disease by Response Evaluation in Solid Tumors (RECIST) version (v)1.1 Toxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute (NCI)-Common Terminology for Adverse Events (CTCAE) version (v)5.0; patients with long-standing stable grade 2 neuropathy or prior grade 2 treatment-related hypothyroidism requiring treatment, provided free T4 within normal range, may be considered eligible after discussion with the study principal investigator (PI) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Karnofsky >= 50%) Life expectancy of >= 4 months Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Hemoglobin > 9 g/dL Patients who have had chemotherapy or RT within 3 weeks prior to start of the study agents, or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier Patients should not have received any other investigational agents within the past 4 weeks Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should be excluded from this clinical trial, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events (AEs); screening brain MRI (or CT if MRI contraindicated) will be required for patients with recurrent NSCLC, TNBC, or SCLC; brain MRI (or CT if MRI contraindicated) is required for PDAC if clinically suspected by patient's symptoms or neurological exam; should patient found to have brain metastasis, treatment of brain metastasis must precede the participation in this study; for patients with known and treated brain metastases is allowed in this study if they fulfill the following The lesions have improved or remained stable radiographically and clinically for at least 6 weeks after completion of brain irradiation or stereotactic brain radiosurgery and off steroids for at least 6 weeks Patients who have received prior inhibitor of VEGF signaling and a poly (ADP-ribose) polymerases (PARP) inhibitor administered in combination; unless administered in combination, patients who received a prior PARP inhibitor or a prior VEGF-signaling inhibitor agent are allowed after discussing with the PI History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension Current use of natural herbal products or other complementary alternative medications (CAM) or "folk remedies" Patients with concomitant or prior invasive malignancies within the past 3 years; subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible Uncontrolled intercurrent illness 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
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Anal Dysplasia Human Papillomavirus Anal Cancer Males, aged ≥ years at baseline Identify as a man who has sex with a men (MSM) Laboratory documentation of HIV-1 infection (enzyme-linked immunoassay and Western Blot) For those on combination antiretroviral therapy, the participant must be on a stable regimen (i,e, virologically suppressed with HIV-1 RNA below the assay's limit of detection for a minimum of sex months).This is one attempt to minimize confounding from dramatic shifts in viral load and/or CD4 count An ability to give informed consent An ability to attend clinic for all study visits For those continuing to the treatment randomized controlled trial (RCT), AIN-2 or -3 found on biopsy of anal canal lesion(s), and willingness to undergo ablative therapy Participants having previously undergone anal cancer screening Prior history of documented treatment of anal dysplasia Prior receipt of any HPV vaccine Current or prior history of cancer of the anogenital regions (e.g. penile, anal, or rectal) Inability to consent
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer healthy volunteer cohort: Healthy female adult volunteers patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 11.0-56.0, Abortion Pregnancy Tests She has been determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria She is willing to use the semiquantitative pregnancy test at home She is wiling and able to comply with the study procedures She speaks and reads English She has signed the study informed consent form
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-49.0, Contraception Women aged 18 through 49 years at the index date at least one claim of the hysteroscopic sterilization procedure or interval laparoscopic tubal ligation at any time during January 1, 2010 -December 31, 2012 Had 6 months of continuous medical and pharmacy benefits pre-index date which is considered the baseline period to capture all patient characteristics prior to the procedure Had 12 months of continuous medical and pharmacy benefits post-index date (i.e., follow-up period) Women who underwent a postpartum tubal ligation procedure during the entire study period Women who had claims of a sterilization procedure during the baseline period Women who had a claim for pregnancy or delivery within 6 weeks prior to the index date Women who had more than one type of sterilization procedure (i.e., combination of hysteroscopic sterilization, laparoscopic tubal ligation or mini-laparotomy) on the same index date Women who had concurrent procedures on the same day as the index sterilization procedure that were performed for reasons beyond the purpose of sterilization
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-49.0, Hysterectomy Age: 18 to 49 years at index date Gender: Female Diagnosis: Women who underwent hysteroscopic device sterilization procedure Diagnosis: Women who underwent tubal ligation sterilization procedure (includes laparoscopic tubal ligation), and salpingectomy Patients undergoing in-vitro fertilization (IVF) procedures Embryo transfer, intrauterine Follicle puncture for oocyte retrieval, any method
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-80.0, Cervical Cancer Women with invasive adenocarcinoma or squamous cell carcinoma of the cervix 2. Stages 1A1 (+LVSI), 1A2 and 1B1 (< 4 cm) 3. If CT, MRI or PET have been performed preoperatively there must be no clear evidence of metastatic disease and/or parametrial involvement. 4. Patients who have signed an approved informed consent. 5. Patients who will undergo surgery that includes a radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy, laparoscopy or robotic-assisted Patients with known allergy to triphenylmethane compounds 2. Pregnant patient 3. Patients with previous retroperitoneal surgery 4. Patients with previous history of pelvic/abdominal radiation 5. Patients with recurrent cervical cancer 6. Any patient treated with neoadjuvant chemotherapy and/or radiation
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Pregnancy Pregnant women at ≥37 weeks gestation by reliable dating as determined by the American College of Obstetricians and Gynecologists (i.e. gestational age supported by one of the following: ultrasound prior to 20 weeks of gestation, fetal heart tones auscultated by Doppler for 30+ weeks, or documented serum or urine pregnancy test 36+ weeks ago) 2. Scheduled induction of labor with indication and timing supported by the Family Birth Center induction of labor guideline entitled "Induction of labor: Indications and Timing" 3. Singleton gestation 4. Cephalic presentation 5. Amniotic fluid index greater than or equal to 5 centimeters 6. Formal prenatal ultrasound documenting the absence of placenta previa 7. Bishop score <6 and cervical dilation <3cm 8. The woman is able to give appropriate consent and has undergone an informed consent process. 9. Maternal age ≥ 18 years old at the time of consent New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy) 2. Vaginal bleeding 3. Active labor 4. Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault. 5. Uterine tachysystole (>5 contractions in 10 minutes) 6. Nonreassuring fetal heart tracing before or after Foley placement 7. Chorioamnionitis or maternal fever 8. Intrauterine fetal demise 9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery) 10. Abnormal placentation including a low lying placenta 11. Prior cesarean delivery 12. Intrauterine growth restriction (growth <10th percentile by formal ultrasound) 13. Known fetal anomaly 14. Human immunodeficiency virus, Hepatitis C, or active herpes infection 15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor 16. Pregestational diabetes 17. Rh isoimmunization 18. Non-English speaking 19. Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer Patient with cervical cancer, at any stage, before any anti-tumoral treatment. 2. Age ≥ 18 years. 3. Patient information and signature of the informed consent or her/his legal representative. 4. Patient having given her/his agreement for a second biopsy at diagnosis if the first one was performed outside of the center and was not cryopreserved Person deprived of liberty or under supervision. 2. Inability to attend scheduled follow-up visits for any psychological, sociological or geographical reasons
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Hereditary Breast Cancer The patient is included in the SCAN-B study. 2. The patient is recently diagnosed with an invasive breast cancer or a ductal cancer in situ. 3. The patient has signed an informed consent form The patient is unable to understand the written information in Swedish. 2. The patient's psychological state, due to chronic och temporary reasons, is such that one could suspect that information about the study or genetic testing could be substantially detrimental to the psychological well-beeing
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-999.0, Patient Adherence Women 30 years and older living in a household visited by Community Health Workers (CHWs) Women with a previous HPV test Women with precancerous lesion or cervical cancer Current pregnancy Women with Mental disability
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-70.0, Cervical Squamous Cell Carcinoma Cervical Adenocarcinoma Malignant Neoplasm of Cervix Stage IB1 Stage IIA1 Cervical Cancer Age >=18 years to <= 70 years Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix Stage IIA1, or IB1 disease Karnofsky performance status >70 Patients who comply with follow-up With written informed consent Age>70 History of lower urinary tract damage or surgery With abnormal urodynamic study results Karnofsky performance status <70 Patients who have uncontrolled psychological disorders Unwilling to or unable to comply with protocol Prior treatment with pelvic radiotherapy
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Pregnancy Pregnant women to 45 years of age Admitted to MUSC in labor or for induction of labor resulting in a vaginal delivery epidural analgesia Postpartum tubal ligation following delivery American Society of Anesthesiologists (ASA) Physical Class 1, 2, and 3 Critically Ill Patients (patients admitted to the ICU) Cognitively Impaired Persons (patients with a diagnosis of cognitive deficit) Cesarean delivery Punctured dura Patients enrolled in other epidural research studies
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-60.0, Endometrial Polyps The patient must be informed about the study, and sign the informed consent Positive Pap smear test Pregnancy Uterine malignancy Abnormal uterine bleeding
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.5-17.0, Rhabdoid Tumors INI1-negative Tumors Synovial Sarcoma Malignant Rhabdoid Tumor of Ovary Age (at the time of consent/assent): ≥6 months to <18 years Cohort 4 only: ≥10 years to <18 years 2. Performance Status If <12 years of age: Lanksy Performance Status >50% If ≥12 years of age: Karnofsky Performance Status >50% NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is considered to be ambulatory for the purpose of assessing their performance status. 3. Has provided signed written informed consent/assent 4. Has a life expectancy of >3 months 5. Has relapsed or refractory disease and no standard treatment options as determined by locally or regionally available standards of care and treating physician's discretion 6. Is ineligible or inappropriate for other treatment regimens known to have effective potential 7. Has a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) or equivalent laboratory certification 8. Has all prior treatment (i.e., chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ≤ Grade 1 per CTCAE, version 4.03 or are clinically stable and not clinically significant, at time of enrollment 9. Has completed a prior therapy (ies) according to the below Other investigational study agent (any medicinal product that is not approved in the country of treatment for any indication, adult or pediatric) (At least 30 days or five half-lives, whichever is longer, since last dose prior to the first dose of tazemetostat) Chemotherapy: cytotoxic (At least 14 days since last dose of chemotherapy prior to first dose of tazemetostat) Chemotherapy: nitrosoureas (At least 6 weeks since last dose of nitrosoureas prior to first dose of tazemetostat) Chemotherapy: non-cytotoxic (e.g., small molecule inhibitor) (At least 14 days since last dose of non-cytotoxic chemotherapy prior to first dose of tazemetostat) Monoclonal antibody (ies) (At least 28 days since the last dose of any monoclonal antibody prior to first dose of tazemetostat) Immunotherapy (e.g., tumor vaccine) At least 6 weeks since last dose of immunotherapy agent(s) prior to first dose of tazemetostat) Has had prior exposure to tazemetostat or other inhibitor(s) of EZH2 2. Is being actively treated for another concurrent malignancy or is less than five years from completion of treatment for another malignancy 3. Has participated in another interventional clinical study and received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the planned first dose of tazemetostat 4. Has had major surgery within 2 weeks prior to enrollment NOTE: Minor surgery (e.g., minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 2 weeks prior to enrollment. 5. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 4.03 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS). Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and MPN (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing. Note: Bone marrow aspirate/biopsy will be conducted following abnormal peripheral blood smear morphology assessment conducted by central lab at screening. Cytogenetic testing and DNA sequencing will be conducted following an abnormal result of bone marrow aspirate/biopsy. 6. Has a prior history of T-LBL/T-ALL. 7. Has clinically active heart disease including prolonged corrected QTcF (>450 msec) 8. Is currently taking any prohibited medication(s) as described in Section 7.3. 9. Is unwilling to grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from time of enrollment to while on study 10. Has an active infection requiring systemic treatment 11. Is immunocompromised (i.e. congenital immunodeficiencies), including subjects known history of infection with human immunodeficiency virus (HIV) 12. Has known history of chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (detectable HCV RNA) 13. Has had a symptomatic venous thrombosis within the 14 days prior to study enrollment NOTE: Subjects with a history of a deep vein thrombosis 14 days prior to study enrollment who are on anticoagulation therapy with low molecular weight heparin are eligible for this study 14. For subjects with CNS involvement (primary tumor or metastatic disease): Have any active bleeding, or new intratumoral hemorrhage of more than punctate size on Screening MRI obtained within 14 days of starting study drug,or known bleeding diathesis or treatment with anti-platelet or anti-thrombotic agents 15.15. Has known hypersensitivity to any of the components of tazemetostat or other inhibitor(s) of EZH2, or hypersensitivity to Ora-sweet or methylparaben 16. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements 17. For female subjects of childbearing potential: Is pregnant or nursing For male subjects: Is unwilling to adhere to contraception from time of enrollment in study to at least 30 days after last dose of tazemetostat
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-45.0, HPV Testing all females attending colposcopy kasrelaini unit aging 18_45 years females with known cervical cancer females less than 18 or more than 45
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-40.0, Cervical Cancer patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-64.0, Cervical Cancer Uterine Cervical Neoplasms Human Papillomavirus Female Aged 25 to 64 years old Living at ≤250% of the federal poverty line Eligible to receive cervical cancer screening from a study-associated clinic Resides within the same or bordering county of a study-associated clinic Completion of cervical Pap screening in preceding 4 years Completion of HPV testing in preceding 6 years Pregnant History of hysterectomy Private insurance Unable to provide informed consent
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervix Cancer Histologic confirmed invasive cervical cancer Diagnosis of FIGO stages Stage 1B to 2A high risk -4B or recurrent disease Patients ≥18 years old Non-invasive uterine carcinoma; 2. Pregnancy; 3. synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer)
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 20.0-40.0, Endometriosis Women in reproductive age group scheduled for laparoscopy for any indication Women subject to any hormonal therapy in the last 3 months Women with chronic endocrine disease like diabetes mellitus Women diagnosed with pelvic inflammatory disease (PID) Severe medical disorder that prohibits the laparoscopic procedure, such as cardiovascular disease and pulmonary disease
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer Women 18 years and older Women with documented HIV-infection in their medical record or by on-site testing through voluntary counseling and testing Women willing to undergo pelvic examination and cervical cancer screening Women willing to provide written, informed consent Pregnancy
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-49.0, Cervical Precancer 49 years HPV-positive Attending the cervical cancer screening program conducted by the Saint-Damien Health-Care Centre Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF) Previous Hysterectomy Conditions that can interfere with visualization of the cervix Pregnancy > 20 weeks Not able to comply with protocol study
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-69.0, Cancer of the Uterine Cervix No previous cervical cancer screening test in the last three years pregnancy previous hysterectomy
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cancer of the Oropharynx Patients older than 18 years of age with histologically proven squamous cell carcinoma of the oropharynx HPV-negative disease status by routine p16 immunohistochemical (IHC) staining or in situ hybridization (ISH) of biopsied tumor tissue or >10 pack-year cigarette smoking history Stage T1-4, N0-3 disease, as defined by American Joint Committee on Cancer (AJCC) Eastern Cooperative Oncology Group (ECOG) (Zubrod) Performance Status 0-2 Patients who have undergone resection of primary disease Patients who have received induction chemotherapy for their oropharynx cancer diagnosis Prior cancer diagnosis within 5 years, except appropriately treated localized epithelial skin cancer or cervical cancer Prior radiation therapy to the head and neck region Women of childbearing potential (a woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study Patient unable to tolerate MRI or having an estimated Glomerular Filtration Rate (GFR) <60 ml/min/1.73 m2 Severe, active co-morbidity, defined as follows Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-65.0, Malignant Neoplasms of Female Genital Organs Women with an abnormal Pap test, positive HPV test or any history of cervical dysplasia 2. Women with an intact cervix (patients who have undergone previous LEEP, cone and/or cryotherapy are eligible) 3. Women of childbearing potential must have a negative urine or serum pregnancy test 4. Women who are at least 21 years of age or older 5. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD) 6. For patients that present to clinic to have a cervical excisional procedure (LEEP) for an already confirmed diagnosis of high grade cervical dysplasia, HRME imaging study will be performed and cervical biopsies might be taken for research purposes only. Since these patients have already the confirmed diagnosis of high-grade cervical dysplasia, any extra biopsies taken will be for research purposes only and our research fund will pay them Women < 21 years of age 2. Women who have undergone a hysterectomy with removal of the cervix 3. Women with a known allergy to proflavine, acriflavine, or iodine 4. Women who are pregnant or nursing 5. Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD)
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-65.0, Malignant Tumor of Cervix Cervical Intraepithelial Neoplasia To be a woman Aged from 30 to 65 years (30 and 65 years included) Without reimbursement of a pap-test by the health insurance for more than 3 years, despite a reminder mailed by the health insurance on the previous year (list set up by the health insurance) Able to understand and sign voluntarily the consent to participate Warranted by the health insurance Able to understand and answer the questions of the study questionnaire alone or with the help of a self-chosen third party No vaginal intercourse ever Pap-test quoted on another budget (hospital, mother and child protection…) conducted less than 3 years ago Known cervical lesion or known HPV status History of hysterectomy History of conisation History of laser treatment of the cervix History of cervical cancer Other medical reason to delay cervical cancer screening Abroad for more than one year Moving to another region (done or expected)
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1
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Human Papillomavirus-Related Cervical Carcinoma Histologic proven of cervical intraepithelial neoplasia or carcinoma in situ (CIS) or invasive cervical cancer or a Pap smear on which at least one HPV has been detected Patients not vaccinated against HPV Age >18 years EOCG performance status ≤ 3 Patient must be affiliated to a social security system Ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study Patients vaccinated against HPV Pregnant woman over 10 weeks Patient who underwent head and neck radiotherapy dating less than one year Patients deprived of liberty or under supervision
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2
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-40.0, Cervix Diseases All cervical screening programme defaulters living in Coventry Pregnancy 2. Total hysterectomy (abdominal/laparoscopic/vaginal) 3. Never been sexually active/ intimate 4. Women who cannot give valid, informed, written consent 5. HPV self-sample returned without a signed consent form 6. Women who request the research team to be excluded from the trial 7. Women who have written to the Screening Services to record their refusal to take part in the 8. Women who are identified as becoming pregnant or undergoing hysterectomy following the initial test will be excluded from the analysis of data for secondary outcomes
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 14.0-50.0, Contraception Postpartum Period Pregnant; at least 28 weeks gestation HIV negative Daily access to a mobile phone Planning to stay in area for 6 months postpartum Able to read/write or has trusted person to help Does not meet above
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1
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-75.0, Pouchitis Signed informed consent Man or woman between 18 and 70 years of age Ileal Pouch-Anal Anastomosis (IPAA) after colectomy for ulcerative colitis Active pouchitis, defined as a modified pouch disease activity index (mPDAI) ≥ 5 and a history of ≥ 4 antibiotic therapies for pouchitis in the last 12 months or Need for ongoing antibiotic therapy (> 4 weeks) to maintain clinical remission and a history of at least 2 attempts in the last 24 months to stop antibiotic therapy resulting in pouchitis episodes Treatment with biologics (e.g. infliximab, adalimumab, golimumab, vedolizumab) Treatment with immunomodulators (azathioprine, 6-mercaptopurine (6-MP), methotrexate), steroids or any investigational drugs Use of cholestyramine Crohn's disease of the pouch Known cytomegalovirus infection of the pouch Clostridium difficile infection Isolated cuffitis Clinical significant strictures of the pouch inlet or outlet Concurrent intestinal obstruction History of familial adenomatous polyposis
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 20.0-999.0, Recurrence Metastasis Death histologically or cytopathologically proven head and neck squamous cell carcinoma Age ≥ 20 years. Measurable or evaluable disease according to Response Evaluation In Solid Tumors(RECIST) criteria. Ability to sign informed consent Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers. Inability to completely with study and/or follow-up procedures
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer years and older Patients previously or newly diagnosed with invasive cervical cancer healthy women without a diagnosis of any type of cancer English speaking Able to provide informed consent, biological and questionnaire data Pregnant women
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2
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-65.0, Cervical HPV-16 and / or HPV-18 Infection Age 25 to 65 years of age with the sex life of female patients HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients Associated with acute, severe bacterial or viral infection Autoimmune diseases Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs Allergies or allergy to the drug known ingredients History of suffering CNS diseases, epilepsy and/or psychological disorder Pregnant and lactating women The researchers do not consider it appropriate clinical trials
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 31.0-65.0, HPV Infection to live in the Ardennes department (France) affiliation to a health insurance organism to 65 years old current follow-up for cervical cytological abnormalities history of hysterectomy reimbursement for a Pap smear in the last 3 years
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-65.0, Papillary Thyroid Carcinoma Newly diagnosed papillary thyroid carcinoma Undergo thyroidectomy according to the China thyroid association guidelines forthe Management of thyroid nodule and thyroid cancer Current substance abuse/dependence Daily tobacco and alcohol use Whole neck irradiation or surgery Prior cancer diagnosis or chemotherapy treatment Active autoimmune disorder Uncontrolled allergic condition or asthma Chronic use of oral steroid medication Hormone therapy (estrogen, progestin compounds)
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-65.0, Cervical Intraepithelial Neoplasia Between 25 and 65 years old Scheduled for a hysterectomy for reasons other than cervical precancer or cancer Diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted Histological evaluation of the cervix does not interfere with the woman's current diagnosis Woman consents to participate after being informed about the study Normal Pap Smear or HPV test in the past 3 years Pregnancy History of cervical surgery in past 5 years Presence of cervical lesion pre-invasive or invasive on the cervix * Current Pelvic Inflammatory Disorder or severe acute cervicitis Cervix shape disfigured or hard to reach
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1
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Healthy Premenopausal Period menstruating, pre-menopausal - pregnant, lactating, post-menopausal, smoking, on birth control pills -
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-45.0, Cervical Cancer women within the age range of 25-45 attending cervical cancer screening previous history of HPV vaccine administration
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2
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervix Uteri Dilation Subjects, females, 18 years of age or older. 2. Subjects undergoing any process that requires dilation (intrauterine procedures). 3. Subjects understanding the nature of the study and willing to sign informed consent form Subjects younger than 18 years of age. 2. Subject with the following infectious diseases: HIV, HBV, HCV, Syphilis. 3. Subject has been treated with any cervix dilating agent within 2 months before the screening. 4. Known contraindications or hypersensitivity to the components of the investigational product. 5. The patient has a condition or a concurrent severe and/or uncontrolled medical disease which could compromise participation, compliance with, and/or completion with study procedures. 6. Subjects undergoing abortion <7 and >9 weeks of pregnancy. 7. Subjects unwilling to sign the informed consent form
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-95.0, Uterine Cervical Neoplasms Patient with a diagnosis of cervical cancer Non applicable
|
2
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Human Immunodeficiency Virus (HIV) Human Papillomavirus (HPV) Currently enrolled in the Women's HIV Interagency Study (WIHS) study Able and willing to undergo anal cytology, anal molecular testing, and high resolution anoscopy with targeted anal biopsies History of high grade anal intraepithelial neoplasia (AIN 2 or 3) History of active anal disease requiring surgery History of anal or cervical cancer
|
1
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-70.0, Alcohol Use Disorder Female/male aged 21-70 years Regular heavy drinkers as defined by averaging 2 heavy drinking days per week over 90 days baseline pre-treatment timeline follow-back (TLFB), and current DSM-IV-TR alcohol dependence that recognize a need to reduce or stop drinking (Note: heavy drinking days will be defined as follows; for men greater than or equal to 5 drinks in a day and for women greater than or equal to 4 drinks in a day) Women of child-bearing potential (i.e., no hysterectomy, bilateral oophorectomy, or tubal ligation or <2 years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative serum pregnancy test prior to initiation of treatment Willingness to provide signed, informed consent to participate in the study A current, clinically significant physical disease or abnormality (i.e., neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine, cardiovascular, hepatic, or autoimmune disease that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities such as hepatic aminotransferase levels (i.e., AST and ALT) greater than 300% of the upper limit of normal or direct bilirubin levels >150% of the upper limit of normal) on the basis of medical history, physical examination, or routine laboratory evaluation. Other specific exclusionary disorders include History of clinically significant renal calculi or renal failure; a significant indication of renal compromise will be defined by an elevation of serum creatinine above the investigators' laboratory's limit of normal, or a known history of renal failure or chronic renal disease, or any current or chronic disease that could reasonably be expected to result in renal failure History of hypersensitivity to ZNS or any sulfonamide, Stevens-Johnson Syndrome, penicillin allergy, or history of any severe drug allergic reaction; History of systemic autoimmune disease such as lupus erythematosis, fibromyalgia, or rheumatoid arthritis Current blood dyscrasia or a history of such, with the exception of a past history of iron deficiency anemia History of seizure disorder Use of any of a number of medications that might prominently influence drinking patterns or cause risk of harm or injury (e.g., topiramate, disulfiram, naltrexone, acetazolamide, stimulants such as amphetamine, or tramadol; Schizophrenia, bipolar disorder, PTSD, or substantial suicide or violence risk (i.e., can't be managed safely in the outpatient setting) on the basis of history or psychiatric examination; j) currently dependent on opioids or benzodiazepines or other sedatives Considered by the investigators to be clinically inappropriate for study participation or have participated in another pharmacotherapy study in the past thirty days Subjects with prominent signs of physical dependence, and/or medical comorbidities such that study physicians feel they should consider immediate detoxification, and referred for medical detoxification in a normal treatment setting
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Neoplasia Age > 18 Women with premalignant cervical lesions who are candidates for conization (group A) Women with a normal cervix who are candidates for hysterectomy (group B) Women with newly diagnosed cervical cancer For group A and B women that had conization in the past
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2
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 20.0-65.0, Bladder Dysfunction Women with cervical cancer stage IB IIA underwent standard type III radical hysterectomy, both open and laparoscopic approach Patient aged 20 years Patient able to give free and informed consent and who agrees to participate be signing the consent form Patient who had an allergic reaction to bethanechol chloride Patient who had neurogenic bladder
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
|
eligible ages (years): 18.0-999.0, Cervix Uteri Dilation Subjects, females, 18 years of age or older Subjects undergoing any process that requires dilation (intrauterine procedures) Subjects willing to sign informed consent form Subjects younger than 18 years of age Subject with sex transmitted diseases, or with infectious diseases (HIV, HCV) Subjects unwilling to sign the informed consent form
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
|
eligible ages (years): 0.0-999.0, Cervical Cancer Women with histological verified CIN 2 or CIN 3 Women with histological verified cervical cancer Women with mild cervical lesions
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2
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
|
eligible ages (years): 18.0-999.0, Giant Cell Tumors Written informed consent for participation in the study (ICF) Patients with diffuse TGCT (diagnosed histologically) confirmed naïve or recurrent case None
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-65.0, Stress Disorders, Post-Traumatic Intimate Partner Violence Alcohol-Related Disorders Female Veterans Lifetime history of ST with at least one risk factor: heavy drinking within the past 3 months, screen positive for current PTSD or for IPV within last 12 months Age 18-65 Seeking treatment through the Women's Primary Care Clinics at the Central Texas VA Healthcare System Ability to understand study procedures in English Not actively in suicidal or homicidal crisis warranting imminent hospitalization
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
|
eligible ages (years): 18.0-999.0, Staphylococcal Infections Infections after fracture fixation or prosthetic joint surgery Affected bone or joint: Long bones of the lower and upper extremity Bacterial growth of S. aureus at the site of interest Written consent Age: 18 and older no prove of bacterial growth at site of interest missing consent infections involving external fixation pins, infections without any implanted hardware
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
|
eligible ages (years): 18.0-999.0, Hematologic Malignancy Histologically confirmed hematologic malignancy Undergoing evaluation at the BMTU at the Puget Sound VA Planning or receiving an autologous or allogeneic HCT • Patients who for any reason elect not to participate
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cancer Histological or cytological confirmation of cancer Patient being considered for participation in an experimental therapeutic trials Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule (such conditions should be discussed with the patient before registration in the study) Age below 18 years old Patient not physically and mentally able to give informed consent
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-65.0, Cervical Cancer Screening Self-identify as lesbian, bisexual, or queer woman Assigned female sex at birth English speaking ages 25-65 years report not having had a pap smear in the last three years (per guidelines) if age 30 or over, report not having a pap smear/HPV co-test within the past 5 years (per guidelines) report having had a hysterectomy report having history of cervical cancer unable to consent Pregnant women Prisoners
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1
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
|
eligible ages (years): 0.0-999.0, Cervical Cancer Urinary Retention FIGO stage IB ASA score 0-2 Radiotherapy or chemotherapy before surgeries ASA score > 2 With abnormal urinary dynamics before surgeries
|
0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-999.0, Method of Tubal Ligation at the Time of Cesarean Section Subjects must have planned cesarean delivery and desire sterilization Subjects must be able to read and provide written informed consent Subjects must be English or Spanish speaking Subjects with known hereditary cancer syndromes Subjects with a history of prior tubal surgery Subjects with a placenta accreta Subjects undergoing trial of labor after cesarean delivery
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cystic Fibrosis Female with Cystic fibrosis Age 18 years or older transplanted or non-transplanted Accepting the principle of a gynecological consultation and the principle of follow-up every 6 months in case of abnormal smear or positive HPV test Patient covered by health insurance Age under 18 Refusal to participate in the study Patient under tutorship / curatorship
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-64.0, Cervical Intraepithelial Neoplasia Grade 2/3 Women with previous abnormal cervical cancer screening test results Women between the ages of 25 and 64 Hysterectomised women Women with known pregnancy Non-consenting women Women that are not able to understand and to sign the informed consent
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Childhood Extracranial Germ Cell Tumor Extragonadal Embryonal Carcinoma Germ Cell Tumor Malignant Germ Cell Tumor Malignant Ovarian Teratoma Stage I Ovarian Choriocarcinoma Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage I Ovarian Teratoma AJCC v6 and v7 Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage I Testicular Choriocarcinoma AJCC v6 and v7 Stage I Testicular Embryonal Carcinoma AJCC v6 and v7 Stage I Testicular Seminoma AJCC v6 and v7 Stage I Testicular Yolk Sac Tumor AJCC v6 and v7 Stage II Ovarian Choriocarcinoma Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage II Testicular Choriocarcinoma AJCC v6 and v7 Stage II Testicular Embryonal Carcinoma AJCC v6 and v7 Stage II Testicular Yolk Sac Tumor AJCC v6 and v7 Stage III Ovarian Choriocarcinoma Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage III Testicular Choriocarcinoma AJCC v6 and v7 Stage III Testicular Embryonal Carcinoma AJCC v6 and v7 Stage III Testicular Yolk Sac Tumor AJCC v6 and v7 Stage IV Ovarian Choriocarcinoma Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7 Testicular Mixed Choriocarcinoma and Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Teratoma Testicular Mixed Choriocarcinoma and Yolk Sac Tumor There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites]) Standard risk 1: Patient must be < 11 years of age at enrollment Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11 Standard risk 2 (SR2) Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25 Patients with any diagnoses not listed including Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection) Pure dysgerminoma Pure mature teratoma Pure immature teratoma COG stage I, grade I Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >= 1000 ng/mL Pure immature teratoma COG stage II IV or FIGO stage IC to IV "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or Primary central nervous system (CNS) germ cell tumor
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 40.0-55.0, Cervical Cancer Being literate Have not received any training on cervical cancer before Being pregnant or postpartum quarterly Have already been diagnosed with any cancer Not having sexual experience Having undergone hysterectomy operation
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0
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