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Prophylactic Oophorectomy

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143. Guidelines on Genetic Evaluation and Management of Lynch Syndrome: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer 2

( Table 10 ). Th e strength of evidence for this guideline is expert consensus — level V and GRADE low-quality evidence. In the absence of data on this issue, several consensus panels have suggested that transvaginal ultrasound for ovarian cancer is a screening consideration in LS ( 122,137,138 ). Prophylactic hysterectomy and oophorectomy . A s dis c uss e d here, patients with LS have substantial risk for uterine and ovar- ian cancer. One US study showed benefi t for prophylactic gyne- cologic (...) surgery to reduce or eliminate gynecologic cancer ( 146 ) ( Table 11 ). Retrospective analysis of 315 women with MMR mu- tations who did and did not have gynecologic surgery revealed no cancers in the surgical group compared with a 33 and 5.5 % rate of uterine and ovarian cancer, respectively, in the nonsurgical gr o u p ( 146 ). C o st-eff ectiveness analysis modeling of gynecologic screening vs prophylactic gynecologic surgery (hysterectomy and bilateral salpingo-oopherectomy) in a theoretical

2014 American College of Gastroenterology

145. The BRCA 1/2 gene mutation test to evaluate the risks of breast and ovarian cancer

as mutation carriers may use chemoprevention to reduce their risks. 10% will undergo a prophylactic bilateral mastectomy and 40% will undergo a prophylactic salpingo-oophorectomy. 5 These interventions reduce cancer risks but some treated women will still have cancer. ? Anxiety Positive test results disclose genetic information about individuals and family members. This may create anxiety for individuals and tension within families. ? Confidentiality Individuals known to be mutation carriers may (...) and control of obesity, limiting alcohol consumption and dietary fat 2. Cancer screening or surveillance 3. Chemoprevention (e. g. tamoxifen, raloxifene) 4. Risk-reducing surgery (mastectomy, salpingo-oophorectomy) Who might consider being tested? 1- Individuals who have a family history of: ? known BRCA1/2 mutation ? ovarian cancer in 2 or more relatives, at any age ? ovarian cancer at any age AND breast cancer under the age of 60 in 3 or more relatives ? breast cancer in 3 or more relatives average age

2014 Cancer Council Australia

146. Regorafenib and Nivolumab Simultaneous Combination Therapy

drug administration. Note 1): A woman who is likely to become pregnant is a woman who has experienced menarche and is not undergoing sterilization surgery (such as hysterectomy, bilateral salpingo ligation or bilateral oophorectomy), a woman without menopause Everything is included. The definition after menopause shall be amenorrhea continuously for 12 months or more even though there is no noteworthy reason. Women who are using oral contraceptives or mechanical contraceptive methods (...) autoimmune disease Patients who require systemic corticosteroids (excluding temporary usage for tests, prophylactic administration for allergic reactions, or to alleviate swelling associated with radiotherapy) or immunosuppressants, or who have received such a therapy <14 days before enrollment in the present study Patients with a history or findings of ≥grade III congestive heart failure according to the New York Heart Association functional classification Patients with a seizure disorder who require

2018 Clinical Trials

147. Niraparib in Combination With Cabozantinib (XL184) in Patients With Advanced Urothelial Cancer (NICARAGUA)

activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons): ≥45 years of age and has not had menses for >1 year Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation a. Post-hysterectomy (...) , post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. Note: Abstinence is acceptable

2018 Clinical Trials

148. PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis

are using contraceptives or whose sexual partners are either sterile or using contraceptives. Women of non-childbearing potential (WONCBP) do not require a urine pregnancy test and must meet at least one of the following criteria: Have undergone hysterectomy or bilateral oophorectomy; Have medically confirmed ovarian failure or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory (...) at any moment of previous patient history 6. Repeated use of non-steroidal anti-inflammatory drugs (NSAIDs), including the non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen (except for prophylactic use of a stable dose of aspirin up to 325 mg / day for cardiac disease). Occasional use of NSAIDs is permitted. 8. Subjects who had received another investigational agent within 30 days before baseline. 9. Any major illness/condition or evidence of an unstable clinical condition (eg, renal

2018 Clinical Trials

149. Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery

the study and for 90 days following the last dose of osimertinib Women of childbearing potential (WoCBP): women between menarche and menopause who have not been permanently or surgically sterilized and are capable of procreation Women NOT of childbearing potential: women who are permanently or surgically sterilized or postmenopausal Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal occlusion; tubal occlusion (...) with chronic hepatitis B virus (HBV) with negative HBV viral load on appropriate antiviral therapy will be permitted, if able to continue appropriate antiviral therapy throughout treatment period Active tuberculosis Signs or symptoms of infection within 2 weeks prior to first day of study Therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to first day of study treatment: Patients receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary

2018 Clinical Trials

150. Age-specific ovarian cancer risks among women with a BRCA1 or BRCA2 mutation. (PubMed)

registry, we identified 5689 women with no previous diagnosis of ovarian or fallopian tube cancer or preventive oophorectomy. Women were followed from the date of completion of the baseline questionnaire until either a diagnosis of ovarian or fallopian tube cancer, prophylactic oophorectomy, death or last follow-up. The annual and cumulative incidence rates of ovarian cancer were estimated.Over a mean follow-up period of 4.7 years (ranges 0-22.6), 195 incident ovarian or fallopian tube cancers were (...) risk of 0.55% to age 35 for BRCA1 mutation carriers and of 0.56% to age 45 for BRCA2 mutation carriers, we recommend bilateral salpingo-oophorectomy before age 40, but ideally by age 35, for women with a BRCA1 mutation and by age 45 for those with a BRCA2 mutation to maximize prevention and to minimize adverse effects.Copyright © 2018 Elsevier Inc. All rights reserved.

2018 Gynecologic Oncology

151. Paediatric dysgerminoma: Results of three consecutive French germ cell tumours clinical studies (TGM-85/90/95) with late effects study. (PubMed)

Paediatric dysgerminoma: Results of three consecutive French germ cell tumours clinical studies (TGM-85/90/95) with late effects study. French patients (≤18years) treated for dysgerminoma between 1985 and 2005 in TGM-85, 90, 95 protocols were included. Treatment was based on primary unilateral oophorectomy followed by prophylactic lymph node irradiation (1985-1998) or a wait-and-see strategy (1998-2005) for localised completely resected tumours (pS1) or by platinum-based chemotherapy (...) received cisplatinum-based (n = 25) or carboplatin-based (n = 8) regimen with lymph node irradiation for one of them and one did not receive adjuvant treatment. With a median follow-up of 14 years, all patients are alive in complete remission. Five events occurred: 2 contralateral dysgerminomas, 1 peritoneal relapse and 2 second neoplasms (teratoma and melanoma). Bilateral oophorectomy was necessary for 12 patients. Desire of pregnancy was expressed for 17/36 patients with unilateral oophorectomy

2018 European Journal of Cancer

152. Cost-effectiveness and comparative effectiveness of cancer risk management strategies in BRCA1/2 mutation carriers: a systematic review.

expectancy (LE), cancer incidence, or quality-adjusted life years (QALYs), with or without costs.Twenty-six economic evaluations and eight comparative effectiveness analyses were included. Combined risk-reducing salpingo-oophorectomy and prophylactic mastectomy resulted in the greatest LE and was cost-effective in most analyses. Despite leading to increased LE and QALYs, combined mammography and breast magnetic resonance imaging (MRI) was less likely to be cost-effective than either mammography or MRI

2018 Genetics in medicine : official journal of the American College of Medical Genetics

153. Palliative surgery for Krukenberg tumors – 12-year experience and review of the literature (PubMed)

of the surgical specimens.Over the study duration, 38 female patients underwent palliative surgery for Krukenberg tumors at our institution. Mean age was 54.2 ± 11.7 years. The colon was the most frequent primary source of metastases (n = 21) followed by the stomach (n = 4). Prophylactic palliative surgery was performed for eight (21.1%) asymptomatic patients. Median post-operative length of stay was 8 d (IQR 6-12 d). Five patients (13.2%) experienced post-operative complications, although high grade (...) morbidity was only seen in one patient (2.6%). Median overall survival from surgery was 17 mo (95%CI: 12.1-21.9) at a median follow-up duration of 12 mo (IQR 8-17 mo). The median survival was shorter for patients who underwent emergency surgery, younger patients, those with a colorectal primary, larger tumors, or synchronous peritoneal or hepatic metastases.Palliative surgery for Krukenberg tumors can be performed safely with acceptable complication rates. Bilateral oophorectomy should be performed

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2018 World journal of clinical oncology

154. Effects of 20,000 EU of Clinical Center Reference Endotoxin (CCRE) Versus Placebo(ENDOHEART)

in peripheral blood PMNs of 20% (compared to baseline values) following inhalation of 20,000 EU of CCRE. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy Normal lung function, defined as (NHanes III predicted set): Forced Vital Capacity (FVC) of > 80 % of that predicted for gender, ethnicity, age and height Forced Expiratory Volume in the first second of the exhale (FEV1) of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > .75 (...) and management of asthma Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). History of intubation for asthma Daily use of NSAIDs, or inability to withhold NSAIDs for 4 days prior to dosing. Use of medications that may impact the results

2018 Clinical Trials

155. Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

to SOC, in Prevention of Post Abdominal Surgery Incisional Infection. Actual Study Start Date : October 4, 2018 Estimated Primary Completion Date : July 2019 Estimated Study Completion Date : October 2019 Arms and Interventions Go to Arm Intervention/treatment Standard of Care (SoC) SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Other: Standard of Care (SoC (...) ) Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. Post-operation: this is each participating center standard practice for this type of procedure Experimental: D-PLEX + SoC D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment Drug: D_PLEX D_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall

2018 Clinical Trials

156. Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients

not yet received a prophylactic HPV vaccine. The 170 SOT patients will be equally divided over 3 different SOT patient groups, namely heart, lung and kidney transplant patients. Therefore the target is to include approximately 57 heart transplant patients, 57 lung transplant patients and 57 kidney transplant patients. Enrolment in a SOT subgroup will be stopped when 57 patients have been included unless recruitment cannot be achieved within one of the other SOT-patient population. All enrolled (...) methods per the protocol. Subjects who have reached menopause, undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation are eligible without the use of contraceptives. Postmenopausal status is defined as: (1) No menses for >1 year but <3 years and confirmed by follicle stimulating hormone (FSH) levels elevated into the postmenopausal range, or (2) no menses for at least 3 years. * Subject has had no temperature ≥37.8°C within 24 hours prior to the first injection. Patient

2018 Clinical Trials

157. Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC

years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation Men and women of childbearing potential must agree to use medically accepted barrier methods of contraception (e.g. male or female condom (...) disease requiring systemic antibiotics, antifungal, or antiviral treatment on day 1 of study drug. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease) are eligible. Known active CNS metastases which are symptomatic. Eligible if metastases have been locally treated 14 days prior to cycle 1 day 1, are clinically controlled, or asymptomatic on cycle 1 day Steroid dose must be equivalent of <10 mg prednisone daily

2018 Clinical Trials

158. HIV-1-Gag Conserved-Element DNA Vaccine as Therapeutic Vaccination in HIV-Infected Persons With Viral Suppression on Antiretroviral Therapy

or laboratory that has a CLIA certification or its equivalent, or is using a point of care (POC)/CLIA-waived test. NOTE: Reproductive potential is defined as girls who have reached menarche and women who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) greater than or equal to 40 IU/mL or 24 consecutive months if an FSH is not available, or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, tubal ligation (...) ) Intrauterine device (IUD) NOTE B: If the female participant is not of reproductive potential (women who are post-menopausal as defined above, or women who have undergone surgical sterilization [e.g., hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy]), she is eligible without requiring the use of a contraceptive method. Acceptable documentation of surgical sterilization and menopause is participant-reported history. Indication of willingness to have the leukapheresis procedure. NOTE

2018 Clinical Trials

159. Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection

) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), or 3) does not have a serum or plasma follicle stimulating hormone (FSH) > 40 mIU/mL and a history of amenorrhea x >= 1 year FCBP must have a negative serum or urine pregnancy test with a sensitivity (...) testing will be repeated in FCBP, and must be negative, within 24 hours of starting each new cycle of pomalidomide Able to take aspirin (>= 81 mg) daily as prophylactic anticoagulation Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Participants who are receiving any other investigational agents Any prior use of thalidomide, lenalidomide, or pomalidomide History of allergic reactions attributed to compounds of similar chemical or biologic

2018 Clinical Trials

160. Tomivosertib (eFT-508) in Combination With PD-1/PD-L1 Inhibitor Therapy

), Not breastfeeding, and Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse from the start of Tomivosertib (eFT-508) until at least 30 days after the last dose of Tomivosertib (eFT-508) or anti-PD-1/anti-PD-L1 therapy. Note: A female subject is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating (...) (for men) or >470 msec (for women); Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis; Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the start of Tomivosertib (eFT-508). Note: Subjects with localized fungal infections of skin or nails are eligible. Subjects may be receiving prophylactic antibiotics as long as the antibiotic is not prohibited by the protocol due to the potential for drug-drug

2018 Clinical Trials

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