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Prophylactic Oophorectomy

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741. Ovarian Cancer

cancer is reduced if prophylactic bilateral salpingo-oophorectomy is done after childbearing is completed. Cancer risk appears to be lower with this approach than with surveillance. Patients with BRCA1 or BRCA2 gene mutations should be referred to a gynecologic oncologist for counseling. Key Points Ovarian cancer affects mostly postmenopausal and perimenopausal women; nulliparity, delayed childbearing, early menarche, delayed menopause, and certain genetic markers increase risk. Early symptoms (eg (...) 125). Diagnosis is by histologic analysis. Staging is surgical. Treatment requires hysterectomy, bilateral salpingo-oophorectomy, excision of as much involved tissue as possible (cytoreduction), and, unless cancer is localized, chemotherapy. In the US, ovarian cancer is the 2nd most common gynecologic cancer (affecting about 1/70 women). It is the 5th leading cause of cancer-related deaths in women and, in the US, will cause an estimated 22,530 new cases and 13,980 deaths in 2019. Incidence

2013 Merck Manual (19th Edition)

742. Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB)

with TB. Sputum positive (at site laboratory) on direct microscopy for acid-fast bacilli (at least 1+ on the IUATLD/WHO scale). Ability to produce an adequate volume of sputum as estimated from a spot assessment (estimated 10 ml or more overnight production). Females may participate if they are: 1) of non-childbearing potential (have had a bilateral oophorectomy, tubal ligation and/or hysterectomy or have been postmenopausal for at least 12 consecutive months), 2) if they are using effective birth (...) not apply if the male participant has been vasectomised or has had a bilateral orchidectomy minimally three months prior to screening, or is not heterosexually active, or practices sexual abstinence or if the female sexual partner has had a bilateral oophorectomy, tubal ligation and/or hysterectomy or has been postmenopausal for at least 12 consecutive months. Exclusion Criteria: Evidence of clinically significant (as judged by the investigator), metabolic, gastrointestinal, cardiovascular

2011 Clinical Trials

743. DFA-02 in Patients Undergoing Colorectal Surgery

antibiotic prophylaxis and improvements in surgical techniques, surgical site infections (SSI) still occur. DFA-02 is a novel bioresorbable modified release gel containing both gentamicin and vancomycin to be applied during surgical incision closure for the prevention of surgical site infections (SSIs) in patients undergoing colorectal surgery. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 30 participants Allocation: Randomized (...) be confirmed by an elevated follicle stimulating hormone [FSH] level > 30 mIU/mL; if amenorrheic for > 1 year, FSH level not required); surgically sterilized (does not have a uterus or has had bilateral tubal ligation); or if of child-bearing potential, she must have a negative serum pregnancy test on entry in the study, and agree to use adequate birth control during the study and for 30 days after the administration of study agent. Medically acceptable contraceptives include: (1) surgical sterilization

2011 Clinical Trials

744. Evaluating the Immune Response to a rAd5 HIV Vaccine Administered in Three Different Ways in Healthy, HIV-Uninfected Adults

to enrollment through the last required study visit for sexual activity that could lead to pregnancy; or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; or be sexually abstinent. More information on this criterion can be found in the protocol. Participants who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro (...) or that are scheduled within 14 days after the first vaccination Investigational research agents received within 30 days before the first vaccination Intent to participate in another study of an investigational research agent during the planned duration of the study Current anti-tuberculosis prophylaxis or therapy Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current

2011 Clinical Trials

745. A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of Non-childbearing potential, defined as: Before menarche or > or =1 year post-menopausal or Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or Congenital sterility or Diagnosed as infertile and not undergoing treatment to reverse infertility or is of Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below (...) ) Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP >100) Stroke within 3 months prior to the Screening Visit Immunologic compromise History of a positive test for HIV, hepatitis B or hepatitis C infection. Clinical visual evidence of oral

2011 Clinical Trials

746. Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers

provided by (Responsible Party): Sheba Medical Center Study Details Study Description Go to Brief Summary: Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a substantial proportion of familial cases, germ-line mutations in either BRCA1/2 can be detected. The only proven modality for active risk reduction (rather than passive early detection), is prophylactic surgery - prophylactic mastectomy and oophorectomy. While the majority of Jewish mutation carriers elect (...) to undergo prophylactic oophorectomy at about age 40 years, in Israel only a minority perform prophylactic mastectomy. Another ramification of being a mutation carrier is the emotional stress associated with that discovery.Genetic information has profound implications for mutation carriers. The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie, trains participants to reduce their perceived level of stress by self-inquiry of their thoughts and beliefs connected to stressful

2011 Clinical Trials

747. Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors

Eligible for Study: Female Accepts Healthy Volunteers: Yes Sampling Method: Probability Sample Study Population 29 postmenopausal women with a history of early stage BCa receiving adjuvant AI therapy and 29 postmenopausal women without cancer Criteria Inclusion Criteria: Postmenopausal as defined by NCCN (any of the following) Prior bilateral oophorectomy Age equal to or greater then 60 years of age Age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen (...) - Conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (Patients taking prophylaxis for joint replacements will not be excluded.) Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its identifier (NCT number): NCT01272570 Locations Layout table for location

2011 Clinical Trials

748. Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer

of Normal (ULN), Alk Phos =< 4 x ULN) Prothrombin time international normalized ratio within institutional normal limits Activated partial thromboplastin time =< 1.5 x ULN New York Heart Association classification I or II Female patients must have a negative urine pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal) Exclusion Criteria: Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand (...) Disease, Hemophilia) Any current evidence of clinically significant active bleeding Any history of significant thromboembolic events (i.e., deep vein thrombosis or pulmonary thromboembolism) within the last five years or requirement for ongoing therapy with oral or parenteral anticoagulants; central venous catheter-related thrombosis > 12 months ago and low dose anticoagulants to maintain patency of lines are allowed; patients taking anticoagulants (e.g., prophylactic heparin or enoxaparin

2011 Clinical Trials

749. Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections After Colorectal Surgery

, and abdominal perineal resection of the rectum. Able to give informed consent. Male or female ≥18 years of age. If female, is non-pregnant (negative pregnancy test result at the Screening/Randomization Visit) and non-lactating. If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth control and agrees to continue (...) surgical incision in the prevention of superficial and deep incisional surgical site infections (SSI) within 30 days after elective colorectal surgery. The study is intended to support a target indication statement of: "E-101 Solution is indicated for the prophylaxis of incisional surgical site infections following elective colorectal surgery". E-101 Solution is comprised of the active ingredients of glucose oxidase (GO) and porcine myeloperoxidase (pMPO) that produce coupled reactions after

2011 Clinical Trials

750. Evaluate Onset of Action of a Fast Release Aspirin

must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy Provide a personally signed and dated informed consent (...) vasoconstrictor and nitrous oxide No use of any analgesics, nonsteroidal anti-inflammatory drug (NSAIDs), aspirin, any other pain reliever over the counter (OTC ) or prescription, or herbal supplements within 5 days of surgery. Oral contraceptives, prophylactic antibiotics, pre-anesthetic medication, anesthesia during the procedure, or other routine medications to treat benign conditions that would not confound the evaluation of the investigational would be acceptable Female subjects of childbearing potential

2011 Clinical Trials

751. Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors

/, absolute neutrophil count (ANC) >/=1500, total Bilirubin bilateral oophorectomy (ovariectomy), bilateral tubal ligation, is post (...) of Day 1 of treatment period. History of venous or arterial thrombosis within 3 months of Day 1 of treatment Period. Current use of therapeutic warfarin. NOTE: both low molecular weight heparin and prophylactic low-dose warfarin are permitted; however, PT/PTT must meet above inclusion criteria. Excessive risk of bleeding or thrombosis as defined by stroke or severe bleeding within the prior 6 months. Patients who received investigational drugs, chemotherapy or immunotherapy patient must be >/= five

2011 Clinical Trials

752. A Study of the Pharmacokinetics and Pharmacodynamics of MK4618 in Women With Overactive Bladder (MK-4618-004 AM1)

: Placebo (vibegron) Other: Placebo (tolterodine ER) Drug: Prophylactic Antibiotic Phase 1 Detailed Description: Participants will be randomized in each of 2 treatment periods to 1 of 4 possible treatments, which will be administered in double-dummy fashion, and participants will undergo urodynamic procedures prior to dosing on Day 1 and after 7 days of treatment. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 4 participants (...) (tolterodine ER) Inactive agent in capsule form, oral administration, once daily, up to 5 weeks, based on treatment assignment in each treatment period. Drug: Prophylactic Antibiotic A pre-procedural prophylactic antibiotic (ie, levofloxacin 250 mg, cephalexin) administered orally, 30 minutes prior to each scheduled urodynamic study intervention. It is up to the discretion of the Investigator, based on study protocol recommendations, as to which type of antibiotic may be administered. Other Names: Levaquin

2011 Clinical Trials

753. Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib

irradiated lesions Cutaneous manifestations (non-discreet lesions only) Age ≥ 18 years. Postmenopausal women defined by one of the criteria: No spontaneous menses for at least 12 months if the subject is ≥ 50 years old; Amenorrheic for at least 12 months if the subject is < 50 years old, with serum estradiol within the institutional postmenopausal range; Bilateral oophorectomy; If prior hysterectomy but intact ovaries, must be ≥ 55 years old, or have serum estradiol within the postmenopausal range (...) ), if it is not the sole site of disease. Subjects must have completed treatment at least one week prior to starting study drugs, and must have recovered from all treatment-related toxicities. Bisphosphonate or RANK ligand inhibitor therapy for bone metastases is allowed. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, is not permitted; Ability to swallow and retain oral medication. Exclusion Criteria: Prior use of pazopanib Premenopausal levels

2011 Clinical Trials

754. Effect of HAART Vs. Statin Treatment on Endothelial Function and Inflammation/Coagulation

not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy). Contraception requirements- All subjects must agree not to participate in the conception process and if participating in sexual activity that could lead to pregnancy, must agree to use at least two reliable methods of contraception for 2 weeks before study treatment, while receiving study treatment, and for 6 weeks after receiving study treatment. As hormone-based contraceptives can affect coagulopathy biomarkers (...) to defer initiation of ART for up to 24 weeks or statin therapy for up to 12 weeks after study entry. CD4+ cell count >500/mm3 within 60 days prior to study entry obtained at any laboratory that has a CLIA certification or its equivalent. No prior ART of more than 10 cumulative days with the following exceptions: Use of ART drugs as part of post-exposure prophylaxis (PEP) provided the participant did not acquire HIV-1 infection from the event that required PEP. ART use during pregnancy that resulted

2011 Clinical Trials

755. Fallopian tube origin of supposed ovarian high‐grade serous carcinomas Full Text available with Trip Pro

Fallopian tube origin of supposed ovarian high‐grade serous carcinomas Serous carcinomas are the most frequent histologic type of ovarian and peritoneal cancers, and can also be detected in the endometrium and fallopian tubes. Serous carcinomas are usually high-grade neoplasms when diagnosed, yet the identification of an associated precursor lesion remains challenging. Pathological examination of specimens obtained from prophylactic bilateral salpingo-oophorectomies that were performed

2011 Clinics

756. BRCA Mutation Testing in Determining Breast Cancer Therapy Full Text available with Trip Pro

for management of affected BRCA mutation carriers with emphasis on the risks of ipsilateral recurrence and contralateral breast cancer. The roles of breast-conserving surgery, prophylactic mastectomy, and oophorectomy are reviewed. In addition, the sensitivity of BRCA mutation-associated breast cancer to endocrine therapy, platinum chemotherapy, and poly (ADP-ribose) polymerase inhibitors is reviewed.

2011 Cancer journal (Sudbury, Mass.)

757. Radical fimbriectomy: A reasonable temporary risk-reducing surgery for selected women with a germ line mutation of 1 or 2 genes? Rationale and preliminary development. (Abstract)

Radical fimbriectomy: A reasonable temporary risk-reducing surgery for selected women with a germ line mutation of 1 or 2 genes? Rationale and preliminary development. Bilateral salpingo-oophorectomy (BSO) is the gold standard prophylactic surgery for BRCA1 or 2 mutation carriers. However, due to the resulting early menopause and fertility desires, young women are reluctant to undergo this procedure. In view of the recent literature on ovarian carcinogenesis, we wish to report a novel (...) conceptual surgical procedure we called "radical fimbriectomy." This procedure is aimed to protect this subset of high-risk women from high-grade serous pelvic carcinoma, while preserving their ovarian function.Women with BRCA mutation, who were scheduled for BSO, were informed of the procedure approved by our local review board. Radical fimbriectomy consists of removing all the tube and the fimbrio-ovarian junction, step immediately followed in this developmental phase by completion oophorectomy. Four

2011 Gynecologic Oncology

758. Optimal Surgical Management of Well-Differentiated Thyroid Cancer Arising in Struma Ovarii: A Series of 4 Patients and a Review of 53 Reported Cases. (Abstract)

Optimal Surgical Management of Well-Differentiated Thyroid Cancer Arising in Struma Ovarii: A Series of 4 Patients and a Review of 53 Reported Cases. Well-differentiated thyroid cancer arising in struma ovarii is rare. The optimal management of this entity remains undefined. Unilateral cystectomy, unilateral salpingo-oophorectomy (USO), or total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH/BSO), in addition to total thyroidectomy and radioactive iodine (RAI) ablation, have (...) spread or distant metastases. Cumulative recurrence rate was determined by using the Kaplan-Meier method.We report the treatment of four patients with well-differentiated thyroid cancer arising within struma ovarii. Patients underwent USO, BSO, or TAH/BSO. One patient underwent prophylactic total thyroidectomy in anticipation of RAI treatment, and was found to have a synchronous papillary thyroid carcinoma. All patients clinically remain without evidence of disease at a median follow-up of 9 (range

2011 Thyroid

759. Premature menopause or early menopause and risk of ischemic stroke. Full Text available with Trip Pro

considering prophylactic bilateral oophorectomy before the onset of natural menopause. (...) bilateral oophorectomy compared with women who conserved their ovaries before age 50 years. The increased risk of stroke was reduced by hormone therapy in one of the studies, suggesting that estrogen deprivation is involved in the association. Four additional observational studies showed an association of all types of stroke or IS with the early onset of menopause or with a shorter life span of ovarian activity. In three of the seven studies, the association was restricted to IS. Age at menopause

2011 Menopause

760. Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: design of a multicenter randomized clinical trial. Full Text available with Trip Pro

Behavioral and psychosocial effects of rapid genetic counseling and testing in newly diagnosed breast cancer patients: design of a multicenter randomized clinical trial. It has been estimated that between 5% and 10% of women diagnosed with breast cancer have a hereditary form of the disease, primarily caused by a BRCA1 or BRCA2 gene mutation. Such women have an increased risk of developing a new primary breast and/or ovarian tumor, and may therefore opt for preventive surgery (e.g., bilateral (...) mastectomy, oophorectomy). It is common practice to offer high-risk patients genetic counseling and DNA testing after their primary treatment, with genetic test results being available within 4-6 months. However, some non-commercial laboratories can currently generate test results within 3 to 6 weeks, and thus make it possible to provide rapid genetic counseling and testing (RGCT) prior to primary treatment. The aim of this study is to determine the effect of RGCT on treatment decisions

2011 BMC cancer Controlled trial quality: predicted high

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