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Prophylactic Oophorectomy

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161. Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)

systemic therapy (including chemotherapy, biologic therapy or immunotherapy) ≤4 weeks prior to treatment Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation (see Section 9.2) Adequate organ function defined at baseline as: ANC ≥1,000/ µL Platelets ≥75,000/ µL Hb ≥9 g/dl INR ≤1.5 (except for patients who are on full-dose warfarin) Calculated creatinine clearance ≥40 ml/min (using Cockcroft-Gault (...) method) Total serum bilirubin ≤1.5 mg/dL AST/ALT ≤5× upper limit of normal Able to provide written informed consent Exclusion Criteria: Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry. Both sexes must use contraception while on study. WOCBP include: Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy

2018 Clinical Trials

162. ASA in Prevention of Ovarian Cancer (STICs and STONEs)

or disease Intervention/treatment Phase Ovarian Cancer Prevention Drug: Acetylsalicylic acid Other: Placebo Phase 2 Detailed Description: The standard or usual treatment for women with a high risk gene mutation, BRCA1 or BRCA2, is to have risk-reducing surgery to remove the fallopian tubes and ovaries (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) after they have decided not to have more children naturally. Acetylsalicylic Acid (ASA) is a safe, well tolerated drug taken (...) : Acetylsalicylic Acid (ASA) Drug: Acetylsalicylic acid 81 mg PO daily or 325 mg PO daily Other Name: ASA Sham Comparator: Placebo Other: Placebo One tablet PO daily Outcome Measures Go to Primary Outcome Measures : Proportion of pre- & malignant lesions found during prophylactic risk reduction surgery using a stratified Cochran-Mantel-Haenszel test [ Time Frame: 5 years ] Secondary Outcome Measures : Acceptance of the ASA intervention from the self-report Credibility/Expectancy Questionnaire [ Time Frame: 5

2018 Clinical Trials

163. Nivolumab, Cabozantinib S-Malate, and Ipilimumab in Treating Patients With Recurrent Stage IV Non-small Cell Lung Cancer

., clopidogrel); (low dose aspirin [=< 81 mg/day] and prophylactic LMWH are permitted) No concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel); allowed anticoagulants are the following: Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted Low molecular weight heparins (LMWH) or unfractionated heparin is permitted Anticoagulation with therapeutic doses of LMWH is allowed (...) out pregnancy A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must use an accepted

2018 Clinical Trials

164. Decision Support for BRCA Testing in Ethnically Diverse Women

syndrome (HBOC) is an inherited condition that is most commonly associated with mutations in the BRCA1 and BRCA2 genes. Mutation carriers have lifetime risks of breast and ovarian cancer of 60-80% and 20-40%, respectively. Risk management options include intensive breast cancer screening, risk-reducing surgeries, and chemoprevention, which have been shown to improve early detection and reduce cancer incidence and mortality. In particular, prophylactic bilateral salpingo-oophorectomy has been associated

2018 Clinical Trials

165. EphB4-HSA Fusion Protein and Cytarabine /or Liposomal Vincristine in Patients With Recurrent or Refractory Acute Leukemia

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 criteria: 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) No major surgery within 4 weeks of first dose of sEPHB4 Peripheral (...) and/or HCV sero-positivity only will be eligible, if nucleic acid amplification testing (NAT) is negative Warfarin (any dose) or full-dose anticoagulation with other agents (low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin) within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you

2018 Clinical Trials

166. Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation

challenge with a decline in FEV1 of ≥20% from baseline in the early asthmatic response and ≥15% in the late asthmatic response. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more. Oxygen saturation of >94% and blood pressure within the following limits: (Systolic between 150-90 mmHg, Diastolic between 90-60 mmHg). Ability to provide an induced sputum sample. Negative intracutaneous tuberculin skin test (PPD) defined (...) (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). Viral upper respiratory tract infection within 4 weeks of challenge. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge. Severe asthma Mental illness of history of drug

2018 Clinical Trials

167. Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation

are not s/p hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more. Oxygen saturation of >94% and blood pressure within the following limits: (Systolic between 150-90 mmHg, Diastolic between 90-60 mmHg). Ability to provide an induced sputum sample. Negative intracutaneous tuberculin skin test (PPD) defined as less than 5mm induration for the purpose of this protocol (positive PPD contraindication to anakinra injection). A negative tuberculosis (TB) test within the past (...) for diagnosis and management of asthma (not to include prophylactic use of albuterol prior to exercise). Viral upper respiratory tract infection within 4 weeks of challenge. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge. Severe asthma Mental illness of history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. Cigarette smoking >1

2018 Clinical Trials

168. Safety, Tolerability and Immunogenicity of a Nine-valent Human Papillomavirus (HPV) Vaccine in HIV and Transplant Patients

(SOT) patients. This study will enrol 140 HIV patients with CD4+ count of >200cells/mm² and 170 SOT patients, all of whom have 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 (...) , 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 considerations HIV patients: have CD4+ T cell count of >200 cells/mm

2018 Clinical Trials

169. Efficacy and Safety of Etripamil for the Termination of Spontaneous PSVT. NODE-301

salpingectomy, or Documented bilateral oophorectomy, or Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; Males, except those who are surgically sterile, must use an approved highly effective form of contraception during the 3 days after any study drug administration; and Signed written informed consent. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from participation in the study: Systolic blood pressure (...) <90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the test dose. In patients treated with a chronic prophylactic drug for PSVT (e.g., beta-blockers, verapamil, and diltiazem), the drug may be stopped for at least the equivalent of 5 half-lives and patients may be rescreened once History of severe symptoms of hypotension, especially syncope, during episodes of PSVT History of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit

2018 Clinical Trials

170. Volitinib in Treating Participants With MET Amplified Metastatic or Unresectable Colorectal Cancer

surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation Male patients with female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug Ability to swallow and retain oral medications Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Cytotoxic chemotherapy (including investigational cytotoxic (...) - 2000 IU/ml (inactive carrier state) and willing to start and maintain antiviral treatment for at least the duration of the study OR HBV DNA levels > 2000 IU/ml but on prophylactic antiviral treatment for the past 3 months and will maintain the antiviral treatment during the study Known serious active infection including, but not limited to, tuberculosis, or human immunodeficiency virus (positive HIV 1/2 antibodies). Human immunodeficiency virus (HIV)-positive patients are excluded because

2018 Clinical Trials

171. sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer

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 Absence of concomitant upper tract urothelial carcinoma (i.e. cancer within the kidney or ureter) as evidenced on computed tomography (CT) urogram and no visible lesion and/or biopsy proven evidence of urothelial carcinoma within the prostatic (...) If they are pregnant or lactating If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed If they have had any active bleeding in the last =< 4 weeks or have an otherwise known bleeding diathesis Patients may not be receiving any other investigational

2018 Clinical Trials

172. Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma

or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), completely abstinent (periodic abstinence from intercourse is not per-mitted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive injec-tions, contraceptive patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit (...) if they accept to receive prophylactic Lamivudine 100 mg/daily for all the period of treatment and at least for 12 months after the end of therapy. Treatment with ABT-199 should be stopped in case of hepatitis reactivation. Active HCV positive hepatitis If female, the patient is pregnant or breast-feeding. 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

2018 Clinical Trials

173. Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable

of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices. The patient is a woman of child-bearing potential who tests negative for pregnancy within 14 days prior to receiving first dose of study medication based on serum pregnancy test and agrees to use 2 methods of birth control or abstain from heterosexual activity during the study and for 6 months following the last dose of the study drug(s) or country requirements, whichever is longer or be of non-child (...) bearing potential. Non-childbearing potential is defined as (by other than medical reasons): ≥45 years of age and has not had menses for greater than 2 years, amenorrheic for < 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation, or post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed

2018 Clinical Trials

174. Phase 1a Study to Evaluate Immunogenicity of ASV

subjects of childbearing potential must have a negative serum pregnancy test at the screening and pretreatment visits, and prior to first dose of study medication. Non-childbearing potential (other than by medical reasons) is defined as 1 of the following: ≥45 years of age and amenorrheic for >1 year by self-report. Amenorrheic for >2 years without a hysterectomy and oophorectomy, and follicle-stimulating hormone value in the postmenopausal range upon screening evaluation. Status post-hysterectomy (...) , -oophorectomy, or -tubal ligation. If of childbearing potential, female subjects must be willing to use adequate birth control during the study, starting with the screening visit through 120 days after the last dose of study therapy. Male subjects with a female partner(s) of childbearing potential must agree to use a condom throughout the trial, starting with the screening visit through 120 days after the last dose of study therapy. Male subjects with pregnant partners must agree to use a condom

2018 Clinical Trials

175. Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

oophorectomy, and who have not gone through menopause. Menopause is defined as the consecutive absence of menstrual periods for >= 12 months In the case of men, the patient must agree after consenting to the study to take contraception for at least 31 weeks after taking the final dose of the investigational drug (a period of 90 days [the spermatogenesis cycle] is added to five times the elimination half-time of immuno-oncology (I/O) agent Exclusion Criteria: Patients who have undergone systemic (...) will also be excluded Patients with concurrent autoimmune disease, or a history of chronic or recurrent 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

2018 Clinical Trials

176. A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients

and is sexually active. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria: Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state; Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure. All other female (...) . Prophylactic intrathecal medication is not a reason for exclusion; Prior chemotherapy within 2 weeks before randomization with the following exceptions: To reduce the circulating lymphoblast count or palliation: ie, steroids, hydroxyurea or vincristine; For ALL maintenance: mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors. Patients must have recovered from acute non hematologic toxicity (to Grade 1 or less) of all previous therapy prior to enrollment. Prior

2018 Clinical Trials

177. ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

until at least 16 weeks after the last dose of ADCT-602. Men with female partners who are of child bearing potential must agree that they or their partners will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of ADCT-602 Women of child bearing potential defined as: Sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been (...) days prior to screening. NOTE: Patients may have a history of CNS leukemic involvement if they have received prior treatment for CNS involvement and no evidence of active disease (defined as >= 2 consecutive spinal fluid assessments with no evidence of disease) is present at screening. Prophylactic intrathecal chemotherapy is allowed on the trial and is not a criterion for exclusion Patients with Burkitt's leukemia/lymphoma Active graft-versus-host disease (GVHD) or severe/extensive chronic GVHD

2018 Clinical Trials

178. Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

). Contraception must begin 4 weeks prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy. 8. A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing. 9. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study (...) medical device within 4 weeks before randomization or is currently enrolled in an interventional investigational study. Contraindications to the use of any components of the backbone treatment regimens, per local prescribing information. Gastrointestinal disease that may significantly alter the absorption of oral drugs Vaccination with live attenuated vaccines within 4 weeks of first study agent administration Unable or unwilling to undergo antithrombotic prophylactic treatment. Contacts and Locations

2018 Clinical Trials

179. Premature ovarian aging in BRCA carriers: a prototype of systemic precocious aging? (PubMed)

or younger and healthy male BRCA carriers, 50 years or younger, were enrolled in the study. Serum anti-mullerian Hormone (AMH), fibroblast growth factor-23 (FGF-23), Klotho and IL-1 were measured by enzyme-linked immunosorbent assay (ELISA). Ovarian AMH and protein kinase B (AKT) mRNA from BRCA carriers who underwent prophylactic oophorectomy and from age-matched, healthy, non-carriers who underwent partial oophorectomy due to benign conditions were analyzed by qPCR.Thirty-three female (median age 35y

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2018 Oncotarget

180. Surgery for BRCA, TP53 and PALB2: a literature review (PubMed)

influence patients to make rash decisions. In healthy BRCA mutation carriers, bilateral prophylactic mastectomy is done to prevent breast cancer from occurring. Bilateral prophylactic mastectomy is highly effective in reducing the risk of breast cancer in healthy BRCA mutation-positive women and may have a survival benefit. Prophylactic oophorectomy reduces the risk of ovarian cancer, but may not have an effect on the risk of breast cancer. There is a lack of studies on surgery for non-BRCA mutations (...) by searching and one article was obtained from other sources.Breast-conserving surgery has equivalent survival, but may have an increased risk of local recurrence, compared to mastectomy among BRCA mutation carriers. Contralateral prophylactic mastectomy may not improve overall survival, despite reducing the risk of developing contralateral breast cancer. The use of preoperative genetic testing allows patients to have combined curative and prophylactic surgery. However, preoperative genetic testing may

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2018 Ecancermedicalscience

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