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Prophylactic Oophorectomy

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161. Prevention of relapse in patients with acquired thrombotic thrombocytopenic purpura undergoing elective surgery: a case series. (Abstract)

followed for acquired TTP with severe ADAMTS-13 deficiency during remission were candidates for seven elective surgeries (inguinal hernioplasty, cholecystectomy, laparoscopic hysterectomy, oophorectomy, parotidectomy and two total hip arthroplasties). Results Four patients were treated with prophylactic plasma exchange (PEX) therapy immediately before surgery. One patient was treated with PEX therapy before her first surgery and with preemptive rituximab once her second surgery was scheduled. Because (...) using prophylaxis to restore ADAMTS-13 activity. Further observational studies or randomized clinical trials are needed to confirm whether prophylactic PEX could be the key factor in preventing relapse.© 2019 International Society on Thrombosis and Haemostasis.

2019 Journal of Thrombosis and Haemostasis

162. PMS2 germline mutation c.1577delA (p.Asp526Alafs*69)-induced Lynch syndrome-associated endometrial cancer: A case report. Full Text available with Trip Pro

months.The patient was diagnosed with cervix CIN III, endometrial cancer (EC), anemia, and LS.Total hysterectomy, bilateral salpingectomy, pelvic lymphadenectomy were performed for treating EC, while ovariectomy was refused by the patient. The patient underwent postoperative chemotherapy with paclitaxel combined with carboplatin for 6 courses of treatment. Laparoscopic partial enterectomy was applied for treating colon cancer 5 years later after the surgery treatment for EC. Besides, Sanger sequencing (...) years.Carrying PMS2 germline mutation (c.1577delA) confers an extremely high susceptibility of suffering from LS-associated cancers. Thus, close clinical monitoring and prophylactic surgery are highly recommended to reduce the morbidity and mortality of LS-associated cancers.

2019 Medicine

164. Imaging the Migraine Brain Pre- and Post-Erenumab

range" for the laboratory involved, OR d) Underwent bilateral oophorectomy, OR e) Underwent hysterectomy, OR f) Underwent bilateral salpingectomy Currently receiving treatment in another drug study or an investigational device study, or less than 90 days prior to screening since ending treatment on another investigational device or drug study(-ies) Has received CGRP monoclonal antibody within 4 months of the start of the run-in phase Active chronic pain condition that in the investigator's opinion (...) (in the head and/or neck region) within 4 months before the start of the baseline phase and throughout the study Ergotamine derivatives, steroids, and triptans used for migraine prophylaxis within 2 months before the start of the baseline phase and throughout the study Procedures (e.g. nerve blocks) used for migraine prophylaxis within 2 months before the start of the baseline phase and throughout the study History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary

2018 Clinical Trials

165. BARDA Securing Anthrax Immunity For the Elderly

to Screening. A female of childbearing potential is defined as post onset menarche and pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal >2 years, tubal ligation >1 year, bilateral salpingo-oophorectomy, or hysterectomy. Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label (...) Description: This is a phase 2, randomized, active-controlled, double-blinded, multi-site study to assess the safety and immunogenicity of BioThrax (Anthrax Vaccine Adsorbed) and AV7909 (Anthrax Vaccine Adsorbed plus CPG 7909 adjuvant) using a post-exposure prophylaxis dosing regimen in adults ≥ 66 years of age in stable health. The safety and immunogenicity profile of BioThrax and AV7909 in adults ≥ 66 years of age will also be compared to the safety and immunogenicity profile of subjects 18-50 years

2018 Clinical Trials

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

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 (...) ., 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

2018 Clinical Trials

167. 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 (...) of contraception between the 2 visits. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, Depo-Provera®, patch, or other injectables) together with supplementary double-barrier methods, such as condoms or diaphragms with spermicidal gel or foam. The following categories define females who are NOT considered to be of childbearing potential: Premenopausal females with 1 of the following: Documented hysterectomy, Documented bilateral

2018 Clinical Trials

168. A Safety and Immunogenicity Study of Intranasal Sendai Virus Vectored Respiratory Syncytial Virus (SeVRSV) Vaccine in Healthy Adults

. Diastolic blood pressure (BP) is 55 to 95 mmHg, inclusive. 9. Women of childbearing potential must use an acceptable method of contraception from 30 days prior to study vaccination until 60 days after study vaccination. Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure (R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year (...) of SeVRSV vaccine following receipt of one intranasal dose; 2) assess the ELISA antibody responses to SeV and to the RSV F protein at 28 days post receipt of one intranasal dose of SeVRSV vaccine; 3) assess the detection of vaccine virus from nasal washes at days 3, 5, 8 and 15 following receipt of one intranasal dose of SeVRSV vaccine. Condition or disease Intervention/treatment Phase Antiviral Prophylaxis Respiratory Syncytial Virus Infection Other: Placebo Biological: SeVRSV Vaccine Phase 1 Detailed

2018 Clinical Trials

169. Evaluating the Safety and Immunogenicity of the IHV01 Protein Vaccine Primed and Co-Administered With HIV DNA CON-S Env Vaccine in Healthy, HIV-1-Uninfected Adults

pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. Reproductive status: A volunteer who was born female must: Agree to consistently use effective contraception (see the protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior (...) of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); 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. Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last

2018 Clinical Trials

170. 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

171. Copanlisib and Nivolumab in Treating Participants With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma

to the start of nivolumab A female of child-bearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a female over 45 in the absence of other biological or physiological causes; in addition, females under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL (...) absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, and gastrointestinal (GI) obstruction which are known risk factors for bowel

2018 Clinical Trials

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

, 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 (...) (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

2018 Clinical Trials

173. 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 (...) chemotherapy for patients without active CNS disease is allowed (e.g., ongoing primary or secondary prophylaxis for patients who cleared the CSF prior to study enrollment); CSF sample is not required for enrollment for patients with no history of CNS disease Chemotherapy within 2 weeks of first dose of sEPHB4-HSA (minimum of 6 weeks for nitrosoureas and 8 weeks for bone marrow transplantation) with the following exceptions: Hydroxyurea allowed prior to, and up to day +5 of cycle 0 of treatment (max 100 mg

2018 Clinical Trials

174. Safety and Efficacy Study of Ftortiazinon in the Treatment of Patients With Complicated Urinary Tract Infections Caused by P. Aeruginosa

are capable of procreation, or sexual partners of participants who are capable of childbirth, should agree to the continued use of a highly effective method of contraception from the beginning of screening to the end of the study (medical and pedagogical observations) (highly effective methods of contraception include hormonal implants, plasters, injectable hormones, oral hormonal contraceptives, intrauterine systems, approved cervical ring, prior bilateral ovariectomy, prior hysterectomy, previous (...) should be removed or replaced prior to collection of an urine sample for analysis and sowing, unless removal or replacement is considered unsafe or contraindicated); presence of known functional or anatomical abnormalities in the urinary system, including malformations, neurogenic bladder, presence of residual urine volume ≥ 100 ml, stricture after surgery and/or malformations of the urinary tract, separate drainage of the kidney and/or bilateral nephrostomy tubes; complete or partial obstructive

2018 Clinical Trials

175. alloSHRINK

is defined as the consequence of hysterectomy, ovariectomy or post-menopause. The patient must, in the opinion of the Investigator, be able to adhere with the study visit schedule and all study procedures described in this protocol. Exclusion Criteria: The patient has a confirmed or suspected tumor metastasis in the central nervous system (CNS). A neurological examination is to be performed systematically at baseline. In case signs or symptoms suggestive of potential CNS disease are observed, CNS imaging (...) pulmonary disease (COPD). Note: Patients with history or suspicion of COPD must have at least Forced Expiratory Volume in the first second (FEV-1)/ Forced Vital Capacity (FVC) >= 0,7 with FEV-1 >= 50% predicted (GOLD 1 or 2 severity). Patients who have active infections necessitating use of antibiotics/antivirals treatment (prophylaxis is acceptable). Patients with significant disorder of coagulation or receiving treatment with warfarin derivatives or heparin. Note: Patients receiving systemic

2018 Clinical Trials

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

(including patients with amenorrhea due to medical reasons, such as chemical menopause), after consenting to the study, the patient must agree to take contraception for at least 23 weeks after taking the final dose of the investigational drug (a period of 30 days [ovulation cycle] is added to five times the elimination half-time of I/O agent). Women with the potential for pregnancy include those who have begun menstruation, who have not undergone a hysterectomy, bilateral tubal ligation, or bilateral (...) 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

2018 Clinical Trials

177. Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis

consent to participate in the study, in accordance with the GCP and applicable regulations, before completing any study related procedures. 2. An understanding, ability, and willingness to fully comply with study procedures and restrictions. 3. Subject must be a male or female between 40 and 75 years of age, inclusive. 4. Female subjects must either not be of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy (...) until completing participation in the study. (The use of ≤325 mg acetylsalicylic acid per day as cardiac prophylaxis is permitted.) The subject will be allowed to take rescue medication (acetaminophen) for pain during the study except during the 24 hours prior to the Second Screening Visit, Baseline (Day1), Week 2, Week 4, Week 8, Week 12, Week 14. 11. Subject must be willing to discontinue applying any topical preparations containing Vitamin A acids [including all trans-retinoic-acid (tretinoin

2018 Clinical Trials

178. Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

salpingectomy or bilateral oophorectomy). If male, is surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. Exclusion criteria: Has diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous (...) of childbearing potential, has a negative serum pregnancy test upon entry into this study and is willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (having undergone a hysterectomy, bilateral

2018 Clinical Trials

179. A Study Evaluating the Safety, Tolerability and Efficacy of Two Injections of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, but NOT tubal ligation), who are sexually active, and who are not willing to use birth control during the study period Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or who are not using birth control Body mass index (BMI) > 35 Partial or complete joint replacement in either (...) or migraine prophylaxis Subjects requiring the usage of opioids >1x per week within 12 weeks prior to Screening Visit 1 Topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) used for the treatment of knee OA within 7 days of Screening Visit 1 Any chronic condition that has not been well controlled or subjects with a chronic condition who have not maintained a stable therapeutic regimen of a prescription therapy in the opinion of the Investigator. In addition, subjects

2018 Clinical Trials

180. Trial Evaluating the Tolerance and Safety of Durvalumab

agespecific requirements apply: Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more (...) following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 17. Patient capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any

2018 Clinical Trials

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