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Progestin Androgenic Activity

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121. Geriatric Trauma Management

Geriatric Trauma Management ACS TQIP GERIATRIC TRAUMA MANAGEMENT GUIDELINESTable of Contents Background and Introduction 3 Trauma Team Activation 3 Initial Evaluation 3 Specialized Geriatric Inpatient Care 5 Patient Decision-Making Capacity and Care Preferences 6 Discharge 7 Appendix I 9 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults Appendix II 17 Legally Relevant Criteria for Decision-Making Capacity and Approaches for Assessment of the Patient Screening (...) with younger patients. An appreciation for the decreased physical reserve, presence of various comorbid diseases, and increased risk of elderly- specific complications such as delirium that are more common in elderly patients has prompted development of elderly-specific care protocols within the multidisciplinary trauma service model. The aim is to employ better risk assessment, adherence to key preventive strategies, active surveillance, and prompt recognition and treatment of complications when

2013 American College of Surgeons

122. Consensus on women?s health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group

–binding globulin(SHBG),which,inturn,resultsinadecreaseincircu- lating free T levels. The progestin in the pill can compete for 5a-reductase at the level of the androgen receptor. Oral con- traception also decreases adrenal androgen production by a mechanism yet unclear, possibly due to a decrease in adre- nocorticotropin hormone (ACTH) production. There are few randomized double-blind studies compar- ing the metabolic effects of a combination of two OCPs, or combined with an insulin sensitizer (21 (...) are applied. Typically, PCOSis?rstidenti?edduringtheearly reproductiveyears.Theclinicalexpres- sion varies but commonly includes oligo-ovulation or anovulation, hyper- androgenism (either clinical or bio- chemical), and the presence of polycystic ovaries. The etiology of the syndrome remains obscure, and the variability in phenotype expression continues to render the clinical care Received July 1,2011; accepted September 13, 2011; published online December 6, 2011

2012 Society for Assisted Reproductive Technology

123. Heart Disease and Stroke Statistics?2012 Update

syndrome, a cluster of major cardiovascular risk factors related to overweight/obesity and insulin resistance, is ≈34% (35.1% among men and 32.6% among women). The proportion of youth (≤18 years of age) who report engaging in no regular physical activity is high, and the proportion increases with age. In 2009, among adolescents in grades 9 through 12, 29.9% of girls and 17.0% of boys reported that they had not engaged in 60 minutes of moderate-to-vigorous physical activity, defined as any activity (...) that increased heart rate or breathing rate, even once in the previous 7 days, despite recommendations that children engage in such activity ≥5 days per week. Thirty-three percent of adults reported engaging in no aerobic leisure-time physical activity. Data from NHANES indicate that between 1971 and 2004, average total energy consumption among US adults increased by 22% in women (from 1542 to 1886 kcal/d) and by 10% in men (from 2450 to 2693 kcal/d; see Chart 20-1). The increases in calories consumed during

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2012 American Heart Association

124. The 2012 Hormone Therapy Position Statement of The North American Menopause Society

. Sexual function A significant effect of ET on sexual interest, arousal, and orgasmic response independent from its role in treating men- opausal symptoms is not supported by current evidence. 8 Low-dose local ET may improve sexual satisfaction by improving lubrication and increasing blood flow and sensa- tion in vaginal tissues. In an analysis of the persistence of sexualactivityintheWHI,HTwas notcorrelatedwithlonger persistence of sexual activity. 9 HT is not recommendedas the soletreatment of other (...) . 36 The excess risk of stroke in this age group observed in the WHI studies would fall into the rare-risk category. Stroke risk was not significantly increased in the Heart and Estrogen/Progestin Replacement Study 52 and the Women’s Estrogen for Stroke Trialsecondarypreventiontrials. 53 TheWomen’sInternational StudyoflongDurationOestrogenafterMenopauseRCTfound no excess risk of stroke in EPT users compared with women on placebo in 1 year. 54 The results of observational studies on the risk

2012 The North American Menopause Society

125. Management of endometrial precancers: recommendations based on risk of endometrioid endometrial cancer

in neoplastic endo- metrial glands in concert with tissue sloughing during withdrawal shedding. 60 Activation of progestin recep- tors is thought to lead to stromal decidualization and thinning of the endometrial lining. 61 Clinical studies of progesterone therapy have limitations. To date, neither the dose nor the schedule for progestational agents has been well-standardized. Published studies tend to be medium in size (with less than 100 partic- ipants) and descriptive clinical series administering (...) - uals receiving medroxyprogesterone acetate, 10 mg daily for 12–14 days per month, or micronized pro- gesterone in vaginal cream, when treated for 3 months. 60,62–64 Daily medroxyprogesterone acetate doses of 600 mg resulted in 82% complete responses among 17 women at a multicenter trial with 25 to 73 months of follow-up. 65–67 Wheeler et al 66 observed that individuals who responded to progestins had decreased gland-to-stroma ratio, decreased glandular cellularity, decreased mitotic activity

2012 Society of Gynecologic Oncology

126. Medicalization of aging and the testosterone deficiency syndrome

it is me- tabolized to dehydroandrosterone, its most active form, thanks to the action of the alpha-reductase enzyme. it acts by binding to nucleus receptors and produces androgenic and anabolic effects. Estradiol is produced as a result of catabolic activity. Testos- terone is segregated by the masculine fetus from the eighth week after conception (plasma levels of 250 ng/dl ) and as a result internal and external genital organs develop. During childhood secre- tion is minimal, and at puberty, males (...) database and PubMed with the following key words: “testosterone deficiency”, “late-onset hypogonadism”, “male andropause” and “androgen deficiency in aging males” filtered by the type of study (clinical practice guidelines, systematic reviews, meta-analyses or clinical trials). Information on consumption and sales was obtained from invoiced prescriptions in Navarre from 2001 upto 2011. Results: many of the signs and symptoms that define this syndrome overlap with those produced by other health problems

2012 Drug and Therapeutics Bulletin of Navarre (Spain)

127. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Acromegaly

of the hyperprolactinemia is often the tumor itself, and up to 50% of somatotroph tumors cosecrete prolactin, versus hyper- prolactinemia from the normal lactotroph cells due to stalk compression from the tumor itself (24 [EL 4], 25 [EL 4]). Menstrual irregularities, often associated with hirsutism, are common in acromegaly and are due to a combination of hyperprolactinemia, androgen excess, and, less often, compressive hypogonadotropic hypogonadism from the tumor itself (26 [EL 3]). Testosterone deficiency may (...) finding, and these changes can be disfiguring. The dental changes, including maxillary and mandibular widening with separa- tion of the teeth, mandibular overgrowth, jaw malocclu- sion, and overbite, may be disabling for patients (35 [EL 3]). Arthropathy develops early in the course of acromeg- aly and, with progression, resembles active osteoarthritis and often results in substantial disability (36 [EL 3], 37 [EL 4], 38 [EL 3]). Joint pains may be present in up to three-quarters of the patients (39

2011 American Association of Clinical Endocrinologists

128. AACE Medical Guidelines for Clinical Practice for Diagnosis and Treatment of Menopause

breast cancer 2. Known or suspected estrogen-sensitive malignant conditions 3. Undiagnosed genital bleeding 4. Untreated endometrial hyperplasia 5. Previous idiopathic or current venous thromboembo- lism (deep vein thrombosis, pulmonary embolism) 6. Active or recent arterial thromboembolic disease (angina, myocardial infarction) 7. Untreated hypertension 8. Active liver disease 9. Known hypersensitivity to the active substances of MHT or to any of the excipients 10. Porphyria cutanea tarda (absolute (...) agent administered (15 [EL 1; RCT]). Some women experi- ence premenstrual-tension-like symptoms, including mood swings, bloating, fluid retention, and sleep disturbance. Switching among various progestational agents may de- crease these symptoms. Differences in lipid effects (25 [EL 1; RCT]), an- drogenic potency, glucocorticoid and antimineralocorti- coid activity (26 [EL 4; NE]), procoagulant activity, and fibrinogen levels (27 [EL 1; RCT]) have been described among various progestational

2011 American Association of Clinical Endocrinologists

129. Diagnosis and Treatment of Hyperprolactinemia

hyperprolactinemia must evaluate the merits of their current medication program with their physicians. Assessment should include the availability of alternative medications—such as antipsychotic agents with lower dopamine antagonist potency ( , ) or aripiprazole, an atypical antipsychotic with both dopamine agonist and dopamine antagonist activity ( ) that can lower prolactin and reverse hyperprolactinemia-related side effects ( )—and their relative merits and downsides, and the potential adverse impact (...) During pregnancy, serum prolactin levels increase 10-fold ( ), reaching levels of 150 to 300 μg/liter by term. Moreover, the pituitary gland increases in volume more than 2-fold, primarily due to estrogen-stimulated increase in the number of lactotrophs ( ). When dopamine agonists are discontinued at the start of pregnancy, serum prolactin levels increase, and subsequent increases in prolactin levels do not accurately reflect changes in tumor growth or activity. Moreover, serum prolactin levels may

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2011 The Endocrine Society

130. Efficacy Study of Progesterone Tablet in Post-menopausal Women

products (soy, black cohosh, dong quai) during the past 3 months before the screening visit Use of any estrogen, progestin or androgen pellet or injectable therapy during the past 6 months before the screening visit Contraindications to hormone therapy: Active liver dysfunction or disease or history of severe liver disease Known, suspected or past history of hepatic tumors (benign or malign) Active or past history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke, coronary (...) no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination, as determined by the medical investigator Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the subject Exclusion Criteria: Use of any estrogen, progestin, or estrogen/progestin drug products, androgens, selective estrogen receptor modulators (SERMs), phytoestrogen supplements or natural

2016 Clinical Trials

131. MLE4901 vs. Placebo for the Treatment of PCOS

by (Responsible Party): Millendo Therapeutics, Inc. Study Details Study Description Go to Brief Summary: This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS. Condition or disease Intervention/treatment Phase Polycystic Ovary Syndrome (PCOS) Drug: MLE4901 40mg Drug: Placebo Phase 2 Detailed Description: Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge (...) Placebo Comparator: Placebo Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets Drug: Placebo Placebo to match active drug Experimental: MLE4901 40mg Plain, round, biconvex, white film-coated tablets of 40 mg strength administered twice per day Drug: MLE4901 40mg Outcome Measures Go to Primary Outcome Measures : Menstrual Cycle Duration [ Time Frame: 28 Week double blind treatment period ] Assessment of the number of days between menstrual cycles from baseline

2016 Clinical Trials

132. Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)

not interfere with the participant's daily activities. Moderate: the attack symptoms interfered with the participant's ability to attend work/school or participate in family life and social/recreational activities and severe: the attack symptoms significantly limited the participant's ability to attend work/school or participate in family life and social/recreational activities. Number of participants with angioedema attacks in different anatomic locations in treatment period was compared to NNA (...) quality of life instrument. It consisted of 17 specific questions that were associated with work, physical activity, free time, social relations, and diet. Each of the 17 items had a 5-point response scale ranging from 1 (Never) to 5 (Very Often). The questionnaire was scored according to the developers' guidelines to produce a total score and 4 domain scores (functioning, fatigue/mood, fear/shame, nutrition). Raw domain scores (mean of the item scores within each scale) and the raw total score (mean

2016 Clinical Trials

133. An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finesteride, spironolactone, flutamide) stopped for at least 4 weeks Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions Known hypersensitivity or contraindications to use GLP1 receptor agonists (exenatide, liraglutide) Known hypersensitivity to heparin/ IV (...) /treatment Active Comparator: Dapagliflozin Arm: dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection) Drug: Dapagliflozin Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12

2016 Clinical Trials

134. Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

corticosteroid systemic drug, systemic antibodies, androgens or enzyme inducer, etc.) or stopped less than 3 months before the randomization (antihypertensive stable long-term treatment tolerated), Regular intake of dietary supplements or "functional foods" which are known to have an impact on lipid metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, capsules containing omega-3 fatty acids from fish oils, containing beta glucanes, konjac extract (...) by maltodextrin. Dietary Supplement: Placebo After randomization (V1 visit), 8 capsules per day of placebo during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner. Experimental: VAL070-A Studied active product n°1, named VAL070-A, is a dietary supplement in shape of capsule. VAL070-A product contains 4 active plant extracts. Dietary Supplement: VAL070-A After

2016 Clinical Trials

135. Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer

cancer will be assayed. Safety and tolerability of SM88 in patients with prostate cancer. [ Time Frame: Six months ] Changes from baseline in blood work results and incidence of adverse events associated with treatment of SM88 in patients with prostate cancer. Anti-cancer activities of SM88 in patients with prostate cancer. [ Time Frame: Six Months ] Changes from baseline in CTCs, and PSA level per Prostate Cancer Working Group 3 (PCWG3) criteria and radiography per RECIST 1.1 criterial, stratified (...) by circulating tumor cells (CTC) and other blood-based markers including lactate dehydrogenase (LDH), total alkaline phosphatase, bone-specific alkaline phosphatase, urine N-telopeptide, hemoglobin, and neutrophil:lymphocyte ratio (NLR). Correlation of toxicity and efficacy with cutaneous hyperpigmentation [ Time Frame: Six Months ] The incident and severity (as assessed by CTCAE v4.0) of treatment-related adverse events and anticancer activities of SM88 are correlated with the degree of cutaneous

2016 Clinical Trials

136. Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males

prior to the first screening visit. Current pregnancy. Known hypersensitivity to progestins or testosterone. Any clinically significant abnormal findings at screening per the Investigator's medical judgement. Use of androgens or other anabolic steroids that may affect testosterone measurements. Known active or chronic dermatitis or other severe skin disorder. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism (...) Ages Eligible for Study: 18 Years to 50 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Male participant - Inclusion Criteria Men who meet all the following criteria will be eligible for enrollment in the trial: Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening; 18 to 50 years of age; BMI ≥ 18 and < 35 kg/m2; No history of androgen use prior to the first

2016 Clinical Trials

137. Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

Recruitment Status : Active, not recruiting First Posted : April 18, 2016 Last Update Posted : May 30, 2018 Sponsor: Shire Information provided by (Responsible Party): Shire Study Details Study Description Go to Brief Summary: This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in preventing acute angioedema attacks in participants with Type I and Type II HAE. Condition or disease Intervention/treatment Phase Hereditary Angioedema (HAE) Drug: DX-2930 Phase 3 Study Design (...) and able to read, understand and sign an assent form. Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study as Females (NOTE: Female rollover participants (those who previously participated in Study DX-2930-03 [NCT02586805]) of childbearing potential may continue to use the birth control method used during Study DX-2930-03 (NCT02586805).) of childbearing potential must agree to be abstinent or it is recommended to use highly

2016 Clinical Trials

138. Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

to participate in the study: have a history of invasive breast cancer or ductal carcinoma in situ, melanoma or any gynecologic cancer. using any of the following: oral estrogen-, progestin-, androgen-, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening (visit 1) transdermal hormone products within 4 weeks before screening (visit 1) vaginal hormone products (rings, creams, gels) within 4 weeks before screening (visit 1) progestin implants/injectables, IUDs (...) to continue activity Severe: sensation of heat with sweating, causing cessation of activity. Secondary Outcome Measures : Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes [ Time Frame: Baseline and 4 weeks ] Change from baseline to week 4 in the average number of moderate and severe hot flashes per day, where change is calculated as week 4 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency. Change From Baseline to Week 4

2016 Clinical Trials

139. Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia

, chronic renal failure or drugs which can increase LDL-C level (e.g. retinoids, cyclosporine A and phenothiazines) or decrease HDL-C level (e.g. progestins, androgens, β-blockers, probucol and anabolic steroid) Patients with lifestyle that may interfere treatment efficacy, such as alcoholism or drinking habits more than 3 times per week, late dinner, late night supper, frequent oversea business traveler, frequent social gathering, and patients who cannot anticipate a diet control and lifestyle changes (...) . Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02719028 Recruitment Status : Active, not recruiting First Posted : March 25, 2016 Last Update Posted : January 29, 2019 Sponsor: Golden Biotechnology Corporation

2016 Clinical Trials

140. Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder

or other anion exchange resins; Use of levothyroxine or other thyromimetics; Hypertriglyceridemia (triglycerides > 3 times the upper limit of normal (ULN)); Liver function or enzyme disorders (serum bilirubin, alkaline phosphatase (AF), gamma-glutamyl transpeptidase (γ - GT), aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3 times the ULN as measured at baseline); Severe kidney failure (eGFR <30 ml/min as measured at baseline); Use of any form of estrogen, progestin or androgen (...) estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older adults. The present study will test the extent to which adjunctive raloxifene treatment improved cognition and reduced symptoms in young to middle-age men and women with schizophrenia. 154 patients with a schizophrenia spectrum disorder will be recruited in a multicenter twelve-week, randomized, double-blind, placebo-controlled

2016 Clinical Trials

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