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The GOP’s future is in flux as the party divides over support for Representatives Marjorie Taylor Greene and Liz Cheney – Yahoo News

National Review

President Joe Bidens recent executive order to expand food assistance to U.S. households, while well-intentioned, represents a substantial overreach of the executive branch and a blatant attempt to override the intent of Congress. If successful, this dangerous precedent would open the door to major expansions of the social safety net without congressional approval. Congress must resist the presidents attempts to subvert the intent of existing law. Less than one week into the Biden presidency, the new administration issued a series of executive orders focused on COVID-19 economic relief. One such order seeks to expand food assistance through the Supplemental Nutrition Assistance Program (SNAP), or food stamps. In it, President Biden instructed the Department of Agriculture (USDA) to take immediate steps to make it easier for the hardest-hit families to enroll and claim more generous benefits in the critical food and nutrition assistance area. In reality, the executive order asks a federal agency the USDA to intentionally misinterpret the Families First Act and subvert the constitutional authority of Congress over the legislative process. The Families First Act, which passed in March 2020, clearly outlined that states could request waivers from the Agriculture Department to provide emergency allotments to SNAP households not greater than the applicable maximum monthly allotment for the household size. In normal times, 60 percent of households enrolled in SNAP do not receive the maximum benefit because they have income from other sources such as earnings that they can use for purchasing food. The emergency allotments recognized that millions of people lost jobs or faced other employment disruptions when the pandemic hit, and that those enrolled in SNAP were at particular risk for job loss in the early aftermath of the pandemic. Rather than requiring SNAP households to report a job or income change to their state agency and wait for bureaucrats to recalculate their benefits, the emergency allotments gave every SNAP recipient the maximum allowed. This was, admittedly, not a very targeted effort. Some families received a boost in SNAP dollars without a change in household income or financial circumstances. But the immediacy of the economic shock brought on by the pandemic, and the employment instability that persists today, necessitated an equally expedient policy response. The Agriculture Department, under President Trump, had approved emergency allotment plans for all 50 states, the District of Columbia, Guam, and the U.S. Virgin Islands but only in accordance with the law. The department extended these emergency-allotment waivers numerous times, most recently extending them through January 2021. The USDA and Congress itself also offered states flexibility in the aftermath of the pandemic. According to federal government spending data, all of the efforts outlined above have caused SNAP benefits to rise more than 40 percent in the last fiscal year, with more than $31 billion in added spending compared to FY 2019. Class-action suits have been filed in Pennsylvania and California by people who disagree with the USDAs interpretation of the law: that regular SNAP plus emergency allotments cannot extend benefits beyond the maximum benefit level. Lawyers for the lawsuits argue that the law allows the USDA to approve emergency allotments in the amount of the maximum benefit, which if true, would mean that households could receive the maximum SNAP benefit plus the maximum emergency allotment essentially doubling benefit amounts. A federal judge in California agreed with the USDA, while the Pennsylvania case is ongoing. The Biden administrations executive order is encouraging its USDA to misinterpret the 2020 law in a similar way. The legislative text is not ambiguous. It is hard to imagine Congress being any clearer than, to address temporary food needs not greater than the applicable maximum monthly allotment for the household size. If Congress had wanted to give people more than the SNAP maximum, it would have done so. In fact, Congress eventually did just that expanding benefits by 15 percent in the COVID-19 relief package passed last month. If the Biden administration is successful in this attempt, it will open the door to a number of executive actions aimed at expanding the safety net without congressional action. If political appointees in the Biden administration feel unconstrained by the law, we will see larger benefits directed to an increasing number of people. Such action not only undermines the integrity of the social safety net by going around Congress, it disregards the separation of powers ensconced in the founding documents of our republic. The American public has been largely supportive of efforts by Congress to provide economic relief to struggling households. Lets keep that authority in its proper place.

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The GOP's future is in flux as the party divides over support for Representatives Marjorie Taylor Greene and Liz Cheney - Yahoo News

[Full text] Dissolution Rates of Calcium Boluses and Their Effects on Serum Calciu | VMRR – Dove Medical Press

Introduction

The onset of lactation results in a sudden and considerable demand for calcium, imposing arduous physiologic challenges to calcium homeostasis in dairy cows.1 Cows that are unable to adapt to this change in calcium demand develop hypocalcemia. Cows with hypocalcemia (colloquially referred to as milk fever) present with weakness, depression, inappetence, and an inability to rise.1 Cows with clinical hypocalcemia are more likely to develop secondary mastitis, as well as muscle and nerve damage from prolonged periods of recumbency.2 As the condition name would suggest, subclinical hypocalcemia shows no overt clinical signs in affected animals, despite low blood calcium; however, there are other negative health consequences. Hypocalcemia reduces the ability of immune cells to respond to stimuli, thus contributing to infections, such as mastitis or metritis.3,4 Hypocalcemia also reduces smooth muscle contraction,5 which can result in reduced rumen and abomasal motility, leading to reduced feed intake and subsequent transition disorders (displaced abomasum, mastitis, metritis, retained fetal membranes, ketosis, etc).6 Subclinical hypocalcemia has also been shown to negatively affect early lactation milk production and reproduction.7 An increased culling rate was also observed for animals with subclinical hypocalcemia.8 Clinical hypocalcemia may occur in up to 510% of dairy cows, whereas its subclinical form is more prevalent, with estimates ranging up to 50% of mature fresh cows.9 Some authors have estimated the overall economic cost of subclinical hypocalcemia to be 4 times that of clinical cases, resulting in a substantial impact on the profitability of dairy operations.10

Several strategies have been studied to enhance the ability of periparturient dairy cows to maintain calcium homeostasis. These practices include limiting total calcium intake prepartum (which may be difficult to achieve), adding a calcium chelator to the prepartum transition ration, and modifying the dietary cation-anion difference (DCAD) by feeding anionic salts prepartum, which has become the mainstay in many herds. Oral supplementation of calcium at calving has proven effective in reducing clinical milk fever.11 Research has shown that, even in very well-managed herds with a low incidence of clinical hypocalcemia, oral calcium supplementation may have health, reproductive, and increased production benefitsmost notably in lame and high producing cows.1214

There are several commercial boluses with substantial differences in composition, primarily with calcium chloride, calcium sulfate, and calcium carbonate. The dissolution properties of the commercial boluses will affect the delivery of product to the animal. Moreover, not all calcium salts are absorbed by the animal in the same manner. Calcium chloride and calcium sulfate are absorbed through the rumen wall by passive transport, whereas calcium carbonate is absorbed in the small intestine by vitamin D-dependant active transport.15 In addition, the acidogenic properties of calcium chloride and calcium sulfate stimulate parathyroid hormone (PTH) function, thereby increasing calcium resorption from bone, kidney tubular reabsorption of calcium, as well as absorption of calcium in the intestine.16

In order to evaluate differences in bolus composition with respect to calcium delivery, this study measured the dissolution times of three different boluses in fistulated animals and the in vivo uptake of two calcium sources utilizing two administration protocols.

The dissolution rate was evaluated for three commercially available boluses, each with different calcium chloride and calcium carbonate compositions: Bolus 1 (high calcium chloride, no calcium carbonate bolus): 209-g Bolus supplying 43 g of calcium from 112 g of calcium chloride dihydrate and 53.6 g of calcium sulfate (Cal-Boost Bolus, Solvet Animal Health, Calgary, Alberta, Canada); Bolus 2 (intermediate calcium chloride, intermediate calcium carbonate bolus): 176-g Bolus supplying 39.0 g of calcium from 106.9 g of calcium chloride, 4.5 g of calcium propionate, and 22.3 g of calcium carbonate (Transition Bolus, Vetoquinol N.-A Inc, Lavaltrie, Quebec, Canada); and Bolus 3 (low calcium chloride, high calcium carbonate bolus): 206-g Bolus supplying 54 g of calcium from 92.2 g of calcium chloride and 72.8 g of calcium carbonate (RumiLife CAL24 Bolus, Genex Cooperative Inc, Shawano, Wisconsin, USA). Table 1 shows the composition of these boluses. The research facility provided two fistulated steers, approximately 28 months of age and weighing 450 kg, 1-year post-cannulation. The steers were housed in an open-air feedlot pen approximately 18 meters deep and 36 meters wide and fed a total mixed ration (TMR) including barley silage, minerals, and vitamins from a feed mixer truck once daily (late afternoon) in a cement feed bunk upon the completion of the bolus study each day. Well water was supplied ad libitum from an automatic cattle waterer. A bolus was placed in a pre-weighed coarse mesh net with a recovery cord. The net and bolus were then placed in the rumen through a fistula. A pretreatment pH was determined using pH strips (pH Test Strips, EMD Millipore) and a pH meter (LRCpH logger, DASCOR Inc., Oceanside, California, USA). After 30, 60, 90, 120, 180, and 240 minutes, the bolus was recovered, weighed, described, and photographed. The recovered bolus was then returned to the rumen. The rumen pH was determined at each sampling time using pH strips, in order to ensure that the boluses were not causing acidosis. If the entire bolus was dissolved at the time of sample collection, sampling was terminated. Each animal only received one bolus at a time, with a minimum of one full day between tests. Each bolus type was tested a total of three times, meaning that it was tested twice in one animal and once in the other; the decision of which animal received which bolus type twice was made at random.

Table 1 Composition of the Commercially Available Boluses Used in This Study

A 380-cow Holstein dairy herd in the province of Quebec, Canada was selected. The study was conducted from November 2019 to March 2020. Cattle were housed in two tie-stall barns for the duration of their lactation, with a third tie stall barn dedicated to the dry and transition cows. Dry cows were moved to this third barn and were fed a dry cow ration. One month prior to their expected calving date, cows were transitioned to a prepartum ration consisting of 20 kg of grass silage, 5 kg of dry hay, 0.85 kg of soybean meal 48% and a 200-g mineral pack. The mineral concentration of this total ration was as follows: calcium 0.52% dry mass (DM.), phosphorus 0.33% DM, magnesium 0.38% DM, and potassium 2.4% DM. In mid-December, the potassium in the close-up ration was lowered. The new ration consisted of 7.85 kg of grass silage, 8 kg of corn silage, 3 kg of dry hay, and 4 kg of a supplement created for this farm. The modified mineral concentrations were calcium 0.56% DM, phosphorus 0.31% DM, magnesium 0.50% DM, and potassium 1.41% DM. The pre-partum ration was not prepared as a Total Mixed Ration (TMR) and therefore implementing a Dietary Cation-Anion Difference (DCAD) strategy was not deemed a practical option. Each cow was transferred to one of the milking barns the morning following calving.

Only cows in their second and third lactations were enrolled in this study. Because of the high level of potassium in both rations, all older cows (>third lactation) received intravenous calcium at calving to prevent clinical milk fever, sometimes followed by oral calcium supplementation, and were therefore not included in this study. Twenty-seven healthy second- and third-lactation cows with body condition score (BCS) of 2.753.5 and an estimated average weight of 767 kg (second lactation) or 787 kg (third lactation) were randomly allocated to one of three oral calcium treatment protocols (9 cows per group irrespective of parity). Treatment 1 received two high calcium chloride boluses (Cal-Boost Bolus, Solvet Animal Health, Calgary Alberta, Canada) at time 0; Treatment 2 received one high calcium chloride Cal-Boost Bolus (Solvet Animal Health, Calgary Alberta, Canada) at time 0 with a second bolus 12 hours later; and Treatment 3 received two high calcium carbonate boluses (RumiLife CAL24 Bolus, Genex Cooperative Inc, Shawano, Wisconsin, USA) at time 0. Treatments were initiated within 12 hours following calving and this was considered Time 0 (t=0). The intermediate calcium chloride/calcium carbonate bolus was excluded from this study as we were most interested in the two extremes (high calcium chloride vs high calcium carbonate). Cows calving between 5:00 p.m. and 5:00 a.m. commenced the protocol at 5:00 am. Cows calving between 5:00 a.m. and 5:00 p.m. started their protocol at 5:00 p.m. Blood was taken in a 10-mL red-topped vacutainer vial from the coccygeal vein pretreatment at time 0, and at 1, 6, 12, 13, and 24 hours post-treatment. The blood was immediately centrifuged on the farm (3000 rpm, 10 minutes) and the serum was transferred into a 3-mL red-topped vacutainer tube for storage at 18C. Total calcium was analyzed by an in-clinic Idexx Catalyst One Chemistry Analyzer. One cow in the Treatment 2 group developed clinical milk fever within 12 hours after receiving the initial bolus and was removed from the study because it did not receive the second bolus. Another cow in Treatment 3 also developed clinical milk fever; however, this was the day after the 24-hour study period and she was therefore included in the trial.

Even though allocation to treatment groups was randomized, there was an age discrepancy between groups. There were more older cows in Treatment 1, which explains the lower Time 0 serum calcium levels (Table 2). Upon analyzing the raw data from the first 27 animals, cows with more severe hypocalcemia had a greater response to oral calcium supplementation than cows with moderate hypocalcemia. With this new information, it was decided to end the original trial and to evaluate serum response to calcium supplementation depending on whether the cow had moderate (1.8 mmol/L) or severe (<1.8 mmol/L) hypocalcemia. The new trial consisted of second and third lactation cows assigned to Treatment 1. The additional enrollment resulted in 11 animals in the moderate and 10 in the severe hypocalcemia groups as depicted in Table 3.

Table 2 Initial Serum Calcium Concentration by Treatment Group

Table 3 Initial Serum Calcium Concentration in Animals with Severe vs Moderate Hypocalcemia

Statistical significance was determined based on a mixed model with repeated measures. Multiple comparisons (treatment effects at each time point) were analyzed using Tukeys multiple comparisons test or Sidaks multiple comparisons test. Data were assessed for normality using a ShapiroWilk test. The cut-off for significance was P < 0.05. The experimental unit was defined as each individual animal. Statistical analyses were carried out in Prism v 8.4.3 (GraphPad Software, San Diego, California, USA).

The dissolution rate of Bolus 1 (high calcium chloride, no calcium carbonate bolus) was the most rapid of the three calcium boluses tested, with the entire bolus being dissolved before 90 minutes in all three trials (Figure 1 and Table 4). Bolus 2 (intermediate calcium chloride, intermediate calcium carbonate bolus) was slower to dissolve, with complete dissolution by 240 minutes in two trials and 180 minutes in the third (Figure 1 and Table 4). Bolus 3 (low calcium chloride, high calcium carbonate bolus) was very slow to dissolve where, after 240 minutes, 75% of the original bolus weight was still present (Figure 1 and Table 4). No major fluctuations in rumen pH were observed over the time course for any of the tested boluses (Table 4).

Table 4 Wet Weights and Rumen pH of Various Calcium Boluses After Incubation in the Rumen of Fistulated Cattle

Figure 1 Dissolution of various calcium boluses in the rumen of fistulated cattle. Representative images of each bolus type are shown for each time point. Note that Bolus 1 had to be photographed in the recovery net at 30, 60, and 90 minutes due to its compromised structural integrity.

Treatment 2 (the single-dose regimen of high calcium chloride) yielded significantly higher serum calcium levels than Treatment 3 (the double dose of calcium carbonate bolus) at 1 hour, with similar calcium levels over the remainder of the time course (Figure 2). Treatment 1 (the double dose of the High Calcium Chloride bolus) yielded significantly higher serum calcium levels at 1 and 6 hours relative to Treatment 3, with similar levels over the remainder of the time course. Importantly, Treatment 1 yielded significantly higher serum calcium levels over the first 13 hours than Treatment 2 (Figure 2), indicating that two calcium chloride boluses at time 0 lead to a greater increase in serum calcium than the traditional regimen of giving one bolus each at t=0 and t=12 hours.

Figure 2 Changes in serum calcium upon treatment with commercial boluses. Treatments were initiated within 12 hours following calving (not before) and this time is considered Time 0 (t=0). Treatment 1 = two high calcium chloride boluses at Time 0; Treatment 2 = one high calcium chloride bolus at t=0 and another at t=12 hours; Treatment 3 = two high calcium carbonate boluses at t=0. Data represent the mean SEM (standard error of the mean) for 9 independent animals per treatment group. *P<0.05; **P<0.01; ***P<0.001, ****P<0.0001. Blue, orange, and red asterisks denote statistically significant differences between Treatment 1 vs 3, 2 vs 3, and 1 vs 2, respectively.

The severe hypocalcemia cattle had a greater and more persistent response to calcium supplementation than cows suffering from moderate hypocalcemia, with statistically significantly higher serum calcium levels at 6, 12, and 13 hours (Figure 3). The moderately hypocalcemic cows receiving Treatment 1 returned to their baseline value after 24 hours, while severely hypocalcemic cows receiving treatment 1 remained well above their baseline value even after 24 hours (Figure 3). These data suggest that two high calcium chloride boluses administered rapidly after calving are more effective at raising serum calcium compared to the traditional treatment of one bolus followed by a second bolus twelve hours later.

Figure 3 Changes in serum calcium upon treatment with two high calcium chloride boluses (Treatment 1) in animals with moderate hypocalcemia (>1.8 mmol/L) versus severe hypocalcemia (<1.8 mmol/L). Treatments were initiated within 12 hours following calving (not before) and this time is considered Time 0 (t=0). Data represent the mean SEM for 10 (severe hypocalcemic cows, treated with 2 high calcium chloride at t=0) or 11 (moderate hypocalcemic cows, treated with 2 high calcium chloride at t=0) animals. *P<0.05.

The objectives of this study were to evaluate dissolution times of boluses containing different calcium salts, and their effect on serum calcium in postpartum dairy cows. Calcium chloride and calcium sulfate are absorbed passively through the rumen wall by a process called paracellular absorption. Resistance to movement across the tight junction between epithelial cells can be overcome if the concentration of a mineral, in a freely ionized state, on the luminal side of the tight junction greatly exceeds the ionized concentration of that mineral in the extracellular fluids within the interstitial space on the other side of the tight junction.17 When ionized calcium in the rumen is greater than 6 millimoles (a fivefold increase from the extracellular fluid concentration), the diffusional force created by this difference will be great enough to push the calcium through the tight junction into the interstitial space, and from there it passes through the openings in the capillary endothelium and into the blood.17 This process is very rapid and serum calcium will peak in about an hour. Calcium carbonate is absorbed in the duodenum through the cell wall by vitamin D-dependent active transport. Parathyroid hormone (PTH) stimulates the kidneys to produce vitamin D which, in turn, activates the calcium-binding protein and the ATPase pump to transfer calcium ions through the cell wall into the blood. This process has little effect on raising serum calcium levels for at least 6 hours15 and this was confirmed in our study. In addition, calcium chloride and calcium sulfate are acidifying agents that increase the sensitivity of receptor cells to PTH. The in vivo dissolution study demonstrates that calcium boluses that contain calcium carbonate dissolve at a slower rate in the rumen. When comparing Bolus 2 and Bolus 3, the concentration of calcium carbonate is a good indicator of the boluss dissolution rate. The calcium uptake study confirmed that the bolus containing a high concentration of calcium carbonate did not raise serum calcium levels before at least 6 hours, even though two boluses were administered at once. Although this high calcium carbonate bolus contains approximately 44% calcium chloride, this calcium does not appear to be available to the cow before 6 hours. This is an important observation as cows need a rapid supplementation of calcium in the early postpartum period.15 The traditional protocol of administering one high calcium chloride bolus shortly after calving followed by a second bolus 12 hours later resulted in a similar two peak graph as reported in a Sampson et al (2009) study.16 Notably, the present study compared the traditional protocol (suggested by all brands) of giving one bolus at t=0 and another bolus 12 hours later to the more convenient protocol of giving two boluses at t=0, as the latter approach would be very appealing to a producer. Although it was not surprising that blood calcium peaked at a higher level following an initial dose of two high calcium chloride boluses because of the greater rumen calcium osmolarity, the persistence of this increase was higher than expected. Serum calcium levels were significantly superior to the two-bolus at a 12-hour interval regimen over the first 13 hours and remained numerically higher after 24 hours. When the trial involving Treatment 1 was prolonged to compare the response of cows with severe subclinical hypocalcemia to cows with normal/moderate hypocalcemia, both the serum calcium peak and serum calcium persistence was greater in the severe group. Both calcium chloride and calcium sulfate dissolve rapidly in the rumen. Passive transport of calcium ions between rumen epithelial cells into the extracellular fluid is dependent on diffusion down a concentration gradient.15 It stands to reason that the greater the difference between rumen calcium concentration and blood calcium concentration, the more efficient this passive transport will be, thus positively affecting the increase in serum calcium.

Before the arrival on the market of the calcium bolus, cows were commonly drenched with calcium salts. In one trial, various amounts of calcium chloride were administered to hypocalcemic cows as an oral drench. Three different amounts of calcium, provided by calcium chloride, were evaluated. Cows were orally administered either 50, 75 or 100 grams of calcium chloride twice within 24 hours. As expected, blood calcium concentrations increased as the doses of calcium chloride increased. However, three hours after the second treatment of 100 grams of calcium, the cow presented signs of severe metabolic acidosis with heavy and deep breathing. A treatment protocol of 75 grams of calcium from calcium chloride twice over 24 hours had no ill effects.15 In this study, calcium was provided as a pure calcium chloride solution.

In a more recent trial, cows received 86 grams of calcium for the first 2 days post calving followed by 3 consecutive days of 43 grams. Calcium was provided by triglyceride-coated oral boluses containing a combination of calcium chloride and calcium sulfate.18 They determined that the Blood pH did not differ with administration of oral calcium and averaged 7.488, 7.483, and 7.483 0.012 for 0, 43, and 86 g of calcium, respectively. Therefore, any negative health effects were not due to metabolic acidosis.

The present study suggests that administering two high calcium chloride/calcium sulfate boluses shortly after calving will be more effective in preventing clinical milk fever than the traditional protocol of one bolus after calving followed by a second bolus twelve hours later. Convenience is a huge factor when it comes to making decisions on the dairy farm and the recommendation to give two boluses 12 hours apart is neither convenient nor management or cow friendly.

Dairy cows experience many metabolic challenges around the time of calving. Some of these cows will experience clinical milk fever (510%), while up to 50% of mature cows in some herds will show no symptoms but have subclinical hypocalcemia (SCH).9,19 Recent studies have shown that chronic SCH is more damaging to health than transitory SCH.19,20 Our study focused on the serum calcium effects of supplementing calcium. Research conducted in the last decade has shown that SCH is associated with metabolic diseases,6 an increased susceptibility to metritis in the early postpartum period,3,4,6 a compromised reproductive performance,7 and increased culling rates in the early lactation.8 The awareness of the effects of subclinical hypocalcemia in postpartum dairy cows on the farm level has increased thanks to communication efforts by veterinarians and publications. The case for calcium supplementation has been made but many questions are left to answer on timing, composition, benefits, and dosing regimen of these boluses. Oetzel and Miller (2012) found that cows with higher previous lactation mature-equivalent milk production at 105% of their herd mates, that were supplemented with oral calcium boluses, produced 2.9 kg more milk at first DHIA (Dairy Herd Information Association) test than similar high producing cows not administered postpartum calcium supplementation.13 They also found that lame cows benefited from calcium supplementation. Martinez et al (2016) provided calcium boluses on multiple days with more than one bolus given at a time.21 High producing cows supplemented with calcium produced 0.8 to 2.7 kg more milk per day than their high producing peers not supplemented with calcium. They also concluded that supplementing cows with oral calcium reduced the incidence and prevalence of SCH, but that oral calcium increased the incidence of metritis. This negative effect was primarily observed in primiparous cows considered to be at low risk of metritis. However, reproductive performance improved in multiparous cows with this same regimen. Martinez et al (2016) suggested that this multiple-dose treatment regimen for oral calcium should be avoided in primiparous cows and target only populations at high risk of developing hypocalcemia.21 Domino et al (2017) found that cows with a high relative herd milk rank, that received calcium either subcutaneously or as a bolus, were almost half as likely as non-supplemented cows to be diagnosed with mastitis in the first 60 Days in Milk (DIM).22 They did not report any other health or production benefits between the control group and the two supplemented groups. Leno et al (2018) researched the effects of a single dose of oral calcium on postpartum plasma calcium concentration in Holstein cows and found that a single dose of an oral calcium bolus did not increase the blood calcium concentration between 1 and 24 hours following administration.12 However, responses observed for health and performance outcomes suggest that, in primiparous cows with higher age at first calving or higher body condition score (BCS) at parturition, calcium supplementation positively affected health status and early lactation performance, respectively.12 In multiparous cows, supplementation of cows with higher parity, higher BCS, and lameness also resulted in improved health status. Leno suggested that supplementing Ca could alleviate some of the underlying causes of increased risk for metabolic disease in these animals by supporting gut motility, which can be compromised when blood Ca declines.12 Improved gut motility could support a more rapid increase in postpartum intake and lead to a reduction in the rate or severity of metabolic disease, and higher DMI would support greater milk yield in these cows.12 For multiparous cows, those with low plasma calcium responded with decreased health disorders but cows with higher plasma calcium had varied responses. The authors concluded that low blood calcium concentration was less reliable than other periparturient risk factors to identify cows with a potential to favorably respond to calcium supplementation.

Target group calcium supplementation strategies have been found to be cost-effective.23 A two-bolus regimen, one administered after calving and the second about 24 hours later, was applied to herds following four treatment strategies: lame cows only, high producers only, lame cows and high producers, and all multiparous cows. Although there was a minor herd net impact with the blanket multiparous cow treatment strategy, the greatest return on investment was with the lame cows.

The question remains to be asked whether two boluses at once would be able to amplify these positive responses and whether giving two boluses simultaneously would reduce the number of animals in a herd with a persistent or delayed subclinical hypocalcemia. Giving two boluses at once would negate the need for additional handling (and the accompanying risk of injury to the animal) and likely reduce the behavioral impact of giving boluses the traditional way 12 hours apart. Our study demonstrates that a treatment of two initial high calcium chloride boluses significantly increases blood calcium over the first 13 hours after administration compared to the traditional administration of two boluses at a 12-hour interval. Furthermore, the persistence of these calcium levels remains numerically greater over the 24-hour period. Therefore, the recommendation to provide two boluses at once after calving is practical, convenient, safe, and will more than likely improve the compliance rate of providing the suggested application of two boluses.

A limitation of this study is the lack of blinding of farm personnel to treatments for the first part of the on-farm trial (27 cows) involving two different calcium boluses. However, treatments were administered to cows according to a randomized list prepared before commencement of the study. Farm personnel abided strictly by this list as well as the pre-established blood collection protocol. For the second part of the on-farm trial, all second- and third-lactation cows were administered the same type of bolus (Bolus 1; high calcium chloride) according to the same treatment regimen (two boluses simultaneously, within 12 hours of calving).

The dissolution study and the serum calcium response study in Quebec clearly demonstrate the complexity of a proper calcium supplementation. Boluses containing calcium carbonate may cause a delayed delivery of calcium when it is needed most, and this may ultimately have an impact on the health and wellbeing of the animal. Further research on the impact of calcium carbonate as it relates to the ability and to the timing of a serum calcium increase seems warranted. There are many different calcium boluses on the Canadian market and the dairy producer would likely benefit from the involvement of the herd veterinarian to help design a calcium bolus strategy. This study demonstrated that the increase in total calcium concentrations lasted for 24 hours when two high calcium chloride boluses were administered shortly after calving. Based on our study findings and on a literature review, the recommendation to provide two boluses at once after calving is practical, convenient, safe, and will likely improve the compliance rate of providing the suggested application of two boluses.

BCS, body condition score; DCAD, dietary cation-anion difference; DHIA, dairy herd information association; PTH, parathyroid hormone; SCH, subclinical hypocalcemia; TMR, total mixed ration.

The present field-based study was conducted in compliance with the best practice of veterinary care in accordance with the research guidelines set forth by the Canadian Council on Animal Care and was approved by the Institutional Animal Care and Use Committee (Airdrie, Alberta, Canada) and the Lacombe Research and Development Centre Animal Care Committee.

The owners provided informed consent for their animals to be used in the present study.

The authors wish to acknowledge the producer and the farm staff responsible for treatment administration, blood sample collection, centrifugation, and storage, as well as the technicians, the researchers, and the dairy animals that contributed to this study.

All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

The funding of both studies was entirely provided by Solvet Animal Health.

Dr Walter Verhoef reports personal fees from Solvet Canada, during the conduct of the study; personal fees from Bureau Vtrinaire de Richmond and Solvet Canada, outside the submitted work; is a partner in Bureau Vtrinaire de Richmond, and was consulting for Solvet. Dr Brenda Ralston reports Dr Merle Olson was her Masters supervisor in 2001; they have published numerous other papers and have collaborated on various grants. Dr Joseph A Ross reports compensation paid to his employer (Chinook Contract Research) for time spent writing, preparing figures, and statistical analyses for Alberta Veterinary Laboratories, during the conduct of the study. Dr Merle Olson reports personal fees from Alberta Veterinary Laboratories, during the conduct of the study; receives salary from Solvet, and Sjoert Zuidhof is providing consulting services to Solvet, which markets the Cal-Boost bolus. The authors report no other potential conflicts of interest for this work.

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15. Goff JP, Horst RL. Oral administration of calcium salts for treatment of hypocalcemia in cattle. J Dairy Sci. 1993;76(1):101108. doi:10.3168/jds.S0022-0302(93)77328-2

16. Sampson JD, Spain JN, Jones C, Carstensen L. Effects of calcium chloride and calcium sulfate in an oral bolus given as a supplement to postpartum dairy cows. Vet Ther Fall. 2009;10(3):131139.

17. Goff JP. Invited review: mineral absorption mechanisms, mineral interactions that affect acid-base and antioxidant status, and diet considerations to improve mineral status. J Dairy Sci. 2018;101(4):27632813. doi:10.3168/jds.2017-13112

18. Martinez N, Sinedino LDP, Bisinotto RS, et al. Effects of oral calcium supplementation on mineral and acid-base status, energy metabolites, and health of postpartum dairy cows. J Dairy Sci. 2016;99(10):83978416. doi:10.3168/jds.2015-10527

19. Caixeta LS, Ospina PA, Capel MB, Nydam DV. Association between subclinical hypocalcemia in the first 3 days of lactation and reproductive performance of dairy cows. Theriogenology. 2017;94:17. doi:10.1016/j.theriogenology.2017.01.039

20. McArt JAA, Neves RC. Association of transient, persistent, or delayed subclinical hypocalcemia with early lactation disease, removal, and milk yield in Holstein cows. J Dairy Sci. 2020;103(1):690701. doi:10.3168/jds.2019-17191

21. Martinez N, Sinedino LDP, Bisinotto RS, et al. Effects of oral calcium supplementation on productive and reproductive performance in Holstein cows. J Dairy Sci. 2016;99(10):84178430. doi:10.3168/jds.2015-10529

22. Domino AR, Korzec HC, McArt JAA. Field trial of 2 calcium supplements on early lactation health and production in multiparous Holstein cows. J Dairy Sci. 2017;100(12):96819690. doi:10.3168/jds.2017-12885

23. McArt JA, Oetzel GR. A stochastic estimate of the economic impact of oral calcium supplementation in postparturient dairy cows. J Dairy Sci. 2015;98(10):74087418. doi:10.3168/jds.2015-9479

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[Full text] Dissolution Rates of Calcium Boluses and Their Effects on Serum Calciu | VMRR - Dove Medical Press

Serum antioxidant vitamin concentrations and oxidative stress markers associated with symptoms and severity of premenstrual syndrome: a prospective…

Participants and study design

The BioCycle Study (20052007) was a prospective cohort study designed to evaluate the relationship between reproductive hormones and oxidative stress levels throughout the menstrual cycle [26, 27]. The participant cohort consisted of 259 regularly menstruating, healthy women between the ages of 1844years, recruited from western New York. Participants were recruited in a variety of ways, including: advertising in clinical practices and the University at Buffalo student health center, paid advertising in print media, radio and television interviews, notices sent via list serves, and flyers at the university and throughout the region. For those interested, an initial screening phone call was conducted, followed by a mailing and an in-person visit. Exclusion criteria included factors that may interfere with a normal menstrual cycle or vitamin levels, such as: use of oral contraceptives during the study period or in the previous three months; use of Depo provera, implant or IUD in previous twelve months; current use of vitamin, mineral, or herbal supplements; use of prescription medications; pregnancy or breast feeding in the previous six months; reported attempts to conceive in the previous six months; diagnosis of uterine abnormalities or chronic conditions, such as ovulatory disorders and premenstrual dysphoric disorder (PMDD); and a self-reported body mass index (BMI) of <18 or >35kg/m2 at screening [27]. Those eligible and interested after the screening visit were scheduled for a baseline enrollment visit 12weeks prior to the start of their next menses. Women were followed for one (n=9) or two (n=250) menstrual cycles (Additional file 1: Figure S1).

Women completed up to 8 clinic visits per cycle for up to 2 cycles. Study visits were scheduled using fertility monitors (Clearblue Easy Fertility Monitor; Inverness Medical, Waltham, Massachusetts) to coincide with critical phases of the menstrual cycle, including menstruation; mid- and late follicular phases; luteinizing hormone (LH) surge (predicted ovulation); and early, mid-, and late luteal phases [28]. At each of these visits, fasting blood samples were collected from participants from which the antioxidant vitamins and oxidative stress concentrations were measured. Participants were highly compliant with the study protocol; 94% of the women completed 7 or 8 clinic visits, and 100% completed at least 5 clinic visits per cycle.

The University at Buffalo Health Sciences Institutional Review Board (IRB) approved this study and served as the IRB designated by the National Institutes of Health under a reliance agreement. All participants provided written informed consent. Further details of the study design are described elsewhere [27].

Ascorbic acid (vitamin C), retinol (vitamin A), and - and - tocopherol (vitamin E) were measured in all blood samples taken from participants across a menstrual cycle and subsequently averaged to reflect the mean levels across a cycle. Total ascorbic acid was determined by the dinitrophenylhydrazine (DNPH) method. Samples for ascorbate analysis were stabilized immediately following phlebotomy and centrifugation by adding 0.5mL of heparin plasma to 2.0mL of 6% meta-phosphoric acid and centrifuging at 3000g for 10min. Clear supernatant was decanted and frozen at 80C for analysis. The absorbance of each DNPH derivatized sample was determined at 520nm on a Shimadzu 160U spectrophotometer (Shimadzu Scientific Instruments, Inc.). Across the study period, the coefficient of variation (CV) for this test reported by the laboratory was 10%.

Fat-soluble vitamins (including retinol, and vitamin E components: - and -tocopherol) were measured at the Kaleida Health Center (Buffalo, New York) simultaneously in serum using high performance liquid chromatography with photodiode array detection [29]. -tocopherol was also detected but was below the lower limit of quantification for our assay (0.28). The limits of detection were 0.0054 for retinol, 0.0768 for -tocopherol, and 0.1052 for -tocopherol. The CV for these tests across the study period were <6% for retinol and <2% for - and -tocopherol. Continuous monitoring of standard reference material 968c from the National Institute of Standards and Technology (NIST) and participation in the NIST Micronutrients Measurement Quality Assurance Program provided external checks on analytical accuracy.

Mean concentrations of antioxidants, including vitamin A, vitamin C, -tocopherol, and -tocopherol, were calculated per cycle and were used in all analyses. Overall median concentrations were also compared with levels reported previously by reproductive aged women (i.e., 2039years) in the 2012 National Health and Nutrition Examination Survey (NHANES) to assess the comparability of our results with those of a nationally representative population [30].

Plasma free F2-isoprostane, a breakdown product of ROS and a marker of oxidative stress, was measured with a gas chromatography-mass spectrometrybased method by the Molecular Epidemiology and Biomarker Research Laboratory (University of Minnesota, Minneapolis, Minnesota) (CV=9.4%).

Frequency and severity of 20 premenstrual symptoms was assessed through questionnaires completed at four time points of each menstrual cycle: menses, follicular phase, peri-ovulation, and luteal phase (Additional file 2: Figure S2). Participants recalled the occurrence and severity of symptoms in the prior week. The symptoms included in this assessment were: sadness, crying spells, anger, nervousness, insomnia, tension, abdominal bloating, cravings of chocolates, cravings of sweets, cravings of salty foods, cravings of other foods, breast tenderness, lower abdominal cramping, general aches, backache, headache, acne outbreaks, change in appetite, fatigue, and swelling of the hands/feet. The severity of each symptom was ranked by the participant on a scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). The symptoms included in this questionnaire were adapted from validated surveysincluding the Daily Record of Severity of Problems (DRSP) and the Premenstrual Symptoms Screening Tool (PSST)but slightly modified, given that DRSP and the PSST were designed to identify patients with PMDD specifically (a population excluded in our study) [31,32,33,34].

We categorized severity as none/mild (reference group) or moderate/severe to estimate odds of having a moderate or severe symptom during the premenstrual week. We then calculated severity scores for groups of related symptoms by summing the severity score of symptoms (as reported in the premenstrual week) within each grouping to generate an overall score. The groupings were established based on clinical expertise and included: depression (sadness, crying spells, anger) and anxiety (nervousness, insomnia, tension); hydration (abdominal bloating) and cravings (chocolate cravings, sweets cravings, salty food cravings, other food cravings); pain (breast tenderness, lower abdominal cramping, general aches, backache, headache); and other (acne outbreak, change in appetite, fatigue, swelling of hands or feet).

Overall PMS severity was evaluated using four different approaches, which utilize information on all symptoms from the luteal and follicular phase questionnaires from each cycle: (1) 5 or more moderate or severe symptoms during the luteal phase; (2) 8 or more moderate or severe symptoms during the luteal phase; (3) 3 or more moderate or severe symptoms where the luteal phase score was 30% greater than the follicular phase and at least one symptom was psychological (referred to as PMS-1 in the tables and results); and (4) 5 or more moderate or severe symptoms where the luteal phase score was 30% greater than the follicular phase and at least one symptom was psychological (referred to as PMS-2 in the tables and results) [8, 35, 36]. When summing the number of moderate or severe symptoms for each cycle, each of the individual cravings symptoms were combined into a single variable. These criteria were based upon various defintions of PMSincluding those of the National Institute of Mental Health, [37] the American College of Obstetrics and Gynecology, [38] the American Psychiatric Association, [39] and the International Society for Premenstrual disorders (ISPMD) [40]which were further expanded and implemented in studies such as Gollenberg et al. [35] and Borenstein et al. [8] Of note, these approaches attempt to establish the necessary temporality between pre- and post-menstrual symptoms in line with traditional PMS definitions and diagnoses that assume resolution of symptoms within 12days of the onset of menses.

At study enrollment, a trained research assistant measured height and weight for the calculation of BMI using standardized protocols. Demographics such as age, race, education, smoking habits, reproductive history, and physical activity were also collected at baseline through self-reported questionnaires. Physical activity was assessed at baseline using the International Physical Activity Questionnaire, and estimated for high, moderate, and low levels of activity based upon accepted cutoffs [41]. Dietary information was obtained using 24-h recalls (up to 4 times per cycle) and analyzed using the Nutrition Data System for Research software (version 2005) developed by the Nutrition Coordinating Center of the University of Minnesota (Minneapolis, Minnesota). Cycle-averaged measures of total energy (kcal/day) and fiber (g/day) were used in these analyses, as we previously found these intakes do not vary significantly across the cycle [42]. All covariates assessed had at least a 95% response rate.

Demographic characteristics were compared between those with <5 versus 5 moderate or severe symptoms during the luteal phase of either study menstrual cycle, and between those with <8 versus 8 moderate or severe luteal phase symptoms in either cycle. Repeated measures ANOVA and McNemars tests were used for comparisons.

We estimated associations between mean antioxidant concentrations and F2-isoprostane concentrations from each menstrual cycle and odds of reporting a moderate/severe symptom during the premenstrual week for each cycle using generalized linear models. Next, we evaluated associations between antioxidant concentrations, F2-isoprostane concentrations, and scores for symptom severity within groups during the premenstrual week (e.g., depression, cravings, pain) using linear mixed models. We used generalized linear models to assess the association between mean antioxidant concentrations, F2-isoprostane concentrations, and overall PMS severity in each cycle using the four different classifications of PMS severity (5 or more moderate or severe symptoms, 8 or more moderate or severe symptoms, PMS-1 criterion, PMS-2 criterion). All models were adjusted for age, race, BMI, physical activity, smoking status, alcohol use, pain reliever use, and average total energy intake per cycle and accounted for repeated measures (i.e., multiple cycles per woman). Results were adjusted for multiple comparisons using the false discovery rate (FDR). An alpha of 0.05 was considered statistically significant. As antioxidants and oxidative stress measures have been shown to vary somewhat over the menstrual cycle [26, 43], we also evaluated associations between time-varying measures of antioxidants and oxidative stress, with time-varying symptoms as a sensitivity analysis. Splines were used to evaluate the assumption of linearity. We did not find evidence to suggest that linear modeling was inappropriate (e.g., quadratic or restricted cubic spline modeling did not help explain the associations in our population). All statistical analyses were calculated using SAS 9.4 (SAS Institute, Cary, North Carolina).

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Serum antioxidant vitamin concentrations and oxidative stress markers associated with symptoms and severity of premenstrual syndrome: a prospective...

COVID antibody treatment – Yahoo News

National Review

President Joe Bidens recent executive order to expand food assistance to U.S. households, while well-intentioned, represents a substantial overreach of the executive branch and a blatant attempt to override the intent of Congress. If successful, this dangerous precedent would open the door to major expansions of the social safety net without congressional approval. Congress must resist the presidents attempts to subvert the intent of existing law. Less than one week into the Biden presidency, the new administration issued a series of executive orders focused on COVID-19 economic relief. One such order seeks to expand food assistance through the Supplemental Nutrition Assistance Program (SNAP), or food stamps. In it, President Biden instructed the Department of Agriculture (USDA) to take immediate steps to make it easier for the hardest-hit families to enroll and claim more generous benefits in the critical food and nutrition assistance area. In reality, the executive order asks a federal agency the USDA to intentionally misinterpret the Families First Act and subvert the constitutional authority of Congress over the legislative process. The Families First Act, which passed in March 2020, clearly outlined that states could request waivers from the Agriculture Department to provide emergency allotments to SNAP households not greater than the applicable maximum monthly allotment for the household size. In normal times, 60 percent of households enrolled in SNAP do not receive the maximum benefit because they have income from other sources such as earnings that they can use for purchasing food. The emergency allotments recognized that millions of people lost jobs or faced other employment disruptions when the pandemic hit, and that those enrolled in SNAP were at particular risk for job loss in the early aftermath of the pandemic. Rather than requiring SNAP households to report a job or income change to their state agency and wait for bureaucrats to recalculate their benefits, the emergency allotments gave every SNAP recipient the maximum allowed. This was, admittedly, not a very targeted effort. Some families received a boost in SNAP dollars without a change in household income or financial circumstances. But the immediacy of the economic shock brought on by the pandemic, and the employment instability that persists today, necessitated an equally expedient policy response. The Agriculture Department, under President Trump, had approved emergency allotment plans for all 50 states, the District of Columbia, Guam, and the U.S. Virgin Islands but only in accordance with the law. The department extended these emergency-allotment waivers numerous times, most recently extending them through January 2021. The USDA and Congress itself also offered states flexibility in the aftermath of the pandemic. According to federal government spending data, all of the efforts outlined above have caused SNAP benefits to rise more than 40 percent in the last fiscal year, with more than $31 billion in added spending compared to FY 2019. Class-action suits have been filed in Pennsylvania and California by people who disagree with the USDAs interpretation of the law: that regular SNAP plus emergency allotments cannot extend benefits beyond the maximum benefit level. Lawyers for the lawsuits argue that the law allows the USDA to approve emergency allotments in the amount of the maximum benefit, which if true, would mean that households could receive the maximum SNAP benefit plus the maximum emergency allotment essentially doubling benefit amounts. A federal judge in California agreed with the USDA, while the Pennsylvania case is ongoing. The Biden administrations executive order is encouraging its USDA to misinterpret the 2020 law in a similar way. The legislative text is not ambiguous. It is hard to imagine Congress being any clearer than, to address temporary food needs not greater than the applicable maximum monthly allotment for the household size. If Congress had wanted to give people more than the SNAP maximum, it would have done so. In fact, Congress eventually did just that expanding benefits by 15 percent in the COVID-19 relief package passed last month. If the Biden administration is successful in this attempt, it will open the door to a number of executive actions aimed at expanding the safety net without congressional action. If political appointees in the Biden administration feel unconstrained by the law, we will see larger benefits directed to an increasing number of people. Such action not only undermines the integrity of the social safety net by going around Congress, it disregards the separation of powers ensconced in the founding documents of our republic. The American public has been largely supportive of efforts by Congress to provide economic relief to struggling households. Lets keep that authority in its proper place.

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COVID antibody treatment - Yahoo News

Mayo Clinic Q And A: Genetic abnormalities and cancer risk – Greater Milwaukee Today

DEAR MAYO CLINIC: My mom was diagnosed with breast cancer. During her care, she was found to have a BRCA2 mutation. Her doctor suggested that my brothers and I get tested for this mutation, too. I am a 26-year-old woman, and I am not sure what this means for me and my risk of cancer.

ANSWER: Having a loved one with a breast cancer diagnosis can be scary. It also can become confusing when you start to hear about genetic mutations. The good news is that the information can help guide your family regarding screening and future cancer risk.

BRCA2 is a genetic abnormality that can be passed down from a parent to children. It is autosomal dominant, which means there is a 50% chance that each of your mom's biological children could have the mutation. Being positive for the mutation would mean that you or your brothers may be at increased risk of developing certain cancers, compared to the general population.

In addition to breast cancer, these cancers are also known to be associated with BRCA2: ovarian cancer, melanoma, prostate cancer and pancreatic cancer.

To understand your risk, you would want to meet with a genetic counselor who can help you understand the implications of undergoing genetic testing and whether this is something you want to do. Typically, genetic testing is performed using a blood or saliva sample. The counselor would review the results with you and, if you are positive, recommend next steps to learn more about personalized screening and specific risk reduction options.

Generally speaking, it is recommended that women who have a BRCA2 mutation begin monthly breast self-examinations, beginning at 18. Clinical breast examinations are recommended every six months, beginning at 25, or before if there is an earlier breast cancer in the family. Annual breast MRIs should begin at 25. Tomosynthesis mammograms are recommended annually, beginning at 30. They are usually alternated with breast MRIs every six months. Based on risk and family history, some woman may choose to undergo a preventive mastectomy to remove their breast tissue and hopefully decrease their risk of developing breast cancer.

There is no screening test for ovarian cancer. However, women can have transvaginal ultrasounds and a blood test called CA 125 every six to 12 months, beginning at ages 30-35, while their ovaries are still in place.

If desired, women can undergo surgery to remove their ovaries and fallopian tubes once they are done having children. Ideally, this would occur between the ages of 40-45. As this surgery results in women going through menopause, some women may be started on hormone therapy until ages 50-51 to alleviate menopausal symptoms and offset some long-term risks associated with early menopause.

Research has shown that many ovarian cancers begin in the fallopian tubes. With this knowledge, women have recently been having surgery to remove their fallopian tubes and delay surgery to remove their ovaries for a few years though the recommended age for a woman to have her ovaries removed is still 40-45 in a BRCA2 mutation carrier. The benefit of removing just the fallopian tubes is that this allows women to preserve their natural hormonal function longer. The safety of this strategy is being studied, and this type of surgery is being performed as part of clinical trials.

Women who undergo surgery to remove their ovaries before menopause have a 50% reduction in their risk of developing breast cancer. In addition to surgeries, there are medications that can be given to help decrease the risk of developing breast and ovarian cancers. Selective Estrogen Receptor Modulators (SERMS) and Aromatase Inhibitors (AIs) are types of medications that can reduce the risk of developing breast cancer. Oral contraceptives can decrease the risk of developing ovarian cancer by 50%.

Since the BRCA2 mutation can be passed down to offspring, understanding your status and that of a future partner is important, as there is a genetic condition called Fanconi anemia that can occur if both the male and female partners have a BRCA2 mutation.

Thus, for men and women who test positive for BRCA2 and have not yet had biological children, it may be worthwhile to meet with a specialist in reproductive endocrinology and infertility to discuss options.

There are no standard screening guidelines for pancreatic cancer or melanoma. Based on your situation, a consultation with a pancreatic specialist may be worthwhile to discuss whether to pursue MRI or endoscopic ultrasound. Likewise, a referral to a dermatologist can be made to initiate skin cancer screenings.

Understandably, you may be nervous about your risk for cancer, given your mother's diagnosis. However, you are young, and you should not feel rushed to make any decisions regarding genetic testing. If you choose to undergo testing and are found to have a BRCA2 mutation, your health care providers will give you the information that you need so that you can begin to think about what makes sense for your life and your priorities.

Casey Swanson, physician assistant, Gynecologic Surgery, Mayo Clinic, Rochester, Minnesota

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Mayo Clinic Q And A: Genetic abnormalities and cancer risk - Greater Milwaukee Today

First period: Early signs, how long it lasts, and self-care tips – Medical News Today

For most females, the first period usually begins around 2 years after the first signs of puberty start. Signs of puberty can include the development of breasts, the growth of body hair, and changes in body shape.

This information comes from the Office on Womens Health.

Knowing the signs of a first period can help young females and their parents or caregivers feel prepared.

Around 98% of females begin their first period by the time they are 15 years of age, but the average age has decreased over time.

This article will look at some of the signs a female can expect before they begin their period, as well as what it might be like and what to do when it begins.

The best way to tell if a female is about to have their first period is to assess whether or not they have begun puberty.

Some signs of puberty include:

The first period will typically begin a couple of years after the first signs of puberty appear. However, there is no precise way of knowing when it will begin.

Several days before the first period, some females may notice spotting in their underwear or abdominal cramps. Some may also notice more acne appearing. Not everyone will experience this, however.

The first period typically occurs after a female first ovulates. This happens when the ovaries release an egg into the fallopian tube.

When this happens, the womb lining thickens in preparation for the egg to be fertilized. If fertilization does not occur, the lining sheds, as the body no longer needs it. This is where period blood comes from.

In most females, this cycle continues regularly from the age of the first period until menopause, which is when periods end.

According to the Centers for Disease Control and Prevention (CDC), the average age at which females began menstruating in the United States in 20132017 was 1112 years old. However, periods can start earlier or later than this.

Every females period is different. Periods can vary in duration, frequency, and heaviness. Some females have very light periods, while others have heavy periods.

For some, the first period is light, with a small amount of blood. It may begin gradually, starting with some spotting or brown discharge before becoming red.

For others, periods begin suddenly, with bright red blood appearing straight away. In either case, this is normal. Period blood can range in color from brown to dark red. Some people may also pass small blood clots.

Having a period can feel similar to having vaginal discharge, but some females do not feel much at all.

When a period begins, try to find a way to absorb the blood. A female can do this by asking a friend or family member for a pad or tampon.

If it is not possible to use a pad or tampon, try to wrap something absorbent, such as toilet paper or a clean washcloth, around the crotch area of some underwear. This can absorb the blood and prevent leaks.

It can be helpful to prepare a period kit before the first period arrives. This can help with feeling ready. This period kit could consist of:

Most periods last for 37 days. However, first periods can be less predictable, so they may be slightly shorter or longer.

During the first few years after a females first period, periods may be irregular, coming at unpredictable intervals. Over time, however, they typically become more regular.

Most females get a period about every 28 days, though the actual length varies from person to person as well as period to period. The cycle length may vary by as much as a week in any given year.

The following sections will look at some absorption methods in more detail.

Sanitary pads are a popular form of period protection. They line the underwear with absorbent material, which soaks up the blood.

Some benefits of pads include the fact that they:

Some drawbacks of pads include the fact that they:

It is also possible to purchase reusable fabric pads or period panties, which absorb blood in a similar way to a pad. These products are washable, meaning that a female can reuse them. This can be more cost effective than using disposable pads.

Change pads every 48 hours or whenever the current one starts to feel uncomfortable.

Some benefits of tampons include the fact that they:

Some drawbacks of tampons include the fact that they:

It is crucial to change tampons every 48 hours and to use the lowest absorbency possible. Parents and caregivers should ensure that young females who want to use tampons understand how to use them safely to prevent TSS.

Menstrual cups are small silicone cups that females can wear internally. They work by catching blood inside the vagina. When the cup is full, it is important to remove it and rinse it with clean water before reusing it.

Some benefits of menstrual cups include the fact that they:

Some drawbacks include the fact that they:

Although many manufacturers say that there is no risk of TSS with menstrual cups, there has been at least one confirmed case of TSS in a cup user.

It takes time to adjust to having a period, and they can sometimes cause discomfort. However, periods are a normal part of life, and they do not have to limit or change anyones daily activities.

The following tips may help females take care of themselves during their first period.

For pain and cramping, try:

After the first period, it can be difficult to predict when the next period will happen. It also takes some time to adjust to using period products. Occasionally, this may result in leaks.

Try:

It is generally safe to assume that most females who get periods can get pregnant.

The first period usually means that ovulation has occurred. Ovulation means that pregnancy is possible. However, both periods and ovulation can be irregular during the first few years after the first period, making it difficult to predict fertility.

Although it is normal for periods to be somewhat irregular to begin with, it is a good idea to talk with a doctor if they do not settle into a regular rhythm or if they cause symptoms that disrupt daily life.

The frequency and heaviness of periods, and any symptoms that accompany them, can be an important indicator of a females health.

It is a good idea for a person to talk with a doctor if they or a young female in their care experiences:

Emergency medical help is necessary if someone develops any symptoms of TSS, which can include:

A females first period is an important milestone. Waiting for it can be scary, exciting, or both. There is no reliable way to predict when it will arrive, and periods affect females in different ways.

Once a period begins, it can take time to learn how to manage them. Talk with a trusted adult, doctor, or nurse to ask questions and get advice.

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First period: Early signs, how long it lasts, and self-care tips - Medical News Today

Aeterna Zentaris Expands Orphan Drug Development Pipeline with Targeted Immunosuppressive Therapeutics – GlobeNewswire

- Company licenses exclusive worldwide rights to develop, manufacture and commercialize targeted, highly specific immunosuppressive therapeutic proteins for the potential treatment of neuromyelitis optica spectrum disorder (NMOSD) from Julius-Maximilians-University of Wuerzburg, Germany- Initial step in growth strategy to build-out pipeline of assets - Aeterna Zentaris to develop potential therapeutic treatment option for neuromyelitis optica spectrum disorder (NMOSD), an orphan indication with strong unmet medical need and significant market opportunity

CHARLESTON, S.C., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), through its wholly-owned subsidiary Aeterna Zentaris GmbH, (Aeterna or the Company), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, today announced that it has licensed the exclusive worldwide rights to develop, manufacture and commercialize targeted, highly specific, autoimmunity modifying proteins (AIM Biologicals) for the potential treatment of neuromyelitis optica spectrum disorder (NMOSD) from the Julius-Maximilians-University Wuerzburg (the University).

This demonstrates Aeternas commitment to execute on our stated plans of expanding our pipeline to have multiple assets in research and development. The work that Dr. Valentin Bruttel and Prof. Joerg Wischhusen have conducted at the University represents what we believe to be a compelling opportunity for innovative development in the high-value indication NMOSD, an orphan indication with significant unmet need, commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

Prof. Joerg Wischhusen of the University added, Based on pre-clinical data obtained by the University to date, the AIM Biologicals technology has the potential to be a breakthrough in the treatment of autoimmune-related diseases. It is based on a mechanism developed by nature to protect the fetus from the mothers immune system without compromising immune protection against foreign antigens. This has the potential to offer a new treatment for NMOSD patients. We believe that the collaboration with Aeterna will accelerate the further development towards the clinic.

Autoimmunity Modifying (AIM) Biologicals - Targeted Immunosuppressive Therapeutics

During pregnancy, the maternal immune system tolerates paternal antigens from the embryo but is still effective to protect mother and embryo from foreign antigens. Parts of the natural mechanisms responsible for this feto-maternal immune tolerance form the scientific basis for the concept of AIM Biologicals.

AIM Biologicals utilize a novel mechanism which is believed to demonstrate that peptide antigens presented on immunosuppressive MHC class I molecules can selectively and efficiently induce antigen-specific tolerance. Based on this mechanism, the targeted immunosuppressive therapeutics are being designed as optimized soluble molecules with the goal that they may be adapted to selectively induce tolerance to various autoantigens. Pre-clinical studies conducted by the University thus far indicate that tolerance induction appears to be achieved via selective elimination of antigen-specific immune effector cells and via induction of antigen-specific regulatory T cells from nave T cells. AIM Biologicals thus have the potential to become highly specific and effective yet not personalized treatments of NMOSD.

For the treatment of NMOSD, it is believed that the AIM Biologicals will present a specific antigen derived from the water channel protein aquaporin-4 (AQP4) loaded to soluble immunoregulatory HLA-G protein to selectively induce immunological tolerance in the central nervous system.

In collaboration with the University and the University clinic, Aeterna plans to conduct further pre-clinical research to identify and characterize an AIM Biologicals based development candidate for the treatment of NMOSD, including meeting with the regulatory authorities to confirm the further pre-clinical data required as we work towards advancing such candidate into human clinical trials.

About Neuromyelitis Optica Spectrum Disorder (NMOSD)

NMOSD is an antibody mediated inflammatory central nervous system (CNS) disorder that affects about one per million population per year. NMOSD, also known as Devic disease, is a chronic disorder of the brain and spinal cord dominated by inflammation of the optic nerve (optic neuritis) and of the spinal cord (myelitis). Typical symptoms include visual loss, muscle spasms, paraparesis, and incontinence. If left untreated, 50% of individuals with NMOSD will be wheelchair bound and blind, and 30% will have died within five years after the first attack. The water channel protein AQP4 is widely expressed in the brain, spinal cord, and optic nerves. Auto-antibodies directed against the AQP4 channel play an important role in the pathogenesis of NMOSD.

Currently there are only three approved medications available for the treatment of NMOSD with very high annual treatment costs, and the risk of the patient contracting serious infections. Therefore, there is a strong medical need to offer new therapeutic options to the patients.

In the U.S. and Europe there are currently approximately 10,000 to 15,000 patients living with NMOSD. Of these the AQP4 antibody seropositive patients who represent about 80% of the NMOSD population are the targeted patients for a potential therapy based on the AIM Biologicals technology.

Transaction Terms and Conditions

Under the terms of the exclusive patent license agreement entered into with the University, Aeterna obtained worldwide rights to develop, manufacture and commercialize products for the treatment of NMOSD using the AIM Biologicals technology for an up-front cash payment of 100,000 and milestone payments to be paid upon the achievement of certain development and regulatory milestones as well as royalty payments on net sales. Aeterna will be responsible for the formal preclinical and clinical development, regulatory activities, and manufacturing of the licensed products. Aeterna has also engaged the University and University clinic to conduct certain pre-development activities with respect to the AIM Biologicals program to be funded by Aeterna.

The Company intends to continue balancing risks and secure growth opportunities by re-establishing a diversified, yet focused, development pipeline to which Aeterna can best leverage its expertise and experience. Aeterna is focused on opportunistically utilizing its network with universities in Europe and the U.S. The license of the AIM Biologicals program for NMOSD demonstrates Aeternas progress towards achieving its goal to obtain access to innovative development candidates in different indications, with a focus on rare or orphan indications with potential significant commercial opportunity.

About Aeterna Zentaris Inc.

Aeterna Zentaris Inc. is a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests. The Companys lead product, macimorelin, is the first and only U.S. FDA and European Commission approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). Macimorelin is currently marketed in the United States under the tradename Macrilen through a license agreement with Novo Nordisk where Aeterna receives royalties on net sales. According to a commercialization and supply agreement, MegaPharm Ltd. will seek regulatory approval and then commercialize macimorelin in Israel and the Palestinian Authority. Additionally, upon receipt of pricing and reimbursement approvals, Aeterna expects that macimorelin will be marketed in Europe and the United Kingdom through a recently established license agreement with Consilient Health Ltd. and Aeterna will receive royalties on net sales and other potential payments.

Aeterna is also leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

Aeterna is actively pursuing business development opportunities for the commercialization of macimorelin in Asia and the rest of the world, in addition to other non-strategic assets to monetize their value. For more information, please visit http://www.zentaris.com and connect with the Company on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements include those relating to the potential to obtain the necessary pre-clinical data and regulatory approvals necessary to advance any product using the AIM Biologicals technology into human clinical trials or to develop the AIM Biologicals to treat NMOSD or any other indication into an approved product, the ability of any product using the AIM Biologicals technology to compete with existing approved products (or any other products in development) for NMOSD, the ability of the Company to obtain approval of macimorelin for CGHD, the Companys ability to secure marketing partners for macimorelin in other key markets, the timing of the commencement of the CGHD Study P02, and may include, but are not limited to statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates", potential and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption "Key Information - Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to raise capital and obtain financing to continue our currently planned operations, our ability to continue to list our Common Shares on the NASDAQ, our now heavy dependence on the success of Macrilen (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, including our heavy reliance on the success of the License Agreement with Novo Nordisk, the global instability due to the global pandemic of COVID-19, and its unknown potential effect on our planned operations, including studies, our ability to enter into out-licensing, development, manufacturing, marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, our reliance on third parties for the manufacturing and commercialization of Macrilen (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, uncertainties related to the regulatory process, unforeseen global instability, including the instability due to the global pandemic of the novel coronavirus, our ability to efficiently commercialize or out-license Macrilen (macimorelin), our reliance on the success of the pediatric clinical trial in the European Union (E.U.) and U.S. for Macrilen (macimorelin), the degree of market acceptance of Macrilen (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, our ability to successfully negotiate pricing and reimbursement in key markets in the E.U. for Macrilen (macimorelin), the outcome of our pre-clinical and clinical development efforts of in-licensed products (including the AIM Biologicals), any evaluation of potential strategic alternatives to maximize potential future growth and shareholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

Investor Contact:

Jenene ThomasJTC TeamT (US): +1 (833) 475-8247E: aezs@jtcir.com

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Aeterna Zentaris Expands Orphan Drug Development Pipeline with Targeted Immunosuppressive Therapeutics - GlobeNewswire

UK variant will cause rise in cases in the U.S., says doctor – Yahoo News

The Daily Beast

Erin Scott/GettyWhether its harassing the survivor of a school shooting for the benefit of a cameraman or accusing the Rothschild family of building a satellite-mounted laser that nearly burned down California, Rep. Marjorie Taylor Greene (R-GA) has made it clear that she will do almost anything for attention.But unlike nearly everyone else in the country, the White House isnt interested in giving it to her. Period.The Biden administrations policy regarding the first-term congresswoman from Georgia was made clear on Wednesday when a reporter asked White House press secretary Jen Psaki whether the president had any reaction to recent reports of online behavior that many found appalling, even for an avowed supporter of the QAnon conspiracy cult.Was there any response to the first-term congresswomans online and in-person behavior, which included the harassment of David Hogg, a survivor of the Stoneman Douglas High School shooting she once called #littleHitler? As well as her apparent belief that the shooting itself was a false flag? And a Facebook comment in which she suggested removing House Speaker Nancy Pelosi with a bullet to the head?We dont, Psaki said curtly. And Im not going to speak further about her, I think, in this briefing room.For an administration that has made fighting disinformation and right-wing extremism a top priority following the attack on the U.S. Capitol earlier this month, and a communications team with a demonstrated unwillingness to cede ground to unhelpful narratives, Psakis blunt refusal even to say Greenes name was surprising. But according to those familiar with the administrations thinking, it was also strategicand proof, they said, that the Biden administration has learned the lesson of the early months of Donald Trumps campaign for the White House, when unfettered attention helped raise his profile and stoke the followers who would eventually carry him to the Oval Office.Like Trump, one person familiar with the communications teams thinking said, Greene thrives off both positive and negative attention, and is validated when those in power stoop to fight her. In a media landscape that plays up conflict, such an engagement would actually raise her profileand while a West Wing-style takedown from the briefing room podium would make great television, it would also give Greenes stans one more battle arena in which to root for her.Refusing even to say her name in the White House briefing room makes their disapproval clear, one administration ally said, without dignifying her behavior with the attention of the leader of the free world.It was the perfect balance, the ally told The Daily Beast, who said that Psakis refusal to feed the trolleven one elected to Congresswas clearly rooted in a rare understanding of the modern environment.She simultaneously displayed sincere condemnation while denying that anthropomorphic hemorrhoid the attention she craves, the ally said, perhaps a bit graphically.Psakis refusal to engage may have been frustrating for those expecting a full-throated condemnation of Greenes conspiracism and calls for violence, but experts in the far right told The Daily Beast that the approach is the least-bad option when dealing with extremists desperate for the spotlight.By talking about her, they make her a hero to the folks on the fringeshed become sort of the right-wing AOC, and then gets more attention than she probably should have, said Randy Blazak, an Oregon-based sociology professor and hate crime researcher who specializes in movements that want to overthrow the U.S. government.The Biden administration is treading carefully on this matter, because its easy to blame them, Blazak said, summing up how far-right extremists would view any on-camera condemnation from the White House. One basket of deplorables comment and theyve got a whole new bunch of recruits to bring in. They have to be very careful in how they navigate this because this is no longer a small fringe groupits now a largely mainstream movement that includes people in our own families.House Democrats, meanwhile, are forced by proximity to deal directly with Greene. And few within their ranks feel like ignoring her: In her short time in office, the freshman congresswoman has explained away the Jan. 6 attack with a conspiracy theory, conspicuously shunned a mask in a crowded safe room where several of her colleagues later came down with COVID, immediately moved to impeach President Joe Biden, and was discovered to have endorsed the execution of the Democratic partys leader and to have flirted with the theory that a Jewish-controlled space laser started California wildfires.Greene has responded by calling the reporting on her publicly available social media activity by CNNs KFILEmuch of which has been scrubbed sincea project of the Democrats and the so-called fake news. They are coming after me because Im a threat to their goal of Socialism, said Greene, in a statement given on Thursday. They are coming after me because like President Trump, I will always defend conservative values. They want to take me out because I represent the people. And they absolutely hate it.On Twitter on Thursday morning, Greene posted a 2016 Facebook comment in which she said I have friends of different races, religions, and political preferences and asked why that sentiment was being ignored alongside her endorsement of killing Pelosi.Many Democratic lawmakers feel that Greenes conduct deserves the most forceful reprimand they can mustera vote to expel her from Congress. On Wednesday night, Rep. Jimmy Gomez (D-CA) introduced a resolution calling for just that, and it could come to the floor as soon as Tuesday. Two-thirds of the House would have to vote in favor to secure her removal, however, and few Republicans expect that dozens of their lawmakers will vote to oust Greene, even if many believe shes the second coming of Steve King, the former congressman and notorious racist.GOP Thought Steve King Was as Bad as It Got, Then Came Marjorie Taylor GreeneHouse Democratic leaders arent disavowing the push to remove Greene, but their careful remarks so far suggest they are just as interested, if not more so, in holding House GOP leadership accountable for Greene than Greene herself.Party brass have zeroed in on the House GOP leader, Rep. Kevin McCarthy (R-CA), who has so far done little to signal any repercussions for Greenes conduct. After the CNN story dropped, McCarthy promised to have a conversation with her about the Facebook posts.At a press conference on Thursday, the first question asked of Pelosi was about concern around Greene, but the first words out of her mouth were about McCarthy. What Im concerned about is Republican leadership in the House of Representatives, said the speaker. Mentioning GOP leaderships appointment of Greenewho has posited that the countrys most horrific school shootings, from Sandy Hook to Parkland, Florida, were false flagsto the House Education and Labor Committee, Pelosi asked, What could they be thinking? before quickly adding thinking might be too generous a word.Asked about Pelosis comments Thursday, a McCarthy spokesperson forwarded the comment they provided to Axios two days ago: These comments are deeply disturbing and Leader McCarthy plans to have a conversation with the Congresswoman about them.Later Thursday, Rep. Pramila Jayapal (D-WA), chair of the Congressional Progressive Caucus, said at a press briefing that the group had not talked about taking a position on Greenes ouster. I know there is a lot of rage and even fear from many of our members, frankly across the Democratic caucus, about serving with people like Marjorie Taylor Greene who condoned putting a bullet in the head of Speaker Pelosi, said Jayapal, when asked by The Daily Beast. Were looking at all of the options, working with leadership on how we bring accountability.But Jayapal hastened to add a question: What is Kevin McCarthy doing about this? What are our Republican colleagues doing about this?To one House Democratic aide, those moves solidified what the partys approach should be. As a matter of strategy, when you start talking about expelling, it puts the onus on Dems, the aide told The Daily Beast. And I think the argument that the onus should be on Republicans is persuasive.Democrats are betting that McCarthy wont reprimand Greene in any serious wayand are laying the groundwork to make Republicans pay for it at the ballot box. Already, those who are working to elect more Democrats in 2021 and 2022 as reinforcements for Biden have seized on the lightning-rod lawmaker the president conspicuously ignores as an effective bogeyman for the post-Trump era.In the last week, the Democratic Congressional Campaign Committee, the partys official House campaign arm, has sent out a press release on a near-daily basis in an attempt to make Greene an albatross for McCarthy and every GOP lawmaker running for re-election. Several Democrats are fundraising off Greeneincluding Terry McAuliffe, the former DNC chair running for another term as governor of Virginia, who put Greenes name as the subject line of a recent fundraising email.Democratic strategists see the attempt to make Greene the face of todays GOP as a potent strategy to put vulnerable Republicans in a tight spot. Tying the opposing party to its most extreme members is the playbook Republicans ran last year against House and Senate candidates. But Democrats are confident that independent-minded suburban voters will find Greenes endorsement of political assassinations and a conspiracy theory about cannibalistic pedophile elites more extreme and off-putting than Rep. Alexandria Ocasio-Cortezs (D-NY) endorsement of, for example, the Green New Deal.While the White House isnt going to engage, Democratic strategists around the House map plan to put her front and center, said one Democratic operative of Greene. Every day that Marjorie Taylor Greene dominates, and is the face of Republicans in the House, is another bad day for them.But as long as Greene remains in a position of authority, she will likely remain a hero to those who see her as an ally in the dream of overthrowing liberal democracy.In Georgia, few believe that Greenes constituents will boot hershe convincingly won a June primary after many of her Q-sympathetic and Islamophobic comments were already public knowledgeand there is not, as of yet, any kind of real effort brewing to defeat her. The district is so heavily Republican that a Democratic win is virtually impossible.Blazak pointed to The Turner Diariesan ur-text of white supremacist fantasies about violently toppling the U.S. government, which he called sort of a flowchart model of how to start a civil war in Americaas a guideline for what those who stormed the U.S. Capitol hope to see out of Greene.Part of the plan is to have people who are sympathetic on the inside who can figuratively, or literally, open the door and let the barbarians into the gates, that can provide access to nuclear code so they can bomb Israel, Blazak said. This is how far it goes.The current unwillingness of Republican congressional leadership to take action against Greene has only emboldened the extremists who back herwith potentially catastrophic consequences.I have this naive hope that Biden, being an old-school politician, can talk to the Democratic leadership and talk to the Republican leadership in a way that says, weve got a real crisis here and we have to determine what the country is going to look like, what these political parties are going to look like, and encourage them, maybe behind the scenes, to push this person off, Blazak said. But the fact that she was given a pretty decent committee position on education, of all things, means that work really needs to be done inside the community.Were gonna see the Tea Party on meth, Blazak said.Read more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

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UK variant will cause rise in cases in the U.S., says doctor - Yahoo News

5 Reasons Why You Sweat in Your Sleep – LIVESTRONG.COM

You might sweat in your sleep because you're too hot, but it could also be a symptom of something more serious.

Image Credit: demaerre/iStock/GettyImages

There are certain times you expect to sweat in the middle of a heat wave, during your spin class and maybe even before a gigantic work presentation. But if you've ever woken up in the middle of the night drenched, you may wonder what's happening.

"Sweating itself is completely normal it's a way for your body to regulate its temperature," says Donald Ford, MD, a family medicine specialist at the Cleveland Clinic.

If you wake up sweaty in the middle of the night underneath a heavy blanket or in a too-hot bedroom, it's one thing. That's due to overheating, and when you remove the culprit, your body temp and your nocturnal awakenings should return to normal.

But if you wake up in soaking sheets and your thermostat is set to a cool 65 degrees, there may be other, underlying health issues causing your night sweats, Dr. Ford says.

They're actually surprisingly common up to 41 percent of people in a primary care setting reported having them in the last month, per a November-December 2012 review in the Journal of the American Board of Family Medicine. They were most common in people ages 41 to 55.

Here, five common reasons you might get night sweats, and what to do about them.

1. You're Going Through Menopause

The years leading up to menopause known as perimenopause are prime time for hot flashes: Almost 80 percent of women report experiencing them as they go through this stage of life.

This is due to significant fluctuations in your body's production of the sex hormones estrogen and progesterone, says Stephanie Faubion, MD, medical director of the North American Menopause Society and director of the Mayo Clinic's Center for Women's Health. These fluctuations occur multiple times a day, including at night, when they cause night sweats.

Fix it: If your hot flashes are mild, you can try lifestyle changes such as keeping your thermostat at a low temperature, using lighter bedding and sleeping in lightweight, loose-fitting clothing, Dr. Faubion says.

You should also avoid caffeine and alcohol, especially in the evening, as they can cause spikes in body temperature and trigger sweating.

Regular exercise may also help: A February 2017 study in Menopause found sedentary people who completed a 20-week exercise program reported reductions in hot flashes, including night sweats.

But if these changes don't help, or your symptoms are more severe, talk to your doctor about your options.

If you're within the first 10 years of menopause and you don't have risk factors such as heart disease, diabetes, high cholesterol, high blood pressure or a history of breast cancer, then you can try a course of hormone therapy, Dr. Faubion notes. You can also ask about Brisdelle, an anti-depressant that's also FDA approved to treat hot flashes.

2. It's a Side Effect of Your Meds

Certain medications are known to be associated with night sweats: "They alter neurotransmitters in your brain, causing it to overproduce the hormone serotonin, which in turn throws your body temperature out of whack," Dr. Ford explains.

The biggest offenders are a class of anti-depressants known as selective serotonin reuptake inhibitors (SSRIs), certain blood pressure and diabetes medications and over-the-counter drugs like the heartburn drug omeprazole (Prilosec) or the pain-reliever naproxen (Aleve).

Fix it: Talk to your doctor. You may be able to switch to another type of medication that won't cause the same reaction, Dr. Ford says. You should also avoid caffeine and alcohol, since they can exacerbate the problem.

3. You've Got a Hormone Issue

Hyperthyroidism (where your body produces too much thyroid hormone) can overstimulate your nervous system, which means you not only have trouble falling and staying asleep, but you can wake up in the middle of the night sweating up a storm, says Peter Bidey, DO, an osteopathic family physician and assistant professor in the Department of Family Medicine at the Philadelphia College of Osteopathic Medicine.

If you have undiagnosed diabetes, that can also wreak havoc with your blood sugar levels and cause you to sweat more easily, including at night.

While there are other conditions caused by adrenal tumors such as pheochromocytoma and carcinoid syndrome that can cause night sweats, these diseases are relatively rare, Dr. Bidey says.

Fix it: See your doctor, especially if you have other symptoms of hyperthyroidism such as heart palpitations, mood swings, hyperactivity and weight loss, or of type 2 diabetes, such as increased thirst, hunger and urination. Your physician can run blood tests to diagnose either condition, Dr. Bidey says.

4. It's a Side Effect of Sleep Apnea

Night sweats occur about three times as often in people with untreated sleep apnea a condition where your throat tissue blocks your airway, causing you to stop breathing multiple times throughout the night according to an April 2013 study in BMJ Open.

This is because each episode of apnea causes your body to release the stress hormone cortisol, which activates your nervous system, Dr. Bidey says.

Fix it: Watch for other symptoms of sleep apnea, including snoring, morning headache and feeling super fatigued during the day (to the point where if you sit down, you sometimes nod off). If you have them, see your doctor, who can refer you to a sleep specialist.

Sleep apnea is diagnosed via an overnight sleep study, where you're hooked up to equipment that monitors your breathing patterns and blood oxygen levels while you sleep.

If you do have sleep apnea, you'll need a CPAP, a machine that delivers air pressure through a mask while you sleep.

Life-threatening infections such as tuberculosis, human immunodeficiency virus (HIV), endocarditis (a heart valve infection) and osteomyelitis (a bone infection) are associated with night sweats, most likely because they can trigger a fever, Dr. Ford says.

Fix it: These diseases usually present with other symptoms, such as chills, fever, body aches, fatigue and loss of appetite, Dr. Ford says. If you notice any of these, see your doctor right away.

When to See a Doctor for Night Sweats

If you get night sweats once or twice, there's no need to be concerned, Dr. Bidey reassures, especially if they're relieved by opening a window or applying ice packs or cold compresses to your body.

But if they occur more often than that, or you've got other symptoms like fatigue, high fever, weight loss or body aches, see your doctor. He or she can rule out underlying medical conditions such as an infection, a hormonal condition, or, more rarely, a blood cancer such as leukemia or lymphoma.

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5 Reasons Why You Sweat in Your Sleep - LIVESTRONG.COM

6 Causes of Morning Diarrhea and How to Treat It – LIVESTRONG.COM

Morning diarrhea is often due to something you ate or drank the day before.

Image Credit: Patcharanan Worrapatchareeroj/Moment/GettyImages

Wow. This morning has been something else. You woke up with diarrhea. Aside from being sick, it might also have to do with what you ate, an as-yet undetected GI condition or even the monster to-do list you have brewing today.

Here's what's up and what you can do about it.

1. Youre Worried About All the Things Today

Not everyone feels well-rested when they get up and you might be swimming in worries about what's on your plate (e.g. a ton of to-dos, a not-so-pleasant meeting with your boss, a worrisome visit to the doctor, news from a friend).

When you're stressed, your body releases cortisol the fight-or-flight hormone and two things can happen in terms of your gut function: you can get diarrhea or constipation, plus bloating and flatulence, Monica S. Borkar, MD, a gastroenterologist with NorthShore University HealthSystem in Glenview, Ilinois, tells LIVESTRONG.com.

Fix it: Taking care of yourself will help out your gut.

"Getting enough sleep, eating a healthy diet, drinking at least 64 ounces of water daily, avoiding caffeine, alcohol and tobacco and exercising can help your gut-brain axis get back on track," she says.

2. You Overserved Yourself Last Night

Alcohol tends to cause diarrhea, Dr. Borkar says. Imbibing too many IPAs or glasses of vino can cause the runs the next morning because you're drinking more fluid and alcohol might change your gut microbiome in ways that alter your BM habits.

Another possible related factor: Midnight snacking, she says. If you drank alcohol and then followed it up by diving into the chips or slices of pizza to quell the booze-induced munchies, then you can see why your BMs are making themselves known this morning.

Research in the Asian Pacific Journal of Cancer Prevention in 2019 suggests that diarrhea following drinking is associated with an increased risk of developing colorectal tumors, so this isn't a sign you should just brush off if it happens to you regularly.

Fix it: To reduce the risks associated with drinking, the Centers for Disease Control and Prevention recommends those assigned male at birth limit themselves to two drinks per day while those assigned female consume no more than one per day.

3. You Took a Laxative a Couple Days Ago

If you're constipated, OTC laxatives can be tricky they don't produce pooping immediately.

"Most over-the-counter laxatives can take anywhere from 8 to 72 hours to work," Dr. Borkar says.

If you popped one a couple of days ago, now just might be your time to have a BM.

Talk to your doctor before starting any of these medications, Dr. Borkar advises: They can interact with other medications you are taking and have the potential to cause incontinence.

4. Youre Sensitive to Your Nighttime Treat

Did you hit the pint of low-cal ice cream hard last night? Some artificial sweeteners and sugar alcohols in these types of desserts and other foods are associated with GI complaints, like bloating or diarrhea in some people, Dr. Borkar says. Dairy can loosen your stools, too, if you're sensitive to lactose, the sugar found in milk.

Fix it: If you notice that this happens frequently after you eat certain foods, you can try avoiding them to see if that quells your symptoms.

For a more thorough investigation to pinpoint your GI triggers, talk to a registered dietitian or your doctor.

5. Youve Got the 'Stomach Flu'

The "stomach flu" (read: viral gastroenteritis) can seemingly strike out of nowhere. You go to bed fine and you wake up with watery diarrhea (that has no blood), stomach pain, nausea, vomiting, a headache and a fever.

Fix it: Unfortunately, there's no treatment for this bug, notes the Mayo Clinic. And sometimes it's tough to know what got you sick in the first place, because the symptoms can appear several days after you came in contact with the contaminated food (or water).

You can make yourself more comfortable by avoiding mediations like NSAIDs that can cause stomach upset, avoiding food until your stomach starts to feel better and taking small sips of water to avoid dehydration. And let your doctor know if symptoms don't subside in a couple days.

Pregnancy is another contributor to morning diarrhea, Dr. Borkar says.

The American Pregnancy Association notes that this not-so-great symptom can be chalked up to newfound sensitivities to foods that didn't bother you before or hormonal changes that slow digestion.

If you have diarrhea, make sure youre drinking adequate fluids to avoid dehydration, which can be dangerous during pregnancy. And if it's persistent, definitely mention it to your ob-gyn.

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6 Causes of Morning Diarrhea and How to Treat It - LIVESTRONG.COM

Heres how sex and gender are different things – Hindustan Times

A 15-year-old girl from Satara district of Maharashtra approached a doctor in Pune because she hadnt started her period yet. Tests revealed that the girl has a condition called Androgen insensitivity syndrome (AIS), that affects only four in 100,000 people.

In AIS, androgen, a hormone found in greater quantities in males, is suppressed and the secondary sex characteristics may or may not resemble that of a males.

In the case of the young girl, she was unable to menstruate because she does not have ovaries.

A team of doctors from the hospital is now helping the young girl to continue to live her life in her chosen gender. The condition disallows her from becoming pregnant, though she may still have children through other procedures like surrogacy or adoption if she so chooses.

Dr Manish Machave, gynaecologist and endoscopic surgeon from Ruby Hall Clinic, who diagnosed and treated her said that the girl had her gonads (testes) removed through laparoscopy and also had a breast augmentation surgery. She will receive hormone injections that will help sustain her through the rest of her teenage years and early adulthood.

She had gonads (testes) positioned in the abdomen and another in the inguinal canal and because of the position of gonads, she had a risk of developing a form of cancer called gonadoblastoma. Hence, we first performed laparoscopic gonadectomy and removed testes from both the sides, around three months ago. Once she turns 18-year-old, we will perform laparoscopic vaginoplasty, Machave said.

Dr Anupama Mane, breast surgeon from Ruby Hall Clinic, who performed the girls breast augmentation surgery said, She was brought up as a girl and hence she wanted to remain so. We performed breast augmentation surgery for her. Hormonal injections will be required for things like hair growth to stop. We are assisting her to complete her transition as a female. The medical treatment to give her feminine characteristics will go on for years.

Activists say that AIS is often used as a means to stigmatise intersex people by bringing their bodies under intense scrutiny, and which the medical fraternity then attempts to correct through surgery. Activists argue that intersex persons like the 15-year-old girl are subjected to a misplaced understanding of what bodies of men and women should look like.

However, as gender and sexuality rights activists point out, all bodies are different and neither gender nor sexuality is derived from a persons biological sex. As the case of this teenager shows, gender does not lie in the body but in the mind.

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Heres how sex and gender are different things - Hindustan Times

Experts treat insomnia, anxiety caused by COVID-19 – City Pulse

RIAN JACKSON

Sachi Tanaka says after having COVID-19 for three weeks, she experienced insomnia in a way that she never had.

At that time, I had gotten myself into a good routine of falling asleep around 10 p.m. and waking up early, said the 24-year-old Texas woman. And then, all of the sudden, it was like I couldnt fall asleep until 6 or 7 in the morning.

Her insomnia was a nagging feeling. She tossed and turned in bed, feeling like she was at the brink of sleep, but would be interrupted by her thoughts.

Tanaka isnt alone. COVID-19 has affected many peoples sleep, whether theyve had the virus or not. Sleep neurologists call it COVID-somnia, a phenomenon where people have trouble sleeping because of the virus. And its effects can last even after the pandemic ends.

Coronavirus upended our lifestyles. Morning commutes were replaced with teleworking, which may mean less physical activity and exposure to sunlight and more screen time, said Dr. George Zureikat, a sleep medicine specialist and director of Mid Michigan Sleep Center in Grand Blanc.

That can ruin sleep by disrupting the circadian rhythm the powerhouse of our sleep-wake cycle.

Stress induced by COVID can also result in insomnia, said Zureikat, who has seen a surge of insomnia cases since the pandemic.

COVID-19 is unlike anything many people have experienced, he said. Insomniacs may lose sleep worrying about unemployment or about contracting the virus. Some people feel trapped during lockdowns and are constantly reading news articles about overcrowded hospitals and rising death numbers.

A recent study by the American Academy of Sleep Medicine found 2.77 million Google searches for insomnia in the first five months of 2020 a 58% increase compared with the same months from the previous three years. Most of those queries happened between midnight and 5 a.m., suggesting people were searching while unable to fall asleep.

Difficulties like trouble falling and staying asleep or waking up too early rose from 36% before the pandemic to 51% during it, Rebecca Robillard, a University of Ottawa professor who leads clinical sleep research at the Royals Institute of Mental Health Research, said in a Medpage Today article.

If your (circadian) rhythms are thrown off, that also throws off your sleep at night time, said Dr. Christopher Morgan, the medical director at Mercy Health Saint Marys Sleep Center in Grand Rapids. Your melatonin may not be producing the right amounts at the right time, which is part of your internal rhythms in your body.

Melatonin is the hormone that your brain produces in response to darkness. It helps time your circadian rhythms and sleep.

Humans are social animals, said Dr. Lila Massoumi, a professor of psychiatry at Michigan State University and chair of the American Psychiatric Association Caucus on Complementary & Integrative Psychiatry.

We draw both strength and calm from our fellow humans. Ripping that social support away by telling us to self-isolate removes that source of strength and calm, she said.

Unsurprisingly, those who contract the virus may also stress about their health.

Morgan said those who struggle with chronic insomnia, or insomnia experienced at least three nights a week for at least a month, may develop bad habits that can be difficult to shake.

You have an acute stressor, which is COVID, and you become an insomniac, he said. And then lets say I still havent gotten a job in six months. Now, Im sitting in bed for 10 hours a day just thinking about how terrible things are in my life, and I have insomnia.

So, now I start watching TV in bed because Im awake during the night time, and I start drinking pop in the middle of the night, and I start laying in bed even longer because I think Im not getting enough sleep. So, all these maladaptive behaviors develop.

Whats worse, according to Mayo Clinic researchers, those whove had chronic insomnia report a lower quality of life than those who sleep well. Chronic insomnia may lead to anxiety or depression, slowed reaction time while driving and increased risk of long-term diseases such as heart disease.

Many professionals treat patients with cognitive behavioral therapy. It works by identifying and replacing thoughts and behaviors that create sleep problems with ones that promote healthy sleep.

Its just a matter of just tweaking certain habits and changing certain things, said Rachel Freedland, a clinical social worker at Bright Spot Therapy, a counseling clinic in Farmington Hills. If there are other mental health needs, for example, if a person already has anxiety or depression, we address those as well.

After assessing a patients sleeping habits with sleep diaries and questionnaires, Freedland, who is certified in cognitive behavioral therapy for insomnia, and her clients design a program that helps them sleep and wake up when they want.

Yoga and mindfulness, a type of meditation where you focus on being aware of what youre feeling and sensing at the moment, can release feel-good hormones that alleviate anxiety and promote healthier sleep, according to Asha Ravindran, a clinical team lead at St. Mary Mercy hospital in Livonia.

If you dont sleep, if youre anxious, youre out of sync with your body, said Ravindran, who owns Stepping Stones Wellness Center in Plymouth and conducts virtual yoga and meditation sessions with her patients.

She advises clients to create a private space where they can journal, practice yoga and meditate. This space can be as simple as the foot of the bed.

The key is to be present in the moment, Ravindran said. From yoga poses to breathing exercises, you can de-stress with strategies that help focus on the present without worrying about the past or future.

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Experts treat insomnia, anxiety caused by COVID-19 - City Pulse

MBCC Offers Review of Burgeoning Advancements in Breast Cancer Management – Targeted Oncology

In 2020 alone, the FDA approved 6 systemic therapies for novel indications across breast cancer subtypes.1 With the continuously evolving treatment landscape for this disease, staying up-to-date with the latest changes is of paramount importance.

To assist in this endeavor, the virtual 38th Annual Miami Breast Cancer Conference(MBCC), hosted by Physicians Education Resource, LLC (PER) will feature presentations from industry thought leaders on innovations in the arena of breast cancer treatment, including topics about systemic therapy and beyond.

It includes both the new data in surgery and radiation oncology [as well as that] in medical oncology, in both early-stage and metastatic disease, Hope S. Rugo, MD, FASCO, one of the program cochairs, said in an interview with Targeted Therapies in Oncology. We cover all of the clinically pertinent information thats come out of the most recent presentations and publications, and theres the ability to discuss this and ask questions of the presenters.

One of the great advantages of the meeting is its juxtaposition to the San Antonio Breast Cancer Symposium (SABCS). The virtual MBCC follows SABCS by approximately 12 weeks, March 4-7, 2021, giving MBCC faculty the advantage of tailoring the program to the most relevant research updates.

We can update the agenda to reflect the most recent data that were presented at San Antonio and apply this to the clinic, Rugo, a professor of medicine and director of Breast Oncology and Clinical Trials Education at the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, said.

Rugo detailed abstracts from SABCS in which the validity of standard treatment approaches for hormone receptorpositive disease was tested in more precise patient subpopulations, with the goal of identifying those who derive the greatest benefit.

RxPONDER in Pre/Postmenopausal Patients

The randomized, phase 3 RxPONDER trial (NCT01272037) evaluated the efficacy of standard adjuvant endocrine therapy with or without chemotherapy in patients with hormone receptorpositive, HER2-negative early-stage breast cancer who had 1 to 3 positive nodes and a recurrence score of 25 or less by Oncotype DX screening.2

Results of the study demonstrated that postmenopausal women did not derive further benefit from the addition of chemotherapy, but premenopausal women with the same characteristics experienced a significant relative risk reduction in invasive diseasefree survival (iDFS).

Using the recurrence score is fascinating and will result in a lot more analyses, Rugo said. This already will impact our care of patients with node-positive, early-stage hormone receptorpositive, HER2-negative breast cancer.

Despite no significant difference in iDFS noted with or without chemotherapy in the primary analysis (P=.3), a prespecified subgroup analysis revealed that an interaction between chemotherapy use and menopausal status existed (P=.004). The hazard ratio for the comparison of both treatment arms favored the use of chemotherapy in patients who were premenopausal (HR, 0.54; 95% CI, 0.38-0.76; P =.0004) versus those who were postmenopausal (HR, 0.97; 95% CI 0.78-1.22; P =.82). At 5 years, the iDFS rate in the premenopausal group was 94.2% for those who received versus 89.0% in those who did not.

Results of a subanalysis of the randomized phase 3 monarchE trial (NCT03155997) of adjuvant endocrine therapy with or without abemaciclib (Verzenio) in patients with resectable hormone receptorpositive, HER2-negative tumors at high risk suggest that a threshold of 20% or greater Ki-67, which is a marker of cellular proliferation, may be a useful clinicopathological feature of response to the CDK4/6 inhibitor.3

Its not just the clinical features, like stage and grade, but Ki-67 also is emerging as an incredibly important factor, Rugo said of the results, which were also reported at SABCS. I think this is likely to be practice changing in the next year.

Patients with high Ki-67 in the overall patient population and patients in cohort 1those with other high-risk clinicopathological features such as tumor involvement, tumor size, and gradewere assessed for superiority of abemaciclib therapy as determined by iDFS. A statistically significant improvement in the primary end point was seen with the agent in both the overall population (HR, 0.685; 95% CI, 0.462-1.017; P=.0591) and in cohort 1 (HR, 0.643;95% CI, 0.475-0.872; 2-sided P=.0042).

J101 Reveals HER2-Low Populations

The phase 1 J101 trial (NCT02564900) of fam-trastuzumab deruxtecan-nxki (Enhertu) indicated that certain patients with low HER2 expression, defined as those with an immunohistochemistry (IHC) score of 2+/1+ and negativity by in situ hybridization, may derive benefit from treatment with the antibody-drug conjugate. These data, which were also presented at SABCS, may help potentially define a patient population of medical unmet need who would otherwise not be treated with anti-HER2 therapy.4

Were going to see data in the next year about the efficacy of these antibody-drug conjugates in other populations, such as patients who have newly-defined HER2-low disease, Rugo said. [These patients are] not HER2 positive but not 0 by IHC.

Patients in the analysis were assessed using deep learningbased digital analysis to produce a novel HER2 quantitative continuous score (QCS), a method found to be more predictive of response to trastuzumab deruxtecan versus manual assessment by pathologists.

Out of 151 patients, 65 were identified as having HER2-low expression by conventional IHC scoring; the response rate in this group was 42%. When investigators further stratified the patients into QCS-high and QCS-low subgroups, they were able to identify 21 of the 27 responders who were missed by conventional screening methods. To validate these promising results, further studies into the use of QCS are ongoing.

Rugo said several immunotherapy agents could possibly become available for use in the adjuvant/neoadjuvant setting in the near future, mirroring the success seen in advanced tumors.

Namely, results of one investigational arm of the open-label, randomized, phase 2 I-SPY 2platform study that were published in JAMA Oncology in February 2020 showed that the addition of pembrolizumab (Keytruda) to standard neoadjuvant chemotherapy more than doubled pathologic complete response rates in patients with hormone receptorpositive/HER2-negative and triple-negative breast cancer.5 Further exploration of this data set examined surrogate markers of this regimen and were presented at SABCS.6 Larger studies are ongoing.

I think the analyses of immunotherapy in the metastatic setting are already practice changing and in the next year will potentially be practice changing for the neoadjuvant setting as well, Rugo said.

Other agents to watch for are antibody-drug conjugates, such as trastuzumab deruxtecan and sacituzumab govitecanhziy (Trodelvy), as therapy for patients with triple-negative breast cancer. Rugo said data from trials involving these agents are likely to be reported this year and have the potential to change the treatment paradigm for triple-negative disease.

To conclude, Rugo reflected on the advantages of MBCC for those treating patients with breast cancer across clinical settings. You will get that great interaction with the speakers and timely updates of [the latest] data put into perspective.

References:

1. Hematology/oncology (cancer) approvals & safety notifications. FDA. Updated December 18, 2020. Accessed December 21, 2020. https://bit.ly/3avuIwR

2. Kalinsky K, Barlow WE, Meric-Bernstam F, et al. First results from a phase III randomized clinical trial of standard adjuvant endocrine therapy (ET) +/- chemotherapy (CT) in patients (pts) with 1-3 positive nodes, hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC) with recurrence score (RS) < 25: SWOG S1007 (RxPonder). Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; virtual. Abstract GS3-0 . https://bit.ly/2WsISGT

3. Harbeck N, Johnston S, Fasching P, et al. High Ki-67 as a biomarker for identifying patients with high risk early breast cancer treated in monarchE. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; virtual. https://bit.ly/2WsISGT

4. Gustavson M, Hanedar S, Spitzmeuller A, et al. Novel approach to HER2 quantification: digital pathology coupled with AI-based image and data analysis delivers objective and quantitative HER2 expression analysis for enrichment of responders to trastuzumab deruxtecan (T-DXd; DS-8201), specifically in HER2-low patients. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; virtual. https://bit.ly/2WsISGT

5. Nanda R, Liu MC, Yau C, et al. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: an analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA Oncol. 2020;6(5):676-684. doi:10.1001/jamaoncol.2019.6650

6. Magbanua MJM, Wolf D, Renner D, et al. Personalized ctDNA as a predictive biomarker in high-risk early stage breast cancer (EBC) treated with neoadjuvant chemotherapy (NAC) with or without pembrolizumab (P). Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; virtual. https://bit.ly/2WsISGT

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MBCC Offers Review of Burgeoning Advancements in Breast Cancer Management - Targeted Oncology

Dangerous Side Effects of Going on a Diet, According to Science | Eat This Not That – Eat This, Not That

Choosing to go on a diet isn't a 100% healthy endeavor. After all, if you're cutting yourself off from certain nutritious foods or entire food groups, drastically limiting your calorie intake overall, fasting for prolonged periods of time, or signing up for a fad-like program that promises extreme results in short order, there's a good chance you're actually embarking on a path that your body may not actually respond favorably to. Whether you're trying the Ketogenic diet or intermittent fasting, going low carb or low fat, below are some common side effects of going on a super-strict dieting regimen you should be aware of. And for more healthy weight loss tips, don't miss this list of Sneaky Weight Loss Tricks That Totally Work, According to Experts.

If you're considering intermittent fasting, in which you restrict your food consumption for long stretches on certain days of the week, you'd be wise to consider some of the consequences. "Depending on the length of the fasting period," write the health experts at Harvard Medical School, "people may experience headaches, lethargy, crankiness, and constipation. To decrease some of these unwanted side effects, you may want to switch from alternate-day fasting to periodic fasting or a time-restricted eating plan that allows you to eat every day within a certain time period."

RELATED: Sign up for our newsletter for daily healthy eating advice.

A simple fact: If you eat less food (also known as fuel), your body will have less energy to burn and you'll ultimately feel sluggish. One study, published in the Annals of Internal Medicine, found that cutting carbohydrates from your diet was associated with a greater risk of fatigue. Another study, which focused entirely on the Ketogenic diet and was published in the Journal of the American Dietetic Association, found that "low-carbohydrate diets enhance fatigability and can reduce the desire to exercises in free-living individuals."

Cutting carbs completely from your diet isn't your only path to lower energy levels. Other studies have linked diets that restrict nutrients such as vitamin B12, folate, and iron with fatigue, as well as anemia. For more weight loss tips, make sure you're aware of the 12 Foods That Drive the Most Weight Loss of All, Say Experts.

A now-famous study published in the journal Obesity that analyzed the weight-loss efforts of contestants of NBC's wildly popular series The Biggest Loser, which was conducted by researchers at the National Institutes of Health, found that people who go on an extreme crash diet hobbled their metabolisms so profoundly that they never fully recovered. The chief reason, according to the researchers, was the influence of leptin, the body's hormone that tells you you're satiated, or no longer hungry. Over the course of the crash diet, the contestants' leptin levels essentially flatlined. The researchers also tracked their ghrelin levelsthe hormone that tells you when you're hungryand it had actually risen. In effect, the dieters had reprogrammed their bodies to be fat-storing, low-energy machines.

According to a study published in the journal Dermatology Practical & Conceptual, embarking on a low-calorie diet is associated with hair loss, as the lack of nutrients disrupts your hair follicles to function as intended. "Nutritional deficiency may impact both hair structure and hair growth," write the researchers. "Effects on hair growth include acute telogen effluvium (TE), a well-known effect of sudden weight loss or decreased protein intake, as well as the diffuse alopecia seen in niacin deficiency."

For a study published in The American Journal of Clinical Nutrition, researchers from the University of Kiel in Germany took 32 non-obese males and slashed their calories by an average of 1,300 for a three-week period. On the whole, the subjects emerged from the experience having gained weight while seeing a dramatic decrease in muscle massroughly 5% across the board.

RELATED: 15 Underrated Weight Loss Tips That Actually Work

"A lack of proper nutrition due to a fad diet can actually strain your organs and muscles," says Ashlee Van Buskirk, a nurse, health and wellness coach with a BS in Dietetics and Clinical Nutrition Studies, and the founder of Whole Intent. "For instance, a high-protein diet can actually lead to dehydration, which may place a significant strain on your kidneys as you may be more prone to developing kidney stones."

"Most diets fail most of the time [and] repeated diet failure is a negative predictor for successful long term weight loss," writes Anna Guerdjikova, Ph.D., LISW, CCRC, director of administrative services at the Harold C. Schott Foundation Eating Disorders Program at the University of Cincinnati. "Chronic dieters consistently report guilt and self-blame, irritability, anxiety and depression, difficulty concentrating and fatigue. Their self-esteem is decreased by continuous feelings of failure related to 'messing my diet up again,' leading to feelings of lack of control over one's food choices and further life in general. Dieting can be particularly problematic in adolescents."

RELATED: This Diet Mistake Can Make Your Depression Worse, Science Says

"Fad diets are not always terrible, but people should understand the food groups and should try to ingest foods from all of them to keep vitamin and mineral balance," says Stephen Newhart, Ph.D., owner of Vigor Active. "Grains provide energy, fiber, iron, and help with constipation, dairy provides calcium and iron, fruits and vegetables provide vitamins and minerals and protein supports muscle mass. Always try and eat something from all the food groups to sustain health, just be sure to eliminate the sugars."

If you're older and you're trying intermittent fasting, you could be at risk of losing too much weight. "If you're already marginal as far as body weight goes, I'd be concerned that you'd lose too much weight, which can affect your bones, overall immune system, and energy level," Kathy McManus, RD, director of the Department of Nutrition at Brigham and Women's Hospital, told Harvard Medical School.

According to the International Journal of Eating Disorders, 35% of "normal dieters" may become pathological dieters, and 20 to 25% of those are prone to develop an eating disorder. "The onset of eating disorders has commonly been associated with following restrictive diets, as they become a way for individuals to exercise control, counting calories and fat grams, limiting types and amounts of food, and obsessing about a number on the scale," write the experts at Behavioral Nutrition.

As the Cleveland Clinic notes, many health experts believe that "80 to 95% of dieters gain weight back that they've worked so hard to lose." If that's an experience you're aware of, don't miss these tips for Losing Weight and Keeping it Off for Good.

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Dangerous Side Effects of Going on a Diet, According to Science | Eat This Not That - Eat This, Not That

What is testosterone: MD explains all commonly asked questions about the T hormone – T3

One way or another, if you are researching the topic 'how to build muscle', you will come across the question 'what is testosterone' and how different levels of the T hormone can affect the muscle building process. Many will say you need to take supplements if your T levels are low in order to build and maintain muscle mass. But is this true? Is testosterone the key to muscle building?

We asked Marc S. Schneider, M.D., surgeon, medical journal author and co-founder of Dioxyme Craft Nutrition, to answer some of the most frequently asked questions about testosterone. Since T3 is not a medical journal and we understand that people won't reference T3 in their dissertations, we kept the discussion on a level that's informative yet doesn't require extensive knowledge about human anatomy and biology.

IMPORTANT: if you have any concerns about your health including testosterone levels, please consult a medical professional and don't rely on information found on the internet. We made sure that all information presented here is accurate but it doesn't mean it replaces GPs and surgeries. Please be mindful about your health and always seek medical help when in doubt.

As Marc explains, "testosterone is the primary sex hormone found in men and is responsible for androgenic effects (male sexual characteristics) and anabolic effects (growth of tissues). It is responsible for brain and sex organ development in the fetus, the changes that occur in puberty, muscle and bone growth, sex drive and fertility."

Although most people associate high testosterone levels with bullish behaviour, normal testosterone levels are required for a male body to work properly. According to Medical News Today, testosterone "has many important functions, including the development of the bones and muscles, the deepening of the voice, hair growth, and other factors related to appearance [and] the production of sperm"

Low levels of testosterone can have a range of negative health effects, as discussed below.

(Image credit: Getty Images)

"Testosterone levels fall within different ranges throughout an individual's life and from day to day. T levels tend to be the highest from ages 16-18 (300-1200 nanograms per deciliter in men) and then drop as the individual enters their 20s and 30s", Marc explains. "As men get older, their testosterone levels may decline about 1 percent per year after age 30", according to Healthline.

Not only the healthy levels of testosterone levels can vary widely in general but also from day to day and right now, the only way to find out T levels is to do a blood test, administered by a medical professional. Despite the broad range in which it's considered healthy, low levels of testosterone can cause health issues in individuals.

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Though physicians generally consider this huge range to be normal, as Marc explains, "lower levels within the normal range may leave the individual feeling tired, cause an increase in body fat, decreased mental attention, affect mood, lead to lack of sexual desire or performance issues, and loss of muscle."

On the other hand, it is incredibly rare for there to be excess testosterone without an individual taking an anabolic steroid. "Excess levels are associated with a host of issues including ED, heart disease, liver disease, blood clots, acne, mood swings and impaired judgement", Marc says.

"Low normal testosterone levels are now commonly seen with increased frequency in young and middle aged men", Marc goes on, "probably the most common causes that we see in our clinic in young men is due to a combination of excess stress, long working hours, lack of physical activity, and the constant use and carrying of cellphones in their pocket."

As explained in a Harvard Medical School articled titled Treating low testosterone levels, possible treatments to low-T levels include skin patch, gels and oral therapy, all being non-invasive type of treatment or pellets and injections, the latter two being on the invasive side.

(Image credit: Getty Images)

According to Marc, "physicians typically recommend adequate levels of Vitamin D, Zinc, sleep, elimination of stress, exercise (particularly weight lifting/resistance training) and losing body fat, to help reverse lower T levels."

"Though these may support normal higher levels of testosterone, we have not seen this approach alone correct lower testosterone levels", he adds.

Of course, eliminating stress factors is usually easier said than done, but the other factors are well within the reach of most individuals. There are vitamin D and zinc supplements available or you can just go for a walk on a sunny day to get some vitamin D and exercising, all in one go. Sleep can be improved by following a sleep schedule and putting your mobile phone away a couple of hours before bedtime.

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As Marc explains, "often men will seek to correct the symptoms of low T on their own by taking over the counter supplements. Tribulus terrestris, Tinospora cordifolia, and icariin are commonly claimed to increase testosterone, however clinical studies in humans do not show benefits. Numerous additional herbal remedies are popular yet human data showing that they increase testosterone is lacking."

"The decision to place someone on hormone replacement (testosterone) or prescribe them a testosterone stimulator such as HCG, is dependent upon a combination of their hormonal levels, their overall health, lifestyle and the symptoms they are feeling", he goes on, "the most effective therapy is often a combination of lifestyle modification along with hormone replacement. Combined with an effective exercise and nutritional plan, not only do the individuals improve their energy and sexuality, they can often drop significant amounts of body fat, gain lean muscle and most importantly, feel youthful and vibrant again."

In short, unless it's medically advised, you shouldn't be worry about increasing your testosterone levels with supplements. Most men can benefit from resistance training regularly and following a healthy diet, not just from a T level perspective, but also for improved health, sleep and mood. Increased testosterone levels are just the icing on the cake.

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What is testosterone: MD explains all commonly asked questions about the T hormone - T3

Pune: 15-Year-Old Girl Comes To Know That She’s A Boy – Punekar News

Pune, January 27, 2021: A 15-year-old girl had a shock of the lifetime when she came to know that shes not a girl. Although born as a girl, her chromosomes are of a boy and not of a girl.

The girl who hails from Satara came for a medical check-up at a doctor in Pune as despite passing the age of 15, she had not attained puberty. When the doctor conducted the medical examination, it was revealed that the girl is not a girl, but a boy.

The doctor after the further investigation came to know that shes having Androgen insensitivity syndrome (AIS). In this, a person is born with the chromosome of a boy having an external appearance of a girl.

Ruby Hall Clinic gynaecologist and endoscopic surgeon Dr Manisha Machave treated the patient. During the investigation, it was found that the girl has partial AIS. Androgen is a hormone found in boys. The breasts in the girl are not developed. Similarly, she does not have a uterus and ovaries. Her vagina too is underdeveloped.

The girl wants to lead a life as a girl. Her parents have supported her decision.

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Pune: 15-Year-Old Girl Comes To Know That She's A Boy - Punekar News

Amunix Announces the Appointment of Healthcare Investment Banking Veteran Zeeshan Merchant as Chief Financial Officer and Trisha Millican to the Board…

SOUTH SAN FRANCISCO, Calif., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Amunix Pharmaceuticals, Inc.. (Amunix), a biopharmaceutical company focused on developing prodrugs to bring the promise of potent immune-activating biotherapeutics to patients with solid tumor cancers, today announced the appointment of Zeeshan Merchant as Chief Financial Officer and Trisha Millican to the Board of Directors.

Mr. Merchant joins Amunix with over 15 years of experience in biotechnology as an investment banker and investor. He joins from Morgan Stanley, where he served as an Executive Director in the healthcare investment banking group, advising biotechnology companies on financings and strategic matters.

Ms. Millican, who will head the audit committee, brings over 20 years of experience in the life science industry, including experience with debt and equity financings, mergers and acquisitions, licensing transactions, co-development and promotional arrangements, and commercial product launches.

We are excited to welcome Zeeshan and Trisha, both leaders in the financial services and healthcare industry, to Amunix, said Angie You, CEO of Amunix. Their expertise and leadership will be invaluable as we continue to grow Amunix and transition into a clinical stage company. We are excited about the potential of our lead development candidate, AMX-818, a protease-activated T cell engager prodrug targeting HER2+ solid tumors, to significantly benefit patients.

ABOUT ZEESHAN MERCHANT

Zeeshan Merchant has over 15 years of experience in biotechnology as an investment banker and investor. Prior to joining Amunix, Mr. Merchant worked as an investment banker at Morgan Stanley, serving as an Executive Director in the firms healthcare investment banking group. In this role, Mr. Merchant advised U.S. and Asia based biotechnology companies on financings and strategic matters, and successfully executed over 50 transactions, including $20 billion in financing and $25 billion in mergers and acquisitions. Prior to Morgan Stanley, Mr. Merchant worked as Senior Analyst at Ayer Capital, a healthcare dedicated investment fund. In this role, Mr. Merchant identified and analyzed biotechnology and healthcare investments globally. Prior to Ayer Capital, Mr. Merchant worked as a private equity Associate at TA Associates, a leading, global growth private equity firm. Mr. Merchant received a B.A. in Economics from the University of Pennsylvania.

ABOUT TRISHA MILLICAN

Trisha Millican has 20 years of leadership experience in the life science industry encompassing debt and equity financings, mergers and acquisitions, licensing transactions, co-development and promotional arrangements, and commercial product launches. She is currently the Chief Financial Officer of Metacrine. Prior to Metacrine, Ms. Millican was the Senior Vice President of Finance at Seragon, a private biotechnology company focused on developing Selective Estrogen Receptor Degraders (SERDs) targeting hormone dependent cancers, which was acquired by Genentech. Prior to Seragon, she served as Vice President of Finance at Aragon, a discovery-stage small molecule company focused on therapeutics for the treatment of hormone-resistant cancers, which was acquired by Johnson and Johnson. Prior to Aragon, Ms. Millican worked in various senior financial management roles at Zogenix, a pharmaceutical company developing and commercializing innovative central nervous system therapies for people living with serious and life- threatening rare central nervous system disorders and medical conditions. Ms. Millican spent five years with the public accounting firm Deloitte LLP. She holds a B.S. in Accountancy from the University of San Diego and is a certified public accountant in the state of California.

About Amunix Pharmaceuticals

Amunix Pharmaceuticals, based in South San Francisco, CA, is focused on developing prodrugs to bring the promise of potent immune-activating biotherapeutics to patients with solid tumor cancers. The company is leveraging its proprietary T cell engager (XPAT) and cytokine (XPAC) platforms to advance a pipeline of novel masked prodrugs that are preferentially activated in the tumor microenvironment. Both platforms utilize Amunixs proprietary masking technology that has been clinically validated to extend drug half-life with limited immunogenicity. Amunix is advancing its lead development candidate, AMX-818, an XPAT T cell engager targeting HER2+ solid tumors, toward the clinic (currently in IND-enabling studies), and has several earlier programs underway. Amunix is also working on their first protease-activated masked cytokine program, IL12-XPAC, which is in discovery.

For additional information about the company, please visit http://www.amunix.com.

Contacts

Company Contact:Jen Herbach Director, Corporate DevelopmentBD@amunix.com

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Amunix Announces the Appointment of Healthcare Investment Banking Veteran Zeeshan Merchant as Chief Financial Officer and Trisha Millican to the Board...

‘Puberty blockers are safe and reversible. So why do campaigners want to deny access to them?’ – The Bristol Cable

Withholding treatment with puberty blockers doesnt save young trans people from making irreversible decisions, writes Sage Brice It just denies them the chance to explore their natural doubts and uncertainties in a safe and supportive environment.

I recently interviewed Jacob, a young transmasculine dad, about his experience of pausing his testosterone treatment to conceive a child with his husband.

Reproductive futures can be a painful topic for trans people. Its also a popular focus for anti-trans campaigners, who argue that gender-affirming medical treatment denies trans young people the right to have genetically-related children later in life.

In a recent case brought against the Tavistock Trust the only NHS service providing gender-related care to young people in England High Court judges ruled that children under 16 were unlikely to be able to give informed consent for medical treatments relating to their gender.

The centres gender identity development service, which has just been rated inadequate by the Care Quality Commission (CQC), has long been struggling under an unmanageable caseload with insufficient funding and resources. Now it is caught between critics from both sides trans advocates claim it is not doing enough to help trans young people, while so-called gender critical campaigners are doing everything they can to stop it in its tracks.

The fear that young people might make hasty, irreversible medical decisions which could harm their future ability to have children makes for a compelling and relatable story. Its easy for an uninformed reader to pick up this concern without thinking to question the reality behind it.

But treatment with puberty-blockers (see box-out) is safe and reversible, and far from being a conveyor belt, the assessment process is already not only rigorous, but hampered by severe delays.

Adding additional legal obstacles to this process will make timely treatment even less accessible. Children and families have been plunged into despair since this unexpected ruling on the Tavistock Trust took away their hope of access to medical care.

Under NHS policy, young people who experience gender dysphoria, and who have begun puberty, may be prescribed puberty blockers as one stage in a therapeutic process, following a period of assessment and exploration. These are temporary, reversible treatments which are routinely prescribed for children and young people experiencing premature and distressing puberty.

For trans young people facing what feels like the wrong puberty, it can seem like the clock is ticking too fast. Blockers buythem some time to mature, explore, and make informed decisions about their futures without undergoing lasting, irreversible changes. From the age of 17 onwards, they can choose to stop treatment allowing delayed puberty to occur as normal or progress onto feminising or masculinising hormones. These, too, are partially reversible, but the decision has implications for parenting, because a person cannot become fertile and conceive if their body has not gone through a puberty that aligns with their reproductive anatomy.

Read more about puberty blockers:

I spoke to Jo Maugham of the Good Law Project who is supporting a teenage boys legal challenge to the NHS over unethical delays, which can range from 18 months to four years for a service, which should legally be provided within 18 weeks.

Withholding puberty blockers, or imposing a long waiting time is like having a five-month waiting list for abortion, Jo told me. Its not delaying treatment, its effectively denying it.

Linking this case to wider questions of reproductive justice is not mere speculation. The lawyer acting against Tavistock has a substantial portfolio of anti-abortion cases, including a failed legal challenge to prevent pregnant under-16s accessing abortion without parental knowledge.

The key thrust of the Tavistock case, however, is the argument that gender-questioning young people who go on from puberty-blockers to cross-sex hormones or surgery might hypothetically, later in life, regret their transition and their inability to conceive.

Underlying this approach is an unspoken belief that being trans is not a real thing, but a fad which society collectively should not indulge, Jo stresses. And that assumption is fundamentally transphobic.

Jos fear is that by not providing a supportive and well thought-through pathway, the NHS risks driving young people to self-administer medication procured from poorly-regulated suppliers, and without access to therapy, monitoring for safety and potential side effects, or the opportunity to make informed choices about their reproductive futures.

In this scenario, young people end up making difficult decisions alone, unsupported, and more quickly than they might have done with appropriate guidance.

If we are concerned for reproductive futures, then obstructing access to gender-affirmative healthcare is counterproductive. In practice, creating a hostile environment for trans healthcare destroys the parenting dreams of many trans people and their partners, of all ages.

For one thing, trans people frequently lack access to timely and accurate health information when starting out on our various journeys. As Ailbhe emphasised in a previous interview, medical information and support should be available to us so that we can live our lives and not continue to feel alienated, pathologised, and dysphoric.

In most cases, we end up educating our healthcare providers, rather than the other way round. For example, many GPs dont know that in certain circumstances they can prescribe temporary hormone treatment to trans people waiting for their GIC diagnosis.

This is a problem when what we dont know can hurt us as is sometimes the case with reproductive side effects of transition. Trans people are often required to live openly in their preferred gender for a year or more before doctors will consider medical treatment such as hormone management. To fulfil this requirement, many trans women and transfeminine people, for example, tuck our genitals so as to prevent a visible front bulge.

This can be necessary in order to feel safe, comfortable and dignified under public scrutiny, or to alleviate feelings of dysphoria. What many women dont know until too late, however, is that the process can significantly impact fertility.

NHS guidelines acknowledge that hormone management can compromise fertility, and recommend that trans women should be able to access cryopreservation of gametes (sperm or eggs) prior to treatment. In practice, this service is rarely authorised by local funding bodies.

Madeleine, a freelance stage manager in Bristol, was refused cryopreservation when she was 17. Although she eventually accessed an alternative service, this meant a ten-month delay to starting hormones, at a critical time in her life. Sian, a student, ended up going private for cryopreservation, which was not only expensive but involved coming off hormones, with a long delay while she searched for a (relatively) affordable clinic.

Even where this policy is respected, however, a formal diagnosis is required to access the treatment on the NHS. Even in the best case scenario (that is, disregarding the years-long delays currently affecting GIC services), this effectively ensures that a trans woman will likely have incurred damage at least a year prior to becoming formally eligible for treatment.

For trans men and transmasculine people, the prevailing medical approach has long assumed that medical transition automatically involves a hysterectomy (removing the womb). While for some this surgery is a desired outcome, for others it is an unnecessary invasive operation that makes pregnancy impossible.

Underlying this approach is an unspoken belief that being trans is not a real thing, but a fad which society collectively should not indulge

There is no medical imperative to remove the dormant uterus unless a complication develops a relatively rare occurrence. Instead, this unofficial policy seems to arise from outdated binary ideas about sex and gender.

The growing number of trans fathers who like Jacob choose to carry and birth their own children shows that this is nonsense. It is important for trans and non-binary people to be supported in reviewing all options and making informed choices when considering medical transition. This applies, regardless what age a person begins their transition journey.

In fact, if young peoples reproductive futures are the priority, then making life difficult for those who want to access gender-affirming medical care may have the opposite of the desired effect. Creating a hostile, suspicious environment for trans young people puts excessive pressure on them to take up and defend a definite, fixed and binary position about their identities and desires for the future.

Knowing its going to take all youve got to fight for access to healthcare may be a deterrent for the fainthearted, but for most of us all it does is deny us the chance to explore our natural doubts and uncertainties in a safe and supportive environment.

This is part of the Struggle for trans healthcare equality mini-series, looking at issues affecting local transgender, nonbinary and gender-diverse (trans) communities, driven by peoples lived experiences.

Read more:
'Puberty blockers are safe and reversible. So why do campaigners want to deny access to them?' - The Bristol Cable

Deciding Between Adjuvant Targeted Therapy and Immunotherapy in BRAF+ Melanoma – OncLive

When selecting between an adjuvant targeted therapy or immunotherapy for a patient with melanoma, its important to consider several factors, including the biologic behavior of the tumor, any comorbidities, toxicities, and patient concerns, according to Reinhard Dummer, MD.

Promising long-term data with targeted approaches have indicated that this class of agents improves progression-free survival (PFS) and distant metastases-free survival (MFS), according to Dummer. However, this approach is not without toxicities. Several patients experience grade 3 adverse effects (AEs), such as pyrexia, which could lead to treatment discontinuation. Notably, however, many of these toxicities will resolve once the treatment is stopped.

Although immunotherapies have been shown to have less grade 3 or 4 toxicities, some of the effects experienced with this approach may become a lifelong burden. Additionally, because these agents require patients to come into the clinic for treatment, safety challenges are presented in light of the coronavirus disease 2019 (COVID-19) pandemic, noted Dummer.

Generally, AEs are rare [with this approach], but there is a class of AEs that do not resolve. [One] example [of this are the], endocrine toxicities like a reduction of [thyroid] hormone production, said Dummer. [Younger patients] are concerned that they will require lifelong medications [due to some of these effects]. I mentioned thyroid hormones, which is very common; however, in rare cases, this can also affect insulin production, so that would mean a young patient would experience lifelong diabetes. This is a very serious medical concern.

In an interview with OncLive Dummer, a professor at the University Hospital Zurich and vice-chairman of the Department of Dermatology in the University Hospital of Zrich, Switzerland, shared his approach for selecting between targeted approaches and immunotherapy agents in the adjuvant treatment of patients with melanoma.

Dummer:Melanoma is a very exciting malignancy; its a paradigm for modern treatment developments. Standard approaches, such as chemotherapy or radiation, do not play a role anymore in the treatment of [patients with] advanced disease. We have 2 main developments [that have changed care]: immunotherapy and targeted therapy. Also, in all areas, we are now positioned to use combination therapies. We have a clear indication that in the field of targeted therapy, a combination of a BRAF inhibitor and a MEK inhibitor is, by far, more efficient than monotherapies.

We have similar data [supporting the use of] immunotherapies. Here, we have antiPD-1 monotherapies as a backbone, but findings suggest that a combination of an antiPD-1 inhibitor with ipilimumab [Yervoy] shows more benefit. This is definitely true for patients who have high-risk diseasefor example, those with brain metastases, those who are younger, or those with negative prognostic indicators like elevated lactate dehydrogenase. In these patients, the combination of ipilimumab and nivolumab [Opdivo], an antiCTLA-4 [inhibitor] and an antiPD-L1 antibody, make a lot of sense.

The patient population that qualifies for adjuvant therapy is larger than [those who are treated] in palliative settings. In our department, I would assume [that many of] the patients who receive systemic therapy are in the adjuvant setting. This is a huge change in melanoma treatment.

Melanoma is a paradigm [that utilizes] modern medications, especially combination targeted therapy and antiPD-1 monotherapy; these are very well-tolerated treatment options. It is justified to use these medications in patients who have a high risk to develop new metastases. This implies that we are also treating a substantial proportion of patients who do not develop metastases. We are [also] treating patients who are healthy.

We unfortunately do not know who these patients are because even low toxicity should be avoided if you can. It's very important that we invest in the identification of biomarkers that can predict the outcomes of disease to identify the patients who will really profit from adjuvant treatment options.

The first essential point is the presence of aBRAFmutation. In the adjuvant setting, theBRAFmutation is not always evaluable because sometimes the material of the tumors is resected in private practices. [In this case,] it might be difficult to assess the primary tumor. Some of these patients only have very small deposits of tumors in the lymph node, which, for example, during the sentinel node procedure, is completely worked up. In this situation, it might be difficult to have enough material [to effectively assess] molecular biology. One possibility that can be helpful is the use monoclonal antibodies that are specific for theBRAF V600E mutation. This can be substituted in some situations for a molecular analysis.

We then have to understand the benefit and risks of adjuvant therapy. If we focus on the benefits first for adjuvant targeted therapy, we have the longest follow-up time here, with 5-year data. The [findings we have seen] are very encouraging. We [see] a risk reduction in the range of 45% and 50% in terms of PFS and distant MFS. Based on the experience that we have, we can assume that this [benefit] will translate into improved overall survival. If you have a close look at the toxicities, we realize that a substantial proportion of patients have grade 3 AEs which usually include pyrexia; this can cause a lot of discomfort. However, these AEs are clearly related to drug exposure; therefore, if we discontinue the medications, they will disappear. All toxicities with targeted therapy completely resolve, so this is a very encouraging sign.

For immunotherapy, we have less acute grade 3/4 AEs; I would say overall, that the therapy is well tolerated. One of the disadvantages [with this approach] is that these therapies are [delivered via] infusions, so this means the patients have to visit an outpatient clinic regularly. Especially nowadays, with all the concerns over [exposure to the] COVID-19, this is a disadvantage. Mostly, AEs are rare [with this approach], but some of them do not resolve.

We talk about all these advantages and disadvantages when we suggest therapies; this is especially true nowadays, when we see medical issues associated with COVID-19 and as [more] information on the risk of diabetes and, in rare indications, cardiomyocytes during immunotherapy [emerges]. More often, younger patients decide to go for a targeted therapy because of these [reasons].

Original post:
Deciding Between Adjuvant Targeted Therapy and Immunotherapy in BRAF+ Melanoma - OncLive

Women With ADHD May Have More Severe Symptoms of Premenstrual Dysphoric Disorder, Postpartum Depression, and Menopause – Psychiatry Advisor

Women with attention-deficit/hyperactivity disorder (ADHD) may be more vulnerable to hormone-related mood disorders such as premenstrual dysphoric disorder (PMDD), postpartum depression (PPD), and climacteric mood symptoms during their lifespan, researchers found in a study that was recently published in the Journal of Psychiatric Research.

The study included 209 adult female patients with ADHD (mean age of 34.5 years, standard deviation (SD) of 11.5 years) who were in care in April and May 2016 at the PsyQ outpatient clinic for Adult ADHD in The Hague, the Netherlands.

Of the participants, 174 were of reproductive age, 35 were peri-or-postmenopausal and 70 had irregular menstrual cycles. Of the 85 participants who had at least 1 biological child, 53 (62.4%) reported having complications antepartum, peripartum and/or postpartum after their first childbirth.

The researchers assessed the patients using the Diagnostic Interview for ADHD in adults 2.0 based on DSM-IV criteria, the Neuropsychiatric Interview Plus (the M.I.N.I. Plus), the Edinburgh Postnatal Depression Scale (EPDS), the Greene Climacteric Scale (GCS) and the Munich Chronotype Questionnaire (MCTQ).

More women with ADHD and PMDD used contraceptives (50.6%) than those who did not have PMDD (68.1%, 2 (1) = 5.82; P =.016, odds ratio (OR) = 2.09). PMDD symptoms were associated with the use of antidepressants (t = 1.991, P =.048), contraceptives (t = 2.515, P =.013), complications during pregnancy (F = 5.385, P =.008) and a mood disorder in remission (t = 2.500, P =.013). Adjusting for covariates and correcting for age and education level, use of contraceptives was associated with lower PMDD symptoms, and using antidepressants was associated with higher PMDD symptoms.

The prevalence of PPD indications (49 of the 85 who had at least 1 biological child) after the first childbirth was higher among the women included in the study than groups included in 2 systemic reviews: 19.6% among low-to middle-income countries and 14.5% in high-income countries. PMDD symptoms were significantly higher in the PPD-group compared to the no-PPD-group, with a medium effect size, (M = 7.38, SD = 3.28 vs. M = 5.53, SD = 4.07; t (81) = 2.30, P =.024, d = 0.50). The PPD-group used significantly more antidepressants (49% of the patients) than the no-PPD-group (25%, 2 = 6.330; P =.010).

The researchers found significant differences on GCS subscores for depression between the 11 women with PMDD and the 14 without PMDD (F (1) = 5.105, P =.030) and sexual dysfunction (F (1) = 5.191, P =.029) as well as a significant correlation between more PMDD symptoms and higher total GCS (r = 0.511, n = 38, P =.001) and the subscores psychosocial (r = 0.441, n = 38, P =.006), anxiety (r = 0.381, n = 38, P =.020), depression (r = 0.0418, n = 38, P =.010) and somatic (r = 0.425, n = 38, P =.009) complaints. The PPD group (n = 18) showed significantly higher GCS scores (vs. no PPD, n = 8) on the total score (F = 7.18 (1), P =.013), the subscores psychosocial (F = 6.01 (1), P =.021), anxiety (F = 5.84 (1), P =.023), depression (F = 4.51 (1), P =.043), vasomotor (F = 7.03 (1), P =.013) and sexual dysfunction (F = 4.56 (1), P =.043).

Limitations of the study include possible recall bias and the inability to find significant association between a broad spectrum of psychiatric disorders and PMDD.

Reference

Dorani F, Bijlenga D, Beekman ATF, van Someren EJW, Kooij JJS. Prevalence of hormone-related mood disorder symptoms in women with ADHD. J Psychiatr Res. Published online December 3, 2020. doi:10.1016/j.jpsychires.2020.12.005

Link:
Women With ADHD May Have More Severe Symptoms of Premenstrual Dysphoric Disorder, Postpartum Depression, and Menopause - Psychiatry Advisor

4 Signs of Aging In Men That You Should Be Aware Of – The Good Men Project

Lets face it, guys: getting old isnt easy. Whether youre just entering your 40s or youre in the middle of your retirement years, you know that your body doesnt look or function the same way it did 5, 10, 20, or even 30 years ago. However, the first step toward slowing the aging process is knowing what signs to look out for. Once you know what age looks like, you can start implementing methods to combat physical signs of aging at their source. So, lets take a closer look at the four signs of aging in men that you should be aware of!

Erectile dysfunction is one of the most common medical issues in men aged 40 or over. While some men feel uncomfortable talking about this problem, theres no shame in it. It is extremely common and is in no way a reflection of your masculinity. As men age, their blood vessels shrink, their hearts weaken, and their circulation slows. As a result, it can become harder to get and maintain an erection. While there are plenty of short-term fixes available on the market, you can also try out GAINSWave therapy through the ThriveMD clinic. In fact, GAINSWave therapy is one of the best ways to improve your sex life for the long-term!

The jury is still out on whether or not the dad bod is a good look for men, but either way, its a common sign that youre getting older. Testosterone is the hormone in your body that is responsible for building muscle mass. As you age, your levels of testosterone begin to taper off and eventually decline. This leads to decreased muscle production throughout the body, including the abdomen. When your abs become weaker, a belly will form. However, regular exercise and even hormone therapy can easily reverse or prevent this issue.

Unfortunately, theres only so much you can do about your genetics. Some men begin balding in their 20s, while others keep a full head of hair well into their 80s, 90s, and beyond! It all depends on your genetics. However, the vast majority of men will start to experience some degree of hair loss when they reach 40. As you age, your hairline will likely continue to recede. However, there are plenty of products that can slow or even reverse this process. If you dont mind taking the artificial route, hair plugs are a great way to cover up bald patches as well.

Though age spots can occur in both men and women, they are a little more common in men. These spots often appear as dark brown or tan spots on the skin. Age spots can appear just about anywhere, though they are most common on the hands, arms, face, neck, and back. Sometimes known as liver spots, age spots are often the result of excessive sun exposure over a long period of time. Thus, you can reduce the risk of getting age spots by limiting your sun exposure and wearing protection against the sun (like sunscreen).

Photo: Shutterstock

Link:
4 Signs of Aging In Men That You Should Be Aware Of - The Good Men Project

Genetic abnormalities and cancer risk | Mind and Body | nny360.com – NNY360

DEAR MAYO CLINIC: My mom was diagnosed with breast cancer. During her care, she was found to have a BRCA2 mutation. Her doctor suggested that my brothers and I get tested for this mutation, too. I am a 26-year-old woman, and I am not sure what this means for me and my risk of cancer.

ANSWER: Having a loved one with a breast cancer diagnosis can be scary. It also can become confusing when you start to hear about genetic mutations. The good news is that the information can help guide your family regarding screening and future cancer risk.

BRCA2 is a genetic abnormality that can be passed down from a parent to children. It is autosomal dominant, which means there is a 50% chance that each of your moms biological children could have the mutation. Being positive for the mutation would mean that you or your brothers may be at increased risk of developing certain cancers, compared to the general population.

In addition to breast cancer, these cancers are also known to be associated with BRCA2: ovarian cancer, melanoma, prostate cancer and pancreatic cancer.

To understand your risk, you would want to meet with a genetic counselor who can help you understand the implications of undergoing genetic testing and whether this is something you want to do. Typically, genetic testing is performed using a blood or saliva sample. The counselor would review the results with you and, if you are positive, recommend next steps to learn more about personalized screening and specific risk reduction options.

Generally speaking, it is recommended that women who have a BRCA2 mutation begin monthly breast self-examinations, beginning at 18. Clinical breast examinations are recommended every six months, beginning at 25, or before if there is an earlier breast cancer in the family. Annual breast MRIs should begin at 25. Tomosynthesis mammograms are recommended annually, beginning at 30. They are usually alternated with breast MRIs every six months. Based on risk and family history, some woman may choose to undergo a preventive mastectomy to remove their breast tissue and hopefully decrease their risk of developing breast cancer.

There is no screening test for ovarian cancer. However, women can have transvaginal ultrasounds and a blood test called CA 125 every six to 12 months, beginning at ages 30-35, while their ovaries are still in place.

If desired, women can undergo surgery to remove their ovaries and fallopian tubes once they are done having children. Ideally, this would occur between the ages of 40-45. As this surgery results in women going through menopause, some women may be started on hormone therapy until ages 50-51 to alleviate menopausal symptoms and offset some long-term risks associated with early menopause.

Research has shown that many ovarian cancers begin in the fallopian tubes. With this knowledge, women have recently been having surgery to remove their fallopian tubes and delay surgery to remove their ovaries for a few years though the recommended age for a woman to have her ovaries removed is still 40-45 in a BRCA2 mutation carrier. The benefit of removing just the fallopian tubes is that this allows women to preserve their natural hormonal function longer. The safety of this strategy is being studied, and this type of surgery is being performed as part of clinical trials.

Women who undergo surgery to remove their ovaries before menopause have a 50% reduction in their risk of developing breast cancer. In addition to surgeries, there are medications that can be given to help decrease the risk of developing breast and ovarian cancers. Selective Estrogen Receptor Modulators (SERMS) and Aromatase Inhibitors (AIs) are types of medications that can reduce the risk of developing breast cancer. Oral contraceptives can decrease the risk of developing ovarian cancer by 50%.

Since the BRCA2 mutation can be passed down to offspring, understanding your status and that of a future partner is important, as there is a genetic condition called Fanconi anemia that can occur if both the male and female partners have a BRCA2 mutation.

Thus, for men and women who test positive for BRCA2 and have not yet had biological children, it may be worthwhile to meet with a specialist in reproductive endocrinology and infertility to discuss options.

There are no standard screening guidelines for pancreatic cancer or melanoma. Based on your situation, a consultation with a pancreatic specialist may be worthwhile to discuss whether to pursue MRI or endoscopic ultrasound. Likewise, a referral to a dermatologist can be made to initiate skin cancer screenings.

Understandably, you may be nervous about your risk for cancer, given your mothers diagnosis. However, you are young, and you should not feel rushed to make any decisions regarding genetic testing. If you choose to undergo testing and are found to have a BRCA2 mutation, your health care providers will give you the information that you need so that you can begin to think about what makes sense for your life and your priorities.

Casey Swanson, physician assistant, Gynecologic Surgery, Mayo Clinic, Rochester, Minnesota

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Originally posted here:
Genetic abnormalities and cancer risk | Mind and Body | nny360.com - NNY360

TMS Therapy: What It Treats, Benefits, Side Effects, and Costs – Healthline

Transcranial magnetic stimulation (TMS) is a type of brain stimulation therapy.

Its a noninvasive treatment that uses electromagnetic pulses to stimulate nerve cells, which may improve symptoms of neurological or mental health disorders.

TMS is mainly used to treat depression. Its had success helping people who dont respond to antidepressant medication and psychotherapy. In fact, in 2008 the Food and Drug Administration (FDA) approved TMS for this purpose.

Theres also some evidence that TMS may help other disorders, like anxiety and Parkinsons disease.

Since TMS uses repetitive electrical impulses, its sometimes called repetitive transcranial magnetic stimulation (rTMS). The terms are often used interchangeably.

If youre curious about the benefits and side effects of TMS, read on.

The therapy is done by a TMS technician or TMS physician. Its an outpatient procedure, so it may be done in a medical clinic. If its done in a hospital, you wont need to stay overnight.

Before the procedure, youll need to remove items that are sensitive to magnets, like jewelry.

Heres what you can expect during TMS:

Youll need to repeat the procedure 5 days a week, for about 4 to 6 weeks. The exact length of your treatment depends on your response and specific condition.

There are many possible benefits of TMS therapy. Researchers are still studying the procedure, but it may help the following conditions:

TMS is primarily used to treat major depressive disorder (MDD), sometimes simply called depression.

Its generally recommended for those who havent found relief from medication and psychotherapy. This is called treatment-resistant depression. Approximately 30 percent of people with depression dont respond to these treatments.

According to 2015 research, depression is linked to reduced activity in the prefrontal cortex. This part of the brain is involved with depression symptoms, like low energy levels and appetite changes.

TMS may help by stimulating nerve cells and increasing activity in this area.

TMS may improve symptoms of obsessive-compulsive disorder (OCD).

The FDA approved TMS for OCD in 2018. As with depression, TMS is recommended if a person with OCD hasnt responded to medication and psychotherapy.

According to one study, people with OCD often have increased activity between the prefrontal cortex and striatum. This hyperconnectivity is associated with severe OCD symptoms.

TMS can be used to inhibit the activity in this part of the brain, thus reducing OCD symptoms.

As TMS treats psychological disorders like depression and OCD, it may also ease anxiety. Thats because these conditions often cause anxiety symptoms.

TMS could also be beneficial for generalized anxiety disorder (GAD).

In anxiety, theres often increased nerve cell activity in the prefrontal cortex. TMS may reduce the activity in this region, according to a 2019 study.

According to a 2019 review, TMS showed effectiveness for post-traumatic stress disorder (PTSD). As mentioned, TMS can target the prefrontal cortex, which regulates how you process fear and worry.

A 2018 trial found that TMS alongside cognitive processing therapy was effective for PTSD. The therapeutic effect of this combination lasted for 6 months.

Theres some evidence that TMS may help stroke rehabilitation.

A stroke happens when blood flow to the brain is blocked or reduced, causing brain cells to die. This can result in long-term loss of muscle movement.

According to research, using TMS after a stroke could promote motor recovery. The idea is that the magnetic impulses can alter the activity of the motor cortex, the part of the brain that controls voluntary movement.

A 2017 article also shares that TMS may improve dysphagia, or difficulty swallowing, by stimulating the motor cortex. They add that dysphagia affects 50 percent of people who have experienced a stroke.

Schizophrenia is a chronic, and often severe, psychiatric disorder.

A main symptom of the condition is auditory hallucinations, which affect 75 percent of people with schizophrenia.

According to a 2019 review, targeting the temporoparietal cortex could be beneficial for auditory hallucinations. This part of the brain, which is involved in language, is typically overactive in schizophrenia.

Parkinsons disease is a neurological disorder. It causes motor dysfunction, including tremors, balance issues, and freezing of gait. Freezing of gait occurs when you feel frozen and cant move while walking.

A 2020 study found that TMS may improve freezing of gait. According to the researchers, TMS normalized the connections between parts of the brain involved in gait freezing.

TMS might have benefits for Alzheimers disease, a form of dementia. This disorder causes progressive memory loss and cognitive decline.

According to newer research, its thought that TMS could help Alzheimers disease by altering the neural connections involved in memory and learning. However, more research is necessary to understand how TMS can manage Alzheimers disease.

TMS could potentially improve chronic pain conditions, such as fibromyalgia. A 2017 analysis shares that it may help by stimulating the motor cortex and controlling neurotransmitters involved in pain.

Its worth noting that depression and chronic pain often occur together. Depression can worsen chronic pain, so TMS may help by treating depression symptoms.

Nicotine releases dopamine, also called the happy hormone. It sends signals to the reward system of your brain, including the prefrontal cortex, resulting in nicotine cravings and addiction.

According to a 2013 study, TMS could help reduce nicotine cravings by targeting the prefrontal cortex.

The researchers think that TMS promotes the release of dopamine, which reduces the need for nicotine.

Multiple sclerosis (MS) is a chronic autoimmune disorder that affects the nervous system. It commonly causes spasticity, or muscle tightness that makes it difficult to move.

In a 2019 study, researchers used TMS on the motor cortex of people with MS. The treatment, combined with physical therapy, was found to decrease spasticity.

To date, TMS therapy has mostly been studied as a treatment for depression.

The success rate of TMS for depression is promising. Response rates for depression are between 30 and 64 percent.

More research is needed to understand the success rate for other medical conditions.

If you have depression, a doctor will likely recommend antidepressants and psychotherapy before TMS.

However, you may be a good candidate for TMS if you:

If youre young, TMS might be an ideal choice. Thats because younger people are more prone to developing adverse side effects from antidepressants.

TMS is considered safe, but its not for everyone.

You should avoid this treatment if you have metal in your head, such as:

The magnetic fields in TMS can make these implants heat up or move, which can cause serious injuries.

Its OK to get the treatment if you have braces or dental fillings.

You may also need to avoid TMS if you:

TMS side effects are uncommon. If complications do occur, they may include:

Symptoms like headaches and lightheadedness usually go away after several treatments.

Theres also the risk of seizures, but this side effect is rare. Theres a 0.1 percent risk of developing seizures during a course of TMS therapy.

One course of TMS can cost between $6,000 to $12,000 out of pocket.

Your health insurance provider might offer coverage, but this depends on your medical history. You may be required to try at least four antidepressants before receiving TMS coverage.

Alternatively, they might provide coverage if you experience negative reactions when using antidepressants.

If antidepressants and psychotherapy dont work for you, Medicare will cover TMS therapy.

Since youre expected to get treatment 5 days a week for multiple weeks, you may have to miss a few hours of work each day. This depends on your schedule, the location of the clinic, and the time of your appointments.

One session can take anywhere from 30 to 60 minutes, so you may be able to do the treatment before or after work.

TMS targets the activity of nerve cells in your brain, which may alleviate depression symptoms. It could also have benefit for disorders like OCD, anxiety, and PTSD as well.

The procedure may even improve motor dysfunction, making it potentially helpful for Parkinsons disease, multiple sclerosis, or stroke rehabilitation.

If youre interested in TMS, talk with a doctor. You may be a good candidate if youre young, have a low risk of seizures, and havent felt relief from antidepressants.

Link:
TMS Therapy: What It Treats, Benefits, Side Effects, and Costs - Healthline

These 3 Women Are Shaping The Future Of Womens Health By Bringing Next Generation Of FemTech Products To The Market – Forbes

breathe ilo, OCON Healthcare and Eli are three femtech startups innovating in the fertility and ... [+] contraception space

Its not a secret that finally, after years of being overlooked, womens health is having its moment. According to Frost & Sullivans report, the femtech (female technology) market revenue is expected to reach $1.1 billion by 2024, growing at a compound annual growth rate (CAGR) of 12.9%. The report states that, through solutions targeting early diagnosis and leveraging connected healthcare services, these technologies can reduce healthcare costs, decreasing the overall cost burden of a country while elevating healthcare standards and quality of life for women. But it took a long time for female healthcare to be where it is today.

Ever since the FDA (The United States Food and Drug Administration) in 1977 issued a guideline banning most women of childbearing potential from participating in clinical research studies (since certain drugs at that time were causing serious birth defects), women werent included (at least not enough) in medical research. In 1985, new guidelines were issued to encourage more inclusion of women in studies. However, even that wasnt enough to close the gender gap in medical research - analyses found that women were still seriously underrepresented in important studies on common diseases such as heart disease. Finally, in 1993, the FDA issued a new guideline which was followed by Congress writing the NIH inclusion policy into Federal law through a section in the NIH Revitalization Act of 1993 titled Women and Minorities as Subjects in Clinical Research.

Fast forward to today, womens health as a category has gone beyond just healthcare, is hugely impacted by the use of technology, and is all but a niche - it affects more than just females - fertility, for example, is not just a womens issue, despite the misconception that (in)fertility is still a largely female problem (40-50% of all fertility problems are due to the male factor).

The femtech industry has generated just over $376 million in venture capital across 57 deals in 2020 and some of the largest exits in recent years include femtech companies - Progynys $130 million IPO in 2019 and Bayers acquisition of KaNDy Therapeutics in 2020 for $425 million. $688.8 million has been invested in digital health companies targeting fertility and pregnancy/motherhood through H1 2020, which represents 65% of all femtech funding. The potential of it is massive - female health is not just female health, it affects men, children, and whole families as women are primary caregivers more often than not. Female health is a public health issue and should be treated as a priority.

Below are three startups leading the way in innovation in this space, proving that no area within the femtech space is saturated with innovative companies and that there is still so much growth potential in this market.

Breathe ilo is the worlds first fertility tracker that uses breath analysis to identify a womans ovulation pattern and fertile window in a way that is easy and comfortable. Its technology is based on measuring the PCO2 parameter, which means the partial pressure within the carbon dioxide. Simply said, the device measures a decrease in womens breath before ovulation. What most women dont know (I certainly didnt!) is that they have a type of hyperventilation 4-5 days prior to ovulation. Through consistent daily use, the breath analysis tracker enables women to understand their body and cycle phases better. Additionally, the breathe ilo app, which is compatible with iOS and Android, features a calendar that displays a clear overview of fertile days and a cycle diary to learn more about individual cycle patterns and also enables users to document further cycle symptoms like breast tenderness, PMS, cervical mucus, or headaches to help prepare women for their next cycle.

breathe ilo is the worlds first fertility tracker that uses breath analysis to identify a womans ... [+] ovulation pattern and fertile window

The technology behind our device means women no longer need to track their cycles by urinating on a stick or by measuring their temperature early in the morning. All they need to do is simply breathe into the device which will display the result in just 60 seconds on the mobile phone, with no consumables or maintenance needed. Another positive thing is that you can use it at any time of the day, which makes it accessible for every woman, even those who have no daily routine, Lisa Krapinger, CMO of Vienna-based Carbomed Medical Solutions, the company behind breathe ilo, shares with me in an interview.

The idea for this type of product came from Prof. Dr. Ludwig Wildt from the University Clinic Innsbruck, who dedicated decades of research on the relationship between the female cycle and CO2. Something that started as a side project for the breathe ilo co-founder and CEO Bastian Rther. Investing in combined hardware and software products needs brave investors. First of all, the funds needed until profitability are usually higher than in pure software products. Furthermore, the skill set of the organization needs to be much broader and the organization will be much more complex because of managing all the supply-chain complexity. Our latest round was a Pre-Series A round of $3.6 million, led by the AWS Grnderfonds, one of the largest Austrian Venture Capitalists, with the participation of our existing shareholders, he shares with me.

We want to continuously improve breathe ilo and make it truly accessible to every woman. Unfortunately, there are a variety of different diseases such as PCOS, which havent been well researched. Therefore, we are trying to research different areas to try and have a holistic view of women's health. We really want to help all women to fulfill their desire to have children, even if there are physical impairments. However, this requires very expensive, time-consuming studies. Furthermore, in the future, we would also like to provide breathe ilo for natural contraception and further breath analysis applications. We have achieved to make breath analysis tremendously affordable and can really see a mass market for it, so I think we are on a good track to revolutionize cycle tracking, concludes Krapinger.

Among the 1.9 billion women of reproductive age (15-49 years) living in the world in 2019, 1.1 billion have a need for family planning, that is, they are either current users of contraceptives - 842 million use modern methods of contraception. Approximately 160 million women (17%) use IUDs (intrauterine devices) globally - varying in market share between countries, IUDs are the most widely used long-term, reversible contraceptive method in the world. Yet there has been no OCON Healthcare innovation in the IUD space since the 1990s with current devices using a deficient delivery platform invented in 1970.

OCON Healthcare, an Israel-based company is here to change that. Its first product is the IUB Ballerine - the first and only 3D intrauterine device shaped for women's anatomy and is a long term, reversible, hormone-free contraceptive method replacing the 2D traditional T-shaped IUDs. But contraception is not the only reason for OCONs innovation in this space. On top of the IUB Ballerine, any drug or substance that can be introduced into the uterus can be potentially put on the flexible, smart memory shape IUB (Intra Uterine Ball) frame to be non-invasively delivered to the uterus and treat various medical conditions, replacing invasive procedures.

OCON's IUB Ballerine is the first and only 3D intrauterine device shaped for women's anatomy and ... [+] is a long term, reversible, hormone-free contraceptive method replacing the 2D traditional T-shaped IUDs

Abnormal Uterine Bleeding (AUB) affects up to 25% of women globally with a $1B annual addressable market, more than 70% of women develop uterine fibroids by the age of 50, which is 9 million women in the U.S. alone, and hormone replacement therapy, of which the market size was valued at $21.8 billion in 2019, are all areas we are looking into and in which we are developing innovative solutions to cater to women who need them, Keren Leshem, CEO of OCON Healthcare, shares with me.

Leshem joined the company in September 2019, and very quickly put the company on the trajectory of growth. The company now has 100,000-plus women who had the IUB Ballerine inserted by their doctor and this innovative contraceptive is currently sold in 30 markets in Europe, Middle East, Africa, and Latin America. Its a company led by women for women, as Leshem says, with 85% of its team being women now, including their newly appointed Chairwoman, California based life science VC leader Dr. Anula Jayasuriya.

In 2020 OCON raised a total of $4.5 million in funding from both internal and external investors as well as non-dilutive government funding for their R&D projects. To date, the company has raised almost $20 million and our investors include Pontifax VC, Docor VC, Rhia Ventures, Merchavia Investments, and other angel groups. This year, for the first time in my life, Ive witnessed the fundraising process being done completely online. It's weird to have such a connection and find amazing support when we haven't met personally with the teams in the U.S. that placed their confidence and money on us, adds Leshem. The company is now actively raising a Series B round to bring their innovative platform to the USA, so investors, what are you waiting for?

Eli is a Canada-based startup developing a hormone tracking product designed to be used at home. From the users perspective, there are three simple steps. You take a saliva sample with the cartridge, you insert it in the small portable device that captures your daily hormone fluctuations, and shortly after, the app provides powerful information tailored to you. This information includes your hormonal profile and precise fertile days. With this data, customers can achieve different goals, including avoiding pregnancy naturally or conceiving a baby. The product will initially be available only for people trying to conceive, while Elis team complete the clinical and regulatory work for the contraception use-case.

Fertility is a booming market, with 1 in 7 couples who experience infertility. This number is still growing because we are waiting longer than any generation ever to have children, and fertility declines with age, but the effects of age are much greater in women compared to men. In their 30s, women are about half as fertile as they are in their early 20s, and womans chance of conception declines significantly after age 35. Male fertility also declines with age, but more gradually.

So what makes Elis product so unique? We first asked ourselves what the ideal solution would look like and asked the same question to hundreds of women and dozens of physicians. It was clear that we had to make no compromise on ensuring its effective and delightful to use, in addition to being hormone-free and non-invasive. That process led us to build technology from the ground up because no existing product met all of those criteria. The technology's ability to measure multiple hormones (instead of proxy variables like temperature or cervical fluid) and to have saliva as an input (instead of urine or blood) is some of the elements that make our product unique. Because we built the technology by keeping contraception in mind, it was critical for the product to be reliable and simple to integrate into a routine that you keep for a long time. Measuring hormones can give the effect we were looking for, and using saliva is the foundation for delivering the best long-term experience, explains Marina Pavlovic Rivas, co-founder, and CEO of Eli.

Eli is developing a hormone tracking product designed to be used at home using woman's saliva

But its not only about fertility, for that matter. After using hormonal contraception for years, many women just want to stop at some point, not for the sake of getting pregnant, but because of many other reasons. Although hormonal contraception is one of the most significant advances of the last century for women and all of society, up to 51% of women using hormonal birth control report unwanted side effects. The problem is that when you want to avoid hormones and invasive devices, youre left with very few effective options. That means you either continue to use a method you no longer want to use or opt for a less effective option, and both cases should be unacceptable. Women's contraceptive needs have evolved, but innovations to meet those needs haven't followed. On top of that, hormones are at the root of so many transitions and conditions women experience, and yet they are still a black box for most of us, Rivas adds.

Since the company's creation a little over a year ago, Eli has raised over $2 million. This includes a $1.5 million seed round that the company closed in December 2020. Vectr Ventures and 2048 Ventures co-led the round with the participation of Real Ventures, Techstars, Panache Ventures, Ramen Ventures, MEDTEQ+, and serial entrepreneur Steven Arless, who also joined the board. Before this round, Eli received around $700,000 in external funding. Most of it came from equity-free sources, such as government programs rewarding companies developing breakthrough technologies. It also includes an initial investment startup received in fall 2019 a few weeks after starting the company from Techstars and Real Ventures, via Techstars Montral AI. Both investors subsequently invested in Eli's seed round.

No one could have predicted the challenges of raising during a pandemic. We were aware that some stats were not favorable even before that new context. Only 90 Latina founders have ever raised $1-plus million, and less than 3% of all VC funded companies have a woman CEO. However, it turns out that the pandemic reduced VC funding for female founders even more. With a 48% drop in funding to female founders from Q2 to Q3 2020, it hit its lowest since 2017. We were operating for a few months only when the global health crisis hit. It certainly added a layer of complexity at first. As a deep tech company with a hardware portion, we couldn't become entirely remote because we still needed to work with specialized equipment and controlled testing environments in the lab. We now have been running for longer under the global pandemic than in the pre-COVID era. It turns out that the current context holds several opportunities that accelerated our operations and amplified the need for our product, concludes Pavlovic Rivas.

Read the rest here:
These 3 Women Are Shaping The Future Of Womens Health By Bringing Next Generation Of FemTech Products To The Market - Forbes

OPINION: Indiana might finally ban conversion therapy. That’s too little, too late. – Indiana Daily Student

Indiana State Sen. J.D. Ford introduced Senate bill 32 last week calling for a ban on the use of conversion therapy for minors. Ford is recognized as Indianas first openly gay state legislator and spoke of the bill as a lifesaving issue. However, the bill will most likely face stiff opposition from the Republican supermajority in the Statehouse.

Conversion therapy is used as an umbrella term to describe practices that involve an attempt to change a persons sexual orientation or gender identity through psychological, spiritual or physical intervention. A therapist can recommend an unsubstantiated medication plan consisting of antipsychotics or hormone injections as a psychological treatment.

[Related: OPINION: Indianas first openly gay senator is right. A vote for Mike Pence is one for homophobia.]

Conversion therapy perpetuates harmful stereotypes by suggesting people can be cured of their deviance. The vile practice treats homosexuality and gender identity as an illness and invalidates any reality other than one consisting purely of heterosexuality and cisnormativity.

Religious leaders might insist homosexuality is a sin, therefore repentance is the answer. Health professionals may perform aversive treatments in the form of electroconvulsive therapy to punish an individual for indulging in thoughts which deviate from the arbitrarily defined sexual norm.

An estimated 700,000 LGBTQ adults in the United States have experienced some form of conversion therapy, and half of which received it while they were adolescents.

Conversion therapy is torture.

Nevertheless, it remains legal in a majority of states, including Indiana.

Indiana lawmakers proposed a ban on conversion therapy in 2019 but it never appeared before the entire chamber for a vote. The measure quickly died in committee.

Although Indianas reconsideration of a conversion therapy ban is a step towards progress, the bill is unlikely to pass. Republicans hold a nearly identical supermajority in the Indiana General Assembly as they did two years ago when similar legislation failed.

If the ban passes, however, legislators should acknowledge the long-term implications of conversion therapy and provide LGBTQ communities with further resources and support.

The American Psychological Association and the World Psychiatric Association are just a few of the many health organizations that denounce the use of conversion therapy and reject its asserted scientific premise.

[Related: IU students conduct LGBTQIA+ health care needs survey to establish free student-run clinic]

The trauma that forced conversion creates for young people in particular is alarming, and the inequality it legitimizes is damaging to the LGBTQ community.

Upwards of 77% of former conversion therapy participants report signifcant long-term psychological distress, according to the American Medical Association. LGBTQ youth who experience extreme rejection from their caregivers are eight times more likely to report a suicide attempt and six times more likely to report chronic depression, according to GLAAD. Furthermore, almost one in five transgender people claim they have been denied healthcare because of their gender identity.

Forced sexual orientation transformation efforts make LGBTQ youth indefinitely reliant on a medical system which is unequipped and unwilling to serve them.

This nation has invested more effort into forcing LGBTQ individuals to conform than acknowledging their humanity. We are now left with a system ill-equipped to provide equal access and service to all communities. The legislation currently moving through the Indiana General Assembly is the bare minimum.

Katelyn Balakir (she/her) is studying Policy Analysis and World Political Systems. She is a member of Indiana Model United Nations.

Excerpt from:
OPINION: Indiana might finally ban conversion therapy. That's too little, too late. - Indiana Daily Student

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