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Effects of low-dose oral micronised progesterone on sleep, psychological distress, and breast development in transgender individuals undergoing feminising hormone therapy: a prospective controlled study

Brendan J Nolan, Aviva S Frydman, Shalem Y Leemaqz, Meg Carroll, Mathis Grossmann, Jeffrey D Zajac, and Ada S Cheung

mg oral micronised progesterone (progesterone) on sleep and psychological distress in trans individuals established on feminising hormone therapy for at least 6 months. Secondarily, we aimed to assess the effect of progesterone on breast development

Open access

The appraisal of chronic stress and the development of the metabolic syndrome: a systematic review of prospective cohort studies

N Bergmann, F Gyntelberg, and J Faber

stress-concept into stressors (strain), stress (the bodily reaction to stressors), and distress (the emotional consequences as reactions to the stressors) (2) . Stress occurs when the sum of stressors exceeds an individual threshold. The stress

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Understanding and supporting women with polycystic ovary syndrome: a qualitative study in an ethnically diverse UK sample

Michelle Hadjiconstantinou, Hamidreza Mani, Naina Patel, Miles Levy, Melanie Davies, Kamlesh Khunti, and Margaret Stone

). Psychological distress Concerns about infertility were described as a source of anxiety: ‘… not being able to have kids when I was older, that was my main worry really (when diagnosed).’ (Participant 4, age 17). ‘We (partner and self) both got slight

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Health-related quality of life is impaired in primary hyperparathyroidism and significantly improves after surgery: a prospective study using the 15D instrument

Eeva M Ryhänen, Ilkka Heiskanen, Harri Sintonen, Matti J Välimäki, Risto P Roine, and Camilla Schalin-Jäntti

, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity) has five levels and the respondent chooses the level best describing her/his current health status for each dimension. The 15D score

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Phase I trial of the androgen receptor modulator CR1447 in breast cancer patients

Martin Zweifel, Beat Thürlimann, Salome Riniker, Patrik Weder, Roger von Moos, Olivia Pagani, Martin Bigler, Karin M Rothgiesser, Christiane Pilop, Hanne Hawle, Peter Brauchli, Coya Tapia, Wolfgang Schoenfeld, Cristiana Sessa, and for the Swiss Group for Clinical Cancer Research (SAKK)

CR1447 (4-hydroxytestosterone, 4-OHT) binds to the androgen receptor and has antiproliferative activity in both ER-positive and ER-negative/AR-positive breast cancer cells in preclinical studies. The objective of this first-in man trial was to evaluate the safety and to determine the dose of CR1447, administered as an ointment, for Phase II. Escalating doses (100, 200, 400 mg) of CR1447 were administered topically on a daily basis to patients with ER-positive/AR-positive/HER2-negative advanced breast cancer pretreated with several lines of therapy. 14 patients have been treated for a total of 42 cycles. Two patients, one at dose level 100 mg and one at dose level 200 mg, showed early tumour progression and were replaced. Related adverse events were all ≤ grade 2 and included fatigue, bone and joint pain, stiffness, dry skin and mouth, nausea, sweating, urinary tract infection, rash, headache and distress. No drug-related dose-limiting toxicities (DLTs) were seen. Two patients (17%) achieved stable disease at 3 months. Pharmacokinetic analysis confirmed dose-dependent transdermal uptake of CR1447. 4-OH-androstenedione (4-OHA), a key metabolite of 4-OHT, was undetectable in most of the plasma samples. Urine metabolites of 4-OHT and 4-OHA indicate high exposure of 4-OHT after topical administration. Oestradiol serum concentrations did not increase, confirming preclinical data that CR1447 is not converted to estrogens in vivo. In conclusion, CR1447 administered transdermally as an ointment is well tolerated and appears to have single-agent activity in heavily pretreated ER-positive/HER2-negative breast cancer patients. The recommended phase II dose is 400 mg/day.

Open access

Experience with burdens of diabetes device use that affect uptake and optimal use in people with type 1 diabetes

Molly L Tanenbaum and Persis V Commissariat

events, fewer episodes of diabetic ketoacidosis (DKA), and better overall diabetes management (as assessed through HbA1c) ( 8 , 9 , 10 , 11 ). These advanced technologies have also shown benefits in improving diabetes distress and quality of life ( 12

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Efficacy of very low-calorie ketogenic diet with the Pronokal® method in obese women with polycystic ovary syndrome: a 16-week randomized controlled trial

Srdjan Pandurevic, Ilaria Mancini, Dimitri Mitselman, Matteo Magagnoli, Rita Teglia, Roberta Fazzeri, Paola Dionese, Carolina Cecchetti, Massimiliamo Caprio, Costanzo Moretti, Justyna Sicinska, Alessandro Agostini, Domenica Gazineo, Lea Godino, Ignacio Sajoux, Flaminia Fanelli, Cristina M Meriggiola, Uberto Pagotto, and Alessandra Gambineri

, visceral adiposity, hyperandrogenism ( 12 , 13 ), low basal metabolic rate ( 14 ), low postprandial thermogenesis ( 15 ), and, frequently, low physical activity ( 16 ), as well as psychological distress ( 17 , 18 ) are major obstacles for weight loss in

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Untreated thyroid autoantibody-negative SCH increases the risk of spontaneous abortions

Ning Yuan, Jianbin Sun, Xin Zhao, Jing Du, Min Nan, Qiaoling Zhang, and Xiaomei Zhang

distress, and pregnancy mortality between ET and SCH pregnant women. Thyroid autoimmunity (TAI) is a major risk factor for SCH. Several studies have shown that SCH with TAI increases the risk of miscarriage, preterm birth, and GDM ( 6 , 7 ). Nevertheless

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The pre- and postoperative illness trajectory in patients with pituitary tumours

Eva Jakobsson Ung, Ann-Charlotte Olofsson, Ida Björkman, Tobias Hallén, Daniel S Olsson, Oskar Ragnarsson, Thomas Skoglund, Sofie Jakobsson, and Gudmundur Johannsson

the tumour, the patients also had to be perceptive to the distress of family members. Some felt that the family members’ worry far exceeded their own fears. As a response, some patients had to pretend to be healthier than they felt in front of their

Open access

Telemedicine assists in the management of proatherogenic dyslipidemia and postprandial glucose variability in patients with type 2 diabetes mellitus: a cross-sectional study

Po-Chung Cheng and Chia-Hung Kao

, patients can experience diabetes-related distress that interferes with diabetes self-care ( 15 ). In contrast, telehealth consultation can provide timely and accurate information that leads to better compliance and clinical outcome ( 16 ). Currently the