Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis.

Unlabelled: This 78-week (18-month) study conducted in 479 postmenopausal women with osteoporosis evaluated the efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of candidate biosimilar CT-P41 relative to US reference denosumab. CT-P41 had equivalent efficacy and pharmacodynamics to US-denosumab, with similar pharmacokinetics and comparable safety and immunogenicity profiles.

Purpose: To demonstrate equivalence of candidate biosimilar CT-P41 and US reference denosumab (US-denosumab) in postmenopausal women with osteoporosis.

Impact of relugolix combination therapy on functioning and quality of life in women with endometriosis-associated pain.

Objective: To evaluate the effect of relugolix combination therapy (relugolix CT; 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethisterone acetate) for up to 2 years in the SPIRIT long-term extension study on functioning and health-related quality of life (QoL), using the Endometriosis Health Profile (EHP)-30 questionnaire, and assess how changes in QoL domains correlated with improvements in dysmenorrhea as well as nonmenstrual pelvic pain (NMPP).

Design: Long-term extension study of the SPIRIT phase 3 trials.

Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study.

Study Question: What is the efficacy and safety of long-term treatment (up to 2 years) with relugolix combination therapy (CT) in women with moderate to severe endometriosis-associated pain?

Summary Answer: For up to 2 years, treatment with relugolix CT improved menstrual and non-menstrual pain, dyspareunia, and function in women with endometriosis; after an initial decline of <1%, the mean bone mineral density (BMD) remained stable with continued treatment.

What Is Known Already: Endometriosis is a chronic condition characterized by symptoms of dysmenorrhea, non-menstrual pelvic pain (NMPP), and dyspareunia, which have a substantial impact on the lives of affected women, their partners, and families. SPIRIT 1 and 2 were phase 3, randomized, double-blind, placebo-controlled studies of once-daily relugolix CT (relugolix 40 mg, oestradiol 1 mg, norethisterone acetate 0.

A Plain Language Summary to learn about relugolix combination therapy for the treatment of pain associated with endometriosis.

What Is This Summary About?: This is a summary of research studies (known as clinical trials) called SPIRIT 1 and SPIRIT 2. The SPIRIT 1 and SPIRIT 2 studies compared how well a medicine called relugolix combination therapy worked in relieving pain in women with moderate to severe endometriosis compared to a placebo, a pill with no active medication. Endometriosis occurs when tissue similar to what normally lines the uterus grows in other places, such as the ovaries, fallopian tubes, and bowels.

Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2).

Background: Endometriosis is a common cause of pelvic pain in women, for which current treatment options are suboptimal. Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, combined with estradiol and a progestin, was evaluated for treatment of endometriosis-associated pain.

Methods: In these two replicate, phase 3, multicentre, randomised, double-blind, placebo-controlled trials at 219 community and hospital research centres in Africa, Australasia, Europe, North America, and South America, we randomly assigned women aged 18-50 years with surgically or directly visualised endometriosis with or without histological confirmation, or with histological diagnosis alone.

Ovarian adenocarcinoma in 14-year-old girl.

Ovarian tumors have an uncommon occurrence in children and adolescent girls compared with adult women. The peak incidence of ovarian tumors is between 15-19 years of age. Malignant ovarian tumors in children and adolescent girls are extremely rare.

Uterine corpus rhabdomyosarcoma in 13-year-old girl.

Embryonal rhabdomyosarcoma (RMS) is the most common malignant tumor of the genitourinary system in children. The most common symptoms in girls include vaginal bleeding, abdominal pain, urinary and/or stool incontinence and hematuria. Treatment includes primary resection of the tumor and adjuvant therapy or neoadjuvant chemotherapy, resection of the tumor and adjuvant therapy.

Mechanical, Chemical, and Processing Properties of Specimens Manufactured from Poly-Ether-Ether-Ketone (PEEK) Using 3D Printing.

As part of the experiments herein, the mechanical properties of specimens made of poly-ether-ether-ketone (PEEK) material using 3D printing technology were determined. Two populations of specimens were investigated, the first of which contained an amorphous structure, while the other held a crystal structure. The studies also investigated the influence of the print directionality on the mechanical properties obtained.

Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial.

Objective: To study the effect of a new investigational oral gonadotropin-releasing hormone antagonist, linzagolix, on endometriosis-associated pain (EAP).

Design: A multinational, parallel group, randomized, placebo-controlled, double-blind, dose-ranging trial.

Setting: Clinical centers.

Body mass composition and dietary habits in adolescents with polycystic ovary syndrome.

Objectives: The aim of the present study is to assess differences in body composition between female participants in the study group who suffer from PCOS versus a healthy control group.

Material And Methods: The study included 85, 14-22-year-old, female participants. Participants belonged to one of two groups.

Late-Onset Puberty Induction by Transdermal Estrogen in Turner Syndrome Girls-A Longitudinal Study.

Objective: Estrogen replacement therapy (ERT) for Turner syndrome (TS) is a widely discussed topic; however, the optimal model of ERT for patients with delayed diagnosis and/or initiation of therapy is still unclear, mainly due to insufficient data. We present the results of a prospective observational single-center study in which the efficacy of late-onset puberty induction by one-regimen transdermal ERT in TS girls was evaluated.

Methods: The analysis encompassed 49 TS girls (63.

Seeking Optimal Nutrition for Healthy Body Mass Reduction among Former Athletes.

The aim of the study was to investigate the efficacy of 6 week Mediterranean diet or 30% calorie restriction on the fatty acid profile and eicosanoids (hydroxyoctadecadienoi acids and hydroxyeicosatetraenoic acids) concentration. Furthermore, basic biochemical variables such as insulin, glucose, HOMA-IR, and a lipid profile were estimated. The study enrolled 94 Caucasian former athletes aged 20-42, with body height of 179 ± 16.

Prediction of Spontaneous Puberty in Turner Syndrome Based on Mid-Childhood Gonadotropin Concentrations, Karyotype, and Ovary Visualization: A Longitudinal Study.

Aims: To investigate whether karyotype, mid-childhood (6-10 years) follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels, and ultrasound ovary visualization results can be used as indicators of spontaneous puberty in Turner syndrome (TS).

Methods: The analysis was based on clinical and biochemical data from 110 TS girls aged >13 years at the end of the study (1,140 visits between 1996 and 2015). The study population was divided according to karyotype: 45,X and non-45,X.

Comparison of Signaling Pathways Gene Expression in CD34(-) Umbilical Cord Blood and Bone Marrow Stem Cells.

The aim of the study was to compare the biological activity of the total pool of genes in CD34(-) umbilical cord blood and bone marrow stem cells and to search for the differences in signaling pathway gene expression responsible for the biological processes. The introductory analysis revealed a big similarity of gene expression among stem cells. When analyzing GO terms for biological processes, we observed an increased activity of JAK-STAT signaling pathway, calcium-mediated, cytokine-mediated, integrin-mediated signaling pathway, and MAPK in a cluster of upregulating genes in CD34(-) umbilical cord blood stem cells.

[What is the nutrition regimen followed by athletes after the end of their sporting career?].

Introduction: The aim of this study is to assess the nutritional habits of participants in the research project “CRON -diet as an alternative method for athletes who have completed their sporting career”.

Materials And Methods: 94 former athletes from Poland participated in this study. A standardized Food Frequency Questionnaire was used for interview.

Coexistence of Mayer-Rokitansky-Küster-Hauser Syndrome and Turner Syndrome: A Case Report.

Background: Turner syndrome is a common chromosomal disorder, with an incidence of 1 in 2000 live-born female infants. Mayer-Rokitansky-Küster-Hauser syndrome (MRKH) affects 1 in 4500 female births and, rarely, it might be associated with gonadal dysgenesis.

Case: A 17-year-old girl was referred to our clinic with short stature and primary amenorrhea.

[CHANGES IN BODY MASS AND BLOOD LIPID LEVELS IN PATIENTS UNDERGOING CALORIC RESTRICTION].

Introduction: Caloric restriction is the only well-documented nutritional intervention prolonging the life of mammals. This method modifies the lipid levels in blood, controlling obesity and delaying the onset of many medical conditions associated with metabolic disorders. The aim of the study was to carry out a comparative analysis of lipid profile in patients on Mediterranean or CRON (Caloric Restriction with Optimal Nutrition) diets, before and after six weeks of dieting.

Blood pressure regulation and resting heart rate abnormalities in adolescent girls with polycystic ovary syndrome.

Objective: To assess the risk of cardiovascular disease on the basis of biochemical, echocardiographic, and 24-hour blood pressure (BP) monitoring parameters in adolescent girls with polycystic ovary syndrome (PCOS).

Design: Cross-sectional study.

Setting: Academic and research institution.

[Budd-Chiari syndrome induced by hormonal oral contraception in the patient with congenital thrombophilia-factor V Leiden mutation--a case report].

The Budd-Chiari syndrome is a rare pathology resulting from various etiological factors which often contribute to its late diagnosis. Liver cirrhosis, malignant tumors and haematological disorders resulting in hypercoagulability, are the most common reasons of Budd-Chiari syndrome. The syndrome is characterized by portal hypertension and splanchnic congestion due to obstruction of hepatic venous outflow.

Comparison of gene expression of mitogenic kinin path in adherent and non-adherent CD 34-stem cells using oligonucleotide microarrays.

One of the more interesting cells present in the umbilical cord blood - as far as their potential clinical use is concerned - are stem cells not presenting the CD34 antigen. These are the pluripotential cells with their biological properties similar to mesenchymal stem cells, with the ability to differentiate into such tissue types as bone, cartilage, nervous (to some extent), glia and muscle. The authors compared the activity of genes coding the proteins in mitogenic signal paths activated by kinin receptors using oligonucleotide microarrays in adherent and non-adherent CD 34- cells derived from umbilical cord blood.

[Diagnostic and treatment of overactive bladder].

The overactive bladder (OAB) is characterized by symptoms of frequency, urgency, nocturia, and urge incontinence, substantially affecting the quality of life of millions of people throughout the world. Diagnosis of OAB made on patient history, physical examination, and clinical tests can be used as the basis for treatment in most cases. In cases where there is uncertainty regarding the diagnosis, urodynamic assessment should be carried out.

[Overactive bladder--definition, epidemiology, pathogenesis].

The overactive bladder is characterized by the following symptoms: frequency, urgency, nocturia and urge incontinence, substantially affecting the quality of life of millions of people throughout the world, with recent findings estimating the prevalence in adults at about 16.4%. The symptoms are associated with significant social, psychological, occupational, domestic, physical, and sexual problems.

Ozone therapy in induced endotoxemic shock. II. The effect of ozone therapy upon selected histochemical reactions in organs of rats in endotoxemic shock.

Mitochondria and lysosomes were evaluated by assessment of changes in activity of selected enzymes: lactate dehydrogenase (LDH), succinate dehydrogenase (SDH), adenosinetriphosphatase (ATPase), acid phosphatase (AcPase) and beta-glucuronidase (BG) in rats under profound hypoxia induced by endotoxemic shock. The study was conducted on adult male Wistar rats. The animals formed the following four groups of 15 rats each: control animals (C);-rats receiving intraperitonally O(2)/O(3) (CO), rats receiving of Escherichia coli toxin (LPS) (CL); rats receiving LPS plus oxygen-ozone mixture (OL).