Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women Comprehensive Longitudinal Assessment of Release With Estradiol Pellet Analysis (CLARA Study)

A multicenter, prospective, open-label clinical study will be conducted, to monitor serum concentration and pharmacokinetic profile after subcutaneous implantation of a 25mg absorbable pellet containing estradiol in climacteric women.

开始日期2023-12-13

申办/合作机构

Science Valley Research Institute

NCT05570786 / Recruiting临床2期IIT

A Phase II, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Investigate the Safety and Exploratory Efficacy of a Subdermal Implant-bioabsorbable Gestrinone Pellet for Pelvic Pain Secondary to Endometriosis Treatment

Pelvic pain is considered a symptom of multifactorial origin among which Endometriosis is the main gynecological cause affecting 5-10% of worldwide women in their reproductive years, negatively impacting their quality of life and work efficiency. Treatment of endometriosis-associated pelvic pain is challenging and there are surgical and/or hormonal treatments available with variable endpoints. Gestrinone is a synthetic derivative of 19-nortestosterone with anti-estrogen, anti-progestin, androgenic, and weak estrogen-like action. Previous studies show that the oral treatment with Gestrinone induced an improvement in symptoms associated with endometriosis but with adverse events such as androgenization and uterine bleeding. Parenteral administration of Gestrinone could be effective to treat pain symptoms secondary to endometriosis and minimize these adverse events. This study evaluates the safety and tolerability of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis after 6 months of Gestrinone pellet insertion versus placebo pellet. PK profile of the gestrinone pellet will be monitored.

开始日期2023-02-13

申办/合作机构

Science Valley Research Institute

[+1]

NCT05102396 / Recruiting临床2期IIT

Topical Oxybutynin Deodorant for Axillary Hyperhidrosis: Local or Systemic Effect? The TODAY Trial

The TODAY trial is a study to evaluate the efficacy and safety of topical oxybutynin deodorant for use in patients with axillary hyperhidrosis.

开始日期2022-09-26

申办/合作机构

Science Valley Research Institute

[+1]

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2024-08-27·NEJM Evidence

Rivaroxaban for Patients with Intermittent Claudication

Article

作者: Aguiar, Valéria Cristina Resende ; Pereira, Felipe Menegueti ; Eikelboom, John W. ; Britto, Karen Falcão ; Krakauer, Rogério ; Anand, Sonia S. ; Agati, Leandro Barile ; Fareed, Jawed ; Caffaro, Roberto Augusto ; Chang, Chiann ; Paganotti, Alexia ; Lopes, Renato D. ; Rached, Heron Rhydan Saad ; Ribeiro, Camilla Moreira ; Volpiani, Giuliano Giova ; Ramacciotti, Eduardo ; Wolosker, Nelson

2024-06-01·Journal of Thrombosis and Haemostasis

2023 ISTH update of the 2022 ISTH guidelines for antithrombotic treatment in COVID-19

Review

作者: Resnick, Helaine E ; Zarychanski, Ryan ; Spyropoulos, Alex C ; Levy, Jerrold H ; Sholzberg, Michelle ; Arnold, Donald M ; Iba, Toshiaki ; Middeldorp, Saskia ; Connors, Jean Marie ; Bradbury, Charlotte A ; Minichiello, Tracy ; Schulman, Sam ; Thachil, Jecko ; Kaatz, Scott ; Samama, Charles Marc ; Nazy, Ishac ; Falanga, Anna ; Broxmeyer, Lisa ; Ramacciotti, Eduardo

Based on emerging evidence from the COVID-19 pandemic, the International Society on Thrombosis and Haemostasis (ISTH) guidelines for antithrombotic treatment in COVID-19 were published in 2022. Since then, at least 16 new randomized controlled trials have contributed additional evidence, which necessitated a modification of most of the previous recommendations. We used again the American College of Cardiology Foundation/American Heart Association methodology for assessment of level of evidence (LOE) and class of recommendation (COR). Five recommendations had the LOE upgraded to A and 2 new recommendations on antithrombotic treatment for patients with COVID-19 were added. Furthermore, a section was added to answer questions about COVID-19 vaccination and vaccine-induced immune thrombotic thrombocytopenia (VITT), for which studies have provided some evidence. We only included recommendations with LOE A or B. Panelists agreed on 19 recommendations, 4 for nonhospitalized, 5 for noncritically ill hospitalized, 3 for critically ill hospitalized, and 2 for postdischarge patients, as well as 5 for vaccination and VITT. A strong recommendation (COR 1) was given for (a) use of prophylactic dose of low-molecular-weight heparin or unfractionated heparin in noncritically ill patients hospitalized for COVID-19, (b) for select patients in this group, use of therapeutic-dose low-molecular-weight heparin/unfractionated heparin in preference to prophylactic dose, and (c) for use of antiplatelet factor 4 enzyme immunoassays for diagnosing VITT. A strong recommendation was given against (COR 3) the addition of an antiplatelet agent in hospitalized, noncritically ill patients. These international guidelines provide recommendations for countries with diverse healthcare resources and COVID-19 vaccine availability.

2024-02-01·International Angiology

Effects of long-pulsed 1064-nm Nd:YAG laser on telangiectasias and reticular veins: a human in-vivo histological study

Article

作者: Ramacciotti, Eduardo ; Caffaro, Roberto A ; Kikuchi, Rodrigo ; Grill, Marcelo H ; Cardoso, Ronie C ; Silva, Maria A ; Neves, Samantha ; Ribeiro, Camilla M ; da Silva, Viviane S

BACKGROUNDTelangiectasias and reticular veins are associated with aesthetic disorders. Sclerotherapy is the gold standard treatment, but long-pulsed 1064-nm Nd:YAG laser (LP1064 laser) is also used. No data on the human histological effects of these lasers are reported. The objective was to test different LP1064 laser parameters and their histological effects on the dermis, collagen, telangiectasias, and reticular veins.METHODSThis was a single-center, prospective, single-arm, case-control, human study. During surgery (dermolipectomy), the abdominal section of 10 female patients was irradiated with 6 different transdermal LP1064 laser parameters after anesthesia. Ten pieces with areas of varying irradiation were evaluated according to the characteristics of the vessels identified by area. In each piece, two irradiation areas were performed per group, totaling 12 irradiation areas per piece, with 120 regions later analyzed at the end of the ten samples. After removing the surgical product, histological sections were extracted, and the dermis, telangiectasias, and reticular veins were analyzed.RESULTSHistological analysis showed that exposition to six different parameters from LP1064 laser led to significant dermal layer separation and collagen alterations. The effects were inconsistent on the loss of endothelial cells, intravascular thrombus formation, and fusion of vascular walls for both telangiectasias and reticular veins. In reticular veins, effects on intravascular thrombus formation and vascular wall fusion were not observed.CONCLUSIONSThe LP1064 laser in monotherapy with fixed settings did not lead to a consistent vascular lesion to promote immediate occlusion in telangiectasias and reticular veins. This strategy may not work as monotherapy for small vein treatment, but the possible late response to the LP1064 laser cannot be ruled out and require further investigation.

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