Clinical Research Directory

Western Sweden Systemic Sclerosis Project

The main aim of the project is to identify key-factors involved in the development and progression of Systemic Sclerosis (SSc), a chronic invalidating rheumatic disease characterized by high mortality and insufficient treatment options. A cohort of patients with SSc will be collected at the Sahlgrenska University Hospital in Gothenburg, Skaraborg Hospital in Skövde, and Södra Älvsborg Hospital in Borås (Sweden). Thanks to a holistic approach including integrated analysis of blood, and skin samples as well as DNA, and with the use of state-of-the-art methods, this project aims to identify factors (e.g. genes, proteins, metabolites, and immune cell types) associated with the development of SSc and with the progression to a more aggressive phenotype. Functional studies using in vitro model systems and patient specimens will be also implemented. The findings of the current project could lead to the identification of possible diagnostic and prognostic markers for the disease as well as potential drug targets. This cohort will be also linked to the European Scleroderma Trial and Research (EUSTAR), which is an international SSc research network aiming to coordinate research activities on SSc from groups all over Europe in order to improve treatment, quality of life and mortality of patients with SSc.

Oral or Topical Catechins for Radiation Dermatitis

Introduction Radiation-induced dermatitis (RID), which includes both acute and chronic forms, affects up to 95% of patients undergoing radiation therapy. Despite its high incidence, there are currently no validated prevention and management recommendations specifically for the mexican population. Catechins, particularly epigallocatechin gallate and epicatechin, are emerging as a promising and readily accessible therapeutic option for radiation damage in skin and other organs, including conditions like esophagitis, intestinal injury, and mucositis. Objective This study aims to evaluate the utility of oral or topical catechins in preventing and managing acute and chronic radiation-induced dermatitis in cancer patients, comparing their effectiveness against standard treatment. Material and Methods This will be a randomized, double-blind, phase III clinical trial with a longitudinal and comparative design. Patients will be allocated into two primary study groups: prevention (n=81) and treatment (n=81). Each group will be further divided into four treatment arms: Epigallocatechin gallate (experimental aerosol) Epicatechin (experimental capsule) Saline control arm (aerosol) Microcrystalline cellulose excipient control arm (capsule) All participants across all groups will receive standard care. Study endpoints will include the assessment of utility, toxicity, quality of life, and cosmesis, using various validated scales and scores. Ethics This study adheres to the principles outlined in the Helsinki Declaration (2024), the Nuremberg Code, and Mexico's General Health Law on health research. Given the wide therapeutic margin of the interventions, the study is classified as minimal risk. Statistical Analysis To evaluate the efficacy of the intervention (specifically, the change in the risk of dermatitis and fibrosis), we will calculate the hazard ratio using Cox regression and compare it with the Log-Rank test. Additionally, both fixed and random effects models will be performed and compared using the likelihood ratio test.

Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery

This prospective study aims to evaluate the safety and effectiveness of AVELI for reducing cellulite and fibrotic tissue in patients undergoing High-Definition Liposculpture, exploring if AVELI improves the aesthetic outcomes, and reduced the clinically evident cellulite and/or fibrosis. The main questions this study seeks to answer are: * Does AVELI safely reduce cellulite and fibrotic tissue without causing serious adverse events? * How effective is AVELI in improving patient-reported outcomes and aesthetic appearance? Through this study, the study team aims to evaluate the safety and effectiveness of AVELI. The study procedures include: * Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, and satisfaction scores. * All patients will undergo the standardized High-Definition Liposculpture technique, with AVELI applied to all identified cellulite and/or fibrosis release. * Photographic and 3D imaging preoperatively and at follow-ups (1, 3, 6, and 9 months).