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Collagen Diseases clinical trials

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NCT ID: NCT05787340 Completed - Rheumatic Diseases Clinical Trials

Investigation From Biopsychosocial Perspective of Patients With Rheumatic Disease With Covid-19 Who Participated in a Biopsychosocial Exercise Program: A Case Series With 6-Month Follow-up

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Objective: This novel study aimed to interrogate from a biopsychosocial perspective the health conditions during the Covid-19 infection and long-Covid periods of 5 patients with rheumatic disease infected with Covid-19 who had acquired the habit of regular exercise before the pandemic. Method: This case study included five patients suffering from Covid-19 infection among patients with rheumatic disease who had acquired the habit of regular exercise before the Covid-19 pandemic. It was applied a questionnaire to the patients from a biopsychosocial perspective to see the short and long-term effects of Covid-19 during and after quarantine. Moreover, the study used the BETY-Biopsychosocical Questionnaire (BETY-BQ) to evaluate a biopsychosocial point, Health Assessment Questionnaire (HAQ) to measure functional status, and the Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression. Results: In BETY-BQ, HAQ, and HADS, there was an unfavorable increase in overall scores of all patients during Covid-19. After six months, although the results from these three scales improved, some of the patients could not return to their pre-covid state. Conclusions: The patients participating in the telerehabilitation were able to return to everyday life after Covid more efficiently and overcome post-Covid symptoms easily. This study is important in guiding the exercise approach for patients with rheumatic diseases in pandemics such as Covid-19.

NCT ID: NCT05786235 Recruiting - Preeclampsia Clinical Trials

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

Start date: December 6, 2022
Phase:
Study type: Observational

The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS. To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM). For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.

NCT ID: NCT05739214 Completed - Diabetic Foot Clinical Trials

The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer

wounds
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive conventional wound care treatment

NCT ID: NCT05719389 Recruiting - Clinical trials for Inflammatory Bowel Diseases

EFFICACY AND SAFETY OF S.C. INFLIXIMAB IN PATIENTS SWITCHED FROM I.V. FORMULATION OF INFLIXIMAB

Start date: September 14, 2022
Phase:
Study type: Observational

Phase-IV, national, multicentric, non-randomized, observational real-life study. The goal of this stud is to investigate the patient's benefits in terms of quality of life and work ability resulting from the switch from infliximab i.v. to s.c. in patients with gastroenterological or rheumatological indication at month 12.Patients who are eligible but were switched before the inclusion in this study will also be enrolled, and the data already collected according to clinical practice and consistent with the study outcome measures will be used retrospectively. All patients will be followed up according to the standard of care of each participating center. The main questions it aims to answer are: 1. To investigate the effectiveness at month 2, 6 and 12 after switching to infliximab s.c. 2. To investigate the safety profile at month 2, 6 and 12 after switching to infliximab s.c. 3. To investigate the difference between patients with rheumatological diseases and patients with IBD in terms of quality of life and work, effectiveness and safety at month 2, 6 and 12 after switching. 4. To investigate the presence of baseline predictors for drug persistence at month 12 (sex, age, disease type, disease severity, body mass index, concomitant medications, smoking habit, presence of comorbidities). 5. To investigate whether there is any change between baseline and week 52 in the following aspects: - Job type and need for any authorization to go to the hospital to receive the study drug - Distance and duration of the travel home-hospital - Mode of travel home-hospital - Need for a caregiver to be present - Time spent at hospital - Patient's preference for the way of study drug administration expressed on a 10-grades VAS scale. The study period for observation will be 12 months from the date of switch. At week 0, month 2, 6 and 12 from the date of the switch, clinical activity, safety data and biomarker levels will be collected. For those patients who have had an endoscopic evaluation of the disease within 2 months of inclusion and repeat the endoscopic evaluation at 12 months ± 8 weeks, endoscopic data will also be collected (valid only in the presence of IBD). In those centers where a blood sample to analyze the minimum levels and anti-drug antibodies of infliximab has been collected and/or stored within 2 months prior to the date of transition, the patient will be asked to give informed consent to the use of this sample and to provide a blood sample for the same analysis at week 0, month 2 and 12. These samples will be analyzed and compared to evaluate the immunogenicity of the drug. These analyzes will be centralized in one lab.

NCT ID: NCT05698251 Completed - Rheumatic Diseases Clinical Trials

Reducing Uncertainty Distress in Long Term Health Conditions

Start date: March 16, 2022
Phase: N/A
Study type: Interventional

The goal of this pilot intervention study is to develop and test a new psychological therapy model in people with long term health conditions (rheumatic conditions) who are experiencing distress (anxiety or low mood) in relation to the uncertainty that their illness causes. The main questions the study aims to answer are: 1. Does the new treatment model help participants reduce uncertainty distress associated with their health condition? 2. Is it a practical treatment that can be ran within a hospital setting? 3. Is the treatment acceptable to participants? Participants will be asked to attend weekly therapy sessions (up to a maximum of 16 sessions) in the hospital or via telehealth. The sessions will be based on the new treatment model and aimed at helping participants reduce uncertainty where they can and learn to live alongside it where it cannot be reduced. The hope is that if participants can better manage uncertainty this will reduce the distress (anxiety or low mood) that they feel.

NCT ID: NCT05676359 Recruiting - Rheumatic Disorder Clinical Trials

Knowledge of Living Will in Patients With Rheumatic Diseases

Start date: February 1, 2023
Phase:
Study type: Observational

The living will is a legal document derived from a communication and deliberation process, medical ethical aspect, currently regulated in Mexico by the General Health Law and the Health Law of Mexico City. Knowledge of living will in the population with chronic diseases, including rheumatic diseases, has been little addressed. Most patients do not know what the living will document is, so they do not carry it out and others, despite knowing it, have a passive attitude toward doing it.

NCT ID: NCT05666115 Completed - Arthritis Clinical Trials

Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study

EMLAS
Start date: January 2, 2023
Phase: N/A
Study type: Interventional

Axial spondyloarthritis (axSpA) is a chronic inflammatory immune disorder with a global prevalence that ranges from 20 to 160 cases per 10000 individuals. axSpA has two forms of clinical presentation (radiographic and non-radiographic) based on the presence or absence of radiographic sacroiliitis. This condition mostly affects the vertebral spine, and is characterized by joint pain and stiffness, fatigue, and restricted function, which leads to a substantial physical, psychological, and socioeconomic burden. The clinical management of axSpA needs to combine pharmacological and non-pharmacological approaches to reduce inflammation and improve health-related quality of life. The aim of the study will be to determine if a 12-week probiotic supplementation will be more effective than an online-delivered strength training program at improving functional capacity in adults with non-radiographic axSpA. As a secondary aim, we will compare the impact of both interventions on disease activity, spinal mobility, quality of life and biochemical measures. This will be the first randomized controlled trial where probiotics are compared with an active intervention.

NCT ID: NCT05637411 Active, not recruiting - Obesity Clinical Trials

GeoHealth: Geographic Information System for Health Management and Clinical, Epidemiological and Translational Research

Start date: December 9, 2020
Phase:
Study type: Observational

The objective of the project is to develop a potentially marketable system for clinical, epidemiological and translational research capable of associating contextual variables and geospatial data with clinical patient information. The GeoHealth system will include a section to perform exploratory analysis that will help identify risk factors to optimize clinical decision making. The system will be used in a study of the influence of environmental factors in more than 800,000 asthmatic patients in the region of Andalucía, Spain. The results of this study will help to develop predictive models of risk of exacerbation in asthma patients. Currently, disease management guidelines state that asthma control has two components: current disease control and future risk of exacerbations. These two components are key when assessing disease management, following a stepwise model that seeks to improve current control and minimize future risk. However, although the current control of the disease is defined and has established methodologies for its measurement (Asthma Control Test -ACT- and Asthma Control Questionnaire -ACQ-), the risk of suffering exacerbations is not yet a measurable component. Therefore, these predictive models could help in professional decision making for asthmatic patients. The predictive models will be validated prospectively and implemented in a decision support system for the management of asthmatic patients.

NCT ID: NCT05621369 Recruiting - Psoriasis Clinical Trials

Psorcast Mobile Study

Start date: January 1, 2022
Phase:
Study type: Observational

The purpose of this study is to understand variation in the symptoms of psoriasis and psoriatic arthritis using simple, scalable smartphone-based measurements. This study uses an iPhone app to record these symptoms through questionnaires and sensors.

NCT ID: NCT05618782 Active, not recruiting - Pain Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

Start date: October 17, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2, randomized, double-blind, placebo-controlled trial of multiple doses and multiple administrations of LEVI-04 for the treatment of pain due to osteoarthritis of the knee.