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NCT ID: NCT05856448 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus

GALACELA
Start date: June 28, 2023
Phase: Phase 2
Study type: Interventional

A study evaluating the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG3667 administered orally once daily for 48 weeks in approximately 180 adult participants with active Systemic Lupus Erythematosus (SLE).

NCT ID: NCT05855382 Recruiting - COVID-19 Clinical Trials

Prevalence of Persistent COVID-19 in Punta Arenas, Magallanes and Chilean Antarctic Region

PCOV-19
Start date: May 15, 2023
Phase:
Study type: Observational [Patient Registry]

This cross-sectional observational study aims to determine the prevalence of Persistent COVID-19 in 282 individuals in Punta Arenas, Magallanes and Chilean Antarctic Region. Persistent COVID-19 is a complex array of symptoms that persist or emerge for more than 4 weeks beyond SARS-CoV-2 infection. Recent studies suggest that up to 80% of survivors may develop chronic multi-organ dysfunction due to persistent inflammation and immune dysregulation, making it an ongoing public health concern worldwide. The study aims to (1) describe and establish the frequency of physical and psychological signs and symptoms in adult patients who have tested positive for COVID-19, (2) identify individuals who meet the WHO case definition of Persistent COVID-19 in Chile, (3) explore risk factors associated with persistent COVID-19 to guide intervention strategies, and (4) explore inflammatory and molecular biomarkers associated with persistent COVID-19. The research project utilizes a stratified random sampling with a mixed-methods embedded design. In the first phase, individuals diagnosed with COVID-19 will be recruited and followed up to complete the study's sample universe. A sociodemographic survey, blood sampling (including complete blood count, biochemical profile, immunoglobulin mutational status analysis, and analysis of inflammatory biomarkers), and a battery of psychological tests will be administered. In the second phase, kinesiology studies and medical consultation and evaluation will be conducted to determine if individuals have Persistent COVID-19 and to derive them to the healthcare network. In the final follow-up phase, participants diagnosed with Persistent COVID-19 will be invited to undergo musculoskeletal and respiratory assessments to complete the diagnosis of symptoms associated with the pathology.

NCT ID: NCT05852431 Recruiting - Clinical trials for Severe Hypertriglyceridemia

To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia

ENTRUST
Start date: June 15, 2023
Phase: Phase 3
Study type: Interventional

To determine the effect of Pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia (TG ≥500 to ≤2000 mg/dL) after 26 weeks of treatment.

NCT ID: NCT05843643 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

SELECT-SLE
Start date: July 19, 2023
Phase: Phase 3
Study type: Interventional

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 3 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib based on their disease activity and their original treatment assignment in Study 1 or 2. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05840211 Recruiting - Clinical trials for Stage IV Breast Cancer

Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

ASCENT-07
Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

NCT ID: NCT05839262 Recruiting - Clinical trials for Osteoarthritis, Knee

Active Video Games for Older Adults With Knee and/or Hip Osteoarthritis.

Start date: November 28, 2022
Phase: N/A
Study type: Interventional

Population aging is currently an issue of primary relevance, constituting an enormous challenge for institutions and society. On the other hand, osteoarthritis (OA) is the most prevalent arthropathy in the elderly, strongly related to loss of functional capacity, limitation of daily activities, increased musculoskeletal pain, and deterioration of quality of life. More specifically, knee and hip OA represent a significant burden for health systems, and in Chile, they are among the ten most frequent diseases in the elderly. The technological development of the last decades has allowed the incorporation of several therapeutic alternatives for the intervention of the elderly, such as virtual reality, which allows interaction with multiple digital environments. Active video games (AVG) or exergames, carried out through commercial non-immersive virtual reality systems, have been proposed as a feasible, innovative, and entertaining alternative to optimize conventional physical rehabilitation (CPR). AVG in healthy older people and those with neurocognitive conditions effectively improves clinical and psychosocial outcomes. However, it has been recommended to advance the study of the effects of AVGs in people with musculoskeletal pathologies, such as knee and hip OA. Accordingly, the purpose is to analyze the effects of an AVG-guided physical exercise protocol adjunct to CPR on functional mobility in older adults with knee and/or hip OA.

NCT ID: NCT05833269 Recruiting - Burnout Clinical Trials

Intercare, Mindfulness and Compassion Based Intervention for Parental Burnout

Start date: December 22, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effectiveness of an adapted mindfulness and compassion-based intervention (IBAP) in reducing parental burnout in Chilean mothers who telework while living with children under 18 years old. The main questions it aims to answer are: - Can the intervention reduce symptoms of parental burnout in the short term (3 months) and medium-term (6 and 9 months) compared to the control group? - Can the intervention improve work engagement in the intervention group compared to the control group? Participants will be randomly assigned to either the intervention group or the active control group. The intervention group will receive the IBAP program while the active control group will receive a relaxation audio guide. Both group will receive parental burnout educational material, invitation to a Whatsapp group and a weekly email reminders. Parental Burnout (PBA) will be measured at baseline, 3, 6, and 9 months, and work engagement will be measured at the same time points. Researchers will compare the intervention group to the active control group to see if the IBM program is more effective in reducing parental burnout and improving work engagement,

NCT ID: NCT05827354 Recruiting - Critical Illness Clinical Trials

Incidence and Factors Associated to the Development of PICS-F Among ICU Relatives: A Longitudinal Exploratory Study

Start date: June 27, 2023
Phase:
Study type: Observational

The constellation of long-term psychological, physical, and cognitive impairments arising after a critical illness among family members of ICU survivors has been labeled as "Post Intensive Care Syndrome - Family" (PICS-F). Despite PICS-F awareness, the long-term issues faced by ICU family members remain poorly understood with several gaps in knowledge remaining such as the role of protective psychosocial factors, caregiver burden, or family satisfaction in the development of the syndrome. This single-center, longitudinal exploratory study, aims to determine the incidence of each PICS-F impairment (psychological, physical, and cognitive) and to identify factors (during ICU stay and after hospital discharge) associated with the development or prevention of the PICS-F impairments among family members of ICU survivors of a public hospital in Chile.

NCT ID: NCT05827016 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Start date: June 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

NCT ID: NCT05826847 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Prone Positioning and Abdominal Binding on Lung and Muscle Protection in ARDS Patients During Spontaneous Breathing

Start date: December 6, 2023
Phase: N/A
Study type: Interventional

Ventilator-induced diaphragmatic dysfunction and intensive care unit (ICU)-acquired weakness are two consequences of prolonged mechanical ventilation and critical illness in patients with acute respiratory distress syndrome (ARDS). Both complicate the process of withdrawing mechanical ventilation, increase hospital mortality and cause chronic disability in survivors. During transition from controlled to spontaneous breathing, these complications of critical illness favor an abnormal respiratory pattern and recruit accessory respiratory muscles which may promote additional lung and muscle injury. The type of ventilatory support and positioning may affect the muscle dysfunction and patient-self-inflicted lung injury at spontaneous breathing onset. In that regard, ARDS patients with ventilator-induced diaphragmatic dysfunction and ICU-acquired weakness who are transitioning from controlled to partial ventilatory support probably present an abnormal respiratory pattern which exacerbates lung and muscle injury. Physiological-oriented ventilatory approaches based on prone positioning or semi recumbent positioning with abdominal binding at spontaneous breathing onset, could decrease lung and muscle injury by favoring a better neuromuscular efficiency, and preventing intense inspiratory efforts and high transpulmonary driving pressures, as well as high-magnitude pendelluft. In the current project, in addition to perform a multimodal description of the severity of ventilator-induced diaphragmatic dysfunction and ICU-acquired weakness in prolonged mechanically ventilated ARDS patients, prone positioning and supine plus thoracoabdominal binding at spontaneous breathing onset will be evaluated.