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NCT ID: NCT05596409 Recruiting - Clinical trials for Metastatic Breast Cancer

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

ELCIN
Start date: May 19, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with ER+/HER2- advanced/metastatic breast cancer who received no prior CDK4/6i in the metastatic setting.

NCT ID: NCT05596292 Recruiting - Clinical trials for Decompensated Heart Failure

Sensation of Dyspnea and Experience of Patients With Heart Failure

MOVE
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This randomized clinical trial aims to evaluate patients with decompensated heart failure undergoing an early mobilization protocol with the use of immersive virtual reality glasses compared with patients undergoing the same protocol but without immersive virtual reality. The primary outcome will be the sensation of difficulty breathing, and the secondary outcome will be whether this technology provided a positive experience for patients in the intervention group that was superior to that of patients in the control group.

NCT ID: NCT05595642 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

ARNASA
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

NCT ID: NCT05595564 Active, not recruiting - Performance Clinical Trials

Influence of PBM on Anaerobic Capacity Under Normoxia and Hypoxia

Start date: August 31, 2021
Phase: N/A
Study type: Interventional

The photobiomodulation (PBM) shows positive results in muscle performance, fatigue reduction, management of blood lactate production, analgesia and in the increase of VO2 maximal, favoring the increase of ATP production and thus the energy metabolism. The association of PBM applied before high-intensity treadmill training shows physiological improvements both in normoxic (Nor) and hypoxic (Hip) conditions. Anaerobic capacity (AC) is the maximum amount of ATP that can be resynthesized by anaerobic metabolism and is an important predictor of high-intensity exercise since an athlete's ability to perform efforts to increase maximal oxygen consumption (VO2max) depends on AL. In view of the above information the main objective of the present research project will be to investigate the effects of PBM on AC under normoxic and hypoxic conditions in amateur runners. To test the effects of exercise training on anaerobic capacity under normoxic and hypoxic conditions, 7 individuals will be randomly submitted to four maximal efforts to exhaustion with intensity corresponding to 110% of VO2max in Hip, Nor, Hip+Ebio and Nor+Ebio conditions. These efforts will be used to estimate the AC, that is, the maximum accumulated deficit of alternative oxygen (MAODRED), from the sum of the energy contribution of the anaerobic and lactic metabolisms.

NCT ID: NCT05595356 Recruiting - Clinical trials for Treatment Resistant Depression

Home-based Transcranial Direct Current Stimulation for Treatment Resistant Depression

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

The aim of this phase II, randomized, double-blind clinical trial is to evaluate the effect of home-based transcranial direct current stimulation (tDCS) in patients with treatment-resistant depression. Major depressive disorder is defined by depressed mood and/or loss of interest in activities, during most of the day, nearly every day, for at least two weeks. It is usually accompanied by other symptoms, such as fatigue, sleep disturbances, thoughts of guilt, suicidal ideation, appetite alterations, difficulty to focus and physical agitation or retardation. It is estimated that its worldwide prevalence is 5%, affecting 280-300 million people. A third of patients with depression will develop treatment resistant depression, where symptoms fail to remit after at least two trials of antidepressants. Beyond psychotropics, another treatment option is neuromodulation, where excitatory or inhibitory signals are delivered to the brain, in order to modulate cortical excitability. The tDCS is a non-invasive brain stimulation method that applies a low intensity direct current (1-2mA) directed to the scalp via the cathode and anode electrodes. The current reaches the cortex, facilitating hyperpolarization or depolarization of the axonal membrane potential. Evidence has shown that this method is presented as a technique able to alter cortical and subcortical neural networks. This technique has been used to treat psychiatric disorders such as depression, bipolar affective disorder, panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation after stroke and pain syndromes such as neuropathic pain, migraine and fibromyalgia. It has a low cost and less side effects than psychotropic medications. In order to be effective, daily repeated sessions of 20-40 minutes are necessary. When applied in a hospital setting, this frequency of sessions can limit its appliance, especially for depressed patients, whose symptoms include fatigue and loss of interest in activities. Furthermore, transportation costs, frequent absences from work and other activities and overload of the healthcare system would also limit its use. Home based devices are portable and easily operated. Thus, it is possible for patients to administer themselves the treatment, in their own home, everyday. Therefore, the aim of this study is to evaluate the effect of home-based tDCS in treatment resistant depression patients in long-term treatment.

NCT ID: NCT05594901 Not yet recruiting - Clinical trials for Liver Transplantation

Impact of a Risk Stratification Tool on the Outcome of Liver Transplant Recipients Colonized With Carbapenem Resistant Enterobacteriaceae: an Observational Study

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

Although CRE infection after OLT have a dramatic impact on patient survival and several implementations have been proposed (i.e. preventive strategies or targeted surgical prophylaxis), a standardized approach in colonized patients is still missing. The investigators recently developed and internally validated a bed-side score to stratify the risk of CRE infection in OLT recipients colonized by CRE. The goal of this pre/post observational study is to investigate the impact on all-cause 90-day mortality in OLT recipients colonized with CRE using such score (CRECOOLT score) for the systematic evaluation of CRE infection risk. The secondary objectives are: - To analyse days of therapy with anti-CRE antibiotic regimens in patients with and without systematic evaluation of CRE infection risk, according to clinical practices. - To evaluate rates of documented CRE infections and their relapses with selection of further resistance in patients with and without systematic evaluation of CRE infection risk. - To evaluate the length of hospital, ICU stay and rates of hospital readmission in patients with and without systematic evaluation of CRE infection risk.

NCT ID: NCT05593770 Terminated - COVID-19 Clinical Trials

International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response

NECTAR
Start date: October 27, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.

NCT ID: NCT05592756 Completed - Measles Clinical Trials

Secondary Attack Rate Measles Vaccine In Second Situation Contacts Cases Confirmed

Start date: April 6, 2020
Phase:
Study type: Observational

This study will be an epidemiological inquiry, in communicating confirmed measles cases. The contacts of the index cases will be asked about the measles diagnosis and previous measles vaccination, and will have their vaccination cards checked. They will also be asked about blocking vaccination (opportune or not opportune) and about the development or not of symptoms. Thus, the investigators will have a group of people exposed to infection with a history of vaccination for measles prior to the outbreak versus a group of people exposed without previous vaccination. The frequency of measles cases will be compared in those two groups, allowing to analyze the effectiveness of the vaccine for individual protection. The effectiveness of the vaccine in preventing the spread of the disease will be analyzed, comparing the relative risk of the vaccine history of contact, in the subgroups of index cases with and without previous measles vaccination. The proposed study will involve the collection and analysis of contact data from measles cases oriented to compare vaccinated and unvaccinated, differing from health surveillance actions. This is based on an exhaustive search for contacts of measles cases, preferably aimed at detecting susceptible individuals, with the purpose of implementing blocking vaccination and interrupting the transmission chain. The proposed study seeks a representation of contacts, without the intention of being exhaustive in the search and detection, but prioritizing selection without bias for one of the exposure groups (vaccination). The results may provide technical and scientific support for future decisions by the Ministry of Health regarding the primary immunization schedule, the priority of the age group in vaccination campaigns, the identification of susceptible individuals, and the assessment of the need for a 3rd dose of the vaccine, for measles.

NCT ID: NCT05592483 Recruiting - Breast Cancer Clinical Trials

An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer

DB RESPOND
Start date: July 7, 2023
Phase:
Study type: Observational

This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) [globally] or HER2-low [North America only] in routine clinical practice.

NCT ID: NCT05592275 Recruiting - Heart Failure Clinical Trials

A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)

Start date: February 3, 2023
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction