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NCT ID: NCT04711057 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

CENTR(AR): Lungs Moving

CENTR(AR)
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Chronic Respiratory Diseases (CRDs) are associated with substantial morbidity and mortality, ranking as the third leading cause of death worldwide. Pulmonary rehabilitation (PR) is a fundamental evidence-based intervention for the management of a variety of CRDs, such as Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Diseases (ILDs). However, the benefits of PR tend to decline over time and there is currently no strong evidence that patients translate those benefits into a more active lifestyle. There is an urgent need for evidence-based interventions to promote physical activity (PA) participation, whilst maintaining PR positive effects in the long-term. Community-based PA interventions adjusted to the local context, as well as patients' needs and preferences, might be a key strategy to meet this target. CENTR(AR) will be a sustainable response to support healthy lifestyles and enhance long-term PR benefits, by providing access to PR within Primary Healthcare Centres (PHC), followed by the inclusion in a community-based PA program, which embraces urban facilities and available resources.

NCT ID: NCT04726150 Completed - Covid19 Clinical Trials

Effect of CoVid-19 (CoronaVirusDisease-19) and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias

CoViDEx
Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

COVID-19 can cause myocarditis, which can cause myocardial fibrosis. This has been shown to increase mortality and morbidity among athletes. Several efforts have been made to guide sports participation after COVID-19, but not much scientific evidence is present to back-up those guidelines. The current initiative aims gain a heightened insight in this matter.To identify the presence of fibrosis athletes who recovered from COVID-19 will undergo CMR (Cardiac MRI). All athletes will also undergo echocardiography, 5-day Holtermonitoring among others. This will allow to determine whether differences between those with and those without fibrosis are present. If fibrosis is present, athletes will be offered an implantation of a very small monitoring device that will be able to detect arrhythmias with a much higher sensitivity. Also an exercise echocardiography will be performed, to determine the safety of continuation of athletic efforts. Amendment: Recently myocarditis and pericarditis have also been observed after the administration of mRNA-vaccines, specifically after the second dose. The effect of vaccination on exercise capacity is less clear. To investigate this we propose to amend the inclusion criteria for COVIDEX with "athletes undergoing or having undergone COVID vaccination"

NCT ID: NCT04730778 Completed - Clinical trials for Acute ST Segment Elevation Myocardial Infarction

Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients

Start date: April 1, 2021
Phase:
Study type: Observational

Contrast induced acute kidney injury has commonly been referred to as contrast induced nephropathy (CIN) defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl from baseline within 48-72 hours with peak incidence 2-5 days after contrast exposure.1. CIN, Which can potentially lead to acute kidney failure or mortality, is still common among hospitalized patients. In addition, contrast medium exposure may lead to long-term outcomes such as dialysis-requiring renal failure or death.2. The incidence of CIN ranges from 7% to 25% in different population subgroups based on the risk status. Hence, risk stratification has an important bearing in order to provide the appropriate preventive therapies to those high-risk individuals before and after contrast media exposure.3. In the past, several risk prediction models have been proposed to envisage the CIN incidence. Mehran proposed a scoring system comprising eight variables which correlated well with the CIN risk. Despite having a fair degree of accuracy; complexity was one of the major limitations of such models.4 .Most predictive models for contrast induced nephropathy in clinical use have modest ability, and are only applied to patients receiving contrast for coronary angiography. Further research is needed to develop models that can better inform patient centered decision making, as well as improve the use of preventive strategies for contrast induced nephropathy.5. ST-elevation myocardial infarction (STEMI) is a clinical syndrome defined by characteristic symptoms of myocardial ischemia in association with persistent electrocardiographic ST elevation (STE) and subsequent release of biomarkers of myocardial necrosis.1 STE is the single best immediately available surrogate marker for detecting acute complete coronary artery occlusion, denoting a significant region of injured myocardium at imminent risk of irreversible infarction, requiring immediate reperfusion therapy.6. Primary percutaneous coronary intervention(PCI) if performed in a timely fashion is the recommended modality of reperfusion in STEMI cases as per guidelines [ACC-ESC-STEMI & revascularization]. Frequently, baseline kidney functions are unknown, nevertheless, to maximize salvaging myocardial tissue for STEMI patients; immediate reperfusion is prioritized over awaiting tests results. Considering the systemic inflammatory response associated with STEMI and that commonly due to severe pain and agony, those patients are not properly hydrated, added to higher prevalence of MI-related myocardial dysfunction and heart failure than in elective cases, primary PCI for STEMI cases might have higher risk than usual of CIN.7,8. The CHA2DS2-VASC score is traditionally used for embolic risk stratification in atrial fibrillation (AF) patients and includes the following variables: congestive heart failure (CHF), hypertension, age ≥75 years, diabetes mellitus (DM), previous stroke, vascular disease, age 65 to 74 years and sex.9. The CHA2DS2-VASC score has been reported recently to have a prognostic utility to predict adverse clinical outcomes in patients with acute coronary syndrome (ACS), regardless of having AF.10. The CHA2DS2VASC score is practical and easy to memorize and apply in STEMI cases, however, strong evidence to validate its prognostic value in predicting CIN in the setting acute STEMI is lacking.

NCT ID: NCT04732481 Completed - Clinical trials for Organ Failure, Multiple

Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling.

CAROT
Start date: April 1, 2021
Phase:
Study type: Observational

Patients hospitalized in intensive care often require intravenous administration of fluid in order to optimize the functioning of the heart and thus ensure perfusion of vital organs such as the kidneys, the brain or the digestive tract. However, it is necessary to find the right balance in fluid intake because it has been shown that excessive administration has a negative impact on patient survival, the length of their stay in intensive care or the duration of invasive mechanical ventilation.The passive leg lifting maneuver is regularly used to determine which patients should be infused with these large volumes (the patient's chest is placed in a horizontal position and the legs are elevated at 30 ° by tilting the bed for 2 minutes ). To be interpreted, this maneuver requires the presence of invasive devices (bloody arterial pressure catheter, PICCO monitor) or an operator experienced in cardiac ultrasound.Our study aims to evaluate an easy-to-use, non-invasive tool widely available in intensive care and emergency departments (carotid vascular doppler ultrasound) to assess the response to a passive leg lifting maneuver. . The measurements are taken before and after a passive leg lifting maneuver and then before and after a filling decided before inclusion by the doctor responsible for the patient.

NCT ID: NCT04732936 Completed - Nerve Injury Clinical Trials

Feasibility Study of a Temporary Peripheral Nerve Stimulator

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

A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.

NCT ID: NCT04733222 Completed - Accidental Fall Clinical Trials

Effect of Treadmill Perturbation Training on Falls

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

This parallel, randomized, controlled trial aims to quantify the effects of slip- and trip-perturbation training on fall rates collected over 12 months, compared to time-matched treadmill walking, among community-dwelling older adults (≥65 years). A sample size calculation estimated that 140 older community-dwelling older adults (≥65 years) are needed. Following baseline measures, the recruited participants will randomly be assigned to either the perturbation or the walking group. The participants in the perturbation group will be assigned to four perturbation training sessions. The walking group will perform four treadmill walking matching the exercise time of the perturbation training. Assessment of the primary outcome, fall rates, will be conducted continuously in 12 months from randomization. When a fall is reported in the fall calendar, a telephone interview will be conducted to assess the circumstances and consequences (e.g., fall-related fractures, fall-related hospital admissions) of the falls. Moreover, assessment of physical, cognitive, and social-psychological outcomes will be made at baseline, post-test, six-month, and 12-months reassessment.

NCT ID: NCT04733911 Completed - Muscle Damage Clinical Trials

Recovery Kinetics Following Eccentric Exercise

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

The aim of this study will be to investigate the recovery kinetics of neuromuscular fatigue, muscle microtrauma indicators, performance and oxidative stress factors after three different exercise induced muscle damage (EIMD) protocols in adult Males. Also, this study will determine the comparison among three different eccentric protocols in neuromuscular fatigue, muscle microtrauma indicators, performance and oxidative stress factors. The eccentric protocols will be differentiated in training volume and specifically in the eccentric repetitions in isokinetic dynamometer.

NCT ID: NCT04735562 Completed - Clinical trials for Peripheral Arterial Disease

Thrombospondin-4 Levels and Peripheral Arterial Disease in Hemodialysis Patients

Start date: April 1, 2021
Phase:
Study type: Observational

Background: Peripheral arterial disease (PAD) a condition characterized by atherosclerotic occlusive disease of the lower extremities is commonly observed in patients with chronic kidney disease (CKD) patients, particularly those on dialysis. The investigators conducted detailed biomarkers such as thrombospondin and related inflammatory biomarkers for the risk of developing and presence of PAD. Thrombospondin-4 (TSP-4) is an extracellular matrix protein of the vessel wall. Despite bench evidence, its significance in the clinical setting of chronic kidney disease (CKD) is missing Methods: This is a cross-sectional, single-center study. A cohort of 450 patients aged 20 or over, who have been on HD for at least 3 months prior to enrollment (Dec 1, 2021) will be included. TSP-4 and TSP-1 will be measured in HD patients using a commercially available ELISA. PAD is diagnosed by the ankle-brachial index (ABI) We will measure related blood biomarkers such as serum hs-cTnT, N-terminal probrain natriuretic peptide, s-Klotho and FABP-4.

NCT ID: NCT04735705 Completed - Clinical trials for Vaginitis and Vulvovaginitis

Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis

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

CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron Ovules® in the Local Treatment of Non-Specific or Endogenous, Symptomatic Vaginitis. The primary objective is to assess the therapeutic performance and tolerability of Cerviron® Ovules in patients with symptomatic, non-specific, non-infectious vaginitis, and endogenous symptomatic infections. The secondary objective of this clinical investigation is the assessment of performance of the medical device by several additionally clinical outcomes (vaginal discharge, vaginal pH, microscopic characteristics of inflammatory cells and characteristics of vaginal microflora). Participants will also evaluate the degree of satisfaction related to the use of the medical device.

NCT ID: NCT04736056 Completed - Clinical trials for Hematologic Malignancy

Mindfulness and CBT for Sleep

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

Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy. Poor sleep quality can contribute to and perpetuate problems with daytime fatigue, pain, and distress that are common among patients with hematologic cancer. There is a need for behavioral interventions that address insomnia and daytime fatigue, pain, and distress once hematologic cancer patients have returned home after inpatient chemotherapy. Mindfulness-Based Therapy for Insomnia (MBTI) is a new approach to treating insomnia. This group-based intervention combines sleep restriction and stimulus control with mindfulness principles and exercises to reduce worry and promote positive responses to insomnia. To date, MBTI has not been applied to patients with hematologic cancer. If MBTI is to meet the needs of hematologic cancer patients, it must be adapted in several ways. First, because hematologic cancer patients are immunosuppressed, MBTI needs to be adapted for one-to-one delivery. Second, because hematologic cancer patients experience significant daytime fatigue, pain, and distress, MBTI needs to be adapted to include systematic training in coping skills for these symptoms. The investigators propose to develop and pilot test an adapted MBTI (MBTI+) protocol for hematologic cancer patients reporting insomnia, fatigue, pain, and/or distress after inpatient chemotherapy. The study will be conducted in two phases. In Phase I, the study team will use focus groups with hematologic cancer patients and hematology-oncology providers to guide development along with user testing with hematologic cancer patients reporting insomnia and daytime symptoms of fatigue, pain, and/or distress. Phase II will involve a small single-arm pilot to examine the feasibility, acceptability, and examine pre- to post-intervention primary (insomnia) and secondary (fatigue, pain, distress, mindfulness, self-efficacy) outcomes of the MBTI+ protocol. MBTI+ will consist of six, 60- to 75-minute therapy sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.