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NCT ID: NCT04700553 Not yet recruiting - Stroke Clinical Trials

Localized Muscle Vibration Post Stroke

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Background and objectives: Lower extremity functional impairments are common consequences of stroke. Thus, continuous examination of effective treatment interventions for lower extremity functions after stroke is a necessity. Localized muscle vibration (LMV) is one of the treatment interventions that incorporate sensory stimulation to improve motor cortical excitability. This study aimed to investigate the influences of 10-minutes lower extremity LMV application along with conventional physical therapy (CPT) on activities of daily living (ADL) and motor recovery on the hemiparetic lower extremity post-stroke. Methods: A sample of 37 patients with stroke (8 females) was randomly allocated to either conventional physical therapy (CPT) control group (n=18) or conventional physical therapy and localized muscle vibration (CPT+LMV) experimental group (n=19). All patients received 3 sessions per week of CPT for 8 weeks. The CPT+LMV experimental group received 10-minute LMV at the end of each CPT session. The outcome measures used were the Barthel Index (BI), Berg Balance Scale (BBS), and goniometry for Range of Motion (ROM) assessment.

NCT ID: NCT04673305 Not yet recruiting - Clinical trials for Cognitive Impairment

Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies

Start date: March 2021
Phase: N/A
Study type: Interventional

BACKGROUND Neurocognitive symptoms have a high prevalence in cancer patients, resulting in a significant impact on daily life and tolerance to therapy. It's estimated that about 30% of cancer patients present a cognitive impairment before treatment, about 75% present this cognitive impairment during the treatment, and about 35% continue to present cognitive difficulties in the following months/years. There is growing evidence that cognitive symptoms have a biological mechanism linked to the activation of immunological cytokines that exert important effects on the brain functions. For example, interferon α is known to increase the levels of IL-1, IL-6 and TNF-α, and this increase is associated with memory deficits, executive function and mood alterations. A neurotoxic action induced by cytokines has been demonstrated both in the early stages of the tumor and after chemotherapy. Several imaging studies suggest that the cognitive impairment pattern in cancer patients, during the treatment and in remission, is related to structural and functional brain changes. Longitudinal studies in women with breast cancer treated with chemoterapy have shown a reduction in the volume of cerebral gray matter, mainly in the bilateral frontal cortex and hippocampus. In parallel, diffusion tensor imaging studies have shown an alteration of the integrity of the frontal, parietal and occipital cerebral white matter, demyelination and axonal degeneration processes. Finally, functional magnetic resonance studies in cancer patients have shown alterations in the connectivity of the default mode network compared to control subjects. Studies carried out to date, show a prevalent impairment of executive functions and working memory. Cognitive impairment has been studied mainly as a possible adverse effect in women treated with chemotherapy for breast cancer, while there are few studies in the literature on patients with haematological malignancies. STUDY DESIGN The study is targeted to patients ages ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months. Once the eligibility criteria have been assessed, the hematologist proposes the enrollment in the study. Once the patient's informed consent has been acquired, a neurological examination is carried out, functional tests required by the protocol are administered. The patient begins, as per clinical practice, the treatment provided for his/her haematological malignancy. Test's evaluation is repeated at 6 months and 12 months after the enrollment. In conjunction with neurological tests, will be performed a venipuncture as per clinical practice, and a blood sample is taken to measure the cytokines involved in inflammatory processes. It is expected that a patient can perform up to a maximum of 3 blood samples for the biological study. STATISTICAL ANALYSIS This is a non-pharmacological, prospective, uncontrolled, open-label single-center interventional pilot study, aimed to describ the progress of cognitive function under treatment for haematological disease. Due to the pilot and exploratory nature of the study and the substantial absence of a specific literature relating to the elderly onco-haematological patient, it is not believed that the conditions exist to be able to formally define the size of the sample. The sample size is arbitrarily fixed at 60 patients. The observation time will be 12 months from enrollment.

NCT ID: NCT04666883 Not yet recruiting - Colon Cancer Clinical Trials

Splenic Hilar Nodes in Splenic Flexure Cancer

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

Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours.

NCT ID: NCT04664413 Not yet recruiting - Clinical trials for Papillary Thyroid Cancer

Percentage of BRAFV600E Alleles and Outcome in Thyroid Carcinoma

ABOUT
Start date: February 1, 2021
Phase:
Study type: Observational

BRAFV600E is the most frequent oncogene in Papillary thyroid carcinoma (PTC). It correlates with greater extension, lymph node metastasis, and advanced stage. However, the prognostic value of BRAFV600Eis weak and the search of this mutation is not recommended in clinical management of thyroid cancer. PTC are characterized by intratumor heterogeneity with wild-type and BRAFV600E tumoral cells. In a previous study, the BRAFV600E/BRAFwild-type ratio correlated with patient age, tumor volume, lymph node metastasis and with worst disease outcome. While the existence of intratumor heterogeneity in PTC is supported by many evidences, its extension, biological significance and clinical utility is questioned and must be further investigated. Primary endpoint of the study is to determine the relationship between the percentage of BRAFV600E alleles and outcome in PTC patients. Secondary endpoints are to determine the mean and median BRAFV600E/BRAFwild-type allele ratio in heterogeneous tumors; determine the relationship between the percentage of BRAFV600E alleles and clinicopathological features. The study protocol entails the assessment by digital-droplet PCR the BRAFV600E/BRAFwild-type allele ratio in a series of PTC and its correlation with clinicopathology features and outcome.

NCT ID: NCT04649944 Not yet recruiting - Covid19 Clinical Trials

Serological Profile of Children and Young Adolescents With at Least One COVID-19 Diagnosed Family Member

Start date: February 5, 2021
Phase:
Study type: Observational

Use of rapid serological tests to assess the vulnerability to SARS-CoV-2 infection of subjects aged 4-16 years old and cohabiting with at least one family member who tested positive to SARS-CoV-2

NCT ID: NCT04649645 Not yet recruiting - Clinical trials for Periodontal Diseases

Changes in Oral Health in Tobacco Cigarettes Smokers After Switching to Combustion-Free Nicotine Delivery Systems

SMILE
Start date: February 28, 2021
Phase: N/A
Study type: Interventional

Although the well-known detrimental effects of conventional cigarette smoking on oral health, there are still lack of evidences about the impact of less harmful alternatives (such as electronic cigarettes or heat not burn products), especially in young smokers with clinical absence of signs of moderate to severe periodontitis. This study aims to investigate whether cigarette smokers who switch to combustion-free nicotine delivery systems (C-F NDS) undergo measurable improvements in oral health parameters and teeth appearance, comparing short- and long-term impact on periodontal health between smokers continuing with conventional cigarette smoking, those switching to combustion-free nicotine delivery systems (C-F NDS), and never-smokers. The investigator propose a prospective, multicenter, interventional, open label, randomized, controlled, three parallel-arms study assessing oral health parameters and teeth appearance of 18 months duration.

NCT ID: NCT04643054 Not yet recruiting - Covid19 Clinical Trials

Efficacy and Safety of Ovotransferrin in COVID-19 Patients

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Chicken egg consists of three main components, egg white (56%), yolk (33%) and shell (11%). The key component of egg white is 88 percent water and 12 percent solids, of which over 90 percent are protein. Ovalbumin, ovotransferrin, and ovomucoid are considered the main proteins, while ovomucin, lysozyme, ovoglobulin, ovomacroglobulin, ovoglycoprotein, ovoflavoprotein, thiamin-binding proteins, ficin/papain inhibitors, avidin, and cystatin are the minor white proteins of the embryo. These proteins and their peptides have been recognized as antioxidants, antimicrobials, metal-chelators, anti-viral, anti-tumor, and angiotensin-converting enzyme (ACE)-inhibitors for their functional significance SARS-CoV-2 virus activates the human cell ACE2 receptor, triggering a series of deleterious events. In COVID19, renin-angiotensin is upregulated and the pathway is overexpressed and a progressive cytokine storm is always observed. In all these pathogenic processes, ovotransferrin could play a modifier function to enhance the condition. Ovotransferrin can be beneficial to the antioxidant effects of Angiotensin II by inhibiting NF-kB. Ovotransferrin is an immunomodulator that downregulates pro-inflammatory cytokines including TNF-α, IL-6, and IL-1 that could extinguish the cytokine storm. Ovotransferrin can also serve as a protective agent against COVID19 cardiotoxicity due to disruption in the ACE2-mediated signaling pathway, cytokine storm, pulmonary dysfunction, and side effects of medications. In patients with coronavirus infection, provided ovotransferrin's possible protective effects, it is suggested as a supportive and therapeutic alternative. Given this background, in the light of the current COVID-19 emergency, it is the intention of the investigators to conduct a prospective, randomized, open-label, controlled study in the cohort of hospitalized patients with covid-19 pneumonia, administering 200 mg of ovotransferrin orally in addition to the standard of care therapy (SOC). The investigators hypothesize that the use of ovotransferrin will be associated with an earlier improvement of clinical and humoral parameters after 10 days of ovotransferrin treatment when compared to the group of patients provided with standard care.

NCT ID: NCT04642209 Not yet recruiting - Anesthesia Clinical Trials

Aggregometry in Elderlies With Hip Fracture and Receiving Clopidogrel

Start date: December 1, 2020
Phase:
Study type: Observational

In elderly patients, hip fracture should be surgically treated within 48 hours from admission, since its deferral worsens the mortality. However, sometimes patients are affected by cardiovascular or cerebral comorbidities, deeming necessary the use of antiplatelets and/or anticoagulant therapies. Clopidogrel is a second-generation thienopyridine antiplatelet drug which exerts its effect by the inhibition of the platelet's purinergic receptor P2Y12 preventing adenosine diphosphate (ADP) from stimulating it. Guidelines recommend to withhold clopidogrel for 5 days before the possibility to perform neuraxial anesthesia, which is frequently the optimal perioperative management of a fragile patient. It should be mentioned however that around 30% of patients are resistant to clopidogrel and they show a normal platelet reactivity despite the antiplatelet therapy. Therefore, in principle, these patients do not require to defer surgery. We have therefore hypothesized that some patients taking clopidogrel might anticipate surgery before 5 days and within 48 hours, following a protocol based on the assessment of coagulation and platelet aggregation through thromboelastography (TEG) in combination with an ADP Platelet Mapping assay kit. After hospital admission for femur fracture, eligible patients would be evaluated by the anesthesiologist and the orthopedic physicians for anesthesia and surgery. Immediately a sample of blood should be collected for TEG with ADP Platelet Mapping test. If both MA-ADP and platelets aggregation (%) will be within normal values, the patient could be considered as candidate for immediate surgery (within 48 hours) with neuraxial anesthesia and ultrasound-guided antalgic femoral nerve block. If MA-ADP and/or platelets aggregation (%) are lower, risk for mortality should be assessed. If the patient would be considered at high risk for mortality, he/she would undergo to general anesthesia and peripheral antalgic block to not postpone surgery. Otherwise, surgery would be postponed until the normalization of both MA-ADP and platelet aggregation.

NCT ID: NCT04641585 Not yet recruiting - Brugada Syndrome 1 Clinical Trials

Brugada Syndrome and Artificial Intelligence Applications to Diagnosis

BrAID
Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Aim of the project is the development of an integrated platform, based on machine learning and omic techniques, able to support physicians in as much as possible accurate diagnosis of Type 1 Brugada Syndrome (BrS).

NCT ID: NCT04632355 Not yet recruiting - Covid19 Clinical Trials

Musculoskeletal Pain in Patients With Covid-19 Who Have Hospital Care

Covid19-Pain
Start date: December 1, 2020
Phase:
Study type: Observational

Worldwide, the COVID-19 pandemic continues to grow. Although COVID-19 mainly affects the lungs and internal organs, musculoskeletal injury from this disease was reported with the presentation of marked elevation in creatine kinase and lactate dehydrogenase levels. Patients with post-acute COVID-19 are considered patients with a post-intensive syndrome (PICS) that results in loss of functional independence. In the physical and rehabilitation medical field, various modalities with therapeutic exercise can be used to manage pain by a physical therapist and psychiatrist. Pain management is particularly important during the COVID-19 pandemic because of the reduced accessibility to hospitals and medical resources.