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NCT ID: NCT04513405 Not yet recruiting - Estrogen Deficiency Clinical Trials

Estrogens Levels and Receptors Status and Skin Tears

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

Background: Skin tears (ST) or "laceration injuries" or "flap wounds" are injuries that are often found in residents of residential care facilities (RCFs). STs were first defined by Payne and Martin in 1993 as traumatic wounds, located mainly in the upper limbs, caused by "shearing, friction or mechanisms combined with the consequent separation of layers of skin. Skin Tears can cause psychological problems for the patient and represent an economic problem with important repercussions on both the patient and the community. The etiology suggests that the physiological changes of the skin related to old age, together with comorbidity, are among the main risk factors for their onset. The precise data on the phenomenon are not many, but it is estimated that STs are much more frequent than the same pressure ulcers, observing prevalence rates in RCFs around 40% Therefore, there are several risk factors hypothesized so far. Much evidence has correlated, in various physiological or pathological conditions, the role of estrogens with the functions and aging of the skin. Objectives: The project will develop on the analysis of populations of residents from RCFs belonging to the national territory. Two populations of residents cared in the RCF will be recruited. A group of subjects suffering from skin tears (group A) and a control group of subjects without skin tears (group B). The inclusion of patients in both groups will take place through a simple randomization procedure. Group A patients will be staged according to the STAR classification for skin tears. For each group a peripheral venous blood sample will be taken (to measure the levels of estrone and estradiol) and a skin biopsy will be performed in order to measure estrogen receptors (ERs) expression. A data collection sheet with angraphic and anamnestic data will be developed to correlate the demographic and comorbidity data with the clinical conditions of the patients and with the laboratory findings from the sampling. Expected results: The primary endpoint will be the correlation between serum estrogen levels, receptor expression and the presence of skin tears. The secondary endopoint will be Correlation between receptor structure and clinical staging of skin tears. Future prospectives: We believe that our study may open new frontiers in the prevention and in the management of these skin lesions.

NCT ID: NCT04469829 Not yet recruiting - Metabolic Syndrome Clinical Trials

Methotrexate Versus Secukinumab Safety in Psoriasis Patients With Metabolic Syndrome

Start date: August 1, 2020
Phase: Phase 4
Study type: Interventional

A prospective, controlled, open trial in psoriasis patients with metabolic syndrome, candidate to methotrexate or secukinumab was conducted between January 2019 and May 2020. The primary end point of the study was investigating any variations in waist circumference, body mass index (BMI), blood pressure, fasting glucose, total cholesterol, low density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine levels between baseline and month-6 and 12 of follow-up.

NCT ID: NCT04446533 Not yet recruiting - Periodontitis Clinical Trials

Effect of a Hydrogen-Peroxide and Hyaluronic-Acid Mouthwash (BMG0703) in the Treatment of Periodontitis

Start date: June 2020
Phase: Phase 3
Study type: Interventional

Assessment of the efficacy of BMG0703 in the treatment of periodontitis and control of supragingival plaque, compared to Chlorhexidine and a placebo product

NCT ID: NCT04445623 Not yet recruiting - COVID19 Clinical Trials

Prasugrel in Severe COVID-19 Pneumonia

PARTISAN
Start date: July 2020
Phase: Phase 3
Study type: Interventional

Inflammatory diseases favour the onset of venous thromboembolic events in hospitalized patients. Thromboprophylaxis with a fixed dose of heparin/low molecular weight heparin (LMWH) is recommended if concomitant inflammatory disease. In severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pneumonia an inflammation-dependent thrombotic process occurs and platelet activation may promote thrombosis and amplify inflammation, as indicated by previous experimental evidence , and the similarities with atherothrombosis and thrombotic microangiopathies. Antiplatelet agents represent the cornerstone in the prevention and treatment of atherosclerotic arterial thromboembolism, with limited efficacy in the context of venous thromboembolism. The use of purinergic receptor P2Y12 inhibitors in pneumococcal pneumonia may improve inflammation and respiratory function in humans. There are no validated protocols for thrombosis prevention in Covid-19. There is scientific rationale to consider a P2Y12 inhibitor for the prevention of thrombosis in the pulmonary circulation and attenuation of inflammation. This is supported by numerous demonstrations of the anti-inflammatory activity of P2Y12 inhibitors and the evidence of improvement in respiratory function both in human and experimental pathology. Prasugrel could be considered as an ideal candidate drug for Covid-19 patients because of higher efficacy and limited Interactions with drugs used in the treatment of Sars-CoV2. The hypothesis underlying the present study project is that in Covid-19 platelet activation occurs through an inflammation-dependent mechanism and that early antithrombotic prophylaxis in non-critical patients could reduce the incidence of pulmonary thrombosis and respiratory and multi-organ failure improving clinical outcome in patients with SARS-CoV2 pneumonia. The prevention of thrombogenic platelet activity with a P2Y12 inhibitor could be superior to fixed dose enoxaparin alone. The proposed treatment is feasible in all coronavirus disease 2019 (COVID-19) patients, regardless of the treatment regimen (antivirals, anti-inflammatory drugs, antibiotics), except for specific contraindications.

NCT ID: NCT04438434 Not yet recruiting - Clinical trials for Impacted Third Molar Tooth

Evaluation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Healing of Post-extraction Sites

Start date: June 2020
Phase: Phase 3
Study type: Interventional

A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the healing of post-extraction sites of wisdom teeth by film forming action.

NCT ID: NCT04438421 Not yet recruiting - Gingivitis Clinical Trials

Efficacy of Hyaluronic-acid and Hydrogen-Peroxide Mouthwash in Gingivitis Treatment

Start date: June 2020
Phase: Phase 3
Study type: Interventional

A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the prevention and management of complications associated gingivitis by film forming action.

NCT ID: NCT04437901 Not yet recruiting - Atrial Fibrillation Clinical Trials

COVIDAR - Arrhythmias in COVID-19

COVIDAR
Start date: June 2020
Phase:
Study type: Observational [Patient Registry]

BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population. MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection. STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected. STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.

NCT ID: NCT04430998 Not yet recruiting - Pain Clinical Trials

Efficacy of Zinc L-Carnosine Mouth Rinse

Start date: June 2020
Phase: Phase 3
Study type: Interventional

A clinical trial to assess the effect of a Zinc-L-Carnosine-based mouth rinse on periodontal tissues and pain after scaling and root planing

NCT ID: NCT04413747 Not yet recruiting - Clinical trials for Coronavirus Infection

Yoga Pranayama Adjuvant to Treat Burden COVID-19

YOCO
Start date: August 15, 2020
Phase: N/A
Study type: Interventional

COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing . In both cases, the causal link is coronavirus within the host response. The rationale of use of deep yoga breathing as adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory cytokines overproduction and contextual lowering of the sympathetic stress response as a first cause of sleep and late mental disorders which can increase the annual suicide rate. An easily breathing medical Yoga protocol has been developed to test a cost-effective care provision, training, contact tracing and mass efficacy testing.

NCT ID: NCT04408235 Not yet recruiting - COVID Clinical Trials

High Versus Low LMWH Dosages in Hospitalized Patients With Severe COVID-19 Pneumonia and Coagulopathy

COVID-19 HD
Start date: June 2020
Phase: Phase 3
Study type: Interventional

Randomized, controlled study conducted in hospitalized patients with severe COViD-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation. Aim of this study is to assess whether high doses of Low Molecular Weight Heparin (LMWH) (ie. Enoxaparin 70 IU/kg twice daily) compared to standard prophylactic dose (ie, Enoxaparin 4000 IU once day) are: 1. More effective to prevent clinical worsening, defined as the occurrence of at least one of the following events, whichever comes first, during hospital stay: 1. Death 2. Acute Myocardial Infarction [AMI] 3. Objectively confirmed, symptomatic arterial or venous thromboembolism [TE] 4. Need for either non-invasive - Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) - or invasive mechanical ventilation for patients who are in standard oxygen therapy by delivery interfaces at randomisation 5. Need for invasive mechanical ventilation for patients who are in non-invasive mechanical ventilation at randomisation 2. Similar in terms of major bleeding risk during hospital stay