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NCT ID: NCT04846283 Completed - Anastomotic Leakage Clinical Trials

Drainage Fluid Biomarkers and Anastomotic Leakage in Colorectal Surgery. A Monocentric Prospective Observational Study

ALbiomarkers
Start date: June 1, 2018
Phase:
Study type: Observational

Anastomotic leakage (AL) is one of the most feared intra-abdominal septic complications (IASC) after colorectal surgery. It is defined as the leak of intestinal content due to an anastomotic dehiscence. Incidence ranges from 2% to 20%. AL is usually associated to systemic inflammatory response, even if in some cases the presentation may be subclinical. Therefore, AL is suspected in patients with a strong inflammatory response and can be confirmed by imaging with contrast enhanced computed tomography (CT) scan or water-soluble contrast studies. Nevertheless, imaging has varying sensitivity and specificity and is usually performed once the patient has a clinical evidence, thus potentially delaying the correct timing for surgery. Despite several studies about this topic and the plenty of known risk factors as mentioned above, AL is still not easy to predict. Different tools other than imaging have been studied in order to make diagnosis of AL at an early stage, as the measurement of some biomarkers of inflammation in serum and in drainage fluid. Biomarkers as white cell blood count (WBC), C-reactive protein (CRP), cytokines (e.g. TNFa, IL-6, IL-1b), markers of ischemia (e.g. lactate) and procalcitonin (PCT) have been used for an early detection of AL and other intra-abdominal septic complications. The primary aim of our study was to assess the role of drainage fluid CRP and lactate-dehydrogenase (LDH) in the early detection of anastomotic leakage.

NCT ID: NCT04845971 Recruiting - COVID-19 Pneumonia Clinical Trials

Efficacy and Safety of Oral Immunotherapy With GcMAF in Hospitalized Patients With COVID-19 Pneumonia

COral-MAF1
Start date: November 5, 2020
Phase: Phase 2
Study type: Interventional

As of August 16, 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been responsible for more than 21 294 000 infections and about 760 000 deaths worldwide. Accumulating evidence suggests that patients with severe acute COVID-19 pneumonia have a cytokine storm syndrome, or unbalanced hyper-inflammatory response. It is now well known that GcMAF plays a crucial role in immune system regulation as a primary defense against infections. Thus, this multifunctional protein, released into the blood stream, acts as a systemic immune modulator without pro-inflammatory activities. In an animal study, IL-6 level was shown to be dramatically decreased after 21 days of oral administration colostrum MAF. Indeed, data from previous studies and clinical practice have been reported its effectiveness and safety in the treatment of many pathologies such as infectious diseases, some types of cancer, juvenile osteopetrosis, immunological, and neurological diseases. These observations suggest that oral immunotherapy with colostrum-MAF is potentially an effective and well-tolerated treatment for COVID-19 pneumonia. In addition, gastrointestinal involvement is well known in coronavirus infections of animals and humans. The angiotensin-converting enzyme II (ACE2), the entry receptor for SARS-CoV, is highly expressed in proximal and distal enterocytes that are directly exposed to foreign pathogens. It considers the mechanism of SARS-CoV-2 can actively infect and replicate in the gastrointestinal tract. SARS-CoV-2 indirectly damages the digestive system through a chain of inflammatory responses. Delivered topically to the small intestine by an acid-resistant enteric-coated capsule colostrum MAF can directly activate a large number of gut mucosal macrophages for virus control, localizing intestinal inflammation and resolving through driven phagocytic scavenger function. Macrophages in the gastrointestinal mucosa represent the largest pool of tissue macrophages in the body, which besides the local functions are directing the systemic immune response.

NCT ID: NCT04845893 Not yet recruiting - Clinical trials for Ewing Sarcoma of Bone

Observational Study on Skeletal Ewing's Sarcoma

EWOss
Start date: May 25, 2021
Phase:
Study type: Observational

Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by skeletal Ewing Sarcoma

NCT ID: NCT04845425 Active, not recruiting - Endometrial Cancer Clinical Trials

Analysis of miRNA Expression in Endometrial Cancer

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

The TCGA project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompasses POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as No Specific Molecular Profile (NSMP). Although the prognostic value of TCGA molecular classification, NSMP carcinomas present a wide variability in molecular alterations and biological aggressiveness. Given that the study aims to evaluate the miRNA expression profile to identify novel potential biomarkers to better stratify the EC patients, taking into account the molecular status

NCT ID: NCT04844632 Recruiting - Clinical trials for Health Care Utilization

COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

SAPIENZAVAX
Start date: February 11, 2021
Phase:
Study type: Observational

Primary objective: 1. Monitor adverse events (Adverse Event Following Immunization - AEFI) in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities. Secondary objectives: 1. Monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities. 2. Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination. 3. Evaluate the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection; 4. Evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus; 5. To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees. Methodology: 1. Administration at baseline of a questionnaire for the collection of clinical data. 2. Perform a blood sample to measure antibody response in vaccinated subjects 3. Administer a questionnaire to evaluate adverse events after vaccination 4. Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination 5. An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine. 6. In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity. 7. In the event that a subject participating in the study presents during the course of the observation the positivity for the molecular research of SARS-CoV-2 RNA to the oro-nasopharyngeal swab, a new sample will be performed and sent to the Istituto Superiore di Sanità for the search for viral variants.

NCT ID: NCT04843436 Not yet recruiting - Open Surgery Clinical Trials

RASM Post Market Clinical Follow Up Study

RASM PMCF
Start date: April 13, 2021
Phase: N/A
Study type: Interventional

Post Market Clinical Follow up Study aimed to collect clinical data on safety and efficacy of Robotically Assisted System called Symani to perform microsurgery techniques such as anastomosis, suturing and ligation for open surgery procedures on small anatomical structures such as blood vessels, lymphatic ducts and nerves.

NCT ID: NCT04843072 Not yet recruiting - Valve Heart Disease Clinical Trials

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

BASELINE
Start date: May 2021
Phase: N/A
Study type: Interventional

Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses. Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success. Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro. Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus. Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by - Absence of procedural mortality AND - Correct positioning of a single prosthetic heart valve into the proper anatomical location AND - Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.

NCT ID: NCT04842955 Recruiting - Alzheimer Disease Clinical Trials

Modulators of Gamma tACS in Alzheimer's Disease (Mod-GammAD)

Mod-GammAD
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

Brain oscillations are ubiquitous in the human brain and have been implicated in cognitive and behavioral states defined in precisely tuned neural networks. In neurodegenerative disorders, neurodegeneration is accompanied by changes in oscillatory activity leading to the emerging concept of neurological and psychiatric disorders as "oscillopathies". Alzheimer's disease, which accounts for the vast majority of age-related dementias, is characterised by a prominent disruption of oscillations in the gamma frequency band. The restoration of gamma oscillations by neural entrainment in animal models of Alzheimer's disease have shown a remarkable decrease in the pathological burden of amyloid and tau via increased microglial activity, resulting in a significant increase of cognitive performances. Transcranial alternating current brain stimulation (tACS), is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that is having an increasingly numerous spectrum of potential therapeutic applications. Recent studies have demonstrated the effectiveness of this method in modulating the natural frequencies of cerebral oscillation, underlying multiple cognitive processes such as verbal memory, perception and working memory. On the basis of these premises, the treatment with gamma tACS is proposed in patients affected by Alzheimer's disease. In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate the modulators of response on cognitive measure to a single stimulation with gamma tACS on the posterior parietal cortex in patients with Mild Cognitive Impairment due to Alzheimer's disease.

NCT ID: NCT04842916 Active, not recruiting - Gastric Cancer Clinical Trials

InteGRAtive Analysis of tuMor, Microenvironment, immunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer

GRAMMY
Start date: September 22, 2020
Phase:
Study type: Observational

Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.

NCT ID: NCT04842409 Not yet recruiting - Breast Cancer Clinical Trials

Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery

SAFE-FORWARD
Start date: May 2021
Phase:
Study type: Observational

SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy is allowed. Main exclusion criteria are mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost. All enrolled patients will be prospectively monitored for 12 months, receiving a complex cardiological assessment before radiation therapy (RT) start (baseline), and at 2-, 6-, and 12-month after RT end of treatment. Both acute- , defined as adverse events recorded within the first 90 days since RT start, and early-late toxicity, will be scored according to EORTC (European Organisation for Research and Treatment of Cancer)/Radiation Therapy Oncology Group (RTOG) and CTCAE (v.5) scales. Patients will undergo six-monthly follow-up clinical visits for the first 5 years and annual follow-up visits thereafter up to 10 year, as per clinical local practice. Breast cosmesis will be evaluated through the use of BCCT.core tool and assessment of the health-related quality of life will be performed through the EORTC quality of life questionnaire (QLQ) C30 and BR45 modules questionnaires at baseline, at the end of RT treatment, at 2- and 6-month.