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NCT ID: NCT04123106 Completed - Pain, Postoperative Clinical Trials

Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery.

Start date: May 11, 2020
Phase: N/A
Study type: Interventional

Postoperative pain still represents an important perioperative issue, affecting more than 80% of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of life, but can compromise rehabilitation plan, increase morbidity and determine the development of chronic pain. Last but not least, far from being just an obligation for physicians, a good analgesia is a fundamental right of every patient. In order to meet these important demands, a great number of guidelines has been provided, all of these underlying that the centerpiece of postoperative analgesia lies in the multimodality management, thereby combining different medications and different ways of delivering them, with the aim of targeting distinct receptor systems and improving efficacy, while limiting side effects. In 2018, the investigators conducted a case-series analysis on 17 patients undergoing lumbar surgery to find out the role of Sublingual Sufentanil Tablet System (SSTS) in a multimodal analgesia regimen. Patients expressed a good pain relief, with most benefit during physiotherapy sessions and early discharges, in absence of side effects. Since then, SSTS has been part of regular clinical practice in our hospital. The aim of this randomized trial is to examine the analgesic efficacy and the opioid sparing role in spine surgery of a recently developed regional anesthesia technique, the Erector Spinae Plane block (ESP block), as opposed to Local Anaesthetic (LA) wound infiltration. The latter is a widespread, simple and unexpensive mean of providing postoperative analgesia. On the other hand, ESP block is an ultrasound-guided interfascial plain block, in which LA is injected below the erector spine muscle, closer to costotransverse foramina and origin of dorsal and ventral rami. It does provide an efficient multidermatomal sensory blockade (according to craniocaudal LA spread), with the advantage of being simple and safe.

NCT ID: NCT04122976 Active, not recruiting - Prostate Cancer Clinical Trials

A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

DAROL
Start date: January 30, 2020
Phase:
Study type: Observational

The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.

NCT ID: NCT04122937 Completed - Ovarian Cancer Clinical Trials

Defining Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.

CarFlog
Start date: March 1, 2017
Phase:
Study type: Observational [Patient Registry]

Inflammation plays an important role in the pathogenesis of peritoneal carcinosis. Patients with elevated levels of different inflammation cytokines show a worse prognosis at the time of diagnosis. In women, ovarian and colon cancer are the main causes of peritoneal carcinosis and a comparison of these two different types of peritoneal invasion have not been conducted yet. We found interesting studying the role of immune response, in particular tumour-associated antigens (TAA) that modulate the metastatic process. We will investigate also mitochondrial defects, such as mutations in mt-DNA, potentially involved in carcinogenesis.

NCT ID: NCT04122911 Completed - Clinical trials for Neuroendocrine Carcinomas

Temozolomide for Second-Line Treatment of Neuroendocrine Carcinomas

TENEC
Start date: January 29, 2017
Phase: Phase 2
Study type: Interventional

To assess the efficacy and safety of Temozolomide for second-line treatment of Neuroendocrine Carcinomas progressing after first-line Platinum-based therapy.

NCT ID: NCT04122612 Completed - Clinical trials for Microbial Colonization

Shaping Microbiome in the First 1,000 Days of Life

AMAMI
Start date: September 23, 2018
Phase:
Study type: Observational

Events occurring in the early stages of life play an important role in the development of chronic diseases; diet and lifestyle during pregnancy are recognized to be crucial determinants in modulating offspring microbiota, throughout a vertical transfer of dysbiotic maternal ambient. Moreover, the intestinal colonization is maximized in the first two years of life through newborn's type and time of feeding. This study will provide the starting point for a future prospective observational study to assessing the association between maternal lifestyle with infant microbiota and their influence future health.

NCT ID: NCT04121832 Completed - Clinical trials for Biofeedback, Psychology

Biofeedback Training, Efficacy Evaluation of Fibromyalgia Treatment, a Pilot Study

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management. In fibromyalgia. The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with fibromyalgia, and also to verify improvement induced by the technique in relation to: Quality of life; Quality of sleep; Perception of pain; Depressive symptomatology; Anxious symptomatology.

NCT ID: NCT04121520 Completed - Portal Hypertension Clinical Trials

Perioperative Care of HVPG Measurement (CHESS1904): An International Multicenter Survey

Start date: October 16, 2019
Phase:
Study type: Observational

Hepatic venous pressure gradient (HVPG) is an invasive test and requires technical skills of the operator and specialized instruments. HVPG measurement and anesthesia can cause stress responses in the body, which in turn lead to inflammatory response and immune function suppression. Thus, the perioperative care for patients undergoing HVPG measurement is crucial. This research trial studies comprehensive patient and medical worker questionnaires in predicting complications in patients with cirrhosis undergoing HVPG measurement. Comprehensive patient and medical worker questionnaires may help identify complications, such as the need for assistance in taking medication, decreased mobility and released tension that may improve outcomes.

NCT ID: NCT04121065 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)

Start date: September 7, 2020
Phase:
Study type: Observational

Multiple Sclerosis (MS) is a chronic autoimmune demyelinating disease of the central nervous system (CNS), which is highly heterogeneous in terms of clinical symptoms, MS subtypes and treatment response. In each patient with MS, inflammatory, neurodegenerative and reparative processes are intermingled in different proportions, making the disease course unpredictable and the treatment approach challenging. Although MS etiology is still unclear, many studies have demonstrated that T and B cells are crucial cellular determinants of MS pathophysiological processes. Auto-reactive T lymphocytes have been also implicated in excitotoxic synaptopathy, an early hallmark of MS recently emerged to link inflammation and neurodegeneration in a complex and inter-regulated circuit. In addition, several reports published in the last few years show the presence of a link between metabolism and immune responses. Indeed, it is now clear that cell metabolism is able to control T cell survival, growth, activation and differentiation. It has been reported that distinct metabolic pathways are able to support specific T cell activities suggesting that the delicate balance among glycolysis, fatty acid oxidation (FAO) and mitochondrial respiration drives specific effector (Tconv) and regulatory T cell (Treg) differentiation and functions. The individual response to treatment varies widely and their use may be burdened by side effects and major adverse events. An explanation of the clinical and pharmacological individual variability can be sought in the pathological heterogeneity and in different genetic, immunological and metabolomics profiles. With this perspective, the lack of a single predictive or diagnostic test remains a great obstacle in the management of MS at most stages and in the choice of the therapy. Consequently, the availability of biomarkers that reliably capture the different aspects of the disease could be extremely useful.

NCT ID: NCT04120935 Recruiting - Colorectal Cancer Clinical Trials

ALFAOMEGA Master Observational Trial

ALFAOMEGA
Start date: October 15, 2019
Phase:
Study type: Observational

AlfaOmega has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of CRC patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improval). This clinical resource for integrative clinical data and sample collection will allow the molecular story-telling of CRC metastatic spread along time and space and the selection of appropriate patients for experimentally-driven trials.

NCT ID: NCT04119843 Completed - Clinical trials for Severe Renal Impairment

Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

SPARKLE
Start date: February 19, 2020
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.