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NCT ID: NCT03918876 Completed - Low Back Pain Clinical Trials

Translation and Psychometric Validation of an Italian Version of the Dance Functional Outcome Survey DFOS-IT

DFOS-IT
Start date: May 11, 2019
Phase:
Study type: Observational

Study Design: Evaluation of the psychometric properties of a translated, culturally adapted questionnaire. Objective: Translating, culturally adapting, and validating the Italian version of the Dance Functional Outcome Survey (DFOS-IT), allowing its use with Italian-speaking dancers to evaluate their musculoskeletal health and wellbeing inside and outside Italy. Summary of Background Data: Musculoskeletal injuries are a phenomenon of huge prevalence and has been a major focus within peer-reviewed literature since the 1980s. Growing attention is devoted to standardized outcome measures to improve interventions for injured dancers. A translated form of the DFOS, the only existing outcome measure that focus on the unique functional requirements of dancers, has never been validated within the Italian dancers population.

NCT ID: NCT03918759 Completed - Clinical trials for Non Functioning Pancreatic Endocrine Tumor

Diagnostic Accuracy of Preoperative Diagnostic Procedure in the Assessment of Lymph Node Metastases by NF-PanNENs

Start date: November 1, 2018
Phase:
Study type: Observational

Pancreatic Neuroendocrine Neoplasms (PanNEN) are a heterogeneous group of neoplasms that arise from the endocrine cells of the pancreatic gland. Non-functioning (NF-PanNEN) represents the most common forms and do not produce syndromes due to hormonal hypersecretion. Several prognostic factors have been demonstrated for NF-PanNEN. The presence of nodal metastasis and lymph node ratio are widely considered predictors of disease-free survival and even the number of positive nodes has been found to be associated with recurrence. In addition to traditional imaging exams, diagnostic work-up should include a Positron Emission Tomography/CT with 68Ga labeled somatostatin analogues, which have shown a high sensitivity and specificity while 18F-FDG PET can be associated for evaluating the possible presence of a high-grade component. Moreover, pancreatic endoscopic ultrasound (EUS) is usually part of the preoperative staging both for imaging details and cytological sampling. Therefore an accurate identification of nodal metastases preoperatively may have important implications for the extent of surgical resection and lymphadenectomy and even for a prognostic outcome. In this study the investigators will evaluate prospectively the accuracy of these diagnostic exams in detecting the lymph node status. Patients with sporadic NF-PanNEN who are candidates for surgical resection will undergo CE-CT scan, 68Ga DOTATOC (and eventually 18F-FDG) PET/MRI and EUS with FNA/B. Reference standard for defining the presence of nodal metastases is represented by pathological examination on the specimen.

NCT ID: NCT03918616 Completed - Clinical trials for Neuro-Degenerative Disease

P2X7 Receptor, Inflammation and Neurodegenerative Diseases

NeuroInfiam
Start date: February 20, 2017
Phase:
Study type: Observational

Parkinson disease (PD) is a chronic degenerative disease characterized by a progressive loss of dopaminergic neurons in the substantia nigra. Its pathophysiological mechanisms are still partially unknown; a main role seems to be played by chronic neuroinflammation. A few reports have addressed the possible involvement of the inflammasome in PD, just describing the protective effect of P2X7 purinergic receptor (P2X7R) blockers in murine models of the disease and in microglial cells, where NLRP3 is activated by α-Synuclein, triggering a neuroinflammation that contributes to degeneration of dopaminergic neurons. It is still unclear whether, in addition to the increased brain expression and function of the nucleotide-binding domain, leucine-rich repeat, pyrin domain containing type 3 (NLRP3) inflammasome platform, a systemic activation of such complex might participate in the pathogenesis of PD, which could be the role of the P2X7R in this scenario, and whether such patterns undergo any specific epigenetic regulation. The present study has been designed to address these issues.

NCT ID: NCT03918434 Completed - Plantar Fascitis Clinical Trials

Efficacy of a Locoregional Anesthesia Technique During Shock Wave Therapy

Start date: June 1, 2019
Phase:
Study type: Observational

Plantar fasciitis and the chronic Achilles tendinopathy are the most common causes of heel pain. The term "plantar fasciitis" implies an inflammatory condition by the suffix "itis". However, various lines of evidence indicate that this disorder is better classified as "fasciosis" or "fasciopathy", as heel pain associated with degenerative changes in the fascia and atrophy of the abductor minimi muscle. High energy shock wave therapy (HESWT) has been proposed as a potential method of treating patients with chronic disease without the need to stop weightbearing. Often a crucial complication of HESWT is the appearance of pain with the subsequent interruption of the procedure. The consequences are a reduced patient compliance, need of a deep sedation and more sessions for the treatment. Frequently, topic anesthesia (TA) (as EMLA) is applied during the therapy to decrease the pain HESWT-induced and enable sham treatment. Multiple publications focused on the evaluation of a clinically relevant effect of shock wave application on plantar heel pain, either of HESWT, applied in a single session with local or regional anesthesia or of low energy HESWT, applied repetitively without local anesthesia. Rompe JD and colleagues have demonstrated that the therapeutic success rate of HESWT with TA is significantly smaller than without TA even after 3 months. Probably, the use of anesthetic topically applied can reduce the efficacy of HESWT for increased impedance. To date, many patients interrupted the HESWT for moderate-severe pain. Consequently, this therapy, which generally is administered in three sessions, required a prolongation of procedure up to six sessions.The clinical application of Posterior Tibial nerve block (already widely used in operating room) during HESWT applied in Orthopedic Day Hospital could offer the possibility to minimize the patient discomfort and to give the therapeutic doses just in few HESWT sessions, reducing the hospital access of outpatients for the treatments and the costs related to prolonged treatment caused by pain. Furthermore, this anesthetic approach could make patients tolerate majorated doses of HESWT in few sessions, with high effectiveness of procedure after several months.

NCT ID: NCT03918148 Completed - Clinical trials for Type 2 Diabetes Mellitus

Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)

GIOIA
Start date: January 15, 2018
Phase:
Study type: Observational

GIOIA represents a multicenter pragmatic prospective cohort study, aimed at evaluating the effects of SGLT2 inhibitors currently marketed (dapagliflozin, canagliflozin, empagliflozin) on markers of vascular, myocardial and renal damage, in patients with type 2 diabetes not well controlled with metformin and/or basal insulin. The changes of the interest outcomes are compared with those obtained with a comparator glucose lowering class (DPP-4inhibitors) over a follow-up of two years.

NCT ID: NCT03917836 Completed - Clinical trials for Helicobacter Pylori Infection

Dysplasia Detection and Helicobacter Pylori Eradication

Start date: May 30, 2018
Phase:
Study type: Observational [Patient Registry]

The investigators in the present study, aimed to assess the efficacy of both White-Light Endoscopy with High Resolution Endoscopy-Narrow-band imaging in the diagnosis of Premalignant Gastric Conditions, before and after Helicobacter pylori-eradication. A prospective study was performed in our institution involving the regular use of high resolution gastroscopes with and without Narrow-band imaging. From May 2018 to April 2019, all patients that received an endoscopic diagnosis of Helicobacter pylori-related gastritis with/without Premalignant Gastric Conditions by an expert endoscopist, were reassessed by White-Light Endoscopy and High Resolution Endoscopy-Narrow-band imaging, including biopsy samples according to the Sydney system, six months later after the proved Helicobacter pylori-eradication.

NCT ID: NCT03917147 Completed - Clinical trials for Endometrial Neoplasms

Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

Start date: January 8, 2018
Phase:
Study type: Observational

A prospective cohort study at a Tertiary University Hospital. From January to December 2018, we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause, endometrial thickening in pre-or post-menopause; tamoxifen usage. Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Senior operators had to foresee histopathological diagnosis using a questionnaire. Histopathological examination was conducted to confirm the diagnosis.

NCT ID: NCT03915665 Completed - Clinical trials for Peri-implant Mucositis

Non-surgical Treatment of Peri-implant Mucositis

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

This a Randomized Controlled Clinical Trial comparing two techniques for the nonsurgical treatment of peri-implant mucositis. The main objective of the present randomized controlled clinical trial is to determine whether the application of a novel treatment strategy for peri-implant mucositis could lead to significantly improved clinical parameters as compared to standard treatment. Half of the patients receives treatment with manual instruments and chlorhexidine gel 1%, half receives treatment with submucosal biofilm removal by erythritol powder.

NCT ID: NCT03914313 Completed - Cognition Disorders Clinical Trials

Robotics Plus VR in Improving Cognition

Start date: April 23, 2019
Phase: N/A
Study type: Interventional

Stroke can be classified as ischemic, i.e. due to the lack of blood flow, and haemorrhagic, caused by bleeding. Stroke results in focal signs and symptoms, with a devastating impact on a patient and his family. Although robotic rehabilitation is very useful in improving motor function, there is no a clear evidence on its role in improving cognitive abilities, which are often compromised in stroke patients. To this end, the investigators designed a randomized controlled experimental study on stroke patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat with and without virtual reality on cognitive functioning in stroke patients, compared to traditional therapy.

NCT ID: NCT03912675 Completed - Clinical trials for Regenerative Medicine

Dermal Micrografts in Regenerative Surgery

Rigenera
Start date: July 11, 2017
Phase: N/A
Study type: Interventional

Objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in an in-vivo homogeneous experimental human acute surgical wound model.