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NCT ID: NCT06339671 Not yet recruiting - Clinical trials for Colorectal Disorders

Post-operative Complications and Smoking Habits in Colorectal Surgery

PASSAGE
Start date: April 15, 2024
Phase:
Study type: Observational [Patient Registry]

PASSAGE is a national multicenter retrospective and prospective observational cohort study in which patients who will undergo colorectal surgery will be enrolled.

NCT ID: NCT06339164 Not yet recruiting - Clinical trials for Breech Presentation; Before Labor

Breech Delivery Skills. Resident Learning Program

Breech
Start date: April 15, 2024
Phase:
Study type: Observational

Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks. Mannequin scenario represents the best way of skill evaluation

NCT ID: NCT06338163 Not yet recruiting - Clinical trials for Surgical Site Infection

Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery

POSSIBLE
Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, & lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center.

NCT ID: NCT06337123 Not yet recruiting - Knee Arthropathy Clinical Trials

Physica TT Tibial Plate Follow up Study

Start date: May 2024
Phase:
Study type: Observational

This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications.

NCT ID: NCT06334692 Not yet recruiting - Nephrotic Syndrome Clinical Trials

Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome

BLINDER
Start date: May 2024
Phase:
Study type: Observational

This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant, compared to those of a control group of patients with nephrotic syndrome due to primary membranous nephropathy (MN).

NCT ID: NCT06334484 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 1

Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics

TiTR_GR1DM
Start date: March 26, 2024
Phase:
Study type: Observational

Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and Control Trial (DCCT) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. In recent years, treatment of T1DM evolved rapidly because of the significant improvements in the use of technology (2). With the spread of continuous glucose monitoring (CGM) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - TIR), time below target glucose range (TBR) and time above target glucose range (TAR), have become commonly used metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates glycated haemoglobin from the average glucose level of CGM readings for 14 days and coefficient of variation (CV) evaluates the amplitude of glucose excursions. Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). Different algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are used by different systems available on the market and are currently used in clinical practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and TIR opening to the possibility to gain even tighter glycemic control. The primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy

NCT ID: NCT06333132 Not yet recruiting - Obesity Clinical Trials

Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat)

DiabEATit
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission.

NCT ID: NCT06331637 Not yet recruiting - Ulcerative Colitis Clinical Trials

Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis

TTSS-Pouch
Start date: July 31, 2024
Phase:
Study type: Observational

This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)

NCT ID: NCT06329752 Not yet recruiting - Ankle Fractures Clinical Trials

Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department

AnkleMan
Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures. The trial aims to assess: - The acceptability of sciatic nerve block - The technical feasibility of sciatic nerve block - The technical success of sciatic nerve block - The analgesic efficacy of sciatic nerve block In addition to that, this study aims to - Describe patient-reported and physician-reported satisfaction - Assess the Adverse Event rate at 48 hours post intervention

NCT ID: NCT06325358 Not yet recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

the EXPOSITION Study

EXPOSITION
Start date: April 15, 2024
Phase:
Study type: Observational

This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage.