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NCT ID: NCT05873621 Recruiting - Rectal Cancer Clinical Trials

Indocyanine Green-guided Lymphadenectomy in Laparoscopic Total Mesorectal Excision for Low Rectal Cancer After Neoadjuvant Chemoradiotherapy

(GreenEye-CRC)
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (ICG)-guided lymphoadenectomy after neoadjuvant chemoradiation. The main questions it aims to answer are: - Does the use of ICG increase the total number of harvested lymph nodes? - Does the use of ICG increase the number of harvested extra-mesorectal lymph nodes? Participants will intraoperatively receive a trans-anal administration of ICG near to rectal cancer; during laparoscopic surgery, ICG-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. A comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of ICG.

NCT ID: NCT05871359 Recruiting - Parkinson Disease Clinical Trials

Transcranial Direct Current Stimulation and Dual Tasks

Tdcs&DT
Start date: October 21, 2022
Phase: N/A
Study type: Interventional

The project aims to evaluate the clinical and biological effects on patients with Parkinson's disease of an innovative treatment characterized by the use of transcranial Direct Current Stmulation (tDCs) with Dual Task (DT), i.e. including the performance of motor activities in conjunction with the request of cognitive performance, such as executive functions (creative flexibility, working memory and divided attention). Randomized controlled, double-blind, non-pharmacological study using device.The project involves the enrollment of 30 patients.Participants will be randomized into 2 groups: 15 / group and will carry out activities in DT associated with tDCS real (test group) or sham (control group). Each will carry out 12 rehabilitation sessions (2 / week) of 30 minutes. A follow-up is foreseen for all 12 weeks after the end of the treatment. Patients will undergo, at baseline (T0), at the end of the session (T1) and at 12 weeks (T2), a motor and a cognitive profile, moreover a blood sample will be taken. The project intends to improve the state of Parkinson's patients both thanks to the type of protocol that associates DT and tDCS, and thanks to the verification of the treatment through personalized biological analyzes. In detail, improvement in clinical performance, space-time variables in gait and cognitive tests are expected; the variability of synaptic and pathological markers will serve to verify the effect of the treatment.

NCT ID: NCT05871216 Recruiting - Clinical trials for Hypermobility Syndrome

Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility

VIPIA
Start date: October 1, 2020
Phase:
Study type: Observational

A joint is considered "hypermobile" when it has a greater range of motion than normal for a given age, ethnicity or gender. Many people have asymptomatic hyperlaxity in multiple joints, a condition called Generalized Joint Hypermobility (GJH). Conversely, hyperlaxity can be symptomatic, a condition that has been defined "Joint Hypermobility Syndrome" - JHS. Diagnosis of JHS is commonly performed by applying the revised Brighton criteria. Based on these criteria, an individual is diagnosed with JHS with a Beighton score >/= 4/9, and arthralgia for 3 or more months in 4 or more joints (major criteria). The dynamic body balance test (i.e. the stability test with multiple single-leg jumps) can provide information regarding the effectiveness of the feedforward and feedback mechanisms in correcting the postural deviations necessary to achieve successful performance during daily and sporting activities. Such assessment may also be useful to demonstrate deficiencies in balance, especially in young patients with increased physical activity. The aim of this study is to examine the postural balance of individuals with JHS by performing stability tests in monopodalic and bipodalic stance with the "Delos Postural Proprioceptive System"

NCT ID: NCT05869955 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases

Start date: September 13, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases.

NCT ID: NCT05869773 Recruiting - Narcolepsy Clinical Trials

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

Start date: June 26, 2023
Phase: Phase 4
Study type: Interventional

The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.

NCT ID: NCT05869279 Recruiting - CLL Clinical Trials

Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia

Start date: December 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single arm, open-label, multi-center, phase I/II study to determine the engraftment, safety and clinical activity of allogeneic CARCIK-CD19 cells in adult and pediatric patients with relapsed/refractory mature B-cell neoplasia expected to express CD19 i.e. B-cell NHL and CLL. CARCIK-CD19 will be produced from the peripheral blood of an at least haploidentical familial donor.

NCT ID: NCT05868837 Recruiting - Clinical trials for Myasthenia Gravis, Generalized

Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)

REFINE
Start date: February 28, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this phase III trial is to investigate if Rituximab can reduce patients' functional impairment caused by MG. The secondary objectives of this trial are to assess whether treatment with rituximab in patients with MG will: - Allow faster and greater corticosteroid tapering - Reduce the frequency of exacerbations - Improve quality of life - Offer an acceptable safety and tolerability profile.

NCT ID: NCT05867693 Recruiting - Clinical trials for Irritable Bowel Syndrome

Palmitoylethanolamide and Polydatin in Pediatric Irritable Bowel Syndrome

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to study the efficacy and safety of co-micronised palmithoylethanolamide/polydatin in pediatric patients (> 10 years) with Irritable bowel syndrome (IBS)

NCT ID: NCT05867615 Recruiting - Cancer Clinical Trials

Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:

LUBASKET
Start date: May 25, 2023
Phase: Phase 2
Study type: Interventional

Phase 2 study, single arm trial enrolling patients with a Gallium-68/Fluorine-18 prostate-specific membrane antigen (PSMA) positive positron emission tomography/Computed Tomography (PET/CT) in order to be treated with Lutetium-177 (177Lu) PSMA. Patients without risk factors for toxicity will receive 7.4 GBq of 177Lu-PSMA while patients with at least 1 risk factor for toxicity will receive 5.5 GBq of 177Lu-PSMA. Patients will receive 4 cycles every 8 weeks (+- 2 weeks)

NCT ID: NCT05867199 Recruiting - Clinical trials for Distal Radius Fracture

Effects of Action Observation Therapy and Motor Imagery Administered During Immobilization Period After Surgical Fixation of Distal Radius

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this trial is to verify the effectiveness of Motor Imagery and Action Observation Training in subjects undergoing surgery for distal radius fracture fixation. The main question it aims to answer is: - can action observation and motor imagery training administered during immobilisation period improve functional outcome after distal radius fracture fixation? Participants will be asked to perform hand dexterity test and grip and pinch strength evaluation Subjects assigned to control group will follow standard care