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NCT ID: NCT05478876 Recruiting - Gynecologic Cancer Clinical Trials

Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract

CYCLE
Start date: September 3, 2020
Phase: N/A
Study type: Interventional

The present monocentric prospective phase 2 study aims to reproduce the results obtained at NIRS thus offering the possibility of obtaining a promising rate of progression-free survival (PFS) and local control (LC) in patients diagnosed with mucosal melanoma of lower genital tract. Systemic treatment with immunotherapy is not the subject of this study but is allowed both in the neoadjuvant and sequential regimens. Melanomas have always been considered poorly radiosensitive. It is now accepted that high LET (Linear Energy Transfer) particle beams, such as carbon ions, can offer a biological advantage, compared to photons treatment, in radio-resistant neoplasms treatment, thanks to their higher biological efficacy (RBE) against tumours with a low α/ ß ratio. In addition, carbon ions have the physical advantage of an inverted depth deposition profile compared to photons, allowing then a steep dose gradients that ensure increased sparing of adjacent healthy organs at risk (OARs).

NCT ID: NCT05478577 Completed - Stroke Clinical Trials

Clinical Features and Rehabilitation Effect in Patients With Stroke

PCR
Start date: September 1, 2021
Phase:
Study type: Observational

Dosage of rehabilitation therapy is a key factor in promoting motor functional recovery after stroke. To date, what is not yet known are the clinical features (e.g. the neurological profile, clinical history, motor, language and cognitive abilities), which allow the clinician to predict the recovery potential of a patient before rehabilitation, based on both the initial assessment and the various treatment pathways available in the National Health System. For these reasons, the study aims to explore clinical features and potential effect of rehabilitation dose that could influence upper limb motor recovery

NCT ID: NCT05478564 Recruiting - Clinical trials for Hemodynamic Instability

Hemodynamic Monitoring During Abdominal Aortic Surgery

HEMAS
Start date: July 26, 2022
Phase:
Study type: Observational

This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence

NCT ID: NCT05478512 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Front-line VenObi Combination Followed by Ven or VenZan Combination in Patients With Residual Disease: a MRD Tailored Treatment for Young Patients With High-risk CLL

VIS
Start date: July 21, 2023
Phase: Phase 2
Study type: Interventional

Multicentric phase 2 study for previously untreated high-risk CLL patients. Patients will receive 6 courses of the Venetoclax + Obinutuzumab combination. - Patients with stable disease or a response (CR/PR) with uMRD in the PB and BM at cycle 9 will continue treatment with Venetoclax single agent until cycle 13 and then stop treatment. - Patients with stable disease or a response (CR/PR) with evidence of residual disease in the PB and/or BM at cycle 9 will continue treatment with Venetoclax and Zanubrutinib combination until cycle 21. then, Patients with uMRD in the PB and BM at cycle 21 will stop treatment whereas patients with residual disease in the PB and/or BM at cycle 21 will discontinue Venetoclax and continue Zanubrutinib until disease progression.

NCT ID: NCT05478434 Recruiting - Stroke Clinical Trials

Cortico-cortical Stimulation and Robot-assisted Therapy for Upper Limb Recovery After Stroke (CCS&RAT)

CCS&RAT
Start date: August 21, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to tested the effect of combination of a paired associative stimulation of two functional interconnected areas of the cerebral cortex (posterior-parietal cortex and primary motor cortex) with robot-assisted therapy in the recovery of upper limb after stroke.

NCT ID: NCT05478187 Completed - Parkinson Disease Clinical Trials

Wearable Visual Cues in Parkinson's Disease

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

One of the most disabling features of Parkinson's disease (PD) is represented by the gait disturbances. Some systematic reviews and meta-analysis have showed that conventional physical therapy might improve gait as well as balance, mobility and functional reach in subjects affected by PD. In addition, several studies and reviews support the effectiveness of external sensory cueing, by means of rhythmic auditory or visual cues, in improving kinematic parameters of gait (gait cadence, stride length, velocity, and postural stability) and the functional performance in people with PD, at least in the short-term. Specifically, cueing refers to the use of temporal or spatial stimuli to regulate movement and facilitate functional performance for individual with motor dysfunction. Basal ganglia act as internal triggers of neuronal activity in the supplementary motor area for well-learned, automatic movement sequences, such as locomotion. This mechanism is damaged in individuals with PD, and external cues may act as an attention resource to compensate the deficient internal rhythm due to basal ganglia dysfunction. Subjects can be coached in concentrating their attention on gait by specific self-prompting instructions or by cues stimulation or a combination of these. Movements generated by the presence of external sensory cues are prompted to use alternative (cortical, parieto-premotor) neuronal pathways which have not been damaged by neuronal degeneration of PD, bypassing the automatic basal ganglia network. Recent studies have provided preliminary evidence that visual cueing based on laser shoes and laser canes may reduce freezing, an established risk for falls, with improvement that can be observed for a variable period of time after rehabilitative intervention. In light of the evidence of effectiveness of cueing, developing wearable devices able to generate cues that match with step and that are effective, easy to use and low cost, would be challenging but very appropriate. The aim of this study was to investigate the non-inferiority of a wearable device producing visual cues (Q-Walk system, QUICKLYPRO s.r.l., Bergamo, Italy) in order to improve gait and balance PD patients, compared to a conventional training (stripes on the floor).

NCT ID: NCT05477563 Recruiting - Sickle Cell Disease Clinical Trials

Evaluation of Efficacy and Safety of a Single Dose of CTX001 in Participants With Transfusion-Dependent β-Thalassemia and Severe Sickle Cell Disease

Start date: August 2, 2022
Phase: Phase 3
Study type: Interventional

This is a single-dose, open-label study in participants with transfusion-dependent β-thalassemia (TDT) or severe sickle cell disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) using CTX001.

NCT ID: NCT05477212 Recruiting - Obesity Clinical Trials

Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.

Start date: April 28, 2022
Phase: N/A
Study type: Interventional

This study is open label, with one arm only. In this study will be enrolled patients with obesity (BMI more than 30). Aim of the study is to determine the influence (if any) of a very low calorie ketogenic diet (VLCKD) on gut permeability and liver steatosis. The first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis. Intestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body. The second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis

NCT ID: NCT05477043 Recruiting - Clinical trials for Surgery--Complications

Ureteral Patency After Uterosacral Ligaments Suspension

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

Uterosacral ligament suspension (USLS) is a commonly performed procedure used to correct prolapse of the vaginal apex. The procedure consists of approximating the vaginal apex to the uterosacral ligaments with a series of sutures placed bilaterally, and is most often performed from a transvaginal approach. USLS is associated with favorable outcomes and is overall safe. However, given the anatomical proximity of the uterosacral ligaments to the ureters, ureteral injury during suspension suture placement may occur. Ureteral occlusion in this setting occurs as a result of partial or complete ligation, kinking or anatomical distortion by the nearby sutures. As a measure for avoiding these undesired sequelae, cystoscopy is usually performed after suspension suture placement during USLS to ensure visualization of bilateral ureteral flow. Any interruption of ureteral flow is usually addressed by removal of the suspension sutures, ureteral stenting, and, rarely, surgical repair of the ureter if severe injury is sustained. Ultrasound can identify the ureteral jet of urine flowing into the bladder. Previous studies demonstrated ureteral jet asymmetry in case of obstruction, with an absent or weaker monolateral jet.

NCT ID: NCT05477030 Recruiting - Type 1 Diabetes Clinical Trials

Effect of Automated Insulin Delivery on Early-stage Diabetic Complications

AID-Comp
Start date: February 23, 2022
Phase: N/A
Study type: Interventional

Aim of this study is to verify the effects of an advanced HCL (Medtronic Minimed™ 780G) compared to SAP with PLGS on metabolic outcomes and markers of early microvascular damage in a population of adults with T1D previously treated with CSII. Evaluation of endothelial disfunction and autonomic neuropathy will also be performed.