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NCT ID: NCT05630664 Recruiting - High Grade Glioma Clinical Trials

Liquid Biopsy in High-grade Gliomas and Meningiomas

SOPRANO
Start date: October 1, 2022
Phase:
Study type: Observational

The general objective of this project is to evaluate the value of cell-free DNA circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas. To this end, we propose to longitudinally collect four samples of plasma at the following time points: - T0: before surgery; - T1: one month after surgery; - T2: one month after the end of radiotherapy; - T3 at the time of radiological progression. The goal is to evaluate whether changes in plasma concentration of circulating cell-free DNA can help predict progression-free survival, overall survival, and response to therapies.

NCT ID: NCT05630547 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis

Start date: December 19, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration is approximately 100 weeks and includes the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)

NCT ID: NCT05630079 Completed - Clinical trials for Acquired Brain Injury

Variation of Atelectasis Score After High-frequency Percussions in Severe Acquired Brain Injury

Start date: February 22, 2021
Phase:
Study type: Observational

Investigators conduced in the Neurological Rehabilitation Unit of the IRCCS "S.Maria Nascente - Fondazione Don Gnocchi", (Milan) a retrospective study on 19 patients hospitalized between September 2018 and February 2021, with the aim of comparing the efficacy of the two devices, MetaNeb® and Intrapulmonary Percussion Ventilation (IPV®). The efficacy was evaluated considering the change of various measures after two weeks of treatment. The main outcome considered is the atelectasis score, assigned by two radiologists who blindly and retrospectively evaluated it on high-resolution computed tomography (HRTC) images

NCT ID: NCT05630066 Recruiting - Angelman Syndrome Clinical Trials

Study to Investigate the Pharmacokinetics and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype.

Aldebaran
Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants with deletion Angelman Syndrome (AS) aged 5-17 years (inclusive) will be enrolled in the study.

NCT ID: NCT05630001 Active, not recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.

APPULSE
Start date: April 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to find out if iptacopan is effective and safe in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who switch from their current standard of care treatment (eculizumab or ravulizumab) to study treatment, iptacopan/LNP023.

NCT ID: NCT05629923 Completed - COVID-19 Pandemic Clinical Trials

EVALUATION OF DIFFERENT PROPHYLACTIC INTERVENTIONS TOWARD COVID-19 IN SOLID ORGAN TRANSPLANT PATIENTS

Start date: February 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to evaluate the immune response after COVID-19 vaccination in Liver(LT) and Kidney(KT) transplant recipient. The main question it aims to answer are: - the evaluation of the antibody response after complete vaccination - the efficacy of prophylaxis with long-acting-antibody prophylaxis (LAAB) All LT and KT patients during follow-up have been enrolled. anti-COVID-19 title was obtained by Electrochemiluminescence Immunoassay (ECLIA) Test(Elyx, Roche). In the case of antibody level <100 IU/ml, patients were invited to prophylaxis with tixagevimab-cilgavimab(AZD7442, AstraZeneca). At three months, a follow-up was performed to assess any COVID-19 infection. At Six months another anti-COVID-19 title is obtained by ECLIA Test(Elyx, Roche) in LT and KT who undergo to LAAB.

NCT ID: NCT05629585 Recruiting - Breast Cancer Clinical Trials

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

NCT ID: NCT05629507 Completed - Pain Clinical Trials

Effectiveness of Immersive Virtual Reality in Patients With Cancer

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to study the effects of Immersive Virtual Reality in patients with cancer undergoing chemotherapy. The main questions it aims to answer are: - Could the immersive virtual reality application prevents or reduces anxiety, prevents or reduces fatigue, prevents or reduces pain, improves therapeutic adherence, prevents or reduces adverse events, then cancer patients treated with narrative medicine, and then cancer patients in standard care only? - Could the immersive virtual reality application show symptoms of cybersickness? Participants will be randomly allocated with balanced allocation ratio 1: 1: 1 into three groups: 1) Virtual Reality group; 2) Narrative medicine group; 3) Standard care group. In the virtual reality arm, patients will use a Virtual Reality headset. The multimedia contents in VR, will have a video quality from 4K to 8K, 360 degrees, and High Definition audio stereo. In control arm, patients will be free to choose different activities during the infusion of chemotherapy, such as conversation with nurses, doctors, trainees, reading, writing, watching television, listening to music or videos on their smartphone. In narrative medicine arm, patients will express their subjective experience regarding to the chemotherapy through writing. The experience will be written in free form by the patient and will cover both the cognitive, emotional and perceptual aspects. A nurse will always be available to guide the patient in the activity of expressing cognitive, emotional and perceptual contents. Researchers will compare the Virtual Reality group, Narrative Medicine group, Standard care group, to see the effects regarding to anxiety, fatigue, pain, improves therapeutic adherence and adverse events.

NCT ID: NCT05629221 Recruiting - Diabetes type2 Clinical Trials

Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values

Telemechron
Start date: December 30, 2022
Phase: N/A
Study type: Interventional

The goal of this randomised trial is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organizational asset for poorly controlled type 2 diabetes individuals in the Autonomous Province of Trento (PAT). The main question aims to answer whether individuals using the "TreC Diabete" platform will improve their haemoglobin glycated level (Hb1Ac) at 12-month post-randomisation. Participants will be asked to perform some tasks and to share their data with the healthcare staff members through the platform. Control group will receive standard care.

NCT ID: NCT05629052 Recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

TrEatment Approach in the Multimodal Era Registry

TEAM
Start date: April 12, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH: - surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) - the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) - drugs Patients can also receive a combination of these treatments. The main question this registry aims to answer are: - How many patients receive a given kind of treatment? - How do expert centers combine the different treatments? - Are patients doing better after they receive a given kind of treatment? - How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment? Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.