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NCT ID: NCT05734183 Active, not recruiting - Clinical trials for Acquired Brain Injury

Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness

MIME
Start date: October 29, 2021
Phase: N/A
Study type: Interventional

Disorder of consciousness (DoC) is a state in which consciousness is altered because of brain damage and can occur under a variety of conditions: in fact, the most frequent causes of DoC are vascular disease, head trauma, and cerebral hypoxia. DoCs result from the loss of regulation of neural function of the two components of consciousness, alertness and awareness. Depending on the patient's behavior and responsiveness, DoCs can be identified in different states, from coma to persistent vegetative state (VS) to intermittent minimally conscious state (MCS). Regarding the prognosis of recovery, in patients with DoC the chance of having functional improvement decreases with time, although some positive functional changes have been observed in chronic patients. Therapies for DoC include some drugs, such as dopaminergic, GABAergic and amantadine drugs, which work to facilitate the recovery of consciousness. Neurorehabilitation, however, seems to be the most recognized intervention that aims to strengthen, in uninjured brain regions, the spontaneous neuroplasticity that occurs to compensate for lost function. Simultaneous stimulation of multiple senses, such as hearing, sight and smell, provides the neural network with more stimuli that are more effective than a single stimulus. In fact, multisensory stimuli can more easily activate attention because cortical processing is predominantly multimodal. As for content, it would seem that those with autobiographical and emotionally salient character could engage multiple brain networks and have priority access to attention. Numerous trials show that stimulus-containing content led to increased behavioural activity, improving self-awareness in patients with DoC. Considering that a communication system that can combine both visual and auditory channels proves to be more effective than a "single-sense" channel, multisensory stimulation is likely to provide simultaneous activation of different brain areas by enhancing plasticity processes. Furthermore, the intensity of stimulation could be one of the main variables with greater impact on the patient: in fact, higher intensity would correspond to a greater effect on the brain.

NCT ID: NCT05730647 Active, not recruiting - Early Breast Cancer Clinical Trials

Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients

GIM 23- POSTER
Start date: October 24, 2019
Phase:
Study type: Observational

This will be a prospective, multicenter, observational study. The primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with estrogen-receptor positive breast cancer. The secondary objective is to correlate adjuvant hormone therapy choices with biological characteristics of the tumor (T size, lymph node status, grade, receptor level, Ki67, HER2 status) and patient characteristics (age, prior chemotherapy treatment).

NCT ID: NCT05729165 Active, not recruiting - Dysphagia Clinical Trials

Local Vibration in Patients With Severe Acquired Brain Injury

Start date: October 29, 2021
Phase: N/A
Study type: Interventional

Severe Acquired Brain Injury (sABI), with a more or less prolonged state of coma, generally causes disruption of the physiological modes of swallowing and feeding and the physiological abilities of communication and phonation. There is broad agreement in the scientific literature for early intervention by the entire rehabilitation team. In the specific case of swallowing and phonatory function, speech therapist intervention is indicated with the goal of restoring the automatic and voluntary movements of the muscles involved in the performance of the previously mentioned functions. Speech-language treatment of buccal structures, sensation, motor and praxie is recommended in conjunction with other types of approaches (dietary modifications, compensation techniques, postural modifications). In the acute and early subacute phase of patients with sABI with a vigilance level of less than 4 according to the Levels of Cognitive Functioning scale, alterations in bucco-linguo-facial structures and swallowing can be observed that prevent the execution of a correct motor pattern of phonation and swallowing. For this reason, passive and/or active stimulation aimed at restoring sensitivity, strength, and movement coordination of the bucco-linguo-facial and laryngeal muscles is necessary to rehabilitate the prerequisites for the initiation of feeding, to restore adequate afferents, and to stimulate communication. A careful search of the literature shows that over the past decade many studies in the rehabilitation field have sought to understand the effects of local vibration therapy at various levels of the central nervous system and the possible benefits in neurorehabilitation. From a speech therapy perspective, there are only three studies on the area of dysphonia in cases of upper laryngeal nerve palsy, combining traditional treatment with the use of Novafon®, a sound wave medical device used for Local Vibrational Therapy. The results show greater improvements in vocal function and voice quality when classical treatment is combined with Local Vibrational Therapy. These studies conclude by affirming the need for further research with a larger sample size to analyze the potential effectiveness of Novafon® applied to the recovery of vocal cord paralysis.

NCT ID: NCT05729152 Active, not recruiting - Myocardial Disease Clinical Trials

Cardiovascular Events for a Long Time End of COVID 19 Infection

LONGCOVIDWP3
Start date: September 6, 2022
Phase:
Study type: Observational [Patient Registry]

In the follow-up of partecipants with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies on the acute phase of Covid-19 infection have demonstrated a significant prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the presence of structural changes in the pericardium and myocardium several months after the acute phase. The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

NCT ID: NCT05728632 Active, not recruiting - Breast Cancer Clinical Trials

Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines

CONTROL
Start date: January 1, 2019
Phase: Phase 3
Study type: Interventional

As the cancer-related prognosis improves thanks to recent advances in cancer-targeted therapies, the prognostic burden of chemotherapy-related complications - including cardiotoxicity - is increasingly recognised. So far, the evidence supporting pharmacological preventive strategies in cardio-oncology has been inconsistent and conflicting, and there is a clear need for well-designed trials with novel interventions. In this study, by using cardiac magnetic resonance, the investigators want to assess if a commonly used beta-blocker with a unique pharmacological profile, i.e. nebivolol, can prevent cardiac dysfunction in patients with breast cancer or diffuse large B-cell lymphoma undergoing chemotherapy with anthracyclines.

NCT ID: NCT05724225 Active, not recruiting - Clinical trials for Tricuspid Valve Insufficiency

"Atriogenic Tricuspid Selected, Omics Profile, Multimodality Imaging and Clinical Outcomes"

ATOMIC
Start date: October 6, 2021
Phase:
Study type: Observational [Patient Registry]

The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling, patients with atriogenic MI and left ventricular remodeling. To achieve these aims, markers obtained from cardiovascular imaging methods, such as 3D echocardiogram, and biomarkers isolated from the peripheral blood of the study participants will be considered.

NCT ID: NCT05724212 Active, not recruiting - Tuberculosis Clinical Trials

Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment

IGRA/MAT-1
Start date: January 27, 2017
Phase:
Study type: Observational

Evaluate the possibility of using an IGRA (Interferon-γ Release Assay) test for monitoring the response to anti-tuberculosis therapy by studying the correlation between the variation in the Interferon-gamma (IFN-γ) response to the QFT-Plus test in the two tubes containing antigens and the gold standard for monitoring TB therapy (culture conversion) in patients with slide positive/culture positive and slide negative/culture positive PTB. Evaluate the level of agreement between the results of the new QFT Access test and the results of the QFT plus and culture in patients diagnosed with active tuberculosis. To evaluate the level of agreement between QFT Access test results and QFT Plus results in healthy controls and contacts.

NCT ID: NCT05724199 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-SHUTTLE
Start date: February 21, 2023
Phase: Phase 3
Study type: Interventional

The coprimary objectives of the study are to: - evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). - evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

NCT ID: NCT05724069 Active, not recruiting - Clinical trials for Chronic Intestinal Pseudo-obstruction

Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).

Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

This is a phase II, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of velusetrag once a day, compared to placebo, in subjects with CIPO.

NCT ID: NCT05717634 Active, not recruiting - Breast Cancer Clinical Trials

Endometrial Changes in Breast Cancer Women.

Start date: January 26, 2023
Phase:
Study type: Observational

This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.