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NCT ID: NCT05710198 Recruiting - Clinical trials for Glaucoma, Open-Angle

Efficacy of Citicoline Eye Drops 2% on Visual Field Preservation in Patients With Open Angle Glaucoma

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of citicoline eye drops 2% in reducing visual field deterioration in patients with progressing OAG treated according to best clinical practice. Secondary objectives are assessing the effect of citicoline eye drops 2% on changes in structural parameters measured by Spectral Domain Optical Coherence Tomography (SD-OCT) and evaluating the safety of citicoline eye drops 2%

NCT ID: NCT05709275 Recruiting - Clinical trials for Hypoplastic Left Heart Syndrome

Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation

HLHS
Start date: July 28, 2022
Phase:
Study type: Observational [Patient Registry]

This project has several objectives ranging from clinical data analysis to computational simulations as listed below: 1. Retrospective review of all patients with HLHS treated surgically and followed medically at the IRCCS Policlinico San Donato aiming to assess the SEVR after each step of Norwood palliation to analyze its influences on: - Mortality; - Occurrence of adverse events; - Outcome of the three-staged palliation; 2. Creation of a prospective registry that will enroll all patients surgically treated for HLHS at the IRCCS Policlinico San Donato.

NCT ID: NCT05709184 Recruiting - Clinical trials for Clostridioides Difficile Infection

Lyophilized Fecal Microbiome Transfer vs. Vancomycin Monotherapy for Primary Clostridioides Difficile Infection

DONATE
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test whether lyophilized fecal microbime transfer - a dried extract of bacteria from the stool of healthy donors - is better than antibiotic therapy only for treating primary clostridioides difficile infection (CDI) in adult participants. The main question it aims to answer is whether lyophilized fecal microbiome transfer lowers the number of episodes of CDI compared to antibiotic therapy. Participants will be assigned to one of two groups: - In the intervention group participants will be given vancomycin by mouth for five days followed by 5 days of capsules of lyophilized fecal microbiome to swallow, up until day 10. - In the control group participants will be given vancomycin by mouth for ten days. - All participants will be asked to arrive for two follow-up visits and to fill out questionnaires. In addition, all participants will be asked to give stool samples before antibiotic therapy and on the two follow-up visits. Researchers will compare the intervention group and the control group to see if there is a difference in symptoms degree after ten days and in recurrence of the infection after two months. They will also compare side effects, the total use of antibiotics and the change in the composition of bacteria in the stool, namely the presence of bacteria that are resistant to many drugs.

NCT ID: NCT05708443 Recruiting - COPD Clinical Trials

Effect of Combined Endurance Training on ADL and Walking in COPD Patients

Start date: January 10, 2023
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability. Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load. The primary aim of this study is to evaluate whether the combined "arm and leg" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test).

NCT ID: NCT05708118 Recruiting - Heart Diseases Clinical Trials

Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.

ARDITAV
Start date: January 20, 2023
Phase:
Study type: Observational

The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients who underwent elective aortic valve replacement or TAVR for stenotic bicuspid aortic valve (BAV) at our institution from 2015 to June 2022. Participants will undergo both a CT and an echocardiographic assessment at least 90 days after surgery.

NCT ID: NCT05708079 Recruiting - Stroke Clinical Trials

Multidimensional Evaluation of Patients With Acute Ischemic Stroke Undergoing Pharmacological and Endovascular Revascularization Procedures for the Identification of Positive Prognostic Factors

Start date: June 1, 2020
Phase:
Study type: Observational [Patient Registry]

In developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Systemic and endovascular thrombolytic treatments in acute cerebral ischemic stroke caused by occlusion of large caliber vessels are currently the standard of care for the acute treatment of stroke. The rationale of this study is to validate the results of this treatment on a large scale, in the context of what can be called "real life". The study will have the characteristics of a descriptive observational study on patients suffering from acute ischemic stroke treated at the Policlinico A. Gemelli-IRCCS from 1 January 2016 to 31 December 2023. These data will be compared with a retrospective control group of patients undergoing mechanical thrombectomy for cerebral ischemic stroke in our polyclinic. The primary endpoint is the outcome of patients treated with mechanical endovascular thrombectomy evaluated with the modified Ranking Scale at 90 days, while as secondary endpoints some individual characteristics of the patient will be considered (sex, age, clinical history, etc.), characteristics of the thrombus (anatomical-pathological, radiological etc) and related to acute management (therapy, rehabilitation, etc).

NCT ID: NCT05707858 Recruiting - Clinical trials for Food Allergy in Children

The Naples Pediatric Food Allergy (NAPFA) Score

NAPFA
Start date: January 23, 2023
Phase:
Study type: Observational

Food Allergy (FA) is one of the most expensive allergic disorders in the pediatric age, and affecting up to 10% of children worldwide, it is recognized as a global health problem. The Oral Food Challenge (OFC) is the gold standard for FA diagnosis, but it is time-consuming, expensive, and potentially dangerous, as it can determine severe anaphylaxis. In addition, causing long-lasting impact on patient anxiety and mental health due to the physical duress and health risks involved with its application, OFC strategy is little applied in clinical practice with consequent diagnostic errors and delays. The goal of the Naples Pediatric Food Allergy (NAPFA) score is to develop a new clinical score including the main anamnestic, and clinical features for the easy identification of pediatric FA in primary care setting.

NCT ID: NCT05706896 Recruiting - Clinical trials for Dry Age-related Macular Degeneration

Atrophic Age-related Macular Degeneration (AMD) Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP): a Pilot Study

CORD-IV
Start date: December 14, 2022
Phase: N/A
Study type: Interventional

The objective of the study will be to evaluate the efficacy of intravitreal injections of Umbilical Cord Blood Platelet-rich Plasma (CB-PRP) in order to reduce or stabilize the atrophic progression in dry Age-related Macular Degeneration (AMD)

NCT ID: NCT05706831 Recruiting - Stroke Clinical Trials

Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

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

The goal of this clinical trial is to evaluate the efficacy of a musical interventionand non-invasive brain stimulation in neurological patients. The main questions it aims to answer are: - to evaluate the residual neuroplastic processes in DOC state related to music exposure - to determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulation - to evaluate the impact of this intervention on caregiver's burden and psychological distress. Participants will be randomly assigned to one of three different music-listening intervention groups. Primary outcomes will be clinical, that is based on the neurologist's observations of clinical improvement, and neurophysiological, collected pre-intervention, post-intervention and post-placebo.

NCT ID: NCT05706740 Recruiting - Terminal Cancer Clinical Trials

Towards Cancer Patient Empowerment for Optimal Use of Antithrombotic Therapy at the End of Life

SERENITY
Start date: February 28, 2023
Phase:
Study type: Observational

Despite the fact that antithrombotic therapy (ATT) has little or even negative effects on the well-being of cancer patients during their last year of life, stopping ATT is rare in clinical practice. In contrast, antithrombotic therapy is often continued until death, resulting in excess bleeding, higher healthcare costs, and increased disease burden. SERENITY aims to develop an information-driven, palliative care shared decision-making process enabled by a user-friendly, easily accessible, web-based shared-decision support tool (SDST) that will facilitate treatment decisions regarding appropriate use of antithrombotic therapy in cancer patients at the end of life. SERENITY will use a comprehensive approach consisting of a combination of realist review, flash mob research, qualitative interviews, epidemiologic studies, and a randomized controlled trial. The sub-project described here uses the flashmob research approach to address healthcare professionals from various institutions, who deal with end-of-life care in cancer patients, or prescribe antithrombotic medication to cancer patients.The survey will be conducted with approx. 800 physicians from eight European countries, all represented in the SERENITY consortium.