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NCT ID: NCT05073406 Completed - Clinical trials for Cognitive Performance

Cognition at Altitude in HEMS - Part II

HEMS II
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The aim of the current study is to evaluate under blinded conditions, both in a simulated environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in providers operating in helicopter emergency medical service (HEMS) exposed to hypobaric hypoxia or to hypobaric normoxia (H0: cognitive effects under hypobaric hypoxia = cognitive effects under hypobaric normoxia). Simulated environment will allow to control different factors. The parallelism between a study branch conducted in a simulated environment and another one conducted under a real-life condition will allow to evaluate the additive effects on additional stressor factors (processive and systemic ones). - Simulation branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions in simulation facility called terraXcube (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the simulated altitude of 4000 m asl (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive tests three times on each of the two tests: before the ascent (TC0), after 5 min from the end of the ascent (TC1) and after around 30 min (TC2), to investigate European Union Aviation Safe Agency (EASA) proposed recommendations. After completing each neurocognitive test session, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests inside the chamber, as well as the cerebral oxygen saturation (ScO2) sensor. Samples will be collected by saliva, urine and/or capillary blood. The same schedule is repeated in each test session. - In-field branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions during helicopter flights (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the altitude of 4000 m (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive test two times on each test: before the ascent (TC0), after around 5 min from the end of the ascent (TC1). After completing each neurocognitive tests, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests. Samples will be collected. The same schedule is planned in each test session.

NCT ID: NCT05070065 Completed - Mood Disorders Clinical Trials

Virtual Reality VAlidation Tool for Cognitive Rehabilitation, Oriented Project for People With Psychosocial Disabilieties

Start date: November 10, 2021
Phase: N/A
Study type: Interventional

Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a VR intervention of 3 months with 2 weekly session of CEREBRUM (cognitive remedy intervention with virtual reality) first to the group A and then to the group B.

NCT ID: NCT05069324 Completed - Acromegaly Clinical Trials

PegvisOMant and the Immune SystEm (PROMISE)

Start date: July 29, 2020
Phase:
Study type: Observational

This is a prospective observational pilot study for the evaluation of immune cells phenotype in acromegalic patients in comparison with a control population and to investigate the impact of disease control and different medical treatments (particularly Pegvisomant) on immune function and its implication on insulin resistance, metabolic complications and fat accumulation.

NCT ID: NCT05067907 Completed - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients.

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

COVID-19 is an infectious disease caused by SARS-CoV2 virus. COVID-19 patients can develop a severe disease that can lead to hypoxic respiratory failure and acute respiratory distress syndrome (ARDS). Severe patients can require access to intensive care unit (ICU). Early rehabilitation is known to be effective in critically ill patients and in ARDS. Early rehabilitation is known to be effective in critically ill subjects. The role of physiotherapy in severe COVID-19 patients is still unclear and few guidelines have been proposed so far. Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not received physiotherapy treatment in ICU.

NCT ID: NCT05065788 Completed - Trauma Clinical Trials

Ophthalmological Emergencies and COVID-19 Pandemia

Start date: February 1, 2020
Phase:
Study type: Observational

To analyze how the COVID 19 pandemia has affected the patient's accesses to the Ophthalmological Emergency Department of a tertiary referral center in northern Italy, during the lockdown period. We will collect data from different periods in 2020, in which the Italian Governement called the total lockdown to same periods of the 2019. The charts of all patients will be evaluated to analyze demographics and clinical data

NCT ID: NCT05065658 Completed - Clinical trials for COVID-19 Respiratory Infection

Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

POSACOVID
Start date: March 1, 2020
Phase:
Study type: Observational

COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.

NCT ID: NCT05064397 Completed - Clinical trials for Chronic Cluster Headache

A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)

CHRONICLE
Start date: September 17, 2021
Phase: Phase 3
Study type: Interventional

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

NCT ID: NCT05062694 Completed - Pain Clinical Trials

Physical Therapy Management Of The Patient With Central Sensitization

Start date: September 20, 2021
Phase:
Study type: Observational

In the literature there is still debate about the concept of central sensitization, as a pain mechanism that can support a neuromusculoskeletal pathology and which for Woolf corresponds to an amplification of neural signaling within the Central Nervous System causing hypersensitivity to pain. This mechanism is often confused with the concept of chronic pain, as in many conditions such as fibromyalgia, traumatic neck pain, low back pain or osteoarthritis, central sensitization supports its maintenance beyond 6 months. We believe it is important to investigate among Italian physiotherapists the management of the patient in which the presence of a central pain sensitization phenomenon is suspected, in order to provide consistent data to direct the education of health professionals towards more effective management of this problem. To achieve this goal we aim to: - Conduct a Delphi study in order to reach consensus, into a panel of experts, on the methods useful for the management, in each phase of the physiotherapy process, of the patient with neuromusculoskeletal problems with pain underlying central sensitization mechanism - Investigate, through a survey among Italian physiotherapists, their clinical approach to the patient in question - Develop a free online course available to clinical professionals and/or students who wish to deepen this issue.

NCT ID: NCT05062564 Completed - Cataract Clinical Trials

Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye

LIPICAT
Start date: September 7, 2021
Phase: N/A
Study type: Interventional

Dry Eye Disease (DED) is a disease of the ocular surface which may be secondary to a variety of causes, including cataract surgery. DED is characterized by loss of tear film stability and dry eye symptoms, and its pathogenesis is related to corneal nerve injury, decreased goblet cells, inflammation of the ocular surface, and dysfunction of the meibomian glands (MGD). MGD is the main cause of evaporative DED and can cause irregularity of the ocular surface, affecting the accuracy of the biometric calculation. In addition, it is a risk factor for DED exacerbation after cataract surgery, that may occur in about 40% of cases. Current therapies for DED include artificial tears, warm compresses, manual squeezing of the glands, eyelid hygiene, omega-3 fatty acids, topical cyclosporine, serum tears, topical azithromycin, oral doxycycline. The above therapies in some cases can provide only transient relief, affecting the outcome of cataract surgery and the quality of life of patients. Therefore, stabilization of the ocular surface before cataract surgery is important to achieve better post-operative comfort and a better refractive result. The introduction of LipiFlow thermal pulsation treatment (LTP) represents a controlled method of squeezing the obstructed Meibomian glands by applying heat to the upper and lower eyelids and simultaneously applying pulsatile pressure to the eyelid skin surfaces. The aim of our study will be to evaluate the effect of preoperative LipiFlow therapy in patients with age-related cataracts and mild to moderate MGD in reducing postoperative DED.

NCT ID: NCT05059808 Completed - Sepsis Clinical Trials

European Sepsis Care Survey

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

The objective of this survey is to investigate the current state of sepsis care around Europe. The study is aiming at hospital structure, emergency departments, wards, intensive care units and clinical diagnostic and microbiological service.