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NCT ID: NCT05213364 Not yet recruiting - Dengue Clinical Trials

Dengue Vaccine Hesitancy and Acceptance in Endemic Regions of Argentina: Impact of Communication Strategies

Start date: April 2022
Phase:
Study type: Observational

Among all arboviruses, Dengue (DEN) is the vector borne disease with the highest burden worldwide. Around 390 million infections per year are estimated, of which around 96 million are clinically apparent. Since its re-emergence in 1998 in Argentina, DEN has shown an epidemic behavior affecting mainly the northern and central regions in which the circulation of serotypes has been heterogeneous. The last significant outbreak was registered between the end of 2019 and the beginning of 2020.. Vaccine development for DEN prevention has been a long and challenging journey. The only vaccine that has reached registration to date is a recombinant attenuated tetravalent vaccine (Dengvaxia, Sanofi Pasteur) showing an efficacy against virological confirmed DEN infection of 36.6% (4.2-61.4) in seronegative subjects at baseline and 77.9% (65.1-86.0) in seropositive. However, this vaccine has not been pre qualified by the World Health Organization. New dengue vaccines are in advanced stages of development worldwide. At least three vaccines are in advanced stages of development including one produced by Takeda, the Butantan Institute and the Merck, Sharp & Dohme development. The implementation of a vaccination strategy in Argentina could be a health-relevant approach. However, the best way to implement this requires prior information describing and investigating numerous aspects of vaccination including acceptability. A systematic review of two acceptability surveys showed an acceptability of 77% to 86% but in countries with endemic DEN at time of the surveys. It is possible that in Argentina, the introduction to the regular calendar, for use in specific regions with a high and periodic burden of disease, of highly effective and safe DEN vaccines will be considered. However, to our knowledge, we do not have available evidence of the potential acceptability of these vaccines. The main objectives of this research will be: To evaluate the acceptability of a DEN vaccine in potential target populations in regions of high burden of disease in Argentina. Describe main determinants of and barriers to DEN vaccine acceptability in regions of high burden of disease in Argentina. Identify information and intervention needs to design and implement communication strategies that have a positive impact on the acceptability of a DEN vaccine.

NCT ID: NCT05222698 Not yet recruiting - Facial Paralysis Clinical Trials

Free Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients

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

The use of free Neurovascularized muscles like free latissimus and gracillis muscles for reanimation of long-standing facial palsy patients using the hypoglossal nerve for innervating these muscles

NCT ID: NCT05227274 Not yet recruiting - Clinical trials for Neuromuscular Diseases

Reliability Study of a Motor Function Measure Digitalized Playful Completion Modules

MFM-Play
Start date: April 2022
Phase:
Study type: Observational

Neuromuscular diseases include more than 200 rare disorders affecting muscles or the nervous system. Functional scales assessing motor function are tools allowing to measure the evolution of motor impairment of patients with a neuromuscular disease. They are frequently used as main outcome measures in clinical trials which are currently in full development thanks to advances in genetic and drug researches. Among the available scales, the Motor Function Measure (MFM), a scale consisting of 32 items, had shown good metrological properties in terms of validity, reliability and sensitivity to change, regardless of the diagnosis and extent of motor impairment. By exploring the potential of digital technologies applied to MFM, investigators created a completion module composed of animations with different playful and informative scenarios displayed on a digital tablet. The main purpose of this project is to conduct a multicentre study to assess reliabilities of the MFM completed using the MFM-Play. Expected benefits of this project are to improve the experience and the participation of the children to who is often imposed multiple assessments during the numerous follow-up visits of clinical trials, while maintaining good metrological properties of the MFM.

NCT ID: NCT05230797 Not yet recruiting - Pulp Necroses Clinical Trials

Zincoxide-propolis vs Zincoxide-eugenol Pulpectomy

Start date: April 2022
Phase: Early Phase 1
Study type: Interventional

The clinical trial aims to evaluate the clinical and radiographic success of Zinc oxide- propolis versus Zinc oxide -Eugenol as obturating material in pulpectomy of non-vital primary teeth.

NCT ID: NCT05249231 Not yet recruiting - Caries Clinical Trials

Parental Satisfaction of Hall Technique Versus SDF in the Management of Carious Primary Molars

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

- The aim of this study is to assess parental satisfaction and duration of the procedure of Hall and silver diamine fluoride techniques in the treatment of carious primary molars with healthy pulp. - primary ourcome: parental satisfaction measurement device: four point likert scale measurement unit: 1-2-3-4 - secondary outcome: duration of the procedure measurement device: Digital chronometer measurement unit: minutes

NCT ID: NCT05249725 Not yet recruiting - Clinical trials for NSAIDs-associated Intestinal Mucosal Injury

Therapeutic Effect of Isogladine Maleate on Small Intestinal Mucosal Injury Associated With NSAIDS in Population

Start date: April 2022
Phase: Phase 4
Study type: Interventional

All patients who met the inclusion criteria and agreed to participate in the study underwent baseline capsule endoscopy. Patients with intestinal mucosal injury detected during the initial capsule endoscopy were randomly divided into isoladin maleate group or magnesium aluminum carbonate control group using computer-generated random numbers. Patients in the isoladine maleate group received 4 mg isoladine maleate (Gesellon, Japan) every morning for 4 weeks (or 8 weeks, duration to be determined); Magnesium aluminum carbonate control group received 1 g magnesium aluminum carbonate every morning, afternoon and evening for 4 weeks (or 8 weeks, course to be determined). After treatment, capsule endoscopy was performed again to evaluate the healing of intestinal mucosa.

NCT ID: NCT05249790 Not yet recruiting - COVID-19 Clinical Trials

Anti-inflammatory Drug Algorithm for COVID-19 Home Treatment

COVER3
Start date: April 2022
Phase: Phase 3
Study type: Interventional

The newly recognised disease COVID-19 is caused by the Severe-AcuteRespiratory-Syndrome Coronavirus 2 (SARS-CoV-2), which rapidly spread globally in late 2019, reaching pandemic proportions. The clinical spectrum of SARS-CoV-2 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness and mild extrapulmonary symptoms, and severe viral pneumonia with respiratory failure and even death. For COVID-19, most primary care physicians have initially treated their patients according to their judgment, with various treatment regimens they believe are most appropriate based on their experience/expertise. We recently published a note on how we were treating patients at home based on the pathophysiology underlining the mild/moderate symptoms at the onset of the illness and the proposal of simple drugs that theoretically better fir these mechanisms. Because the common early mild symptoms of COVID-19 highlight a systemic inflammatory process, there is the recommendation of using anti-inflammatory agents to limit excessive host inflammatory responses to the viral infection, including non-steroidal anti-inflammatory drugs and corticosteroids. Moreover, COVID-19 patients are exposed to the risk of thromboembolic events and anticoagulant prophylaxis is recommended even at home, in particular settings, unless contraindicated. In an academic matched-cohort study, we found that early treatment of COVID-19 patients at home by their family doctors according to the proposed recommendation regimen almost completely prevented the need for hospital admission (the most clinically relevant outcome of the study along with death) due to progression toward more severe illness (2 out of 90 patients), compared to patients in the 'control' cohort who were treated at home according to their family physician's assessments (13 out of 90 patients). However, the rate of hospitalization was a secondary outcome of the study and the possibility of a casual finding cannot be definitely excluded. Moreover, these findings were achieved in a retrospective observational study with two matched cohorts of COVID-19 patients, a possible additional limitation of the robustness of the conclusions that would deserve further validation. Thus, we have considered the observed reduction in patient hospitalization a hypothesis generating finding to be confirmed. In this pragmatic, prospective, three-months, cluster randomized, open-label, blinded endpoint (PROBE) clinical trial, we will compare two groups of family doctors according to a randomized approach, who will treat their COVID19-patients with the proposed recommendation algorithm or other treatment regimens they normally feel appropriate according to their usual clinical practice, and monitor them longitudinally up to 3 months. Our working hypothesis is that following the proposed recommendation algorithm the early COVID-19-related inflammatory process is limited, preventing the need of hospital admission at larger extent than with other therapeutic approaches also targeting early symptoms of the illness at home. Should the findings be confirmed, the tested standardized treatment protocol would achieve major benefits for patients with early COVID-19 in particular in relation to a remarkably reduced risk of hospitalization that is expected to translate into reduced morbility and, possibly, mortality. Notably, these expected clinical benefits would be associated with remarkably reduced treatment costs related to reduced hospitalization.

NCT ID: NCT05254704 Not yet recruiting - Quality of Life Clinical Trials

Validation of the French Version of the TEX-Q Questionnaire.

TEX-Q-F
Start date: April 2022
Phase:
Study type: Observational

It is now known that the level of patients' expectations about a treatment (intervention, medication) can influence their prognosis. Positive expectations impact the effectiveness of the intervention, while negative expectations may lead to adverse events. It would therefore be useful to measure these expectations. However, there is no standardized questionnaire to report the overall level of expectation in the pre-operative phase. A team (led by Pr Meike C Shedden-Mora) has recently developed a questionnaire that aims to assess a patient's general level of expectation regarding a therapeutic intervention, taking into account the direct benefits and the expected adverse effects. This questionnaire, the brief version of the treatment expectation questionnaire (TEX-Q) is composed of 15 items. There's currently no French translation of the TEX-Q, nor has it been tested on a population scheduled for surgery. In addition to expectations regarding the surgical procedure, patients seem to have various expectations regarding the impact and specific role of anesthesia. Little literature exists on specific expectations regarding the role of anesthesia. Thus, we believe it is necessary to validate a French version of the TEX-Q questionnaire (TEX-Q-F) applied to the context of scheduled surgery, as well as to evaluate the specific expectations of anesthesia.

NCT ID: NCT05268861 Not yet recruiting - Clinical trials for Cognitive Impairment

The Role of Cognition in Motor Learning After Stroke

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

Stroke leads to lasting problems in using the upper limb (UL) for everyday life activities. While rehabilitation programs depend on motor learning, UL recovery is less than ideal. Implicit learning is thought to lead to better outcomes than explicit learning. Cognitive factors (e.g., memory, attention, perception), essential to implicit motor learning, are often impaired in people with stroke. The objective of this study is to investigate the role of cognitive deficits on implicit motor learning in people with stroke. The investigators hypothesize that 1) subjects with stroke will achieve better motor learning when training with additional intrinsic feedback compared to those who train without additional intrinsic feedback, and 2) individuals with stroke who have cognitive deficits will have impairments in their ability to use feedback to learn a motor skill compared to individuals with stroke who do not have cognitive deficits. A recent feedback modality, called error augmentation (EA), can be used to enhance motor learning by providing subjects with magnified motor errors that the nervous system can use to adapt performance. The investigators will use a custom-made training program that includes EA feedback in a virtual reality (VR) environment in which the range of the UL movement is related to the patient's specific deficit in the production of active elbow extension. An avatar depiction of the arm will include a 15 deg elbow flexion error to encourage subjects to increase elbow extension beyond the current limitations. Thus, the subject will receive feedback that the elbow has extended less than it actually has and will compensate by extending the elbow further. Subjects will train for 30 minutes with the EA program 3 times a week for 9 weeks. Kinematic and clinical measures will be recorded before, after 3 weeks, after 6 weeks, and after 9 weeks. Four weeks after the end of training, there will be a follow-up evaluation. Imaging scans will be done to determine lesion size and extent, and descending tract integrity with diffusion tensor imaging (DTI). This study will identify if subjects with cognitive deficits benefit from individualized training programs using enhanced intrinsic feedback. The development of treatments based on mechanisms of motor learning can move rehabilitation therapy in a promising direction by allowing therapists to design more effective interventions for people with problems using their upper limb following a stroke.

NCT ID: NCT05268900 Not yet recruiting - Clinical trials for Laparoscopic Colectomy

Ventilation Modes Effect on Intracranial Pressure During Laparoscopic Colectomy by Optic Nerve Sheath Diameter

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

Patients who undergo laparoscopic surgery often experience increased intracranial pressure (ICP). In laparoscopic colectomy surgery, the duration always exceeds 2h with more liability to changes in arterial blood gases, hemodynamics, also the patient is in Trendelenburg position about 30° head down, Trendelenburg position is believed to create changes in hemodynamics, respiratory mechanics, metabolic response, and ICP as it affects vital organs especially if steep positioning. Various modes of mechanical ventilation have been experimented to achieve good intraoperative oxygenation which may cause changes in arterial blood gas values and hemodynamic parameters that might lead to changes in the ICP. In this study we will measure ONSD, basal, intraoperative, and in the PACU to evaluate the effect of different ventilation modes (both VCV mode and PCV-VG mode) on intracranial pressure.