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NCT ID: NCT05225376 Completed - Pregnancy Related Clinical Trials

Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior

PregMouv
Start date: April 28, 2022
Phase: N/A
Study type: Interventional

Background: Physical activity (PA) has beneficial effects on health, physical condition, and the maintenance of autonomy and independence at all ages of life. It also has numerous benefits during pregnancy: maintenance or improvement of physical condition, prevention of excessive weight gain, aid in postpartum weight loss, prevention of gestational hypertension, reduction in number of macrosomic infants at birth, reduction in lower back and pelvic pain, and prevention and improvement of postpartum depressive symptoms. A recent systematic review of the literature concluded that interventions to increase PA levels among pregnant women have a positive effect on this level. The studies included in the review also showed that these interventions have a positive effect on these women's well-being and their mental and physical health. Nonetheless, no study has examined this subject in France. Moreover, to our knowledge, no study in the international literature has looked at online interactive video sessions of PA during pregnancy. Overall, few studies allow an assessment of the effect of sedentary behavior and inadequate PA during pregnancy on maternal, neonatal, or infant outcomes. This is equally true for the health of adults whose mothers were physically active during pregnancy. Moreover, we do not know the actual level of PA of women in France. Finally, we do not know what types of intervention described in the literature would enable the best adherence by French women to their initiation or maintenance of an adequate PA level. Study hypothesis: Our hypothesis is that setting up a free program of physical and sports activity session for pregnant women will enable them to meet the guidelines for PA practice during this period and to reduce their sedentary behavior. Objectives: 1.1. Principal objective To study the feasibility of setting up physical activity (PA) sessions for pregnant women during their prenatal care, by assessing its acceptability, the perceived difficulty of the sessions, and their satisfaction with these sessions. 1.2. Secondary objectives - To evaluate the effect of these sessions: - on the PA level and sedentary behavior of pregnant women, - on their quality of life (QoL). - The feasibility and impact of the sessions will be studied according to their PA level at inclusion: active or inactive. - To identify the facilitators of and obstacles to the acceptability of these sessions, other than those studied in the objectives above. - To measure the willingness to pay of pregnant women so that we can quantify how much they would be willing to pay for such a program, were it were not free. Willingness to pay (measured in €) makes it possible to measure indirectly the acceptability of the program to the participants and the monetary value they attribute to it.

NCT ID: NCT05224830 Completed - COVID-19 Clinical Trials

Relationship Between Hyperventilation Syndrome and SARS-CoV-2 Infection

Hypercovid
Start date: January 1, 2021
Phase:
Study type: Observational

Following an acute COVID-19 infection, many patients suffer from long lasting physical symptoms that may greatly impair quality of life. Persisting dyspnea and other functional respiratory complaints could evoke Hyperventilation Syndrome (HVS) as a putative contributor of the long-COVID presentation in COVID-19 survivors. We aimed to assess the possible relationship between a HVS and previous acute SARS-CoV-2 infection.

NCT ID: NCT05224648 Completed - Clinical trials for Postoperative Residual Curarization

Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Neostigmine

DECURATOF 2
Start date: June 22, 2022
Phase: N/A
Study type: Interventional

Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio threshold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration. Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by an anticholinesterase agent (neostigmine). Neostigmine will be injected once four muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (40 µg/kg) in accordance with the clinical practice worldwide admitted. Two questions have to be investigated. First, is this dose of neostigmine sufficient to allow a complete recovery of tetanus stimulations ? Second, due to the pharmacological properties of neostigmine, does a recurarisation phenomenon occur following repeated tetanus stimulations ? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.

NCT ID: NCT05224570 Completed - Gunshot Wound Clinical Trials

Epidemiology of Gunshot Wounds Injuries Admitted in ICU in France

GSW_in_ICU
Start date: January 1, 2015
Phase:
Study type: Observational

In civilian practice, the incidence of firearm violence depends on the country. In high income countries, most cases are reported in the USA or South Africa. In these countries, gunshot wounds (GSW) represent 20% of death cases in trauma centers, more than motor vehicle collisions. The mortality in civilian practice occurs during the first 24 hours following GSW, mainly due to hemorrhage and traumatic brain injury, though long term effects on physical and psychological outcomes have also been shown. Some factors of mortality specific to GSW have been established: multiples wounds, homicide vs suicide attempt, impact zone, or firearm caliber. Few specific guidelines have been published concerning civilian GSW management. These cases are mostly treated in standard guidelines, such as hemorrhagic shock or traumatic brain injury guidelines. As in other trauma mechanisms, the "platinum ten minutes and golden hour" concept is applicable. In Europe, the incidence of civilian GSW is much lower and few European studies have been published recently. Penetrating injuries in Europe are less likely to be GSW, and are more often self-inflicted than in the USA. In addition, European studies are heterogeneous, due to the difference in populations, healthcare systems and GSW being grouped with stabbing wounds under the label "penetrating trauma". However, there is a global concern in Europe regarding a potential rise of GSW, with higher severity score than conventional trauma patients and often necessitate ICU admission. Studies analyzing data from different European countries show significantly different ICU admission rates for overall GSW, ranging from 17% up to 30%. Therefore, the investigators conducted a multicenter, retrospective study on four French University Hospitals aiming to describe the epidemiology (mortality and type of organ damage) and identify prognosis factors of civilian GSW admitted in ICU.

NCT ID: NCT05224232 Completed - Clinical trials for Lower Limb Amputation

Protocole Access-Socket

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

Lower limb amputation has a definitive impact on a person's locomotor abilities, considerably reducing his or her autonomy in everyday life. 50% of lower limb amputees in France are trans-femoral. The femoral prosthesis must be adapted to allow the amputee to walk in everyday situations and to make the range of activities practiced by non-amputees accessible to them. Sitting posture, which represents an important part of a day, must also be comfortable. Comfort will be closely linked to the socket, which ensures the transmission of the mechanical actions of the prosthesis to the body of the amputee through the residual limb. This must be done without damaging the integrity of the biological tissues at the interface. The challenge is therefore to transmit the mechanical actions inherent to the use of the prosthesis while being as comfortable as possible. The most common form of femoral socket is the one with included ishions, which by its structure limits the rotation of the socket around the residual limb. However, it limits hip joint amplitudes, which significantly impacts comfort during walking, especially when the individual must evolve in constraining environments (irregular terrain, slopes, uphill, downhill). Comfort is also limited when putting the prosthesis in place and when sitting, because of the limits of the socket that go up into the groin and the buttock. Discomfort can also be induced by contact and clamping surfaces. Only 42% of amputees are satisfied with their sockets. An uncomfortable or wound-inducing brace will not be worn or will be worn only a little, which can increase the risk of comorbidities. One solution to the comfort issue could be the Access Socket (AS) soft socket, which is exactly the same shape and manufacturing principles as the Rigid Included Carbon Socket (ER), but combines a rigid structure with soft areas. These soft areas allow pressure to be distributed within the socket, allowing for some deformation, while maintaining the mechanical properties necessary for walking. The objective of this study is to compare the comfort perceived by amputees when wearing an AS soft socket versus their RE, both sockets being mounted identically on the patients' usual medical devices. The hypothesize is that scores on the various comfort, satisfaction, and mobility scales should be better when patients wear the soft socket compared to the rigid socket. In this multicenter, randomized, cross-over study, patients will wear the rigid socket and then the access-socket (or vice versa), over a 4-week period for each socket. The two sockets will have an identical shape and will be mounted in the same way on the patients' medical device. At the end of each 4-week period, patients will fill out self-questionnaires (PEQ, SCS, PLUS-M, ESAT and SF-36) to evaluate their comfort, satisfaction and ambulation.

NCT ID: NCT05223868 Completed - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis

FRONTIER 1
Start date: February 3, 2022
Phase: Phase 2
Study type: Interventional

Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

NCT ID: NCT05221346 Completed - Clinical trials for Hypercholesterolemia

Effect of Oleactiv® on LDL Oxidability

e-POL
Start date: December 13, 2021
Phase: N/A
Study type: Interventional

Oleactiv® have previously demonstrated beneficial effects in an animal model of diet-induced atherosclerosis. After a 12-week supplementation, a substantial reduction of aortic fatty streak area has been observed. Also, Oleactiv®-supplemented hamsters displayed significant decrease of both non-HDL-cholesterol and triglycerides levels. Also, phenolic compounds from Oleactiv® demonstrated that increase of cholesterol efflux capacity (CEC) is one of the mechanisms that may explain preventive effect on atheroma development. These effects observed in animals will thus be investigated in human. The main hypothesis of the present study is that phenolic compounds from Oleactiv® may improve LDL oxidability in volunteers with moderate hypercholesterolemia after 3 weeks of consumption.

NCT ID: NCT05221216 Completed - Acute Kidney Injury Clinical Trials

Retrospective Observational Study of Cotrimoxazole Dosing in Intensive Care Unit

Start date: October 15, 2021
Phase:
Study type: Observational

Trimethoprim/sulfamethoxazole (TMP/SMX, cotrimoxazole) is the first-line therapy for Pneumocystis jirovecii pneumonia and bacterial infections in critically ill patients, where acute kidney injury (AKI) and renal replacement therapy (RRT) are regularly observed. Both may change half-life and subsequent concentrations. Specifically, Trimethoprim (TMP) is eliminated renally, whereas sulfamethoxazole (SMX) elimination is 80%metabolic/20%renal. Despite decades of cotrimoxazole use, data in acute kidney injury (AKI) are scarce and no consensus on dosing strategy has been established. Besides, pharmacodynamic parameter has not been determined, leading to an uncertainty on the dosing regimen.

NCT ID: NCT05220696 Completed - Shock Clinical Trials

Central Venous Oxygen Saturation and Carbone Dioxide (CO2)-Derived Indices in the Critically:

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

The optimal management of shock states requires a precise evaluation of several parameters, clinical, biological, hemodynamic, and echocardiographic. Among these, parameters that measure O2 and CO2 consumption are of a great interest, especially PCO2 arteriovenous gradient (PCO2 gap) and O2 arteriovenous difference [D(a-v) O2]. The PCO2 gap best correlates with cardiac output while the PCO2gap/D(a-v)O2 ratio would be earlier and more specific than blood lactate assay in assessing tissue hypoperfusion secondary to shock. The PCO2 gap and the PCO2gap/D (a-v) O2 ratio have been evaluated from gas measurements of venous blood collected from the pulmonary artery and from the superior vena cava area. However, in some patients the placement of a catheter in the superior vena cava is difficult or even impossible due to thrombosis, vascular occlusions and other reasons… In these cases, the inferior vena cava is used for drugs infusion, nutrition and possibly samples. Gasometric samples in lower cellar territory have not yet been validated and may not be correlated with measurements in upper cellar territory. It is therefore useful for current practice to validate samples in lower cellar territory and demonstrate their correlation with measurements made in upper cellar territory. During an observation period, in patients with catheters in the superior and inferior vena cava for therapeutic indications (renal replacement therapy,...), the investigators systematically took gas measurements at the femoral and jugular sites. the investigators used these data to assess the correlation of PCO2 gap measurements and carbon dioxide-derived indices according to the harvest site : jugular and femoral venous.

NCT ID: NCT05220657 Completed - Sedentary Behavior Clinical Trials

Exploring the Relationship Between the Gut Microbiome, Physical Fitness Levels and Metabolic Responses to Exercise

EXOMIC
Start date: January 20, 2022
Phase:
Study type: Observational

Gut microbiota are all microorganisms including bacteria and microscopic eukaryotes that live in the digestive tracts of humans or mammals. During the last decade, some authors highlighted that a link exists between gut microbiota and sport performance. In this project, we hypothesize that gut microbiota is able to adapt to the energy needs of the body, really higher in top-level athletes or considerably lower in inactive individuals. In this context, this clinical study aims to characterize the bacterial metagenome of gut microbiota from populations located in a continuum from sedentary people to top-level athletes with high (i.e. soccer players), even very high energy needs (i.e. cyclists). The finality of this project is thus to determine if it exists some bacterial profile allowing to characterize, even to predict, the energy metabolism of an athlete and so the probability to be performant in competition.