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NCT ID: NCT05271812 Not yet recruiting - Breast Feeding Clinical Trials

Professional Supporting and Women's Education for Breastfeeding Promotion: Preliminary Study

PSWED
Start date: March 2022
Phase:
Study type: Observational [Patient Registry]

Background The long-term benefits of breastfeeding for newborns and mothers are undeniable and scientifically recognized. Current WHO/UNICEF guidelines suggest increasing exclusive breastfeeding to 75.0% by 2030 worldwide. However, there is substantial heterogeneity in breastfeeding practices around the world. Because while breastfeeding promotion is complex, breastfeeding instructions remain without any educational design in general. Primary Objective: - Determine the effectiveness of breastfeeding educations among the nursing mothers during first month after childbirth. Secondary objectives: - Identify the theoretical and pedagogical engineering framework the breastfeeding educations proposed in antenatal among nursing mothers and professionals. - Assess the perceived usefulness of nursing mothers regarding to the educational interventions for breastfeeding management and its frequently complications. - Assess the perceived usefulness of professionals, regarding to the pedagogical engineering of educational interventions offered to nursing mothers. - Assess women's competency regarding to the educational interventions for breastfeeding management and its frequently complications. - Evaluate the organization of educational interventions proposed by professionals. Method & Results: The results will be obtained by calculating the mean, standard deviation, median and interquartile range. The Chi-square and Yates' uncorrected and corrected tests will be applied for comparison calculation. Evaluating criteria for feeling of usefulness and breastfeeding competency will be studied using Likert's four level model, 10-Point numerical scales and short answer questions. The relationships between these variables will be studied by using a sequential mixed method combining interpretative, comprehensive, and explanatory approach.

NCT ID: NCT05264259 Not yet recruiting - BK Virus Infection Clinical Trials

New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies

AcMBK
Start date: March 5, 2022
Phase:
Study type: Observational

BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.

NCT ID: NCT05261061 Not yet recruiting - COVID-19 Clinical Trials

Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19

PROVID-Ger
Start date: July 2022
Phase:
Study type: Observational

Old patients hospitalized in Acute Geriatric Units are characterize by advanced age, frailty, high number of comorbidities, cognitive impairment and loss of functional autonomy. Although, intra-hospital mortality in geriatric population (out of COVID) is low (6%) the long-term prognosis is often worse (30 to 60% of loss of autonomy and 30% of one-year mortality among hospital survivors). For geriatric patients with COVID19, intra-hospital mortality is higher than in younger Covid patients (1), but also higher than in geriatric patients outside the Covid context (30 vs 6% (2, 3)). Our hypothesis is that geriatric patients surviving hospitalization for COVID-19 have a worse vital and functional prognosis at 12 months than geriatric patients surviving hospitalization for another medical reason.

NCT ID: NCT05258383 Not yet recruiting - Breast Cancer Clinical Trials

Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

ELISA
Start date: May 15, 2023
Phase:
Study type: Observational

In image-guided radiotherapy (IGRT), the repeated and increasingly intensive use of on-board positioning imaging, using 2D or 3D Mega-Volt (MV) or kilo-Volt (kV) imaging devices (cone-beam or CBCT scanners), is leading the international medical community to question the potential impact of these additional doses delivered to the patient, especially in at-risk populations such as children and young adults. The doses delivered to the patient by positioning imaging are still relatively unknown, due to the lack of experimental means and software available in clinical routine to easily and accurately evaluate these doses. The main objective is to estimate by personalized Monte Carlo calculation the physical doses delivered to the patient's organs by the onboard imaging systems during their radiotherapy treatment. The obtained imaging doses will be compared according to different irradiation scenarios commonly used in clinical routine as well as according to the treated location.

NCT ID: NCT05250128 Not yet recruiting - Clinical trials for Obstructive Pulmonary Disease

The Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

MICROBOPH
Start date: September 2022
Phase:
Study type: Observational

Mild to moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD); such a complication is associated with increased risks of exacerbation and decreased survival. A small proportion of COPD patients may present with severe pulmonary hypertension, defined by a mean pulmonary artery pressure more than 35 mmHg (or more than 20 mmHg with a low cardiac index < 2 l/min/m2) with pulmonary vascular resistance more than 3 Wood units, measured by right heart catheterization (RHC). In these patients, pulmonary microvessels remodeling is the main cause of increase in pulmonary arterial pressure and is thought to result from the combined effects of hypoxia, inflammation, and loss of capillaries but the mechanisms are complex. For these patients, no drugs have been approved for treatment and lung transplantation must be considered for the more severe patients who are eligible. A better characterization of these patients is needed. We hypothesize that microvesicles generation and endothelial damage could be related to the severity of pulmonary hypertension due to COPD, assessed by pulmonary hemodynamic parameters. Circulating biomarkers of vascular damage and cell activation will be measured in blood samples from 80 COPD patients who have hemodynamic assessment by RHC. To go further, the origin of the particles will be characterized.

NCT ID: NCT05247580 Not yet recruiting - Clinical trials for Pedagogical and Psycho-social Impact of in Situ Simulation

Impact of Pediatric Medical Emergencies' in Situ Simulations

Impact-SUrVIS
Start date: May 2024
Phase:
Study type: Observational

Simulation in healthcare is becoming more and more essential in the training of paramedical and medical caregivers. It is a powerful educational tool that can enrich knowledge and skills, whether technical (setting up a venous catheter, intubation, etc...) or transversal (teamwork, communication, stress management in crises, etc.). The hospital environment requires nurses, nurses' aides, residents, and doctors to provide human care in increasingly technical work environments while exercising increasing responsibilities. These caregivers are therefore exposed to many stressors. Several studies highlight the benefits of simulation on the ability of professionals to deal with rare and/or complex crises which they have previously faced during simulation sessions. Beginning January 2022, the Necker - Enfants Malades hospital will start a hospital' scale training program for pediatric medical emergencies using in situ simulation of the Necker - Enfants Malades hospital. The SUrVIS (Simulation d'Urgences Vitales In Situ) project is based on interprofessional training courses divided into four parts theoretical training (recognition of the critically ill child / cardiorespiratory arrest, how to call for assistance), procedural simulation (ventilation / chest compression / set up an intraosseous access / call for help...), three in situ simulation scenarios of pediatric medical emergencies (with live audiovisual retransmission for observers) each ending with a debriefing and a conclusion of the day with handing over of best practice documents. The study investigation team plan to train 400 caregivers each year (including 300 nurses and nurses' aides). The Impact-SUrVIS (Impact de la Simulation d'Urgences Vitales In Situ) study is built around the SUrVIS sessions. Through questionnaire, the study investigation team will assess the impact of this hospital program on self-confidence, the feeling of professional efficiency, interprofessional communication, and work-related stress.

NCT ID: NCT05247515 Not yet recruiting - Colorectal Cancer Clinical Trials

Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection

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

Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.

NCT ID: NCT05241561 Not yet recruiting - Cancer of Kidney Clinical Trials

Cabo-POLARIS : A Trial to Evaluate Cabozantinib Among Haemodialysied Patients

Cabo-POLARIS
Start date: June 2022
Phase: Phase 2
Study type: Interventional

Among patients with renal cell carcinoma (RCC), 2.7 to 4.7 % of patients are at risk of progressing to dialysis or transplantation after partial and radical nephrectomy respectively. Of note, similar risk factors can be seen in both disease: RCC and renal impairment leading to dialysis. Currently, three types of systemic therapies (ST) are mainly used among patients with metastatic renal cell carcinoma (mRCC): anti-angiogenics (mostly tyrosine kinase inhibitors and bevacizumab), mTOR inhibitors and immune checkpoint inhibitor. ST prescription for patients undergoing HD may be more dangerous than in other patients. This is partially explained by the fact that several adverse events can be induced by both the ST and HD e.g. thromboembolic disease, or hypertension. Patients in HD are usually excluded from major clinical trials and available data concerning safety and activity of ST in this specific population are lacking. In most cases, drugs' label is driven by the eligibility criteria of large randomized phase 3 trials that exclude this type of patients. The main source of information for these patients comes from academic publications of patients' cases or small cohorts, but they are not included within the drug label. Moreover, no clear guidelines are given by savant societies regarding those patients. It is known that patients with HD are at high risk of specific adverse events that can sometimes overlap with the safety profile of anti-cancer drugs: thromboembolic complications, cardio-vascular comorbidities, hematologic and metabolic abnormalities. Having a dedicated clinical trial to this particular population would definitely help the community to improve the care of HD patients by getting prospective data in order to increase the level of evidence and therefore to optimize anticancer drug use in this specific population.

NCT ID: NCT05237609 Not yet recruiting - Post-fall Syndrome Clinical Trials

Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome in Elderly Persons

RM-SDP
Start date: January 2023
Phase: N/A
Study type: Interventional

The post-fall syndrome or psychomotor disadaptation syndrome can be considered as a complication of a fall and can lead to a total loss of autonomy. This syndrome remains little studied, despite its important frequency in acute geriatric services or geriatric rehabilitation care, and despite its recognized seriousness. Decreased grip strength seems to be a risk factor for psychomotor disadaptation syndrome in after a fall, which is why we hypothesize that muscle strengthening adapted to the elderly subject would limit the appearance of this syndrome. By limiting this risk, it would reduce complications such as loss of functional independence, but also reduce the number and duration of hospitalization of elderly patients.

NCT ID: NCT05233930 Not yet recruiting - Gonarthrosis Clinical Trials

Total Knee Arthroplasty and Augmented Reality-based Navigation System

Start date: September 2024
Phase: N/A
Study type: Interventional

The purpose of Total Knee Replacement (TKR) is to remove worn cartilage surfaces and replace them with artificial parts of the same shape. TKR can be used in cases of osteoarthritis, inflammatory rheumatism, bone necrosis of the knee or following malformative or traumatic sequelae. Implant alignment is paramount in TKR and the last years have seen a proliferation of alignment techniques following the introduction of computer and robotic-assisted surgery. Among Computer-assisted surgery, the augmented reality-based navigation system can be an option to improve accuracy in orthopaedic surgery. The hypothesis of this study is: the use of augmented reality-based navigation system allows a prosthesis alignment and positioning that is at least as good as with the traditional mechanically aligned technique, and therefore improves knee functional results. This study also aims at assessing the cost-effectiveness of this new technology.