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NCT ID: NCT06462287 Recruiting - Apnea, Obstructive Clinical Trials

EFFECT OF A SUBSTANCE P ANTAGONIST ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME AND ARTERIAL HYPERTENSION

APHOS 3
Start date: March 5, 2024
Phase: Phase 2
Study type: Interventional

Obstructive sleep apnea syndrome (OSAS) is associated with hyperaldosteronism with elevated plasma aldosterone/renin ratio, the physiopathological mechanism of which remains uncertain. This hyperaldosteronism contributes to the development of arterial hypertension and cardiovascular complications observed in patients with OSA, in particular by increasing arterial stiffness and heart rate variability. The frequent association of OSA with obesity with metabolic syndrome suggests that excess weight could be responsible for stimulation of aldosterone secretion independent of the renin/angiotensin system. Several studies indicate in particular that the production of mineralocorticoids by the adrenals could be activated by various adipocyte secretion products such as leptin and certain fatty acids after oxidation in the liver. In addition, a recent study showed that basal aldosterone secretion is also controlled by substance P released within the adrenal tissue itself by nerve fibers belonging to the splanchnic contingent. Thus, the oral administration of aprepitant, an antagonist of the substance P receptor (NK1 receptor), to healthy volunteers induces a reduction of approximately 30% in the overall secretion of aldosterone assessed by measuring aldosteronemia and 24-hour aldosteronuria. To the extent that OSA causes sympathetic hypertonia, the hypothesis is that the associated hyperaldosteronism could result from activation of the nervous control of aldosterone secretion, involving substance P and the NK1 receptor. If this is indeed the case, the administration of aprepitant to patients with OSA should result in a significant reduction in aldosteronemia.

NCT ID: NCT06461689 Not yet recruiting - Clinical trials for Prostate Cancer Metastatic

Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer

PROLUT
Start date: September 1, 2024
Phase:
Study type: Observational

To demonstrate the prognostic value of using post-therapy 177Lu-PSMA SPECT/CT versus 68Ga-PSMA-11 PET/CT in mCPRC patients progressing despite chemotherapy and treated with 177Lu-PSMA.

NCT ID: NCT06461325 Active, not recruiting - Clinical trials for Complication,Postoperative

Surgical Management Of Gastroschisis

LAPS
Start date: May 1, 2024
Phase:
Study type: Observational

The investigators aim to analyze the management of children born with gastroschisis between January 2009 and December 2023, i.e. to evaluate post-operative follow-up, hospitalization costs, the risk of post-operative umbilical hernia, and the parents' and the child's appreciation of the scar.

NCT ID: NCT06461052 Recruiting - Ambulatory Surgery Clinical Trials

Information and Music Therapy as a Means of Reducing Preoperative Anxiety in Outpatient Surgery.

Harmonie
Start date: March 12, 2024
Phase: N/A
Study type: Interventional

This is a monocentric, prospective, before-and-after, open-label controlled study, two groups of 99 patients each: "control" group - usual care - versus "intervention" group "Intervention" group - patient information via an explanatory video followed by a 15-minute music therapy session of the patient's choice in the operating waiting room.

NCT ID: NCT06460909 Recruiting - Clinical trials for Hallux Valgus Surgery

Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery

PrePS HV
Start date: February 2, 2023
Phase: N/A
Study type: Interventional

Catastrophizing is a negative evaluation of events. What surgery concerns, pain catastrophizing is one of the main risks of postoperative pain and / or poor functional recovery. The best survey to evaluate pain catastrophizing is the PCS (Pain Catastrophizing Scale). According to the authors, catastrophizers report more negative pain related thoughts, more emotional distress and more pain than non-catastrophizers. The PCS is a significant predictor of pain intensity and so of poor functional recovery. It is already well known that anxiety and catastrophizing predict postoperative pain. The actual studies focus mainly on functional recovery of knee and hip arthroplasties, but less on pain and functional recovery of hallux valgus surgery. According to several authors, adapted psychological support of preoperative catastrophizing could allow a better postoperative evolution. Our hypothesis is that a preoperative psychological consultation of catastrophizing patients is efficient to lower pain catastrophizing in adult patients undergoing a surgical operation for hallux valgus. The first objective is to evaluate the impact of a psychological support of preoperative pain catastrophizing during a hallux valgus surgery.The principal evaluation scale is the pain catastrophizing score before and after surgery. The second objective is to evaluate the pain and functional recovery of pain catastrophizing patients. The criteria of this survey are: anxiety score (usual and actual), pain and function according to the FAOS (Foot and Ankle Outcome Score) pain (Analogic Visual Scale).

NCT ID: NCT06460896 Not yet recruiting - Clinical trials for Bypass Bariatric Surgery

Analysis of the Influence of Gastric By-Pass on the Pharmacokinetics of Common Drugs

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

Lack of knowledge of digestive absorption of drugs used in metabolic syndrome (MS) before and after gastric by-pass (GBP) in obese patients. The main objective is to study the changes in apparent clearance of candesartan, amlodipine, metformin and rosuvastatin, used in the treatment of metabolic syndrome in obese patients, between the preoperative period and 1 and 6 months after the performance of a GBP.

NCT ID: NCT06460558 Recruiting - Diabetes type1 Clinical Trials

T1D Closed-loop and Physical Activity

Start date: May 6, 2024
Phase:
Study type: Observational

"Physical activity is recognized as beneficial for patients living with type 1 diabetes (T1DM), with a demonstrated effect not only on HbA1c control [1] but also on reducing the incidence of diabetes-related complications [2,3]. It is recommended that patients living with T1DM perform 150 minutes of accumulated physical activity per week, without exceeding two consecutive days without physical activity [4]. Indeed, one meta-analysis reported that moderately vigorous activity (≥4.5 METs) was beneficial compared with lower-intensity activity, while three other studies noted that only vigorous physical activity (≥6 METs) predicted lower all-cause mortality rates [5]. However, T1DM can represent a major obstacle to physical activity because of the occurrence of fairly frequent hypoglycemia, including after physical effort, the need for early resugaring but also the risk of hyperglycemia (rebound or with certain activities) [6]. The advent of automated insulin delivery systems has led to a significant improvement in time on target and a reduction in the frequency of hypoglycemia, including during physical activity in some studies [7-9]. The aim of this study is therefore to evaluate, in a cohort of patients with T1DM, whether the implementation of a closed-loop automated insulin delivery system increases physical activity in patients with T1DM. Based on the interpretation of the ONAPS-PAQ [10], the investigator hypothesize that the implementation of the closed-loop system enables an individual to reach the 3000 MET/min/week threshold (considered ""Active+"" from this threshold onwards).

NCT ID: NCT06460519 Not yet recruiting - Shock Clinical Trials

The Prevalence of the Aortic to Radial Pressure Gradient in States of Shock, Outside the Context of Cardiac Surgery, a Prospective Study

PARECHOC
Start date: August 1, 2024
Phase:
Study type: Observational

First described in cardiac surgery, the aortic to radial pressure gradient (ATRAP) is the cause of an underestimation of the aortic pressure with a measure assumed with a radial catheter, and he can concert 1 of 3rd patients. The risks factor well known are small height, previous hypertension, long and difficult surgery, radial artery diameter less than 1.8mm. The ATRAP definition is a pressure difference between radial and femoral (same of the aortic pressure) pressure of 25mmHg on the systolic pressure, or a pressure difference on the mean pressure of 10mmHg, both measures realised by arterial canulation, and with a duration superior than 5 minutes. If this gradient appears in pathophysiological specifics situations, there is a risk of inappropriate administration of vasopressors, with more hospitalisation days, more side effect of vasopressors like an augmentation of myocardial work. The ATRAP is documented in septic shock with a prevalence between 21% and 27%. The ATRAP can appear in shocks, moreover with doses of equivalent norepinephrine of 0.5 µg/kg/min who is use for the definition of refractive shock, the difference between the two pressure is higher if the dose of equivalent norepinephrine is higher than 1µg/kg/min. But the prevalence and risks factors are barely unknowns in this situation. Most of the time, a radial arterial catheter is used for hemodynamic monitoring for his simplicity of utilisation and the lows complications associated. Some medical teams in cardiac surgeries, or in intensive care unit (ICU) for the management of shocks used often radial and femoral arterial catheter. It seems there is no at risk for the utilisation of a radial and femoral arterial canulation. Out of the situation of cardiac surgery, there is a lack of information of the ATRAP, the objective of the study is to evaluate the prevalence of the ATRAP in shock, out of the situation of cardiac surgery.

NCT ID: NCT06459791 Not yet recruiting - Clinical trials for Metastatic Breast Cancer

Efficacy of Personalized Tumorogram-based Therapy in Cancer Established From Patient-derived Organoid

AVATAR
Start date: September 15, 2024
Phase: N/A
Study type: Interventional

A biopsy of a breast tumor lesion will be performed for processing to establish avatars (patient-derived organoids -PDO). A personalized tumorogram for each patient will be provided, based on the results of the drug screening (= tumor predicted as sensitive, intermediate, resistant or non-evaluable for each drug tested). Patients with an informative tumorogram will receive one of the recommended treatments (line N+1) in the event of tumor progression, administered according to standard procedures and validated at medical meetings specific to each center, and their fate will be monitored.

NCT ID: NCT06458699 Active, not recruiting - Stoma Ileostomy Clinical Trials

Management Of Stoma In Patients Younger Than 3 Months Old

STOMP
Start date: May 30, 2024
Phase:
Study type: Observational

Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also acquired conditions, such as enterocolitis or intestinal perforation. The aim of these stomas is to divert stool in the event of intestinal obstruction or risk of fecal contamination. Depending on the indication and the type of stoma used, the post-operative follow-up, such as resumption of intestinal transit and feeding, secondary closure of the stoma or not, and the duration and cost of hospitalization differ. The aim of this study is to compare these differences in order to extract an optimal management strategy, in the light of what is reported in the international scientific literature.