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NCT ID: NCT05015985 Not yet recruiting - Regional Anesthesia Clinical Trials

MUSIC-CARE and Locoregional Anesthesia for Orthopedic Surgery

Start date: March 10, 2023
Phase: N/A
Study type: Interventional

Anxiety, fright, stress and pain have always been sources of emotional distress for patients undergoing invasive procedures in clinical settings. Experts have long used traditional methods such as analgesics and anxiolytics to address these issues. But, backed by a movement aiming at reducing the use of pharmacological products, alternative interventions, including music therapy, have gained some steam in recent years. These interventions may have the ability to reduce pain and anxiety while increasing relaxation, coping skills and the overall experience of the procedure. For orthopedic surgery, anesthetics could propose general anesthesia or locoregional anesthesia. The upper limb orthopedic surgery is often performed under locoregional anesthesia and in the ambulatory procedure. However, with the known exacerbating effects of stress and anxiety on pain, the affective experience of the patient can be negatively influenced. In order to mitigate these problems, various types of sedatives and anxiolytics and even low-dose propofol can be used. The Montpellier Regional University Hospital, along with the Music Care Company developed a software so as to standardize this technique around these recommendations. This model demonstrated its efficacy in both acute and chronic pain settings. Indeed, a single music therapy session was found to be effective for decreasing anxiety and promoting relaxation, as indicated by decreases in heart rate, blood pressure, BIS and respiratory rate over the intervention period in intubated patients during weaning phase. Also, a patient-controlled music intervention administered by Music Care has shown to alleviate negative psychological (e.g., depression) and physiological (e.g., pain and discomfort) outcomes and, very importantly, to reduce the consumption of medication in patients with chronic pain due to lumbar pain, fibromyalgia, inflammatory or neurological diseases. Given the recent availability of a standardized and proven delivery method of music therapy (i.e. MUSIC-CARE), the principal aim of this randomized clinical trial is to assess the effect of this music therapy program delivered by application compared to usual playlist music on drug consumptions and physiological parameters, pain, anxiety levels in patients undergoing forearm orthopedic surgery under locoregional anesthesia.

NCT ID: NCT05015790 Recruiting - Cancer Clinical Trials

Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety

LURVIDOC
Start date: February 5, 2021
Phase: N/A
Study type: Interventional

To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer

NCT ID: NCT05015530 Recruiting - Microbiome Clinical Trials

Impact of Symbiofilm On Nasal Microbiota

ISONAM
Start date: December 12, 2022
Phase:
Study type: Observational

Healsea® chronic is CE marked medical device indicated in adults for the treatment of nasal symptoms of chronic rhinosinusitis. This is an hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract (0.2%) isolated from marine bacteria. In vitro, Symbiofilm® inhibits at early stage biofilm formation from bacteria found to be more prevalent and abundant in CRS patients (e.g. Staphylococcus aureus, Pseudomonas aeruginosa). This exploratory study is designed with aim to determine if the antibiofilm properties of Symbiofilm® may modify sino-nasal microbiota, impacting α and/ or β diversities.

NCT ID: NCT05015244 Recruiting - Clinical trials for Von Willebrand Disease, Type 2B

Impact of Von Willebrand Factor-platelet Aggregates in Patients With Type 2B Disease

Von2B
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

The working hypothesis is that patients with Von Willebrand Disease-type 2B may have neurological symptoms due to the chronic formation of platelets/Von Willebrand Factor aggregates. Interestingly, several patients present nonspecific neurological symptoms (nystagmus, headaches, memory disorder, …) which may be associated with cerebral microangiopathy and chronic microvessel inflammation secondary to Von Willebrand Disease-type 2B due to chronic exposure to Von Willebrand Factor-platelets complexes.

NCT ID: NCT05015153 Recruiting - Pulmonary Embolism Clinical Trials

Impact on Quality of Life With Pulmonary RehAbilitation After Pulmonary eMBOlism: RAMBO Study

RAMBO
Start date: May 11, 2022
Phase: N/A
Study type: Interventional

Pulmonary Embolism (PE) is a common and serious disease. Indeed, the annual incidence is 1/1000 patients per year and the 3-month mortality is 10%, which is twice that of myocardial infarction. The treatment is based on anticoagulation for at least 3 months. However, after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases. Several mechanisms explain dyspnea and impairment of quality of life after PE, such as residual pulmonary artery obstruction, exercise deconditioning, depressive syndrome or development of a cardio-respiratory pathology. Pulmonary rehabilitation (PR) has been shown to be effective on dyspnea and quality of life and is included in the therapeutic management of chronic respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis. Furthermore, PR is also used after a myocardial infarction. However, PR after PE is still not included in therapeutic management of PE while outpatient management is recommended for the majority of patients after an acute PE episode. Study hypothesis is that PR has the potential to improve quality of life and dyspnea perception in patients who have received anticoagulation for at least 3 months after PE and who present an impairment of quality of life and/or a persistent dyspnea. This study presents several innovative aspects. First, to our knowledge, This study is the first large randomized trial assessing PR at least 3 months after acute symptomatic PE. Only one small randomized trial on 18 patients evaluating the impact of PR after PE has been published; as PR was performed just after the acute phase of PE in this trial, the clinical status improvement observed in this study could not be explained by PR alone, but also by anticoagulation. In this study, the investigators will include 112 patients at least 3 months after PE in order to exclude the bias related to anticoagulation effect. Second, This study is the first large randomized trial. Third, this study is the first that have the potential to demonstrate efficacy and safety of delayed PR after PE in patients with impaired quality of life due to persistent residual dyspnea.

NCT ID: NCT05015101 Not yet recruiting - Arthroplasty Clinical Trials

Evaluation of the Clinical and Radiological Outcome of Uncemented Femoral Stems According to Their Proximal Coating

ETNA
Start date: September 2021
Phase:
Study type: Observational

Evaluation of the clinical and radiological outcome of uncemented femoral stems according to their proximal coating. Retrospective study

NCT ID: NCT05015036 Not yet recruiting - Spine Surgery Clinical Trials

Evaluation of an Enhanced Recovery Protocol After Minimally Invasive Lumbar Surgery.

ERAMIS
Start date: October 2021
Phase:
Study type: Observational

Prospective longitudinal multicentre observational study carried out on a population of patients undergoing minimally invasive spine surgery and divided into two parallel cohorts according to the presence or absence of a Enhanced Recovery After Surgery (ERAS) programme. The patient will be assessed during 4 visits: At inclusion before surgery, at D0 (day of surgery), at D1 (postoperative visit) and at M1 (follow-up visit).

NCT ID: NCT05014932 Not yet recruiting - Clinical trials for Arthroplasty Complications

Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem

ATHENS
Start date: September 2021
Phase:
Study type: Observational

Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem. Retrospective and prospective multicentric study.

NCT ID: NCT05014815 Active, not recruiting - Clinical trials for Nonsmall Cell Lung Cancer, Stage IV

Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer

Start date: November 16, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized investigator and participant blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC

NCT ID: NCT05014698 Active, not recruiting - Clinical trials for Differentiated Thyroid Cancer

IDEntification of New Predisposition Genes in Differentiated THYroid Cancer

IDENTHY-K
Start date: February 23, 2022
Phase: N/A
Study type: Interventional

The purpose of this research is to find new predisposition genes for differentiated thyroid cancer (DTC).