Clinical Trials Logo

Filter by:
NCT ID: NCT05855746 Not yet recruiting - Acute Myocarditis Clinical Trials

Colchicine Versus Placebo in Acute Myocarditis Patients

ARGO
Start date: June 22, 2024
Phase: Phase 3
Study type: Interventional

Myocarditis is an inflammatory disease of the heart, mostly caused by viruses. Patients with acute myocarditis are exposed to several complications: recurrence, ventricular arrhythmias (from 5 to 30%), heart failure (5-10%), death or heart transplantation (< 4%). To date, there is no specific treatment for myocarditis. Patient management only focuses upon empirical optimal care of arrhythmia and heart failure. There is a strong rationale for using colchicine in acute myocarditis: - the IL1 (Interleukin1) pathway plays a detrimental role in acute myocarditis. NLRP3 (NOD-like receptor family, pyrin domain containing 3) inflammasome assembly, and subsequent IL-1beta production, are profoundly inhibited by colchicine. - colchicine has been shown to improve cardiac outcomes in inflammatory cardiac disorders, including pericarditis, coronary artery disease, and post pericardiotomy syndrome. - In murine model of CVB3-induced myocarditis (coxsackievirus B3), colchicine improved myocarditis through reduction of NLRP3 activity. - Small case series with improvement of left ejection fraction in myocarditis following low-dose colchicine in addition to conventional heart failure therapy have been reported. With its pleiotropic anti-inflammatory effect in the pro-inflammatory cascade, reducing the myocardial damage and cell death induced during myocarditis, colchicine has the potential to reduce the risk of heart failure and ventricular arrhythmias. Finally, colchicine is a drug widely available, at low cost, and has a long and well-known safety record.

NCT ID: NCT05855733 Active, not recruiting - Clinical trials for Infected Pilonidal Sinus

Radiofrequency Treatment for Pilonidal Disease : Safety of Use, Efficacy and Patient Satisfaction at 6 Months

RaTPiD
Start date: July 3, 2023
Phase: N/A
Study type: Interventional

Infected pilonidal sinus is a common suppuration that occurs twice as often in men as in women, usually between the ages of 15 and 30. Clinical diagnosis is easy, whether the presentation is acute or chronic. Exeresis with a wound left open requiring secondary postoperative healing is the most widely practiced technique in France because its recurrence rate is the lowest, but it has the disadvantage of requiring daily or even twice-daily local nursing care, long healing, and a break in activity. In order to limit the disadvantages of the open technique, "conservative" minimally invasive techniques have also recently been developed in response to strong patient demand: such as endoscopic treatment (EPSIT = Endoscopic Pilonidal Sinus Treatment, or VAAPS = Video-Assisted Ablation of Pilonidal Sinus), or the SiLaT (Sinus Laser Therapy) laser. More recently, radiofrequency has emerged as a new technique in the treatment of hemorrhoidal pathology according to the Rafaelo procedure as well as the Fistura procedure for anal fistulas. The principle of the treatment is similar to that of the laser, based on radio frequency thermocoagulation using very high frequency electromagnetic waves (4MHz), similar to the principle of microwaves. However, its use in the infected pilonidal sinus has not yet been described. The fibers used in anal fistulas are perfectly adapted to the treatment of the pilonidal sinus. In addition, and in contrast to the laser, several fiber diameters are available depending on the size of the fistula path(s). For example, the large diameters of 9 Fr seem to be more adapted to the deep and wide cavities of the pilonidal sinuses than those of the SiLaT, which has a single fiber diameter. The investigators can therefore think that this type of fibers could allow a more efficient destruction of the granulation tissues and a better docking of the cavity walls. According to published studies in the treatment of anal fistulas, the safety profile of this treatment is perfectly reassuring since the penetrance of the energy released does not exceed 3 mm in depth. The aim of this study is to propose a competing alternative to the SiLaT laser, which is radiofrequency according to the Fistura® procedure, by evaluating its safety, efficacy and patient satisfaction on a series of consecutive patients treated

NCT ID: NCT05855317 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS

THROMBO-EVTF
Start date: October 31, 2023
Phase:
Study type: Observational

In this study, 120 patients with Acute Respiratory Distress Syndrome (ARDS) will be included on a two years-period in an intensive care unit (Assistance Publique des Hôpitaux de Marseille, France). Those patients will benefit from a blood test at inclusion in order to measure several coagulation biomarkers, including EV-TF. Subsequently, these patients will be treated according to the usual practices of the department, following recommendations. Patients who received an injected CT scan between Day 5 and Day 28 will be divided into two groups based on the presence or absence of a pulmonary embolism on imaging. The measured values of EV-TF levels and other studied biomarkers will be compared between these two groups in order to detect a possible association between them and the diagnosis of pulmonary embolism. It should be noted that patients receiving an injected CT-scan between Day 5 and Day 7 will be included in the main analysis while those receiving it between Day 8 and Day 28 will be included in the secondary analysis. Others will be excluded from any analysis. At the same time, several collections of clinical data will be carried out: on Day 1, Day 7, Day 28, and on the day of the CT scan if it is performed at another time.

NCT ID: NCT05855200 Recruiting - Colonic Neoplasms Clinical Trials

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

AZUR-2
Start date: August 2, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

NCT ID: NCT05855109 Recruiting - Clinical trials for Arthritis, Rheumatoid

Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors

Start date: October 17, 2023
Phase:
Study type: Observational

The overall aim of the study is to develop and validate a Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) clinical prediction model (screening tool) based on risk factors to guide screening for ILD in patients with RA using High Resolution Computed Tomography (HRCT).

NCT ID: NCT05854914 Not yet recruiting - Clinical trials for Appendicitis With Peritonitis

Benefit of Hypnosis on Smartphone for Acute Post-operative Pain (HYPNO-APP)

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

Appendicitis is a common pathology and the one of the most common surgical procedures performed in France. Young subjects are the most frequent patients with appendicitis. Appendicular peritonitis increases post-operative pain, morbidity, and the average length of hospital stay compared to uncomplicated appendicitis. Pain alters perioeprative rehabilitation of patients. Surgery, performed urgently, generates more anxiety and pain than scheduled surgery. But, intensity of chronic postoperative pain is in correlation to intensity of acute postoperative pain. In addition, admission of emergency cases is more axiety-inducing, due to wait times, packed emergency room, worklaod of medical staff. Sex and age also modify perception of postoperative pain. Adults under 50 feel more pain than older patients for similar procedures. Medication for pain is required in perioperative period et is administered according protocol of each medical center ; these protocols include analgesics, opioids or not, benzodiazepine... However, opioids analgesic (example: morphine) can induce side effect, such as confusional syndrome, cardio-pulmonary manifestations, ileus, nausea and vomiting... Non-pharmacological approaches have been also proposed to reduce anxiety and pain. Hypnosis is frequently used but not always adapted to the emergency: need for qualified and available staff, environment not conducive to hypnotic induction... Hypnosis is a modified state of consciousness ; it is neither a state of vigilance nor a state of sleep. Several types of hypnosis can be distinguished according to the medical application, such as hypnoanalgesia or hypnosedation. Using hypnosedation during surgical or invasive procedure can reduce the use of painkillers and sedatives. Interest of hypnosis has been observed for extraction of wisdow teeth, delivery... Young patients are very comfortable with the use of their smartphone which is often the first object recovered when they return from the operating room. Many hypnosis videos are available free of charge on Internet, and some of which are produced by specialized practitioners and university teachers. A recent study has shown that among young people, addiction to smartphone is a predisposition to hypnosis. However, the use of hypnosis videos on smartphone has never been studied for the control of postoperative pain.

NCT ID: NCT05854368 Recruiting - Gastric Cancer Clinical Trials

Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer

PREGASIGN#1
Start date: July 3, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to characterize and validate a signature of circulating biomarkers in plasma, associated with the presence of gastric preneoplasia in patients with preexisting gastric lesion compared with a control group. For this purpose: - Patients with pre-existing gastric lesions will be invited to participate to this study. If they are willing to participate an additional blood sample (10mL) will be collected at the time of the blood collection performed during their routine care - Healthy subjects will be invited to participate to constitute the control group. If they are willing to participate a blood sample (10 ml) will be drawn specifically for this study

NCT ID: NCT05853575 Recruiting - Metastatic Cancer Clinical Trials

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

Start date: February 1, 2024
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

NCT ID: NCT05853419 Recruiting - Coronary Disease Clinical Trials

Change History and Adopt a Robotic SolutioN for anGioplasty procedurE

CHANGE
Start date: June 20, 2023
Phase:
Study type: Observational [Patient Registry]

The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.

NCT ID: NCT05853406 Recruiting - Aging Clinical Trials

Determination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.

Start date: June 1, 2023
Phase:
Study type: Observational

The main objective of the study is to determine the Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly by a statistical method. The first secondary objective of the study is to determine the Minimal Clinically Important Difference by the Anchor method based on a qualitative assessment by the patients of their own response. The second secondary objective is to determine the Minimal Clinically Important Difference by the Delphi method, based on the search for a consensus between physiotherapists specializing in geriatrics.