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NCT ID: NCT05124262 Not yet recruiting - Clinical trials for Irritable Bowel Syndrome

Effect of a Low- Fermentable-Oligo-Di- Monosaccharides and Polyols Diet Group Intervention on IBS Symptoms and Fatigue

FODMAPS
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Irritable bowel disease (IBS) is a functional gastrointestinal disorder that affects 10% of the population. Comorbidities are common and fatigue is the most common extraintestinal complaint in IBS patients. There are no cure for the disease but there are nutrition treatments that can relieve symptoms. The main goal of this randomized controlled trial is to test the hypothesis that low-Fermentable- oligo-di- monosaccharides and polyols (FODMAPs) diet kan decrease gastrointestinal symptoms and improve quality of life and fatigue in patients with IBS.

NCT ID: NCT05215756 Not yet recruiting - Healthy Volunteer Clinical Trials

The Accuracy and Efficacy of AI-driven tVNS Algorithm

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Pain, including somatic and visceral pain, is a common symptom. Persistent pain can lead to repetitive visits to hospitals and can limit patients' daily activities, which can result in tremendous medical cost and lower quality of life. For example, the prevalence rates of 25% are reported only for abdominal pain among adults (3), and it costs $10.2 billion each year in the US. Pain is usually treated according to the World Health Organisation (WHO) 3 steps analgesic ladder. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are mainly used in step 1, which can cause serious side effects such as GI bleeding, renal failure and cardiovascular disease. In step 2 & 3, opioids are used and are also associated with serious side effects (e.g., psychological addiction, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression). Therefore, a new effective non-pharmacological treatment is beneficial for patients. One such method is transcutaneous vagal nerve stimulation (tVNS). The auricular or cervical branch of the vagal nerve runs just under the skin and can be electrically stimulated through the skin by tVNS devices, which have shown the analgesic effects on various pain conditions. The autonomic activity, including parasympathetic tone, can be estimated from the beat to beat intervals in the electrocardiogram, which is called heart rate variability (HRV). To date, we have shown that visceral and somatic pain triggered the autonomic response with the change in HRV, and HRV could be a biomarker of pain. We hypothesised that the development of pain, including somatic pain and visceral pain, could be predicted by analysing heart rate pattern by artificial intelligence (AI). In this proof of concept study, we evaluate the detection rate of pain by the AI analysis of heart rate pattern. We also evaluate the effect of tVNS on the pain threshold.

NCT ID: NCT05325944 Not yet recruiting - Depression Clinical Trials

Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This is a feasibility trial of a digital mental health intervention aimed at young adults (ages 18-25) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. We will pilot three arms: a self-guided DMHI, the DMHI with low-intensity coaching, or an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.

NCT ID: NCT05364853 Not yet recruiting - Epilepsy Clinical Trials

Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

To compare in-person to remote video assessments in children to determine the reliability of remote evaluations for future neuropsychological assessments and set a precedent for future investigations.

NCT ID: NCT05419661 Not yet recruiting - Aneurysm Cerebral Clinical Trials

Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms

Anev3D
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

It is now considered that 1% to 2% of the French population has an intracranial aneurysm. The major risk of this malformation is essentially the rupture which will lead in 10% of cases to death immediately, in 30% to 50% death within three weeks and in 30% of cases the patients will present a permanent disability. The management of this pathology represents today a major health challenge. Historically, neurosurgery was the discipline of first choice for the treatment of this pathology. This consists of clipping the aneurysm by a surgical approach to exclude it from the blood circulation and thus avoid its rupture. For many years now, interventional neuroradiology has established itself, through its "minimally invasive" and endovascular approach, as the reference treatment for ruptured and non-ruptured intracranial aneurysms: this is embolization. This so-called minimally invasive technique consists of placing directly into the aneurysm, using micro-catheters that are navigated under radiological control from the femoral artery, turns of plates called "coils" or prostheses called " stent" or "flow-diverter". This technique makes it possible to secure the aneurysm from the inside and thus reduce the risk of rupture. Today, 95% of patients are treated using this innovative technique and limited intraoperative risks. Interventional neuroradiology has constantly known in recent years a set of revolutions and innovations in terms of implantable medical devices (IMD) allowing to treat more and more patients with excellent clinical results. Today, the interventional neuroradiologist, assisted by the radiographer, has a very wide range of IMDs that he can combine with each other depending on the type, location, size and shape of the aneurysm. The role of the manipulator, here, is to work closely with the neuroradiologist so that he has, on the one hand, quality images and on the other hand, that he can count on a precious ally, an expert in IMDs, during embolization procedures. However, the wide choice of medical devices and the complexity of the aneurysms to be treated sometimes make treatment complicated. On the day of the "cold" treatment of the aneurysm (i.e. non-ruptured), the technicality of the catheterization and aneurysm's spatial conformation complicates the deployment of embolization equipment. This then sometimes leads to undesirable events such as intraoperative rupture. The very purpose of this study is to be able, by means of a 3D printer, to print the patient's aneurysm from the segmented 3D images obtained during the initial assessment and thus proceed to a simulation of the embolization procedure. This pre-operative planning (PPO) carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment.

NCT ID: NCT05490732 Not yet recruiting - Toxicomania Clinical Trials

Pharmacokinetic Modeling of Methadone

PKMETHAHOME
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The management of patients with opioid addiction is a challenge insofar as many distractors or variability factors can interfere with the control of the addiction, whether they are psychological, psychiatric, environmental, pharmacokinetic or pharmacodynamic. Understanding this variability is potentially to be able to adjust a priori a dosage and to identify the factors of clinical response. Few population pharmacokinetic models exist for methadone and they generally concern the management of pain in palliative care patients or the management of opioid withdrawal syndrome in neonates. The hypothesis is therefore that the creation of such a model would make it possible to reduce patients' withdrawal periods, to set a target for plasma concentrations with a view to reducing dosages, and to empower the patient in his choice to monitor blood concentrations facilitated by a minimally invasive sampling device.

NCT ID: NCT05545826 Not yet recruiting - Parkinson Disease Clinical Trials

Vibrotactile Coordinated Reset (VCR): A Treatment for Early Stage Parkinson's Disease

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on early stage Parkinson's symptoms. VCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.

NCT ID: NCT05570422 Not yet recruiting - Cervical Cancer Clinical Trials

A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

This is a seamless Phase 1/2 study consisting of two components. Phase 1 component is a dose-escalation, single arm, open label study in 10 patients to evaluate the safety and tolerability of KRC 01. Phase 2 component is a randomized, open label, controlled, multi-center study in 60 patients to evaluate the preliminary antitumor effect of KRC-01 in combination with CRT.

NCT ID: NCT05587621 Not yet recruiting - Clinical trials for ST Elevation Myocardial Infarction

Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)

GoT
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Intensive Lipid-Lowering Therapy guided by a cloud-based Software System (CLIMEDO GmbH) improves (European Society of Cardiolofgy/European Atherosclerosis Society) ESC/EAS-guideline recommended LDL-cholesterol target attainment and adherence in patients with ST-Elevation Myocardial (STEMI) and Non-ST-Elevation Myocardial Infarctions (NSTEMI).

NCT ID: NCT05619627 Not yet recruiting - Anesthesia Clinical Trials

Oral Dexmedetomidine in Pediatric MRI

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI