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NCT ID: NCT05565313 Active, not recruiting - Clinical trials for Head and Neck Carcinoma

Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI

AI4rENE
Start date: March 22, 2022
Phase:
Study type: Observational

Development and validation of a model that predicts rENE from radiological imaging using annotated / labeled scans by means of deep learning

NCT ID: NCT05562934 Active, not recruiting - Clinical trials for Resistant Hypertension

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.

Start date: November 8, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC) injections, compared to placebo. Since all study participants will be patients with rHTN, all study treatments will be given on top of maximally tolerated background antihypertensive therapy recommended by international guidelines for treatment of HTN (i.e., a thiazide or a thiazide-like diuretic, an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), and a long-acting dihydropyridine calcium channel blocker (CCB).

NCT ID: NCT05559931 Active, not recruiting - Stroke Clinical Trials

Single and Repeat Doses of DMT in Healthy Subjects

Start date: January 13, 2023
Phase: Phase 1
Study type: Interventional

This study aims to assess the safety and tolerability of single ascending, and fixed repeated doses of N,N-Dimethyltryptamine (DMT) in healthy subjects, when given by intravenous (IV) infusion.

NCT ID: NCT05556512 Active, not recruiting - Obesity Clinical Trials

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

SURMOUNT-MMO
Start date: October 11, 2022
Phase: Phase 3
Study type: Interventional

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

NCT ID: NCT05551403 Active, not recruiting - Epilepsy Clinical Trials

Cortical Excitability and Treatment Response in People With Epilepsy

eCORTA
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

Epilepsy is a medical condition marked by the occurrence of unpredictable, recurrent seizures. One-third of people with epilepsy continue to experience seizures, despite having attempted multiple forms of anti-seizure medication (ASM). Currently, response to ASM is assessed on a trial-and-error basis as their efficacy can only be determined in hindsight. This causes delays in finding the proper treatment per individual. Responsiveness of the outer brain layer to external stimuli, termed cortical excitability (CE), may be used as additional means of treatment evaluation. In this study, the investigators aim to measure CE before and after starting with ASM, so as to determine whether indicators of CE can be used to predict favorable response to the medication. Participants in this study are adult individuals with uncontrolled seizures that will start with the novel anti-seizure medicine cenobamate. The investigators hypothesize that, after starting with ASM, the CE will decrease in people with epilepsy who show a favorable response to the medication. Conversely, the investigators anticipate that the CE will not decrease in those that do not react to the mediation. The investigators will address this hypothesis by evaluating both brain activity (electroencephalography, EEG) during rest and during different types of stimulation (magnetic, light flashes). Besides, the investigators will measure the subjective experiences of participants by using questionnaires on the quality of life and feelings of anxiety or depression. These measurements are performed at a baseline instance, just before starting with ASM, and at two instances after start with the ASM. Participants in the study will track the occurrence of seizures - using a diary - from 12 weeks before ASM start up till 12 months after ASM start. The investigators will compare seizure frequency with both changes in brain activity and subjective experiences by the participants.

NCT ID: NCT05551377 Active, not recruiting - Parkinson Disease Clinical Trials

Head-up Tilt Sleeping to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease

Start date: January 18, 2023
Phase: N/A
Study type: Interventional

Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and often coincides with supine hypertension. This co-occurrence complicates pharmacological treatment as treatment of one can negatively affect the other. Head-up tilt sleeping (HUTS) could improve both. This phase II randomized controlled trial (RCT) aims to investigate the efficacy and tolerability of this understudied intervention, leading to optimal implementation strategies.

NCT ID: NCT05537571 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events

Start date: January 3, 2023
Phase: Phase 2
Study type: Interventional

Phase 2 study to evaluate the efficacy, safety and tolerability of SLN360 administered subcutaneously (SC) compared with placebo in adult participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events

NCT ID: NCT05526157 Active, not recruiting - Clinical trials for Type 2 Diabetes Mellitus

An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice

FINEGUST
Start date: October 1, 2022
Phase:
Study type: Observational

This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied. In observational studies, only observations are made without specified advice or interventions. People receiving the following CKD or T2D treatments as recommended by their doctors will be included: - Sodium-glucose cotransporter 2 inhibitors (SGLT2i), - Glucagon-like peptide-1 receptor agonists (GLP-1 RA), - Steroidal mineralocorticoid receptor antagonists (sMRA), - Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA) - Other nsMRA (only in Japan) Kidneys filter extra water and waste from the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to properly filter blood. In people with T2D, the body does not make enough of a hormone called insulin or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. The new drug, finerenone, works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys. By lowering their stimulation, finerenone reduces the risk of progressive worsening of the kidney disease. Finerenone is available and approved in several countries for doctors to prescribe to people with CKD and T2D. The main purpose of the study is to collect and describe characteristics of participants in each treatment group who have started or will start treatment before and after finerenone became available. To do this, the researchers will collect data on: - Patient characteristics (e.g., age sex) of the participants - Clinical characteristics (e.g., history of CKD and T2D, heart and liver health, other health problems) of the participants - Treatments for T2D and CKD - Other medications used Data will be grouped by type of treatment that is initiated (e.g., SGLT2i, a GLP-1 RA, a sMRA, finerenone, or other nsMRA). Two time periods will be compared. Study period I is the time until finerenone became available in the respective country, starting from 2012 (2014 for Japan). Study period II will begin when finerenone becomes available in the respective country and will end at the end of the study (planned in September 2024). Researchers will also collect data on treatment patterns and changes for each type of treatment in both time periods. Health care data will be collected from various sources in five countries (e.g., Denmark, the Netherlands, Spain, Japan, and the US). The patients will receive their treatment as prescribed by their doctors during routine practice according to the approved product information. Each patient will be in the study from first use (in Study period I and II) of one of the listed drug classes until: - End of study - The data are somehow no longer available - The patient leaves or has to leave the study

NCT ID: NCT05525520 Active, not recruiting - Pruritus Clinical Trials

Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

PACIFIC
Start date: October 6, 2022
Phase: Phase 2
Study type: Interventional

This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)

NCT ID: NCT05519605 Active, not recruiting - Pancreatic Cancer Clinical Trials

Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD

BESTDRAIN
Start date: August 1, 2022
Phase:
Study type: Observational [Patient Registry]

The vast majority of patients with distal biliary, pancreatic head or uncinate process cancer have jaundice caused by distal malignant obstruction (DMO) of the common bile duct. Biliary drainage by Endoscopic Retrograde Cholangiopancreatography (ERCP) with trans-papillary stent placement is the treatment of choice. ERCP has a failure rate ranging from 12 - 25 percent. Percutaneous transhepatic biliary drainage (PTBD) is the alternative conventional way to drain the biliary tree after ERCP failure, which is related with substantial morbidity (62%) and mortality (17%). Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is a novel promising drainage modality with reported excellent outcomes in terms of clinical success and complications. The implementation of EUS-BD besides ERCP and PTBD into Dutch daily clinical practice raises many questions related to performance, costs, QoL, training, implementation and overall oncological treatment success. This structured learning/proctoring program with an additional national registry provides insights into EUS-BD and how to implement EUS-BD in the Dutch standard of care.