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NCT ID: NCT06078891 Enrolling by invitation - Clinical trials for Alzheimer Disease, Late Onset

Does BCG Vaccination Reduce Biomarkers of Alzheimer's Disease?

BCG-AD
Start date: July 1, 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to test whether vaccination with the BCG vaccine may improve the blood level of a biomarker of Alzheimer's disease (AD) in participants who are cognitively- and functionally- intact elderly (70-80 years old) participants, who display pathologically high levels of the blood biomarker. The main questions it aims to answer are: - Does BCG vaccination lower the plasma level of phosphorylated Tau protein (p-tau181). - Do vaccinated participants remains stable cognitively. Participants will be asked to: - Undergo cognitive and behavioral evaluation. - Receive 3 BCG vaccinations over the course of 1 year. - Perform blood tests on several occasions. All participants will be treated and followed.

NCT ID: NCT06041906 Enrolling by invitation - Clinical trials for Congenital Porto-Systemic Shunt (CPSS)

International Registry of Congenital Portosystemic Shunt (IRCPSS)

IRCPSS
Start date: April 26, 2018
Phase:
Study type: Observational [Patient Registry]

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

NCT ID: NCT05933018 Enrolling by invitation - Type1diabetes Clinical Trials

Night Hyperglycemia and Fatty Liver in Type 1 Diabetes

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

This clinical trial aims to discover the relationship between hyperglycemia at night and early morning hours and the presence of fatty liver in patients with type 1 diabetes. The main question it aims to answer are: • if hyperglycemic patterns related to metabolic parameters in type 1 diabetes The data from the insulin pump and sensor will be processed. The patients will be divided into two groups. One group without night hyperglycemia and the other with night hyperglycemia. Investigators will perform liver elastography for these two groups. The presence or absence of hepatic steatosis will be evaluated in these groups according to the data.

NCT ID: NCT05841953 Enrolling by invitation - Fecal Incontinence Clinical Trials

The Use of Electrical Stimulation to Increase Anal Pressures

Start date: April 24, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the feasibility of inducing contraction of the anal sphincter by transcutaneous neuromuscular electrical stimulation in patients with fecal incontinence. The main questions it aims to answer are: - Efficacy of the specific stimulation protocol to increase anal pressures - Tolerability and safety Participants will be exposed to the stimulation with the changes in pressure will be studied using high resolution anorectal manometry

NCT ID: NCT05825898 Enrolling by invitation - Clinical trials for Tricuspid Regurgitation

Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment

TRIGISTRY
Start date: September 1, 2022
Phase:
Study type: Observational

Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population >75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR. What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.

NCT ID: NCT05707949 Enrolling by invitation - Episodic Migraine Clinical Trials

Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Episodic Migraine

Start date: June 5, 2023
Phase: Phase 3
Study type: Interventional

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with episodic migraine. Atogepant is a medicine currently approved to treat adults with episodic migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, open-label study of atogepant in participants with a history of episodic migraine. Participants must have completed participation in another study of atogepant (lead-in study) or completed the screening period of that study. Participants must have 4 to 14 migraine days and less than 15 headache days in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 250 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

NCT ID: NCT05688644 Enrolling by invitation - Overactive Bladder Clinical Trials

Sacral Neuromodulation in Neurogenic Patients

Start date: December 19, 2021
Phase:
Study type: Observational

The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. [. The main question[s] it aims to answer are: - determine efficacy and safety of the therapy in neurogenic patients. - compare outcomes of the therapy to idiopathic patients. If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.

NCT ID: NCT05685303 Enrolling by invitation - Heart Failure Clinical Trials

Alleviant ALLAY-HF Study

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

Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.

NCT ID: NCT05676177 Enrolling by invitation - Clinical trials for Non-Alcoholic Fatty Liver Disease

CT Liver Fat Fraction Quantification

Start date: January 29, 2023
Phase: N/A
Study type: Interventional

Our aim is to develop an AI based tool to use ultra-low dose CT in two separate energy levels using a single-energy CT machine to quantify liver fat in individuals at risk for having non-alcoholic fatty liver disease (NAFLD), compared to MRI which serves as the standard of reference. Secondary aim of our study is to validate the developed artificial intelligence (AI)-based model on a second group of participants ("external validation").

NCT ID: NCT05626751 Enrolling by invitation - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.