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Polyneuropathies clinical trials

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NCT ID: NCT06414746 Recruiting - Clinical trials for Carpal Tunnel Syndrome

Hereditary Transthyretin Amyloidosis Polyneuropathy in Patients With Carpal Tunnel Syndrome in Russia

LOCUS
Start date: December 29, 2023
Phase:
Study type: Observational

This is a multicenter observational study consisting of retrospective and prospective phases. The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who underwent surgery for CTS to assess their probability of having ATTR PN.

NCT ID: NCT06377033 Recruiting - Parkinson Disease Clinical Trials

Using the EHR to Advance Genomic Medicine Across a Diverse Health System

Start date: June 10, 2024
Phase: N/A
Study type: Interventional

Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place. Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management.

NCT ID: NCT06365593 Recruiting - Clinical trials for Hereditary Transthyretin Amyloidosis

hATTR Polyneuropathy in Russia

PRIMER
Start date: December 29, 2023
Phase:
Study type: Observational

A multicenter observational retrosPective Registry of patIents with transthyretin aMyloid polynEuropathy (hATTR-PN) and chRonic idiopathic axonal polyneuropathy (CIAP) in the population of the Russian Federation (PRIMER) There are no comprehensive epidemiological data on patients with hereditary ATTR-PN (hATTR-PN) and CIAP in the Russian Federation. Therefore, there is a need to conduct a large-scale observational study in the Russian population to obtain information on clinical, electrophysiological and demographic characteristics of patients with hATTR-PN and CIAP. Obtaining the study data will help to identify the patients with axonal polyneuropathy, who deserve TTR gene sequencing, and therefore to allow early treatment and potentially modify disease progression in patients.

NCT ID: NCT06360289 Recruiting - Clinical trials for Hereditary Amyloidosis, Transthyretin-Related

Observational Study of Neurofilament Light Chain (NfL) as a Biomarker in Asymptomatic Carriers of the Transthyretin (TTR) Variants and Patients With Hereditary Transthyretin-mediated (hATTR) Amyloidosis With Polyneuropathy

Start date: April 25, 2024
Phase:
Study type: Observational

This is a single-center observational study evaluating the potential value of NfL as a biomarker for diagnosis, detection of disease onset, monitoring of disease progression, and treatment response in asymptomatic carriers of TTR variants and symptomatic hATTR amyloidosis patients with polyneuropathy.

NCT ID: NCT06290141 Recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

VITALIZE
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.

NCT ID: NCT06290128 Recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work

MOBILIZE
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.

NCT ID: NCT06186479 Recruiting - Clinical trials for Chemotherapy-induced Polyneuropathy

Clinical Trial With Aconite Pain Oil in Oncology Patients Under Chemotherapy to Prevent CIPN Grade-II, to Reduce Symptoms and to Improve the Quality of Life of Patients With CIPN

Start date: March 13, 2024
Phase: Phase 3
Study type: Interventional

The clinical trial is planned as a prospective, multicentre, blinded, randomised, placebo-controlled, national clinical trial in Germany. The clinical trial is designed for testing the prophylactic and therapeutic effects of Aconite pain oil as compared to placebo in oncological patients receiving neurotoxic chemotherapy with taxanes and/or platinum derivatives.

NCT ID: NCT06183645 Recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.

ActiCIDP
Start date: August 28, 2023
Phase:
Study type: Observational

ActiCIDP is a monocentric academic study. Patients with Chronic inflammatory demyelinating polyradiculoneuritis may be included on a voluntary basis. The investigators plan to include a group of approximately 40 patients with CIDP. The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.

NCT ID: NCT06124586 Recruiting - Diabetes Mellitus Clinical Trials

Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)

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

The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in PTA readiness ("immediate treatment," within 48h) has advantages over the "standard of care", i.e., an elective procedure ("elective PTA") in terms of clinical endpoints such as wound healing and infection according to WiFI classification, amputation rate, "major adverse limb events" (MALE=amputation, reintervention of the vessel, death), but also systemic complications such as "major adverse cardiac and cerebrovascular events" (MACE=myocardial infarction, stroke, death, restenosis, severe cardiac and cerebrovascular complications). Furthermore, the impact of PTA on the local wound microbiome remains unclear. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating pAVD by revascularization in DFS after initial diagnosis is unknown and has yet to be fully understood.

NCT ID: NCT06072573 Recruiting - Pain Clinical Trials

Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy

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

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with pain disorders due to diabetic polyneuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to diabetic polyneuropathy.