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Lyme Disease clinical trials

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NCT ID: NCT06397794 Recruiting - Parenting Clinical Trials

Navigating Pregnancy and Parenthood With Lyme Disease

Start date: March 20, 2024
Phase:
Study type: Observational

This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and/or chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.

NCT ID: NCT06392815 Recruiting - Clinical trials for Borrelia Burgdorferi Neuroborreliosis

64Cu-DOTATATE-PET Imaging for Lyme Neuroborreliosis

DOTATATE-LYME
Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the applicability and performance of 64Cu-DOTATATE PET/CT/MR for diagnosis in patients with Lyme neuroborreliosis (LNB) . In this prospective, observational cohort study with 64Cu-DOTATATE, we wish to include a total of 50 patients clinically suspected of LNB. We will investigate the diagnostic value of 64Cu-DOTATATE-PET comparing clinically suspected and CSF verified LNB patients with clinically suspected patients without CSF verification. We hypothesize that the information obtained from 64Cu-DOTATATE PET/CT/MRI can improve the diagnostics of LNB. We also hypothesize that 64Cu-DOTATATE PET/CT/MRI will be able to contribute to the follow-up of patients by adding prognostic information and the risk of persistent symptoms. The application of 64Cu-DOTATATE PET/CT/MRI in the diagnostic work-up of LNB would thus expectedly lead to a more precise diagnosis and risk assessment.

NCT ID: NCT06045416 Not yet recruiting - Lyme Disease Clinical Trials

Borrelia B-cell Diagnostics

BRILLIANT
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

The investigators propose a single center, prospective observational study in children with Lyme disease (LD), the Borrelia B-cell diagnostics (BRILLIANT) study, to assess the immune response against Borrelia burgdorferi (Bb) with the following main objectives: 1. Development of Bb-specific ASC ELISpot as a new test method for diagnosis of early LD. There is an urgent unmet clinical need for a better diagnostic tool for early LD, as the current standard two-tier testing has low sensitivity in recently infected patients and may show false positive results in recovered patients due to long-term persistence of antibodies against Bb. The measurement of Bb-specific ASC with the ELISpot assay my has the potential to overcome these issues and to improve diagnosis in early LD. 2. Extensive analysis of the immune response in LD. The immune response in LD is not well understood. Large-scale studies assessing the detailed immune cell subsets/phenotypes present in blood, CSF, or synovial fluid of LD patients with respective manifestations are lacking. 3. Isolation and characterization of causative Bb species. Existing literature suggests that Bb genospecies and/or genotypes may determine virulence and manifestations, but large-scale studies assessing Bb genospecies/genotypes in different manifestation of LD are lacking. 4. Collection of clinical data about symptoms, severity, routine laboratory and diagnostic test results, treatment, and outcome of LD. 5. Biobanking samples for analysis in the future. Project population Inclusion criteria: Children, 0-17 years of age, at University Children's Hospital Zurich: - LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician. - Control cohort: Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department Exclusion criteria: Primary or secondary immunodeficiency.

NCT ID: NCT06026969 Recruiting - Child Development Clinical Trials

Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure

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

The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.

NCT ID: NCT05975099 Active, not recruiting - Lyme Disease Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age

Start date: July 26, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.

NCT ID: NCT05856812 Recruiting - Clinical trials for B. Burgdorferi Infection

BOrrelia BUrgdorferi IN Children and Adolescents

BOBUINCA
Start date: June 23, 2023
Phase:
Study type: Observational

The aim of this study is to assess B. burgdorferi antibodies in children and adolescents in north-western Switzerland and neighbouring countries ("Triregio") treated at the University Children's Hospital Basel to define age-dependent B. burgdorferi seroprevalence rates.

NCT ID: NCT05776251 Suspended - Clinical trials for Post-Treatment Lyme Disease

taVNS for Persistent Symptoms From Lyme Disease

Start date: May 8, 2023
Phase: N/A
Study type: Interventional

This study is one of the first studies to investigate a non-antibiotic approach to the treatment of symptoms that persist after antibiotic treatment for Lyme disease (PTLS). Transcutaneous auricular vagus nerve stimulation (taVNS) offers the potential of being an effective and non-toxic approach to reduce the burden of multisystem symptoms in patients with PTLS. This study seeks to address an important goal: to assess the safety, feasibility, and tolerability of a new non-invasive, non-pharmacologic treatment for patients with symptoms that persist despite prior antibiotic treatment for Lyme disease.

NCT ID: NCT05678478 Recruiting - Lyme Disease Clinical Trials

Perceptions,Social Representations and Experience of Lyme Borreliosis and Ticks in Adolescents Likely to be Infected and Their Parents

ADO-LY
Start date: February 1, 2023
Phase:
Study type: Observational

the study is offered to adolescents aged 12 to 17 and their families suspected of or suffering from Lyme barilliosis. During inclusion, three interviews will be carried out for each family. This choice of the number of interviews per family seems the most appropriate to have a plurality of answers to the questions asked. Thus, these will have a duration of 30 min to 1 hour and will be carried out by an anthropologist. The first interview will be with the teenager. The second interview will then concern the parent(s). Finally, the last appointment will be with the teenager and his parents.

NCT ID: NCT05641116 Recruiting - Physical Activity Clinical Trials

Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.

LyMouv'
Start date: September 14, 2023
Phase: N/A
Study type: Interventional

Lyme borreliosis, commonly known as Lyme disease, has been clinically described for more than a century, but has been officially recognized for 40 years, with the detection of the Borrelia bacterium by W. Burgdorfer, in ticks of the Ixodes ricinus complex, identified a few years before.

NCT ID: NCT05634811 Active, not recruiting - Lyme Disease Clinical Trials

Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

Start date: December 12, 2022
Phase: Phase 3
Study type: Interventional

This study is to understand if the study vaccine (called VLA15) is safe in healthy children. We are looking for children who: - are healthy - are age 5 through 17 - have not been diagnosed with any form of Lyme disease in the past - have not received any vaccines for Lyme disease in the past Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group. Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo. Everyone participating in this study will: - get the shots in a clinic or in a hospital office - receive a total of 4 shots - receive the first 3 shots within 6 months - receive the last shot about 1 year afterwards - need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.