Optimizing Exclusion Criteria for Clinical Trials of Persistent Lyme Disease Using Real-World Data.

Background/objectives: Although eligibility criteria for clinical trials significantly impact study outcomes, these criteria are often established without scientific justification, leading to delayed recruitment, small sample sizes, and limited study generalizability. Persistent Lyme disease (PLD) presents unique challenges due to symptom variability, inconsistent treatment responses, and the lack of reliable biomarkers, underscoring the need for scientifically justified eligibility criteria.

Objective: This study examines the effects of commonly used enrollment criteria on sample yield in PLD clinical trials using real-world data (RWD) from the MyLymeData patient registry.

Does Biological Sex Matter in Lyme Disease? The Need for Sex-Disaggregated Data in Persistent Illness.

Background: Biological sex should be included as an important variable in clinical research studies to identify outcome differences between men and women. Very few Lyme disease studies were designed to consider sex-based differences or gender bias as an important component of the research design.

Methods: To assess sex-based differences in Lyme disease patients who were clinically diagnosed and reported remaining ill for six or more months after receiving antibiotic treatment, we analyzed self-reported clinical data from 2170 patients in the MyLymeData patient registry.

Role of hydroxychloroquine in multidrug treatment of COVID-19.

No abstract present.

Hydroxychloroquine Pre-Exposure Prophylaxis for COVID-19 in Healthcare Workers from India: A Meta-Analysis.

To date, the COVID-19 pandemic has resulted in more than 200 million cases of SARS-CoV-2 infection and more than four million deaths world-wide. 1 Although novel COVID-19 vaccines have become clinically available, the safety and efficacy of these vaccines remains open to question. 2 Alternate approaches to prevention of disease have received little attention, and one medication, hydroxychloroquine (HCQ), has been attacked and dismissed based on flawed studies and political controversy that obscured the value of this treatment as pre-exposure prophylaxis (PrEP) for SARS-CoV-2 infection.

Dermatological and Genital Manifestations of Lyme Disease Including Morgellons Disease.

Although the erythema migrans (EM) skin rash is traditionally considered a hallmark of Lyme disease, other dermatological manifestations of the tickborne disease are less well known. We describe a 49-year-old woman with erosive genital ulcerations, secondary EM rashes and jagged skin lesions associated with Lyme disease. The skin rashes exhibited fibers characteristic of Morgellons disease.

Pre-Exposure Prophylaxis for COVID-19 in Pregnant Women.

Pregnant women are at higher risk for developing severe complications of COVID-19 including preterm delivery, respiratory failure, and death. Although vaccines to prevent COVID-19 are being developed, pregnant women are not included in the current COVID-19 vaccine trials and initially this population may not be eligible for COVID-19 vaccines due to lack of safety testing in pregnancy. As an alternate approach, we discuss the concept of pre-exposure prophylaxis (PrEP) using medications that are approved for use in pregnant women to prevent gestational problems and severe illness in this high-risk population.

Flattening the Risk: Pre-Exposure Prophylaxis for COVID-19.

To date, more than 35 million people worldwide have been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the agent of coronavirus disease 2019 (COVID-19), and more than one million have died in the COVID-19 pandemic. International economies are stalled and social isolation based on palpable fear of death remains the order of the day. The United States and other countries are moving toward resuming work activities and social interaction to boost economic recovery.

Antibiotic Treatment Response in Chronic Lyme Disease: Why Do Some Patients Improve While Others Do Not?

There is considerable uncertainty regarding treatment of Lyme disease patients who do not respond fully to initial short-term antibiotic therapy. Choosing the best treatment approach and duration remains challenging because treatment response among these patients varies: some patients improve with treatment while others do not. A previous study examined treatment response variation in a sample of over 3500 patients enrolled in the MyLymeData patient registry developed by LymeDisease.

Lyme Disease: Diversity of Species in California and Mexico Detected Using a Novel Immunoblot Assay.

Background: With more than 300,000 new cases reported each year in the United States of America (USA), Lyme disease is a major public health concern. sensu stricto (Bbss) is considered the primary agent of Lyme disease in North America. However, multiple genetically diverse species encompassing the sensu lato (Bbsl) complex and the Relapsing Fever (RFB) group are capable of causing tickborne disease.

Classification and Staging of Morgellons Disease: Lessons from Syphilis.

Introduction: Morgellons disease (MD) is a contested dermopathy that is associated with spirochetal infection. A simple classification system was previously established to help validate the disease based on clinical features (classes I-IV).

Methods: Drawing on historical and pathological parallels with syphilis, we formulated a more detailed staging system based on clinical features as well as severity of skin lesions and corresponding histopathological infection patterns, as determined by anti- immunohistochemical staining.

Line Immunoblot Assay for Tick-Borne Relapsing Fever and Findings in Patient Sera from Australia, Ukraine and the USA.

Tick-borne relapsing fever (TBRF) is caused by spirochete bacteria of the genus termed relapsing fever (RFB). TBRF shares symptoms with Lyme disease (LD) caused by related Lyme disease (LDB). TBRF and LD are transmitted by ticks and occur in overlapping localities worldwide.

Mixed and Biofilms in Morgellons Disease Dermatological Specimens.

Background: Morgellons disease (MD) is a dermopathy that is associated with tick-borne illness. It is characterized by spontaneously developing skin lesions containing embedded or projecting filaments, and patients may also experience symptoms resembling those of Lyme disease (LD) including musculoskeletal, neurological and cardiovascular manifestations. Various species of Borrelia and co-infecting pathogens have been detected in body fluids and tissue specimens from MD patients.

Erosive Vulvovaginitis Associated With Borrelia burgdorferi Infection.

We describe a case of acute erosive vulvovaginitis accompanying Borrelia burgdorferi infection. The patient is a 57-year-old woman previously diagnosed with Lyme disease who presented with a painful erosive genital lesion. At the time of the outbreak, she was being treated with oral antibiotics, and she tested serologically positive for B burgdorferi and serologically negative for syphilis.

Detection of tick-borne infection in Morgellons disease patients by serological and molecular techniques.

Background: Morgellons disease (MD) is a skin condition associated with Lyme disease (LD) and tick-borne illness. Patients with this skin disorder experience ulcerative lesions that contain multicolored filamentous collagen and keratin inclusions. Infection with various species of and other tick-borne pathogens has been detected in tissue and body fluid specimens from MD patients.

Relapsing fever in California: a pilot serological study.

Background: spirochetes are tick-borne Gram-negative bacteria that cause disease in humans and animals. Although many studies have focused on (Bb), the agent of Lyme disease, recent studies have examined the role of Relapsing Fever (RFB) in human disease. In this pilot study, we have evaluated serological reactivity against Bb and RFB in patients residing in California.

Better drugs for Lyme disease: focus on the spirochete.

Twenty-five years ago, the AIDS epidemic was wreaking havoc around the world. Although "HIV denialists" threatened to undermine research efforts to combat the epidemic, development of targeted antiviral therapy eventually provided effective treatment for the disease. Now the Lyme disease epidemic is wreaking havoc around the world, and "Lyme denialists" are undermining efforts to combat the epidemic.

Clinical evaluation of Morgellons disease in a cohort of North American patients.

Morgellons disease (MD) is a dermatological condition characterized by aberrant production of keratin and collagen fibers in skin. Although infection with , the causative agent of Lyme disease (LD), has been associated with MD, relatively few studies have hitherto provided epidemiological evidence regarding this association. A cohort of 1000 seropositive North American LD patients was evaluated for the presence of MD.

Persistent Borrelia Infection in Patients with Ongoing Symptoms of Lyme Disease.

Introduction: Lyme disease is a tickborne illness that generates controversy among medical providers and researchers. One of the key topics of debate is the existence of persistent infection with the Lyme spirochete, , in patients who have been treated with recommended doses of antibiotics yet remain symptomatic. Persistent spirochetal infection despite antibiotic therapy has recently been demonstrated in non-human primates.

History of Morgellons disease: from delusion to definition.

Morgellons disease (MD) is a skin condition characterized by the presence of multicolored filaments that lie under, are embedded in, or project from skin. Although the condition may have a longer history, disease matching the above description was first reported in the US in 2002. Since that time, the condition that we know as MD has become a polemic topic.

Morgellons disease: a filamentous borrelial dermatitis.

Morgellons disease (MD) is a dermopathy characterized by multicolored filaments that lie under, are embedded in, or project from skin. Although MD was initially considered to be a delusional disorder, recent studies have demonstrated that the dermopathy is associated with tickborne infection, that the filaments are composed of keratin and collagen, and that they result from proliferation of keratinocytes and fibroblasts in epithelial tissue. Culture, histopathological and molecular evidence of spirochetal infection associated with MD has been presented in several published studies using a variety of techniques.

Lyme disease: the promise of Big Data, companion diagnostics and precision medicine.

Lyme disease caused by the spirochete Borrelia burgdorferi has become a major worldwide epidemic. Recent studies based on Big Data registries show that >300,000 people are diagnosed with Lyme disease each year in the USA, and up to two-thirds of individuals infected with B. burgdorferi will fail conventional 30-year-old antibiotic therapy for Lyme disease.

Sexual transmission of Lyme disease: challenging the tickborne disease paradigm.

Lyme disease caused by the spirochete Borrelia burgdorferi has become a major worldwide epidemic. In this article, we explore the clinical, epidemiological and experimental evidence for sexual transmission of Lyme disease in animal models and humans. Although the likelihood of sexual transmission of the Lyme spirochete remains speculative, the possibility of Lyme disease transmission via intimate human contact merits further study.

Exploring the association between Morgellons disease and Lyme disease: identification of Borrelia burgdorferi in Morgellons disease patients.

Background: Morgellons disease (MD) is a complex skin disorder characterized by ulcerating lesions that have protruding or embedded filaments. Many clinicians refer to this condition as delusional parasitosis or delusional infestation and consider the filaments to be introduced textile fibers. In contrast, recent studies indicate that MD is a true somatic illness associated with tickborne infection, that the filaments are keratin and collagen in composition and that they result from proliferation and activation of keratinocytes and fibroblasts in the skin.