1 |
NCT02446626 |
Recruiting |
Xenodiagnosis After Antibiotic Treatment for Lyme Disease |
|
- Procedure: Skin biopsy
- Procedure: Blood draw
- Other: Xenodiagnosis
|
Interventional |
Phase 1 Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- This study is powered to detect difference in the positivity rate between symptomatic and asymptomatic individuals.
- The study will continue to assess the safety of xenodiagnosis in humans.
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT02446626 |
150131 15-I-0131 |
|
May 13, 2015 |
December 1, 2020 |
December 1, 2030 |
May 18, 2015 |
March 29, 2018 |
|
- Mansfield Family Practice
Storrs, Connecticut, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States - Tufts Medical Center
Boston, Massachusetts, United States - New York Medical College
Valhalla, New York, United States
|
2 |
NCT00028080 |
Recruiting |
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease |
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
400 |
All |
Child, Adult, Senior |
NCT00028080 |
020055 02-I-0055 |
|
November 21, 2001 |
|
|
December 12, 2001 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
3 |
NCT00001539 |
Recruiting |
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations |
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Long term outcome
- Immunological markers
- Biomarkers
|
600 |
All |
13 Years and older (Child, Adult, Senior) |
NCT00001539 |
960052 96-I-0052 |
|
March 25, 1996 |
|
|
November 4, 1999 |
April 20, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
4 |
NCT03501407 |
Not yet recruiting New |
Understanding Tick-borne Diseases |
|
- Diagnostic Test: Blood samples
- Diagnostic Test: skin biopsy
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Isolate new microorganisms—both unknown or unexpected—from patients suffering from unexplainable symptoms following tick bites
|
130 |
All |
18 Years and older (Adult, Senior) |
NCT03501407 |
2017-002 |
OHTICKS |
June 2018 |
June 2019 |
June 2020 |
April 18, 2018 |
April 18, 2018 |
|
|
5 |
NCT03201042 |
Recruiting |
Lyme Test Indication Combinations (LyTIC) Study |
|
- Diagnostic Test: PCR based assay
- Diagnostic Test: Serology based assay
- Diagnostic Test: Tcell based assay
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
500 |
All |
5 Years and older (Child, Adult, Senior) |
NCT03201042 |
L3 |
LyTIC |
June 8, 2017 |
December 1, 2018 |
February 2019 |
June 28, 2017 |
April 4, 2018 |
|
- Paradigm Clinical Research
Redding, California, United States - Coastal Connecticut Research
New London, Connecticut, United States - Circle CARE Center
Norwalk, Connecticut, United States - (and 58 more...)
|
6 |
NCT03505879 |
Not yet recruiting New |
Next Generation Sequencing Detection of Lyme Disease |
- Lyme Disease
- Pediatric Infectious Disorder
- Erythema Migrans
|
|
Observational |
|
- Stony Brook University
- Karius, Inc.
|
Other / Industry |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Ability of Next Generation Sequencing to detect Borrelia burgdorferi DNA in blood
- NGS detection of Borrelia burgdorferi DNA in blood compared to serology
- Changes in NGS detection of Borrelia burgdorferi DNA in blood over time
|
30 |
All |
1 Year to 17 Years (Child) |
NCT03505879 |
1205731-1 |
|
May 15, 2018 |
November 1, 2019 |
November 1, 2019 |
April 23, 2018 |
April 23, 2018 |
|
|
7 |
NCT00576082 |
Recruiting |
Borrelia Species in Cutaneous Lyme Borreliosis |
|
|
Observational |
|
- University Hospital, Strasbourg, France
- Société de Dermatologie Française
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
900 |
All |
18 Years and older (Adult, Senior) |
NCT00576082 |
3977 |
|
March 2008 |
April 2022 |
April 2022 |
December 18, 2007 |
March 22, 2018 |
|
- Service de Dermatologie, Hôpital Civil
Strasbourg, France - Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
|
8 |
NCT00132327 |
Recruiting |
Analysis of Lyme Disease Lesions |
- Erythema Migrans Lesions
- Erythema Migrans
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00132327 |
050219 05-I-0219 |
|
August 17, 2005 |
|
|
August 19, 2005 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
9 |
NCT03418441 |
Recruiting |
Central Nervous System Infections in Denmark |
- Central Nervous System Infections
- Bacterial Meningitis
- Viral Meningitis
- (and 9 more...)
|
- Other: Community-acquired CNS infections
|
Observational |
|
- Aalborg Universitetshospital
- Danish Study Group of Infections of the Brain
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence
- Glasgow Outcome Scale score
- Glasgow Outcome Scale score for viral meningitis
- (and 5 more...)
|
1400 |
All |
18 Years and older (Adult, Senior) |
NCT03418441 |
DASGIB |
DASGIB |
January 1, 2015 |
January 1, 2025 |
January 1, 2025 |
February 1, 2018 |
February 6, 2018 |
|
- Department of Infectious Diseases, Aalborg University Hospital
Aalborg, Denmark - Department of Infectious Diseases, Aarhus University Hospital Skejby
Aarhus, Denmark - Department of Infectious Diseases, Rigshospitalet
Copenhagen, Denmark - (and 4 more...)
|
10 |
NCT02463942 |
Recruiting |
Tick-borne Encephalitis and Positive Borrelial Antibodies |
|
- Drug: Doxycycline
- Drug: Symptomatic therapy
- Other: Questionnaire
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
- University of Ljubljana School of Medicine, Slovenia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective manifestations of Lyme borreliosis
- Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02463942 |
TBE-LB2014 |
TBE-LB2014 |
September 2014 |
September 2018 |
September 2019 |
June 4, 2015 |
May 12, 2016 |
|
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
11 |
NCT01793168 |
Recruiting |
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford |
- Rare Disorders
- Undiagnosed Disorders
- Disorders of Unknown Prevalence
- (and 260 more...)
|
|
Observational |
|
- Sanford Health
- National Ataxia Foundation
- International WAGR Syndrome Association
- (and 23 more...)
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- To accelerate research into rare disorders by connecting individuals who are interested in research and who have been diagnosed with a rare disorder (or a disorder of unknown prevalence, or who are undiagnosed) with researchers who study rare diseases.
|
20000 |
All |
Child, Adult, Senior |
NCT01793168 |
03-10-014 Hypersomnia Foundation National Ataxia Foundation 4p- Support Group CdLS Foundation Hyperacusis Research Limited Kabuki Syndrome Network Kawasaki Disease Foundation Klippel-Feil Syndrome Freedom Leiomyosarcoma Direct Research MSS Support Group ML4 Foundation Stickler Involved People IWSA Soft Bones PWN4PWN aHUS Klippel-Feil Syndrome Alliance American MEN Support Kleine-Levin Syndrome All Things Kabuki WSS Foundation BIVA ABDA PROS Foundation (HLH) |
CoRDS |
July 2010 |
December 2100 |
December 2100 |
February 15, 2013 |
October 2, 2017 |
|
- Sanford Health
Sioux Falls, South Dakota, United States
|
12 |
NCT02669212 |
Recruiting |
Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health |
|
|
Observational |
|
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- To explore the clinical and biological phenotypes of post-infectious chronic fatigue syndrome (PI-ME/CFS)
- To explore the pathophysiologies of fatigue and post-exertional malaise (PEM).
|
206 |
All |
18 Years to 60 Years (Adult) |
NCT02669212 |
160058 16-N-0058 |
|
January 21, 2016 |
September 15, 2018 |
September 15, 2020 |
February 1, 2016 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
13 |
NCT03462329 |
Not yet recruiting |
Patient's Pretreatment Expectations About Post-Lyme Symptoms |
|
- Drug: Antibiotics (preferentially oral doxycycline 100 mg bid)
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for erythema migrans
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans
- (and 2 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03462329 |
Pretreatment expectations |
|
June 1, 2018 |
June 1, 2022 |
June 1, 2022 |
March 12, 2018 |
March 12, 2018 |
|
|
14 |
NCT03337932 |
Recruiting |
Duration of Doxycycline Treatment in MEM Patients |
- Erythema Chronicum Migrans
|
- Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days
- Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days
- Drug: Controls without a history of lyme disease.
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
- (and 2 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03337932 |
MEM-Doxy |
|
January 1, 2018 |
January 2024 |
January 2024 |
November 9, 2017 |
February 20, 2018 |
|
- University Medical center Ljubljana
Ljubljana, Slovenia
|
15 |
NCT03153267 |
Recruiting |
Duration of Doxycycline Treatment in EM Patients |
- Erythema Chronicum Migrans
|
- Drug: Doxycycline 100 MG Oral Tablet bid, 7 days
- Drug: Doxycycline 100 MG Oral Tablet bid, 14 days
- Drug: Controls without a history of lyme disease.
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
- University of Ljubljana School of Medicine, Slovenia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
- Comparison of nonspecific symptoms in patients with erythema migrans and control subjects
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT03153267 |
EM-Doxy714 |
|
June 1, 2017 |
June 30, 2019 |
June 30, 2020 |
May 15, 2017 |
December 5, 2017 |
|
- University Medical centzer Ljubljana
Ljubljana, Slovenia
|
16 |
NCT02414789 |
Recruiting |
Lyme Borreliosis and Early Cutaneous Diagnostic |
|
|
Interventional |
Not Applicable |
- University Hospital, Strasbourg, France
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02414789 |
6084 |
DIABOLYC |
August 2015 |
August 2019 |
August 2019 |
April 13, 2015 |
September 8, 2017 |
|
- Centre Hospitalo-Universitaire Jean Minjoz
Besancon, France - Centre Hospitalier William Morey
Chalon-sur-Saône, France - Hôpital Pasteur
Colmar, France - (and 4 more...)
|
17 |
NCT02147249 |
Recruiting |
Cytokines and Chemokines in Erythema Migrans |
|
- Drug: antibiotic treatment
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
- University of Ljubljana School of Medicine, Slovenia
- Medical University of Vienna
- Harvard University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- inflammatory proteins in erythema migrans patients
- gene polymorphisms in erythema migrans patients
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT02147249 |
EM-0613 |
|
July 2013 |
December 2017 |
|
May 26, 2014 |
May 5, 2017 |
|
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
18 |
NCT01163994 |
Recruiting |
Antibiotic Treatment of Multiple Erythema Migrans |
- Multiple Erythema Migrans
|
- Drug: ceftriaxone
- Drug: doxycycline
- Other: erythema migrans patients treated with doxycycline
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
|
500 |
All |
15 Years and older (Child, Adult, Senior) |
NCT01163994 |
MEM-0510 |
|
June 2010 |
October 2017 |
October 2017 |
July 16, 2010 |
May 5, 2017 |
|
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
19 |
NCT00910533 |
Recruiting |
Study on Early Lyme Neuroborreliosis |
- Nervous System Lyme Borreliosis
|
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis
- Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis
|
50 |
All |
15 Years and older (Child, Adult, Senior) |
NCT00910533 |
LNB-0509 |
|
June 2009 |
June 2018 |
|
June 1, 2009 |
May 5, 2017 |
|
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|