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Displaying 1 - 25 of 25

Vagus Nerve Stimulation: A New Treatment Study for Previously Treated Lyme Disease Patients with Persistent Symptoms

Condition: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Currently Recruiting
Are you suffering from persistent symptoms that began after you were diagnosed and treated with antibiotics for Lyme Disease? This new research study aims to test a new form of treatment for people with persistent symptoms despite antibiotic treatment for Lyme disease. This treatment involves stimulating a nerve on the surface of your ear. This is called…
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A Study to Test the Effects and Safety of Riliprubart in People with Chronic CIDP for Which the Usual Treatment Does Not Work

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Currently Recruiting
This is a global, multicenter, placebo-controlled, phase 3 study evaluating the efficacy and safety of riliprubart in adult participants with CIDP who are refractory or had an insufficient response to standard of care (SOC) therapies, defined as Ig administered IV (IVIg) or SC (SCIg), or corticosteroids. Treatment duration will be 48 weeks. Participant must…
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ALIGN AR-HDE: JenaValve Pericardial TAVR Aortic Regurgitation Study

Condition: Valve Disease / Aortic Valve Disease
Investigator: Torsten Vahl, MD
Status: Currently Recruiting
The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will…
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Transcranial Direct Current Stimulation (tDCS): A New Treatment of Brain Fog in Previously Treated Lyme Disease Patients

Condition: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Currently Recruiting
Have you been treated for Lyme Disease but continue to have brain fog or other cognitive problems? This research study will assess a non-medication non-invasive intervention to improve cognitive functioning in people with persistent cognitive problems despite prior antibiotic treatment for Lyme Disease. Participants will complete this 4 week intervention at…
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Clinical Research Registry for Lyme and Other Tick-borne Diseases

Condition: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Currently Recruiting
This patient case registry for Lyme and other Tick-borne Diseases is a component of the Clinical Trials Network that was launched in 2021 by a grant from the Steven and Alexandra Cohen Foundation. The registry will gather general information such as demographics, medical history, and current functional status. This information will help researchers to…
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ACURATE IDE: Study of Acurate Valve for Transcatheter Aortic Valve Replacement

Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Currently Recruiting
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-…
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The PROMOTE Study

Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of…
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Portico NG Approval Study in Patients with Symptomatic Severe Aortic Stenosis

Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need for treatment. This is a study that is collecting safety and…
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The Leaflex Early Feasibility Study Protocol in Patients with Symptomatic Severe Aortic Stenosis

Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
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The Progress Trial - Evaluating Transcatheter Aortic Valve Replacement (TAVR)

Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
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Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With Aortic Stenosis and no symptoms.

Condition: Valve Disease / Aortic Valve Disease
Investigator: Susheel Kodali, MD
Status: Closed
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
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A New Treatment Study for Previously Treated Lyme Disease Patients with Persistent Fatigue

Condition: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Closed
Are you suffering from chronic fatigue that began after you were diagnosed and treated with antibiotics for Lyme Disease? This new treatment research study investigates whether disulfiram, commonly known as "Antabuse", has the potential to be used as a treatment option for patients experiencing chronic post-treatment Lyme symptoms. This well-known…
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A Study to Assess the Clinical and Biological Predictors of Disease Course in Patients with Guillain-Barre Syndrome

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
International GBS Outcome Study (IGOS) is a study of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barr syndrome (GBS). Guillian Barre syndrome is an autoimmune disorder affecting the peripheral nervous system, leading to paralysis and potential fatality if it progresses to involve…
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A Study for Charcot-Marie-Tooth type 1A Patients to Compare 2 doses of PXT3003 vs. a Placebo

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
Charcot-Marie-Tooth type 1A (CMT1A) disease is a rare, slowly progressing and debilitating hereditary condition commonly causing weakness of muscles in the feet and lower parts of the legs. There is currently no approved drug to cure CMT1A disease, and the available treatments commonly target the pain and inflammation associated with the disease. In order…
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A Study of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (MyCIDPchoice)

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
We are doing this study to find out if the research drug known as Rozanolixizumab can have additional benefit for people who are already receiving IVIG( Intravenous Immune Globulin) treatment for CIDP, and to have further safety evaluation of the research drug as well. If you choose to be part of this research study, the following procedures will occur:…
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A Study for Patients with Neuropathy Associated Pain to Compare study drugs Nortriptyline, Duloxetine, Pregabalin and Mexiletine

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
Peripheral Neuropathy is a result of nerve damage, which may cause weakness, numbness, tingling, and pain in your hands, feet, and other areas of your body. Over 20 million Americans are affected by peripheral neuropathy, most commonly caused by diabetes. In approximately 25-50% of all people with peripheral neuropathy, the cause is unknown. These cases…
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Top-CSPN Study

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
This study is looking at using topiramate as a potential therapy for patients with cryptogenic sensory peripheral neuropathy. Patients who are randomized into the study will return to the clinic for follow up every 16 weeks. The total length of the study is 96 weeks.
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Optimize PRO TAVR (Post Market Study)

Condition: Valve Disease / Aortic Valve Disease
Investigator: Tamim Nazif, MD
Status: Closed
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
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Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment with Subcutaneous Immunoglobulin

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to see how effective two doses of an investigational new drug called IgPro20 is when given subcutaneously (a shot given into the fat layer between the skin and the muscle) to treat CIDP in patients that still require IVIG and also to look at how safe the IgPro20 is for patients.
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Meditation and Stretching for Post-Treatment Lyme Disease Syndrome

Condition: Infectious Disease / Lyme Disease
Investigator: Brian Fallon, MD
Status: Closed
The CDC estimates that 10-20% of patients with Lyme disease will go on to have chronic symptoms despite having had appropriate treatment, a condition known as Post-Treatment Lyme Disease Syndrome (PTLDS). While there is currently no known cure, various therapies are being investigated. One promising approach is the practice of meditation and yoga which have…
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Study for patients with Amyloidsis (TTR) using an investigational drug, ALN-TTR02 for treatment

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to collect information about how patients with FAP respond to the study drug ALN-TTR02 over 18 months. This includes studying any potential improvements in FAP and any side effects that participants may have from the study drug. In addition, the study will examine how the body handles (distributes, break down, eliminates) the…
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Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
You are being considered to participate in this research study because you have type I or II diabetes with current treatment control and, you are experiencing painful diabetic peripheral neuropathy (DPN) in both lower extremities legs.The specific events that result in painful diabetic peripheral neuropathy are not well understood, but high blood sugar,…
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Study for treating patients with neuropathy using study drug fingolimod

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to evaluate the efficacy and safety of study drug, fingolimod taken daily compared with a placebo (does not contain active medication) on delaying disability progression in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The study will consist of 3 periods: a Screening Period (lasting for up to 45…
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A Study to Assess the Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
Subjects with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) will be enrolled in the study and Intravenous Immunoglobulin (IVIg) will be given to eligible subjects on the study. CIDP is a chronic inflammatory condition that causes the immune system to attack the nerves. IVIg is one common treatment for CIDP. IVIG is a blood product that is…
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Study of patients with neuropathy using study drug, ISIS TTR Rx

Condition: Neurological Disorders / Neuropathy
Investigator: Thomas Brannagan, MD
Status: Closed
The purpose of this study is to evaluate the efficacy and safety of ISIS TTR Rx given for 65 weeks in patients with Familial Amyloid Polyneuropathy (FAP). The purpose of this study is to determine if ISIS 420915 can help people with mild or moderate FAP. To be in this study you must have FAP and be able to walk without help or walk with using only one cane.
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