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A First-in-human Study of a New Gene Therapy (AMT-260) in Adults with Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE)
Official Title A Multi-center, Phase 1/2a, First-in-human (FIH) Study Investigating the Safety, Tolerability, and Efficacy of AMT-260 in Adults with Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE) Administered via Magnetic Resonance Imaging (MRI)-guided Convection-enhanced Delivery (CED)Purpose
You are being invited to participate in a study about mesial temporal lobe epilepsy (MTLE) on only 1 side (unilateral) of the brain that has not responded to medication (refractory).
The study will test AMT-260, which is a new gene therapy under investigation for use in treating people like you with MTLE. It is not yet approved as a drug for treating MTLE. It can only be used in a study like this one. This is the first time this gene therapy will be used in humans. It has previously been studied in animals.
AMT-260 is a gene therapy designed to reduce the electrical signals between nerve cells (neurons) in the parts of your brain where nerve cells are abnormally connected. This reduces the extra electrical signals that happen at the same time and is intended to reduce your seizure activity.
The overall goals of this study are:
- To observe whether participants have any side effects from AMT-260 or from the procedure to deliver AMT-260 into the brain and how well participants tolerate any side effects that may occur.
- To measure if participants have changes in:
- frequency of their seizures
- how their seizures affect their life
- how the human body takes up and removes AMT-260
- To find the best dose of AMT-260 for future participants to ensure clinical benefit with minimal or no side effects.
Could this study be right for you?
Adult, 18-65 years of age, inclusive, capable of giving informed consent.
Written informed consent is given freely after the nature of the study has been explained to the participant and the completion of data disclosure.
Willingness to undergo necessary surgical procedures.
Diagnosis of unilateral refractory MTLE for ≥360 days, confirmed by an Epilepsy Monitoring Unit.Additional Eligibility Criteria to be assessed by neurosurgery team, and as described in the study protocol.
Age Range
18 - 65 years -
IMPROVE-AD Trial: IMPRoving Outcomes in Vascular DisEase
Official Title IMPROVE-AD Trial: IMPRoving Outcomes in Vascular DisEase – Aortic DissectionPurpose
The goal of this study is to figure out the best way to treat type aortic dissection. An aortic dissection is a tear in the wall of the aorta. The aorta is a big blood vessel that carries blood from your heart to the rest of your body. Individuals with this problem usually get medicine or a special repair procedure. This procedure is called thoracic endovascular aortic repair (TEVAR). TEVAR is a procedure where a metal tube (called a stent), is inserted in the damaged part of the aorta. The study is being done to figure out which treatment works better. The results of the study may help to prevent future problems with the aorta or other health issues.
Could this study be right for you?
Inclusion:
- Age > 21 years
- Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity)
- Acuity: within 48 hours – 6 weeks of index admission
Exclusion criteria:
- Ongoing systemic infection
- Pregnant or planning to become pregnant in the next 3 months
- Life expectancy related to non-aortic conditions < 2 years
- Prior surgery for aortic dissection
Age Range
21 years and up -
AAA-SHAPE Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Official Title AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of ExpansionPurpose
The purpose of this research is to determine if the IMPEDE-FX RapidFill System is safe and helps to shrink abdominal aortic aneurysm (AAA - a bulge or swelling due to weakening of the walls of the aorta, which is the main blood vessel that carries blood from your heart to other parts of your body) sacs after an endovascular stent graft (a fabric tube supported by metal wire stents that reinforces a weakened aorta) has been placed. The IMPEDE-FX RapidFill System used in this study is classified as investigational, which means it has not been approved by the Food and Drug Administration (FDA).
Could this study be right for you?
Inclusion:
- A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥ 5.0 cm in women
- Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA
- Maximum Lumen diameter within the AAA sac of ≥40mm
- The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200
Exclusion:
- An inability to provide informed consent
- Enrolled in another clinical study that could interfere with the outcomes being studied in this trial
- Unable or unwilling to comply with study follow-up requirements
Inclusion and Exclusion Criteria varies, please contact Study Coordinator for more information.
Age Range
18 years and up -
Operating microscope versus traditional dental loupes - improving the view of dental surgery to save dental implants.
Official Title Operating Microscope versus Traditional Loupes during Regeneration Therapy for Peri-implantitis: A Randomized Controlled Trial with Ultrasonographic and Biomarkers EvaluationPurpose
The purpose of this study is to compare the one-year outcomes of treating peri-implantitis with periodontal surgical means between the use of an Operating Microscope and dental loupes.
This study includes the comparisons of the changes of inflammation of the gums, the bacteria present, and wound healing at the surgical site between the two methods. The hypothesis is that the use of the operating microscope, compared to dental loupes, is associated with better bacteria removal, quicker inflammatory resolution, and improved wound healing, which will contribute to better outcomes.
This study is 15 months, but your actual appointment time in the study, outside of the surgery itself, will be 6 – 9 hours. This will be in 6 study visits of 60 – 90 minutes in length.
Could this study be right for you?
Inclusion criteria: Participant has at least one implant indicated for peri-implant regenerative treatment.
Exclusion criteria: Participant has known systemic conditions and medication interactions that can affect healing of the surgical site.
Age Range
18 - 99 years -
A Study about How Essential Oil Inhalers and a Wearable TENS Unit Affect Nausea and Stress
Official Title AROMA-NT: Assessment of the Mechanisms of Action of Inhaled Essential Oils and Wearable TENS unit device on NauseaPurpose
The purpose of this research study is to understand how a combination of two aromatic inhalers containing a blend of essential oils and a wearable TENS unit affects nausea and stress in those suffering from chronic nausea and anxiety.
Could this study be right for you?
- Able to understand English
- Nausea going on for longer than 6 months
Age Range
18 - 80 years -
Decay of HIV-1 Reservoirs in Participants on Long-Term ART
Official Title Decay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) StudyPurpose
The purpose of this study is to examine longitudinal changes in HIV-1 reservoirs among participants with HIV-1 who are either currently receiving antiretroviral therapy (ART) or who received ART previously. Participants will undergo blood and hair sample collections for immunologic, virologic, and pharmacologic evaluations to study HIV-1 reservoirs in the body.
Could this study be right for you?
This study is currently only enrolling in Group 6 which includes participants who acquired HIV while taking long-acting cabotegravir (CAB).
Age Range
18 years and up -
Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission
Official Title A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV RemissionPurpose
The purpose of this study is to evaluate the safety and efficacy of combination bNAbs in addition to ART initiated during acute HIV infection and to evaluate the impact on HIV viral reservoirs.
Could this study be right for you?
- Newly diagnosed HIV+ individuals who have not yet started antiretroviral therapy (ART)
- Willingness to start ART at enrollment
- Ability and willingness to participate in scheduled study visits and analytic treatment interruption (ATI)
- Weight <115kg
Age Range
18 - 70 years -
Ohio Mood Disorder Registry and Repository
Official Title Ohio Mood Disorder Registry and RepositoryPurpose
Mood disorders like Major Depressive Disorder and Bipolar Disorder can be chronic, recurrent illnesses. Our treatments to date can help many people but are often trial and error, and continuity and access to care form major barriers. Our purpose is to create a research registry and repository of individuals with mood disorders who are willing to provide clinical data yearly, and who are willing to be contacted to participate in current and future studies of mood disorders.
Could this study be right for you?
Inclusion Criteria
- 8-70 years of age.
- Fluency or advanced conversational English abilities, by self-report.
- Eligible individuals will have a history of two or more mood disorder episodes (depression events of at least 2 weeks meeting 5 of the criteria for major depressive disorder).
Exclusion Criteria
- Head injury with loss of consciousness of five minutes or greater.
- Hospitalization for drug-related concerns.
- Evidence of intellectual disability.
- Diagnosis of a developmental condition like autism spectrum disorder.
- Evidence of psychosis outside of a mood episode (e.g., schizophrenia).
- Hospitalization or infusion for eating condition.
Age Range
8 - 70 years -
Neurodevelopmental Effects of Youth Tackle Football
Official Title Understanding the Neurodevelopmental Effects of Youth Tackle Football ParticipationPurpose
In this study we are aiming to identify risk factors for higher exposure to football-related neurotrauma in youth tackle football players and to determine the effects of football-related neurotrauma exposure on neurodevelopment in children with no previous tackle football participation.
For this specific posting, we are looking for boys ages 8-12 who are non-athletes or athletes who play non-contact sports to serve as control subjects for our fMRI study.
Could this study be right for you?
We are looking for boys ages 8-12 who are either non-athletes or do not participate in any contact sports.
- Boys must have no metal implanted in the body
- Have no prior history of head trauma
- Have no serious health or mental health diagnoses
- Must not have a fear of enclosed spaces
Age Range
8 - 12 years -
Exploring the Development of the Infant and Fetal Brain
Official Title Exploring the Connectivity and Functional Organization of the Infant BrainPurpose
The purpose of the study is to investigate how the brain that we are each born with leads to our own unique behavior later in life, and the similarities and differences between maternal and child brains. We are studying infants prenatally and postnatally, following up with them as they grow and develop, and studying their mothers to understand how similar/different they are to their child.
Could this study be right for you?
- Infants under 3 years of age, and pregnant persons who are at least 20 weeks pregnant
- All participants must have no metal implanted in the body
- Have no significant health conditions or history of serious mental illness
- Not suffer from a (fear of enclosed spaces)
- Pregnancies must be without complication.
Age Range
Up to 40 years