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

Official Title IMPROVE-AD Trial: IMPRoving Outcomes in Vascular DisEase – Aortic Dissection

Purpose

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

Official Title AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Purpose

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

Official Title Testing Equivalence of Measures of Parental Socialization Beliefs and Behaviors Across Racial/Ethnic Groups

Purpose

This study aims to investigate the similarity and differences in parents' beliefs and practices across racial/ethnic backgrounds.

Could this study be right for you?

Eligibility Criteria includes:

• Must be proficient in written English
• You are parents of a child aged 3 to 10, who was born in the U.S.

Age Range

18 - 80 years

Official Title Operating Microscope versus Traditional Loupes during Regeneration Therapy for Peri-implantitis: A Randomized Controlled Trial with Ultrasonographic and Biomarkers Evaluation

Purpose

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.

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

Official Title Bisexual Health and Relationships Project

Purpose

The purpose of this study is to better understand the health behaviors and health outcomes for married bisexual people. 

Could this study be right for you?

Our study examines the health of married Bi+ (defined as bisexual, pansexual, queer, etc.) people. We are interviewing both Bi+ individuals and their partners over Zoom. We are specifically looking to speak with:

• Bi+ men married to men
• Bi+ people of color of any gender

Age Range

35 - 65 years

Official Title Examining the safety and clinical efficacy of psilocybin therapy for Veterans with PTSD: An open label proof-of-concept trial

Purpose

The study will demonstrate the safety and efficacy of psilocybin in treating post-traumatic stress disorder (PTSD) in veterans. Psilocybin-assisted therapy has shown great promise in treating anxiety symptoms that comprise post-traumatic stress disorder (PTSD).  Current therapeutic treatments for PTSD are difficult to tolerate and limited in efficacy, especially in the US military veteran population. This study will examine the safety and efficacy of two psilocybin sessions, combined with psychotherapy, among military veterans with severe, treatment resistant PTSD.

Could this study be right for you?

Inclusion criteria:

• Be a United States military veteran 
• 21 to 64 years old  
• Have at least a high-school level of education or equivalent (e.g. GED)
• Current diagnosis of PTSD
• Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests  

Exclusion criteria:  

• Women who are pregnant
• Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), artificial heart valve, or TIA in the past year  
• High blood pressure
• History of seizures or epilepsy

Exclusion Criteria varies, please contact Study Coordinator.

 

Age Range

21 - 64 years

Official Title Lipid Composition of the Tear Film in Healthy Participants and Dry Eye Disease Patients

Purpose

The purpose of this study is to explore the lipid concentration of the tear film in healthy participants and those who have dry eye disease. 

Could this study be right for you?

Inclusion criteria:

• At least 18 years of age (30 years of age for dry eye disease cohort).
• Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
• Ability to give informed consent
• Willing to spend time for the study; approximately one hour for study assessments
• Either gender

Exclusion criteria:

• Use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
• Currently having punctal plugs inserted in lacrimal puncta

Inclusion and Exclusion Criteria varies, please contact Study Coordinator for more information. 

Age Range

18 years and up

Official Title AROMA-NT: Assessment of the Mechanisms of Action of Inhaled Essential Oils and Wearable TENS unit device on Nausea

Purpose

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

Official Title Preschooler's Language Use and Media (PLUM) Study

Purpose

This study is designed to investigate media’s role in language development during early childhood. The goal of the proposed work is to examine the relation between the quantity of children’s media use and their language development trajectories, as well as how characteristics of media use (i.e., parent-child joint engagement, interactive media features, and educational content) predict growth in language over time. 

Could this study be right for you?

• Children 3 to 3.5 years of age (36 to 42 months).

Age Range

36 - 42 months