Official Title SIJ Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

Purpose

To determine whether placement of iFuse-3D across the ssacroiliac joint (SIJ) in the Bedrock configuration provides
clinical and/or radiographic benefits in patients undergoing multilevel spine fusion (MLF) surgery with fixation to the pelvis

Could this study be right for you?

You may be eligible for this study if you are:

1. Age 21-75 at time of screening
2. Scheduled for multilevel (4 or more levels) spinal fusion surgery with planned fixation to the pelvis using S2AI screws
3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria

1. The reason for your multilevel spine fusion surgery is any of the following:
   • Congenital neuromuscular disease
   • Prior pelvic fixation (already have S2AI or iliac bolts in place, current surgery indicated to revise this hardware)
   • Grade IV spondylolisthesis
2. Prior sacroiliac joint fusion/fixation on either side
3. Presence of spinal cord stimulator
4. Presence of severe hip pain that could impair functional and quality of life improvement from complex spine surgery
5. Surgeon plans to use iliac screw for pelvic fixation
6. Severe osteoporosis
7. Known allergy to titanium or titanium alloys
8. Current local or systemic infection that raises the risk of surgery
9. Currently receiving or seeking short- or long-term worker's compensation and/or currently involved in injury litigation related to the SIJ or low back pain.
10. Currently pregnant or planning pregnancy in the next 2 years
11. Known or suspected drug or alcohol abuse
12. Fibromyalgia

Age Range

21 and up

Official Title A PHASE 1, SINGLE DOSE PK AND SAFETY STUDY WITH NI-03 FOLLOWED BY A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP DOSE-RANGING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NI-03 COMPARED TO PLACEBO IN SUBJECTS WITH CHRONIC PANCREATITIS

Purpose

The purpose of this study is to learn if a study drug called NI-03 (also known as Camostat) can help people with chronic pancreatitis. We want to find out what effects, good or bad, the study drug has on the disease. It has been approved in Japan and has been available by prescription for the treatment of the acute pain associated with chronic pancreatitis. The study drug will not be approved for sale in the United States until tests from studies like this one show that it is safe and effective.

Could this study be right for you?

• You are between the ages of 18-80
• You have a diagnosis of chronic pancreatitis
• For males: documented surgical sterilization, sexual abstinence, or agreed upon means of contraception from screening until 28 days after final dose of study medication is required
• For females: documented surgical sterilization, sexual abstinence, postmenopausal status for at least 1 year, or agreed upon means of contraception from screening until 28 days after final dose of study medication is required

Age Range

18 and up

Official Title Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies PROCEED Study)

Purpose

This study is done for researchers to understand pancreatitis and learn how the disease progresses naturally over time.

From the results of this study, researchers hope to develop some lab tests to support early diagnosis of chronic pancreatitis and to also discover any genetic factors that may affect your chances of developing chronic pancreatitis. The results of this study may also provide information that will open opportunities for new drug discovery.

Could this study be right for you?

• You have a history of acute or chronic pancreatitis OR
• You have experienced pain in your abdomen that a doctor has suggested could be due to pancreatitis
• You are between the ages of 18 and 75

Age Range

18 and up

Official Title A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

Purpose

RheOx (Gala Therapeutics, Inc.) is an investigational device designed to reduce cough and mucus production through a minimally-invasive procedure. The procedure is performed through a bronchoscope, a thin flexible tube that is inserted through the mouth into the lungs. Once in place, RheOx delivers short bursts of electrical energy to the inner walls of the bronchi, eliminating the mucus-producing cells. Over the next several days, new cells grow and produce less mucus. The right lung is treated first, followed by treatment of the left lung about 1 month later.

RheOx has been studied in three clinical trials and has shown a significant improvement in quality of life and a reduction in cough and mucus at 12 months.

Could this study be right for you?

You may be eligible if:

• You are at least 35 years of age.
• Have chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out
• You are receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization
• You have a cigarette smoking history of at least ten pack years.
• Other criteria that will be reviewed by the study team

You will not be eligible if you have:

• A known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
• A steroid-dependent condition requiring more than 10 mg of oral corticosteroid per day.
• Any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices).
• A history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, or sinus bradycardia with heart rate less than 45 beats per minute.
• Unresolved lung cancer.
• A pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
• Had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable.
• Asthma based on Global Initiative for Asthma (GINA) criteria.
• Smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
• Unable to walk over 238 feet in 6 minutes.
• Uncontrolled GERD.
• Had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation.
• A known allergy to nickel.
• Other criteria will be reviewed by the study team

Age Range

35 and up

Official Title A PHASE 3, DOUBLE-MASKED, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT INJECTION IN PATIENTS WITH MODERATELY SEVERE TO SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY

Purpose

The purpose of this 28-week study to investigate the effects and safety of a medication in participants with Center Involving Diabetic Macular Edema (CI-DME). .

Could this study be right for you?

• 18 years and older
• Macular edema associated with diabetic retinopathy (DR)
• Diagnosis of diabetes mellitus (DM)

Age Range

18 and up

Official Title Mindfulness-based cognitive therapy for comorbid depression and type 2 diabetes

Purpose

The aim of this study is to improve mood and diabetes-related outcomes for those with type 2 diabetes mellitus (T2DM) AND symptoms of depression. The present study will examine the effect of mindfulness-based cognitive therapy (MBCT) on symptoms of depression and diabetes.

Your participation in this study will last 8 weeks.

Could this study be right for you?

You may qualify if:

• You are between the ages 18-75
• You have type 2 diabetes
• You are feeling symptoms of depression

Age Range

18 and up

Official Title Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)

Purpose

The purpose of this study is to improve hemoglobin A1c levels in patients with type 2 diabetes experiencing food insecurity.

The study will examine the effects of a produce referral program alone and in combination with other interventions. Our research is designed to develop a deeper understanding of how to provide patients with type 2 diabetes that are experiencing food insecurity with the resources, skills, and education to manage their health and social needs.

Could this study be right for you?

Inclusion Criteria:

• Age 18 years and older
• Type 2 diabetes based on American Diabetes Association Criteria
• Hemoglobin A1c level > 7.5%
• Worried about running out of food before you have money to buy more

Exclusion Criteria:

• Pregnant

Official Title DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping Phase II

Purpose

Deep Brain Stimulation (DBS) surgery is FDA approved for the treatment of Parkinson's Disease. The purpose of this study is to examine a technology (DBS-Expert system) that uses objective measurements to guide DBS programming. The DBS-Expert system analyzes motion data and provides recommendations to the physician or healthcare professional regarding DBS programming settings.

Could this study be right for you?

You may be eligible if you:

• Over the age of 18
• Able and willing to provide informed consent
• Clinical diagnosis of idiopathic Parkinson's Disease
• Implanted Boston Scientific DBS system

Exclusion Criteria

• You are currently participating in any study with an investigational medicinal product (IMP) or investigational device.

Age Range

18 and up

Official Title A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants with Treatment-resistant Depression

Purpose

The purpose of this study is to see if esketamine nasal spray alone is effective as a medication to improve depressive symptoms in adults with treatment-resistant depression when compared with placebo nasal spray.

The duration of the study consists up to a maximum of 24 weeks.

Could this study be right for you?

• Aged 18 years or older
• Must have had no response (less than 25% improvement) to at least 2 oral antidepressant treatments in the current episode of depression

Age Range

18 and up

Official Title SMALL Talk: Study of Milestones to Advance Language Learning

Purpose

The goal of this study is to identify early risk for developmental language disorder (DLD) among young, low-income children, and to determine how caregiver and child chronic stress and interaction quality interact to disrupt language growth among these children. The long-term objective is to identify pathways through which early family situations and the conditions of poverty disrupt early language paths among low-income children and contribute to heightened rates of DLD.

Could this study be right for you?

Inclusion criteria are:

• have a child that is 9 months or younger
• child resides in a low-income household, using some sort of government assistance or using the 200% threshold from the Department of Health and Human Services based on annual household income and number of persons in home

Exclusion criteria:

• Children who are multiple births, preterm (<35 weeks), and have profound or severe disabilities will be excluded, with the latter including congenital blindness, deafness, Down syndrome, and other frank neurological deficits.

Official Title Mobile Health (mHealth), Breast Disease, and Lifestyle Modification: Developing a Grounded Theory

Purpose

The purpose of this study is to understand breast cancer survivors use of mobile health (mHealth) apps for lifestyle behavior change - eating a healthier diet, exercising more, dealing with stress, & stopping smoking. Interviews will last approximately 60 - 90 minutes.

Could this study be right for you?

• You have a diagnosis of breast disease or are a breast cancer survivor.
• You are age 18 or older
• You are a female

Age Range

18 and up

Official Title Laying the Groundwork for Personalized Medicine in Aphasia Therapy: Genetic and Cognitive Predictors of Restorative Treatment Response

Purpose

This NIH-funded project will investigate patient-specific factors that may influence response to therapy for language impairment after stroke, or aphasia. Results from this work will assist with better estimation of prognosis for stroke survivors with aphasia, which could empower patients and families to make more informed health care decisions about how to pursue the most appropriate rehabilitation services based on their unique characteristics, such as genetics, cognitive skills, and brain structure after stroke.

Could this study be right for you?

Participants must meet the following criteria:

• Native English speaker
• Able to have an MRI

Age Range

18 and up