Official Title "What do physicians know about intellectual disability?" Getting information to design better medical training

Purpose

The purpose of this study is to explore the physicians’ knowledge of intellectual disabilities (ID) and their medical training and practice. The information resulting from this study will help to design adequate interventions and training programs for medical students and physicians aimed to improve their ID knowledge and the health care services provided to patients with ID. This is an observational cross-sectional study of physicians in the US using an anonymous online survey. The entire survey has 156 items and will require 15-20 minutes to complete.

Could this study be right for you?

• You are an American medical resident, an attending physician, or a medical educator in any type of medical specialization, and
• You have or do not have experience with patients with intellectual disabilities

Age Range

24 and up

Official Title A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis.

Purpose

The overall objective is to investigate to investigate how safe, how well tolerated, and how effective R3R01 is in treating uncontrolled proteinuria in patients with Alport syndrome and steroid-resistant Focal Segmental Glomerulosclerosis. All eligible participants will be enrolled to receive R3R01 over a treatment period of 12 weeks. The study will consist of 3 periods, including a screening period of 3 weeks, a treatment period of 12 weeks, and a follow up of period of 12 weeks.

Could this study be right for you?

You may be eligible to participate if:

• You are aged 18 years or older
• Female patients and female partners of male patients willing to not become pregnant for the duration of the study
• Have not had an organ transplant and/or on a organ transplant list
• Have high protein in urine Alport Syndrome (AS) specific:
• Have X-linked AS and autosomal recessive AS
• Confirmed diagnosis of AS by genetic testing or kidney biopsy
• Do not have another kidney disease
• FSGS specific:
• Not older than 75 years of age
• Primary Focal segmental glomerulosclerosis (FSGS) (not caused by other condition) that is confirmed by kidney biopsy or documentation of genetic mutation
• Steroid-resistance: previous steroid treatment without remission

Age Range

18 and up

Official Title A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

Purpose

The purpose of this study is to examine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

The duration of the study will consist over a 5 year period. You will visit the study site approximately 23 times after your implant surgery.

Could this study be right for you?

• Aged 18 years or older
• Must be in a major depressive episode (MDD or bipolar disorder) for ≥ two years or have at least had four episodes of depression including the current episode
• Patients depressive illness meets a minimum criteria of four prior failed treatments of adequate dose and duration

Age Range

18 and up

Official Title AN OBSERVATIONAL, LONGITUDINAL, PROSPECTIVE, LONG-TERM REGISTRY OF PATIENTS WITH HYPOPHOSPHATASIA

Purpose

The purpose of this registry is to collect information about Hypophosphatasia (HPP), a rare bone disorder characterized by the abnormal development of bones and teeth. This long-term registry will collect and store patient medical information, and other related information to use in medical research. The registry may help researchers better understand the condition and learn more about patients who have HPP. In the future, this data may help other people with HPP.

Could this study be right for you?

• 18 years of age or older
• Been diagnosed with Hypophosphatasia (HPP) - a rare genetic disorder characterized by the abnormal development of bones and teeth.
• Not participating in another Alexion-sponsored clinical trial

Age Range

18 and up

Official Title Disability after ACL Reconstruction: Development of an Alternative Model of Care

Purpose

The anterior cruciate ligament (ACL) in your knee can be injured and treated with an ACL reconstruction surgery. An ACL reconstruction may impact function, muscle strength, the way you move, and knee joint health. However, outcomes at 2 years after ACL reconstructions in young persons are not well-understood. Findings from this study will provide information regarding the clinical, function, muscle strength, and movement patterns after ACL injury and reconstruction to help inform physicians and physical therapists who work with these patients.

Could this study be right for you?

You may be eligible if:

1. You are between the ages of 16-35 years old
2. 2 years (+/- 8 months) status post ACL Reconstruction
3. Regularly participated in physical activity prior to their ACL injury

Age Range

16 and up

Official Title M16-046: A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis

Purpose

The purpose of this study is to compare the effectiveness and safety of upadacitinib (ABT-494) versus dupilumab for the treatment of adult subjects (18-75 years of age) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Could this study be right for you?

• Subject must have chronic Atopic Dermatitis (AD) with onset at least 3 years prior to study participation
• Subject must have > or = 10% body surface area involvement of atopic dermatitis
• Subject must have had inadequate response to topical corticosteroids or topical calcineurin inhibitors within the past 6 months
• OR documented systemic treatment for AD within the past 6 months
• OR for whom topical treatments are otherwise medically inadvisable
• No prior exposure to any JAK inhibitor (e.g., ruxolitinib, tofacitinib, baricitinib, upadacitinib, PF-04965842, and filgotinib)
• No prior exposure to dupilumab

Age Range

18 and up

Official Title Remote assessment of cognition, insulin resistance and omega-3s (RACIR O-3) in breast cancer survivors

Purpose

We are studying the relationships between cognitive function, insulin resistance, and omega-3 fatty acids in the blood and from the diet among breast cancer survivors and women without a history of cancer diagnoses. We hope to learn more about how to potentially protect breast cancer patients from uncomfortable mental changes during and after treatment for breast cancer, such as “chemo brain”.

This is a completely remote study, meaning all study tasks can be completed from the comfort of home. Enrolled participants will complete several online surveys and questionnaires, a Zoom video call for additional assessments, and will be sent materials to complete finger-stick blood sample collections from the comfort of home over a period of 3-4 weeks.

The information we gain from this research study will help us design a future clinical trial to test if dietary interventions can help reduce or prevent cognitive changes like chemo brain in breast cancer patients.

Could this study be right for you?

• Accepts healthy volunteers - YES
• Females
• Age 45-75 years
• Post-menopausal (at least 12 months no menses)
• Stage I-III Breast Cancer diagnosis
• 1-4 years post initial breast cancer diagnosis
• No diagnosis of diabetes
• English speaking

Age Range

45 and up

Official Title The Chaperone Study: A multi-center, double-masked, randomized, placebo-controlled, phase III study of the safety and efficacy of atropine 0.1% and 0.01% ophthalmic solutions administered with a microdose dispenser for the reduction of pediatric myopia progression

Purpose

Is your child nearsighted?

Nearsightedness, or myopia, is a condition that results in blurry vision when looking at distant objects.

Myopia happens when the eyeball grows too long or the cornea (the clear front cover of the eye) is too curved.
As a result, light entering the eye is not focused correctly. While glasses and contact lenses can help a person with myopia see clearly, they do not address the underlying stretching of the eye.

Myopia detected in young children tends to increase through the school years . As myopia progresses, it can increase the risk of retinal detachment, cataracts, myopia maculopathy and even blindness. To date, FDA has not approved any drug therapies for reducing myopia progression.

This is why researchers are working to develop new medications and technologies that may help children and teens with this condition. The CHAPERONE Study is a research study testing the safety and effectiveness of microdosed atropine eye solution to see if it slows the progression of myopia in children.

Could this study be right for you?

• Is your child between 3-12 years old?
• Does your child need glasses to see distant objects?
• Is your child able to go to periodic visits at the study clinic to check his/her vision and overall eye health over a 4-year period (11 scheduled visits will be required)?
• Are you available to speak with study staff by phone periodically between your child’s clinic visits to review your child’s experience using study medication?

This study is not for children who have:

• Used atropine or other myopia drug therapies
• Had prior eye surgery
• A systemic disease or condition that can affect their vision

Age Range

3 and up

Official Title Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)

Purpose

This research study aims to determine the effects of a noninvasive form of brain stimulation on alertness for night shift workers.

Could this study be right for you?

• You are age 18 to 65
• You are currently working the night shift at least 3x/week
• You are suffering from sleepiness at work
• You do not have significant heart and lung problems
• You work within the Columbus, OH area

Age Range

18 and up

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