Official TitleA 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 be 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 remissionAge Range18 and up
Official TitleA 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 durationAge Range18 and up
Official TitleAN OBSERVATIONAL, LONGITUDINAL, PROSPECTIVE, LONG-TERM REGISTRY OF PATIENTS WITH HYPOPHOSPHATASIAPurpose
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. This data may help other people with HPP in the future.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 trialAge Range18 and up
Official TitleNeural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention StrategyPurpose
This research study will look at how patterns of brain activity influence thoughts and behaviors. This research is being done to better explain why people have thoughts about suicide and how different suicide prevention strategies impact brain responses to emotional information.Could this study be right for you?
Eligibility Criteria includes:
- 18-65 years old
- generally medically and physically healthy
- current suicidal ideation and intent OR no lifetime history of DSM-5 disorder, no lifetime suicidal intent or lifetime suicide attempts
(partial list of inclusion criteria)
- Diagnosis of bipolar disorder, schizophrenia, mania, or psychosis
- Currently pregnant (positive pregnancy test), or trying to become pregnant (female)
- Presence of ferrous-containing metal in the body
- Inability to tolerate enclosed spaces
(partial list of exclusion criteria)Age Range18 and up
Official TitleFitness, Aging, Stress & TBI Exposure Repository (FASTER)Purpose
The purpose this study is to examine how individual differences in health changes (muscle strength, blood pressure) and behavioral changes (sleep, physical activity) impact memory, attention, and the brain. We study these relationships in among a variety of older adults, including those with a history of concussion, traumatic brain injury (TBI), and posttraumatic stress disorder (PTSD). The long-term goal of this project is to identify modifiable factors that exacerbate or protect from age-related cognitive decline.Could this study be right for you?
Eligibility Criteria: • Aged 18 years and older • Speak English • History of concussion, traumatic brain injury, and/or posttraumatic stress disorder • Must have primary care physicianAge Range18 and up
Official TitleDisability after ACL Reconstruction: Development of an Alternative Model of CarePurpose
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 injuryAge Range16 and up
Official TitleDevelopment and Validation of a Diagnostic Interview to Assess Psychopathology in Youths with Intellectual DisabilitiesPurpose
This study will help researchers to learn more about mental health for youth with intellectual disabilities. The purpose of our study is to develop a diagnostic interview to assess mental health issues in youths with Intellectual Disabilities. The instrument would address a significant need and allow for more accurate estimation of mental disorders in the Intellectual Disabilities population.
We are recruiting youths with Intellectual Disabilities aged 14-21, and their caregivers as well. Each participant would take part in one individual session of approximately 60-90 minutes (with breaks) at the Ohio State University Nisonger Center. Youths will be asked to respond to a set of interview questions about mental health, including providing feedback on a set of illustrations related to the interview questions about emotions, feelings, and behaviors. Parents or caregivers will be asked to provide feedback on the interview questions asked of youth.Could this study be right for you?
You may be eligible to participate in the study if you are:
--14 to 21 years old AND have been diagnosed with an Intellectual Disability
Youths will be asked to respond to a set of interview questions about mental health, including providing feedback on a set of illustrations related to the interview questions about emotions, feelings, and behaviors. Parents or caregivers will be asked to provide feedback on the interview questions asked of youth.Age Range14 and up
Official TitleM16-046: 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 DermatitisPurpose
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 ( eg. ruxolitinib, tofacitinib, baricitinib, upadacitinib, PF-04965842, and filgotinib) - No prior exposure to dupilumabAge Range18 and up
Official TitleAggression and Social-Emotional Information Processing: Neural Correlates During Alcohol Intoxication (Columbus Brain Activity Study or CBA)Purpose
The purpose of this study is to see how alcohol changes brain activity in different groups of study participants who currently drink at least 10 drinks a week and who have (or do not have) “anger issues”. Brain activity will be measured by Magnetic Resonance Imaging (MRI). Total time you will be in the research study will be for about 4-8 weeks from your initial visit.Could this study be right for you?
- Healthy men and women 21-55 years of age - Drink on a regular basis (~ 10 alcoholic beverages per week) - With a current history of "anger issues" - Able to complete study sessions during the weekAge Range21 and up
Official TitleExploring the Connectivity and Functional Organization of the Child BrainPurpose
The purpose of the study is to investigate how the brain develops and how it leads to our own unique behavior later on in life. We are studying children as they start school and learn new skills, and following up with them as they grow.
Children will perform computer based tasks such as seeing colorful faces, objects, and scenes, watching or listening to stimuli and making a response (e.g., button or verbal response), or move areas of his/her body (e.g., tapping his/her fingers) while we monitor their brain activity using functional Magnetic Resonance Imaging (fMRI). We may also monitor the participant’s eye position with a special eye-tracking camera so that we can assess where the participants are looking during the tasks.
The total length of the study will be between 3 and 5 hours, including up to 3 hours outside the MRI scanner and 2 hours in the scanner. Because the purpose of this study is to track development in each individual across time, we will ask you if you would like to participate in subsequent scan sessions as your child gets older.Could this study be right for you?
- Children ages 3-15 years of age
- Born at greater than 37 weeks or to term
- no family history of mental illness
- No alcohol or drug use
- normal vision and hearing
- Native English speakersAge Range3 and up
Official TitleRemote assessment of cognition, insulin resistance and omega-3s (RACIR O-3) in breast cancer survivorsPurpose
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
- 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 speakingAge Range45 and up
Official TitleDosing of Ketorolac Impacts post-cesarean paiN manaGement (KING): A Randomized Controlled TrialPurpose
The purpose of this study is to compare the use of morphine milligram equivalents (MME) in the first 24 hours of post-op C-Section delivery in patients getting a single dose of 30 mg ketorolac injected through the vein vs. 60 mg ketorolac injected through the vein in the operating room after the end of surgery.
Participation in this study starts from enrollment until being discharged from the hospital.Could this study be right for you?
• Pregnant women aged between 18 to 45 years old
• C-Section as the planned delivery process
• Regional anesthesia (Spinal, Epidural, Combined Spinal Epidural)
• Known allergy or adverse reaction to NSAIDs, aspirin, or ketorolac
• Patients with peptic ulcer disease, preexisting kidney or liver disease
• Patients with bleeding problem
• Acute or chronic pain disorder
• General anesthesia
• Opioid use disorder
• Emergent Cesarean delivery
• Active asthma
• Patients weighing <50 kgAge Range18 and up