This is a Phase 3 clinical research study for adults with pulmonary hypertension associated with interstitial lung disease, also called PH-ILD. The study will compare an investigational inhaled drug called treprostinil palmitil inhalation powder, or TPIP, with placebo. Participants will be assigned by chance to receive TPIP or placebo once daily for 24 weeks. The main purpose is to determine whether TPIP improves how far participants can walk in six minutes and whether it delays worsening of PH-ILD. Participants will complete study visits, physical examinations, blood tests, heart and lung testing, questionnaires, and six-minute walk tests. Participation may last up to approximately 32 weeks, including screening, treatment, and follow-up. An optional hemodynamic sub-study will include an additional right heart catheterization near the end of study treatment for eligible participants who separately consent.
Young adults who smoke are at a high risk of developing tobacco-related diseases and cancers. Young adults are also less likely to quit smoking than older adults, and having a parent who also smokes can make quitting even harder. This study looks at how family relationships affect smoking and quitting among young adults ages 18 to 29 who smoke every day and have a parent who currently smokes. In the first phase of this study, young adults will complete online surveys about their smoking habits and their relationship with their parent. In the second phase, some of those young adults and their parents will take part in one-on-one interviews to talk about how their relationship affects smoking and quitting. All study activities will be done remotely. What researchers learn will help guide the development of a future program that helps young adults and their parents quit smoking together.
This study will examine how medications called GLP-1 receptor agonists should be managed before an upper endoscopy. Participants taking a weekly GLP-1 receptor agonist will be randomly assigned to continue their medication, stop it for 7 days before the procedure, or stop it for 14 days before the procedure. Before the endoscopy, an ultrasound will be used to assess the amount and type of contents remaining in the stomach. The study will compare the groups to determine how different medication hold times affect the amount of stomach contents present at the time of endoscopy. The results may help inform future recommendations for managing GLP-1 receptor agonists before endoscopic procedures.
Approximately 25% of children with cerebral palsy (CP) cannot walk and completing movements or skills with their arms, legs and bodies can be difficult. The reason these children have difficulty in walking comes from differences in their brain. Physical and occupational therapy when provided every day for several hours a day over a few weeks up to 60 hours in total can help children's brain, movements, and skills improve. Another treatment called vagal nerve stimulation when done in combination with physical and occupational therapy may help boost improvements in children's brain, movements, and skills.
This study will recruit, voluntarily consent and enroll 6 children with CP who cannot walk. All children will receive 60 hours of physical or occupational therapy over three weeks. Three of these children will also receive vagal nerve stimulation by the physical or occupational therapist. Children whose parents consent will be assessed. Movement, sensory awareness, and heart rate will be measured before and after the investigational treatment. Findings from this study may document improved brain activity, movements, or skills in children with CP who cannot walk, but this cannot be guaranteed.
The purpose of this study is to evaluate a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone/Bupropion) and behavior therapy for adults considering bariatric surgery. This pilot randomized control trial will study whether the intervention helps with weight loss and smoking cessation by comparing it to the current standard of care. This study will provide important data needed to improve readiness for bariatric surgery utilization and reduce risk for smoking relapse long term.
The purpose of this study is to test the use of a new treatment program to improve medication adherence for people with HIV and PTSD for patients at HIV care clinics in Charleston (Medical University of South Carolina) and New Orleans (Louisiana State University). Participants will be assigned to one of two groups. Participants in Group A will be asked to attend 12 clinic sessions (twice a week for 6 weeks, 90-minute sessions) via telehealth or in person at a HIV care clinic. Participants in Group B will receive a one session adherence intervention (60 minutes) and get the same standard treatment that someone with a trauma history and co-occurring HIV and PTSD symptoms would receive at a local HIV care clinic. The study is provided at no-cost, and participants may learn useful information and coping skills while being in the study. It is hoped the information that we get from this study will help researchers and clinicians better design treatment programs for people living with HIV and PTSD. Participants will receive study compensation for their time.
This study is trying to find out if ORKA-002 study drug has an effect on your type of Hidradenitis Suppurativa (HS) and to assess the safety of ORKA-002 study drug when given to participants who have your type of HS. Understanding this could help people with Hidradenitis Suppurativa (HS) in the future. About 160 people will take part in this research. Study participation will include up to 4 weeks of screening and up to 40 weeks of study drug administration. At the completion of the study drug administration period, and if qualified, you may be presented with the option to consent and enter into an open-label (OL) extension study where you will continue to receive the study drug. If you do not enter the OL study or choose not to participate, you will be followed in this study for an additional 48 weeks for safety.
This study is for patients diagnosed with de novo oligometastatic HER2+ breast cancer. The study is evaluating the use of HER2-targeted systemic therapy in combination with locoregional therapy and ablation of metastatic sites. The subjects will be randomized (like flipping a count) to determine if they will receive locoregional therapy plus SRT to all metastatic sites or no surgery or radiation therapy unless required for palliation. The primary purpose of this study is to determine if overall survival (OS) between participants with de novo stage IV oligometastatic HER2+ breast cancer who experience at least a partial response (PR) after initial systemic therapy similar to those used in stage III disease with curative intent, and are randomized to a multimodality approach including definitive locoregional therapy with surgery and radiotherapy and ablative intent stereotactic radiotherapy to detectable metastatic lesions followed by additional HER2-directed systemic therapy, similar to those used for residual disease after neoadjuvant therapy, (Cohort A, Arm 1) versus those who are randomized to physician's choice standard of care HER2-directed systemic therapies without local and metastasis directed ablative therapies(Cohort A, Arm 2).
Acne affects over 50 million Americans every year, with teens and young adults making up the vast majority of cases. While standard acne medicines often work well, they can sometimes cause significant side effects like dry, peeling, or irritated skin. Because of this, researchers are looking into alternative options, such as light-based treatments, that might clear breakouts without the harsh side effects. The goal of this study is to test a new at-home treatment for mild to moderate acne to see if it is safe and effective. Specifically, we aim to determine if combining a special blue and red LED light device with a common acne face wash (benzoyl peroxide) works better than using the face wash by itself. Since this specific combination of light therapy and face wash hasn't been tested on teens yet, we hope the results will give young people a new way to clear their skin and feel more confident in their daily lives.
This will be a prospective study on a new technique to measure Pelvic Organ Prolapse. This study will look to see if we can demonstrate good inter-examiner reliability.