This project examines how to improve speech understanding with cochlear implants (CIs), particularly for older CI recipients. While older individuals benefit from CI technology, performance is poorer than that of younger implanted adults for difficult listening tasks. The mechanisms that contribute to this variability are not well-understood. The current project examines how differences in brain structure and function may contribute to success with a cochlear implant. To compare, we will also be examining how older patients without cochlear implants understand speech in difficult listening situations.
The study is for a patient that have been diagnosed with multiple myeloma. The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first).
In this study, the participants will take pembrolizumab for 24 months or get pembrolizumab plus a course of radiation therapy for 24 months until the cancer progresses. After the study treatment is finished, the study doctor will continue to follow the participants condition for a total of 3 years. Some risks in this study is that pembrolizumab with radiation may not be as good as the usual approach for cancer shirking or stabilizing. Some risks associated with pembrolizumab and radiation which are reduction in blood counts, mouth or throat pain and difficulty swallowing. The potential benefit of this study is that radiation and chemotherapy/pembrolizumab can be effective at shrinking or stabilizing the cancer. The purpose of this study is to compare using pembrolizumab with radiation to pembrolizumab without radiation.
This study is enrolling subjects with non-obstructive hypertrophic cardiomyopathy (nHCM). nHCM is typically a genetic condition in which the main pumping chamber of the heart (called the left ventricle) becomes abnormally thickened and stiff, which makes it harder for the ventricle to fill and pump out enough blood. This study involves the investigational medication Aficamten, which means it is not approved for commercial use by the Food and Drug Administration. (FDA) Aficamten is designed to reduced excessive heart pumping function. This is a randomized study which means all subjects are assigned to receive either Aficamten or placebo. Subjects have a 50:50 chance of being assigned to either group, but will not know which group they are assigned. Placebo looks like the medication but does not have any active ingredients in it. Study procedures include exercise testing, echocardiograms (ultrasound test of the heart), blood work, questionnaires and genetic testing. Study risks include risks associated with the study medication including decreased heart pumping, nausea, headache and dizziness. There are also study procedure related risks, and the risk of loss of confidentiality. There may be no benefit but the information learned may benefit others in the future. Study participation will last between 10.5 and 19 months and include up to 13 visits to the study site. Visits will generally last 2-3 hours.
The purpose of this research study is to study if the investigational drug, MK-6194, is safe and effective to treat adults with non-segmental vitiligo. In this study, MK-6194 or placebo administration will occur every two weeks or every four weeks to evaluate how well MK-6194 may treat non-segmental vitiligo. This study can last up to 60 weeks, including up to 4 weeks for screening, up to 52 weeks for treatment, and 14 days for safety follow-up. Eligible participants will be randomized 1:1:1 to receive MK-6194 every two weeks, every four weeks, or receive placebo.
This is a Phase 2, double-blind, randomized, placebo-controlled study of KER-012 (study drug) compared to Placebo in adult participants with a primary diagnosis of Pulmonary Arterial Hypertension (PAH) on stable background PAH therapy. About 90 participants, in approximately 60 study centers worldwide, will take part in this study. Participation in this study may last up to 2 years and the study has a Screening period, Treatment period, Extension period, and Follow-up period.
The goal of this study is to help compare scans from the new photon counting CT scanner of a solid lung tumor with traditional lab and biopsy results. Subjects enrolled in this study will receive their normal CT scan on the new photon counting CT scanner that has the capacity to provide pictures that are better quality. These images will provide useful information that may lead to future improvements for patients with similar conditions.
This study will evaluate possible new treatments for advanced stage head and neck cancer. Patients who have undergone surgery to remove their tumor may qualify if the tissue is positive for a specific type of squamous cell cancer. The purpose of this study is to compare the current standard treatment, radiation therapy along with chemotherapy with a drug called cisplatin, to two other treatments. One experimental treatment is radiation therapy along with two chemotherapy agents, docetaxel and cetuximab, and the other experimental treatment is the standard treatment currently used along with the addition of an immunotherapy drug atezolizumab. Patients who qualify for participation will be randomly assigned to one of the 3 treatment groups (done with a computerized system). In the current standard treatment group, participants will receive radiation therapy 5 days per week for 6 weeks, and cisplatin once a week through a vein for the 6-week treatment period. The group receiving doxetaxel and cetuximab (both FDA approved medications for the treatment of certain cancers) will receive the same 6 weeks of radiation along with cetuximab through a vein 1 week prior to the start of radiation therapy, and then once a week for the 6 weeks of radiation and the doxetaxel will also be given through a vein once a week for the 6 weeks of radiation therapy. The final group will get the current standard treatment with 6 weeks of radiation and 6 weeks of cisplatin, along with atezolizumab through a vein 1 week prior to your starting radiation and then every 3 weeks for a total of 8 doses, There will be twice as many patients in this last group than the other two groups.
Follow-up will be at Month 1 & 3 and then every 3 months for 2 years, and then every 6 months for 3 more years, and then annually for as long as a participant is willing and able. There will be blood tests and CT scans that will occur throughout the study, however they are standard for the type of cancer being treated and how each individual responds to the treatment. The benefit of participation is there may be improved outcomes in this group of patients however the risks involved with receiving new treatments may be more than with the usual standard treatment. Some of the most common side effects that the study doctors know about are infection, nausea, vomiting, diarrhea, pain, tiredness, kidney problems, numbness/tingling in hands and feet. There may be some risks that the study doctors are not aware of at the moment. There will be a total of up to 480 participants across all sites and approximately 24 participants at MUSC.