A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED MULTICENTER OUTPATIENT PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF STACCATO ALPRAZOLAM IN PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH EPILEPSY WITH A PREDICTABLE SEIZURE PATTERN.
Staccato alprazolam is being developed for the indication of rapid cessation of a prolonged focal or generalized seizure that has not progressed to status epilepticus in patients with epilepsy 12 years of age and older. After completing the study, eligible study participants will be allowed to enroll in an open-label extension (OLE) study.
A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression
The purpose of this study is to see how easy it is to use an intermittent light therapy device in adults with a major depressive episode (MDE), and to see how mood is impacted by the light therapy. Participants will complete 15 non-invasive light stimulation sessions, online surveys, and assessments.
A First-in-human (FIH) Study of Inhibitory Interneurons (NRTX- 1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
The purpose of this two part study is to evaluate the safety (Stage 1 and Stage 2) and efficacy (Stage 2) of NRTX-1001 in subjects with drug resistant mesial temporal lobe epilepsy (MTLE).
A First-in-Human Phase 1a/1b Trial to Assess the Safety Tolerability and Preliminary Efficacy of LY4170156 an Antibody-Drug Conjugate Targeting Folate Receptor a Expressing Tumor Cells in Participants with Selected Advanced Solid Tumors
This study will test a new drug called LY4170156, an antibody drug conjugate (ADC) to see how it works in the body, and if it helps patients with different types of cancer, like ovarian, endometrial, cervical, lung, breast, pancreatic, and colorectal cancers. The study has two phases. In Phase 1a, doctors will find the best dose of LY4170156 by giving it to patients and checking for side effects and how well it works. If needed, they will try different doses to see which one is the safest and most effective. In Phase 1b, the best dose from Phase 1a will be given to more patients to see how well it works as a single treatment. Patients will be divided into groups based on the type of cancer and a specific antigen in their tumors to which the ADC binds, which will be tested in a lab. The study will make sure that the drug is given at the right dose and checks how patients feel during the treatment.
A First in Human Study of theMenin-KMT2A (MLL1)Inhibitor JNJ-75276617 in Participants with Acute Leukemia
A First in Human Study of theMenin-KMT2A (MLL1)Inhibitor JNJ-75276617 in Participants with Acute Leukemia
A Follow-Up Open-Label Research Evaluation of Sustained Treatment with Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)
This is an open-label study of CK-3773274 in patients with HCM. The treatment duration is anticipated to be multiple years, concluding when marketing authorization is achieved in the patient’s country or Cytokinetics terminates the study. Approximately 600 patients will be enrolled in this study. After (up to) 56-days of screening, eligible patients will be administered a daily dose of CK-3773274. The highest maximum tolerated dose of CK-3773274 in CY 6022 will be informed by the ongoing conduct of other studies of CK-3773274. Each patient will start at the lowest prespecified dose and undergo echocardiography-guided dose titration to their maximum tolerated dose (not to exceed the highest prespecified dose). Dose adjustment may be made no more frequently than every 2 weeks.Approximately 95 investigative sites worldwide.
A Global Prospective Observational Registry of Patients with Pompe Disease
The purpose of this registry is to evaluate clinical outcomes in participants with Pompe disease. This includes what happens to participants who are not on any treatment and the long-term safety and effects of different types of treatments for Pompe disease.
A green activity prescription program for Chinese Americans living with dementia
This study will iteratively develop and test the feasibility and acceptability of a 12-week green prescription program among Chinese American people living with dementia and their care partners. Development of the intervention will be guided by focus groups consisting of experts in green activities, Alzheimer's disease and related dementias, occupational therapy, BE, implementation science, and Chinese American people living with dementia and their care partners. Stakeholders will also identify preferred recruitment strategies and meaningful outcomes to prepare the green intervention for future pilot testing.
A MIXED METHODS SINGLE-GROUP SINGLE-CENTER FEASIBILITY STUDY OF A FOOD RESPONSE AND ATTENTION TRAINING TO REDUCE UNHEALTHY DIETARY INTAKE AND PROMOTE WEIGHT LOSS IN RACIALLY AND ETHNICALLY DIVERSE PATIENTS WITH OBESITY
Over 40% of American adults have obesity, with a higher prevalence for racial/ethnic minorities such as Hispanic (47%) and non-Hispanic Black/African American populations (46.8%), increasing their cardiovascular disease risk. Most behavioral interventions do not target attention bias that may be driving food intake, and this may limit their effectiveness. Attention bias to unhealthy foods describes the automatic processes by which these foods capture attention, and activate the brain’s reward system. During computer-based food response training, people can learn to counteract this attention bias by repeatedly inhibiting their responses to unhealthy foods. Afterward, people devalue these foods, experience fewer cravings, and reduce their food intake, binge eating symptoms, and weight. Food response training may be particularly beneficial for people with low inhibitory control who, by definition, demonstrate decreased ability to suppress task-irrelevant behaviors. Food response training has promise as a novel weight-loss treatment, yet most studies to date have taken place in laboratory settings with students. Thus, it is unclear whether findings are generalizable to diverse patient populations and within clinical settings. Using a mixed-methods approach, this study aims to determine the acceptability and feasibility of a food response training intervention among racially and ethnically diverse patients with obesity and elevated cardiovascular disease. We will conduct a single group pre-post study to examine the acceptability and feasibility of the food response training intervention and 12-week outcomes (i.e., dietary intake, weight, and blood pressure). We will also conduct individual interviews with a subset of patients to examine patients’ perceptions of the food response training intervention. We also explore if the effects of the food response training intervention on reduced dietary intake and weight will be stronger for patients who score low on the inhibitory self-control scale. Food response training is a novel and potentially scalable weight-loss intervention that may help diverse patients with obesity to consume healthy foods, lose weight, and improve their cardiovascular health.
A Modular Open-label Phase I/II Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies
EP0031-101 is an interventional, modular, multi-arm, multi-centre, open-label Phase I/II study to investigate the safety, tolerability, PK, and PD of EP0031, to determine the RP2D of EP0031, and todetermine preliminary efficacy of EP0031 in defined patient populations with RET-altered malignancies.The design consists of a core study protocol and individual Modules, as follows:? Module A: Monotherapy dose escalation and RP2D optimisation in patients with RETaltered solid tumours (including a paired biopsy cohort)? Module B: Dose-expansion cohorts will be opened to further explore the safety andtolerability and provide preliminary efficacy data in selected patient populations withRET-altered tumours? Module C: Further dose expansion and initial efficacy investigation in patients who haveprogressed following first-generation SRI therapy