There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The goal of this randomized controlled trial is to compare Promoting First Relationships - Home Visit (PFR-HV) to Promoting First Relationships - Telehealth (PFR-T) among parents of 6-12 month olds in the child welfare system. The main questions it aims to answer are: - Is PFR-T effective relative to PFR-HV and Usual Care with respect to observed parent sensitive and responsive care, parent knowledge of child social and emotional development, and child externalizing behavior? - Is PFR-T effective relative to PFR-HV and Usual Care with respect to child out-of-home placement in foster care relative to the control group? - How does PFR-T compare in a benefit-cost analysis to the cost-effectiveness relative to PFR-HV and Usual Care? - Are eligible families impacted by the lack of technology and Wi-Fi/cellular data to engage in PFR-T? - How does provider adherence and fidelity in delivery of PFR-T compare to adherence and fidelity of PFR-HV? What will participants be asked to do? 1. Participants will be asked to agree to randomization, resulting in their placement in one of three groups: PFR-HV, PFR-T, or the control group. 2. Participants will be asked to participate in three virtual research visits, over the course of approximately 12 months (families could be finished as early as 9 months, however in our experience, intervention sessions and research visits often need to be rescheduled, delaying completion of the study). The research visits take approximately 80 minutes, and families will be paid $75 for each visit they participate in. 3. During the research visit, the families will be asked to participate in videotaped research activities involving parent-child play and interaction. Parents will be asked to answer questions regarding their background, feelings, parenting opinions, and stress. 4. Families randomized to the PFR-HV intervention are asked to participate in a 10 week in home parenting program which includes videotaped caregiver-child interactions and feedback. 5. Families randomized to the PFR-T intervention are asked to participate in a 10-week parenting program that will occur over Zoom, which will include videotaped caregiver-child interactions and feedback. 6. Families randomized to the control group will be emailed a resource packet with some information about services or programs that might be helpful for them.
The CUV105 study will assess the efficacy and safety of afamelanotide and NB-UVB light in patients with vitiligo on the body and face versus NB-UVB light alone.
The current protocol aims to enroll up to 806 participants from 8 study sites in a clinic-supported intervention which will connect them to Vivent Health care team and a cohort of peer mentors for a year-long intervention period to support patient HIV care to maintain viral suppression and clinic appointments.
The purpose of the study is to test the effects, both good and bad, of the research study drug Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX chemotherapy. This study will also look at the safety of Neratinib in combination with Trastuzumab, Pembrolizumab and FOLFOX in HER2 overexpressing Gastroesophageal cancers.
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, and a Maintenance Phase. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268 followed by weekly doses of ALTB-268 for 12 weeks. Primary efficacy endpoint will be evaluated at week 12. Week 12 dosing will occur during the 40 wks Maintenance Phase. During 40 weeklong maintenance phase SC doses of ALTB-268 will be administered every other week. At week 52, all subjects will have an endoscopy performed and efficacy and safety evaluation will take place.
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing abdominoplasty (Cohort 2).
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).
The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.
In this study, the investigators aim to improve image acquisition and preprocessing pipeline for FDA application. Our previous research has used various methodologies to identify images to input into the algorithm. The investigators aim to evaluate the effect of image quality and field of view on the output of the device in addition to performing a precision study to evaluate the effect of different camera operators on image selection and device output. Additionally the investigators aim to assist conducting pivotal clinical study for assistive diagnosis. Based on two previous meetings with the FDA, the clinical study will test the following hypothesis: use of the i-ROP DL VSS improves the accuracy of plus disease diagnosis among clinicians performing telemedical review of images. The investigators also aim to assist in conducting pivotal clinical study of autonomous ROP screening. Preliminary data suggests that the i-ROP DL system could achieve 100% sensitivity for detection of severe ROP. The investigators will perform a clinical study to support a revised indication for use as an autonomous AI screening device. Output of the i-ROP DL system will be compared to masked telemedicine grading for identification of referral-warranted and treatment-requiring ROP.
Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab. Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 2 stages to this study. In Stage 1, there are 3 treatment arms and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug), atezolizumab in combination with bevacizumab, or tremelimumab in combination with durvalumab. In Stage 2, there are 2 treatments arms and participants will be randomized in a 1:1 ratio. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab or tremelimumab in combination with durvalumab. Approximately 660 adult participants will be enrolled in the study across 185 sites worldwide. Stage 1: In arm 1, participants will receive intravenously (IV) infused livmoniplimab (Dose 1) in combination with IV infused budigalimab, every 3 weeks. In arm 2, participants will receive IV infused livmoniplimab (Dose 2) in combination with IV infused budigalimab, every 3 weeks. In Arm 3 (control), participants will receive the investigator's choice: IV atezolizumab in combination with IV bevacizumab every 3 weeks or single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. Stage 2: In arm 1, participants will receive IV infused livmoniplimab (optimized dose) in combination with IV infused budigalimab, every 3 weeks. In Arm 2 (control), participants will receive single dose IV tremelimumab in combination with IV durvalumab every 4 weeks. All participants will continue treatment until disease progression or discontinuation criteria are met, whichever occurs first. The estimated duration of this study is about 56 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.