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NCT ID: NCT06072066 Not yet recruiting - Rosacea Clinical Trials

Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.

NCT ID: NCT06072040 Recruiting - Microtia Clinical Trials

Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia

AUR-201
Start date: January 26, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.

NCT ID: NCT06071884 Not yet recruiting - Pain Clinical Trials

Bridge Device for Surgical Pain for Rotator Cuff Surgery

Start date: July 31, 2024
Phase: N/A
Study type: Interventional

The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation.

NCT ID: NCT06071858 Recruiting - Schizophrenia Clinical Trials

Enhanced Coordinated Specialty Care for Early Psychosis

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is: • Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis? Participants will either: - Receive care as usual (CSC) or - Receive care as usual (CSC) plus five additional care elements (CSC 2.0): 1. Individual peer support 2. Digital outreach 3. Care coordination 4. Multi-family group therapy 5. Cognitive remediation Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.

NCT ID: NCT06071845 Recruiting - Barrett Esophagus Clinical Trials

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples

SOS4C
Start date: October 16, 2023
Phase: N/A
Study type: Interventional

This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.

NCT ID: NCT06071832 Recruiting - Child Development Clinical Trials

Using Structured Video Chat to Improve Relationships Between Young Children and Remote Grandparents

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

During the Coronavirus (COVID-19) pandemic many families are using video chat (e.g., Zoom) to maintain relationships with distant relatives, including grandparents. While 67% of all grandparents reported liking the idea of video chatting with their grandchildren, only 28% did so regularly. Increasing this percentage could significantly improve grandparent-grandchild relationships because the Preliminary Study 1 showed that video chat frequency is a strong predictor of grandparent's ratings of closeness to their grandchild, even after controlling for the geographic distance between them. The overall goal of the past, ongoing, and future research is to understand the cognitive and social developmental challenges of video chat in order to support its use with children. As the next step towards this goal, the investigators propose to directly compare two approaches to instructing grandparents on how to improve video chats between grandparents and young grandchildren (18-72 months of age). Families will use video chat without the involvement of researchers during each video chat. Parent-child- grandparent triads (n=180; the largest multi-session observational study of young children and video chat to date) will record 10 video chats under one of three randomly-assigned conditions: structured play, structured reading, or when given no instructions (control). The overall hypothesis is that structured video chat will increase children's engagement and joint attention (primary outcome measures), as well as grandparents' enjoyment of video chat and closeness with their grandchild (secondary outcome measures). The investigators will use detailed behavioral coding of the video recordings of these chats to objectively assess many of the outcome measures. The Preliminary Study 2 showed that structured video chat facilitates more positive social interactions. The proposed work extends the preliminary work because it translates laboratory methods to a complementary ecologically-valid approach in families' naturalistic environments. In Aim 1, the investigators will determine whether and for whom structured video chat improves child engagement and increases child-initiated screen- based joint attention during video chats between grandparents and grandchildren. In Aim 2, the investigators will determine whether structured video chat increases grandparents' enjoyment of the video chats and leads to greater feelings of closeness to their grandchild. Both principal investigators, who are at R15-eligible institutions, are well-qualified to complete the proposed work. Since 2017, they have published 9 papers on video chat, 12 papers on reading, and collaboratively completed 3 preliminary studies and 2 papers. They have mentored 77 undergraduate students, many of whom were co-authors on conference posters or presentations (37 students in total; 22 as a presenter) or journal articles. Importantly, 17 students came from underrepresented groups (BIPOC, first- generation in college, LGBT). A total of 47 are pursuing or have completed graduate work in health-related sciences, including 15 for doctoral degrees. The proposed work addresses a National Institute for Child Health & Development, Child Development and Behavior Branch's (CDBB) priority of advancing understanding of "Effects of Technology and Digital Media Use on Child and Adolescent Development."

NCT ID: NCT06071767 Recruiting - HIV-1-infection Clinical Trials

Evaluation of Safety, Immunogenicity and Efficacy of a Triple Immune Regimen in Adults Initiated on ART During Acute HIV-1

Start date: April 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus (ChAdV)- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the Toll-like Receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).

NCT ID: NCT06071728 Completed - Aging Clinical Trials

Restoring Glycocalyx Thickness in Older Adults to Improve Vascular Function

RESTORE
Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The glycocalyx serves as the interface between flowing blood and endothelial cells, the single cell layer that lines blood vessels, and is crucial for normal blood vessel function. Specifically, the glycocalyx protects endothelial cells from oxidative stress and inflammation and enables blood vessel dilation, which is largely dependent on the bioavailability of the vasodilatory molecule nitric oxide. Importantly, glycocalyx thickness decreases with age and is predictive of major adverse cardiovascular events in older adults free of cardiovascular disease. Therefore, interventions aimed at restoring glycocalyx thickness in older adults are desperately needed. Endocalyx Pro is a commercially available glycocalyx precursor supplement, manufactured by Microvascular Health Solutions, designed to 1) repair a damaged glycocalyx, 2) protect against damage to the glycocalyx, and 3) synthesize new glycocalyx components, and has been used to increase glycocalyx thickness in humans. However, no study has tested if glycocalyx thickness restores glycocalyx thickness in older adults and improves blood vessel function. Thus, the purpose of this investigation is to determine if 12-weeks of Endocalyx Pro supplementation alters glycocalyx thickness and blood vessel function in older adults. The investigators will use a camera placed under the tongue to determine glycocalyx thickness. The investigators will measure blood vessel function by measuring brachial artery dilation with ultrasound and arterial stiffness using pressure probes placed on the carotid and femoral artery.

NCT ID: NCT06071715 Recruiting - Phantom Limb Pain Clinical Trials

Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation

Start date: February 12, 2024
Phase: N/A
Study type: Interventional

When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain. Unfortunately, phantom pain goes away in only 16% of afflicted individuals, and there is currently no reliable definitive treatment. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that actually increase with worsening phantom pain. These abnormal changes may often be corrected by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain with a simultaneous resolution of the phantom limb pain. However, when the nerve block resolves after a few hours, the phantom pain returns. But, this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation are not necessarily fixed, and may be dependent upon the "bad" signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve block-lasting many months rather than hours-may permanently reverse the abnormal changes in the brain, and provide definitive relief from phantom pain. A prolonged nerve block lasting a few months may be provided by freezing the nerve using a process called "cryoneurolysis". The ultimate objective of the proposed research study is to determine if cryoanalgesia is an effective treatment for intractable post-amputation phantom limb pain. The proposed pilot study will include subjects with an existing above-knee amputation who experience intractable daily phantom limb pain. A single ultrasound-guided treatment of cryoneurolysis (or sham block-determined randomly like a flip of a coin) will be applied to the major nerves of the thigh. Although not required, each subject may return 4-6 months later for the alternative treatment (if the first treatment is sham, then the second treatment would be cryoneurolysis) so that all participants have the option of receiving the active treatment. Subjects will be followed for a total of 12 months with data collected by telephone.

NCT ID: NCT06071624 Recruiting - Clinical trials for Chronic Myelomonocytic Leukemia

Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.

Start date: February 21, 2024
Phase: Phase 1
Study type: Interventional

This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory CMML. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells.