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NCT ID: NCT06333041 Not yet recruiting - Sanfilippo Syndrome Clinical Trials

Study of Cannabidiol in Sanfilippo Syndrome

Start date: May 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to test cannabidiol in Sanfilippo syndrome. The main questions it aims to answer are: 1) determine the safety of cannabidiol in Sanfilippo syndrome, and 2) explore the efficacy of cannabidiol in treating the neurobehavioral symptoms and functional outcomes of Sanfilippo syndrome. Each participant's caregiver will be asked to complete surveys related to the participant's behavior, mood, sleep, stooling, pain, and caregiver stress intermittently throughout the study. All participants will be enrolled into one of two cohorts based on enrollment order: 1. Sentinel Safety Cohort (first 5 participants) - all participants treated with Epidiolex (cannabidiol) 2. Controlled Cohort (next 30 participants) - participants randomized 1:1 (equal chance) to start treatment with Epidiolex (cannabidiol) or placebo for 16 weeks, followed by an 8-week washout period (no treatment). Participants then switch to the opposite treatment group for 16 weeks followed by all participants treated for 52 weeks with Epidiolex (cannabidiol).

NCT ID: NCT06333028 Recruiting - Cataract Clinical Trials

A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Start date: May 30, 2024
Phase:
Study type: Observational

A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction

NCT ID: NCT06333015 Not yet recruiting - Cataract Clinical Trials

Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction

Start date: April 2024
Phase: N/A
Study type: Interventional

This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes.

NCT ID: NCT06332963 Recruiting - Anorexia Nervosa Clinical Trials

Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

Start date: April 19, 2024
Phase: N/A
Study type: Interventional

The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored.

NCT ID: NCT06332352 Recruiting - Clinical trials for Acetabular Labrum Tear

Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears

PRP for ALT
Start date: January 25, 2024
Phase: N/A
Study type: Interventional

Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function. Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants.

NCT ID: NCT06332339 Recruiting - HIV Clinical Trials

Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV.

Start date: March 15, 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV. The main question[s] it aims to answer are: - Are these vaccine regimens safe and well tolerated? - Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses? Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary.

NCT ID: NCT06332144 Recruiting - Clinical trials for Autism Spectrum Disorder

Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning

PLAUSL
Start date: January 13, 2024
Phase:
Study type: Observational

The goal of this observational study is to test a reciprocal relationship between statistical learning and the development of language and literacy in first-graders with autism and their non-autistic peers. The main questions it aims to answer are: 1. whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school; 2. how children's brains automatically learn patterns from speech and prints; 3. whether children's learning in the lab reflects the language patterns they have learned over the years from their native language. First-grade students will participate in the study twice across three months. During Time 1, children will complete - a battery of language, reading, and cognitive assessments - a series of computer-based statistical learning games both inside and outside of functional MRI scanner. During Time 2, children will complete a battery of language and reading assessments to detect the growth in three months. Researchers will compare the autistic and the non-autistic groups to see if statistical learning plays a similar or different role in predicting children's language and literacy growth.

NCT ID: NCT06332131 Not yet recruiting - Melanoma Clinical Trials

Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

Start date: May 2024
Phase:
Study type: Observational

This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.

NCT ID: NCT06332092 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma

HNSCC
Start date: April 10, 2024
Phase: Phase 2
Study type: Interventional

The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle.

NCT ID: NCT06332040 Recruiting - Catheter Infection Clinical Trials

Gentamicin Bladder Instillation on CAUTI

Start date: October 9, 2023
Phase: Phase 4
Study type: Interventional

Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare & Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs.