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NCT ID: NCT06044675 Recruiting - Clinical trials for Post Traumatic Stress Disorder

MDMA-Assisted CBCT for PTSD vs CBCT RCT

Start date: October 15, 2023
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery. CBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads. MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness. This randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.

NCT ID: NCT06043427 Recruiting - Clinical trials for Gastroesophageal Adenocarcinoma

Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma

Start date: April 16, 2024
Phase: Phase 2
Study type: Interventional

This study is being done to answer the following question: Can the chance of gastroesophageal cancer growing or spreading be lowered by adding a drug called zanidatamab to the usual combination of drugs? We are doing this study because we want to find out if this approach is better or worse than the usual approach for this type of cancer. The usual approach is defined as care most people get for gastroesophageal cancer

NCT ID: NCT06042920 Recruiting - Clinical trials for Palmoplantar Psoriasis

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Start date: October 10, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.

NCT ID: NCT06042491 Recruiting - Disability Physical Clinical Trials

The STRIVE Before Surgery Pilot Trial

Start date: January 30, 2024
Phase: N/A
Study type: Interventional

The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence, and follow-up) associated with participating in a home-based multimodal prehabilitation program supported through an online platform. Half of the participants will be randomized into the prehabilitation group, while the other half will be randomized into the control group.

NCT ID: NCT06042478 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.

Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).

NCT ID: NCT06042387 Recruiting - Healthy Clinical Trials

Diverse Ancestry Study in IBD

Start date: May 1, 2022
Phase:
Study type: Observational

Objective: To use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD in diverse ancestries: African, African American, Black, Afro-Caribbean, Afro-Latino/a/x, Latino/a/x, Hispanic, or any other Black or Latin or indigenous ancestry.

NCT ID: NCT06041269 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (RENOIR)

Start date: August 31, 2023
Phase: Phase 2
Study type: Interventional

RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)

NCT ID: NCT06041152 Recruiting - Clinical trials for Amnestic Mild Cognitive Impairment

Does Psilocybin Change Synaptic Density in Amnestic Mild Cognitive Impairment

Start date: November 27, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate the effects of psilocybin on synaptic vesicular density (SVD) as measured by the positron emission tomography (PET) radiotracer, 18F-SynVesT-1, in participants with amnestic Mild Cognitive Impairment (aMCI) and healthy participants. The investigators hypothesize that SVD levels in the brain will be higher following the ingestion of psilocybin in comparison to placebo, and that increases in SVD will be associated with improvements in cognition. 60 participants (30 with aMCI, and 30 sex and age matched healthy volunteers) will: - Be randomized to receive either: 1. Two 25 mg macrodoses of psilocybin separated by 1 week. 2. Two placebo doses separated by 1 week. - Receive a baseline 18F-SynVesT-1 PET scan, clinical, and neuropsychological assessments. - Receive a 18F-SynVesT-1 PET scan one week after the last dose of treatment. - Receive a third PET scan at any time within 4 weeks of the screening visit to quantify tauopathy with the [18F]T807 radiotracer. - Receive clinical and neuropsychological testing 1, 4, and 12 weeks after the last treatment. Researchers will compare placebo vs. experimental groups to see if psilocybin will increase SVD, and if increases in SVD are associated with cognitive improvements.

NCT ID: NCT06041087 Recruiting - Healthy Clinical Trials

Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

BIONEX
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

This study investigates whether dairy products will positively impact loading exercise-induced bone turnover and bone cell activity and/or the post-exercise inflammatory response in healthy young adults compared to a carbohydrate drink and/or water.

NCT ID: NCT06040749 Recruiting - Spinal Cord Injury Clinical Trials

Virtual Sport for Adults ≥ 50 Years With Spinal Cord Injury

Start date: May 5, 2023
Phase: N/A
Study type: Interventional

Sport is a physical activity that has many physical, psychological and social benefits for those with spinal cord injury (SCI). However, most sport research involves people with SCI who are <50 years old. This is a problem because many people are >50 years old when first injured. Moreover, people with a SCI are now living longer lives, meaning they also experience more health challenges. Unfortunately, there is limited research studying the impact of sport for adults with SCI aged ≥50 years old.