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NCT ID: NCT05900479 Enrolling by invitation - Clinical trials for Stress Disorders, Post-Traumatic

Multi-site, Longitudinal Trial Evaluating the Efficacy, Mechanisms, and Moderators of Service Dogs for Military Veterans With PTSD

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

Posttraumatic stress disorder (PTSD) among military Veterans is a critical public health concern. Veteran suicide rates exceed those of the general population, with the disorder creating a mental health challenge that is costly and debilitating. The majority of Veterans with PTSD also have comorbid mental health diagnoses, such as generalized anxiety disorder, substance abuse disorder, and major depression. The treatment of Veteran PTSD and comorbid disorders represents an important therapeutic and rehabilitation problem. The disorder is complex and difficult to treat, with high treatment dropout and nonresponse rates spurring some Veterans to seek complementary integrative health strategies. One promising complementary strategy is the provision of a trained service dog. Initial evidence across multiple research groups highlights service dogs as a promising complement to evidence-based practices that can offer short-term improvements. However, the long-term effectiveness, mechanisms of action, and moderators of efficacy remain largely unknown. Thus, the overarching objective of this proposal is to understand how, why, and for whom PTSD service dogs are most effective. To address this objective, the present project will assess the longitudinal efficacy and dose-response curve of service dogs for Veteran PTSD symptomology and psychosocial functioning. The research design will consist of a two-arm, randomized clinical trial (RCT) with longitudinal assessments at 0, 3, 9, and 15 months. Results are expected to elucidate the clinical impact of service dogs for military Veterans with PTSD, as well as the biobehavioral mechanisms of action and characteristics that moderate efficacy. These outcomes will support the long-term goal of accelerating complementary and integrative health interventions, through optimized and evidence-based service dog interventions. As such, this project will further advance the scientific understanding of human-animal interactions for psychosocial health.

NCT ID: NCT05900440 Enrolling by invitation - Education, Medical Clinical Trials

Artificial Intelligence for Learning Point-of-Care Ultrasound

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether artificial intelligence systems improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning with artificial intelligence vs devices with no artificial intelligence. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and performance on quizzes.

NCT ID: NCT05900284 Enrolling by invitation - Sepsis Clinical Trials

Safety and Feasibility of Metformin for Sepsis Induced AKI

Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

Acute kidney injury (AKI) is an independent risk factor for death that affects 10-15% of hospitalized patients and more than 50% of patients admitted to the intensive care unit. Sepsis is the most frequent cause of AKI, affecting 48 million people worldwide every year, and accounting for approximately 11 million of annual global deaths. Despite these figures, there are no known therapies to prevent or reverse septic AKI; hence this study aims to establish the safety and feasibility of the implementation of metformin in the treatment of AKI in patients with sepsis. This study is the first critical step to inform the design of a future, full-scale efficacy randomized clinical trial.

NCT ID: NCT05899673 Enrolling by invitation - Clinical trials for Alpha1-Antitrypsin Deficiency

An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease

Start date: August 8, 2023
Phase: Phase 3
Study type: Interventional

The main aim of this study is to learn if fazirsiran is safe during long-term use in people with liver disease caused by the abnormal Z-alpha-1 antitrypsin (Z-AAT) protein. People who are currently taking part in or have completed previous fazirsiran studies (AROAAT2001 [NCT03945292] or AROAAT2002 [NCT03946449]) can continue to receive fazirsiran in this study. Participants will receive fazirsiran every 3 months for almost 2 years and will then be followed for an additional 6 months. The study may also provide information on whether fazirsiran has a long-term effect in reducing liver fibrosis or slowing down the progression of liver fibrosis in people with liver disease due to the abnormal Z-AAT protein.

NCT ID: NCT05899322 Enrolling by invitation - Clinical trials for Post Traumatic Stress Disorder

Adaptation of the PCIP for Spanish Speaking Adolescents and Families

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smart phone delivery), to 10 Spanish speaking youth and their families. Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. Following RE-AIM guidelines, the investigators will assess: Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. This treatment ranges from 1-3 sessions which last 30-50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth. All treatment materials have been developed in both Spanish and English.

NCT ID: NCT05897957 Enrolling by invitation - Parkinson Disease Clinical Trials

Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01

Start date: May 16, 2023
Phase:
Study type: Observational

This is a multicenter study to evaluate the safety and clinical outcomes of BRT-DA01 in subjects with PD who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101.No investigational therapy will be administered in this study.

NCT ID: NCT05897086 Enrolling by invitation - Gender Dysphoria Clinical Trials

Polyethylene-glycol Assisted Nerve Repair in Phalloplasty

Start date: August 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Phalloplasty, a genitourinary surgery for transmasculine patients, reconstructs a neophallus using tissue transferred from other parts of the body to the groin. However, this technique fails to provide adequate sensation, causing regret and persistent dysphoria. Peripheral nerve regeneration is the greatest barrier to sensory recovery, given the slow rate of regrowth coupled with the negative effects of axonal degeneration. Topical application of polyethylene glycol (PEG) fuses severed axonal membranes, restoring the nerve's immediate ability to conduct electrical signals across the repair site. The investigators hypothesize that utilizing PEG in phalloplasties will significantly improve neophallus sensation and postoperative quality of life.

NCT ID: NCT05896878 Enrolling by invitation - Opioid Use Clinical Trials

The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

This is a research study to evaluate the effectiveness of daily supplementation with Root.Health, a plant-based dietary supplement, on reducing levels of 11 abnormal urine biomarkers associated with chronic pain. Biomarkers are molecules found in blood, tissues, or other body fluids (such as urine) that indicate normal or abnormal processes.

NCT ID: NCT05894343 Enrolling by invitation - Parkinson Disease Clinical Trials

Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease

Start date: May 19, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to evaluate the long-term safety of AAV-GAD delivered bilaterally to the subthalamic nuclei (STN) in participants with Parkinson's disease.

NCT ID: NCT05892770 Enrolling by invitation - Spasmodic Dysphonia Clinical Trials

Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

Start date: August 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment. This initial study was in the context of facial aesthetics. The purpose of the present study is to determine the effect, if any, of oral zinc supplementation prior to BT in the treatment of spasmodic dysphonia. If positive effects will be observed, this would help reduce the burden of disease for these patients.