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ANTAGONIST - ClinicalTrials.gov

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Last Updated: 10 August 2022

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Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation

Both tibialis anterior and lateral gastrocnemius muscles were built through coaptation of the tibialis anterior and lateral gastrocnemius muscles stretching either end of the tendon portion, which was positioned in the proximally positioned tarsal tunnel, and coaptation of the tibialis posterior and perpendic muscle muscles to either end of the tendon passage through the distally positioned tunnel. The findings of performance testing in this first AMI recipient's first AMI recipient showed that AMIs can enable both prodigulation and prosthesis control, as well as prognostic prostitution. Hence, the AMI tissue architecture inherently preserves natural, bi-directional communication between surgically reconstructed limb musculature and the central nervous system, thus raising the AMI tissue architecture's ability over previously described neural interfacing techniques such as targeted muscle stimulation, regenerative peripheral nerve interfaces, and peripheral nerve interfaces. The AMI transtibial amputation paradigm has the ability to restore human central nervous system as the primary mediator of prosthetic joint control by providing a platform for robust decoding of movement intention as well as usable afferent feedback from a prosthetic joint. PROTEKTibial amputations: This report is intended for healthy, active participants with transtibial amputations: an experimental group of participants with AMI transtibial amputations; a control group of participants with standard transtibial amputations. HYPOTHESIS: AMIs manufactured within the amputated residuum will offer a more accurate representation of joint position and impedance in a multi-degree of freedom prosthesis, as well as demonstrating prosocial sensations from each prosthetic joint to the central nervous system. SPECIFIC AIM 1: Motion Control in Free Space Aim 1 examines whether AMIs can increase voluntary free-space prosthetic control. Aim 1B explores whether AMIs can improve motion control of a prosthesis that allows independent activation of powered ankle and subtal joint motions, as well as EMG-modulated control of prosthetic joint positions and stiffnesses. Terrain Adaptation AIM 2: Terrain Adaptation Aim 2 determines whether AMIs can contribute to voluntary and involuntary prosthetic terrain adaptations. The task involves conversion of the prosthetic subtalar joint so that the lateral edge of the prosthetic foot meets a vertically offset block, but the prosthetic foot's medial side remains at its normal height. AIM 3: Human-Device Communication Aim 3: Human-Device Aim 3: Specific AIM 3: Human-Device Communication Aim 3: Human-Device Communication Aim 3 explores whether AMIs could facilitate new possibilities for bi-directional human-device communication and provides insight into the establishment of closed-loop prosthetic control methods. The participant is blindfolded and asked to plantar flex the phantom ankle joint, causing the prosthetic ankle joint to press down on a foot pedal against mechanical resistance. Participants are also encouraged to plantar flex at various fitness levels, and FES is also applied to specific target muscles in accordance with prosthetic sensor results from each effort level.

Source link: https://clinicaltrials.gov/ct2/show/NCT03913273


Prospective Cohort Study to Identify the Predictive Factors of Response to PD-1 or PD-L1 Antagonists

According to the research's protocol, 670 patients with melanoma, NSCLC, or HNSCC are expected to receive chemotherapy with a single-agent PD-1 or PD L1 antagonist therapy as indicated in the respective European MA or under the conditions of a TAU. Patients at certain participating hospitals will also be required to test stool and saliva samples. After 42 days of PD-1 or PD-L1 antagonist therapy, and in the event of disease progression or recurrence, additional optional biopsy samples may be obtained from consenting patients. Whether PD-1 or PD-L1 antagonist therapy is ongoing or has stopped, additional blood samples will continue to be collected at regular intervals throughout the observation period until disease progression, regardless of whether PD-1 or PD-L1 antagonist therapy is ongoing or not discontinued. The 'training' cohort will be made up of the first patients to be included in the study and will be used to produce a predictive response score.

Source link: https://clinicaltrials.gov/ct2/show/NCT03412058


Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)

Posttraumatic stress disorder is a common psychiatric disorder linked to significant morbidity and mortality in the United States. Both PTSD and Major Depression have been shown promise for treating both PTSD and Major Depression. Hypothesized Glucocorticoid receptor antagonists such as mifepristone are hypothesized to recaliburrate the HPA axis by blocking peripheral and central GR blockade and central glucocorticoid signaling and raising central glucocorticoid signaling. Increased central glucocorticoid signaling and normalization of HPA axis control could hinder stress responsive systems, such as the sympathetic nervous system, which are essential to clinical development, which may be limited in PTSD-related neurotic dysfunction. At 4 weeks in a subgroup of Veterans with PTSD without traumatic brain injury, a newly completed trial of mifepristone, a GR antagonist that can modulate dysregulation of the HPA axis, demonstrated clinical benefits. CORT108297, a second-generation glucocorticoid receptor antagonist with no affinity for the PR and is being tested in Veterans with PTSD as part of a Phase IIa clinical trial. Veterans with PTSD are a result of two separate trials, designed, double-blind, placebo-controlled Phase IIa clinical trial to determine the effectiveness and safety of CORT108297-180 million mg daily for 7 days. In a two-site study, male and female Veterans between the ages of 18-69 who meet the requirements for new full syndrome PTSD will be enrolling. A final sample size of 88 participants over a 26-month enrollment window will be determined by a medically fit male and female Veterans with persistent PTSD who will be randomized CORT108297 or b placebo n=22 per site.

Source link: https://clinicaltrials.gov/ct2/show/NCT04452500


A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer

In patients with advanced non-small cell lung cancer who receive first-line systemic therapy, the feasibility and safety of long-term administration of two doses of a peripheral opioid receptor antagonist remain unclear. Patients randomly assigned to placebo or placebo will have less decline in health-related quality of life than patients randomized to placebo. Determine the difference in the adverse peripheral effects of opioid therapy between patients receiving naloxegol or placebo. Systemic therapy's adverse events and deaths related to systemic therapy's transition rate. To determine the difference in systemic therapy's discontinuation rate due to adverse events and deaths due to systemic therapy, visit www. v. com.

Source link: https://clinicaltrials.gov/ct2/show/NCT03087708


Phase 2 Study of Systemic IL-6 Receptor Antagonist ACTEMRA® (Tocilizumab) for the Treatment of Progressive/Recurrent Pediatric Adamantinomatous Craniopharyngioma

Adamantinomatous Craniopharyngioma is a chronic pediatric brain tumor that does not respond to drug therapy. We suspect that the IL6- receptor antagonist ACTEMRA will be safe and effective at inducing tumor formation in children with persistent ACP. Up to 38 patients will be treated with tocilizumab for pediatric Systemic Juvenile Arthritis in this research. It will be a multi-center Phase 2 trial for patients aged >1 year and 25 years with unresectable ACP who may have been treated with radiation or without radiation.

Source link: https://clinicaltrials.gov/ct2/show/NCT05233397

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions