All clinical trials

This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants.

Recent studies indicated positive effects of mindfulness-based interventions (MBI) for schizophrenia (SCZ), but also on oxytocin (OXT) levels in healthy persons. It was also shown that response to MBI could be shaped by genetic factors. However, the interplay between mindfulness and empathy and genetic factors with the oxytocinergic system has not yet been examined in SCZ. The aim of the current explorative study is to (1) explore the effect of mindfulness-based group therapy (MBGT) on OXT levels as well as empathy in persons with SCZ; (2) investigate whether polygenic risk scores (PRS) for empathy can predict empathy levels in persons with SCZ; (3) investigate whether PRS for empathy and specific genetic configurations in the oxytocin receptors are associated with MBGT outcomes and OXT levels; 4) examine changes in positive- and negative symptoms, depression, anxiety, social functioning, and mindfulness at a within-group level and between both conditions. A parallel-group, proof-of-concept randomized controlled trial with 30 participants allocated to each trial arm (N = 60) will be conducted. Participants will be randomly assigned to MBGT alongside treatment as usual (MBGT+TAU) or treatment as usual (TAU). For a treatment period of four weeks, participants will receive weekly MBGT sessions. Four weeks after baseline assessments (T0), post-intervention assessments (T1) will take place. As a pilot study, effect sizes will be estimated for within- and between-group effects with corresponding confidence intervals. Outcomes of our proof-of-concept study can provide insight into potential biological mechanisms underlying mindfulness in SCZ, determine a valid biomarker associated with empathy and negative symptoms and pave the way for a personalized treatment approach for individuals with SCZ.

Many individuals with serious mental illness have difficulty accurately interpreting interpersonal cues and effectively engaging in social exchanges. Difficulties related to the interpersonal aspects of work can lead to isolation, poor productivity, and job loss. The goals of this study are to: 1) adapt an evidence-based social cognitive skills intervention for work settings and use with Veterans, 2) examine the acceptability of the work focused skills training intervention, 3) assess the feasibility of combining the social cognitive skills training program with supported employment, and 4) examine change on functional outcomes. The current study will use feedback from veteran and employment specialist stakeholders to adapt an evidence-based social cognitive skills training program, Social Cognition and Interaction Training (SCIT). The intervention will be modified to tailor it to work relationships and to address any unique relationship concerns among Veterans that are identified by stakeholders. SCIT-Work Edition (SCIT-WE) will add: 1) education about work-related social norms; 2) examples of work-related social interactions that require perspective taking and problem- solving; 3) individual sessions with the study therapist to enhance learning and relevance to each participant's goals; 4) structured interactions with the participant's employment specialist to practice skills outside of group; and 5) skill application sessions with the participant's employment specialist that prompt use of skills after training is completed. SCIT-WE will be developed and piloted in an open trial with 20 Veterans enrolled in the supported employment program at the Minneapolis VA who have a qualifying serious mental illness diagnosis. SCIT-WE will be offered for 2 hours weekly over 13 weeks, when most participants are in the job development and job search phases of supported employment. While participating in the group skills training, participants will have weekly, individual homework review sessions with the group facilitator to promote understanding of the skills and to discuss relevance of the skills to personal goals. Participants also will practice skills weekly with their employment specialist for 10-15 minutes to promote use of skills outside of group sessions. In the 3-months following skills training completion, participants will complete 10 15-minute skills review sessions with their employment specialist to encourage continued skill application in a work setting. Participants will complete assessments at baseline, before receiving the intervention; 3-months post-enrollment, after participating in a weekly skills training group; and 6-months post-enrollment, after receiving 10 additional individual skills review sessions with their employment specialist. Accessibility will be measured with rate of treatment uptake, rate of treatment completion, and participant attitudes toward the intervention. Feasibility of the intervention will be assessed by examining retention in supported employment and the study at 3- and 6-months post-enrollment. Impact of the intervention will be examined with measures of quality of life, social adjustment, self-efficacy, and work relationship quality. It is hypothesized that the intervention will be acceptable to Veterans. The investigators predict a 50% treatment uptake rate, a 70% intervention completion rate, and positive ratings on measures of satisfaction, interest, and value. The investigators hypothesize that it will be feasible to complete this intervention in combination with supported employment activities. The investigators predict that retention in both skills training and supported employment will be 75% at 3-months post-enrollment and 60% 6-months post enrollment. The investigators hypothesize that positive change will be seen at 3-months post-enrollment and sustained at 6-months post-enrollment on measures of quality of life and social adjustment. The investigators predicted that self-efficacy regarding return to work will be improved at 3-months post-enrollment. The investigators predict that Veterans will report being productive and having positive work relationships 6-months post-enrollment. The findings will inform the development of a novel intervention targeting the social and functional impairments associated with serious mental illness. The knowledge gained from this study will guide the development of the next generation of interventions. Given that employment is a critical part of recovery, advancement in therapeutic interventions that support Veterans in this process will be of significance.

Since the introduction of sepsis bundles, there have been multiple published trials that have demonstrated a consistent, strong association between implementation of sepsis "bundles" (3-hour bundle) and improved survival. The current proposal is a Hybrid 2, pragmatic, cluster randomized clinical effectiveness/implementation trial evaluating mortality and respiratory failure-based outcomes, in patients admitted to the emergency department with sepsis, comparing the effectiveness of implementation of the hour-1 bundle to 3-hour bundle, while facilitating adherence to both bundles. In addition, 4 distinct sepsis phenotypes will be derived from routine clinical data to identify specific patient phenotypes that allow for a more precision-based application of sepsis bundles in future studies.

This study is a Randomized, Double-Blind, Placebo-Controlled Trial. The objective of the study is to assess the effect of doxycycline in levodopa treated Parkinson's disease patients regarding motor performance and cognitive functions. Parkinson's disease patients on levodopa medications will be assigned to receive doxycycline 50mg twice daily or placebo over 8 weeks. The motor and cognitive symptoms of Parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.

Autism spectrum disorder (ASD) is a pervasive and lifelong developmental disorder that currently affects 1 in 54 children. Individuals with autism are often severely impaired in communication, social skills, and cognitive functions. Particularly detrimental characteristics typical of ASD include the inability to relate to people and the display of repetitive stereotyped behaviors and uncontrollable temper outbursts over trivial changes in the environment, which often cause emotional stress for the children, their families, schools and neighborhood communities. To date, there is no cure for ASD, and the disorder remains a highly disabling condition. Recently, transcranial direct current stimulation (tDCS), a noninvasive neuromodulation technique, has shown great promise as an effective and cost-effective tool for reducing core symptoms, such as anxiety, aggression, impulsivity, and poor social communication, in patients with autism. Although the empirical findings in patients with ASD are encouraging, it remains to be determined whether these experimental data can be translated into real-world benefits. An important next step is to better understand the factors affecting the long-term efficacy of tDCS treatment - in particular, the possible risk factors associated with relapse in patients with ASD and the role of booster session tDCS as an add-on treatment to induce long-lasting neuroplastic effects in ASD.

Peripheral neuropathic pain is a disabling chronic pain condition that is difficult to treat. Repetitive transcranial magnetic stimulation (rTMS) to the motor cortex is a treatment method with growing evidence in its ability to alleviate neuropathic pain. This also applies to new deep rTMS coils which permits stimulation of larger cortical areas and with deeper penetration. The aim of this study is to investigate the analgesic efficacy of 5 days of deep rTMS compared to sham stimulation. We will also assess effects of deep rTMS on sleep, psychological fatctors, everyday functioning, and executive functioning.

This is an open label, phase 1 clinical study to evaluate the safety and tolerability of different doses of QLH11906 monotherapy in patients with relapsed/refractory, unresectable locally advanced or metastatic advanced solid tumors with abnormal MAPK pathway, and determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD, if MTD cannot be determined) and Recommended Dose in Phase II Clinical Studies (Recommended Phase II Dose, RP2D).

This randomized, single blinded, clinical trial aims to investigate the efficacy of a multimodal pain control regimen for shoulder arthroplasty. Patients who receive a multimodal pain control regimen alone (study group) will be compared to patients who receive a multimodal pain control regimen plus a standard prescription of an opioid containing medication (comparison group). The primary outcome is average daily Numerical Rating Scale (NRS) pain score in the first 10 days after surgery. We hypothesize that there will be no significant difference in the primary outcome between the two groups.

This is the first clinical trial of IDRX-42. The study is designed to evaluate the safety, tolerability, PK, and preliminary antitumor activity of IDRX-42 in adult participants with advanced (metastatic and/or surgically unresectable) GIST.