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NCT ID: NCT05453201 Active, not recruiting - Long COVID Clinical Trials

Developing an Integrative, Recovery-Based, Post-Acute COVID-19 Syndrome (PACS) Psychotherapeutic Intervention

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Post-Acute COVID-19 Syndrome (PACS), colloquially known as Long COVID, is a prevalent phenomenon that affects thousands of Veterans in VA care. VA patients suffering from Long COVID not only experience lingering physical symptoms following COVID-19 infection, but have increased mental health problems including sleep disorders, anxiety disorders, trauma and stress-related disorders as well as increased use of opioid and non-opioid pain medications, antidepressants, and sedatives to treat these conditions. Developing recovery-oriented care, "a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential" is a VA priority, however available Long COVID treatments primarily target symptom relief and are not designed to promote the recovery and rehabilitation of Veterans in a mental health context. Long COVID Coping and Recovery (LCCR) is a promising manualized, recovery-focused psychotherapeutic group intervention which aims to improve psychological adjustment to Long COVID symptoms, promote resilience, and facilitate coping, based on established psychotherapeutic techniques such as skills training, acceptance-based and identity-based principles. The investigators will assess rates of recruitment, intervention engagement, and session attendance (feasibility), Veteran satisfaction (acceptability), treatment adherence (fidelity) and preliminarily explore response to Long COVID Coping and Recovery (LCCR). Findings will be used to make a final adaptation of the treatment materials and to develop a research protocol for a large scale RCT of LCCR for Veterans with Long COVID. This study will pilot test a well-specified, group-based intervention tailored to the unique needs of Veterans with Long COVID. The results of the proposed study will provide data to 1) identify adaptations needed to optimize LCCR for Veterans with Long COVID; 2) identify possible benefits of LCCR; 3) inform development of a large scale RCT of LCCR for Veterans with Long COVID.

NCT ID: NCT05453110 Active, not recruiting - Low Back Pain Clinical Trials

Does Self-efficacy Predict Outcomes Among U.S. Military Academy Cadets During Initial Entry Training?

Start date: July 4, 2022
Phase: N/A
Study type: Interventional

Background: Lower back injuries are a common occurrence in athletes, sports programs, and in the military (Bengtsson, 2018; Lovalekar, 2021). The Army's new fitness test includes a three-repetition maximum deadlift, and this inclusion has raised concern amongst servicemembers and healthcare workers due to the association between deadlifts and lower back injuries. There is debate amongst researchers about the role of deadlift form in lower back injury prevention, specifically related to flexion of the spine (Sjoberg, 2020). Purpose: The purpose of this study is to investigate the effect of low back pain education (either cautionary regarding injury risk or reassuring regarding spine resiliency) on deadlift performance (weight lifted), and if this education has an effect on self-efficacy and perceived spine vulnerability. Participants: Participants will be incoming new cadets at the United States Military Academy (USMA). Inclusion criteria are cadets age 17-26 (cadets under the age of 18 are legally emancipated therefore able to consent), those participating in the ACFT, and speak and understand English. Study Design: This study will be a randomized controlled trial with parallel design and 1:1 allocation ratio. The investigators plan to use cluster randomization. There will be three groups- control, cautionary, reassuring (Jackson, 2005). The investigators are also planning a prospective cohort study to assess self-efficacy, injury, and performance over time. Procedures: Data will be collected at the United States Military Academy during the summer of 2022 during cadet basic training. Shortly after new cadets arrive at USMA, the investigators will gather demographic and initial self-efficacy information. The randomized control element of this study will occur before and during the maximum deadlift (MDL) of the Army Combat Fitness Test (ACFT). At the start of cadet basic training, investigators will randomly allocate each company of cadets into one of three groups (three companies per group.) The investigator will administer the education (cautionary, reassuring, or control) shortly prior to cadets taking the MDL, and will collect results after the ACFT. The cautionary education is similar to standard information provided to many servicemembers before the start of an ACFT or a maximum deadlift.

NCT ID: NCT05453006 Active, not recruiting - Cervical Cancer Clinical Trials

HPV Self-Sampling in Somali Women

Isbaar
Start date: February 20, 2023
Phase: N/A
Study type: Interventional

This study plans to assess the effect of implementing HPV self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old Somali women who are due for cervical cancer screening.

NCT ID: NCT05451849 Active, not recruiting - Colorectal Cancer Clinical Trials

A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

Start date: June 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.

NCT ID: NCT05451641 Active, not recruiting - Clinical trials for Endothelial Function

Blood Flow Restriction Resistance Training Intervention on Vascular Function

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of blood flow restriction (BFR) resistance training on vascular function. The investigators aim to compare the effects of different BFR devices (wide-rigid cuffs and narrow elastic bands) on vascular function. The investigators hypothesize that BFR resistance training with wide-rigid cuffs might have a minor negative effect (short-term and reversible) on vascular function, while BFR resistance training with narrow-elastic bands may improve vascular function. Both training methods are equally effective in increasing muscle strength.

NCT ID: NCT05451017 Active, not recruiting - Marijuana Abuse Clinical Trials

The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers

Start date: January 4, 2023
Phase: Phase 1
Study type: Interventional

Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority. The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. In the 3 early studies conducted with AEF0117, AEF0117 was administered orally after a light breakfast. AEF0117 showed a good bioavailability and favorable, dose-proportional pharmacokinetics . In this protocol, the effects of food on AEF0117 bioavailability in healthy volunteers will be investigated by comparing the rate and extent of AEF0117 when 1 mg AEF0117 is administered in fed state versus fasting state. The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This trial will provide data on the effect of food on the oral bioavailability of AEF0117 to support the next stage of the clinical development of the drug.

NCT ID: NCT05450965 Active, not recruiting - Clinical trials for Small-cell Lung Cancer

Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Start date: July 19, 2022
Phase: Phase 2
Study type: Interventional

This phase II clinical trial will study the safety and efficacy of onvansertib to treat patients with small cell lung cancer (SCLC) who have either not responded to or are unable to tolerate chemotherapy. Onvansertib is a drug that inhibits polo-like kinase 1 (PLK-1), an enzyme that is over-expressed in many cancer cells and is involved in cellular repair.

NCT ID: NCT05450692 Active, not recruiting - Clinical trials for Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

LATIFY
Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

NCT ID: NCT05450536 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Self-Advocacy Training for Autistic College Students at a Public University

ACS
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Cases in autism spectrum disorder (ASD) have dramatically risen over the past 30 years, with the current rate of 1 in every 44 (Maenner et al., 2021) children born with the condition. Much emphasis rests on the need for various interventions, practices, and therapies during childhood to improve quality of life and success across a variety of settings. Nonetheless, as they age, all children advance through the education system and eventually leave the school system. Consequently, it should not be surprising that these children must grow up and face realities after high school. For some, this may include residential placements, living at home with family members, or working part or full time. For others, this comes in the form of postsecondary education. However, many individuals with autism might not be prepared to handle the requirements future education entails. As stated in articles by Chiang et al. (2012) and Blackorby and Wagner (1996), persons with disabilities, regardless of type, do not have successful transitions after high school compared to individuals without disabilities-even with having access to many resources in school and the community. Barriers, therefore, exist that prevent successful outcomes for students with autism attending college and obtaining a postsecondary degree. Thus, there is a need to identify strategies that can be effective in assisting autistic adults in postsecondary education to succeed, both academically and socially.

NCT ID: NCT05449496 Active, not recruiting - Obesity Clinical Trials

Dietary Intervention to Improve Kidney Transplant Outcomes

Start date: June 27, 2022
Phase: N/A
Study type: Interventional

Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant