Treatment Trials

46 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees
Description

Quality improvement project with the aim to use a standardized assessment tool (EMR-STAT) to establish learning curves and competence thresholds for key cognitive and technical colorectal EMR core skills among advanced endoscopy trainees (AETs).

COMPLETED
The Effect of Immediate Versus Delayed Debriefing on Basic Life Support Competence In Undergraduate Nursing Students.
Description

The goal of this clinical trial is to find out if immediate (hot) or delayed (cold) debriefing is better for undergraduate nursing students during Basic Life Support (BLS) training. The study aims to: * Identify the effect of hot versus cold debriefing in BLS training for nursing students. * Identify which debriefing method students prefer. Researchers will compare the two debriefing methods. Participants will: * Be randomly assigned (by flipping a coin) to either hot or cold debriefing. * Take part in a simulation about Basic Life Support.

COMPLETED
Developing Resilience Skills and Social Competence in Youth in a School Setting
Description

Our study aimed to answer the question: Can a resilience-based intervention improve the psychosocial and educational outcomes of students with psychosocial difficulties? We examined the effectiveness of a resilience-based group intervention, the Resilience Builder Program® (RBP), with students in low-SES school settings to determine if this treatment improves psychosocial and educational outcomes.

ACTIVE_NOT_RECRUITING
First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum
Description

The goal of this clinical trial is to learn about the feasibility and acceptability of a behavioral intervention in designed to provide sexual education and improve the behavioral skills of autistic adults for intimate relationships. The main questions it aims to answer are: * Acquire feasibility and acceptability data for delivery of the CRUSH curriculum in a group didactic setting plus 1-1 coaching. * Acquire feasibility and acceptability data regarding the assessment battery for future clinical trials. Participants will complete: * A screening call. * Provide documentation of a diagnosis of autism spectrum disorder. * 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing). * 15-20 training sessions to participate in the CRUSH curriculum. After each session, provide feedback about the session.

COMPLETED
The Effect of Simulation-based Training on Confidence and Competence in Obtaining Vitals in a Child With Autism
Description

The objective is to evaluate the efficacy of an online learning module combined with high fidelity simulation-based training in improving medical assistants' and registered nurses' self-confidence and competence scores in taking vital signs in a child with Autism Spectrum Disorder in clinic. The study will explore the efficacy of high-fidelity simulation which has not been studied to date as a training modality for teaching healthcare workers about Autism Spectrum Disorder. The investigators will also evaluate patient encounter data to provide insight into trainees' transformation of knowledge into clinical practice. The hypothesis is that nurses and medical assistants who participate in an online learning module combined with simulation-based training will demonstrate improved self-confidence and competence scores in evaluating children with Autism.

COMPLETED
Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop
Description

Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos. Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.

RECRUITING
Prospective 4D CTA of BAV Competence
Description

The study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5 years. CTA is often standard of care for BAV patients, but patients in this study will receive a higher radiation dose with a 4D imaging protocol. There may also be patients enrolled in the study who have a 4D CTA for research purposes when a routine CTA is not required for clinical care.

Conditions
COMPLETED
Enhancing Social Competence in Adults With Autism
Description

SENSE Theatre®, combines several well-documented, effective behavioral strategies, such as the inclusion of trained peer models, theatre play techniques involving predictable (i.e., scripted) and flexible (improvised) role-play, and repeated performance of newly learned skills resulting in greater automaticity of behavior. The intervention has the potential to enhance social cognition and behavior in adults with autism spectrum disorder.

COMPLETED
Investigating the Impact of A Veteran-Focused Parenting Program on Parenting Stress, Competence and Parenting Practices
Description

Veterans or spouses of veterans with a minor child will participate in a five-week parenting program. The goals of the parenting program are to assist in improving parent's sense of competence, improving parent's emotional regulation abilities, and lower parental stress by incorporating mindfulness and values-based parenting principles. The program will utilize evidence-based practices that will be delivered in a manner that incorporates aspects of military culture (i.e., language and concepts are tailored to that used within military culture). Mindfulness and acceptance and commitment therapy have been shown to be effective in treating service members \[1\], and this will be the first study that examines how learning these principles do or do not impact parenting stress, competence, and practices. The parenting program is free, and is offered by the investigators as a community service. Participation in the parenting program does not obligate enrollment in the research study.

COMPLETED
Comparative Effectiveness Research to Improve the Health of Sexual and Gender Minority Patients Through Cultural Competence and Skill Training of Community Health Center Providers and Non-clinical Staff
Description

The primary goal of this PCORI proposal is to evaluate the impact of enhanced provider and clinical staff training to address the health disparities of SGM CHC patients to ultimately improve their health outcomes because CHCs are a key part of the U.S. health care delivery system for underserved populations. The current application proposes to test an intervention designed to understand how CHCs, including front line staff and safety net clinical providers, can identify and provide optimal care for their SGM patients, and will determine whether enhanced training of CHC staff in best practices for the provision of primary care for SGM patients will improve their clinical outcomes. The time is right for routinization of SOGI measures in EHRs and evaluation of the optimal methods to train primary care providers in the best practices for the care of SGM patients.

COMPLETED
Investigating Social Competence in Youth With Autism
Description

Our treatment, SENSE Theatre, combines several well-documented, effective behavioral strategies and theatre techniques. The proposed project will extend previous findings showing improving improvement in memory for faces. The multisite randomized control trial will include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage Together).

COMPLETED
Mitochondrial Activity of Cumulus Cells From the Cumulus-oocyte Complex and Oocyte Competence
Description

The need for non-invasive biomarkers of oocyte competency has become urgent as women increasingly delay attempts at childbearing. The aging process is complex and includes impaired mitochondrial dysfunction, oxidative stress, diminished metabolic activity, and activity of several cell-signaling systems. Cumulus cells form an intimate association with the oocyte in the follicle, and they can have a significant impact on oocyte meiotic and developmental competence. In the IVF lab, the clump of cumulus cells is typically cut away from the oocyte immediately after an oocyte retrieval procedure, and then the cumulus cells are discarded. Measuring the mitochondrial respiratory activity of cumulus cells may serve as a non-invasive biomarker for oocyte competency and a predictor of reproductive success in IVF patients in the future.

Conditions
COMPLETED
Blood Donor Competence, Autonomy and Relatedness Enhancement
Description

The purpose of this study is to determine whether enhancing blood donor competence, autonomy, and/or relatedness increases intrinsic motivation to donate and improves donor retention.

Conditions
COMPLETED
Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients
Description

Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the effects of immunosuppression which is necessary to prevent rejection of the transplanted organ. However, transplant patients are less likely to produce antibodies when vaccinated and when they do, the peak and duration of antibody responses are reduced compared to healthy controls. There are considerable differences in the magnitude of these responses, reflecting variability in individual responses to the influenza vaccine and to the immunosuppression regimen. The investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression will have post vaccine immune responses that are comparable to age and gender matched healthy controls.

Conditions
COMPLETED
Treatment of Social Competence After Traumatic Brain Injury
Description

The aim of this study is to determine the effectiveness of holistic group treatment program (called Group Interactive Structured Treatment, or GIST) to improve social communication skills for individuals with Traumatic Brain Injury. Hypothesis: Compared to an alternative intervention, those receiving the GIST intervention will show improved social competence, improved quality of life, and stronger group cohesion.

COMPLETED
Improving Asthma Outcomes Through Cultural Competence Training for Physicians
Description

The proposed randomized clinical trial will compare two educational interventions: Physicians Asthma Care Education (PACE) and PACE Plus with 90 physicians in Atlanta and the Bronx and their 1192 patients.

Conditions
TERMINATED
Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction
Description

This study will look at how pacing your heart may assist your daily activities and how you are feeling.

Conditions
COMPLETED
The Use of Bacteriophage Phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo
Description

The objective of this study is to evaluate the safety and utility of bacteriophage phi X174 immunization as a tool to assess the immune competence of HIV-infected patients at different stages of disease in vivo, and to assess the impact of viral load levels and therapy-induced changes in viral load levels on the response to immunization with the neo-antigen bacteriophage phi X174. Bacteriophage phi X174 immunization is a method that has been in use for more than 25 years to assess the immunity of patients with various types of primary and secondary immunodeficiencies, including 48 HIV-infected patients. This is a prospective open-label, controlled study which will enroll 39 HIV-infected patients and 13 healthy volunteers, male or female with 18 years of age and over. The HIV-infected patients will be divided into 3 groups according to their CD4 cell count: less than 200 cells/mm(3), between 200 and 500 cells/mm(3) and greater than 500 cells/mm(3). After screening and a two week pre-study evaluation, all eligible participants will receive a primary, secondary and tertiary immunization with 2 x 10(9) PFU/kg of bacteriophage phi X174 six weeks apart. Patients who present with detectable levels of viral load at entry will be offered a more effective antiviral drug regimen. Patients will have to be on a stable antiviral regimen for at least one month prior to receiving the primary immunization. Patients will return for visits 1, 2 and 4 weeks after each immunization for clinical and laboratory evaluations. The study endpoints are: safety (as measured by incidence of adverse events, CD4 cell count and HIV plasma RNA), kinetics of bacteriophage clearance following primary immunization, quantitation of bacteriophage phi X174 specific antibody titers following primary, secondary and tertiary immunizations and determination of qualitative and quantitative antibody isotype switching following secondary and tertiary immunizations.

Conditions
COMPLETED
Quantifying the Influence of Expert Modeling
Description

The purpose of this study is to learn more about the effects of various types of simulation preparation methods on novice nurses' competence and self-efficacy. Participants will be recruited from an academic course (N424 Integrated Practicum). Participants will be randomized to three intervention groups (i.e. expert modeling video, voice over PowerPoint, and traditional readings). All participants will complete self-efficacy surveys and two simulations. During simulation, participants will be scored based on their competence according to a performance rubric. The hypothesis is that participants in the expert modeling group will demonstrate more change in competence and report more change in self-efficacy scores than participants in other groups.

TERMINATED
Effects of ACT OUT! Social Issue Theater on Youth and Adolescents
Description

The ACT OUT! Trial is designed as a proof-of-concept, cluster, randomized, superiority trial with two parallel groups. Although the unit of measurement is student, the unit of randomization is classroom, stratified by school. For each grade, an even number of classrooms will be selected from each school; half of the selected classrooms will be randomly assigned to intervention arm, whereas the other half will be assigned to control arm. This way, sociodemographic and school-level factors will be made approximately comparable between intervention and control arms.

COMPLETED
Teachers Thriving Together
Description

This is a randomized, controlled, hybrid implementation-effectiveness design.whose primary aim is to examine the impact of ParentCorps plus Thrive Professional Learning, relative to Thrive Professional Learning and Inspire Professional Learning alone, on teachers' classroom teaching (knowledge, beliefs, skills and practice related to family engagement and social emotional learning) and teachers' social emotional development. The study also aims to understand the impact of Thrive Professional Learning versus Inspire Professional Learning alone on teachers and classrooms.

COMPLETED
Construct Validity, Responsiveness, and Demographic Predictors of the IAPCC-SV
Description

There are three purposes for this study: I. to establish the construct validity (via factor analysis) of the Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals - Student Version (IAPCC-SV) II. to determine the responsiveness of the IAPCC-SV III. to investigate demographic predictor variables of the IAPCC-SV It is hypothesized that: I. the variables will load on only one component, with each component being represented by a number of strongly loaded variables II. the IAPCC-SV will demonstrate responsiveness, evidenced by significantly higher post-module IAPCC-SV scores of the experimental group when compared to the control group III. the cultural composite score and race will be significant predictors of IAPCC-SV score

NOT_YET_RECRUITING
Increasing Kindergarten Social-Emotional Skills for Positive Long-Term Mental Health
Description

The goal of this clinical trial is to learn if the Social-emotional Skills for Thriving and Relating at School (SSTRS) Program can help children entering kindergarten and their families. The main questions it aims to answer are: 1) Do children who participate in SSTRS have better social-emotional skills and mental health? and 2) Do parents who participate in SSTRS have more positive parenting skills and involvement in their children's learning? Researchers will compare the SSTRS Program to the regular kindergarten curriculum without SSTRS to see if being in SSTRS helps children to have better mental health and parents to have better parenting skills. Kindergarteners will have daily SSTRS lessons in their kindergarten classes for 8 weeks. Their parents will watch videos and attend group meetings with other parents and answer questions about their own and their children's behaviors and mental health

RECRUITING
The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Description

This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.

ACTIVE_NOT_RECRUITING
Well-being in Students and Teachers Study
Description

The goal of this randomized trial is to test the effectiveness of two universal classroom-based mindfulness social and emotional learning (SEL) programs (one for students and one for teachers) by examining behavioral outcomes on 5th and 6th grade students and their teachers. The main questions it aims to answer are: * What are the singular and combined effects of a mindfulness-based SEL education programs for teachers and their students on the development of students' and their teachers' social, emotional, and cognitive competence, and well-being? * Can mindfulness-based SEL education programs for students and teachers foster the creation of caring, inclusive, equitable, and collaborative classroom contexts? * Can mindfulness-based SEL education programs support the development of students' and teachers' prosocial attitudes, mindsets that positively impact student learning? * Are the effects durable beyond the end of the programs with regard to the singular and combined mindfulness-based SEL interventions? A total of 24 classrooms will be randomized into one of three study conditions: 1. Mindfulness SEL program for Educators only 2. Mindfulness SEL program for Educators and Mindfulness SEL program for Students in combination, and 3. "Business as usual" (comparison groups in which regular classroom SEL curricula is implemented). Data will be obtained via multiple objective and subjective methods (e.g., self- and teacher-reports, peer behavioral assessments) from different sources (e.g., self-, peer-, and teacher-reports). Data will also be collected to monitor implementation of the two programs. To explore the ways in which these two programs impact student, teacher, and classroom outcomes, data will be analyzed to compare students and teachers in the three conditions. In Phase One (year one), the investigators will conduct an experimental "outcome" study to examine the singular and combined effects of the two programs by comparing pre-test and post-test measures across the three conditions. In Phase Two (year two), the investigators will conduct a six-month follow up with those teachers and students who participated in Phase One in order to determine the degree to which the program effects are durable after the program has ended.

UNKNOWN
Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students
Description

The team aims to develop and test the efficacy of a serious mental illness (SMI) and suicide ideation and attempt (SIA) stigma reduction intervention for medical students. The team expects that after intervention exposure, relative to control group, participants in the experimental condition will manifest more favorable change in knowledge, attitudes, and behaviors.

COMPLETED
Mindful Kala: Virtual Bharatanatyam Wellness Program for Students
Description

In the current study, the researchers propose to develop and pilot test a Bharatanatyam (i.e. Indian classical dance) program called Mindful Kala with the hopes of decreasing stress and increasing psychosocial well-being, mindfulness, cultural competence, and connectedness amongst a group of college students. The investigators hope that this program can help students cultivate well-being during the challenging and stressful time of COVID-19.

ENROLLING_BY_INVITATION
Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19
Description

The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.

ACTIVE_NOT_RECRUITING
Social Experiences of Adolescents and Young Adults With Cancer
Description

Participants are being asked to take part in this clinical trial, a type of research study, because investigators want to learn more about the social experiences adolescents and young adults who are being treated or have been treated for cancer. Primary Objectives * Describe differences in social experience variables (peer connectedness, perceived social competence, parent versus peer attachment) based on treatment status: on versus off therapy. * In on-therapy patients, describe differences in social experience variables (peer connectedness, perceived social competence, parent versus peer attachment) based on developmental stage: high school versus post-high school. Secondary Objectives * Assess the social support and peer interaction needs of AYA with cancer as a means of determining stakeholder interest and need for psychosocial interventions targeting social experiences. * Using qualitative interviews, explore patient perceptions of the impact of cancer on social experiences among AYA, particularly with regards to changes in friendships as a result of the cancer diagnosis and the role of the hospital in helping or hindering friendship maintenance/development. Exploratory Objectives * Explore differences in social experience by demographic, disease and treatment factors, including: gender, diagnostic category (brain tumor, leukemia/lymphoma, solid tumor), late effects/symptom burden, and treatment (e.g., treatment intensity, serious medical events). * Explore associations between perceived impact of cancer and social experience in AYA. * Explore associations between use of social media and social experience. * Explore associations between social experiences and overall functioning (quality of life, distress, coping). * Explore the possibility of subclasses of AYA by using person-centered analyses to empirically derive profiles of social experience.

UNKNOWN
Social Intelligence Training for Custodial Grandfamilies
Description

This study is a randomized clinical trial designed to compare an online social intelligence intervention with an active control condition at improving the emotional, physical, and social well-being of custodial grandmothers and their adolescent grandchildren,