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NCT ID: NCT04861896 Completed - Quality of Life Clinical Trials

A Research Study for Latina Women With Breast Cancer

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

The purpose of this study is to examine the feasibility and preliminary efficacy of a psychosocial eHealth intervention designed to improve hormone therapy adherence among Hispanic/Latinx women with breast cancer. Our proposed secondary outcomes are health-related quality of life and self-efficacy in managing hormone therapy side effects. The intervention components include breast cancer knowledge, hormone/endocrine therapy knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over a 12-week period. All participants will receive the intervention application (described below). Aside from using the Smartphone application for the recommended 12 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 12-week follow-up.

NCT ID: NCT04861792 Completed - Clinical trials for Alcohol Use Disorder (AUD)

Michigan SPARC Trial

MI-SPARC
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Unhealthy alcohol use is a major contributor to morbidity and mortality in the US. Although effective prevention for unhealthy alcohol use and medication treatment for alcohol use disorders (AUDs) can be provided in primary care (PC), they have historically not been included in routine services. As a result, most patients do not receive evidence-based prevention or treatment for unhealthy alcohol use. Several efforts have successfully implemented alcohol-related preventive care-referred to as screening and brief intervention (SBI), but efforts to increase treatment of AUDs with medications have been less successful. Moreover, implementation efforts have usually neglected smaller PC practices, in which most PC is provided. The Michigan SPARC trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, bringing extensive expertise implementing evidence-based alcohol-related care, and Altarum Institute in Ann Arbor, Michigan, bringing demonstrated success engaging over 500 small to medium Michigan-based PC practices in effective quality improvement (QI) efforts. The project builds on Altarum's innovative approach to implementing new or improved clinical care using practice facilitators to provide continuing medical education and maintenance of certification (CME/MOC) programs to PC providers, along with ongoing support for QI using evidence-based implementation strategies. The KPWHRI team recently finished the highly successful AHRQ-funded Sustained Patient-centered Alcohol-Related Care (SPARC) trial using similar implementation strategies in KP Washington, including use of electronic health records and performance monitoring and feedback, and also developed a patient decision aid to support shared decision-making between patients with high-risk drinking and/or AUDs and their PC providers. The Michigan SPARC trial combines Altarum's expertise in QI in small-medium PC practices in Michigan with KPWHRI's expertise implementing evidence-based prevention and treatment of unhealthy alcohol use-specifically alcohol SBI and medication treatment for AUDs. Specific Aims of the Michigan SPARC trial had to be markedly modified due to the trial beginning in March 2020 at the same time as the COVID pandemic. A trial was not possible. The revised aims were to describe alcohol screening, brief intervention, AUD diagnosis and initiation of medication treatment for AUD, before and after the Michigan SPARC model was implemented, in small to medium PC practices in Michigan.

NCT ID: NCT04861597 Completed - Ulcerative Colitis Clinical Trials

Digital Behavioral Interventions in Inflammatory Bowel Disease

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

Given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.

NCT ID: NCT04861324 Completed - Type 2 Diabetes Clinical Trials

Effects of a Lifestyle Intervention on Gestational Diabetes Management

Start date: April 28, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.

NCT ID: NCT04860999 Completed - Postural; Defect Clinical Trials

The Ability of Osteopathic Structural Evaluation to Assess Gait

Start date: August 15, 2017
Phase: N/A
Study type: Interventional

Movement and loading asymmetry have been associated with injury risk for a variety of both acute and chronic musculoskeletal injuries. In addition, asymmetric movements have been identified as compensatory strategies to allow for ambulation in a variety of post-operative populations. Osteopathic physicians have been assessing both structure and function through the use of structural evaluation techniques along with postural assessment that can identify somatic dysfunction. However, no studies have identified the ability of an osteopathic structural evaluation and postural assessment to identify potential movement disorders and loading asymmetry. Therefore, the primary objective of this study is to determine the acute impact of an osteopathic manipulation on restoration of side-to-side symmetry during walking gait in participants who are categorized as having lower extremity dysfunction. We enrolled 51 participants who are pain-free and without a history of major orthopaedic injuries that required surgical intervention. Each subject completed an osteopathic structural evaluation and postural assessment along with an osteopathic manipulation. All participants completed instrumented gait analyses before and after the osteopathic manipulation using a motion capture system and an instrumented treadmill to determine the participant's movement and loading asymmetry during walking.

NCT ID: NCT04860986 Completed - Clinical trials for Autism Spectrum Disorder (ASD)

A Repeatability and Reproducibility Study of the EarliPointâ„¢ Device

RnR
Start date: May 7, 2021
Phase:
Study type: Observational

The study is a prospective randomized repeatability and reproducibility (R&R) study of the EarliPoint DeviceTM in pediatric subjects 16-30 months of age. The study will enroll subjects who are both clinically-positive and clinically-negative for ASD. The study will be conducted at a single center in the US. The Study consists of a screening period in order to review the subject's medical history to determine subject eligibility, followed by a device administration period during which subjects will undergo testing with the EarliPoint Devices and Expert Clinician Diagnosis (ECD) procedures to determine if they are clinically-positive or clinically-negative for ASD.

NCT ID: NCT04860869 Completed - Covid19 Clinical Trials

Endocrine, Metabolic and Microbiome Influence on the Post COVID-19 Syndrome

Start date: May 12, 2021
Phase:
Study type: Observational

The aim of this study is characterize the endocrine, metabolic and microbiomes of patients with post-COVID syndrome and patients that have recovered from COVID without lingering symptoms.

NCT ID: NCT04860856 Completed - Femur Fracture Clinical Trials

Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial

Start date: August 17, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.

NCT ID: NCT04860804 Completed - Pain Clinical Trials

A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain

Start date: April 22, 2021
Phase: Phase 4
Study type: Interventional

Acute Pain is one of the most frequent chief complaints and the main reason for visiting the Emergency Department (ED). The acute pain in the ED is largely prevalent across the country with recent literature demonstrating that 61-91% of patients are admitted to the ED due to a variety of acute painful syndromes. There is a lack of good options for pain control in such settings.

NCT ID: NCT04860713 Completed - Pain Clinical Trials

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

Start date: April 22, 2021
Phase: Phase 4
Study type: Interventional

Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache. Most headaches managed in the ED are benign, with 90% of these headaches classified as tension, migraine, or cluster. At present, the satisfaction with ED treatment of headache is low, and despite the multitude of available medications, the evidence- based treatment options are often quite limited. There are over twenty different types of medications available to the ED clinicians for managing headache, many with different routes of administration (parenteral, intranasal, subcutaneous, and oral). Many of these medications are provided in so-called "headache cocktail", which varies based on the physician, institution, and patient preferences.