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NCT ID: NCT04266353 Withdrawn - Chemoprevention Clinical Trials

Effect of Resveratrol on Serum IGF2 Among African American Women

Start date: April 24, 2019
Phase: N/A
Study type: Interventional

African American (AA) women with breast cancer (BC) have higher mortality and are associated with worse outcomes when treated with available adjuvant treatments. Addressing this survival disparity will depend on identifying contributing biologic factors that can be translated into new treatments. Preclinical studies have shown that Insulin-like growth factor-II (IGF-II)expression was significantly higher in AA cell lines and tissue samples when compared to Caucasians indicating that IGF-II is an important biologic factor contributing to higher breast cancer mortality in AA women and is also responsible for chemoresistance in BC cells. In addition preclinical studies also demonstrated that resveratrol (RSV) inhibits IGF-II and induces apoptosis in BC cell lines. Researchers want to test IGF-II levels at baseline in healthy African American women and monitor levels while on resveratrol therapy for 6 weeks.

NCT ID: NCT04266314 Withdrawn - Pregnancy Related Clinical Trials

Maternal Marijuana Use and Fetal and Infant Outcome

Start date: April 10, 2019
Phase:
Study type: Observational

Marijuana and cannabis-containing products are growing in popularity and availability in the United States, and use during pregnancy has increased dramatically. The overarching aim of this proposal is to provide pilot data for a submission which will explore the impact of chronic maternal marijuana use (primary or secondary) on fetal functioning, maternal reflective functioning and infant birth and neurodevelopmental outcomes. Chronically marijuana using pregnant women in treatment at the Center for Addiction and Pregnancy will be enrolled and asked to provide information about participants' marijuana and other licit and illicit substance use and feelings about parenting and participants' infant and undergo fetal monitoring at 36 weeks gestation. The neonates will undergo neurobehavioral examination during the first and fourth weeks of life.

NCT ID: NCT04262895 Withdrawn - Clinical trials for Posttraumatic Stress Disorder

TTI-0102 for Veterans With TBI

Start date: October 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Traumatic brain injury (TBI) is a signature wound of the recent wars. How chronic TBI symptoms develop after a mild brain injury is not fully understood, but it is now thought that injury results in damage that reduces brain energy production, increases inflammation, and results in a leaky blood-brain barrier. Difficulties in daily function may persist in areas such as thinking (e.g., attention, learning, memory, planning, and problem-solving), pain (e.g., headache) and behavior (e.g., sleep, posttraumatic stress disorder, depression). No medications for TBI have been developed, so evidence-based cognitive rehabilitation interventions such as Compensatory Cognitive Training (CCT) are the mainstay of treatment. The investigators are proposing to study a medication, TTI-0102, that shows anti-inflammatory activity, as a potential adjunct treatment with CCT for Veterans with TBI-related symptoms. The investigators plan to first determine the best dose of TTI-0102 to use, and then to conduct a pilot study to test the feasibility and acceptability of combining TTI-0102 with CCT in Veterans with mild to moderate TBI and PTSD.

NCT ID: NCT04260776 Withdrawn - Clinical trials for Tobacco Use Disorder

Adaptive Treatment Strategies for Improving Engagement With a Web-Based Smoking Intervention in Socially Anxious Smokers

Start date: April 15, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial will use a pilot sequential multiple assignment randomized trial (SMART) to examine protocol feasibility and acceptability of new components of a web-based intervention for socially anxious smokers. This study will be used to help build an adaptive treatment strategy to improve engagement with and effectiveness of the web-based intervention. Adaptive treatment strategies provide individualized sequences of intervention components to accommodate the changing needs of individuals based on their characteristics, treatment response, or engagement.

NCT ID: NCT04259190 Withdrawn - Anxiety Sensitivity Clinical Trials

A Comparison of Treatment Rationales on Willingness to Tolerate Distress in Interoceptive Exposure

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

The purpose of the current study is to examine the effect of emphasizing values in the treatment rationale on treatment response, willingness to tolerate distress, and acceptability of a one-session interoceptive exposure intervention for the reduction of anxiety sensitivity. A standard treatment rationale without values emphasis will serve as a control.

NCT ID: NCT04259060 Withdrawn - Ulcerative Colitis Clinical Trials

Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission

HARBOUR
Start date: January 2024
Phase: Phase 2
Study type: Interventional

This is a 4-week pilot, multicenter, randomized, double-blinded placebo controlled trial of hydroxocobalamin and butyrate in ulcerative colitis (UC) that will occur in two phases. The main objectives of this study are to determine the capacity of hydroxocobalamin and butyrate to reduce calprotectin in those with inflammatory disease in UC to determine the safety and preferential dose of hydroxocobalamin with butyrate in UC.

NCT ID: NCT04258969 Withdrawn - Colorectal Cancer Clinical Trials

Pedaling at a Low-Moderate Intensity During Chemotherapy Administration

Start date: December 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility of completing a low-moderate intensity pedaling session concurrent to chemotherapy treatment for colorectal cancer. Secondary objectives for this study consist of evaluating the role of pedaling on sarcopenia rates, quality of life markers, chemotherapy side effects, rate of hospital admissions, and treatment delays.

NCT ID: NCT04258852 Withdrawn - Clinical trials for Electronic Cigarette Use

Understanding Factors That Influence Electronic Cigarette Nicotine Delivery Through PET Imaging of Beta-2 Nicotinic Acetylcholine Receptors

Start date: December 30, 2022
Phase: N/A
Study type: Interventional

The goal of this proposal is to test the overall hypothesis that e-cigarettes (ECs) provide efficient nicotine delivery to the brain and arterial blood in non-EC-naïve smokers and e-cigarette users and that EC liquid characteristics modulate this effect. This study will test the hypothesis through complementary methods that include [ [18F]NCFHEB (aka [18F]Flubatine) PET neuroimaging, arterial blood nicotine measurements, and subjective drug effects assessments.

NCT ID: NCT04257435 Withdrawn - Clinical trials for Traumatic Brain Injury

The Utility of Positive Psychology in Military TBI Rehabilitation

Start date: September 2019
Phase: N/A
Study type: Interventional

Service members and veterans (SMVs) report more persisting symptoms following traumatic brain injury (TBI) compared to civilian populations (Ommaya, Ommaya, Dannenber, & Salazar, 1996). Therefore, it is important to utilize interventions that reduce psychological impairments and increase resiliency during military TBI rehabilitation. Unlike traditional behavioral health treatments that focus on reducing maladaptive behaviors and negative thoughts, positive psychological treatments focus on increasing positive emotions to increase well-being. There is substantial growing evidence demonstrating that cultivating positive emotions is preventative and improves resiliency and psychological (Bolier et al., 2013; Sin & Lyumbomirsky, 2009), cognitive (Estrada, Isen, & Young, 1997; Ashby & Isen, 1999; Isen & Daubman, 1984; Isen, Daubman, & Nowicki, 1987; Fredrickson & Branigan, 2001), and health outcomes (Pressman & Cohen, 2005). This study will examine the effectiveness of traditional behavioral health treatment versus behavioral health treatment with an added positive psychological group treatment in terms of psychological, cognitive, and health outcomes during TBI rehabilitation. The hypothesis is that SMV's with TBI will experience improved outcomes with added positive psychological treatment compared to traditional behavioral health treatment alone. There will be about 100 people taking part in the study, randomly assigned to either a traditional behavioral health treatment group or an alternative behavioral health treatment group (therefore, up to 50 people will be enrolled in each) at the Fort Belvoir Intrepid Spirit Center over a period of 30 months. Study participants will be randomly assigned to groups, and over 3 months the study procedures include participating in group behavioral health treatment and/or individual behavioral health treatment and completing pre/post-treatment questionnaires focusing on psychological, cognitive, and health outcomes. The behavioral health intervention has not been well-studied; thus, the behavioral health intervention is considered experimental for the treatment of psychological symptoms. Additionally, the impact on other areas of functioning (i.e., cognitive functioning and overall health) is currently unknown.

NCT ID: NCT04256148 Withdrawn - Clinical trials for Warm Autoimmune Hemolytic Anemia

ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia

Start date: July 2021
Phase: Phase 2
Study type: Interventional

The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).