Symptoms and General Pathology

All Conditions

Necrosis

All Drugs and Chemicals

Reproductive Control Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Gastrointestinal Agents

Glucocorticoids

Mifepristone

Etanercept

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Immunosuppressive Agents

Immunologic Factors

Contraceptive Agents

Contraceptives, Oral

Contraceptive Agents, Female

Contraceptives, Postcoital

Hormones

Hormone Antagonists

Contraceptive Agents, Hormonal

All participants will receive etanercept 50 mg weekly for 12 weeks. After completion of the etanercept course, participants will be randomized between two Arms of mifepristone. Participants randomized to Arm 1 will receive one week of mifepristone at 300 mg daily.

All participants will receive etanercept 50 mg weekly for 12 weeks. After completion of the etanercept course, participants will be randomized between two Arms of mifepristone. Participants randomized to Arm 2 will receive one week of mifepristone at 600 mg (2x300 mg) daily.

Amanpreet Cheema, PhD

Nancy Klimas, MD

Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal/joint pain. This phase I single-site, open-label two-arm study will assess the safety and mechanistic efficacy of a sequential etanercept-mifepristone intervention for Gulf War Illness. The results of this phase I study will be compared to those from an existing short-duration study to identify the optimal duration and dosage for use in a future phase II study.

This is a study in male Veterans 45-70 years of age who meet the modified Kansas and Centers for Disease Control and Prevention (CDC) criteria for GWI (Gulf War Illness) and have high physiologic stress. This phase I single-site, open-label, two-arm study will focus on optimizing the dosage of a sequential etanercept-mifepristone intervention for GWI. Twenty participants will be assessed at baseline, 6, 12, 13, 16 and 24 weeks. The investigators will use systems biology methods to perform computational modelling of physiological responses to supervised maximal exercise challenge studies on a fitness bicycle at baseline and 24 weeks. These analyses will assess the impact of the treatment on homeostatic networks: the changes in levels of physiological parameters and the changes in inter-correlations among the measured parameters (e.g., cytokines), cross-sectionally and over time. Participants will also undergo subjective assessments of functional health, symptom severity, pain, fatigue, and cognition at baseline, 6, 12, 13, 16, and 24 weeks. Participants will be observed through the treatment period and for 3 months after completion to assess immediate effects and durability of the response.

The results of this phase I study will be compared to those from an existing short-duration study to identify the optimal duration and dosage for use in a future phase II study.

TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset

Tumor Necrosis Factor (TNF) and Glucocorticoid Antagonist for Gulf War Illness (GWI)-Associated Multi-symptom Disease Homeostasis Reset

The plan is to release primary results from the study to ClinicalTrials.gov. Data are the property of Nova Southeastern University, but data and publication thereof will not be unduly withheld. Those interested in E/M data should reach out to Nancy Klimas (PI) for more information.

Safety is assessed by the incidence and severity of adverse events, by relation to the study intervention.

Mechanistic effects on biomarker network dynamics are measured by the change in median summary score for network-level distance between the Gulf War Illness biomarker profile at rest and model-predicted stable (healthy) states. These summary scores have a minimum value of zero and reflect the overall difference between the multidimensional relationships of the immune, autonomic, and neuroendocrine systems of ill participants at rest, relative to predicted values for stable (healthy) states. The analysis will be completed using the results of physical measures and biomarker assays performed on blood draws taken at rest prior to exercise challenges at baseline and 16 weeks. These include a Gulf War Illness-specific nanostring gene expression platform, an 18-multiplex cytokine assay, flow cytometry, neuropeptide, sex and stress hormone panels, and physical autonomic measures. Decreases in summary scores between baseline and 24 weeks indicate a better outcome.

The degree of correction of the homeostatic network toward normal is measured by the median summary score for network-level differences in connectivity of biomarker networks at multiple times during dynamic exercise challenges. These summary scores have a minimum value of zero and reflect overall changes within the immune, autonomic, and neuroendocrine systems during exercise, relative to predicted values for stable (healthy) states. The analysis will use the results of physical measures and blood draws taken before, during, and after exercise challenges at baseline and 24 weeks. The biomarker assays and physical measures include a Gulf War Illness-specific nanostring gene expression platform, an 18-multiplex cytokine assay, flow cytometry, neuropeptide, sex and stress hormone panels, and physical autonomic measures at multiple times during each exercise challenge and 24 hours afterward. Decreases in summary scores between baseline and 16 weeks indicate a better outcome.

RTI International

Miami VA Healthcare System

Nova Southeastern University

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Diabetes Mellitus

Hypertension

Chronic Disease

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Respiratory Tract Diseases

Disease Attributes

Lung Diseases, Obstructive

Chronic Graft Versus Host Disease

Nicotine

Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking

Family-supported

Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions

Standard Telephone counseling

Lori Anne Bastian, MD MPH

The overarching aim of the study is to evaluate in a randomized trial the impact of a family-supported intervention compared to a standard veteran-focused telephone counseling control group to promote smoking cessation among cancer and heart disease patients.

ANTICIPATED IMPACT(S) ON VETERAN'S HEALTHCARE:

Veterans with chronic disease who continue to smoke exact a significant burden on the VA health care system. Effective smoking cessation programs, that target veterans who continue to smoke after the diagnosis of a smoking-related chronic illness, are needed.

BACKGROUND/RATIONALE:

Chronic diseases related to tobacco exposure are common among veterans. Persistent tobacco use after being diagnosed with these diseases decreases quality of life and survival. Yet, 30% of veterans with these conditions continue to smoke. Researchers have found that the social environment is important for smokers. In our current NCI-funded study, 70% of veterans with lung cancer identified at least one family member who smokes and 45% live with a family member that smokes. A family-supported smoking cessation intervention timed to follow a veteran's diagnosis of cancer or heart disease could be effective for helping veterans quit smoking.

OBJECTIVES:

The overarching aim of the study is to evaluate in a randomized trial the impact of a family-supported intervention compared to a standard veteran-focused telephone counseling control group to promote smoking cessation among cancer and heart disease patients.

AIM 1: To evaluate the impact of a family-supported intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 2 weeks, and 12-month post-treatment follow-ups.

Hypothesis 1: Abstinence rates will be significantly higher among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.

AIM 2: To evaluate the impact of a family-supported intervention on perceived support for quitting 2 weeks and 12-month post-treatment follow-ups.

Hypothesis 2: Perceived support for quitting smoking will be significantly greater among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.

AIM 3: To measure the impact of a family-supported intervention on quality of life in veterans 2 weeks, and 12-month post-treatment follow-ups.

Hypothesis 3: Symptom-related quality of life will be significantly greater among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.

METHODS: Proposed is a two-group design in which 470 veterans who smoke will be randomized to receive:

STANDARD TELEPHONE COUNSELING control including a letter from a VA physician encouraging the patient to quit smoking, nicotine replacement (if not contraindicated), a self-help cessation kit, and 5 standard telephone counseling calls; or FAMILY-SUPPORTED intervention that includes all components of the control arm plus a Family-supported intervention that includes a support skills booklet and an additional telephone counseling protocol focusing on social support. .

Family-supported Smoking Cessation for Chronically Ill Veterans

Family-Supported Smoking Cessation for Chronically Ill Veterans

self-reported 7-day point prevalent abstinence

self-reported 7- day point prevalent abstinence

US Department of Veterans Affairs

Family-supported smoking cessation

Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking

Arm 1

Standard smoking cessation

Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions

Arm 2

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Dr. Lori Bastian

The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention

The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up

Family-supported Smoking Cessation

Standard Smoking Cessation

Overall Study

Neoplasms

Digestive System Diseases

Colorectal Neoplasms

Adenoma

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Colonoscopies performed at a VA facility with computer assisted detection (CADe) artificial intelligence available.

Colonoscopies performed at a VA facility without CADe artificial intelligence available

Computer-aided polyp detection system that utilizes artificial intelligence (AI) during colonoscopy

Computer Assisted Detection

Jason A. Dominitz, MD, MHS

The purpose of this study is to evaluate the effect of artificial intelligence systems used during colonoscopy on the detection of precancerous polyps in the colon.

Colonoscopy is a key diagnostic and therapeutic procedure for the prevention of colorectal cancer incidence and mortality. Central to colonoscopy's effectiveness is the identification and removal of colorectal neoplasia, including adenomatous polyps and sessile serrated lesions. The endoscopist's adenoma detection rate (ADR), classically defined as the proportion of screening colonoscopies in which one or more adenomas are detected, has been demonstrated to be strongly inversely associated with their patients' risk of post-colonoscopy colorectal cancer. Therefore, improving adenoma detection is a major target of quality assurance efforts.

In 2022, the FDA approved the first artificial intelligence (AI) system for computer assisted detection (CADe) of colorectal neoplasia (also known as colorectal polyps). These CADe devices project an image on the endoscopy monitor (i.e., a bounding box) to alert the endoscopist to the presence of a suspected polyp within the colon. Initial studies, including randomized controlled trials, have demonstrated that use of CADe systems result in a significant improvement in adenoma detection, with a reduction in the miss rate of adenomas (i.e., fewer adenomas are found on a second colonoscopy when the first colonoscopy was performed with a CADe system compared to when the first colonoscopy did not use CADe). However, more recent studies have not demonstrated a clear benefit of these devices. Moreover, most of the additional adenomas that are detected are diminutive polyps, the vast majority of which are thought to be of minimal, if any, clinical significance. When multiple adenomas are detected during colonoscopy, current guidelines recommend repeating colonoscopy sooner than would otherwise be recommended. Also, the CADe systems may have unintended consequences, such as creating alert fatigue through false alarms or negatively impacting training of gastroenterology fellows.

As part of ongoing quality assurance efforts, the Veterans Health Administration's (VHA) National Gastroenterology and Hepatology Program (NGHP) purchased over 100 Medtronic GI Genius CADe devices in late 2022. As funds were not available to supply the CADe systems to all VHA medical centers, these devices were allocated to randomly selected medical centers across the United States.

With the introduction of the CADe devices within the VHA, the NGHP will evaluate the quantitative and qualitative impact and outcomes of use of CADe within VHA medical centers. The NGHP has built a colonoscopy quality dashboard that reports adenoma detection rates for facilities and individual endoscopists at VHA medical centers. For select medical centers, additional quality metrics are also available (e.g., colonoscope withdrawal time, adenomas per colonoscopy, polyps per colonoscopy).

Using these data, outcomes will be compared within facilities (i.e., pre- vs. post-CADe) and between facilities (i.e., facilities with CADe vs. facilities without CADe). Endoscopists at medical centers with CADe devices will be surveyed and interviewed about their use of and satisfaction with these devices.

The initial evaluation will compare outcomes at the facility level. Subsequent analyses will compare outcomes at the individual endoscopist level.

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

Change in the adequacy of bowel preparation during colonoscopy using either the Boston Bowel Prep Scale (0-9, where 9 is best) or the Aronchick Scale (Poor to Excellent)

Change in the proportion of colonoscopies in which one or more adenomas are detected

Change in the duration of colonoscope withdrawal when no intervention (e.g., polypectomy, biopsy) is performed

Change in the duration of colonoscope withdrawal irrespective of interventions

Change in the number of adenomas detected per colonoscopy

Change in the proportion of colonoscopies where one or more adenomas are detected

Change in the number of polyps detected per colonoscopy

Provider ratings of satisfaction with the CADe device

Change in the proportion of colonoscopies where colorectal cancer is detected

VA Salt Lake City Health Care System

San Francisco Veterans Affairs Medical Center

VA Puget Sound Health Care System

Executive Director, National Gastroenterology and Hepatology Program

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Lung Neoplasms

Neoplasm Metastasis

Breast Neoplasms

Melanoma

Carcinoma, Renal Cell

Brain Neoplasms

Kidney Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

CALM optimally consists of six individual sessions of 45 to 60 minutes, delivered over a three- to six-month period. CALM sessions address four broad and interrelated domains found to be important and relevant in this population: (1) symptom management and communication with healthcare providers, (2) changes in personal relationships, (3) sense of meaning and purpose, and (4) the future, hope and mortality.

Treatment as usual (TAU) for managing distress in brain cancer involves being provided a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.

The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.

CALM

Treatment as usual includes a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.

Treatment as usual

Giuliana Zarrella

Ashlee Loughan, Ph.D

Ashlee Loughan, Ph,D

The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.

CALM: Managing Distress in Malignant Brain Cancer

Managing Distress in Malignant Brain Cancer - Phase IIc RCT

Percent of interested individuals who undergo screening

Percent of eligible individuals who consent to the trial

Percent of consented individuals who complete the CALM intervention

Percent of consented individuals who complete post-intervention questionnaires

Percent of consented individuals who complete follow-up questionnaires

Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).

Percent of participants who would recommendation CALM to others will be assessed during the exit interview (e.g., Would you recommend this program to others?)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset	NCT04254627	Gulf War Illnes...	Etanercept Mifepristone	45 Years - 70 Years	Nova Southeastern University
Family-supported Smoking Cessation for Chronically Ill Veterans	NCT00448344	Chronic Disease Neoplasm Cardiovascular ... Pulmonary Disea... Diabetes Mellit... Hypertension	Family-supporte... Standard Teleph...	18 Years -	VA Office of Research and Development
Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation	NCT05888623	Colorectal Neop...	Computer Assist...	-	VA Puget Sound Health Care System
Family-supported Smoking Cessation for Chronically Ill Veterans	NCT00448344	Chronic Disease Neoplasm Cardiovascular ... Pulmonary Disea... Diabetes Mellit... Hypertension	Family-supporte... Standard Teleph...	18 Years -	VA Office of Research and Development
CALM: Managing Distress in Malignant Brain Cancer	NCT06180460	Brain Tumor Brain Metastase... Brain Cancer Metastatic Lung... Metastatic Brea... Metastatic Mela... Metastatic Colo... Metastatic Kidn...	CALM Treatment as us...	18 Years -	Virginia Commonwealth University

Spots Global Cancer Trial Database for veterans

Every month we try and update this database with for veterans cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for veterans

Every month we try and update this database with for veterans cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for veterans cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.