Treatment Trials

20 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness
Description

This unblinded Phase II clinical trial will test the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners will have had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness will be randomized to either six months of biweekly acupuncture treatments (group 1, n=100) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=100). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).

COMPLETED
Acupressure for Pain Management and Fatigue Relief in Gulf War Veterans
Description

This study will provide symptomatic veterans with acupressure treatment and determine its effectiveness in fatigue relief and pain management for Gulf War Illness (GWI). Investigators plan to recruit patients reporting symptoms of GWI through the Department of Veterans Affairs (VA), and randomize them into acupressure group (to receive acupressure treatment) and control group (to receive Reiki treatment). The acupressure treatment, twice per week for 6 weeks, will be offered by a licensed acupressure practitioner. Evaluations will be made before and after treatment (at 6 weeks). Clinical outcomes will be compared between groups (acupressure group vs. control group) and between different timepoints (before treatment vs. after treatment) within the same group. The results of this study may provide useful information to develop more effective treatment for veterans with GWI disease. Since acupressure treatment is of Asian origin and has shown excellent promise within its Eastern traditions, if successful, this study has the potential to produce a paradigm shift in clinical practice to more effectively relieve the symptoms of veterans with GWI disease. Meanwhile, as a non-invasive therapeutic massage, acupressure may lend to better patient acceptance and ultimately, greater clinical accessibility. Hypotheses 1. Acupressure besides routine clinical care will produce a more complete fatigue relief and pain alleviation in veterans with GWI versus routine clinical care plus reiki treatment. 2. EEG measures will exhibit a positive change when fatigue is relieved and pain is alleviated for symptomatic veterans after effective treatment.

COMPLETED
Gulf War Illness Nasal Irrigation Study
Description

The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with Gulf War Illness.

COMPLETED
Acupuncture in the Treatment of Gulf War Illness
Description

This unblinded Phase II clinical trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n=52) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n=52). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P).

COMPLETED
Mindfulness-Based Stress Reduction for Gulf War Syndrome
Description

This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at equivalent time points for veterans randomized to TAU only. Following completion of all study activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.

COMPLETED
Treatment Study of Carnosine Versus Placebo in Gulf War Illness (GWI)
Description

The purpose of this study is to perform a randomized double-blind, placebo-controlled, 12 week study of the effects of carnosine on cognitive, psychometric, autonomic, and muscle strength outcomes in 100 GWI subjects.

COMPLETED
Exercise and Behavioral Therapy Trial (EBT).
Description

This trial is a study of Gulf War era veterans who have unexplained chronic medical symptoms such as pain, fatigue, and/or cognitive difficulties. The treatments to be studied, cognitive behavior therapy (CBT) and aerobic exercise, have been shown to be effective in alleviating symptoms in individuals with other similar types of illnesses, such as chronic fatigue syndrome and fibromyalgia. This is a Phase 3, 2X2 factorial designed study. All study participants are assigned to one of four treatment groups - CBT and aerobic exercise, aerobic exercise alone, CBT alone or usual and customary care. This study durations is 28 months; 1092 participants were enrolled and will be followed in clinic at 3, 6 and 12 months after enrollment.

COMPLETED
Antibiotic Treatment of Gulf War Veterans' Illnesses
Description

In 1990 and 1991, the U.S. deployed approximately 700,000 troops to the Persian Gulf to liberate Kuwait from Iraqi occupation. While there were few casualties associated with the Gulf War, many individuals returned from this conflict with unexplained symptoms and illnesses. This constellation of symptoms has been termed Gulf War Veterans' Illnesses (GWI). Although several explanations have been offered as to the cause of GWI, none of the putative etiologic agents or conditions is currently supported by sufficient evidence. One explanation that has received fairly widespread attention is systemic Mycoplasma fermentans infection. It is the purpose of this study to determine if antibiotic treatment directed against Mycoplasma species (i.e. doxycycline) will improve functioning and symptoms in deployed Gulf War veterans with GWI.

COMPLETED
Investigate Olfactory Functioning as a Possible Proxy for Neurotoxic Exposure in Cohorts of Deployed and Non-Deployed Gulf War-Era Veterans.
Description

Significant subsets of military veterans have reported such health problems as headache, joint pain, fatigue, and memory/concentration difficulties subsequent to their participation in the Gulf War. However, the etiology remains controversial. A number of toxins have been implicated as etiologic factors for GW-related health problems; however, exposure levels have been difficult, if not impossible, to document retrospectively. These difficulties with exposure verification have led GW researchers to de-emphasize methods typical of neurotoxicological research examining exposure-symptom relationships and instead focus on epidemiological approaches emphasizing identification of coherent symptom patterns.

RECRUITING
Coenzyme Q10 for Gulf War Illness: A Replication Study
Description

The purpose of this study is to assess whether a high quality preparation of ubiquinone (coenzyme Q10) benefits symptoms, function, and quality of life in veterans with Gulf War illness.

UNKNOWN
Understanding GWI: Integrative Modeling
Description

The investigator proposes to perform a Phase I study assessing safety, efficacy, and biomarker response to the therapeutic interventions of Etanercept followed by mifepristone for veterans with Gulf War Illness. The investigator will conduct and repeat the exercise challenge before treatment and on therapy to assess the impact of the interventions on homeostatic regulation and the dynamic model identified in prior studies.

COMPLETED
Mitochondrial Cocktail for Gulf War Illness
Description

The purpose of this study is to develop preliminary evidence, such as effect size and variance estimates, to guide successful conduct of a properly-powered clinical trial to assess the benefit of a mitochondrial cocktail (incorporating individualization of treatment) in Gulf War illness (GWI).

COMPLETED
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
Description

An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).

COMPLETED
Exercise in Gulf War Illness (GWI)
Description

The purpose of this study is to determine if submaximal exercise by bicycle stress tests with pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days causes a higher level of "exertional exhaustion" in GWI compared to healthy veterans (HVets).

COMPLETED
Effects of Low Dose Naltrexone in Fibromyalgia
Description

Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom Illnesses, to assess the drug's efficacy in treating the condition.

RECRUITING
Resistant Potato Starch to Alleviate GWI
Description

Gulf War Illness (GWI) affects an estimated 25-32% of the over 700,000 coalition troops deployed to the Persian Gulf as part of the First Gulf War. GWI causes a range of pain, fatigue, gastrointestinal, skin, neurologic, and respiratory symptoms. New treatments to reduce GWI-associated morbidity are critically needed. Research suggests a role for the gastrointestinal microbiome in mediating health, including through impacting metabolism and immunity. The disruption of this microbiome plays a role in multiple diseases, and preliminary data suggest that Veterans with GWI have altered gut microbiota. The investigators will evaluate the effectiveness of a dietary fiber prebiotic supplement intervention on improving the quality of life of Veterans with GWI.

COMPLETED
Mechanisms of Mitochondrial Defects in Gulf War Syndrome
Description

The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the "power plants" of the body. Mitochondria take the food you eat and break the food down into a form of energy that the body can use. The investigators propose that Gulf War Syndrome is determined by a complex interaction of factors that interfere with mitochondrial function. This study will be the first investigation of mitochondrial function in Gulf War Syndrome. The investigators objective is to establish the cause for symptoms in affected veterans, develop testing that can more easily identify Gulf War Syndrome, and ultimately develop treatment protocols for Gulf War Syndrome.

WITHDRAWN
Gulf War 1 Veteran Healthcare Satisfaction
Description

The purpose of this study is to investigate Gulf War 1 Veteran (GW1V) patient perceptions of, and satisfaction with, their VA primary care treatment, and physician effectiveness in delivering improved point of service, in the Primary Care Clinics at the Veterans Administration (VA) Salt Lake City Health Care System.

COMPLETED
Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms
Description

The purpose of this study is to investigate clinical benefits of a novel sleep-focused mind-body program on Gulf War Illness (GWI) symptoms.

COMPLETED
Study of Gulf War Illness (GWI) by Comparing GWI and Healthy Veterans
Description

Determine if: * genetic differences of CNDP1 gene * the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid proteome contents * psychometric * other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms and those without these complaints.