Clinical Trials Logo

Filter by:
NCT ID: NCT04092101 Active, not recruiting - Clinical trials for Tobacco Use Disorder

Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder

Start date: September 18, 2019
Phase: Phase 2
Study type: Interventional

Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US adult population. The mortality rate of opioid-dependent smokers is four times that of opioid-dependent nonsmokers, and their response to smoking cessation interventions is notoriously poor. A national policy of reducing the nicotine content of cigarettes has the potential to be an effective method of reducing tobacco use prevalence, dependence, and related adverse health outcomes. Controlled trials in the general smoker population have demonstrated that switching smokers to low nicotine content cigarettes results in reductions in cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences. The investigators believe that the impact of reduced nicotine standards on use of combusted cigarettes in this population will be moderated considerably by other tobacco market conditions including (1) availability of alternative sources of non-combusted nicotine, and (2) whether these alternatives are available under conditions that optimize their appeal. The investigators hypothesize the same for other vulnerable populations as well, but achieving significant reductions in use of combusted cigarettes in smokers with OUD seems especially unlikely in the absence of readily available and appealing alternative sources of non-combusted nicotine. The goal of the proposed trial is to experimentally model whether increased availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) will enhance the effectiveness of a reduced nicotine standard for cigarettes in smokers with OUD. Additionally, the investigators will test whether allowing participants to personalize the favor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking. Daily smokers who are receiving methadone or buprenorphine treatment will be recruited at University of Vermont and Johns Hopkins University. The investigators will study two research cigarettes referred to here as RC1 and RC2. One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as EC1 and EC2. Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2. Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath [FeNO]).

NCT ID: NCT04091516 Active, not recruiting - Blood Pressure Clinical Trials

Feasibility & Implementation of a Plant-Based Weight-Loss Program in an Office-Based Setting

Start date: August 30, 2019
Phase: N/A
Study type: Interventional

This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.

NCT ID: NCT04091386 Active, not recruiting - Hemophilia A Clinical Trials

Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study)

LIFE-ACTIVE
Start date: June 10, 2021
Phase:
Study type: Observational

In this study researcher want to learn more about the change of physical activity of hemophilia A patients treated with damoctocog alfa pegol. Patients enrolled in this study will be wearing a small device measuring daily active time. Researcher will compare these physical activity data with patient's clinical data including bleeding events to gain information on how bleeding levels are related to the activity level of the patients. The study aims to enroll about 80 patients who are at the same time also participating in the HEM-POWR study (NCT03932201) evaluating the effectiveness and safety of damoctocog alfa pegol.

NCT ID: NCT04091048 Active, not recruiting - Clinical trials for Symptomatic Aortic Stenosis

Optimize PRO Study

Start date: September 16, 2019
Phase:
Study type: Observational

The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolutâ„¢ PRO and Evolutâ„¢ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.

NCT ID: NCT04091022 Active, not recruiting - Clinical trials for Non-melanoma Skin Cancer

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer

Start date: January 18, 2021
Phase: Phase 2
Study type: Interventional

This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of 1) topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non melanoma skin cancer/ keratinocytic cancers.

NCT ID: NCT04090879 Active, not recruiting - Clinical trials for Tobacco Use Disorder

Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

Start date: September 18, 2019
Phase: Phase 2
Study type: Interventional

While the prevalence of smoking in the United States general population has declined over the past 50 years, there has been little to no decline among people with mental health conditions. Affective Disorders (ADs) are the most common mental health conditions in the US, and over 40% of people with ADs are current smokers. A national policy of reducing the nicotine content of cigarettes has the potential to reduce tobacco use, dependence, and related adverse health outcomes. Controlled trials in psychiatrically-stable smokers have shown that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences. The goal of the proposed trial is to experimentally model whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effect of altering the nicotine in cigarettes in smokers with ADs. Additionally, investigators will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking. Daily smokers with current ADs will be recruited at Brown University and the University of Vermont. Investigators will study two research cigarettes referred to here as Research Cigarette 1 (RC1) and Research Cigarette 2 (RC2). One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as E-Cigarette Condition 1 (EC1) and E-Cigarette Condition 2 (EC2). Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2. Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath [FeNO]).

NCT ID: NCT04090723 Active, not recruiting - HIV Clinical Trials

Using CBPR to Engage Hazardous Drinking Women in the HIV Prevention and Care Continuum

Start date: September 14, 2021
Phase: N/A
Study type: Interventional

Unhealthy alcohol use among women with and at risk for HIV can interrupt critical steps in the HIV prevention and care continuum, is associated with HIV transmission risk behaviors, and contributes to health disparities. Thus it is critical to accurately identify alcohol use and implement alcohol interventions among women with and at risk for HIV to optimize health outcomes. The proposed pilot study will examine the implementation and effects of a computer delivered brief alcohol intervention with peer navigation/Community Health Worker compared to usual care on alcohol use, linkage to health services, and uptake of HIV prevention practices.

NCT ID: NCT04090619 Active, not recruiting - Clinical trials for Advanced Malignant Solid Neoplasm

Frequency of Cachexia in Ambulatory Cancer Patients and Psychological Burden in Patients and Their Primary Caregivers

Start date: June 22, 2021
Phase:
Study type: Observational

This trial studies the frequency of cachexia in ambulatory cancer patients and the psychological burden in patients and their primary caregivers who are referred to an outpatient supportive care clinic. Studying how often loss of appetite and/or unintentional weight loss (cachexia) occurs in patients seen in the supportive care clinic may help researchers develop new ways to lower stress in patients who suffer from loss of appetite and weight loss as well as their family caregivers.

NCT ID: NCT04090528 Active, not recruiting - Prostate Cancer Clinical Trials

pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer

Start date: October 21, 2019
Phase: Phase 2
Study type: Interventional

This trial will evaluate the use of one versus two DNA vaccines, delivered concurrently with PD-1 blockade using pembrolizumab followed by treatment with pembrolizumab alone, and delivered over a prolonged period of time (for a maximum of 2 years (32 cycles) or until radiographic progression) on the treatment of castrate-resistant, metastatic prostate cancer. The hypothesis to be tested is that delivering two vaccines with PD-1 blockade will elicit a greater frequency and magnitude of tumor-directed CD8+ T cells, and thereby increase the percentage of patients experiencing objective anti-tumor effect as measured by PSA declines and/or objective radiographic responses. Participants must be 18 years of age or older and can expect to be on treatment for 2 years (32 cycles) and on study for up to 4 years (including 2 years of follow up via phone).

NCT ID: NCT04090398 Active, not recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones

Start date: August 4, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well radium-223 dichloride and paclitaxel work in treating patients with advanced breast cancer that has spread to the bones. Radium-223 dichloride is a radioactive drug that behaves in a similar way to calcium and collects in cancer that has spread to the bones (bone metastases). The radioactive particles in radium-223 dichloride act on bone metastases, killing the tumor cells and reducing the pain that they can cause. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radium-223 dichloride and paclitaxel may work better in treating patients with metastatic breast cancer compared to paclitaxel alone.