Official Title AMC-111 Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study

Purpose

This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV quit smoking.

 

In this study, you will have lung cancer screening performed via a CT scan. You will also be enrolled into a self-guided smartphone-based HIV-specific smoking cessation intervention called “Positively Smoke Free - Mobile” lasting 42 days. After starting the intervention, you will be evaluated at 3, 6, and 12 months. 

Could this study be right for you?

Must have at least a 20 pack-year history of smoking (a way to measure how much a person has smoked over time, 1 pack-year is a pack per day for a year or 2 packs of cigarettes for half a year, etc.)

Must have not had a CT scan in the past 12 months

HIV positive, and must be receiving antiretroviral therapy and have a CD4 count of at least 200cells/uL within 6 months of enrolling in the study

Able to understand and provide informed consent

Possess a smart phone that can browse the web

Not receiving any other smoking cessation interventions currently or within the prior 30 days

Female volunteers cannot be pregnant, lactating, or breast-feeding

Age Range

45 - 80 years

Official Title LOWFLC Study: Addiction potential of low nicotine filtered little cigars

Purpose

Researchers from The Ohio State University are recruiting adult users of little cigars and cigarillos to help improve understanding of the products’ health impact.

Could this study be right for you?

• Current smoker
• No significant health problems

Age Range

21 - 75 years

Official Title Establishing Reference Values and Clinical Decision Points for Quantitative Videofluoroscopic Measures of Swallowing

Purpose

This study will help create healthy reference values clinicians can use to evaluate adult patients of all ages and is sponsored by the National Institute on Aging.  During this study, we will perform an x-ray swallowing exam and breathing tests with persons who do not have a personal history of swallowing problems or any disorders that could contribute to a swallowing problem.  Study participation will consist of a screening meeting (approximately 15 minutes) via phone call, video chat, or email to verify eligibility, and one in-person visit to our laboratory (approximately 1 hour).

Could this study be right for you?

• If you are biologically female and of child-bearing age (<63), you must not be pregnant or breastfeeding.
• No personal history of surgery or radiation therapy to the head or neck (mouth, jaw, neck, brain, nose, face, thyroid, throat, or voice box) other than having your tonsils, adenoids, or teeth removed.
• No personal history of cancer involving structures of the head, neck, spine, respiratory, or lymphatic system.
• No personal history of stroke or other progressive nerve disease.
• No current diagnosis or personal history of Chronic Obstructive Pulmonary Disease (COPD).
• No known allergies to barium.

Age Range

54 - 89 years

Official Title A prospective randomized unblinded study of ketogenetic versus mixed diet on exercise tolerance in subjects with the metabolic phenotype of heart failure with preserved ejection fraction

Purpose

The purpose of this study is to compare the effects of a well-formulated ketogenic diet with a low-fat diet on exercise tolerance in patients with diabetes or pre-diabetes or obesity; with shortness of breath or heart failure.

Could this study be right for you?

Inclusions:

• Age ≥ 18 years old and ≤ 80 years old & willingness to be randomized to either diet.
• NYHA class I – III for at least 3 months.
• Ejection fraction ≥40% by biplane 2D, or 3D echo, or CMR.
• Echo findings of abnormal or indeterminant diastolic function or RHC data: At rest: mean pulmonary capillary wedge pressure (PCWP) > 15 mmHg. Pulmonary vascular resistance (PVR) < 3 Wood Units.
• Stable medical therapy for at least 3 months as determined by the treating physician (no new cardiac or diabetic medications within 3 months of enrollment or during enrollment and dosage should be stable for 1 month prior to enrollment).
• Dose of oral diuretics changes allowed but must be stable for 1 week prior to randomization.
• Body Mass Index (BMI) ≥ 25 and ≤ 50 or Type 2 Diabetes Mellitus or prediabetes (fasting glucose of 100 - 125 mg/dL or hemoglobin A1C 5.7-6.4%) or metabolic syndrome.
• Ability to participate in exercise treadmill testing.
• Ability to sign written consent.

Exclusions:

• Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the study.
• Known allergy or sensitivity to gadolinium-based contrast agents.
• Implanted pacemaker, cardioverter defibrillator, Cardiac resynchronization therapy, left ventricular assist devices.
• Other metallic implants/aneurysm clips that are contraindicated in MRI.
• Claustrophobia
• History of severe kidney disease of eGFR < 30 ml/kg/1.73m2.

Exclusion Criteria varies, please contact Study Coordinator.

Age Range

18 - 80 years

Official Title Reducing exercise intolerance through inspiratory muscle training in obese breast cancer survivors (IMOCS)

Purpose

The purpose of this study is to better understand why some survivors of breast cancer have difficulty exercising. We also want to learn if breathing exercises can make it easier to tolerate exercise. 

Could this study be right for you?

• Breast Cancer Survivor
• Completed treatment within 6 months–5 years
• Have obesity, defined as body mass index between 30-50 kg/m2
• Can exercise independently

Age Range

18 years and up

Official Title The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function
in a High-Risk Cohort for Lung Cancer

Purpose

The purpose of the study is to examine the effects of exercise on long-term smokers in reducing lung cancer risk.

Could this study be right for you?

• Males and females aged 55 to 77 years old
• Current or former smokers with a 20-pack year smoking history (equals 1 pack a day for 20 years, 2 packs a day for 15 years, etc) and smoked within the last 15 years
• Sedentary Lifestyle: fewer than 60 minutes of participation in moderate intensity physical activity each
• Health Status: participants must be free of severe heart, respiratory (e.g. COPD), or systemic disease that would make moderate intensity exercise participation unsafe
• Not currently undergoing cancer treatment
• Not currently taking Immunosuppressants, bisphosphonates, steroids, or probiotics
• No plan to change smoking status

Age Range

55 - 77 years

Official Title A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)

Purpose

The purpose of this study is to see if benralizumab (biologic drug), given as injections under the skin, can help control your Hypereosinophilic Syndrome (HES) better if it is added to available standard of care HES medications which you may be currently taking. 

HES (Hypereosinophilic Syndrome) is a disease characterized by high levels of eosinophils (a particular type of white blood cell) in your blood and a build-up of eosinophils in some organs and tissues (like skin, heart, lungs, intestines or others) causing their dysfunction.

The duration of the study will last 18 months.

Could this study be right for you?

• Eosinophil (a type of white blood cells) count ≥ 1000 cells/μL at screening
• Documented diagnosis of Hypereosinophilic Syndrome (HES)
• History of persistent eosinophilia >1500 cells/μL (at least 2 examinations, interval ≥1 month)
• End organ manifestations attributable to the eosinophilia

Inclusion and Exclusion Criteria varies, please contact Study Coordinator for more information.

Age Range

18 years and up

Official Title [American Lung Association (ALA)] Lung Health Cohort (LHC) Study

Purpose

The purpose of this study is to examine why some people have better lung function than others as young adults during the period of peak lung health (ages 25 to 35 years old). The long-term goal of this study is to come up with ideas about how to promote the best possible lung function in young adults.

Participation in this study will be 4.5 years.

Could this study be right for you?

Inclusion Criteria:

• Men and women aged 25-35 years old at time of examination
• Able to read and understand English or Spanish
• Have a social security number

Exclusion Criteria:

• Severe asthma or other chronic lung disease
• Diagnosed cardiovascular disease
• History of cancer other than non-melanoma skin cancer
• Currently pregnant

Age Range

25 and up

Official Title A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

Purpose

RheOx (Gala Therapeutics, Inc.) is an investigational device designed to reduce cough and mucus production through a minimally-invasive procedure. The procedure is performed through a bronchoscope, a thin flexible tube that is inserted through the mouth into the lungs. Once in place, RheOx delivers short bursts of electrical energy to the inner walls of the bronchi, eliminating the mucus-producing cells. Over the next several days, new cells grow and produce less mucus. The right lung is treated first, followed by treatment of the left lung about 1 month later.

RheOx has been studied in three clinical trials and has shown a significant improvement in quality of life and a reduction in cough and mucus at 12 months.

Could this study be right for you?

You may be eligible if:

• You are at least 35 years of age.
• Have chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out
• You are receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization
• You have a cigarette smoking history of at least ten pack years.
• Other criteria that will be reviewed by the study team

You will not be eligible if you have:

• A known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
• A steroid-dependent condition requiring more than 10 mg of oral corticosteroid per day.
• Any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices).
• A history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, or sinus bradycardia with heart rate less than 45 beats per minute.
• Unresolved lung cancer.
• A pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
• Had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable.
• Asthma based on Global Initiative for Asthma (GINA) criteria.
• Smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
• Unable to walk over 238 feet in 6 minutes.
• Uncontrolled GERD.
• Had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation.
• A known allergy to nickel.
• Other criteria will be reviewed by the study team

Age Range

35 and up

Official Title A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)

Purpose

The purpose of this study is to determine the safety and effectiveness of a device called the RejuvenAir® System, developed for patients with chronic bronchitis. The primary objective of this trial is to demonstrate the safety and effectiveness of the RejuvenAir® System for the treatment of adult subjects with a diagnosis of CB defined as COPD with classic 3 months of cough and sputum production for a minimum of 2 years who demonstrate ongoing symptoms of cough and significant mucus production. You will be in the study for approximately 36 months, including the screening period.

Could this study be right for you?

Inclusion Criteria:

1. Males and females 40-80 years of age
2. Must demonstrate daily cough and significant mucus production
3. Have had a diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) for a minimum of two years. (CB is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded)
4. Smoking history of at least 10 pack years
5. Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study

Exclusion Criteria:

1. Have had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy
2. Diagnosis of Asthma
3. You have had any type of transplant procedure
4. Use e-cigarettes, vaping or inhaled substances not prescribed by a physician RejuvenAir® System
5. You are pregnant, nursing, or planning to get pregnant during study

* This is not a complete list of either inclusion or exclusion criteria

Age Range

40 and up