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Search Results Within Category "Prevention & Wellness"

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23 Study Matches

Pediatric Obesity Weight Evaluation Registry (POWER) Study (POWER)

All
up to 18 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02121132
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Inclusion Criteria:

• age 18 years or younger
• overweight or obese patient
• initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.
Exclusion Criteria:

• no exclusion criteria
Overweight, Obesity
Overweight, Obesity
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A Low Biologically Available Glucose and High Protein Diet for Treatment of Type 2 Diabetes Mellitus

Randomized clinical trial investigating the LoBAG diet versus a control diet for treatment of type 2 diabetes mellitus over a 3 month intervention period.

Anne Bantle
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02717078
1601M82501
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Inclusion Criteria:
18 years of age or older, Diagnosis of type 2 diabetes mellitus, Hemoglobin A1c of 7.0-9.5%, Taking no medications for diabetes or taking metformin
Exclusion Criteria:
Type 1 diabetes mellitus, Treatment with insulin, BMI < 25 kg/m^2, Change in weight of >5 lbs over the past 3 months, Estimated glomerular filtration rate (GFR) < 60 ml/minute/1.73 m^2, Urine albumin > 300 mg/g creatinine, Anemia, Pregnancy or immediate plans to become pregnant, Current breastfeeding, Use of antibiotics in the past 3 months, Some dietary restrictions
Other: Diet Therapy
Type 2 Diabetes Mellitus, Diabetes & Endocrine, Microbiota, Prevention & Wellness
Carbohydrate, Diet, Nutrition, Protein, Type 2 diabetes mellitus, dstudy, diet, carbohydrate, protein, glucose, type 2 diabetes mellitus, DSTUDY
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Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA (GABA)

The purpose of this study is to determine the effects of altered glucose metabolism on the brain. For example, patients with long duration diabetes mellitus lose their ability to secrete the hormones necessary to protect them against hypoglycemia, which may be due to alterations in glucose availability to the human brain.

All
18 Years to 65 Years old
N/A
This study is also accepting healthy volunteers
NCT02829593
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Inclusion Criteria:

• well controlled type 1 diabetes (hemoglobin A1c <7.5%)
• age 18-65
• healthy controls
Exclusion Criteria:

• history of stroke, seizures, neurosurgical procedures, or arrhythmias
• use of drugs that can alter GABA metabolism (such as benzodiazepines).
• Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.
Other: hypoglycemia (low blood sugar) and MRI
Type 1 Diabetes, Healthy
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Improving Outcome for Family Caregivers of Older Adults With Complex Conditions: The Adult Day Plus (ADS Plus) Program (ADS Plus)

To evaluate the efficacy of ADS Plus, a family-based intervention program, in 30 adult day service programs throughout the United States among 240 family caregivers over a 12-month evaluation period.

All
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02927821
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Inclusion Criteria:
Caregivers are eligible to participate at time of intake at an Adult Day Service (ADS) if they:
• are initially enrolling their relative in one of the 30 participating ADS sites
• expect to use ADS for a minimum of 1 week for 6 months
• have primary responsibility for care of the ADS client
• speak English
• provided > 8 hours of assistance to client in past week
• have a telephone and are willing to participate in 4 telephone interviews (baseline, 3 month check-in; 6 and 12 month follow-ups)
• are 21 years of age or older (male or female).
Exclusion Criteria:
caregivers and older adult clients are not eligible if:
• they plan to move from the area within 6 months
• either caregiver or client has been hospitalized >3 times in past year
• either caregiver or client is in active treatment for a terminal illness or are in hospice
• caregiver is involved in other caregiver support services/trials.
Behavioral: ADS Plus
Stress
Adult Day Care Centers, Caregivers
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Targeting emotional eating and weight loss in adolescents (a.k.a Families, Responsibility, Education, Support, Health for Teens (FRESH-TEEN Study) (FRESH-TEEN)

The two primary aims of the study are: -To evaluate the efficacy of PEER and BWL on the target adolescent’s weight over the 18 months of the study, and -To evaluate the efficacy of PEER and BWL on the target adolescent’s emotion regulation skills and emotional eating over the 18-months of the study.

Carol Peterson
All
13 Years to 16 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03674944
STUDY00003419
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Inclusion Criteria:

• Adolescent age 13-16 years
• BMI percentile 85%85%-99.9% (adolescent only)
• Ability to read English at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent)
Exclusion Criteria:

• Current enrollment in a weight management program (Child and Parent);
• Medication that is specifically prescribed for weight loss (Child and Parent);
• Medical or psychiatric condition that may interfere with treatment participation (Child and Parent);
• Regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (Child and Parent);
• Current pregnancy or lactating (Child and Parent);
• Change in psychotropic medication during the previous three months (Child and Parent).
Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER), Behavioral: Behavioral Weight Loss (BWL)
Overweight and Obesity
Overweight, Obesity, Overeating, Treatment, Body Mass Index, Intervention, Behavioral Treatment, Dialectical Behavior Therapy, Emotion Regulation
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Sleep SMART: Sleep for Stroke Management And Recovery Trial (Sleep SMART)

Investigator-initiated, phase 3 multicenter, prospective randomized open-, blinded-endpoint (PROBE) controlled trial to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure is effective for secondary prevention and recovery after stroke.

Kamakshi Lakshminarayan
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03812653
STUDY00006842
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Inclusion Criteria:

• TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.
Exclusion Criteria:

• pre-event inability to perform all of own basic ADLs
• unable to obtain informed consent from subject or legally authorized representative
• incarcerated
• known pregnancy
• current mechanical ventilation (can enroll later if this resolves) or tracheostomy
• current use of positive airway pressure, or use within one month prior to stroke
• anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
• severe bullous lung disease
• history of prior spontaneous pneumothorax or current pneumothorax
• hypotension requiring current treatment with pressors (can enroll later if this resolves)
• other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
• massive epistaxis or previous history of massive epistaxis
• cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
• recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure
• current receipt of oxygen supplementation >4 liters per minute
• current contact, droplet, respiratory/airborne precautions
Device: CPAP
Ischemic Stroke, Sleep Apnea, Sleep Apnea, Obstructive, TIA, Stroke, CPAP, Telemedicine, Home Sleep Apnea Test, Randomized Clinical Trial, Multicenter Trial
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Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1 (MINUTES)

All
18 Years to 60 Years old
N/A
This study is also accepting healthy volunteers
NCT03896425
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Inclusion Criteria:

• Ability to provide consent and comply with study procedures.
• Age 18 - 60 years old.
• Estimated IQ range within the range: 70 ≤ IQ ≤ 115.
• No Serious and Persistent Mental Illness (SPMI) or addictive disorder diagnosis as measured by the MINI (Mini International Neuropsychiatric Interview), or sleep disorder;
• Ability to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.
Exclusion Criteria:

• Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV).
• Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: The research team will utilize the CMRR Center's screening tools and adhere to the screening SOP during enrollment of all research participants in this protocol. The CMRR Center's screening tools and SOP are IRB approved under the CMRR Center Grant (HSC# 1406M51205) and information regarding screening procedures is publicly available on the CMRR website (CMRR Policies / Procedures).
Device: Transcranial direct current stimulation (tDCS)
Transcranial Direct Current Stimulation, Healthy
tDCS, cognitive training, functional connectivity, non-invasive brain stimulation
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Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in At-risk Older Adults (Exergames)

The purpose of this study is to examine the efficacy of a new low-cost Virtual Reality Cognitive Training (VRCT) combined with concurrent cycling intervention called exergame on improving cognition in at-risk community-dwelling older adults at risk for Alzheimer's disease and dementia. We will conduct this study in two phases: Phase I (Feasiblity Testing)aims: Aim1. Develop a prototype exergame that supports integrated, concurrent cycling and VRCT. Aim 2. Examine the feasibility of the exergame in older adults at risk for AD. Phase II (Effect Testing) aims: Aim 1. Develop a fully-featured version of the VRCT aspect of the exergame. Aim 2. Determine the efficacy of the exergame in older adults at risk for AD using an RCT. We hypothesize that cognitive improvement will be greatest for exergame subjects followed by cycling subjects, and least in control subjects. Aim 3. Assess the distraction effect of the concurrent VRCT in exergame on gains in aerobic fitness. We hpothesize that exergame subjects will achieve similar gains in aerobic fitness to cycling only subjects (difference is < 1 standard deviation).

All
65 Years and over
N/A
This study is also accepting healthy volunteers
NCT04311736
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Inclusion Criteria:

• Cognitive complaint (defines as answering yes to the question "Do you feel that your memory or thinking skills have gotten worse recently within the last 2 years?");
• Not engaging in aerobic exercise or cognitive training >2 days/week, 30 minutes a session in the past 3 months;
• Age 65 years and older;
• Written consent.
• Medical clearance to participate in a supervised exercise program
Exclusion Criteria:

• Resting heart rate > 100 or <50 beats/min with symptoms;
• Dementia or mild cognitive impairment (self-report, diagnosis, or scoring <26 on the Telephone Interview for Cognitive Status;
• Evidence that cognitive decline or memory complaints were caused by underlying neurological or psychiatric disorder or chemical dependency as determined by primary health care provider;
• Current enrollment in another intervention study;
• ACSM contraindications to exercise or other factors that make exercise impossible or unsafe.
Behavioral: Exergame, Behavioral: Cycling, Behavioral: Stretching
Mild Cognitive Impairment, Exercise Training
mild cognitive impairment, cognitive decline, aerobic exercise, physical exercise, exercise training, cognitive exercise, cognitive games, virtual reality
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Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy

Hepatic Energy Fluxes

Sayeed Ikramuddin
All
40 Years to 67 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03997422
STUDY00006269
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Inclusion Criteria:

• Diagnosed with type-2 diabetes mellitus (T2DM) or prediabetes for at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, hemoglobin A1c (HbA1c)< 8% and NOT requiring insulin or other oral/ injectable hypoglycemic agents
• Aspartate aminotransferase (AST) >32 IU/L or an alanine aminotransferase (ALT)>39.9 IU/L
• Body Mass Index (BMI) 30.0-39.9 kg/m2 at eligibility visit
• Willingness to accept surgical intervention after an individual seminar session
• All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all patients enrolled in the study
• Expect to live or work within approximately one-hour traveling time from the study clinic for the duration of the one-year trial
• Willingness to comply with the follow-up protocol and successful completion of the run-in (described in section 5.2)
• Written informed consent
• Suitable for liver biopsy using the percutaneous approach
• Vulnerable populations will not be targeted for inclusion, but those noted in section
• 1 may be allowed to participate provided they met all of the inclusion and none of the exclusion criteria.
Exclusion Criteria:

• Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
• Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
• Cardiac stress test indicating that surgery or IMM would not be safe.
• Pulmonary embolus or thrombophlebitis in the past six months.
• Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
• Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
• Serum creatinine >1.5 mg/dL.
• Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome, or alkaline phosphatase or ALT or AST greater than twice the upper limit of normal. Elevated international normalized ratio (INR).
• Alcohol intake more than one drink or >20 grams per day
• History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
• Gastric or duodenal ulcer in the past six months.
• History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
• Previous organ transplantation.
• Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
• Currently pregnant or nursing, or planning to become pregnant in the next two years.
• History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
• Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
• Depression A Center for Epidemiologic Studies Depression (CESD) score more than 17 and a psychologist determination that the patient is not a good fit for surgery.
• Current participation in a conflicting research protocol.
• Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
• 12-lead electrocardiogram (EKG) indicating that surgery would not be safe.
• Serum c-peptide <1.0 ng/ml post prandial.
• Exclusions may also be made at the discretion of the attending physician or the eligibility committee.
• Contraindication to magnetic resonance imaging (MRI) scanning. MRI contraindications are assessed by MR technologists on the day of scanning using a standard safety screening form.
• Gastroesophageal reflux disease requiring medications. History of endoscopy demonstrating esophagitis or Barretts changes in the esophagus. Any history of dysphagia.
• More than 2 cups of coffee per day.
• Treatment with drugs associated with nonalcoholic fatty liver disease (amiodarone, methotrexate, oral glucocorticoids at doses greater than 5 mg/day, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, valproic acid) for more than 4 weeks within the last 2 months prior to the initial screening.
• Treatment with pioglitazone or high-dose vitamin E (>400 IU/day) within the last 2 months prior to the initial screening.
• Initiation of treatment with a glucagon-like peptide-1 (GLP-1) agonist or a dose change within the last 2 months prior to the initial screening
Procedure: Vertical Sleeve Gastrectomy (VSG)
NASH - Nonalcoholic Steatohepatitis, NAS, Overweight or Obesity, Weight Loss, Bariatric Surgery Candidate
Clinics and Surgery Center (CSC)
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Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens

Dorothy Hatsukami
All
18 Years and over
Phase 2
This study is also accepting healthy volunteers
NCT03978117
STUDY00003508
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Inclusion Criteria:

• Adult Male or female. Participants can be smokers or non-smokers
• In good physical health
• In stable and good mental health
• Not using any medications that may affect the Nrf2 pathway
• Women who are not pregnant or nursing or planning to become pregnant
• Participants have provided written informed consent to participate in the study
Exclusion Criteria:

• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
• Vital signs outside of the allotted range
• Not willing to abstain from eating cruciferous vegetables during the course of the study
Dietary Supplement: Freeze dried Powder, Dietary Supplement: Placebo Preparation
Healthy, Prevention & Wellness
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The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults

All
30 Years to 64 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04931836
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Inclusion Criteria:

• Classified as overweight or obese with BMI 25.0-39.9 kg/m2.
• Documentation* of a prediabetes diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of
• 7%-6.4%76; OR a study screening lab value of HbA1C within the afore mentioned range.
• Currently engaged in <100 min/week of physical activity - confirmed by questionnaire.
• No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)78-this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status, with answering "yes" to any one of these questions requiring a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention.
• No self-reported physical/mental disabilities or gastrointestinal conditions.
• No antibiotic usage within the last 45 days.
• Stable weight over the last 6 months (<10% change).
• Not currently pregnant, planning to become pregnant, or currently breastfeeding.
• Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
• Note: Documentation can include either a print out or screen shot of the lab value illustrating eligibility, along with the date of the test and the participant's name. If a hard copy is provided, the date and name will be redacted.
Exclusion Criteria:

• Self-reported use of metformin and/or other medications that could interfere with the primary outcome.
• History of bariatric surgery or a history of other medical interventions that would interfere with the primary outcome.
Behavioral: Physical Activity Intervention
Obesity, Overweight, Overweight and Obesity, PreDiabetes, Type 2 Diabetes, Type 2 Diabetes Mellitus, Type 2 Diabetes Mellitus in Obese
Microbiome, Physical Activity
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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

We will conduct a double-blind, placebo-controlled, randomized clinical trial at two sites to enhance the diversity of the study sample and generalizability of the results. We will enroll healthy pregnant women (n=320) who have recently quit smoking and intend to stay abstinent postpartum. Using a 2×2 factorial design, participants will be randomized into one of four assignments: (1) Prog + DMPA, (2) Prog + placebo, (3) placebo + DMPA, and (4) placebo + placebo. Participants will be followed for days to smoking relapse (primary outcome), smoking relapse-related risk factors (e.g., craving), and infant health outcomes from gestational week 36 through 9 months postpartum. This study proposes a safe and innovative intervention to examine the impact of manipulating postpartum physiological to influence the behavior of a new mother which will lead to improved health outcomes for her and her infant. The implications of this novel study will directly advance the current state of the science by expanding on the role of Prog and DMPA in addressing smoking-related behaviors within this highly vulnerable population. Further, should our central hypothesis be supported, the clinical translatability of this intervention is high and may be immediately pursued.

Sharon Allen, PhD
Female
18 Years to 40 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT04783857
STUDY00010569
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Inclusion Criteria:

• stable physical and mental health with confirmed, uncomplicated pregnancy at gestational week 30-35
• established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider
• self-report of a minimum of 4 weeks of smoking abstinence with confirmation of acute abstinence by expired carbon monoxide level of ≤ 5 ppm at the time of enrollment
• history of ≥ 5 cigarettes a day for at least 6 out of the last 12 months
• self-report of motivation to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
• willingness to use non-hormonal contraceptives postpartum if sexually active until 12 weeks postpartum
Exclusion Criteria:

• current use of tobacco products (e.g., cigars, e-cigs), nicotine replacement therapy or smoking cessation medications
• current major depressive disorder based on the Structured Clinical Interview for DSM-5 (SCID)
• contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy)
• contraindications to DMPA treatment (e.g., current use of aminoglutethimide or planning to become pregnant in the next year)
• current use of illicit drugs or alcohol abuse
• treatment for illicit drug use or alcohol use disorder within the last 3 months
• any condition that, in the opinion of the clinical team, precludes participation in the trial.
Drug: Progesterone 200 MG Oral Capsule, Drug: Depot-Medroxyprogestereone Acetate, Other: Placebo Oral Tablet, Other: Placebo Injection
Smoking, Smoking Cessation, Smoking Reduction
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PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial

More than 65% of people with lower extremity peripheral artery disease (PAD) are overweight or obese. Overweight or obese people with PAD have greater functional impairment and faster functional decline than normal weight people with PAD. Walking exercise is first line therapy to improve walking performance in PAD. However, our NHLBI-funded observational longitudinal study of functional decline in PAD showed that overweight and obese PAD participants who combined weight loss with walking exercise had significantly less functional decline than those who walked for exercise but did not lose weight. Therefore, we hypothesize that among people with PAD who are overweight or obese, a weight loss intervention combined with exercise will improve walking ability more than exercise alone. However, the effects of intentional weight loss in overweight or obese people with PAD are unknown and may not be beneficial if weight loss exacerbates PAD-related sarcopenia. Behavior change that achieves sustained weight loss is particularly challenging in older obese people with chronic disease. Therefore, among people with PAD and BMI>28 kg/m2, we will conduct a randomized clinical trial to test the hypothesis that a weight loss intervention combined with walking exercise achieves greater improvement in functional performance than exercise alone at 12-month follow-up.

Diane Treat-Jacobson
NA
This study is NOT accepting healthy volunteers
NCT04228978
STUDY00006194
Overweight or Obesity, Peripheral Artery Disease
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Methodology and Development of Tobacco Related Biomarkers Methodology and Development of Tobacco Related Biomarkers, part of 'Metabolism of Carcinogenic Tobacco-Specific Nitrosamines'

The purpose of this study is to better understand how tobacco and nicotine products affect our bodies. In this observational study smokers, vapers, smokeless tobacco users, nicotine replacement product users, non-users, and ex-users will be asked to provide biological samples. We will look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. Collected samples will be used for the development of biomarkers of toxicant exposure and for assessing exposure between the different groups. The intent is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases. This study will allow us to test currently used biomarkers, and to establish a biorepository (sample bank) to identify and develop new biomarkers associated with tobacco exposure and cessation. The type of samples and amount collected will depend on the specific biomarker(s) being developed or tested. Potential samples include saliva, cheek (buccal) & oral cells, blood, urine, hair, and/or nail clippings.

Stephen Hecht, PhD
18 Years and over
NA
This study is also accepting healthy volunteers
2009NTLS059
0908M70881
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Inclusion Criteria:

• 21 years or older
• Daily user of tobacco or nicotine products
Exclusion Criteria:

• Unstable health condition
• Pregnant or nursing
Cancer, Community Health, Prevention & Wellness
nicotine, nicotine replacement, smokeless tobacco, smoker, smoking, tobacco, vaper, vaping
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New biomonitoring methodologies to measure DNA adducts in urinary cells

Tobacco smoking and the consumption of well-done cooked meats are considered risk factors for bladder cancer. However, exactly how these exposures contribute to bladder cancer is still mostly unknown. The purpose of this pilot study is to evaluate the potential of urine to serve as a biospecimen for the analysis of cancer biomarkers. Participants will be asked to collect their urine from when they first wake up until 6 hours afterward.

Robert Turesky
NA
This study is also accepting healthy volunteers
2016NTLS094
1605M87561
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Inclusion Criteria:

• Daily Smoker
• 21 years of age or older
• In general good health
• Willing to collect urine for 6 hours
Exclusion Criteria:

• Unstable health condition
• Pregnant or nursing
Prevention & Wellness
cigarette, nicotine, smoking, tobacco
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Assistive Technology and Functional Outcomes Following Spinal Cord Injury

The purpose of this study is to begin to build empirical evidence needed to support adequate funding of assistive technology (AT) for both veterans and civilians with SCI. Information gathered from this mixed-methods investigation will be used as a foundation to develop population-specific tailored information and interventions to improve access to and utilization of AT.

Kimberley Monden
18 Years and over
NA
This study is NOT accepting healthy volunteers
PMR-2021-29956
STUDY00011544
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Inclusion Criteria:

• You are between 18 and 65 years of age
• You are living with tetraplegia (C7 or higher) and have limited hand function
• You are greater than 1-year post-spinal cord injury
• You are fluent in English
Exclusion Criteria:

• Spinal cord disorder (e.g., ALS, MS, transverse myelitis, Guillain-Barre)
• SCI without neurologic impairment (i.e., ASIA Impairment Scale E ? normal motor and sensory function)
• Severe cognitive impairment
• Active military personnel
Community Health, Prevention & Wellness
assistive technology, quadriplegia, spinal cord injury, tetraplegia
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Stress Response and Opioid Dysfunction in Nicotine Dependence

This study includes healthy adults between 18-70 years old who are either non-smokers or cigarette smokers interested in quitting. The purpose of this study is to learn more about how people respond to stress and to taking one dose of a widely and safely used drug called naltrexone as well as to learn about how these responses relate to whether or not someone smokes, smoking cessation, and smoking relapse.

Mustafa al'Absi
18 Years and over
NA
This study is NOT accepting healthy volunteers
DMED-2019-28512
STUDY00008687
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Inclusion Criteria:

• Live in Minnesota.
• Between 18-70 years old.
• Generally healthy.
• Want to quit using tobacco and nicotine.
• Are willing to attend up to 11 online (videoconference) study visits over a period of approximately 4 months (though you may be asked to complete the last visits over a period of up to 1 year).
Exclusion Criteria:

• Do not live in Minnesota.
• Not between 18-70 years old.
• Not willing to attend to up to 11 online (videoconference) study visits over a period of approximately 4 months.
Heart & Vascular, Mental Health & Addiction, Prevention & Wellness
cigarette, nicotine, quit smoking, smoker, smoking, smoking cessation, stress, tobacco
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What Teens Want: A Qualitative Exploration of Diverse Adolescents' Views on Online Physical Activity Video Resources

This is a qualitative study of 14-18 year olds thoughts about online physical activity content and of two physical activity videos that have been designed to promote health equity and adolescent wellbeing.

Barbara McMorris
up to 18 Years old
NA
This study is also accepting healthy volunteers
SON-2021-30307
STUDY00012842
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Inclusion Criteria:
14-18 years old; can speak and read English; living in the United States; has an internet-connected device; willing to watch 2 physical activity videos; willing to attend one Zoom focus group
Exclusion Criteria:
Younger than 14; older than 18; cannot speak or read English; does not have an internet-connected device; not willing to watch physical activity videos or attend Zoom focus group; does not have parent permission
Children's Health, Prevention & Wellness
Physical activity, adolescents, exercise, online, social media, teenagers, workout, youth, zoom
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Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

The purpose of this study is to better understand how varying levels of common sugars found in cigarettes affect how you smoke the cigarette and your responses to them.

Irina Stepanov
18 Years and over
NA
This study is also accepting healthy volunteers
2020LS236
STUDY00011825
Community Health, Prevention & Wellness
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Impact of Sugars on Tobacco Product Toxicity and Abuse Liability

The purpose of this study is to better understand how varying levels of common sugars found in cigarettes affect how you smoke the cigarette and your responses to them.

Irina Stepanov
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT05308316
STUDY00011825
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Inclusion Criteria:

• Male or female age 21 years or older
• Smoking cigarettes that have been evaluated to have medium levels of sugar content
• No quit attempts in the past month nor intentions to quit smoking in the next month
• Participants are in good physical health (no unstable medical conditions) as determined by the licensed medical professional
• Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis) as determined by the licensed medical professional
• Stable vitals sign measurements (systolic BP ≤ 160 and >90 mmHg, diastolic BP ≤ 100 and >50 mmHg and heart rate ≤105 and > 45 bpm) as determined by the licensed medical professional
• Participants must be able to read for comprehension or completion of study documents (confirmed during informed consent process)
• Participants have provided written informed consent to participate in the study.
Exclusion Criteria:

• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
• Women who are pregnant or nursing or planning to become pregnant.
Other: Sucrose cigarettes
Tobacco Use, Community Health, Prevention & Wellness
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Biomarkers of Exposure and Effect in SREC Users

The purpose of this study is to better understand how switching from smoking to the use of electronic cigarettes (e-cigarettes) may change users’ exposures to various harmful chemicals. Your participation will also help us to understand how nicotine that is present in e-cigarettes is taken in and modified by your body.

Irina Stepanov
All
18 Years and over
Phase 1
This study is also accepting healthy volunteers
NCT04003805
STUDY00002033
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Inclusion Criteria:

• Male or female smokers who are 18-65 years of age and are willing to stop smoking and completely switch to e-cigarettes or medicinal nicotine;
• Report smoking ≥ 5 cigarettes daily and not using any other nicotine or tobacco product;
• Biochemically confirmed regular smoking status by a NicAlert test level of 6;
• Smoking daily for at least 1 year and no serious quit attempts (e.g., quit for 24 hours or longer) in the last 3 months (to ensure stability of daily smoking, particularly for those randomized to the continued smoking group);
• No unstable and significant medical or psychiatric conditions as determined by medical history and Prime-MD (to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
• Subjects are in good physical health (no unstable medical condition);
• Subjects are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse);
• Subjects who are not taking anti-inflammatory medications or any medications that affect relevant metabolic enzymes;
• Women who are not pregnant or nursing or planning to become pregnant;
• Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products).
Exclusion Criteria:

• Regular tobacco or nicotine product use (e.g., 9 days in last 30 days) other than cigarettes;
• Currently using nicotine replacement or other tobacco cessation products;
• Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
• Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, unstable COPD, seizure disorder and cancer, as determined by the licensed medical professional);
• Unstable mental health (to be determined by medical history, CESD, Prime-MD after review by the licensed medical professional);
• Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
• Blood alcohol test > 0.01 (g/dL) as measured by a breath sample at screening (participants failing the breath alcohol screen will be allowed to re-screen once;
• Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP. Failing temperature strip for the sample. Marijuana will be tested for, but will not be an exclusionary criterion. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. Participants failing the toxicology screen will be allowed to re-screen once;
• Pregnant or breastfeeding;
• Failure to agree to take adequate protection to avoid becoming pregnant during the study;
• Vital signs outside of the following range (participants failing for vital signs will be allowed to re-screen once):
• Systolic BP greater than or equal to 160 mm/hg
• Diastolic BP greater than or equal to 100 mm/hg
• Systolic BP below 90 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Diastolic BP below 50 mm/hg and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Heart rate greater than or equal to 105 bpm
• Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)
• Expired air carbon monoxide (CO) level greater than 80 ppm;
• Self-reported allergies to propylene glycol or vegetable glycerin;
• Adverse reactions when previously using electronic cigarettes;
• Household member enrolled in the study concurrently;
• Unable to read for comprehension or completion of study documents;
• Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits.
Drug: Standardized Research E-cigarette (SREC), Drug: Nicotine Mini-Lozenge
Smoking, Cigarette, Prevention & Wellness
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Neighborhood Park Youth Sports Program Fee Waiver and Intensive Family Outreach (PARKS)

All
6 Years to 12 Years old
Phase 3
This study is also accepting healthy volunteers
NCT05231837
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Inclusion Criteria:

• age 6-12 years
• do not meet guidelines for recommended level of physical activity
• live in neighborhood served by one of 24 study parks
• able to be physically active
• do not plan to move in the next two years
Exclusion Criteria:

• younger than 6 or older than 12 years of age
• do not live within 2 miles of study park
• already meet physical activity guidelines
• not able to be physically active plan to move within two years
Behavioral: Experimental: Fee Waiver, Behavioral: Fee Waiver Plus Intensive Outreach
Physical Activity
Physical Activity Low Income Youth Parks
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Ten Thousand Families Study

The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.

Logan Spector
Not specified
NA
This study is also accepting healthy volunteers
PEDS-2017-25905
STUDY00000877
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Inclusion Criteria:

• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
Exclusion Criteria:

• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Cancer, Microbiota, Prevention & Wellness
Colon Cancer, Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS
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