Official Title Phase 2 Study of Low Dose Tamoxifen +/- High Dose Omega-3 Fatty Acids in Overweight Postmenopausal Women at Increased Risk for Breast Cancer

Purpose

This study wants to measure the effects of low dose tamoxifen and omega-3 fatty acids (may also be known as fish oil) on a woman's risk of developing breast cancer.

In this study, half of the participants will be asked to take low dose tamoxifen and the other half low dose tamoxifen with omega-3 fatty acids for about six months. Everyone taking part in the study will be watched carefully for any side effects, which may or may not happen. Tissue and blood collection will be a part of the study participation.

This study is looking for volunteers with an above average risk of developing breast cancer. We will enroll up to 66 participants at institutions across the country. The study lasts about eight months.

Could this study be right for you?

• Postmenopausal
• At increased risk of breast cancer, due to genetic mutation, family history, prior DCIS, LCIS, or atypical hyperplasia
• Overweight or obese (BMI ≥ 25 kg/m2)
• Do not have breast implants
• Seen in Stefanie Spielman Comprehensive Breast Cancer Center in Columbus, OH

Age Range

45 - 65 years

Official Title Longitudinal Modeling of Interpersonal Stress Induced Rumination to Understand Depression Risk in Adolescent Girls (MARIS)

Purpose

This study looks at how young girls think about and react to stress—both in their brains and in their daily lives—to see how these patterns might lead to or predict depression. It aims to understand whether certain ways of handling stress put some girls at higher risk for developing depressive symptoms.

If eligible, the child will complete assessments which include clinical interviews over Zoom, surveys, cognitive testing, and an MRI each year, for up to three years.

A parent/guardian is required to enroll in the study and will complete questionnaires and a clinical interview as well.

Could this study be right for you?

Inclusion Criteria:

• Female
• 10-14 years of age at enrollment
• Youth assent and parent consent

Exclusion Criteria:

• Psychotropic medication use in the past 4 months
• Metal braces or plans for braces in the next 2 years
• Developmental disorder
• History or diagnosis of depression, substance use disorder, bipolar disorder, psychosis or seizures
• Traumatic brain injury
• Claustrophobia

Age Range

10 - 14 years

Official Title Phase IIA Trial of Acolbifene (20 mg) vs Low Dose Tamoxifen (5 mg) in Pre-menopausal Women at High Risk for Development of Breast Cancer

Purpose

This study wants to see if two medicines, acolbifene or a small dose of tamoxifen, can lower the chance of getting breast cancer in women who are at high risk before menopause.

Acolbifene and tamoxifen work by blocking estrogen, a hormone that can help cancer cells grow. By blocking estrogen, these medicines may lower the chance of breast cancer in women at high risk. The study lasts between 6 and 8 months.

If this study works, it could give us new ways to help prevent breast cancer.

Could this study be right for you?

• Pre-menopausal
• At increased risk of breast cancer, due to genetic mutation, family history, prior DCIS, LCIS, or atypical hyperplasia
• Seen in Stefanie Spielman Comprehensive Breast Cancer Center in Columbus, OH

Age Range

35 years and up

Official Title Phase II - Modular Convertible Child Safety Seat to Improve Usage

Purpose

We want to learn parents' and caregivers' opinions on a new design for a child car safety seat. You will be asked to install a rotating child seat and a regular child seat into a provided vehicle and tell us what you like and don't like about each one.

Could this study be right for you?

To qualify for the study, you must be:

1. Between the ages of 18 and 65
2. A parent or care provider to a child who is 0 to 4 years of age
3. Have installed a child safety seat in the last 2 years 
4. Able to lift and install a child car safety seat into a vehicle

Age Range

18 - 65 years

Official Title Examining Heavy Metal Exposure and Respiratory Health in Young Adult Electronic Cigarette Users

Purpose

This study will examine heavy metal exposure among young adult electronic cigarette users.

Participation involves taking part in a study at The Center for Tobacco Research. You will be asked to attend 1 study visit, lasting about 2 hours. You will be asked to bring your own preferred e-cigarette device to the study visit. 

Could this study be right for you?

• Must be a current e-cigarette user
• Must be 18-29 years old
• Willing to attend 1 vaping session with personal electronic cigarette device at OSU

Age Range

18 - 29 years

Official Title Anti-inflammatory Activities of Vitamin C Supplementation on the Gut Barrier Function in Adults with Obesity

Purpose

This study is testing whether taking vitamin C can improve gut health and reduce inflammation in adults with obesity. We want to learn if vitamin C helps strengthen the gut lining (“gut barrier”), improve digestion, and support overall health.

Could this study be right for you?

• Body weight: Have overweight or obesity (BMI 30 or higher)

• Location: Able to come to The Ohio State University campus in Columbus, Ohio for study visits

• Diet: Willing to follow a low vitamin C diet during the study

• Health status: Generally healthy, without major chronic diseases other than obesity

• Other: Non-smoker, not pregnant or breastfeeding, not currently taking high-dose vitamin C supplements

Age Range

18 - 55 years

Official Title A randomized, double-blind, placebo-controlled, parallel group, pilot study to evaluate the effect of a ketone ester on muscle and immune function in older men and women who are at risk for strength and mobility decline

Purpose

The purpose of this study is to measure the effect of 20 weeks of Ketone Ester consumption on a composite score of vigor-frailty in older adults who are at risk for mobility and strength decline and to investigate the effect of 20 weeks of Ketone Ester consumption on additional physical function measures, cognitive and immune function, muscle metabolism, safety, tolerability, gut microbiome, and quality of life in older adults who are at risk for mobility and strength decline. 

Could this study be right for you?

65 years of age or older

• living independently
• English speaking and able to understand study procedures and provide Informed Consent
• women must be post menopause
• ambulatory and able to pass the walk speed criteria at screening            
• minimum body weight of 50kgs (110 lbs.) at time of screening
• able to fast and abstain from alcohol, cannabis products and not exercise for 10 hours prior to study visits
• maintain current diet, exercise, medication and supplement use
• must not have a known allergy, intolerance, or sensitivity to any soy or milk protein
• must not be under active surveillance or treatment for cancer
• has not followed a ketogenic diet or used any ketone products within 30 days of screening or at anytime during the study period
• does not work night shifts or shifts that do not allow for a consistent meal schedule during the day
• does not take any immunosuppressive medications,  weight loss medications or supplements, chronic antibiotic usage or receiving chemotherapy
• must not adhere to any extreme dietary habits, including intermittent fasting, Atkins, vegan, high protein low carbohydrate
• must not be a heavy alcohol drinker (women 8 drinks or more per week; men 15 drinks or more per week)
• must not have uncontrolled elevated cholesterol upon results of screening laboratory results

Age Range

65 - 99 years

Official Title Sex Differences in Alcohol Use: Neural and Hormonal Influences

Purpose

The goal of the study is to gain a better understanding of how hormonal fluctuation across the female menstrual cycle impact brain activity and associated drinking behaviors.

Participation includes:
•    One orientation session (2 hours)
•    Three brain imaging (fMRI)/alcohol and saline administration sessions (7 hours each)
•    Six follow-up online surveys (30 mins each)
•    Two follow-up sessions (1 hour each)

The total time commitment of the study is 28 hours over the course of 21 months.

Could this study be right for you?

1. Age: 21–26 years old (must bring proof of age to Orientation, e.g., driver’s license or passport)
2. In good health, as confirmed by responses to the Screening Interview
3. No contraindications for fMRI (e.g., no metal in the body, as confirmed by MRI screening form)
4. Reports typical weekly alcohol consumption 
5. No current or past treatment for a drug or alcohol use disorder
6. Not currently pregnant, breastfeeding, or planning to become in the next 3 months (women only)
7. Regular menstrual cycles (women only)
8. No use  of hormonal contraception or plans to begin use within the next 3 months (women only)

Age Range

21 - 26 years

Official Title Pain Sensitivity and Endogenous Pain Modulation in Autistic Adults (R21)

Purpose

The purpose of this project is to study how pain may differ in adults with or without autism. Our goal is to study whether or not pain is experienced of felt differently in autistic adults compared to non-autistic adults.

Participants will be screened by phone. After meeting the initial screening criteria, the study visit will be scheduled. Participants can expect one study visit lasting 2-3 hours with time built in for breaks.

Could this study be right for you?

• Not currently on any daily pain medications

Age Range

30 - 70 years

Official Title Examining the efficacy of a soft soy pretzel intervention in altering chronic inflammation and immune profiles in obese individuals

Purpose

The objective of this study is to evaluate if soy isoflavones, delivered via soft soy pretzels (SSP), can be an effective, feasible intervention for chronic inflammation.

 

All study visits will be at The Ohio State University Medical Center and the study will last 8 weeks and involve 7 clinic visits.

Could this study be right for you?

You may be eligible if you:

• Are a male between 18 and 49 years old
• Have a body mass index (BMI) less than 25 or greater than or equal to 30
• Are not allergic to soy or soy-containing products
• Are not actively trying to lose weight

Exclusion criteria: 

• Current or prior history of Type 2 diabetes mellitus as defined by ICD-10-CM E11
• Current or prior history of cancer (excluding non-melanoma skin cancers)
• History of blood clotting disorders or adverse events relating to blood draws
• Use of antibiotic regime lasting longer than one week within the last six months
• Strict veganism (no consumption of animal, fish, or egg products)
• Heavy alcohol consumption (defined as consumption of >14 drinks/week on average)
• Current or prior history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias
• Regular usage of inflammation lowering medications which include but not limited to nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, and naproxen, or anti-pyretic medications such as acetaminophen

 

Age Range

18 - 49 years