The purpose of this two-visit brain imaging (magnetic resonance imaging, MRI) study is to identify brain targets for improving treatment and preventative interventions for individuals at risk for co-occurring bipolar disorder and alcohol use disorder. The preliminary visit for a parent and his/her biological child will include completion of clinical interviews, surveys, and labwork to determine study eligibility. If they are considered eligible for the study, brain imaging visits will occur within 1-2 weeks at which a 1-hour MRI will be completed along with additional clinical interviews, surveys, and labwork. Brief follow-up phone call interviews will be completed with participants every 3 months for 1 year. Study participation is confidential and compensated.
The purpose of this research is to evaluate whether the Relivion®DP device is safe and helpful in alleviating Major Depressive Disorder (MDD) symptoms. The research study includes up to 6 visits, each visit could be performed either at the clinic or remotely using digital means such as a video call or the use of another dedicated platform.In this research study the participant will randomly receive either an active device or a non-active (sham) device and the participant will be asked to preform daily treatments with the device for 8 weeks after which the participant will have the option to continue to an additional 8 week open-label extension with the active device.
We expect that the time commitment for taking part in this research will last up to 20 weeks (including the screening period).
This is a Phase 3 multicenter, single-arm, open-label extension (OLE) study designed to investigate the long-term safety, tolerability, and efficacy of risankizumab 150 mg or 55 mg by weight every 12 weeks (Q12W) in the treatment of moderate to severe plaque Ps in eligible subjects who have completed all assessments in Study M19-977 and elect to participate in Study M19-973. The study is comprised of a 216-week treatment period and a follow-up phone call for safety approximately 140 days (20 weeks) after the last dose of study drug.
The purpose of this study is to compare the safety and efficacy of the PMX cartridge ( Toramyxin) (in Addition to Standard Medical Care for Patients with Endotoxemic Septic Shock:
Eligible and consented subjects will be randomized to receive either the PMX cartridge (administered twice for 1½ to 2 hours per treatment session approximately 24 hours apart) plus standard medical care or standard medical care alone. For all subjects in whom treatment has been initiated, a follow-up visit (if they are still in the hospital) or a telephone call will be completed at Day 28 (or later) to determine their mortality status. In surviving subjects, a follow-up visit or telephone call to determine their mortality status will also take place at approximately three months (i.e. Day 90) and 12 months after the subject was randomized.
This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.
There are two classes of drugs for preventing blood clots in patients with atrial fibrillation (AF), an irregular heartbeat, after cardiac surgery: antiplatelet drugs (like aspirin) and anticoagulants (blood thinners). This study aims to determine whether the addition of blood thinners to antiplatelet drugs will improve treatment outcomes in patients who develop AF after coronary artery bypass grafting (CABG) surgery.
In this study, you will be randomized (assigned to a group by chance--like flipping a coin) into one of 2 study groups; the assignment to receive the antiplatelet drug alone or the antiplatelet drug plus a blood thinner.
Before discharge from the hospital, you will undergo an electrocardiogram (ECG), which examines the electrical activity of your heart. At 1 and 2 months after randomization, you will receive a phone call from the study staff. At 3 months after randomization, you will return to the institution where you received your surgery for an in-person visit. At 6 months, you will receive a phone call from the study staff. Your total participation will be about 6 months.
This study is for patients scheduled for a bronchoscopy procedure for evaluation of lung transplantation, lung disease, and lung nodules. Those who give consent to participate in this study will be randomized into one of two lung biopsy sampling method groups: Group 1) 1.1 mm single-use Cryoprobe or Group 2) conventional 2.0 mm forceps. These devices are used with a bronchoscope to obtain lung tissue biopsy samples and are being evaluated to determine which is better for confirming a diagnosis. All procedures will be done via standard of care and screening will be accomplished via medical chart review. Subjects will have two in-person appointments and one follow-up telephone call. The first of which is their standard of care office visit with the doctor to go over their plan of care. The second visit is for the standard of care bronchoscopy procedure to obtain biopsy samples. Thirty days following the procedure, a member of the study team will call the subject to assess whether any adverse events may have occurred since the procedure.
The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.
The study seeks to evaluate the effectiveness of ARINA-1, an investigational inhaled medication, in reducing cough and mucus production in patients who are diagnosed with chronic bronchitis. If enrolled in this study, there will be four clinic visits, one telehealth visit, and one phone call. As part of the study assessments, a cough monitor will be worn on the wrist, as well as repeat spirometry, questionnaires, and bloodwork will be completed. The ARINA-1 will administered with a nebulizer provided to participants and is taken twice daily for 28 days. The total duration of this study is up to 12 weeks for each enrolled participant.
Compensation will be provided for your time for each visit that is completed.
This study is to treat cutaneous squamous cell cancer that cannot be removed with surgery and is relatively large or has spread beyond its original location with the combination of radiation therapy and cemiplimab. Cemiplimab is FDA approved for this head and neck cancer, but the combination of cemiplimab and radiation is investigational. This treatment consist of 17 weeks of cemiplimab followed by 7 weeks of cemiplimab + radiation followed by 28 weeks of cemiplimab alone. There will be 3 clinic visits during treatment so the study doctor can check on the participant's health and see if they are having any side effects. Some of the most common risk and side effects that the study doctors know about are lack of energy or feeling tired (fatigue), loose or watery stools (diarrhea), rash, allergic reaction to study drug, and possible effects on liver, kidney, heart, and blood. Treatment will last a year with a follow-up call at the end of year 2.