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Discover 23,476 clinical trials near Baltimore, Maryland. Find research studies in your area.
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NCT06560021
The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy (HDWLC) with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation (limited biopsy strategy) or HDWLC with targeted biopsies plus 4 biopsies every 10 cm throughout the colon, at a minimum in all segments of the colon known to have been affected by IBD at any time, regardless of the extent of disease (random biopsy strategy). Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy. Follow-up via chart review may continue for up to 15 years from enrollment.
NCT05245695
The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test
NCT05477524
The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence. Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months after end of primary vaccination series. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. A subset of participants will be followed for a third Lyme disease season. Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective. If enrolled, participants will need to visit the research site at least 7 times during the study, and for a subset of participants up to 9 times. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.
NCT05533775
The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL).
NCT05958342
The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.
NCT00352534
This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.
NCT06534905
The goal of this clinical trial is to learn if adults 50 years and older who currently smoke tobacco and are in treatment for opioid use disorder will switch to using e-cigarettes instead of continued smoking. Participants will not have a plan to quit smoking and will not be actively trying to quit smoking at the start of the trial. The main questions the study aims to answer are: * Are e-cigarettes a feasible and acceptable harm-reduction tool among older adults who currently smoke tobacco and don\'t have a plan to quit? * Will switching to e-cigarettes and reducing tobacco use be more likely among patients given access to e-cigarettes compared to individuals who are exposed to a standard brief intervention for smoking cessation (control)? * Does the accuracy of nicotine/tobacco knowledge change after participants are exposed to education on the harms of nicotine relative to no education? Participants will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8, each lasting 30-90 minutes, for a total of approximately 3-4 hours of participation in the study. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning. Patients will be randomly assigned at baseline (if meeting eligibility criteria) to receive an e-cigarette product (name of product: NJOY Ace) or brief advice to quit smoking (in alignment with recommendations by the American Society of Addiction Medicine).
NCT06880744
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs). Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide. For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study. The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.
NCT04276883
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.
NCT07111078
Background: Influenza (flu) is a contagious respiratory illness caused by viruses. Flu symptoms can range from mild to severe, and the illness can be fatal. Vaccines help the body learn to prevent or fight infections such as flu. Some vaccines are combined with adjuvants. Adjuvants are special salts or fats that help vaccines work better. Researchers are looking for ways to make flu vaccines more effective. Objective: To test a new flu vaccine with and without a new adjuvant. Eligibility: Healthy adults aged 18 to 50. They must have had at least 1 flu vaccine since 2020. Design: Participants will have 12 clinic visits over 15 months. The vaccine is given as an injection into the muscle of the upper arm. Participants will be vaccinated during 2 visits spaced 4 months apart. Half will receive just the vaccine; half will receive the vaccine plus the adjuvant. They will be monitored for at least 30 minutes after each shot. Participants will keep a diary for 7 days after each shot. They check their temperature every day and record any symptoms. Participants will have 10 follow-up clinic visits plus 4 phone calls. They will have 4 to 10 tablespoons of blood drawn at each clinic visit. Fluid samples will be collected from their nose and mouth. They will be checked for any health changes. Participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a different needle.
NCT01306084
Background: \- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development. Objectives: \- To collect samples and data from individuals who have been exposed to or have contracted viral infections. Eligibility: * Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases. * Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate. Design: * Participants will be pre-screened to determine if they meet the eligibility criteria for the trial. * If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies. * Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing. * Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection. * Treatment is not offered under this study.
NCT07310420
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).
NCT07109869
This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.
NCT07217171
The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.
NCT06829953
The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.
NCT07021742
This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).
NCT07069738
This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.
NCT06779630
The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) \>36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm. Patients enrolled in the United States will be followed for 2 years post index procedure with follow-up visits at 1, 6, 12 months and 2 years post index procedure. Patients enrolled outside of the United States will be followed through 5 years post index procedure with additional follow-up visits at 3 and 5 years post index procedure.
NCT07287150
This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.
NCT05890677
The aim of this study is to test whether lymphatic surgery provides better QoL (assessed with the Lymph-ICF-UL, (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema)) 15 months after randomization (and therefore about one year after surgery) compared to conservative treatment only for patients with chronic lymphedema (LE)
