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A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial

Bladder Cancer Β· Urothelial Carcinoma Β· Upper Tract Urothelial Carcinoma

Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant/systemic therapy. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their bladder or urothelial cancer.

Seattle, WA18+ yrsAll genders
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Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis

Symptomatic Irreversible Pulpitis (SIP)

All Patients coming to the Operative Dentistry Department (DIDC-DUHS) with complain of pain in posterior teeth will be invited to participate. The treatment will be done by one dentist. Patient's medical and dental history will be recorded, and tooth will be checked for swelling, sensitivity, cavity type, and loosening of tooth. Special tests like the cold test, electric pulp test, and an X-ray will help assess the tooth's condition. Patient will also be asked to rate pain from 1-10. Before starting the treatment, the procedure will be explained to patient in detail, and written consent will be taken. The treatment will be done in two visits by one dentist. Patient will be given an injection to make tooth pain-free so that patient does not feel any discomfort during the treatment and the area will be kept clean using a rubber sheet. The dentist will remove the hole in tooth and remove the infected soft part of tooth and stop the bleeding. Then one of the two materials will be placed inside the tooth. A temporary filling will be placed first, and patient will come the next day for the final filling. An X-ray will be taken to check the result. If patient feel pain, may take ibuprofen (400 mg) as needed, and if the pain continues, please contact the dentist. Patient will be called for follow-ups after 1 day, 1 week, 1 month, and 3 months to make sure the tooth is healing properly.

Karachi18–40 yrsAll genders
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Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)

Paroxysmal Atrial Fibrillation

This is a prospective, descriptive study. Safety endpoints will not be assessed. All eligible patients that have a history of paroxysmal atrial fibrillation and an indication to undergo Micra AV2 device placement as per standard of care (SOC) across the participating sites within the Northwell Health System can be included in this analysis. Micra AV2 placement indications will be at the discretion of the treating electrophysiologist, but are expected to be predominantly atrioventricular block. Periodic device interrogations will be reviewed for the presence of effective atrial tracking during sinus rhythm . The presence of paroxysmal atrial fibrillation and the degree to which atrial activity and A4 amplitude trend changes will be assessed using a designated Medtronic Research Holter monitor that detects Micra AV2 signals at any point in the study during a episodes of sinus rhythm and atrial fibrillation. Patients who have atrial fibrillation during index hospitalization will undergo placement of the Medtronic Holter monitor as part of the standard of care index hospitalization. Eligible outpatients will undergo placement of the Medtronic Research Holter Monitor in the office.

New Hyde Park, NY18+ yrsAll genders
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Screening Strategies Among High-risk Populations for Anal Cancer

Neoplasms Β· HPV-Related Anal Squamous Cell Carcinoma

The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.

Miami, FL +1 more30–80 yrsAll genders
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Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 mAb, Administered Alone and in Combination With a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study)

Non Small Cell Lung Cancer Β· Pancreatic Ductal Adenocarcinoma

This is a first-in-human, Phase 1/2, open-label, study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Mavrostobart (PT199) alone and in combination with a PD-1 inhibitor or chemotherapy.

Huntersville, NC +4 more18+ yrsAll genders
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Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients

Diffuse Large B-cell Lymphoma

In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. Part II is a Phase II single-arm, open-label, multi-centre study evaluating the efficacy and safety of MB-CART2019.1 in younger, fit participants with R-R DLBCL. Part II will start after completion of enrolment in Part I.

Multiple locations18–70 yrsAll genders
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Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive Disorder

Major Depressive Disorder Β· Post-Traumatic Stress Disorder (PTSD)

Trauma-related Major Depressive Disorder (MDD) is frequently associated with poor response to conventional antidepressants, persistent psychological distress, and alterations in gut-brain axis function. Existing assessment tools primarily diagnose depression or PTSD but provide limited guidance for integrated clinical management. This study aims to develop and validate the Trauma Anxiety Depression Emotion (TADE) management tool while simultaneously evaluating the effectiveness of psilocybin-assisted Structured Integrated Reframing Therapy (SIRT) in improving clinical and biological outcomes. This prospective, four-arm randomized controlled trial will compare conventional therapy, psilocybin therapy, SIRT, and psilocybin-assisted SIRT. Participants will undergo assessment using the newly developed TADE tool together with established psychometric scales including HAM-D, PCL-5, and GAD-7. Biological outcomes will include serum gut-brain axis and inflammatory biomarkers, including Short-Chain Fatty Acids (SCFAs), Interleukin-6 (IL-6), Interleukin-10 (IL-10), Zonulin, Occludin, and Glial Cell Line-Derived Neurotrophic Factor (GDNF). Assessments will be performed at baseline, during treatment, and at 12-week follow-up. The study aims to determine whether combining psilocybin with SIRT provides superior clinical improvement and favorable biological changes compared with either intervention alone while establishing the validity and clinical utility of the TADE management tool.

Islamabad18–60 yrsAll genders
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A Registry-based Randomized Controlled Trial in Type 2 Diabetes With Cardiovascular Risk Factors (REMATCH)

Type 2 Diabetes

Glycemic control is a mainstay of diabetes management to reduce the risk of microvascular complications and cardiovascular outcomes in people with type 2 diabetes (T2D). However, intensive control to near-normal glycated hemoglobin (HbA1c) yielded complex results in previous landmark trials. Potential risks of intensive glycemic control, such as hypoglycemia and weight gain, may partly contributed to the possible harms associated with this approach. Recent advances in diabetes management with development of newer antidiabetic drugs which minimize possible harms of intensive glycemic control as well as reduce cardiorenal risks enabled safer glycemic reduction. Thus, this randomized trial aims to evaluate the effects of near normalization of HbA1c with novel approaches on microvascular complications and cardiovascular outcomes in people with T2D.

Multiple locations19+ yrsAll genders
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A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer

Metastatic Colorectal Cancer

This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002) and chemotherapy in participants with metastatic colorectal cancer (mCRC).

New Haven, CT +3 more18+ yrsAll genders
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Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on Ξ²-Cell Function in Early-stage Type 2 Diabetes

Type 2 Diabetes Mellitus (T2DM)

The goal of this clinical trial is to explore whether quinoa diet can improve glycolipid metabolism and glucose fluctuations in patients with early-stage type 2 diabetes mellitus (T2DM) and observe its impact on islet Ξ²-cell function and insulin resistance in patients with early-stage T2DM (diagnosed according to the 1999 WHO criteria, disease duration \<5 years, HbA1c 6.5%-10%, no history of insulin therapy, aged 20-70 years). The main question it aims to answer is: Can quinoa diet reduce blood glucose (fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin), improve lipid metabolism (cholesterol, triglycerides), and stabilize glucose fluctuations (time in range, time above range) in patients with early-stage T2DM? Does quinoa diet improve islet Ξ²-cell function (HOMA-Ξ²) and insulin resistance (HOMA-IR), and reduce the need for oral hypoglycemic medications? Comparison group: Researchers will compare the quinoa diet (QD) group (replacing traditional starchy foods with quinoa products) vs. the regular diet (RD) group (conventional diet) to see if quinoa diet demonstrates better metabolic improvement and medication reduction effects. Participants will: Be randomly assigned to the QD group or RD group. Undergo oral glucose tolerance tests (OGTTs) and continuous glucose monitoring (cGMS) at baseline and after the intervention. The QD group will consume quinoa-based foods (noodles, blended powder, cookies) as substitutes for staple foods, beverages, and snacks for 14 weeks, documenting daily intake in a record book. Both groups will receive standardized dietary and exercise education, with monthly follow-ups for food distribution and data collection.

Jinan20–70 yrsAll genders
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Effect of EMDR for Reduction of Pain Interference in Children With Sickle Cell Disease

Sickle Cell Disease Β· Pain Β· Pain, Chronic Disease

Children with sickle cell disease may experience frequent painful episodes. This, together with the traumatic experiences during a hospitalization, can lead to the development of posttraumatic stress reactions. As the stress can trigger painful episodes (pain crisis) in children with sickle cell disease, the investigators think that treating these stress symptoms can reduce the pain-related problems in their lives. Eye Movement Desensitization and Reprocessing (EMDR) is proven to be an effective trauma treatment for posttraumatic stress disorder. Research studies show that EMDR can reduce pain in adults. The investigators want to study now if EMDR effective is in reducing pain-related problems in children with sickle cell disease.

Multiple locations6–18 yrsAll genders
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Diagnostic Performance of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer

Prostate Cancer After a Radical Treatment Β· Biochemical Recurrence of Malignant Neoplasm of Prostate Β· Biochemical Persistence of Prostate Cancer

Following numerous retrospective studies and Phase-3-Studies with promising results, \[18F\]PSMA-1007 has been approved by european authorities. Therefore, it is a growing deployment of this diagnostic method anticipated. This study aims to investigate the diagnostic performance and clinical impact in a real-world-evidence in the context of regular clinical care. The evidence generated by this approach is supposed to assist in optimizing the management of prostate cancer patients.

DΓΌsseldorf18+ yrsMen
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sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)

Gastro-Intestinal Cancer

The primary objective is to determine the clinical efficacy of treatment regimen in terms of objective response rate (ORR). The secondary objectives is to determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS). Additionally, to characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.

Hamilton, NJ18+ yrsAll genders
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Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Blood Pressure Β· Heart Disease Β· Hypertension (HTN)

This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.

Birmingham, AL +4 more18+ yrsAll genders
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Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers

Endometrial Cancer Β· Cervical Cancer

After surgery to remove the main endometrial and/or cervical tumor, most women receive radiation therapy. This study uses hypo-fractionated radiation therapy, which is a type of radiation therapy in which the total prescribed dose of radiation is delivered in fewer but larger doses than conventional or standard radiotherapy. This research study aims to determine if hypo-fractionated radiation therapy given after surgery can improve treatment tolerability (i.e., fewer treatments) with comparable side effects. Participants will be in the study for about 5 years: Radiation therapy: * 5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy (SBRT). * Each treatment session will occur on a weekday (typically consecutive weekdays) and will last approximately an hour. Treatment Follow-Up: * Check-up Appointment and answer questions at 3 months post RT * Check-up Appointments with physical exam every 6 months (+/- 4 weeks) for up to 5 years.

Los Angeles, CA18+ yrsWomen
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