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Displaying 1 - 9 of 9

AXONICS: a study of Sacral Neuromodulation (SNM) therapy for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI).

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the safety and effectiveness of a device called the Axonics SNM System in reducing symptoms for people who have Overactive Bladder (OAB) and/or Fecal Incontinence (FI). The study will enroll up to 130 participants at up to 20 sites in the United States and Western Europe. The Axonics System delivers mild electric…
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BOOM-IBD2: A study of sacral neuromodulation (SNM) for the treatment of Inflammatory Bowel Disease (IBD)

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
If your doctor has determined that you have a diagnosis of Ulcerative Colitis (UC), you may qualify for treatment with Sacral Nerve Stimulation (SNS). The purpose of this study is to evaluate the safety and effectiveness of SNS in study participants who have UC. While the investigational medical device used in this research study has been studied and…
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Study of ONC-392 in Combination with PLUVICTO in Male Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The main purpose of the study is to determine whether the study drug, ONC-392, together with a standard of care drug PLUVICTO (Lutetium Lu 177 Vipivotide Tetraxetan), are safe and well tolerated, and whether two drugs are effective in treating prostate cancer, in comparison with the standard of care PLUVICTO alone. ONC-392 has not yet been approved by the…
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Study of JNJ-87189401 in Combination with JNJ 78278343 in Patients with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The purpose of this study is to find out the side effects of JNJ-87189401 given in combination with JNJ-78278343 to patients with metastatic castration-resistant prostate cancer, and to find which doses of the two study drugs when given in combination cause the least side effects. The study will also look at how long JNJ-87189401 and JNJ-78278343 stay in…
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Study of JNJ-78278343 in Patients with Advanced Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
You are being invited to take part in a research study that includes studying JNJ-78278343 in subjects with prostate cancer. This is an investigational drug which means that this is a new approach for the treatment of people who have prostate cancer. The main purpose of this study is to find a safe dose of JNJ-78278343 that can be used in the treatment of…
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Study of REGN5678 (Anti-PSMAxCD28) With Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-resistant Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness of REGN5678 which will be given alone first and then be given in combination with cemiplimab. Neither REGN5678 nor Cemiplimab is FDA-approved to treat your type of cancer. Cemiplimab is approved by the FDA for the treatment of certain…
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IRONMAN: International Registry for Men with Advanced Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The main goal of a research study is to learn things to help patients in the future. The decision to join or not join the research study will not cause you to lose any medical benefits. If you decide not to take part in this study, your doctor will continue to treat you. The purpose of this study is to learn more about prostate cancer and: to describe the…
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Study of Whole-Food Plant-Based Diet (WFPBD) to Control Weight in Overweight/Obese Men with Prostate Cancer

Condition: Cancer / Prostate Cancer
Investigator: Mark Stein, MD
Status: Currently Recruiting
The purpose of this study is to assess the efficacy of a home-delivered whole-food plant-based diet (WFPBD) intervention in promoting weight loss in overweight or obese men with prostate cancer receiving androgen deprivation therapy (ADT), as compared to general nutritional counseling only. Another purpose is to assess how easy or difficult it is for…
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Study of C2 CryoBalloon Focal Ablation System for Patients with Barrett's Esophagus

Condition: Gastrointestinal and Digestive Diseases / Barrett's Esophagus
Investigator: Julian Abrams, MD
Status: Currently Recruiting
This research study will look at a newer treatment option for Barrett's Esophagus (BE) which uses nitrous oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA-cleared…
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