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Displaying 1 - 12 of 12

Stem Cell Treatment for Patients with Perianal Fistula due to Crohn's Disease

Condition: Gastrointestinal and Digestive Diseases
Investigator: Marco Bertucci Zoccali, MD
Status: Currently Recruiting
The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for perianal fistulizing Crohns disease. The study will enroll up to 36 participants across multiple sites. Your participation in this study will be…
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Crohn's Disease treatment with Vedolizumab (ENTYVIO) With and Without Upadacitinib (Rinvoq)

Condition: Gastrointestinal and Digestive Diseases
Investigator: Bo Shen, MD
Status: Currently Recruiting
The Takeda study drug used in this study is vedolizumab, a monoclonal antibody. Monoclonal antibodies are proteins made in laboratories that act like proteins in our bodies called antibodies. Vedolizumab acts specifically in the gut and works by preventing certain immune cells from going to the gut and helps reduce inflammation that can cause the symptoms (…
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Ulcerative Colitis Treatment with Afimkibart (phase III)

Condition: Gastrointestinal and Digestive Diseases
Investigator: Bo Shen, MD
Status: Currently Recruiting
The purpose of this study is to compare the effects, good or bad, of RO7790121 versus placebo inpatients with ulcerative colitis. In this study, you will get either RO7790121 or placebo. You will have the opportunity to participate in an open-label extension phase (getting the active drug - RO7790121), if your condition has not improved. RO7790121 is an…
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Balloon Dilation Treatment for Bowel Strictures

Condition: Gastrointestinal and Digestive Diseases
Investigator: Bo Shen, MD
Status: Currently Recruiting
The purpose of this study is to assess the safety and effectiveness of GIE Medical's ProTractX3 TTS drug coated balloon (DCB) for the treatment of benign stricture in the bowel. This study is conducted to see whether this new drug coated balloon dilation device can treat strictures and reduce the rate of recurrence. Up to 215 subjects will participate…
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MASTER-2 TRIAL: Study to treat patients with newly diagnosed multiple myeloma

Condition: Cancer / Multiple Myeloma
Investigator: Rajshekhar Chakraborty, MD
Status: Currently Recruiting
The purpose of the study is to determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who are MRD "positive" at the end of 6…
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Study of Daratumumab in Addition to Chemotherapy for Patients with Smoldering Multiple Myeloma (SMM)

Condition: Cancer / Multiple Myeloma
Investigator: Rajshekhar Chakraborty, MD
Status: Currently Recruiting
The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period…
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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 150 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 Linvoseltamab in Patients with Multiple Myeloma (NDMM)

Condition: Cancer / Multiple Myeloma
Investigator: Rajshekhar Chakraborty, MD
Status: Currently Recruiting
This study is looking at people who have recently been newly diagnosed with a type of cancer called multiple myeloma (NDMM). The purpose of this study is to learn about the safety, tolerability (how your body reacts to the study drug), and effectiveness (tumor shrinkage) of linvoseltamab (called study drug) in participants with NDMM as a first step in…
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Study of BMS-986393 in Patients with Multiple Myeloma (MM)

Condition: Cancer / Multiple Myeloma
Investigator: Divaya Bhutani, MD
Status: Currently Recruiting
The purpose of this study is to test whether BMS-986393 in combination with other anti-cancer drugs is safe and effective at treating people with multiple myeloma (MM) that has come back after previous treatment (relapsed) or is not responding to current treatment (refractory). The researchers think that the combinations of alnuctamab, mezigdomide, or…
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Study of REGN5458 in Patients with Multiple Myeloma

Condition: Cancer / Multiple Myeloma
Investigator: Rajshekhar Chakraborty, MD
Status: Currently Recruiting
This study is the first time REGN5458 will be combined with other cancer therapies. The main goal is to understand if REGN5458 can be given safely with other cancer study treatments, and if so, what dose of REGN5458 should be used for each combination. The investigational drug, REGN5458, is not approved by the Food and Drug Administration (FDA).
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Study of Venetoclax in Combination with Dexamethasone in Patients with Light Chain Amyloidosis

Condition: Cancer / Multiple Myeloma
Investigator: Rajshekhar Chakraborty, MD
Status: Currently Recruiting
The purpose of this study is assess the safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis. Furthermore, the purpose of phase 2 part of this study is to compare the effectiveness of venetoclax and…
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