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Filter by:This study will be conducted in three parts. Part A is a dose-escalation study to determine two safe and tolerable doses of ASN001 for men with metastatic castration resistant prostate cancer. Part A will also characterize the pharmacokinetics and pharmacodynamics of the ASN001 through blood sampling. Subjects in Part B will receive one of two doses identified in Part A to determine which one is more effective, and collect additional pharmacokinetic data. Part C is an extension for subjects completing either Part A or B.
The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.
LAY SUMMARY Clostridium Difficile (C.difficile) is a bacterial infection that can cause an inflammation of the colon, (C.difficile colitis). This sometimes progresses to a sudden and severe illness. The present treatment for fulminant colitis is a total abdominal colectomy with end ileostomy. This means, a surgery is performed which removes the entire diseased colon. The end of the small intestine is then brought out to the front of the abdomen as a stoma, and the patient wears a bag. Despite this invasive treatment, there remains a significant rate of death (38-50%). In addition, patients have a long recovery after this long operation and many (67%) will not be fit for a second big operation to remove the stoma (that is to reconnect the intestine). The purpose of our study is to determine if a loop ileostomy with colonic lavage will result in better outcomes. A loop ileostomy is when a loop of small intestine is brought out to the abdomen and the colon remains in the abdomen. The diseased colon, which is preserved, is washed with a warm solution (like the solution used in a colonoscopy preparation) and then treated with an antibiotic via this ileostomy. So far, one study has been done using a loop ileostomy with colonic lavage. 42 patients who underwent this treatment were compared to 42 patients that underwent the standard of care (complete removal of the colon with end ileostomy). The 42 patients who underwent a loop ileostomy showed a significant decrease in rate of death compared to the standard of care. Also, in the study, patients who underwent a loop ileostomy had a much higher rate of reconnection of the intestine (closing the stoma). The purpose of this study is to see if a loop ileostomy with colonic lavage can treat patients with fulminant colitis with less risk of death than the standard of care. Once the patient is diagnosed with fulminant colitis and meets the eligibility criteria, he/she will be asked by the surgeon on-call if they would like to participate in this research study. If they agree to be in this study, they must first sign a consent form. They may be asked by the surgeon to enroll in either the investigational arm (loop ileostomy) or the standard of care arm. After surgery, all patients will receive the same standard routine care. During the hospital stay, information will be taken from their chart for purposes of the study. Routine follow up visits with their surgeon will be at 2, 3, 6, and 12 months after surgery. If the patient decides to be in the study, the patient will be expected to complete all the follow up study visits. The patient will not be required to do anything extra or have any extra tests if they decide to be in the study at any of these visits.
The purpose of this study is to evaluate the safety and tolerability of humanized IgG4 (kappa) isotype monoclonal antibody against CEACAM1 (CM-24 [MK-6018]), administered intravenously as monotherapy and in combination with Pembrolizumab (MK-3475), in participants with selected advanced or recurrent malignancies. Escalating multiple doses will be evaluated to determine the recommended dose for Phase 2 clinical studies.
This phase II trial studies how well combination chemotherapy works in treating patients with pancreatic cancer before undergoing surgery. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil (FOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
This study will assess the safety and effectiveness of ImmunoPulse IL-12® in treatment-refractory metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC). ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid deoxyribonucleic acid [DNA] vaccine therapy (tavo-EP) administered using the OncoSec Medical System (OMS). Intratumoral tavo is a gene therapy approach to directly induce a pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.
The investigators wish to conduct a preliminary study to examine the efficacy of meditation among patients with Post Treatment Lyme Syndrome (PTLDS). Specifically, the investigators will use the breathing, meditation, and stretching techniques common to Kundalini Yoga practice. The investigators plan to assess the degree in which this practice can reduce Post-Treatment Lyme Disease symptoms. Because fatigue and pain are so common among patients with PTLDS, the primary focus of this study will be fatigue and pain. Secondary outcomes will include cognitive complaints, physical and mental functioning, medical utilization, somatic symptoms, and psychopathology.
The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).
The purpose of this pilot study is to test the safety of oral ketamine to treat acute pain after amputation surgery. The objective of the proposed research is to conclusively determine if oral ketamine is a safe alternative analgesic to opioid for acute pain in subjects undergoing elective amputation of the lower extremity. All participants will receive oral ketamine.
This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.