View clinical trials related to Recurrence.
Filter by:This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic Breast Cancer (MBC) who experienced disease recurrence or progression during or after treatment with CDK4/6i therapy for at least 8 weeks. As of 9th October 2020, participants in the Venetoclax + Fulvestrant arm, have all discontinued Venetoclax treatment and have continued on Fulvestrant treatment alone.
Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with recurrent Clostridium difficile Associated Disease (CDAD). 162 male or female subjects will be enrolled in the study. Enrolled subjects will be randomized at each site to receive either FMT by enema or placebo by enema in a 2:1 ratio. Study duration is 3 years, subject participation duration is approximately 1 year. The primary study objectives are: 1) to evaluate the safety of FMT(s) delivered by enema vs. placebo delivered by enema and 2) to determine efficacy of FMT delivered by enema vs. placebo delivered by enema.
Crohn's Disease (CD) is a chronic pathology characterized by exacerbations and remissions. Recurrent inflammation can cause bowel strictures, fistulae (often perianal) or abscesses. CD often requires intestinal resection. Surgery in CD is not curative, Therefore, endoscopic follow-up 6-12 months after surgery is recommended. Given the association between enteric bacteria and postoperative CD recurrence, antibacterial agents were shown to be effective in reducing the severity of endoscopic recurrence, but prolonged administration causes significant toxicity. The efficacy of "systemic antibiotics" and the experimental evidence of the central role of luminal flora as an essential factor in the development of post chirurgic CD recurrence provide the rationale for evaluating a locally acting antibiotic like Rifaximin.
This phase I/II trial studies the side effects of durvalumab, tremelimumab and hypofractionated radiation therapy in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving durvalumab, tremelimumab, and hypofractionated radiation therapy may work better in treating patients with recurrent or metastatic head and neck squamous cell carcinoma.
In this prospective pilot study, patients with DFU visiting the Indiana University Comprehensive Wound Center will be enrolled. Patients enrolled in the study will be followed for 16 weeks for wound closure(Phase A), and will then begin Phase B where TEWL measurements and wound recurrence will be followed up for up to 12 weeks.
This is a study looking at the feasibility of conducting a larger definitive research trial looking at the effectiveness of high intensity interval training in individuals who are scheduled for electro-cardioversion. Usual care for these participants is to go home and continue with their typical daily routine. The investigators will test whether participating in 3-weeks of thrice-weekly high intensity interval training before electro-cardioversion can lengthen the time to recurrence of atrial fibrillation after electro-cardioversion in these individuals. Participants will be asked to come to the University of Ottawa Heart Institute for a baseline visit at which fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), heart rate variability and habitual exercise levels will be measured. Participants will then be randomized to either the exercise group or the usual care group. Those randomized to the usual care group will go home for 3-weeks and continue with their typical daily routine. Those randomized to the exercise group will return to the Heart Institute three times per week for 3-weeks to participate in a high intensity interval training program prior to their electro-cardioversion. All participants will be asked to measure daily heart rate and rhythm using the AliveCor system which is compatible with their Smartphones, for up to 12-months following their electro-cardioversion. All participants will be asked to return at 3-weeks (and prior to their electro-cardioversion) to measure fitness (cycle ergometer), body composition (weight, height, waist circumference and percentage body fat), and habitual exercise levels. The entire study should last approximately 24-months. Participants will be involved for 52-weeks. The investigators are looking to recruit 20 participants total for the feasibility trial. The investigators hypothesize that recruitment rates, drop-out rates, and adherence to the intervention will support a larger definitive trial.
The combination lenalidomide plus low-dose dexamethasone (Rd) is an active treatment for Multiple Myeloma (MM) patients, both at diagnosis and at relapse. Pomalidomide, is an immunomodulatory molecule (IMID), derivative of thalidomide, developed to improve the efficacy and reduce the toxicity of the parent molecule. Pomalidomide and dexamethasone (pom-dex) proved to be an effective and safe treatment in MM patients refractory to lenalidomide and refractory/intolerant to bortezomib. The addition of chemotherapy to novel drugs has been evaluated both at diagnosis and at relapse. The combination of pomalidomide-cyclophosphamide-prednisone proved to be safe and effective in relapsed/refractory MM patients. The combination pomalidomide-cyclophosphamide-dexamethasone (pom-cyclo-dex) was tested in a phase II study in patients with relapsed and refractory MM, demonstrating a good tolerability using pomalidomide at the dose of 4 mg. Pom-cyclo-dex resulted in a superior response rate and Progression-Free Survival (PFS) compared to pom-dex. The increased hematologic toxicities, as a result of the addition of oral cyclophosphamide, were manageable. With an overall response rate of 65% the combination demonstrated a promising efficacy.The first aim of our trial, is to compare the combination of pom-cyclo-dex vs pom-dex. Relapsed myeloma is defined as previously treated myeloma that progresses and requires the initiation of salvage therapy. According to International Myeloma Working Group (IMWG) recommendation, biochemical relapse is defined as an increase of ≥ 25% of tumor burden from lowest value, without any CRAB feature (CRAB is defined as the onset of clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) and detected in 2 consecutive determinations. Clinical relapse requires one or more direct indicators of progressive disease and end organ dysfunction (CRAB features). Treatment at relapse should start in case of clinical relapse or a significant paraprotein increase (doubling of M-component in 2 months). In case of biochemical relapse the standard is observation only, as in case of asymptomatic MM at diagnosis. However, a recently published trial, showed improved PFS and OS for newly diagnosed asymptomatic patients treated with lenalidomide and dexamethasone in comparison with observation only. Our hypothesis is that similarly, in the relapse setting, patients may benefit from an early intervention, meaning a treatment at biochemical relapse and not only in case of clinical relapse or rapid increase of M-component.
Phase I/II trial in which participants with recurrent glioblastoma will receive a combination of tumor treating fields(portable device), nivolumab with or without ipilimumab.
This phase II trial studies how well computed tomography perfusion imaging works in predicting outcomes in patients with ovarian, fallopian tube, or primary peritoneal cancer who are receiving bevacizumab. Computed tomography perfusion imaging monitors the effects of the drug treatment on the blood flow to the tumor, and may help to predict whether a certain drug therapy is likely be successful in a patient with ovarian, fallopian tube, or primary peritoneal cancer.
The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.