Clinical Trials

The purpose of this study is to better understand why patients get infectious complications after colon or rectal surgery by identifying the bacteria present on the skin and within the gastrointestinal tract in both healthy volunteers undergoing a colonoscopy, and in patients undergoing colon and rectal surgery. By comparing the bacteria within these two groups, we will better understand the causes of postoperative infectious complications.

Does a wound vac dressing prevent wound infection after heart surgery?

The purpose of this study is to determine the sensitivity, specificity, positive and negative predictive values of molecular detection of microorganisms, detection of microbial proteins and antibodies against microorganisms, and inflammatory markers (e.g., leukocyte esterase, CRP) in synovial fluid for the diagnosis of prosthetic joint infection (PJI).

The purpose of the study is to determine the extent of donor site morbidity after harvesting the medial femoral condyle for scaphoid nonunion treatment. The outcomes being measured are: superficial infection, deep infection, pain (short term), pain (long term), knee function and quality of  scar.

The purpose of this study is to demonstrate the tests' performance when compared to the detection of periprosthetic joint infection (PJI) using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI. This criteria-based definition of PJI places emphasis on culture techniques that identify pathogens, but also provides for minor criteria that can be used to diagnose PJI. This study will also calculate the tests' clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV).

The aim of this study is to identify difficult to diagnose microbial pathogens causing infections using blood or urine for identification of bacteria, viruses, fungi or parasites that are not detectable or are difficult to detect using current diagnostic techniques.

This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with parainfluenza infection.

All subjects will have additional PK and Immunogenicity blood samples collected.

The overall aim of this study is to evaluate the clinical utility of the QuantiFERON-CMV test in solid organ transplant recipients on CMV prophylaxis to predict development of CMV disease after completion of prophylaxis. Our hypothesis is that in CMV D+/R- solid organ transplant recipients, the development of immunity as measured by a positive QuantiFERON CMV assay will predict a lower risk of CMV disease after prophylaxis is completed.

The purpose of this study is to test whether our developed real-time HPV detection platform (HPView) performs at a comparable level to the clinical gold-standard.

The DRCFI treatment will influence the time to first pulmonary exacerbation compared to placebo.

The primary purpose of this study is to assess novel tumor genomic biomarkers (TRAF3 and CYLD gene defects and HPV integration) of recurrence risk in patients with Human papillomavirus+oropharyngeal squamous cell carcinoma (HPV+OPSCC) undergoing curative-intent therapy. 

The purpose of this study is to describe the clinicopathological features and characterize the genetic variants (by Whole exome sequencing).

The purpose of this study is to learn more about the microbes (bacteria) that live in the vagina and the bladder. The investigators are doing this research study to understand the relationship between microbes (the microbiome) and the occurrence of urinary tract infection following surgical removal of the uterus and pelvic organ prolapse repair.

The purpose of this research is to study the natural history of "ventilator associated pneumonia" and its causes and treatments.

The purpose of this study is to examine the impact on HPV rates in the overall clinical practice before and after the practices changes have been implemented based on the focus groups from prior protocols.

The objective of this study is to evaluate the impact of the Alere™ PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.

This study is to see if PCR test developed at Mayo Clinic to diagnosis C. Difficile infections is able to predict the risk of recurrent infection.

The purpose of this study is to compare the rates of postoperative urinary tract infections (UTI) between patients who undergo cystoscopy using 50% dextrose injection plus bladder washout versus normal saline after hysterectomy for benign indications

The purpose of this study is to evaluate clinical experience with donor screening for fecal transplant, and to evaluate the outcomes from fecal transplant and understand risk factors for fecal transplant failure and relapse after fecal transplant.

The overall aim of this study is to determine whether solid organ transplant recipients who develop immunity to cytomegalovirus (CMV) after an initial episode of CMV disease as measured by the QuantiFERON-CMV assay are at lower risk of CMV recurrence in the future.

The purpose of the study is to ascertain the efficacy of implementation of standard treatment guidelines for the treatment of C. difficile infection based on disease severity and number of instances of this infection.

Subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to assess safety and efficacy of SER-109 in reducing recurrence of Clostridium difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in Study SERES-012.

The purpose of this study is to compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and received antilymphocyte induction therapy.

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.

Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.

The purpose of this study is to see how effective a new technology called the electronic nose is in identifying specific infection (C. difficile) from stool samples, by analyzing the gasses the stool gives off.

The purpose of this open-label extension of CDI-001 (subsequently referred to as PRISM 3) is to evaluate the safety and efficacy in reducing recurrence of CDI in adults who had a recurrence within 8 weeks of receiving CP101 or placebo in PRISM 3. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in the extension study and administered CP101. Approximately 70 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The ...

This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota® (CP101) in Subjects with Recurrence of Clostridium difficile Infection (PRISM3)

The purpose of this study is to estimate the success, recurrence, and complications over the 90 day follow up period for the treatment of C. difficile infection in adult solid organ or stem cell transplant patients.

The purpose of the study is to determine if overall mortality is affected one year after a hematopoietic stem cell transplant (HCT) in patients given a vaccine to prevent cytomegalovirus (CMV). Safety of ASP0113 in subjects undergoing allogeneic HCT will also be evaluated.

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in subjects with recurrence of Clostridium difficile infection.

The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infections in children. In the current protocols, which are more than 90% effective, each child who is receiving a fecal transplant has to provide their own donor stool, usually from a parent or close relative. This requires considerable screening costs for each case and is logistically complicated as the donor must be present and must stool ...

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary hypothesis is that the area under the concentration-time curve from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of adults with bezlotoxumab,

The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of ASP0113 in this patient population.

The purpose of this study is to study HIV infected individuals or others who have had another infection or inflammatory condition that may affect the content or structure of lymph nodes or may have none of these conditions and the sample will be used as a normal control.

To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor.

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

The purpose of this study is to evaluate the safety and effectiveness of the VERIS CMV Assay as an aid in the management of anti-CMV treatment for solid organ transplant patients by showing that virus levels are in agreement with the observed clinical status.

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%.

There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer ...

The purpose of this study is to determine if an investigational treatment (Maribavir) is safe and effective in treating transplant recipient patients with cytomegalovirus (CMV) infections that are refractory or resistant to treatment.

The purpose of this study is to evaluate the efficacy of initial diagnosis of H Pylori with Tech Lab Quik Chek and efficacy of H. Pylori Chek on patients that have been treated for H Pylori. 

This is a study of two different approaches for the prevention of CMV disease in liver transplant recipients. The primary purpose is to determine if Preemptive therapy is the same or better than Prophylaxis therapy for the prevention of CMV disease in CMV seronegative recipients that receive a CMV positive liver transplant. Patients meeting study criteria and who have provided informed consent will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg orally once daily for 100 days or preemptive therapy (weekly monitoring for asymptomatic CMV viremia by ...

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

The purpose of this study is to evaluate the clinical difference between the LASER and topical vaginal estrogen in treating patients with recurrent urinary tract infections (rUTI). 

The purpose of this study is to see if the investigators can identify early those patients who are admitted to the hospital and have a urinary tract infection (UTI) or those patients that develop a UTI during their hospitalization.

The purpose of this study is to evaluate if Vancomycin Resistant Enterococci (VRE) can be eradicated in patients with Clostridium Difficile infection (CDI) through treatment with Fecal Microbiota Transplantation (FMT) when FMT is being done to treat recurrent CDI rather than VRE.

608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

The purpose of this study is to evaluate the safety and effectiveness of CP101 treatment in adults who had a Clostridum difficile Infection (CDI) recurrence within 8 weeks of receiving CP101 or placebo.

The purpose of this study is to assess the effectiveness and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.

The purpose of this study will evaluate the safety and effectiveness of VE303 for participants with recurrent Clostridium difficile infection (rCDI).

The purpose of this study is to reduce disparities in cervical cancer screening and mortality among women vulnerable to health disparities based on social determinants of health. We are specifically interested in identifying non-traditional sites for cervical cancer screening and education regarding HPV vaccination outside of the primary care and gynecologic clinic settings.   

The purpose of this study is to extend the previous SERES-004 study in patients who had a recurrence of clostridium difficile infection within the first 8 weeks of participation.  

The purpose of this study is to demonstrate the efficacy and safety of RBX7455 (an oral microbiota based drug) for the treatment of recurrent clostridium difficile infection (CDI) in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy. Study subjects will have their diarrhea resolved, i.e., would be having less than 3 watery bowel movements at the time of study enrollment for 48 hours or more.

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.

The purpose of this trial is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with Vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.

The purpose of this research study is to establish a pool of healthy donors who will regularly participate in our research studies of human immunity. The studies in our laboratory investigate the role of human blood cells in immunity to fungal disease and lung fibrosis. Most of our studies require blood that is freshly drawn. Thus, we propose to draw blood on an as needed, ongoing basis.

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment with RBX2660 (microbiota suspension).

To assess the safety and tolerability of RBX2660 in subjects with recurrent CDI who have had prior recurrent CDI that was resolved with antibiotic treatment.

The purpose of this study is to evaluate the safety and tolerability of ART24 after 7 or 28 days of daily administration in recently-cured C. diff infection subjects.

The purpose of this research is to evaluate the primary objectives of safety and effectiveness (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults > or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentrations and HRQoL outcomes of CRS3123 and additional efficacy endpoints as secondary objectives.

The purpose of this study is to confirm the effectiveness of RBX2660 as compared to a placebo in preventing recurrent episodes of Clostridium difficile Infection (CDI) through 8 weeks.

This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

The purposes of this study are to assess awareness and acceptability of HPV testing for cervical cancer screening and patient self-collection of vaginal swabs among women aged 30 to 65 years old, to assess awareness and acceptability of HPV testing for cervical cancer screening and patient self-collection of vaginal swabs among primary care clinicians, and to identify insights from regional and national thought leaders in the fields of primary care and cervical cancer screening on strategies to improve uptake of primary HPV screening and opinions on patient self-collection by conducting key informant interviews. 

The purpose of this study is to see if molecular methods can predict Helicobacter pylori antimicrobial resistance patterns and predictions agree with current gold standard antibacterial susceptibility testing (AST) agar dilution.  

The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

The purpose of this study is to evaluate microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of Clostridium Difficile Infection (CDI) after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

The purpose of this study is to evaluate surgical sterility, the microbiome, and infections post mastectomy with immediate/tissue expander surgery by using OR camera recording, surgical site and/or microbiome analysis.

The purpose of this trial is to evaluate the effectiveness, safety, and tolerability of a single oral administration of study drug CP101 for the prevention of recurrent Clostridioides difficile Infection (CDI) in adult patients.

This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm (Part A) and an optional open-label treatment arm (Part B). After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized to receive either the study drug CP101 or placebo in Part A of the trial.  Patients will be evaluated for CDI recurrence and safety ...

The purpose of this study is to answer whether plasma circulating tumor DNA (ctDNA) obtained by serial analysis before, during, and following surgery, radiotherapy, chemotherapy, and/or immunotherapy for cervical cancer will allow for risk stratification, individualized treatment decision making, monitoring of treatment response, and early detection of residual or recurrent disease in patients presenting with human papillomavirus (HPV) mediated cervical cancer.

The purpose of this study is to create a special preparation protocol for the vaginal and perineal area that would include an occlusive dressing over the anal orifice (Anal Occlusive Dressing-AOD). We do hypothesize that it would eliminate or significantly reduce cross contamination of the bowel content with the surgical site and hence reduce the risk of SSI.

This clinical trial is studying biomarkers in diagnosing cervical lesions in patients with abnormal cervical cells. Studying biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.

What is the difference in the outcomes of patients treated with an articulating antibiotic spacer versus a static articulating spacer in the setting of two stage exchange for an infected total knee arthroplasty?

Some patients with head and neck cancer caused by human papilloma virus have a higher risk of recurrence. We are proposing to treat these patients with HPV vaccine with or without pembrolizumab during the window prior to surgery, in hopes of stimulating an immune response.

The purpose of this study is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).

The purpose of this study is to evaluate vaginal microbiome at baseline and at 3 months in menopausal women with either vaginal atrophy (with or without rUTI) or rUTI, following treatment of vaginal estrogen and LASER therapy, to evaluate the bladder microbiome at baseline and at 3 months in menopausal women with vaginal atrophy with rUTI undergoing treatment of vaginal estrogen or LASER therapy, and to compare the microbial communities between women who undergo vaginal estrogen with those who undergo LASER therapy.

The objectives of this study are to reduce the rate of bacterobilia driven surgical site infection (SSI) in patients undergoing pancreatic head resection by providing surgical team with NS data in the post-operative setting, and to reduce cost of care through reduction in SSI and improved antibiotic stewardship.

Achilles tendon rupture is a common injury and surgical treatment poses the risk of infection. An infected Achilles tendon is a difficult entity to treat due to a thin surrounding soft tissue envelope as well as poor tendon vascularity. In this retrospective review of cases examined at Mayo Clinic-Rochester, we seek to elucidate the clinical outcomes of patients who have undergone treatment for an infected Achilles tendon. 

The purpose of this study is to assess the outcome of prosthetic joint infection (PJI) treated with various therapeutic regimens using a prospective cohort study.

The purpose of this study is to evaluate the safety and effectiveness of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).

The purpose of this study is to evaluate the immune status of patients with Candida infection, particularly those that have infection that is difficult to treat. The study will also assess the role of interferon-gamma (a substance secreted by cells of the immune system).

The purpose of this study is to assess patients suspected of recurrent C. difficile disease (rCDI) and using a combination of clinical and laboratory markers to determine disease versus post infectious irritable bowel syndrome (IBS) with C. difficile colonization.

The purpose of this study is to compare ridinilazole with vancomycin as comparator to treat Clostridium difficile Infection (CDI) with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease.

The purpose of this study is to perform independent analysis of optimal synovial fluid diagnostic cutoffs for acute periprosthetic joint infection of the knee.

The purpose of this study is to evaluate the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients. evaluates the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients.

The study will consist of two parts. The purpose of Phase Ib is to evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies. The purpose of Phase II part 1 is to evaluate the effectiveness of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies including oropharyngeal SCCHN. The purpose of Phase II part 2 is to compare the Progression-Free Survival (PFS) of TG4001 in combination with avelumab vs avelumab alone in patients with recurrent or metastatic ...

The purpose of this study is to characterize the mucosal microbiome in patients who have recently been treated for Clostridium-difficile Infection (CDI) in comparison to that of control population to determine the effect of the mucosal associated microbiome on outcome of CDI.

 

Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and tolerability of the combination and to identify a RP2D.

Part B: Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their recurrent/persistent or metastatic cervical cancer.

The purpose of this study is to assess epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. 

The purpose of this study is to characterize mucosal and luminal microbiome in patients diagnosed with Clostridium difficile infection (CDI), at the time of diagnosis and after treatment, to determine the effect of mucosa associated microbiome on outcome of CDI and the effect of antibiotic treatment on mucosa associated microbiome

The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients.

The microbiome within the gut lumen has been found in prior studies to differ in individuals with C. difficile infection (CDI) in comparison to those without diarrhea. The microbiome associated with the mucosal surface on the colon has been noted to differ from that of the lumen in other clinical scenarios, although this has not been studied in depth in patients with CDI. The goal of this research is to characterize the mucosal microbiome in patients with CDI after treatment to characterize this microbiome and determine the effect on recurrence of CDI.

The purpose of this study is to  evaluate Lamprene (Clofazimine) to treat non-tuberculous mycobacterial (NTM) infections.

Preliminary indicates that there is a significant seasonal and regional variation in incidence and causative organisms for post traumatic wound infections after open fractures. This finding makes the current use of a generic antibiotic for prophylaxis suboptimal. In order to validate this original finding we need to conduct a large scale study to determine if the patterns of infection truly vary depending on the time of year and the region in which the fracture occurs, and if so to change the way prophylactic antibiotic use is administered.

The purpose of this study is to determine the quality of life scores for patients that have undergone subtotal petrosectomy and ear canal closure for cholesteatoma and/or chronic otitis media utilizing two previously validated quality-of-life scales.

This study is designed for patients with a cancer of the oropharynx (tonsils or base of tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six weeks of daily radiation therapy. This study investigates a less intense radiation treatment following surgery that uses half the dose of radiation given over two weeks rather than six weeks. Patients will be randomly assigned to receive the less intense treatment versus the traditional treatment by coin flip. Patients are twice as likely to receive the less intense treatment during randomization.

The purpose of this study is to determine whether 2-drug therapy is non-inferior to 3-drug therapy against pulmonary mycobacterium avium complex (MAC) disease, and whether 2-drug therapy is better tolerated than 3-drug therapy.

The purpose of this study is to assess the effectiveness of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory Invasive Pulmonary Aspergillosis (IPA).

The purpose of this study is to evaluate the effectiveness of ALIS + azithromycin (AZI) + ethambutol (ETH) compared to the empty liposome control (ELC) + AZI + ETH on patient reported respiratory symptoms at Month 13.

The purpose of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints.

We are doing this research study to find out if partners of subjects with oropharyngeal cancer are infected with human papillomavirus (HPV) in their mouth or throat. Human papillomavirus causes some types of oropharyngeal cancer. It is not known if sexual partners of patients are at higher risk of having oral or throat HPV infection. It is also unknown if certain sexual behaviors increase the risk of oral HPV infection

This study is being conducted to determine gene and protein expression profiles (i.e. which genes and proteins are turned off and on) of those with a possibility of developing osteolysis, infection, arthrofibrosis or metallosis of their THA/TKA.

This phase II trial studies how well radiation therapy and docetaxel work in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with docetaxel my kill more tumor cells.

The purpose of this study is to evaluate the effectiveness of inhaled molgramostim, administered open-label, to adult cystic fibrosis subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.

The primary goal of this study is to prospectively incorporate ctHPVDNA in combination with clinical and pathologic factors to appropriately select patients for treatment intensity. 

The purpose of this study is to evaluate the role of interferon-gamma (IFN-γ) in antifungal defense and its potential use in adjunctive immunotherapy.  Solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients are at increased risk for invasive fungal infections.  Mortality rates remain unacceptably high despite antifungal treatment. Novel therapeutic modalities are urgently needed. In this project, we propose to study the role of interferon-gamma (IFN-gamma) in antifungal defense and its potential use in adjunctive immunotherapy. 

The purpose of this study is to determine whether a common virus, cytomegalovirus (CMV), may increase fatigue and other symptoms following treatment for ovarian cancer.  

The purpose of this study is to evaluate the safety and tolerability of PC945 for the prevention of fungal aspergillus infections in the lung in patients who have received a lung transplant.

The purpose of this study is to determine the incidence of anogenital infection with high-risk HPV serotypes and HPV-associated anogenital lesions in female patients with newly diagnosed HPV(+)OPSCC and female partners of patients with HPV(+)OPSCC, and compare this with retrospective review of exams and paps obtained during routine well woman checks in Rochester MN.  

The purpose of this study is to evaluate the effectiveness and safety of PDS0101 administered in combination with Pembrolizumab in the first line treatment of adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

The purpose of the study is to evaluate the microbiological response and clinical effectiveness of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). Additionally, to determine the safety and tolerability of SPR720 in a participants population with NTM- PD 3. Also, the pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in a participant population with NTM-PD.