Clinical Research Directory

Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery

This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Use of POCUS and STONE Criteria Together in the Diagnosis of Nephrolithiasis

Patients presenting to the emergency department with symptoms suggestive of renal colic will be included in the study at Kocaeli City Hospital's emergency department. Patients with nephrolithiasis considered among the preliminary diagnoses will be enrolled in the study; demographic data, vital signs, and physical examination findings will be recorded on pre-prepared standard data forms. STONE criteria scores will be calculated by emergency assistants, and bedside ultrasound will be performed for patients. Ultrasonographic findings suggestive of renal colic, such as hydronephrosis, the presence of primary stones, acoustic shadowing of the stone, the presence of twinkle artifact, presence of jet flow, and presence of bladder debris, will be evaluated, and the obtained data will be recorded on the standard data form by the performing assistant physician. In patients where computed tomography, which is the gold standard for detecting stone presence without intervention, is deemed appropriate without any intervention to the primary examining physician, the computed tomography results and ultrasound findings will be compared. The study aims to evaluate the effectiveness of bedside ultrasound application in diagnosing stone presence in patients, its success in predicting re-admission to the hospital within 1 month, its success in predicting possible alternative diagnoses and complications, in addition to the stone criteria applied in the patients.

Application of the Sentire C1000 for Ureteral Stricture Repair

The purpose of this clinical study is to evaluate the safety and efficacy of the Sten® Laparoendoscopic Surgical System C1000 for benign ureteral reconstruction surgery. This is a single-arm, open-label, prospective, non-randomized cohort study. Eligibility criteria for recruitment to this study included how to include labeling: (1) patients aged ≥18 years and ≤80 years, male and female; (2) patients who need to undergo upper urinary tract repair surgery; (3) patients who are suitable for ureteral reconstruction surgery as confirmed by the investigator; (4) subjects voluntarily participating in the clinical trial and agreeing to, or their guardian agreeing to, and signing an informed consent form; (5) willingness to cooperate with and complete the trial follow-up and related examinations. The research subjects of this project were recruited openly, and the patients were enrolled after being informed of the study-related information, risks and benefits by the project participants and then screened to meet the enrollment criteria. A total of 50 patients will be enrolled. The study objectives and endpoints include the following: primary endpoints: (1) the rate of surgical non-referral (2) the success rate of surgical treatment; secondary endpoints: (1) the loading time (2) the operating time of the surgeon (3) the estimated intraoperative blood loss (4) the postoperative patient's pain scores (5) the evaluation of the physiological load of the surgeon (6) the evaluation of the mental load of the surgeon (7) the rate of intraoperative transfusion (8) the duration of the hospital stay after the operation (9) the evaluation of physician satisfaction (9) the evaluation of physician's satisfaction). (9) Physician satisfaction rating (10) Overall postoperative complication rate (11) Adverse events and serious adverse events (12) Device defects (13) Postoperative readmission rate (14) Reoperation rate (15) Mortality rate. The expected overall duration is 9 months, with an expected enrollment time of 6 months and a subject follow-up time of approximately 3 months.

Mild Fetal Hydronephrosis, Gestational Diabetes and Spontaneous Resolution vs Moderate-severe Fetal Hydronephrosis, Obstructive Causes and Worse Postnatal Outcome

Renal pelvis dilatation can be a relatively common finding on obstetric antenatal ultrasounds occurring in 1% to 5% of all pregnancies, with a known predilection for the male sex. Fetal hydronephrosis can be ascribed to structural obstructive conditions or functional origin causes. The latter are characterized by the transience of the clinical picture, which appears milder in degree, onset at later gestational ages, a course of substantial stability and spontaneous regression, sometimes as early as during pregnancy or early postnatal life. Fetal hydronephrosis related to structural obstructive causes, on the other hand, classically presents an earlier onset, a worsening course during pregnancy and often requires postnatal surgical correction. Additional ultrasound findings that contribute to prognosis include those indicative of an associated congenital anomaly of the kidneys and urinary tract (CAKUT). The risk of postnatal pathology in mild prenatal hydronephrosis is reported to be between 11% and 15%. It increases up to 27-45% in fetuses with moderate prenatal hydronephrosis and up to 53- 88% in cases of severe hydronephrosis. In the outpatient clinical practice of prenatal ultrasonography, is hypothesized an association between mild, mono- bilateral fetal hydronephrosis as an isolated ultrasound finding and gestational diabetes. In this population, this study aims to highlight the stability of the sonographic picture, relative improvement with effective glycemic control with diet or medical therapy, and subsequent spontaneous resolution in early postnatal life. A possible causal link between the two conditions could lie in the association of poorly controlled gestational diabetes with fetal hyperglycemia, which would cause increased osmotic diuresis resulting in polyuria and subsequent hydronephrosis. In contrast, is hypothesized an association between earlier-onset moderate-to-severe fetal hydronephrosis, its worsening progression throughout pregnancy and the anatomic abnormalities finding in the fetal urinary tract, in no correlation with maternal gestational diabetes. This condition correlates with increased postnatal complications (e.g., recurrent urinary infections, need for antibiotic prophylaxis, etc.) and a more severe postnatal outcome that may require surgical correction. To date, there is limited scientific literature concerning the functional causes of fetal hydronephrosis, as opposed to obstructive causes, which have been more analyzed and classified. This ambispective observational case-control study aims to evaluate pregnant women accessing the obstetric ultrasound and obstetric day hospital outpatient clinics of the Fondazione Policlinico A. Gemelli- IRCCS with ultrasound finding of mono-bilateral fetal hydronephrosis during the second and third trimester of pregnancy. In this population we will define the fetal hydronephrosis degree, its evolution, the association with maternal metabolic disorders, in order to estimate postnatal morbidity. All prenatal ultrasound images will be interpreted by the same group of specialists. To assess the degree of fetal hydronephrosis, the classification system developed by SFU in 1993 will be used. The latter is the most commonly used among pediatric urologists for grading neonatal and infant pelvic disorders: * grade 0: no dilatation, calico walls paired with each other * grade 1 (mild): dilation of the renal pelvis without dilation of the calyces * grade 2 (mild): dilatation of the renal pelvis (mild) and calyces * grade 3 (moderate): moderate dilatation of the renal pelvis and calyces; dulling of the fornixes and flattening of the papillae; possible mild cortical thinning * grade 4 (severe): gross dilatation of renal pelvis and calyces; cortical thinning. The diagnosis of gestational diabetes will be defined by an altered oral glucose tolerance test (OGTT) result or elevated glycosylated hemoglobin (HBA1c) values. In addition, the presence of a flat OGTT trend suggestive of an insulin resistance condition will also be considered pathological. The OGTT will be performed between weeks 24 and 28 of pregnancy, as per the guidelines. In patients at high risk of developing gestational diabetes, early screening will be performed between sixteen and eighteen weeks of pregnancy. Amniotic fluid will be assessed according to one of the following ultrasound criteria: * calculation of amniotic fluid index (AFI) by summing the vertical depth of amniotic fluid measured in each quadrant of the uterus * With the single deepest pocket (SDP). Polydramnios is diagnosed when the amniotic fluid index (AFI) is ≥ 250 mm, the single deepest pocket (SDP) is ≥ 80 mm, or when the examiner subjectively assesses an increase in amniotic fluid. Oligohydramnios is diagnosed when the AFI is ≤ 50 mm or when the SDP is ≤ 20 mm.

Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture

To conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.