160 Clinical Trials for Various Conditions
The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life.
The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.
The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.
The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.
This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.
Although much investigation has been done on the use of ferning in the second and third trimesters, particularly with the development of rapid protein clinical assays, there appears to be lower ferning rates in clinical practice with traditional techniques compared to previous published research on the subject. Much of the older study designs are lacking in detail and lack a large enough sample sizes at each gestational age to appropriately interpret the significance of ferning results by gestational age. Additionally, a large premise for the current tests used to diagnose rupture of membranes is based on these older studies. Given this, we propose collecting amniotic fluid vaginally to evaluate for the presence of ferning in the second trimester to determine if there is a difference in ferning based on gestational age as well as the time interval after rupture of membranes in which ferning can observed on microscope examination.
The majority of patients suffering an Achilles tendon rupture develop long term functional deficits in the affected leg. The goal of the proposed study is to evaluate a new rehabilitation protocol using Neuromuscular Electrical Stimulation (NMES) for reducing muscle atrophy and improving tendon properties. If proven beneficial, the proposed protocol can be easily adopted and incorporated as part of routine care for Achilles tendon rupture.
Randomized controlled trial studying the use of vaginal cleansing with chlorhexidine gluconate for pregnant women with PPROM (preterm pre labor rupture of membranes). The primary outcome will be pregnancy latency. Secondary outcomes will include various maternal and neonatal outcomes, and inflammatory markers from maternal blood, amniotic fluid, fetal cord blood and placental analysis.
This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy in the rehabilitation of Achilles tendon rupture (ATR). Muscle atrophy occurs following Achilles tendon rupture, whether managed non operatively or operatively, which has implications on patient outcomes. The goal of physical therapy in the perioperative period is to regain and ultimately return to activity. BFR has been proposed to reduce atrophy and maintain strength, which would theoretically mitigate the deconditioning effects of an injury on surrounding musculature. BFR is proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia and induction of growth cytokines, thus leading to muscle hypertrophy. The goal of this investigation is to determine if using BFR as an adjunct in physical therapy following ATR would reduce muscular atrophy and lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR accelerates the rehabilitation process and allows patients to perform standard rehabilitative functional tests and return to play sooner. Furthermore, the investigators will investigate patient reported outcomes metrics. The investigators hypothesize that the BFR group will have significantly greater strength gains at all time points in both non operatively and operatively treated ATR. Previous studies have shown that BFR has potential in increasing Achilles tendon stiffness, tendon cross-sectional area, muscle strength and muscle hypertrophy. However, there is a lack of evidence regarding the use of BFR in both the pre and postoperative period specifically relating to ATR. The investigators believe that the use of BFR in the perioperative period surrounding an Achilles tendon rupture and ATR has the potential to significantly decreased muscle atrophy, improve patient satisfaction and lead to earlier return to sport.
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.
The study is to evaluate the accuracy of a test device called "PAMG-1" to see if a pregnant women has ruptured membranes in comparison to standardly used testing methods.
The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (MSC) recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of post-traumatic osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38 total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who have agreed to participate in the study and who will undergo primary surgical reconstruction by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw. Subsequent imaging and clinical evaluations will be longitudinally performed at several postoperative timepoints up to 12 months postoperatively.
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or because they do not have an AAA (control group). The purpose of this research study is to further study, through FEA, changes that occur in the mechanical properties of the aortic wall. The investigator will compare two radiotracers, 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan. The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth and/or rupture.
Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.
This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
The purpose of the study is to investigate imaging findings, which can help us to predict factors contributing to abdominal aortic aneurysm growth and rupture.
Premature rupture of membranes refers to the rupture of the fetal membranes prior to the onset of labor. Premature rupture of membranes is associated with a number of neonatal and maternal complications including an increased incidence of perinatal mortality and intra-amniotic infection. There is a need for improved diagnostic testing because of limitations of the current methods. PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.
Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the lack of data to support its benefits, and increasing evidence pointing to potential harms. In this study, the effects of bed rest compared to moderate activity will be on maternal mood and muscle strength will be evaluated in patients with preterm premature rupture of membranes (PPROM).
Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the vaginal canal before the onset of labor. The integrity of the amniotic membrane is compromised thereby increasing the risk of intrauterine infection and compression of the umbilical cord. PROM complicates 3% to 8% of pregnancies in the US and is responsible for 30% of preterm births. Intrauterine infection remains the most significant maternal and neonatal sequelae associated with PROM and this risk increases with the length of time from ruptured membrane to delivery. Induction of labor has been shown to reduce the rates of chorioamnionitis, endometritis and NICU admissions4. Specifically, induction of labor with prostaglandin agents followed by oxytocin, versus oxytocin alone has been shown to be effective for labor induction resulting in vaginal delivery. Management strategies for PROM have been controversial, and published studies on outcomes are over one to two decades old, which does not account for changes in clinical trends and practice patterns. Recently ACOG recommends that patients presenting at 37 weeks gestation or greater with PROM should be induced if not in labor, and "generally with oxytocin". In women with PROM without the onset of labor, the cervix is commonly unfavorable and induction with oxytocin alone may lead to an increased risk of cesarean section. With a c-section rate as high as 33%, women undergoing induction of labor have an increased risk of c-section and its associated morbidity and long term sequela. ACOG's recommendation for the use of oxytocin as the induction agent may be meant to avoid a theoretical increased risk of chorioamnionitis in this patient population however it does not take into account the status of the cervix, which may result in a increased risk of c-section. The purpose of the proposed study is to determine whether cervical ripening in women with PROM and an unfavorable cervix is associated with increase rates of vaginal delivery and decreased cesarean section rate compared to induction of labor with oxytocin alone. The investigators aim to determine the incidence of endometritis, and neonatal infection associated with PROM in the current medical environment of antibiotic prophylaxis and antenatal steroid use, taking into account the changes in patient characteristics.
Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery. Inclusion Criteria: * English speaking * pregnant woman \>15 weeks gestation undergoing an exam for ruptured membranes Exclusion Criteria: * Known placental previa * Active vaginal bleeding
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.
The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm. Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of AAA growth or rupture.
Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.
With evolving endovascular technologies there is a growing debate centered on the relative safety and efficacy of the currently accepted alternatives for the treatment of ruptured cerebral aneurysms in the face of acute subarachnoid hemorrhage (SAH). The purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular coiling of acutely ruptured cerebral aneurysms in a prospective, randomized fashion.
Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in stomach upset in some patients, causing them to stop taking the medication. Therefore, azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The working hypothesis is that there is no difference in the clinical effectiveness between antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging latency in PPROM.
The objective of this study is to determine, through a randomized clinical trial, whether bed rest is helpful for the management of pregnancies complicated by preterm premature rupture of membranes (PPROM).