1,739 Clinical Trials for Various Conditions
The proposed pilot study is aimed at preliminary characterization of the TMNB injection in 20 healthy volunteers. Assessment of bite-force distribution and surface electromyographic activity of the temporalis and the masseter muscles, at rest and clench, before and after unilateral TMNB injection, will be the primary outcome measures. Post-injection assessments will be performed at 30 minutes, 2 hours, and 2 weeks after the injection. Participants will be surveyed regarding their experience receiving the TMNB injection (secondary outcomes).
Occlusion
Heart disease is a leading cause of death in the US. . Heart blood vessel chronic total occlusions are 100% blockages of the heart vessels. These patients often suffer from chest pain, shortness of breath, and depression. Heart doctors thread special cables from the groin and wrist to the heart and open up these 100% blocked vessels. . This treatment improves symptoms and quality of life. Exercise is very beneficial for health. Previous studies suggest that even a 1000 steps/day increase in daily steps can improve health. But, patients with occluded heart vessels are often inactive because they have chest pain, feeling tired, or are short of breath. It is unknown whether opening these 100% blocked heart vessels will help patients have a more active lifestyle, which is good for health. The goal is to measure the impact of opening these occluded heart vessels on daily exercise in this project. Specifically, the investigators will give a smart watch to patients referred for this treatment. The smart watch will track the patients' daily steps before and after the procedure.
Chronic Total Occlusion, Occlusion
The purpose of this study is to find out what effects (good and bad) that the study medicine called "liposomal bupivacaine" has on subjects that are undergoing a sternotomy. Liposomal bupivacaine solution, is a drug that the doctor will inject before they make the cut through patient's breastbone (sternotomy). Normally pain medicine like this is given right before the surgeon closes up the patient's breastbone, at the end of the surgery. For this study, they want to see if giving the medicine before they make the cut into the patient's breastbone helps their pain. They also want to find out if patients feel less pain after surgery with the study drug than they do with saline and possibly decrease the need for pain medicine. Subjects will be in the study for about 72 hours or until they are discharged from the hospital.
Cardiovascular Surgery, Pain, Postoperative, Block
The quadratus lumborum has since 2016 become standard of care for abdominal and retroperitoneal surgeries at UPMC-Shadyside Hospital, replacing paravertebral blocks, and as part of a broader multimodal analgesia institutional Enhanced Recovery After surgery protocol. Since the first description of this technique, several approaches to and anatomic targets within the quadratus lumborum plane have been described although their mechanism of action, spread, and relative clinical effectiveness remain areas of some debate. What is proposed here is to investigate the relative clinical effectiveness of the relationship high volume/low concentration of local anesthetic or low volume/ high concentration of local anesthetic.
Analgesia, Postoperative Pain, Block
A randomized trial comparing small versus large catheters in terms of occlusion and need for replacement to confirm differential occlusion risk based on catheter size. This study will be done to determine whether external ventricular drain catheter diameter has any effect on risk of occlusion.
Occlusion
Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. We are looking for ways to make them work better and last longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. All people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. This study will enroll 60 participants from UAB hospitals.
Pain
The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or treatment naïve.
Ischemia, Retinal Vein Occlusion, Pathologic Processes, Retinal Diseases, Eye Diseases
To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity
Dentine Hypersensitivity, Dental Pain
The present study is being conducted to assess the natural history of intermittent exotropia and to establish the effectiveness of occlusion in its treatment. Study Objectives: * To determine the effectiveness of occlusion for the treatment of intermittent exotropia among patients aged 3 to \< 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest * To determine the natural history of intermittent exotropia among patients aged 3 to \< 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest
Exotropia
The RAVE (Rubeosis Anit-VEgf) trial, utilizes monthly intravitreal Ranibizumab (Lucentis) injections for 9 months to see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic central retinal vein occlusion.
Ischemic Central Retinal Vein Occlusion
The purpose of this study is to assess and compare the clinical outcomes associated with common surgical interventions for the treatment of nasal airway obstruction (NAO).
Nasal Airway Obstruction
We are performing this research to study if routine flushing is necessary to prevent obstructions of a nephrostomy tube. This study will evaluate patients that have nephrostomy tube or will have nephrostomy tubes placed as part of their standard clinical care. If you agree to participate in this stuy, you will undergo randomized assignment to either continue to routinely flush your nephrostomy tube with normal saline or not to routinely flush your nephrostomy tube with normal saline. You will be in the study for approximately 3 months if you decide to stay for the whole study.
Nephrostomy
CERES-TANDEM is a multicenter study designed to improve the understanding of "tandem" ischemic stroke -those caused by two blockages in series, one in a neck artery and one in a brain artery-. Because tandem occlusion-related stroke tend to cause more severe brain injury and have been under-represented in major clinical trials, there is no clear consensus on which treatments work best. This study will help identify who is most at risk and which therapies lead to the best recovery. OBJECTIVES: Identify Risk Factors: Compare common stroke risk factors (e.g., high blood pressure, diabetes, high cholesterol, smoking) in patients with tandem occlusion versus those with single-site large vessel occlusions. Compare Clinical Outcomes of Reperfusion: Evaluate whether acute reperfusion treatments-such as clot-dissolving drugs (thrombolysis), mechanical clot removal (thrombectomy), and emergent carotid stenting-lead to better 3-month functional outcome (assessed by the modified Rankin Scale, ranging 0 to 6, with good functional outcome identified with mRS score 0-2) compared to medical management alone in tandem occlusion and isolated cervical artery occlusion. Assess Post Stent Therapy: Among patients who receive emergent stenting, determine whether different post-stenting regimens (antiplatelet agents, anticoagulants, or no additional therapy) affect functional outcomes, bleeding events, or stroke recurrence. STUDY DESIGN: Type: cohort study pooling data from prospective registries of cerebrovascular diseases at participating sites Setting: Stroke Unit, Cesena Hospital (PI MR), Interventional Neuroradiology, Vall d'Hebron Research Institute, Barcelona (PI FD), Radiology, Boston Medical Center (PI TN); and other participating stroke centers Time Frame: Patients treated between 2018 and 2024. Sample Size: Approximately 2800 cases overall DATA COLLECTION: Sources: Clinical records, imaging reports (CT perfusion, angiograms), lab results, hospital discharge summaries, and longitudinale stroke registry databases. Data Safety: case information is anonymized using encrypted study IDs; only aggregate data will be reported. Follow-Up: Standard-of-care follow-up visits at 3 months (minimum) and up to 12 months or until death. Outcomes include functional status (mRS), recurrence of stroke or TIA, symptomatic intracranial hemorrhage, major bleeding, and all-cause mortality OUTCOMES AND ANALYSIS: Primary Outcome: Functional outcome, identified by the mRS and tested between groups with ordinal shift between mRS categories (0-6). Secondary Outcomes: functional status at 3 months (excellent outcome mRS 0-1, good outcome mRS 0-2) Additional outcomes: early neurological deterioration; symptomatic intracerebral hemorrhage and successful recanalization (defined as TICI 2b or higher). PLANNED ANALYSIS (see Detailed Description for full analytical protocol): * Compare outcomes in emergent stenting vs no stenting groups depending on stent subtype and endovascular approach * Compare outcomes in emergent stenting vs no stenting groups depending on antithrombotic treatment before, during and after the endovascular procedure * Define the potential impact of early statin treatment on the interplay between stenting vs no stenting and the outcomes. STATISTICS: Medians with IQRs and means with SDs together with percentages will be used to present the distribution of ordinal, continuous, and categorical variables. Baseline characteristics across groups will be compared using the Pearson χ2 test for categorical variables and t test or the Kruskal-Wallis test, as appropriate, for continuous and ordinal variables. Given the nature of data deriving from prospective registries, inverse probability of treatment weighting (IPTW) will be implemented, which is an application of propensity scores that calculates the probability of being exposed to one treatment versus the other and creates a pseudo-population based on the probabilities so that potential confounders are equally distributed across the treatment groups. Models will be weighted for prespecified variables known to potentially impact the outcome, and will also consider factors of imbalance between groups. In case of crossovers, a stratum-based analysis according to predefined estimand will be applied (direct intervention effect on outcomes and total-effect; estimand approach in detailed description). DISSEMINATION The results will be disseminated in international peer reviewed journals. CERES-TANDEM is promoted by * Bufalini Stroke Center, AUSL Romagna, Cesena, Italy (PI Dr. M. Romoli) * Interventional Neuroradiology Unit, Vall d'Hebron Institut de Recerca, Barcelona, Spain (PI Dr. F. Diana) * Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts, USA (PI Dr. T. Nguyen)
Acute Ischemic Stroke Related to Tandem Occlusion, Acute Ischemic Stroke Due to Isolated Cervical Artery Occlusion
This single-center study aims to evaluate both immediate and long-term outcomes of stellate ganglion block (SGB) in a cohort of rigorously phenotyped patients with Postural Tachycardia Syndrome (POTS). By assessing the effects of SGB, this study seeks to determine its viability as an intervention for symptom control in POTS.
Postural Tachycardia Syndrome
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).
Analgesia
The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).
Congenital Diaphragmatic Hernia
The goal is to look for qualitative differences in visual search behavior when one search is performed many times in a row compared to when multiple search tasks are intermixed. Four search tasks are tested. The target is the same in every task but the types of distractors change from task to task. In this version, observers get some degree of choice in what they are searching.
Vision, Healthy, Attention
The goal is to look for qualitative differences in visual search behavior when one search is performed many times in a row compared to when multiple search tasks are intermixed. Four search tasks are tested. In the Mixed condition, the four tasks are randomly changed from trial to trial. In the Blocked condition, each task is run as a block of 100 trials.
Vision, Healthy, Attention
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.
Nasal Airway Obstruction
This pilot study aims to investigate the effects of nerve blocks in patients with diabetic peripheral neuropathy through a double-blinded, randomized trial involving 4 patients. Each participant will receive bilateral peripheral nerve blocks using either lidocaine or papaverine. Following randomization, each patient will receive one medication in one leg and the alternate medication in the contralateral leg. Researchers will measure parameters including motor strength, sensory function (two-point discrimination), arterial blood flow via Doppler ultrasound, and microvascular perfusion using near-infrared spectroscopy both prior to and following nerve block administration. This research seeks to explore potential diagnostic and therapeutic applications for peripheral nerve entrapment, a common yet challenging clinical condition.
Drop Foot
The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are: 1. Does obstruction of the olfactory cleft predict return of the sense of smell? 2. Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell? Participants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP), Smell Loss
Regional anesthesia techniques (or nerve blocks) are used to provide sensory blockade over the chest wall. The most established technique is thoracic epidural. This provides bilateral spread but is also associated with neuraxial complications, which has led to a decrease in clinical usage. Alternative peripheral nerve block techniques, such as intercostal nerve blocks, eliminate the neuraxial complications but, in turn, require numerous injections to provide unilateral coverage. The introduction of ultrasound-guided (USG) nerve blocks has generated clinical interest in the development of novel paraspinal (non-epidural) nerve block techniques, which will provide multiple dermatomal coverage with a single injection. Two such techniques are the Erector Spinae Plane (ESP) block and the Intertransverse Process (ITP) block. The Intertransverse Process (ITP) block targets a slightly deeper plane than the Erector Spinae Plane (ESP) block and was specifically designed to address the ESP block's variable anesthetic spread. Despite its potential for more localized and precise dermatomal coverage, no prior studies have directly compared the two techniques in terms of their cutaneous distribution. Thus, this randomized, double-blinded trial aims to compare the cutaneous distribution of both these blocks in healthy adult volunteers. To compare the dermatomal sensory block distribution, the investigators will use detailed mapping with pinprick, cold, and heat stimuli. In addition to assessing the distribution and coverage of the ESP and ITP blocks, this study also seeks to investigate the pharmacokinetics (PK) of lidocaine in each technique. The rationale for this lies in the anatomical differences between the two blocks. Theoretically, there may be a difference in the anatomical target for both blocks, but the investigators hypothesize that there is no difference in the local anesthetic absorption. Therefore, the investigators expect similar systemic absorption, the chances of local anesthetic systemic toxicity (LAST) should be equally low, and both blocks should be similarly safe. A total of 14-18 healthy adult volunteers will be included. There will be two different procedure days, separated by at least one week. On each day, the subjects will receive a paraspinal block, according to the randomization process. Each volunteer will undergo pre-procedure screening on the first visit. The blocks will be performed on the same side, at the same level, by the same anesthesiologist, at least one week apart. An ultrasound-guided ESP block will be administered in one day, and an ITP block on the other. The order will be randomized, and both the subject and the research team member assessing the block will be blinded. Sensory testing will be performed at baseline and 60-90 minutes after the block injections. Serial samples of blood will be drawn to analyze lidocaine PK (between 0 and 240 minutes post-block).
Acute Pain, Postoperative, Regional Anesthesia Block
This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.
Nasal Obstruction
The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also assess safety and other health outcomes to guide care for stroke patients.
Stroke, Acute
The Comparison of Outcomes of Management of Bowel Obstruction (COMBO Pilot) Pilot trial is a patient-level randomized trial of a short course of dexamethasone + supportive care vs supportive care alone for patients with adhesion-related small bowel obstruction (aSBO). The goal of the COMBO trial is to answer the question: Can Dexamethasone increases the proportion of patients with resolution of aSBO with non-operative management (without complication) based on an established minimal important clinical difference.
Adhesive Small Bowel Obstruction
This clinical trial compares efficacy in postoperative pain management in thoracic surgery between erector spinae block versus liposomal bupivacaine injections.
Lung Cancers
Patients undergoing hand, wrist, and elbow surgery may experience pain after surgery. The orthopedic surgeon may provide prescription pain medications after surgery to assist with pain control. However, with concern of the opioid epidemic, many patients would rather minimize the use of narcotic pain prescriptions after having surgery. As an alternative, ultrasound guided regional nerve blocks can assist with postoperative pain control. patients consented to this study will be randomized into three groups: 1) will receive an ultrasound guided nerve block with local anesthesia only, 2) will receive an ultrasound guided nerve block with local anesthesia and a steroid dexamethasone, 3) will receive an ultrasound guided nerve block with liposomal bupivacaine. our study team will make phone calls after surgery to the patient to determine how long the block lasted for, and how many opioid pain pills were taken up to 3 days after surgery.
Hand Surgery, Wrist Surgery, Elbow Surgery, Fracture Fixation, Dupuytren Contracture, Finger Fracture, Wrist Arthropathy, Distal Radius Fracture
Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).
Kidney Stones
Surges in the sympathetic nervous system occur at the ictus of a variety of neurological critical illnesses including intracranial hemorrhage and ischemic stroke. It is hypothesized that these exaggerated increases in sympathetic nervous activity produce maladaptations that promote secondary brain injury. One of these possible mechanisms include diffuse vasospasm that cause cerebral ischemia. Hence, methods to abrogate the sympathetic nervous system in this context are under active investigation. One possible method is the regional anesthesia technique of the stellate ganglion nerve block, which is ordinarily used for complex regional pain syndrome, but has been shown to reduce cerebral sympathetic activity and reduces vasospasm in patients with subarachnoid hemorrhage. However, its effect on the microcirculation is not clear. Hence, we propose to study patients receiving the stellate ganglion nerve block as part of their standard medical care and to image their retinal microcirculation before and after the procedure using Optical Coherence Tomography Angiography (OCTA).
OCTA, Severe Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
This is a study to evaluate the safety and effectiveness of the Acolyte Catheter System used in CTO-PCI procedures. The system will be used for the placement and positioning of guidewires and catheters in the coronary vasculature for the treatment of patients with coronary chronic total occlusions with persistent symptoms following medical therapy.
Coronary Chronic Total Occlusions, Ischemic Heart Disease, Ischemic Heart Disease (IHD), Ischemic Heart Disease Chronic