Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 544 trials
NCT06615518
The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery. This study also aims to perform a radiological analysis of MRI scans before and after treatment to optimize patient selection and surgical strategies. The main questions it aims to answer are: * Does FELD provide superior early postoperative pain relief (measured by VAS) compared to MD? * Does FELD offer better functional recovery (measured by COMI and ODI scores) postoperatively compared to MD? * Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies? Researchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes. The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making. Participants will: * Undergo either FELD or MD surgery * Complete VAS, COMI, and ODI questionnaires at pre-specified follow-up intervals (1, 3, 6, and 12 months post-surgery) * Have MRI scans 24 hours before surgery, 24 hours after surgery, and at each follow-up to assess disc recurrence, residual pathology, and to optimize surgical strategies.
NCT07626645
Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.
NCT07603531
The trial aims to determine whether the dynamic compression device, used in combination with elastic compression garments, is non-inferior to currently available compression devices (CACD) during the maintenance phase of lower-limb lymphoedema treatment. This is a two-arm, parallel-group trial. Both groups will include patients being discharged after the inpatient intensive treatment phase for lower-limb lymphoedema. Eligible participants will be enrolled on the afternoon of their final inpatient treatment day, prior to discharge. Participants will be allocated to one of the following groups: DDS group: elastic compression garment worn at least during the day and as often as possible during the night, according to patient preference and expert advice, plus DDS use for a minimum of 2 hours at the end of the day, used alone without an elastic garment. Control group: elastic compression garment worn at least during the day and as often as possible during the night, according to patient preference and expert advice, plus currently available compression devices, including multicomponent bandages, pneumatic compression devices, and compression wraps, according to patient preference and the center's recommendations. Manual lymphatic drainage will be permitted in both groups. Patients will undergo three assessment visits: Visit 1 / Baseline-Inclusion (V1): afternoon of the final inpatient treatment day, prior to discharge from intensive treatment; Visit 2 (V2): end of week 6, ± 7 days; Visit 3 (V3): end of week 12, ± 7 days.
NCT07463365
This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, particularly those known as venous leg ulcers (VLUs). VLUs are open sores that commonly occur on the lower legs due to poor blood flow in the veins. These wounds can be painful, slow to heal, and difficult to treat, especially in older adults and people with conditions like diabetes or obesity. LUT017 is a gel that will be applied directly to the surface of these wounds. The goal of the study is to find out if the gel is safe and well tolerated when applied once a week for up to 8 weeks. The researchers will also look for early signs of whether the gel helps the wounds heal more quickly or completely. The gel contains a medicine that has been shown in animal studies to activate natural skin repair processes and promote cell growth, potentially speeding up the healing process. The study will involve between 12 and 18 adult participants who have had a chronic leg wound for at least 4 weeks. All participants will go through a screening process to make sure they are eligible. If they qualify, they will first complete a two-week "run-in" phase where their wound will be treated with standard medical bandages. This phase helps ensure that only participants whose wounds are not healing with normal care are included. If participants remain eligible after this period, they will start the treatment phase. During this phase, they will come to the clinic once a week for 8 weeks to receive the LUT017 gel treatment directly on their wound. Each visit will include a physical exam, vital signs, wound evaluation, photographs of the wound, and blood tests to monitor safety. After the 8-week treatment period, participants will return for two follow-up visits-one at 3 months and one at 6 months after their first treatment. These visits will help the researchers understand how long any benefits of the treatment might last and monitor for any delayed side effects. In total, participants will be involved in the study for about 6.5 months and will have approximately 12 to 14 visits to the clinic. Participation is entirely voluntary, and individuals can withdraw at any time. The research team is committed to ensuring participant safety and privacy throughout the study.
NCT07593586
The goal of this clinical trial is to learn if the Mckenzie Extension Protocol with and without Graston technique works to treat Lumbar Myofascial Pain Syndrome.This clinical trial compares the Effects of Mckenzie Extension Protocol with and without Graston technique on Pain intensity, Range of Motion and functional Disability in Patients with Lumbar Myofascial Pain Syndrome.Adults with Lumbar Myofascial Pain were included in this study. A total of 70 participants were divided into two groups with 35 patients in each group. One group received Mckenzie Extension Protocol with Graston technique and the other group received Mckenzie Extension Protocol without Graston technique . Pain was assessed using the visual analogue scale and functional disability was measured using modified oswestry disability index . Range of motion was also evaluated before and after treatment by universal goniometer.
NCT07538609
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
NCT07585552
1. What is this study about, and why is it required? The goal of this observational study is to learn if anesthesia type (e.g., general anesthesia, spinal anesthesia) affects the safety and efficiency of HoLEP surgery. The main question it aims to answer is: \- Is a particular type of anesthesia related to less or more bleeding during the surgery? 2. What will be assessed to answer the main question of this study? (Outcome measure(s)) 2.1. Primary outcome measure of this study is: \- Change in the hemoglobin level perioperatively. 2.2. Secondary outcome measures are: * Requirement for the usage of any vasoactive medication due to low blood pressure * Time passed until discharge. * Time passed until the removal of the bladder drainage catheter. * Ratio of the unwanted events that require additional intervention other than medication, fluids, or blood transfusions (Complications, Clavien-Dindo Grade III or higher). * International symptom questionnaire score 3 months after surgery. * Quality of life (QoL) score 3 months after surgery. * Peak urinary current velocity (Qmax) and post-void residual volume measurement 3 months after surgery. 3. Can anyone participate in this study? Voluntary participants should meet the following criteria: * Being older than 18 years old. * Having bothersome lower urinary tract symptoms due to prostatic enlargement requiring surgical treatment. * Having no untreated or uncontrolled systemic disease, which refers to having an ASA (American Society of Anesthesiologists Physical Status Classification System) score III at most.
NCT07483320
Midportion Achilles tendinopathy is a common cause of pain and functional limitation in both athletes and the general population. Progressive tendon loading programs are considered first-line treatment but do not lead to satisfactory outcomes in all patients. Extracorporeal shockwave therapy (ESWT) and platelet-rich plasma (PRP) injections are commonly used interventions for refractory symptoms, yet evidence supporting their combined use is limited particularly in treating Achilles tendon disorders. This randomized controlled trial will evaluate the effectiveness of a standardized exercise program alone or in combination with PRP injection, ESWT, or both therapies in active adults with midportion Achilles tendinopathy. Participants will be randomized to one of four treatment groups and followed for six months. The primary outcome will assess changes in Achilles tendon symptoms and function using the Victorian Institute of Sport Assessment-Achilles (VISA-A) score. Secondary outcomes will include patient-reported outcomes, physical function testing, ultrasound tendon structure measures, and gait biomechanics.
NCT04799275
This phase II/III trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-miniCHOP\]) versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma. R-miniCHOP includes a monoclonal antibody (a type of protein), called rituximab, which attaches to the lymphoma cells and may help the immune system kill these cells. R-miniCHOP also includes prednisone which is an anti-inflammatory medication and a combination of 3 chemotherapy drugs, cyclophosphamide, doxorubicin, and vincristine. These 3 chemotherapy drugs, as well as oral azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combining oral azacitidine with R-miniCHOP may shrink the cancer or extend the time without disease symptoms coming back or extend patient's survival when compared to R-miniCHOP alone.
NCT06076499
Multi-center post-market, observational study to assess the long-term effectiveness and safety of the NTX100 TOMAC System for patients with Restless Legs Syndrome.
NCT07552766
This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Ninety pediatric patients, ages 3-18 will be enrolled and randomized 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery. All participants will receive standardized anesthesia care and postoperative pain management. Opioid consumption and pain scores will be measured intraoperatively and throughout the postoperative recovery, with the primary outcome focused on total opioid use 60 minutes after arrival to the post-anesthesia care unit (PACU). Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use and the relationship between infusion duration and outcomes. Patients will be closely monitored for signs of local anesthetic systemic toxicity and other adverse events. The goal of this study is to determine whether IV lidocaine is an effective opioid-sparing adjunct in pediatric orthopedic surgery and to support safer, multimodal analgesia strategies.
NCT03218969
This is an exploratory, double blinded cross-over study of the D1 antagonist ecopipam treat patients currently having dopamine agonist induced augmentation in restless legs syndrome. Each arm is 6 weeks composed of an unforced titration up to 100mg/day separated by a 2-week wash-out period. Efficacy points will include the IRLS, augmentation scales, sleep scales, clinical impressions and fatigue/mood scales.
NCT03992404
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.
NCT07199504
The purpose of this clinical trial is to determine whether dipyridamole can treat restless legs syndrome in patients with uremia. In addition, the safety of dipyridamole will also be evaluated. The main questions this study aims to answer include: Can dipyridamole improve the symptoms of restless legs syndrome in participants? Can dipyridamole improve participants' anxiety, depression, sleep quality, and quality of life? What adverse reactions might participants experience while taking dipyridamole? This study is a self-controlled trial in which all participants receive active drug treatment. Participants will take dipyridamole daily (50 mg per dose, three times a day) for 12 weeks. The efficacy of dipyridamole will be evaluated by comparing relevant scale scores and laboratory indicators before and after treatment. In addition, adverse reactions during the treatment follow-up will be monitored to assess the safety of dipyridamole in this patient population.
NCT05287646
Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.
NCT07541196
The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are: * Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care? * Does PAW-hydrogel reduce bacterial load in the wound bed? * Is PAW-hydrogel safe and well-tolerated (local adverse events, pain)? Participants will be randomly assigned to one of two groups: * Experimental group: Topical application of PAW-hydrogel (Carbopol® 940 neutralized to pH 5.5, loaded with reactive oxygen and nitrogen species from plasma activation) 2-3 times per week. * Control group: Standard advanced wound care (cleaning, debridement, conventional dressings). Wound area (planimetry), bacterial load (semi-quantitative cultures), pain (Visual Analog Scale), tissue quality (Bates-Jensen scale), and adverse events will be assessed over a 12-week follow-up period.
NCT05966636
Veterans who use prosthetic limbs commonly suffer from skin problems such as scars that create discomfort and pain to the point that wearing the prosthesis is no longer tolerable. The Veteran must then discontinue prosthetic use to allow healing prior to wearing the limb again. Current treatments for skin problems include manual scar mobilization and massage, stretching, desensitization techniques, pain medication, prosthetic adjustment, steroid injection, scar excision and others. Most of these have not proven to be a long-term solution. A dermatologic procedure common in non-amputees for scar and skin lesion management, fractionated laser therapy, may be a long-term solution minimizing discomfort, pain and time out of the prosthesis. This preliminary study seeks to determine if fractional laser therapy can improve prosthetic use, and quality of life of Veterans with amputation who use lower limb prostheses.
NCT06181708
This project aims to investigate 'The minimum diagnostic requirements for patients presenting to primary care with suspected venous ulcers.' In order to do this, the investigators intend to run a series of questionnaires with primary care services, vascular science services, and perform some cost effectiveness modelling on running diagnostic services in primary care and in secondary care settings. A one off questionnaire, designed in Qualtrics, will be sent out to primary care practitioners via social media and email contacts. This will be aimed at establishing their current role and any guidelines they follow with regards to the diagnosis and management of venous leg ulcers in primary care, and to determine their opinion of what this patient pathway should involve. A Delphi consensus will be carried out amongst vascular scientists across the UK to determine current and streamline future practice in diagnostics for patients with venous leg ulcers. The consensus will be achieved when there is ≥ 70% agreement. Cost effectiveness modelling will be carried out on two different scenarios of managing this cohort of patients, one in primary care and one in secondary care settings. Descriptive statistics will be performed on the results.
NCT07084740
The aim of reconstructive surgery is to restore physical integrity altered by trauma, congenital malformations or cancerous pathologies. Several techniques are available, including flap surgery, which enables tissue to be moved from one anatomical location to another. Perforating skin/subcutaneous flaps are segments of skin and subcutaneous cellular tissue vascularized by a feeder vascular pedicle. This surgical technique has virtually zero donor-site morbidity, as it is no longer necessary to harvest muscle to ensure reliable vascularization of the flap. Flap vascularization is a variable mechanism, complex to describe and understand. For cutaneous and subcutaneous (fatty) flaps, which account for the majority of flaps used, perforator flaps (vascularized by a subcutaneous perforator artery) have become the benchmark. Unfortunately, their vascularization is currently poorly understood, and depends on experimental work carried out on fresh cadaveric anatomical specimens. These cadaveric studies fail to take into account several key factors influencing perforasomes (perforasome: skin territory vascularized by a pedicle), namely body temperature, blood pressure, heart rate, intraoperative patient position and biological parameters.
NCT06071715
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain. Unfortunately, phantom pain goes away in only 16% of afflicted individuals, and there is currently no reliable definitive treatment. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that actually increase with worsening phantom pain. These abnormal changes may often be corrected by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain with a simultaneous resolution of the phantom limb pain. However, when the nerve block resolves after a few hours, the phantom pain returns. But, this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation are not necessarily fixed, and may be dependent upon the "bad" signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve block-lasting many months rather than hours-may permanently reverse the abnormal changes in the brain, and provide definitive relief from phantom pain. A prolonged nerve block lasting a few months may be provided by freezing the nerve using a process called "cryoneurolysis". The ultimate objective of the proposed research study is to determine if cryoanalgesia is an effective treatment for intractable post-amputation phantom limb pain. The proposed pilot study will include subjects with an existing above-knee amputation who experience intractable daily phantom limb pain. A single ultrasound-guided treatment of cryoneurolysis (or sham block-determined randomly like a flip of a coin) will be applied to the major nerves of the thigh. Although not required, each subject may return 4-6 months later for the alternative treatment (if the first treatment is sham, then the second treatment would be cryoneurolysis) so that all participants have the option of receiving the active treatment. Subjects will be followed for a total of 12 months with data collected by telephone.