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NCT03404895
The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot.
NCT06138652
The purpose of this study was to examine whether an app- and mentor-based program reduced anxiety among individuals reporting difficulties with anxiety. For the intervention group, this study involved completing an 8-week program focused on helping participants reach their personality goals. The program involved app-based games, journaling, and completing behavioral challenges. Participants engaged with the study app for approximately 15 minutes per day and spoke with a study mentor weekly for 1 hour. Participants were asked to complete surveys prior to and after the program. The pre-program survey lasted approximately 1 hour, and the post-program survey lasted approximately 30 minutes. For the control group, this study involved completing surveys. Participants were asked to complete surveys 8 weeks apart. The first batch of surveys lasted approximately 1 hour, and the follow-up surveys lasted approximately 30 minutes.
NCT05301933
Access to evidence-based psychosocial interventions, particularly Behavioral Parent Training (BPT), for youth with Attention Deficit/Hyperactivity Disorder (ADHD) is limited. An approach to increasing such access is to utilize trained paraprofessionals (Family Peer Advocates; FPAs) in the delivery of BPT, particularly through modalities, like telehealth, that further improve access and availability. This approach, FPA-delivered BPT via telehealth has yet to be studied. This study will evaluate the benefits of a FPA-delivered BPT for parents of children identified with ADHD in Developmental Behavioral Pediatric (DBPs).
NCT05358860
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
NCT04543409
The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.
NCT02753127
This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
NCT03149003
This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.
NCT05719935
The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study. The main questions it aims to answer are: * What is the range of motion (flexion, extension, radial, ulnar, grip and pinch strength) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant. * What are the patient reported outcomes (PROMIS, PRWE, HSS wrist expectations) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant. * How do range of motion and patient reported outcomes change over the 10 years after total wrist replacement surgery? Participants will be followed according to standard of care and preoperative and post-operative information for up to 10 years after surgery will be collected and entered into an electronic data base. Patients are eligible to enroll into the registry before or after they have had their wrist replacement surgery.
NCT04914507
Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device
NCT06094855
The goal of this observational study to examine the effects of cooling on balance in persons with Multiple Sclerosis. Persons with Multiple Sclerosis frequently have problems with balance leading to falls and related injuries, as well as avoidance of activities that may challenge balance. Persons with Multiple Sclerosis are also well known to experience worsening of their symptoms when they become too warm, a condition known as thermosensitivity. This suggests that heat may worsen balance and increase falls risk in persons with Multiple Sclerosis. In this study we are examining the effects of wearing a cooling vest on balance performance in persons with MS. The main questions our study aims to answer are: Question 1- Does wearing a cooling vest result in better balance performance in persons with MS when compared to a condition when they are not wearing the vest. Participants will be given a balance test to assess their baseline balance performance. Following the test participants will be randomly assigned to either a cooled or an uncooled condition. In the cooled condition, participants will wear a commercially available cooling vest while pedaling for 20 minutes at their best comfortable pace on a recumbent stationary bicycle. Immediately following the 20 minutes of exercise the vest shall be removed and the balance test repeated. Subjects in the uncooled condition will perform the same task but without wearing the vest. One week later, participants will return and will perform the opposite of what they did the previous week; subjects who were in the cooled group will perform the 20 minute exercise test without the cooling vest and subjects who were uncooled will perform the test with a cooling vest. The same balance test will be performed before and after the exercise bout.The change in the balance scores between the 2 conditions will be compared.
NCT02357849
We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.
NCT05525468
Multi-center, randomized, double-blind, vehicle-controlled, parallel group, dose escalation study of TDM-180935 following topical administration in healthy male subjects, 18 to 55 years old
NCT06139835
This study was designed to find our whether a novel toothpaste containing safe digestive enzymes (Tartarase) was able to remove pre-existing dental tartar when compared to a well-known toothpaste (Crest). A group of 40 test subjects that had at lease 9 mm of tartar on the tongue side of the 6 lower front teeth, were randomly divided into 3 groups unknown to the the team overseeing the measurements. All the groups brushed with a toothbrush approved by the American Dental Association. Group A (20 subject) was the control group. They brushed in the morning and before bed with Crest for 2 minutes. Group B (10 subjects) brushed in the morning and before bed using the same procedure, first with Tartarase for 30 seconds, spit, but did not rinse, then repeated. After 30 minutes then brushed with Crest. Group C (10 subjects) brushed for 30 seconds with Tartarase, spit but did not rinse, then filled a dental tray with Tartarase and covered the 6 lower front teeth and waited 30 minutes, spit but did not rinse and brushed for ann additional 30 seconds with Tartarase. After 30 minutes they brushed with Crest. They brushed with crest before bed, without another Tartarase treatment. The study was a 4-week study, with tartar measured at the start (baseline), again after 2 weeks and again at the final study point of 4 weeks. If any of the study subjects experienced anything unpleasant, they were to inform the team overseeing the study. The tartar measurements were compiled into the 3 groups and statistically analyzed to determine if there were any changes in the amount of tartar within the groups and between the groups.
NCT05390775
The main objective of this study is to determine whether remote delivery of written exposure therapy after motor vehicle collision reduces incidence and severity of posttraumatic stress symptoms in high risk individuals. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy. This data can be used to adequately power a larger randomized controlled trial.
NCT05793684
The VicTor Study is a randomized, double blind, placebo-controlled, 3-period, multiple-dose crossover study in participants with OSA.
NCT05745064
In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID. The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.
NCT03806933
The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).
NCT03409458
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.
NCT04596865
Pancreatic head malignancies are aggressive cancers that are often inoperable when they are diagnosed. In the \~20% of patients who are diagnosed when the disease is still operable, surgery is the only treatment that can provide a chance of cure. Unfortunately, up to 75% of patients undergoing surgery will have the cancer come back (recur). One of the reasons for this is the challenge of removing the whole tumour with some surrounding non-cancerous tissue to ensure that every tumour cell has been removed. This is difficult because there are many structures very close to the pancreas (such as the blood vessels that supply the intestines) that cannot be removed. A recent review study of \>1700 patients who had a Whipple's operation (the cancer operation that is performed to remove the head of pancreas) and found that whilst the majority of patients had cancer recurrence in distant sites (like the liver) that would not be affected by how the operation was performed, 12% of patients had the cancer recur just at the site of where the operation had been; this is known as 'local' recurrence. This suggests that a small amount of cancer was not removed at the time of surgery in these patients. Very few studies have looked at the relationship between the Computerised Tomography (CT) scan before surgery and the histology results (information about the tumour after it has been examined under the microscope) and whether this can predict exactly where the tumour recurs. If investigators can find factors that predict which patients get local only recurrence, investigators may be able to offer improved surgical techniques or other therapies during or immediately after the operation to these patients, hopefully leading to improved cure rates. This retrospective international study will look at these factors in patients who underwent a Whipple's operation for pancreatic cancer, bile duct cancer or ampullary cancer over a three year period between 2012 and 2015. Participating centres will provide data on pre-operative scans, complications around the time of surgery, any therapies (e.g. chemotherapy) that the patients had and if and where the cancer recurred. With this information, investigators hope to find ways to predict which patients will get local-only recurrence, so researchers can select them for future studies to see if additional treatments can improve the chance of cure from surgery for these patients.
NCT06136702
This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).
