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NCT04793932
The main aim of this study is to compare the efficacy of short-course versus long-course pre-operative chemotherapy with PAXG or mFOLFIRINOX in patients who receive a diagnosis of pancreatic ductal adenocarcinoma (PDAC) resectable or borderline resectable.
NCT06228235
The objective of this pilot clinical trial is to test the effects of different types of thinking strategies at the time of repetitive Transcranial Magnetic Stimulation (rTMS), applied to the left Dorsolateral Prefrontal Cortex (DLPFC), on smoking craving and brain activity. Participants will be individuals with moderate to high smoking dependence (smoking at least 8 cigarettes a day) who have no intention of quitting in the next 3 months and are eligible to have rTMS and functional magnetic resonance imaging (fMRI). The main objectives of the trial are: 1. To compare the craving-reducing effects of "upregulation" and "downregulation" of craving while looking at pictures related to cigarette smoking during rTMS versus no regulation of craving while looking at neutral pictures unrelated to smoking. 'Upregulation" is thinking about the immediate positive experience of smoking. "Downregulation" is thinking about the long-term negative consequences of smoking. 2. To examine changes in brain activity that accompany craving reductions produced by rTMS paired with upregulation and downregulation of craving while looking at pictures related to cigarette smoking versus no regulation of craving while looking at neutral pictures unrelated to smoking. Following screening for eligibility, participants will be trained on how to do upregulation and downregulation of craving. The participants will then participate in 3 testing sessions. In each session, the participants will receive rTMS at 20Hz in 50 trains (2000 pulses total), followed immediately by fMRI. Sessions will take place 1-2 weeks apart and will differ in the type of thinking strategy participants will use while looking at pictures during the rTMS: * upregulation of craving while viewing smoking-related images * downregulation of craving while viewing smoking-related images * no regulation of craving while viewing neutral smoking-unrelated images The order of sessions will be randomized across participants.
NCT06768957
After reconstruction of the anterior cruciate ligament, the aim for the vast majority of sportspeople is to return to the field. To date, 65% of patients who have undergone ACL rehabilitation return to their previous level, and 55% return to competition. To achieve this, physiotherapy sessions need to prepare the return to sport as well as possible, by simulating the cognitive demands (reading the game, double task, etc.) that might be encountered on the pitch. Tests to assess the athlete's performance do exist, in order to optimise this return to sport, but they do not include the cognitive tasks that are present in sport. The high cognitive demands of the sporting environment therefore justify the inclusion of cognitive tasks in these return to sport tests. The aim of this research is to assess the impact of the cognitive task on the performance of a return to sport test following ACL reconstruction. Patients who have undergone ACL reconstruction and healthy subjects will therefore be given a return to sport test called the 'Single Leg Hop for Distance' with and without a cognitive task in order to observe the influence of the cognitive task on the results of the hop. Including healthy subjects in this study will make it possible to study the impact of the cognitive task in these subjects, who have no neurophysiological dysfunction linked to ACL reconstruction. The aim of this study is therefore to try to develop the return to sport tests currently described in the literature by proposing a new, improved test that takes account of the cognitive dimension, which is omnipresent in the sporting environment.
NCT06910514
The objetive of this clinical trial is to evaluate the efficacy and safety of a solution for endoscopic mucosal resection of colonic lesions in patients undergoing endoscopic resection procedures. The main questions it aims to answer are: Does the investigational solution improve the efficacy of endoscopic mucosal resection compared to standard practice? Is the investigational solution safe for use in colonic lesion resection procedures? Researchers will compare the investigational solution (Demirex) to a standard or placebo solution to see if it improves procedural outcomes and safety profiles. Participants will undergo endoscopic mucosal resection using either the investigational solution or the comparator, and will be monitored for procedural success, safety, and any adverse events.
NCT06917846
MRONJ is an acronym used to describe medication-related osteonecrosis of the jaw bones. It has been reported by the AAOMS that bisphosphonates or denosumab can cause this condition. The management of medication-related osteonecrosis of the jaw (MRONJ) is challenging, and there is ongoing debate over whether medical or surgical treatment is the gold standard. The aim of this retrospective study is to investigate the efficacies of medical and surgical treatments of MRONJ and comparatively evaluate their outcomes.
NCT06729775
There remains a need for novel research that facilitates RBRR in a manner that raises data and environmental health literacy (D/EHL) and supports communities striving for environmental health and structural change. Rooted in bioethics and building upon trusted and established long-term partnerships and leveraging existing datasets, the project goal is to create and pilot a national model of report back that is centered in the margins and engages diverse rural and urban EJ communities to ensure that RBRR reaches all populations in a manner tailored to their individual needs, including culture, life stage, language, and design.
NCT06915623
This study aims to evaluate a gel's potential to improve gum health around dental implants when used alongside traditional cleaning methods. The central research question is: Does the gel reduce gum bleeding? Researchers will compare the effects of traditional dental cleaning alone wit those of dental cleaning combined with gel administration, focusing on overall gum health around implants. The study will enroll eight participants-some with early gum issues, such as bleeding gums, and others with healthy gums. Each participant will be randomly assigned to receive either regular dental cleaning or the cleaning paired with gel application. The study process includes the following steps: 1. Participants will visit the clinic and receive one of the two treatments randomly. 2. One week later, they will complete a printed survey detailing any symptoms or discomfort experienced . 3. After four weeks, participants will return to the clinic for checkups and tests to measure progress.
NCT06916871
A large number of patients at the Neurological and Functional Rehabilitation Centre of the University Hospital of Liège have associated pathologies, including diabetes. These patients may have diabetes-related complications that require recurrent hospitalizations in an acute structure or in rehabilitation. One of the ways to limit complications is to set up patient education. 1. Objectives * To compare the impact of management through formal education with that of awareness. * To evaluate the impact on knowledge of structured education. * To evaluate the impact of structured education on the quality of life experienced by diabetic patients. * Identify the patient's level of satisfaction with the education sessions. * To evaluate the impact of structured education on the biological improvement of glycated hemoglobin. * To evaluate the impact of structured education on diabetes-related complications. 2. Working Hypothesis The implementation of structured diabetes education allows "patients to acquire, or maintain, the skills they need to manage their lives as well as possible despite the constraints of chronic disease... ". 3. Study population All diabetic patients hospitalized in all care units. 4. Collection tools and techniques Collection tools 1\. "Diabetes Knowledge Questionnaire". 2. SF-36 Health Questionnaire. 3. Satisfaction questionnaire for structured sessions on diabetes. 4. Questionnaire to identify complications and/or re-hospitalizations after your stay in rehabilitation. Collection technology At admission (D+1) * Validation of inclusion and exclusion criteria. * Submission and distribution of the information and consent form. * Obtaining informed consent from the patient. * Distribution of collection tools 1 and 2 (collection on D+2). * Control of glycated hemoglobin. At the end of hospitalization (D-2) * Distribution of collection tools 1, 2 and 3 on D-2 before the release (collection on D-1). * Control of glycated hemoglobin. 3 months after the end of hospitalization * Sending collection tools 1, 2 and 4 by post. The patient will be invited to complete them and return them by post. * The patient will be invited to take a blood test for glycated hemoglobin.
NCT05615779
This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based on personalized responses), provided by an IBD dietician, based on our novel translational research findings.
NCT06054230
This study follows an observational prospective cohort design. Women with fetal structural anomalies are routinely offered diagnostic testing with chorionic villus sampling or amniocentesis, with analysis for chromosomal analysis using karyotype or microarray analysis. Women in whom such testing does not explain the fetal phenotype, or in whom a genetic disease is strongly suggested based on the phenotype or a pattern of recurrent anomalies, will be offered exome sequencing (ES) and/or genome sequencing (GS) through the UCSF CLIA certified Genomic Medicine Laboratory. In advance of study enrollment, patients have been counseled regarding the structural anomalies in the fetus and offered pregnancy termination. The sequencing results for on-going pregnancies have a turnaround time of 2-4 weeks, and in the majority of cases are available after decisions have been made regarding continuation or termination of pregnancy. Patients who decline diagnostic testing but who have a prenatally identified anomaly may be offered the option of testing on umbilical cord blood at delivery or on the placenta or other products of conception after a stillbirth or pregnancy termination. The project is exploratory in nature, with the ultimate goal of contributing to a growing body of phenotypic data and understanding how providers and patients utilize genomic (either exome or genome) sequencing results during pregnancy.
NCT06064825
The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus arteriosus (PDA). In these patients, PDA has been associated with increased mortality and morbidity in the neonatal period, and neonatal morbidities may in turn be associated with later deficits in cognitive functioning. PDA treatment with COX inhibitors, as ibuprofen or indomethacin, aiming at closing the PDA have been associated with numerous adverse effects and failed to demonstrate significant clinical benefits. Early treatment of PDA with paracetamol (acetaminophen ) has been proposed as an alternative to COX inhibitors. The ongoing pan-European TREOCAPA phase III study (NCT04459117) is a multicentre, double-blind, randomised, placebo-controlled superiority trial that assesses prophylactic use of paracetamol to improve survival without severe neonatal morbidity until discharge from hospital in infants of 23-28 weeks of gestational age. As long-term follow-up was not planned by the TREOCAPA protocol, TREOCAPA-LT study will use an existing European research infrastructure, the RECAP Preterm platform (https://recap-preterm.eu/), to follow-up the patients enrolled in the TREOCAPA trial using a parent-report questionnaire at 2 years of corrected age. The TREOCAPA-LT primary hypothesis is that there will be improved cognitive outcome at 2 years of corrected age in children born at less than 29 weeks of gestational age who were treated with paracetamol during the first 5 days of life in the TREOCAPA phase III trial.
NCT06422312
This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.
NCT04383210
This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.
NCT04273776
The primary objective of this study is to evaluate two pharmacotherapeutic approaches to sleep induction, both of which have been shown to be effective hypnotics, but may have unique side effect profiles. These profiles may have markedly different impacts on performance in a military setting. In this randomized, double-blind, placebo controlled study, the side effects of these drugs will be compared - suvorexant, a dual orexin receptor antagonist and zolpidem, a non-benzodiazepine gamma-aminobutyric acid (GABA) A agonist - in healthy controls comparable in age and gender to the target military population.
NCT06900049
The purpose of this study is to evaluate the safety, tolerability, and efficacy of LE051 intravenous therapy in DMD patients treated with exon 51 skipping therapy.
NCT03981328
Real-time continuous glucose monitoring (CGM) systems provide users with information about current glucose levels and alert the patient before the upper or lower glucose threshold is reached or when glucose levels change rapidly. Hence, glycaemic excursions can be early identified and accordingly adapted by behavioural change or pharmacologic intervention. Randomized controlled studies adequately powered to evaluate the impact of long-term application of real-time CGM systems on the risk reduction of adverse obstetric outcomes are missing.
NCT06631950
This RCT investigates the impact of an educational video on fecundity knowledge among young adults. The video discusses several risk factors associated with fecundity, such as age and smoking. The primary outcome measure of the RCT is fecundity knowledge. The knowledge level is defined based on the following factors: Age; smoking; sexually transmitted infections; Success of spontaneous pregnancy according to female age; Success of pregnancy according to female age and fertility treatment. The secondary outcomes are: intentions regarding the timing of desired pregnancy/childbirth; fecundity-protective behaviors; life goals; realized fertility later in life.
NCT05979610
The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point. Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.
NCT06722755
The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.
NCT06902311
This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy. The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.