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NCT07186231
The goal of this clinical trial is to compare two types of shoulder strength training: low-load training with blood-flow restriction (BFR) and high-load training without BFR. The study includes healthy adults. The main questions it aims to answer are: Are changes in shoulder strength, power, endurance, and muscle mass similar with low-load BFR and high-load training? Researchers will compare strength training with BFR to strength training without BFR to see whether changes in shoulder muscle performance are similar. Participants will: * Provide basic personal details, body measurements (e.g., height and weight), and a brief medical history before starting. * Train in one of the two programs (BFR or no BFR) two times per week for 4 weeks. * Complete tests of shoulder maximum strength, power, endurance, and muscle mass at the start and at the end of the protocol.
NCT07186829
The goal of this randomized controlled trial is to compare the effectiveness, complications, and cost-effectiveness of three surgical techniques (intramedullary screw fixation, locked plating, and percutaneous pinning) for treating simple transverse extra-articular fractures of the proximal phalanges and metacarpals (excluding the thumb) in adult patients. The main questions it aims to answer are: The primary outcome is to define which technique results in better functional outcomes, as measured by pulp-to-palm distance at 6 weeks? The main secondary outcome is to define which technique has lower complication rates and is more cost-effective over 12 months? Participants will be randomly assigned to one of the three surgical techniques (intramedullary screw fixation, locked plating, or percutaneous pinning). Follow-up visits at weeks: 3, 6 and months: 3,6 and final follow-up at 12 months will assess hand function, range of motion, grip strength, radiographic healing, complications, satisfaction, and costs.
NCT06376682
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.
NCT07176299
This study compared different methods of pain control after laparoscopic gallbladder removal. A total of 160 patients were randomly assigned to receive either a unilateral laparoscopic TAP block, local anesthetic infiltration, a combination of both, or no regional anesthesia. Pain scores, use of pain medication, and complications were measured up to 24 hours after surgery. The TAP block group experienced less pain and fewer wound-related problems, showing that this method is safe and effective for postoperative pain relief.
NCT05327387
Neuropsychiatric disorders are a leading cause of disability worldwide with depressive disorders being one of the most disabling among them. Also, millions of patients do not respond to current medications or psychotherapy, which makes it critical to find an alternative therapy. Applying electrical stimulation at various brain targets has shown promise but there is a critical need to improve efficacy. Given inter- and intra-subject variabilities in neuropsychiatric disorders, this study aims to enable personalizing the stimulation therapy via i) tracking a patient's own symptoms based on their neural activity, and ii) a model of how their neural activity responds to stimulation therapy. The study will develop the modeling elements needed to realize a model-based personalized system for electrical brain stimulation to achieve this aim. The study will provide proof-of-concept demonstration in epilepsy patients who already have intracranial electroencephalography (iEEG) electrodes implanted for their standard clinical monitoring unrelated to this study, and who consent to being part of the study.
NCT04942093
Obesity is a major public health problem and is constantly on the rise. Therapeutic approaches based on dietary advice, physical activity and the management of psychological difficulties are not always sufficient to achieve a lasting weight reduction. Bariatric surgery (or obesity surgery), accompanied by therapeutic education and adequate medical and dietary monitoring, can lead to significant and lasting weight loss. It is indicated as a second-line treatment for patients who have failed medical treatment, whose BMI is greater than or equal to 40 or whose BMI is greater than or equal to 35 with comorbidities (type 2 diabetes, arterial hypertension, obstructive sleep apnoea-hypopnoea syndrome, severe joint disorders). The surgeon may be very bothered by the intra-abdominal fat mass and especially by steatotic hepatomegaly (increase in the size of the liver and its fat load). Faced with this problem, various preoperative strategies such as the placement of an intra gastric balloon have been tried to decrease the size of the liver but a systematic review from 2016 indicates that a low calorie diet is preferable. Preoperative weight loss can reduce fat load and liver volume very rapidly. This meta-analysis shows that all low-calorie, high-protein diets are effective and that the optimal duration (4 weeks), compliance and tolerance are important factors for success.
NCT07187206
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
NCT05022264
The vital signs (pulse, systolic and diastolic blood pressure, respiratory rate, oxygen saturation and body temperature) are critical in assessing the severity and prognosis of infections. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). Accurately obtaining vital signs is also important when managing other categories of patients where it may be relevant to obtain some of the vital signs such as pulse and blood pressure. This project aims to evaluate a new camera-based system for contactless measurement of vital signs.
NCT02690441
Generalised anxiety disorder (GAD) is a severe and debilitating anxiety disorder that is highly prevalent among older adults. Anxiety and GAD is a well-documented risk factor for the development of other severe conditions such as depression and dementia, and effective treatments are called for. However, recommended treatment for GAD has consistently been found to yield blunted response rates for older adults compared to younger patients. The purpose of this study is to evaluate the effects of exercise-augmented cognitive behaviour therapy for older adults with GAD. Exercise augmented CBT is expected to yield better results than standard CBT in terms of greater reduction of symptoms and increased rates of remission. The investigators will also investigate the effects of treatment on biological, physiological and neuropsychological measures.
NCT07185672
Neuroendocrine tumours (NETs), better defined as neoplasms (NENs), are a heterogeneous group of neoplasms that range from well-differentiated tumours to more aggressive carcinomas. Peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the established standard of care for patients with well-differentiated metastatic or locally advanced GEP-NETs. It has demonstrated a significant improvement in outcomes compared to Octreotide LAR, both as a first-line and second-line treatment approach, following the results of NETTER-1 and NETTER-2 trials, respectively. ENETS guidelines recommend the use of Ga-68 labeled DOTANOC/TOC/TATAE imaging only for WHO Grade 1 NET whereas FDG PET is the preferred modality for WHO Grade 3 NEN and NEC. For Grade 2 tumors (Mib index ranging from 3-20%), there are no strong recommendations for the addition of FDG PETCT in existing diagnostic algorithm. FDG PET positivity has been shown to be an independent predictor of shorter progression-free and overall survival in NET patients undergoing peptide receptor radionuclide therapy (PRRT). (8) Consequently, it is imperative to address FDG-avid tumors by integrating PRRT and chemotherapy. There are no strong recommendations for the grade wise management of GEP-NETs particularly grade 2 \& 3. Although recently published NETTER 2 trial substantiated the role of PRRT as a first line treatment for advanced grade GEP-NETs, still there is lack of evidence supporting the addition of chemotherapy in management of GEP-NETs. Given the absence of a prospective study to establish this treatment regimen, we designed a Phase 3 Randomized Controlled Trial to evaluate the combination of PRRT and CAPE-TEM-based chemotherapy in patients with FDG-positive metastatic well-differentiated NETs.
NCT07186621
This study is an open-label, randomized controlled, multicenter, phase III clinical trial
NCT07184918
This clinical trial evaluates whether continuing or withholding ACE inhibitors (specifically Ramipril) before coronary angiography affects the risk of contrast-induced nephropathy (CIN). CIN is a known complication of iodinated contrast exposure, particularly in patients with chronic conditions such as hypertension or diabetes. The trial involves 44 adult patients randomized into two groups: one continuing Ramipril and the other withholding it 48 hours before and restarting 72 hours after the procedure. Renal biomarkers including serum creatinine, NGAL, and superoxide dismutase will be assessed to evaluate renal function.
NCT06015438
The purpose of the study is to characterize the challenges to physical activity and exercise for HS patients and design an exercise program (EP) with evidence-based techniques and examine its outcome.
NCT04863859
Immediate family members shoulder the majority of care responsibilities for persons living with dementia. However, due to various societal changes, elder care responsibilities have expanded to extended family members, including grandchildren, siblings, nieces/nephews, siblings, and step-kin. The main objective of this study is to understand the caregiving journeys of various extended family members involved in dementia care. We aim to learn about caregivers' care management strategies; their use of home and community-based services and informal support; and barriers to service usage. We will use the results from the study to help enhance service delivery, alleviate care-related stress, and improve the quality of life of dementia patients and their caregivers. We will use a mixed-methods design to explore the challenges faced by caregivers as well as their service usage for the person living with dementia. Our methodology involves an initial telephone interview (approx. 70 minutes) that includes open-ended questions, standard items, and structured measures, followed by an 8-day semi-structured daily diary interview about daily care responsibilities and experiences with services (15-20 minutes each evening). This study will be conducted with 240 extended family members serving as one of the main caregivers for a person living with dementia in a community setting.
NCT07184827
The goal of this clinical trial is to learn if drug U101 works to prevent recurrent urinary tract infection (rUTI) in women (≥ 20 and \< 76 years old) with a medical history. It will also investigate the safety and the impact on the Quality of Life improvement of drug U101. The main questions it aims to answer are: * Does the drug prevent or decrease the recurrence of urinary tract infection (UTI) during the 24-week treatment? * Will the Quality of Life be improved during the 24-week treatment? * What medical problems do participants have when taking drug U101? Researchers will compare drug U101 to a placebo (a look-alike substance that contains no drug) to see if drug U101 works to prevent rUTI. Participants will: * Orally take drug U101 or placebo every day for 24 weeks in the main study, three times per day (TID) for 8 weeks and twice per day (BID) for 16 weeks. * Visit the site once every 4 weeks for checkups and tests during the main study. * be asked to enroll in extensional study (the open-label extension (OLE) with drug U101 treatment or the Safety Follow-Up Visits with no investigational product treatment) for 24 weeks after they complete the 24-week main study. * Visit the site when the suspected UTI occurred during the main study or the extension study.
NCT07186036
The aim of this study is to investigate the effect of soft lumbosacral body braces on postural control and walking speed in children with cerebral palsy. Hypothesis 1: Soft lumbosacral orthoses that support physiological lordosis in children with cerebral palsy improve postural control. Hypothesis 1: Soft lumbosacral orthoses that support physiological lordosis in children with cerebral palsy correct posture. Hypothesis 2: A soft lumbosacral body corset increases walking speed in children with cerebral palsy. The number of individuals to be included in the study has been determined using G\*Power 3.1.9.7 effect size: 0.80, α = 0.05, power: 0.95. Individuals with CP who attend specific rehabilitation centres in Gaziantep and Kahramanmaraş and have GMFCS levels 1 and 2 will be included in the study. The necessary permissions will be obtained from the centres. The demographic information, clinical levels, and clinical types of the individuals will be recorded using a form. The Postural Control Measurement in Sitting, Paediatric Berg Balance Test, and Functional Reach Test will be used to assess the postural control of children with SP. Walking speed will be assessed using the Timed Up and Go Test. In our study, a lordosis angle will be created to support the existing lordosis using a steel-baleen elastic soft lumbosacral orthosis, and its effect on performance will be investigated using the tests applied. A soft lumbosacral orthosis suitable for the individuals will be used in three dimensions. Half of the individuals will be evaluated using these test methods first with a corset and then without a corset; the other half will be evaluated first without a corset and then with a corset. Tests will be repeated before and after orthosis use to determine the effectiveness of the orthosis.
NCT05425511
Work stress and psychosocial risks are a major public health problem. Health-care workers (HCW) are particularly at risk. Moreover, non-HCW staff of hospitals can also be at risk, with working environment described as the main risk factor. The University Hospital (CHU) of Clermont-Ferrand is one of the 3 CHUs in France with more than 10% absenteeism, and the first CHU for duration of sick leave. The political orientations favor an approach to improve the quality of life at work. Sophrology is a psychocorporal method used as a therapeutic technique or experienced as a philosophy of life. It is an exclusively verbal and non-tactile method. It combines a set of techniques that will act both on the body and on the mind through breathing exercises, muscle relaxation and mental imagery (or visualization). It allows to find a state of well-being and to activate all physical and psychological potential in order to acquire a better knowledge of oneself. NLP is a set of communication and self-transformation techniques that focuses on reactions rather than the origins of behaviors. NLP associated with sophrology proposes above all to mobilize the resources of the unconscious. Neurolinguistic programming (NLP) strategies are effective in the improvement in mental (anxiety and depression), physical, and social health, both in the general population, in individuals with social/psychological problems or in patients, both in hospital settings or outside hospital. Similary, sophrology also demonstrated some benefits on symptoms of patients. However, these approaches have never been provided in the workplace for the benefits of workers at risk of stress-related disorders. This protocol may permit improvements of stress-related outcomes. Putative short-term benefits: This protocol may incidentally detect cardiac disorders. Any abnormality discovered will not be covered by promotor's insurance (our exploratory study cannot lead to such event) and will be supported by health insurance. In general, the investigators aim to demonstrate the effectiveness of a workplace sophrology / NLP intervention for HCW at risk of stress-related disorders. Stress and well-being will be the target of the intervention, and will be measured both in a subjective (questionnaire) and objective (biomarkers).
NCT01015417
Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified. The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics. The secondary objectives are: * Rates of infectious complications according to duration of preoperative antibiotic * Influence of surgical drainage after surgery for occurrence of postoperative infectious complications * Analysis of the nature of infectious complications (surgical site infections, remote surgical site infections) * Comparison of germs found in the bile during the postoperative infectious complications * Duration of hospitalization * Readmission rate for surgical site infections * Rate of reoperation for surgical site infection * Overall mortality rate at 30 days * Mortality rates specific to 30 days
NCT07184489
The goal of this implementation study is to learn if the CFIR-ERIC matching tool is effective indeveloping implementation strategies for pediatric nurse. The evidence practised in this study is the pediatric venous access device selection decision tree from clinical practice guideline on infusion therapy in children. The main questions it aims to answer are: 1. Does the implementation strategies developed by CFIR-ERIC matching tool improve nurses knowledge in venous access devices selection. 2. Does the implementation strategies developed by CFIR-ERIC matching tool lower the error rate of appropriate venous access device selection. Researchers will compare the CFIR-ERIC group to a blank group to see if CIFR-ERIC matching tool works to improve nurses knowleged and lower the error rate of venous access device selection. Participants will: 1. Receive the implementation strategies made by CFIR-ERIC matching tool. 2. Using the pediatric venous access device selection decision trees in daily catheterization. 3. Record their venous access device selection informantion, consumables usage and pediatric patients' outcome.
NCT07182513
High-risk infants are defined as an infant with a history of adverse environmental and biological factors that may lead to neuromotor developmental problems. This group includes premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various reasons. These babies are also monitored for cerebral palsy (CP). CP is the most common physical disability in childhood, with an incidence of 2.1 per 1000 births. CP encompasses a group of permanent impairments in movement and posture development resulting from injury to the developing brain. Thanks to preventive measures and advances in obstetric and neonatal care, the incidence and severity of CP are currently decreasing in some countries, and it is emphasized that recovery can be more rapid with the use of early diagnosis guidelines or protocols in follow-up units. Early detection and monitoring of infants in the community for CP is essential only with appropriate, valid, and reliable tools to minimize potential sequelae through the timely implementation of CP-specific interventions. International guidelines require monitoring of infants at high risk of CP. This follow-up should be conducted by an interdisciplinary team, including a neonatologist, pediatrician, pediatric neurologist, pediatric physiotherapist, speech-language-swallowing therapist, and special education specialist. Pediatric physiotherapists are an important part of this team for developmental follow-up and rehabilitation. The Hammersmith Neonatal Neurological Examination (HNNE) is a method developed by Dubowitz and used in both clinical and research neurological examinations of preterm and term infants, is the neonatal form of the Hammersmith Infant Neurological Examination (HINE). Its use in the Neonatal Intensive Care Unit (NICU) is crucial for beginning risk assessment as early as possible. Research has determined the optimality score for this test for term infants evaluated in the first days after birth. Subsequently, the current version of the HNNE was standardized by evaluating low-risk term and high-risk preterm infants (25-34 weeks) at term ages, 6-48 hours after birth.The aim of this study was to develop a Turkish version of the HNNE for high-risk infants in Turkey and determine its validity and reliability. The translated HNNE version, which was found to be valid and reliable in this population, will be suitable for use by all healthcare professionals in Turkey. This study also aimed to determine the predictive value of HNNE at corrected 3-4/6 and 12 months when used in the follow-up of at-risk infants in NICUs in Turkey.The study consists of two phases. The first phase consisted of translating the short version of the survey into Turkish and conducting its cultural adaptation. The second phase involved reliability analysis. The principles of Guillemin et al. and Beaton et al. will be used in the translation and cultural adaptation processes.