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## Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique - NCT ID: NCT06365359 - Study ID: 23_RIPH2-12 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-11-15 - Lead Sponsor: University Hospital Center of Martinique ### Study Description Chlordecone, an organochlorine pesticide, was widely used on banana farms in the French West Indies. Studies by Inserm and health authorities have confirmed the contamination of the food chain and the majority of the population of the French West Indies by chlordecone.Epidemiological studies conducted in the French West Indies have shown that exposure to chlordecone at the levels observed is associated with an increased risk of developing several diseases, including premature birth and prostate cancer. Many of the adverse effects associated with chlordecone could be explained by its estrogenic hormonal properties, and systemic lupus erythematosus (SLE) is an autoimmune disease whose sensitivity to estrogen is well known and is reflected by 1) its clear predominance in women, 2) its predominance in women of childbearing age, 3) its risk of exacerbation in the event of pregnancy.Chlordecone has the potential to modify the activity of SLE through mechanisms other than its pro-estrogenic effects. In rats, chlordecone was observed to induce alterations such as a reduction in lymphocyte count, thymic atrophy, and a decrease in splenic germinal centers and NK cells.In a mouse model of systemic lupus erythematosus (SLE), exposure to chlordecone results in increased production of immune complexes and anti-DNA antibodies, which are markers of disease activity and monitoring.Chlordecone also has a cellular effect that reduces the apoptosis of potentially auto-reactive lymphocytes and stimulates the production of GM-CSF, IL-2, TNF-alpha, and IFN-gamma. The latter is central to the pathophysiology of SLE. While experimental studies suggest a potential impact of chlordecone on SLE, no human studies have been conducted to date, and the chlordecone impregnation of lupus patients in Martinique remains unknown.The most serious and feared complication of SLE is kidney damage. Kidney damage from the disease and the necessary immunosuppressive treatments can lead to significant morbidity and mortality, including death and end-stage chronic renal failure. Therefore, it is important to manage the disease carefully. Suspected lupus nephritis is confirmed by a renal biopsy, which allows for formal diagnosis and categorization into several classes. Suspected cases are identified by a proteinuria to creatininuria ratio greater than 0.5 g/g (or 24-hour proteinuria greater than 0.5g).The objective of this project is to determine whether there is a positive association between lupus nephritis occurrence in patients followed by the internal medicine department of the Martinique University Hospital and organochlorine pesticide chlordecone impregnation. ### Conditions - Systemic Lupus Erythematosus - Renal Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample for analysis of plasma of organochlorine pesticides concentration - Blood sample for cell collection ### Outcomes Primary Outcomes - To estimate the risk of presenting a renal complication of lupus disease based on the level of impregnation with chlordecone in the lupus patients seen at the Martinique University Hospital. Secondary Outcomes - To compare the activity of lupus according to the level of impregnation with chlordecone. - To compare the after-effects of lupus according to the level of impregnation with chlordecone. - To describe the distribution of the plasma concentration of chlordecone in lupus patients followed by the internal medicine department of the Martinique University Hospital. - To describe the distribution of the plasma concentration of p,p'-DDE in lupus patients followed by the internal medicine department of the Martinique University Hospital. - To describe the distribution of the plasma concentration of βHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital. - To describe the distribution of the plasma concentration of γHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital. - To describe the distribution of the plasma concentration of PCB 153 in lupus patients followed by the internal medicine department of the Martinique University Hospital. ### Location - Facility: University Hospital Center of Martinique, Fort-de-France, N/A, 97261, France @@
## Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers - NCT ID: NCT06365346 - Study ID: 2024.075-T - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-08-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description This pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress. ### Conditions - Resilience ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dyadic video-assisted gamified group-based music breathing therapy - Online educational modules ### Outcomes Primary Outcomes - Resilience levels of children - Resilience levels of parents Secondary Outcomes - Children's emotional and behavioral symptoms - Parenting stress - Parents' psychological distress (i.e., depression, anxiety and stress) - Feasibility outcomes - recruitment rate - Feasibility outcomes - retention rate - Feasibility outcomes - attendance - Acceptability of the intervention - level of satisfaction - Acceptability of the intervention ### Location - Facility: The Chinese University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@
## Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study - NCT ID: NCT06365333 - Study ID: 1451_04/BVNTW-VNCSKTE - Status: COMPLETED - Start Date: 2016-01 - Completion Date: 2024-04 - Lead Sponsor: National Children's Hospital, Vietnam ### Study Description In pediatric patients, intussusception predominantly occurs in the ileocecal region, with over 90% of cases lacking identifiable causative factors, initiating through peristalsis-driven invagination of bowel segments leading to compromised blood flow and subsequent bowel edema. Persistent obstruction may progress to bowel ischemia and infarction. Vietnam exhibits a higher incidence of intussusception compared to other countries, albeit with similar clinical presentations and anatomical locations, hinting at shared pathophysiology. Despite evidence supporting the safety and efficacy of non-surgical reduction techniques, many medical centers in low- to middle-income countries (LMICs) have not adopted these methods, resulting in unnecessary surgical interventions. The Vietnam National Hospital of Pediatrics (NCH) has employed air enema reduction since the early 2000s but lacks a comprehensive study on fluoroscopic-guided air-enema reduction (FGAR) techniques or success rates. Thus, this study aims to evaluate the long-term outcomes of pneumatic reduction for intussusception at NCH, a high-volume institution in a lower-middle-income country. ### Conditions - Intussusception ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Fluoroscopic-guided air-enema reduction (FGAR) ### Outcomes Primary Outcomes - Complicated intussusception - ICU admission - Death - Failed FGAR - Recurrence Secondary Outcomes ### Location - Facility: The National Hospital of Pediatrics, Hanoi, N/A, N/A, Vietnam @@
## Association Between Training Load and Lactate and Other Metabolites Analyzed by Metabolomic and Proteomic Techniques - NCT ID: NCT06365320 - Study ID: PROTEOMET - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: Fundació Eurecat ### Study Description Physical exercise induces numerous changes in the body in a complex signalling network caused by or in response to increased metabolic activity of contracting skeletal muscles.The application of omics analytical techniques such as proteomics and metabolomics in the field of sport allows us to understand how the human body responds to exercise and how sports results can be improved by optimising nutrition and training. Both omics techniques offer a quantitative measurement of the metabolic profiles associated with exercise and are able to identify metabolic signatures of athletes from different sports disciplines.Basketball is a high-intensity exercise modality interspersed with low-intensity. The performance requirements of basketball include aerobic and anaerobic metabolism, with anaerobic metabolism being considered the main energy system. Therefore, basketball players need great athletic ability to produce a successful performance during competition.For optimal sports performance it is important to adjust the training load, i.e. the degree of effort that the player can withstand in a single training session. Coaches require effective and objective load monitoring tools that allow them to make decisions about training plans based on the needs of each player.Microsampling systems emerge as an alternative to venipuncture by facilitating self-sampling, which can be carried out outside healthcare centres, in a comfortable and precise way from a small finger prick that the user can perform. These systems are less expensive and can be effective in measuring the levels of glucose metabolism products, such as lactate, through the application of metabolomics and proteomics. On the other hand, the use of non-invasive methods of measuring lactate levels is becoming increasingly popular in sports medicine. The use of saliva as an alternative fluid to the blood shows promise for identifying the concentrations of metabolites that occur during and after sports training. ### Conditions - Lactate - Sports Performance - Metabolomics - Proteomics ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Single basketball training ### Outcomes Primary Outcomes - Correlation between blood lactate levels and the subjective sensation of perceived effort Secondary Outcomes - Change in saliva lactate levels - Change in blood lactate levels - Change in levels of lipid metabolic markers determined in capillary blood samples - Change in levels of other lipid metabolic markers determined in capillary blood samples - Change in levels of polar metabolites determined in capillary blood samples - Change in levels of lipid metabolic markers determined in saliva samples - Change in levels of other lipid metabolic markers determined in saliva samples - Change in levels of polar metabolites determined in saliva samples - Change in levels of proteomic markers determined in capillary blood samples - Change in levels of proteomic markers determined in saliva samples - Pittsburgh Sleep Quality Index - Heart rate variations - Sociodemographic data: age and birth date - Sociodemographic data: sex - Lifestyle data: weekly training load - Lifestyle data: playing position - Clinical data: use of supplementation - Clinical data: use of medication - Clinical data: previous muscle injuries - Physiological data - Anthropometric data: weight - Anthropometric data: height - Anthropometric data: body mass index - Anthropometric data: fat mass percentage - Anthropometric data: muscle mass percentage ### Location - Facility: Fundació Eurecat, Center for Omic Sciences, Reus, Tarragona, 43204, Spain @@
## Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion - NCT ID: NCT06365307 - Study ID: Histograft-SF-2023 - Status: RECRUITING - Start Date: 2023-11-13 - Completion Date: 2025-04 - Lead Sponsor: Histograft Co., Ltd. ### Study Description The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion prosedure in comparison with bone autografts and synthetic material based on β-TCP ### Conditions - Cervical Disc Disorder With Radiculopathy - Spinal Stenosis - Lumbar and Other Intervertebral Disc Disorders With Radiculopathy - Biomechanical Lesion, Unspecified ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft") - Synthetic osteoplastic material based on β-TCP or bone autograft ### Outcomes Primary Outcomes - Spinal fusion - Adverse events and Severe Adverse Events Secondary Outcomes - SF- 36 score (The Short Form-36) - Unexpected Adverse Drug Reaction ### Location - Facility: Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky", Moscow, Moscow Oblast, 117588, Russian Federation @@
## Rescue Extracranial Vertebral Stenting in Tandem Occlusions - NCT ID: NCT06365294 - Study ID: REVET Study - Status: RECRUITING - Start Date: 2020-12-31 - Completion Date: 2024-05-31 - Lead Sponsor: Dr. Cuong Tran Chi ### Study Description The acute vertebrobasilar occlusion associated with the poor prognosis, particularly tandem occlusion. However, few data on the efficacy of the endovascular therapy was indicated in this occlusion. The investigators reported whether the additional rescue extracranial stenting improved clinical outcome by modified Rankin Scale (mRS) score within 3 months after the procedure ### Conditions - Acute Stroke - Ischemic Stroke, Acute - Vertebro Basilar Ischemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Rescue extracranial stenting ### Outcomes Primary Outcomes - The good 3-month outcome rate Secondary Outcomes ### Location - Facility: Can Tho SIS Hospital, Cần Thơ, N/A, 900000, Vietnam @@
## Caries Prevalence, Experience and Risk Related Factors Among Early Middle-aged Patients Attending Cairo University - NCT ID: NCT06365281 - Study ID: CARIES PREVALENCE - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-08 - Lead Sponsor: Cairo University ### Study Description Dental caries, a widespread oral health issue, results from a complex interplay of factors including behavior, hygiene, diet, and socio-demographic aspects. While preventive measures are available, it remains prevalent globally, affecting numerous teeth per individual. Improved oral hygiene practices and increased awareness have led to a reduction in caries prevalence. However, rising sugar consumption exceeds dietary guidelines, contributing to the problem. Despite limited epidemiological studies in Egypt, addressing individual-level factors is crucial. Surveillance of oral health in the early middle age group is standard, allowing decision-makers to assess the impact of caries and oral health care provision. Stratifying data by age, geography, and gender aids in understanding prevalence and planning effective prevention strategies. Overall, promoting awareness of dietary habits and preventive practices is vital for improving oral health outcome So, The purpose of this study is to assess the prevalence of dental caries among early middle age patients attending dental hospital in Faculty of Dentistry, Cairo university and to analyze the related risk factors utilizing WHO Oral Health Questionnaire for Adults. ### Conditions - Dental Caries - Caries,Dental ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of dental caries Secondary Outcomes - Caries experience - Caries risk related factors ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Perinatal Thoraco-abdomino-pelvic Tumors Study - NCT ID: NCT06365268 - Study ID: APHP231139 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-09 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Congenital tumors are a rare diagnosis in the fetus and newborn. They differ from those of children and adults in terms of the nature, location and evolution of the tumor.Indeed, some histologically benign tumors may have lethal potential in utero (e.g. sacrococcygeal teratomas) or even undergo malignant transformation if left untreated. In contrast, other tumors that are malignant by histological criteria may have a very good prognosis, regressing spontaneously within the first year of life (e.g. neuroblastoma).Despite advances in imaging, benign and malignant solid tumors remain a major diagnostic and prognostic challenge in the antenatal context.The management of congenital tumors requires multidisciplinary expertise, taking into account the perinatal context, which poses specific problems, particularly in terms of therapeutic aspects, but also the frequent existence of associated malformations and/or genetic predisposition syndromes.This study focuses on solid tumors of the thoraco-abdomino-pelvic region, the main objective being to investigate the correlation between antenatal clinical and radiological analysis and confirmed postnatal diagnosis of congenital solid truncal tumors, as well as the developmental spectrum in which they fit. ### Conditions - Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Collection of data from the patient's medical file ### Outcomes Primary Outcomes - Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors - Description of the developmental spectrum of solid congenital truncal tumors Secondary Outcomes - Characteristics and location of the tumor on pre- and post-natal imaging - Ile-de-France epidemiology of perinatal tumors - Evolution of solid congenital truncal tumors - Associated genetic abnormalities and malformations - Intercurrent obstetric events and obstetric outcomes based on the diagnoses made - Development of a management algorithm based on prenatal findings ### Location - Facility: Hôpital Necker-Enfants Malades, Paris, N/A, 75015, France @@
## National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes - NCT ID: NCT06365255 - Study ID: 2022-A01453-40 - Status: COMPLETED - Start Date: 2023-01-17 - Completion Date: 2024-02-28 - Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète ### Study Description The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres.In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres. ### Conditions - Diabetes Type 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionnaires ### Outcomes Primary Outcomes - The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps. Secondary Outcomes - Identify sub-populations of patients who feel stressed - Establish and categorise the different stress factors - Establishing a relationship between personality type and the impact of stress - Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities ### Location - Facility: Angers University Hospital, Angers, N/A, 49100, France @@
## Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study. - NCT ID: NCT06365242 - Study ID: DOACS1_2024 - Status: COMPLETED - Start Date: 2020-07-23 - Completion Date: 2022-12-23 - Lead Sponsor: University of Pisa ### Study Description Evaluation of DOACs treatment on post-extraction bleeding ### Conditions - Post Operative Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Peri-operative hemorrhage - Post-operative bleeding Secondary Outcomes ### Location - Facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale, Pisa, N/A, 56126, Italy @@
## Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol - NCT ID: NCT06365229 - Study ID: 2022-P2-336-02 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Beijing Friendship Hospital ### Study Description A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS). ### Conditions - Lumbar Spinal Stenosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Oswestry Disability Index (ODI) Secondary Outcomes - Magnetic resonance imaging (MRI) - Computed tomography (CT) scans - Creatine kinase (CK) - Erythrocyte sedimentation rate (ESR) - Surgical complication - VAS (visual analogue scale) for leg pain - VAS (visual analogue scale) for lower back pain - Japanese Orthopaedic Association (JOA) score - Modified MacNab criteria - Operation time - Blood loss - Postoperative hospital stays - Age - Gender - Body mass index (BMI) - Medical comorbidity - Smoking status - Alcohol status - Symptoms duration - Physical examination finding - Previous spinal surgery - Affected level - Stenosis grade - Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) ### Location - Facility: Beijing Friendship Hospital, Beijing, Beijing, 100050, China @@
## ALS Phase II Study of NX210c - NCT ID: NCT06365216 - Study ID: AXO-CLI-210c-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-02-01 - Lead Sponsor: Axoltis Pharma ### Study Description This study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple intravenous infusions of NX210c, at two dose levels, in patients with Amyotrophic lateral sclerosis (ALS). ### Conditions - Amyotrophic Lateral Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NX210c - Placebo ### Outcomes Primary Outcomes - The effect of NX210c on blood neurofilament light chain (NfL) or on a blood and cerebrospinal fluid (CSF) biomarker of BBB integrity. Secondary Outcomes ### Location - Facility: CHU de Lyon HCL, Bron, N/A, 69500, France @@
## Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function - NCT ID: NCT06365203 - Study ID: Through knee amputation - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to search and compare outcomes of through knee amputation (TKA) and above knee amputation (AKA) in terms of Technique ,wound healing ,infection rate , function and ambulation ### Conditions - Amputation of Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Through knee amputation - Above knee Amputation ### Outcomes Primary Outcomes - Wound healing rate - Incidence of infection Secondary Outcomes - Function of the limb Rehabilitation Quality of life - Mortality rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease - NCT ID: NCT06365190 - Study ID: AHMU-PD-rTMS - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-04-06 - Completion Date: 2024-07-31 - Lead Sponsor: Anhui Medical University ### Study Description Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD. ### Conditions - Transcranial Magnetic Stimulation - Parkinson's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcranial magnetic stimulation - Pharmacotherapy（antiparkinsonian drugs） ### Outcomes Primary Outcomes - Unified Parkinson's Disease Rating Scale III scores Secondary Outcomes - Hoehn-Yahr(H-Y) stage - Levodopa equivalent dose ### Location - Facility: Cognitive Neuropsychology Lab Anhui Medical University, Hefei, Anhui, 230022, China @@
## Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation - NCT ID: NCT06365177 - Study ID: 29BRC22.0243 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: University Hospital, Brest ### Study Description This study concerns elderly person aged more than 65 years with autonomous mobility.It is a multicentric randomized trial in two arms :Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultationConsultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient. ### Conditions - Rehabilitation - Elderly Person - Teleconsultation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Physical consultation - Teleconsultation ### Outcomes Primary Outcomes - Five Time Sit To Stand test completion time in teleconsultation - Five Time Sit To Stand test completion time in face-to-face consultation Secondary Outcomes - Satisfaction questionnaire - Five Time Sit To Stand test completion time in teleconsultation - Five Time Sit To Stand test completion time in face-to-face consultation - Presence or absence of falls - Number of falls ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex - NCT ID: NCT06365164 - Study ID: 38RC23.0354 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-11 - Lead Sponsor: University Hospital, Grenoble ### Study Description The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness.The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness.The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn. ### Conditions - Premature - Development, Child - Rooting Reflex ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tactile stimulation ### Outcomes Primary Outcomes - The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening. Secondary Outcomes - The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn. ### Location - Facility: University Hospital Grenoble, Grenoble, Isere, 38 000, France @@
## An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia - NCT ID: NCT06365151 - Study ID: TMDs fibromyalgia - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2026-04-05 - Lead Sponsor: Universitat de Lleida ### Study Description Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders. ### Conditions - Fibromyalgia - Temporomandibular Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Osteopathic manual therapy - Sham osteopathic manual therapy ### Outcomes Primary Outcomes - catastrophizing - functional limitation - functional status, disability and pain - pain and tinnitus - myofascial trigger points - Range of motion Secondary Outcomes ### Location - Facility: Osteopatia i Fisioteràpia Cornellà, Cornella de Llobregat, Barcelona, 08940, Spain @@
## Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms - NCT ID: NCT06365138 - Study ID: Aortic Rupture - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2030-12-01 - Lead Sponsor: University Hospital Augsburg ### Study Description It is currently unclear what activities aneurysms are involved in at the time of rupture. The aim of the study is to determine the activity performed at the time of aneurysm rupture. ### Conditions - Aortic Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bahaviour at the time of an aortic aneurysm rupture ### Outcomes Primary Outcomes - Occupation at the time of the aortic aneurysm rupture Secondary Outcomes ### Location - Facility: University Hospital Augsburg, Augsburg, N/A, 86156, Germany @@
## College Student Daily Life and Alcohol Use Study - NCT ID: NCT06365125 - Study ID: 7313E - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-05-01 - Lead Sponsor: Boston University Charles River Campus ### Study Description Heavy alcohol use among college students is associated with a range of negative consequences. However, college students rarely seek resources or treatment to change their alcohol use. Brief alcohol interventions (BAIs) have been developed as an alternative method to address heavy alcohol use among college students and show promise in reducing hazardous alcohol use in college students. Despite the established efficacy of BAIs, effects are often small and short-lived, and additional research is needed to investigate how BAIs can become more efficacious and endure for longer periods of time, particularly for computer-delivered interventions to improve accessibility and scalability of these interventions to a wider range of college students. Boosters or adjunctive components to BAIs have been suggested as a method to enhance the magnitude and duration of intervention effects. However, there remains a need to identify and test booster approaches that are both appealing and engaging to college students and effective in reducing heavy/hazardous alcohol use above and beyond the magnitude and duration seen by BAIs alone. The purpose of the study is to develop and test a novel, text-messaging booster as an adjunct to a current, evidence-based brief intervention, eCHECKUP TO GO, aimed at reducing college student heavy/hazardous alcohol use. Participants will complete baseline measures and will then be randomized to 1 of 3 conditions, stratified by sex at birth: 1) assessment only, 2) BAI only, and 3) Enhanced Intervention (BAI + four weeks of text messaging boosters). It is hypothesized that those randomized to the enhanced intervention condition will show a greater reduction in heavy/hazardous alcohol use at 3-month follow-up compared to the BAI and assessment only groups. ### Conditions - Drinking, College - Drinking Heavy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - eCHECKUP TO GO - Text messaging boosters ### Outcomes Primary Outcomes - Heavy drinking episodes - Alcohol-related negative consequences Secondary Outcomes ### Location - Facility: Boston University Charles River Campus, Boston, Massachusetts, 02215, United States @@
## Endoscopic Acetabulum Surgery - NCT ID: NCT06365112 - Study ID: R21154 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2028-01 - Lead Sponsor: Tampere University Hospital ### Study Description Try to develop an endoscopic surgical technique to treat acetabulum fractures ### Conditions - Acetabulum Fracture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Endoscopy assisted ### Outcomes Primary Outcomes - Number of patients with major complications - Number of patients with minor complications - Operation time - Patient satisfaction using EQ5D Secondary Outcomes ### Location - Facility: Tampere University hospital, Tampere, N/A, 33521, Finland @@
## Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke - NCT ID: NCT06365099 - Study ID: STUDY00000896_Exp2 - Status: RECRUITING - Start Date: 2024-02-02 - Completion Date: 2026-03-31 - Lead Sponsor: University of Texas at Austin ### Study Description Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and promote poststroke hand motor recovery. To maximize the effects of such interventions, they must be delivered during brain activity patterns during which TMS best activates the residual CST and enhances its neural transmission. This approach is termed brain state-dependent TMS. The investigators have recently developed a machine learning framework that identifies personalized brain activity patterns reflecting strong CST activation in neurotypical adults. In this study, the investigators will apply this framework to the poststroke brain for the first time. They will also evaluate relationships between this framework's ability to detect strong and weak CST activation states and measures of CST pathway integrity.Participants will visit the laboratory for two days of testing that are separated by at least one night of sleep. On Day 1, participants will provide their informed consent. The MacArthur Competence Assessment Tool and the Frenchay Aphasia Screening Test will be used to evaluate consent capacity and confirm the presence of expressive aphasia as needed. Afterwards, participants will complete eligibility screening and clinical assessment of upper extremity motor impairment, motor function, and disability using the Upper Extremity Fugl-Meyer Assessment, the Wolf Motor Function Test, and the Modified Rankin Scale. Participants will then be screened for the presence of residual CST connections from the lesioned hemisphere to the affected first dorsal interosseous muscle. Recording electrodes will be attached to this muscle in order to record TMS-evoked twitches in these muscles. During this procedure, single-pulse TMS will be applied to each point of a 1 cm resolution grid covering primary and secondary motor areas of the lesioned hemisphere at maximum stimulator output. If TMS reliably elicits a muscle twitch in the affected first dorsal interosseous, that participant will be considered to have residual CST connections and will be eligible for the full study. If no muscle twitch is observed, the participant will not be eligible for the full study. Afterwards, recording electrodes will be removed and the participant will leave the laboratory.On Day 2, participants will return to the laboratory. The investigators will confirm continued eligibility and place recording electrodes on the scalp using a swim-type cap. The investigators will also place recording electrodes on the affected first dorsal interosseous as well as the affected abductor pollicis brevis and extensor digitorum communis muscles. After identifying the scalp location at which TMS best elicits muscle twitches in the affected first dorsal interosseous muscle, the investigators will determine the lowest possible TMS intensity that such evokes muscle twitches at least half of the time. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while participants rest quietly with their eyes open. Stimulation will be delivered at an intensity that is 20% greater than the lowest possible TMS intensity that evokes muscle twitches at least half the time. Afterwards, all electrodes will be removed, participation will be complete, and participants will leave the laboratory.The investigators will recruit a total of 20 chronic stroke survivors for this study. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Single-pulse TMS ### Outcomes Primary Outcomes - Personalized classifier performance Secondary Outcomes - Corticospinal tract-lesion overlap ### Location - Facility: University of Texas at Austin, Austin, Texas, 78712, United States @@
## Targeting Personalized Brain States Reflecting Strong and Weak Corticospinal Tract Output in Real-time - NCT ID: NCT06365086 - Study ID: STUDY00000608 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-27 - Completion Date: 2025-01-01 - Lead Sponsor: University of Texas at Austin ### Study Description Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and enhance recovery of paretic hand function after stroke. To maximize the therapeutic effects of such interventions, they must be delivered during poststroke brain activity patterns during which TMS best activates the residual corticospinal tract and enhances neural transmission within it (i.e., brain state-dependent TMS). In this study, the investigators will test the feasibility of real-time, personalized brain state-dependent TMS in neurotypical adults.Participants will visit the laboratory for one day of testing. Upon arrival, participants will provide their informed consent; afterwards, they will complete eligibility screening. The investigators will then place recording electrodes on the scalp using a swim-type cap and on the left first dorsal interosseous, abductor pollicis brevis, and extensor digitorum communis muscles. After determining the location at which TMS best elicits muscle twitches in the left first dorsal interosseous, the investigators will determine the lowest possible intensity at which TMS elicits muscle twitches at least half of the time in this muscle. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while the participant rests quietly with their eyes open; stimulation will be delivered at an intensity that is 20% greater than the lowest possible intensity at which TMS elicits muscle twitches at least half of the time. Afterwards, the investigators will use the muscle and brain activity recordings acquired during these 6 blocks to build a personalized mathematical model that identifies which patterns of brain activity correspond to the largest TMS-evoked muscle twitches. The investigators will then use this model to detect the occurrence of these brain activity patterns in real-time; when these patterns are detected, single TMS pulses will be delivered. Afterwards, all recording electrodes will be removed, participation will be complete, and participants will leave the laboratory.The investigators will recruit a total of 16 neurotypical adults for this study. ### Conditions - Neurotypical Adults ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Personalized brain state-dependent single-pulse TMS ### Outcomes Primary Outcomes - Motor-evoked potential (MEP) amplitudes elicited from the left first dorsal interosseous muscle during personalized strong and weak CST states Secondary Outcomes - State-targeting accuracy ### Location - Facility: University of Texas at Austin, Austin, Texas, 78712, United States @@
## A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax - NCT ID: NCT06365073 - Study ID: TJIRB20231276 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-12-31 - Lead Sponsor: Qin Ning ### Study Description This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge. ### Conditions - Anthrax ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - mortality rates of severe anthrax Secondary Outcomes - incidence of complications - Peripheral blood biomarkers associated with 28-day and 90-day mortality - the improvement in 28-day and 90-day mortality with treatment for severe anthrax ### Location - Facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, N/A, China @@
## Screening for AL Amyloidosis in Smoldering Multiple Myeloma - NCT ID: NCT06365060 - Study ID: 00003143 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-02-27 - Lead Sponsor: Tufts Medical Center ### Study Description In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm. ### Conditions - Smoldering Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Creating a network to enroll patients on a collaborative study requiring marrow and blood specimens, to collect data for a training set of likelihood statistics and to plan a future validation study. - Validating an NGS assay that identifies IGLV genes in clonal plasma cells Secondary Outcomes ### Location - Facility: University of Alabama Hospital, Birmingham, Alabama, 35233, United States @@
## Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine - NCT ID: NCT06365047 - Study ID: STUDY00004926 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06-01 - Lead Sponsor: Tufts University ### Study Description This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product. ### Conditions - Xerostomia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 8% Arginine toothpaste - 1000 ppm F toothpaste ### Outcomes Primary Outcomes - Salivary pH Impact Secondary Outcomes - Measuring the change in the oral microbiome ### Location - Facility: Tufts University School of Dental Medicine, Boston, Massachusetts, 02111, United States @@
## Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma - NCT ID: NCT06365034 - Study ID: YKLL-KY-2024（024） - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-01-31 - Lead Sponsor: Qianfoshan Hospital ### Study Description To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC). ### Conditions - Carcinoma, Hepatocellular ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pathologic response rate Secondary Outcomes ### Location - Facility: the Qianfoshan Hospital, Jinan, Shandong, 250000, China @@
## ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder - NCT ID: NCT06365021 - Study ID: 88887.687583/2022-00 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2026-08 - Lead Sponsor: Beny Lafer ### Study Description The goal of this clinical trial is to test the efficacy of Acceptance and Commitment Therapy (ACT) as a psychotherapeutic treatment for patients with Bipolar Disorder (BD). The following questions will be investigated:* The efficacy of ACT in reducing depressive symptoms in patients with BD.* The efficacy of ACT in improving the quality of life in patients with BD.* The efficacy of ACT in improving functionality in patients with BD.* The efficacy of ACT in improving sleep quality in patients with BD.* The efficacy of ACT in improving psychological flexibility in patients with BDParticipants in the clinical group will undergo 12, 2 hours, weekly sessions of Acceptance and Commitment Therapy, in addition to their regular pharmacological treatment.Participants in the control group will undergo 3, 2 hours, weekly sessions of Bipolar Disorder Psychoeducation Therapy, in addition to their regular pharmacological treatment.Scales and assessments will be used to measure study outcomes on 3 different time-points: pre-intervention (month 0), post-intervention (month 3) and follow-up (month 6). Mood scales will be assessed every 2 weeks for the duration of treatment and every 4 weeks during the additional 12 week follow-up period. Psychological Flexibility scale will be assessed every week for the duration of treatment; as well as brief mood diary, which will be assessed daily for the duration of treatment.Results will be compared among both groups to assess the effectiveness of Acceptance and Commitment Therapy as an intervention for syndromic and sub-syndromic depression in bipolar disorder. ### Conditions - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acceptance and Commitment Therapy - Bipolar Disorder Psychoeducation Therapy ### Outcomes Primary Outcomes - Montgomery-Asberg Depression Scale - Young Mania Rating Scale Secondary Outcomes - Functional Assessment Staging Tool - World Health Organization Quality of Life Brief Scale - Pittsburgh Sleep Quality Index - Psychological Flexibility Questionnaire ### Location - Facility: Tatiana Cohab Khafif, São Paulo, SP, 01231010, Brazil @@
## Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer - NCT ID: NCT06365008 - Study ID: SYSKY-2024-210-01 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2027-09-30 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the salvage therapy for patients diagnosed with unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. The primary endpoint is progression-free survival (PFS). The investigators estimated that 40 patients were necessary. Secondary endpoints include overall survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer. ### Conditions - Unresectable/Metastatic Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sintilimab+irinotecan+leucovorin folinate+fluorouracil ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Overall survival - Objective response rate - Disease control rate - Adverse Events ### Location - Facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guangzhou, Guangdong, 510000, China @@
## Effects of Specialised Physical Education in Volleyball on Middle School Students' Physical Fitness and Performance - NCT ID: NCT06364995 - Study ID: JKEUPM-2023-1364 - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2024-07-05 - Lead Sponsor: Universiti Putra Malaysia ### Study Description Physical education stands as a collaborative, bilateral activity essential for the development and improvement of young people's physical qualities and plays a pivotal role in youth sports promotion. Volleyball offers a blend of aerobic and anaerobic exercises, developing muscle strength, bone density, cardiovascular health, and fine-tuning the nervous system. It is effective in improving physical attributes such as strength, speed, agility, endurance, and coordination, which are crucial for holistic student development and success in the standardized PE entrance examinations for senior high school.Recent trends have highlighted a decline in physical fitness among youth, as evidenced by rising obesity rates and increasing failure rates in fitness assessments. To counteract this, the Ministry of Education of the People's Republic of China 2021 has initiated a shift towards "specialised physical education," integrating health knowledge with basic and specialised motor skills training. This innovative educational model hopes to improve student physical fitness across educational tiers.Therefore, this study chose volleyball specialised physical education as an intervention to study the effect of physical fitness and The PE entrance examination for senior high school performance of middle school students. ### Conditions - Physical Fitness - Performance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Volleyball - Traditional Physical Education ### Outcomes Primary Outcomes - Effects of physical fitness of middle school students - Effects on middle school students' PE entrance examination for senior high school test performance Secondary Outcomes ### Location - Facility: Yimou MAO, Chengdu, Sichuan, 610044, China @@
## Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. - NCT ID: NCT06364982 - Study ID: PER-ECL-2023-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-12-31 - Lead Sponsor: Universitat Internacional de Catalunya ### Study Description The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances. ### Conditions - Peri-implant Mucositis - Peri-Implantitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Two contiguous dental implants placed with less ≤ 3mm from each other. - Two contiguous dental implants placed with > 3mm from each other. ### Outcomes Primary Outcomes - Prevalence of peri-implant diseases. Secondary Outcomes - FMPI - FMBI - mPI - mBI - SoP - PPD - MR - KM - Implant location - Implant position - Implant type - Implant brand - Implant roughness - Implant diameter - Implant length - Apico-coronal position of the implant - Inter-implant distances (IID) - Implant placement protocol - Bone grafting procedures (BGP) at implant placement - Implant-supported restorations - Cleansability of the prosthesis ### Location - Facility: Clínica Universitaria de Odontologia, Sant Cugat Del Vallès, Barcelona, 08195, Spain @@
## Investigation of the Pruritogens of Liver-related Diseases - NCT ID: NCT06364969 - Study ID: 2021-06-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-08-01 - Lead Sponsor: Peking University ### Study Description This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP). In this study, a combination of skin application and needle-free subcutaneous injection was used to investigate whether human endogenous molecules can cause itching. And a questionnaire is used to quantify the intensity of different candidates-induced itch. ### Conditions - Cholestasis - Intrahepatic Cholestasis of Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Itch intensity Secondary Outcomes - Flare areas ### Location - Facility: Peking University, Beijing, Beijing, 100000, China @@
## Phase Ib/II Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma - NCT ID: NCT06364956 - Study ID: SYSKY-2024-124-02 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2026-06 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma, a phase Ib/II study was conducted.This study will adopt a 3+3 design and include two predefined dose groups of palbociclib: 100mg QD, 125mg QD. Initially, Tislelizumab, 200 mg administered by intravenous infusion on Day 1 of each 21-day will be administered in combination. The trial will use the first cycle (28 days) as the observation period for tolerability, observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dose/maximum administered dose (MTD/MAD) and recommended phase 2 dose (RP2D) of the combination therapy (30 patients) .This study provide further evidence for improving the efficacy of neoadjuvant treatment forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for precision treatment of bladder cancer. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tislelizumab combined with two predefined dose groups of palbociclib - RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial. ### Outcomes Primary Outcomes - Phase I: the safety dose of the combination of Tislelizumab and palbociclib - Phase II: Pathological complete response rate(pCR) Secondary Outcomes - Pathological Downstaging(pDS) - Event-free survival (EFS) - overall survival (OS) - Safety and AE ### Location - Facility: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, N/A, China @@
## Tear Ferning Test for Dry Eye Diagnosis - NCT ID: NCT06364943 - Study ID: 202400020B0 - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2025-04-04 - Lead Sponsor: Chung Shan Medical University ### Study Description Application of tear ferning test for clinical dry eye diagnosis ### Conditions - Dry Eye Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - with/without dry eye syndrome ### Outcomes Primary Outcomes - Schirmer's test - Tear film breakup time - Ocular surface health evaluate Secondary Outcomes - Ocular surface disease index - Intraocular pressure ### Location - Facility: Jen-Ai Hospital, Taichung,, N/A, 412, Taiwan @@
## SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus - NCT ID: NCT06364930 - Study ID: SGLT2i_HBV Study - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2031-03-30 - Lead Sponsor: Chinese University of Hong Kong ### Study Description This is a five-year, double blinded, randomised trial of dapagliflozin versus placebo in patients with chronic hepatitis B and DM or IFG complicated with compensated advanced chronic liver disease (cACLD). 412 subjects will be recruited. Subject will be randomly assigned to receive dapagliflozin 10mg daily or dapagliflozin placebo one tablet daily for up to 5 years. After randomization, subject will be followed up at month 3, month 6 and then 6-monthly until 60 months (follow up ± 4 weeks from scheduled clinic visit is allowed). At each visit, drug compliance, physical examination, observed or reported adverse events will be assessed. 10ml of blood will be taken at each visit and transient elastography to assess fibrosis regression will be performed at 60th month or at withdrawal visit. You are discouraged to use (pegylated)-interferon, any other NA including lamivudine, adefovir, and telbivudine, another SGLT2i Empagliflozin (Jardiance), Dapagliflozin + Metformin XR (Xigduo). ### Conditions - Chronic Hepatitis B ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dapagliflozin 10mg Tab - Placebo 10mg Tab ### Outcomes Primary Outcomes - The primary endpoint is liver complications Secondary Outcomes - Cardiovascular complications - change in liver stiffness measurement - change anthropometric parameters - change anthropometric parameters ### Location - Facility: Prince of Wales Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC - NCT ID: NCT06364917 - Study ID: IRB-300012781 (UAB2432) - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2027-06 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The purpose of this study, known as DISCERN, is to compare two different treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that does not show a marker known as PD-L1. This study will help us understand if using two types of immune therapy together with chemotherapy is better than using one type of immune therapy with chemotherapy. We're doing this by looking at changes in the subject's cancer's DNA in the blood after starting treatment. ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab - Carboplatin - Paclitaxel - Pemetrexed - Nivolumab - Ipilimumab ### Outcomes Primary Outcomes - Rate of Molecular Response in Patients with PD-L1 Negative Advanced NSCLC Treated with Dual vs. Single ICB Plus CT Regimens Secondary Outcomes - Efficacy Evaluation - Correlation Analysis ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## An Phase III Study, Multicenter，Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma. - NCT ID: NCT06364904 - Study ID: SYSKY-2024-123-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2029-04-15 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib - Tislelizumab, Cisplatin, Gemcitabine ### Outcomes Primary Outcomes - Progression-Free Survival(PFS) - Incidence of Grade 3/4 Neutropenia Secondary Outcomes - ORR - overall survival (OS) - Safety and AE - Disease Control Rate(DCR) - During Of Response(DOR) - Biomarker Endpoint Analyses ### Location - Facility: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, N/A, China @@
## Assessing the Impact of a Digital VMMC Platform - NCT ID: NCT06364891 - Study ID: VMMC NEXUS - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description VMMC has been identified as a crucial intervention by UNAIDS to achieve the 2030 global target of a 90% reduction in new HIV infections compared with 2010 levels. CIDRZ, a key partner to the Ministry of Health, has worked with DesireLine to develop a mobile application that supports mobilisers to segment potential clients and provide them with targeted messaging based on their segmentation type. The hypothesis of our proposed study is that targeted interventions addressing the barriers for each of the seven segments, assisted by the Digital Mobilization Tool, will better meet the needs of potential clients and therefore improve uptake of VMMC services, specifically among the three most-resistant segments.The objective of this study is to evaluate the effect of a segment-targeted mobilization intervention supported by the VMMC NEXUS Digital Mobilization Tool on the uptake of VMMC services at 30 intervention sites, compared with 30 control sites.The research questions are:1. What is the effect of segment-targeted mobilization interventions designed to address the specific psycho-behavioral barriers each of the seven segments face, supported by the VMMC NEXUS Digital Mobilization Tool, on the overall numbers of men receiving VMMC in each site?2. What is the effect of the same on the numbers of men by segment receiving VMMC in each site?3. What is the effect of the same on the numbers of men by age receiving VMMC in each site?Secondary goals will be the following, to the extent possible:* Assess the incremental cost of the intervention, including by MC* Assess and document process learnings from the intervention* Develop a workplan to enable national and regional scale-up of the mobilization model and NEXUS Digital Mobilization Tool if demonstrated as effective ### Conditions - Voluntary Medical Male Circumcision ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - VMMC NEXUS Digital application ### Outcomes Primary Outcomes - Total number of VMMC's conducted in intervention vs control - Total number of VMMC's by segment - Total number of VMMC's by age Secondary Outcomes - Costing - Process evaluation - Develop a workplan and handbook to allow for the intervention to be scaled up elsewhere. ### Location - Facility: Ministry of Health facilities, Lusaka, N/A, 10101, Zambia @@
## Non-invasive Diagnostics of Microbial Keratitis - NCT ID: NCT06364878 - Study ID: 813533 - Status: RECRUITING - Start Date: 2023-08-23 - Completion Date: 2028-04-08 - Lead Sponsor: Sorlandet Hospital HF ### Study Description Infectious keratitis is a significant cause of partial vision loss and blindness and places a large burden on eye care professionals. One of the main challenges for the ophthalmologist when presented with a case of suspected microbial keratitis is the determination of the subtype of keratitis. It must be determined whether the origin of the infection is bacterial, viral, fungal, or parasitic, in order to prescribe a correct, effective treatment aimed at the causative pathogen. In daily practice this can be challenging, and general treatments with antibiotics are prescribed. Some cases then experiences deterioration, resulting in more patients visits and further rounds of invasive treatments and progressive vision deterioration.This project is designed to break this cycle of nonspecific diagnosis, suboptimal treatment, and progressive worsening of vision with increased interventions. New, advanced diagnostics will be brought into the clinic to provide additional information which, if our hypothesis is correct, will result in more rapid and accurate diagnosis of the keratitis subtype. This will translate into earlier administration of a more targeted treatment, avoiding the repeated round of non-targeted treatment and progressive worsening of the patient's vision. This can directly reduce to number of clinic visits and specialist time required for treatment and follow-up of keratitis, knowledge of how the eye responds to various microbes by initiating a specific cascade of molecular inflammatory signals and changes in protein expression in the tear film.Using in vivo confocal microscopy (IVCM) we will document the cellular status of the cornea and identify microbes infecting the cornea in real-time. Secondly, tear samples will be obtained from patients with keratitis to evaluate and quantify the molecular cytokine signatures associated with specific microbial species, confirmed by microbiological culture. We will for the first time develop cytokine profiles for the various types of infection, identifying diagnostic cytokines which in the longer term can lead to development of rapid point-of-care biomarker diagnostics.The project aims are translated into the following hypotheses:H1: In vivo confocal microscopy imaging features detect microbial keratitis consistent with clinical assessment and outcome at a greater frequency than microbiological culture results.H2: Cytokine profiles (or a subset of molecules) in the eye are specific for viral, bacterial, fungal, or amoebic keratitis; and H3: A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis. ### Conditions - Infectious Keratitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - In vivo confocal microscopy - Tear film sampling ### Outcomes Primary Outcomes - IVCM findings and cytokine profile in infectious keratitis is specific for the different microbial subtypes. Secondary Outcomes ### Location - Facility: Sorlandet hospital, Arendal, N/A, N/A, Norway @@
## AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study - NCT ID: NCT06364865 - Study ID: 2022-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-03-30 - Lead Sponsor: Teleflex ### Study Description This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback. ### Conditions - Gall Bladder Disease - Bile Duct Diseases - Acute Cholecystitis - Kidney - Liver - Appendix - Spleen Disease - Prostate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - laparoscopic procedure ### Outcomes Primary Outcomes - Evaluating the safety of AE05ML - Evaluating the performance of AE05ML Secondary Outcomes - Evaluating device performance characteristics - Evaluating operator reported feedback ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Evaluation of LY007 Cell Injection for r/r B-NHL - NCT ID: NCT06364852 - Study ID: LY007C1101 - Status: RECRUITING - Start Date: 2021-12-25 - Completion Date: 2026-05-31 - Lead Sponsor: Ruijin Hospital ### Study Description An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research ### Conditions - B-NHL ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - LY007 ### Outcomes Primary Outcomes - Maximum tolerated dose or clinically recommended dose; - Dose limiting toxicity - Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern, Including cytokine release syndrome , neurotoxicity,physical examination, vital signs, ECOG score, ECG, laboratory testing, etc. Secondary Outcomes - PK aspect - PK aspect - PD aspect - therapeutic effect - Anti LY007 antibody - The titer of human anti mouse antibody ### Location - Facility: Ruijin hospital, Shanghai, N/A, N/A, China @@
## Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases - NCT ID: NCT06364839 - Study ID: CT2024-ZJU-OBS7 - Status: COMPLETED - Start Date: 2024-02-20 - Completion Date: 2024-03-25 - Lead Sponsor: Xiao Xu ### Study Description Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients.Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively. ### Conditions - Hepatocellular Carcinoma, Non-cirrhotic Liver ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - N/A ### Outcomes Primary Outcomes - Postoperative complications were evaluated by postoperative imaging and serological examination - The overall survival rate was evaluated by follow-up investigation and outpatient review - The tumor-free survival rate was evaluated by follow-up investigation and outpatient review Secondary Outcomes ### Location - Facility: Xiao Xu, Hangzhou, Zhejiang, N/A, China @@
## Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma - NCT ID: NCT06364826 - Study ID: NPC-202403 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-04-22 - Lead Sponsor: Zhejiang Cancer Hospital ### Study Description This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles. ### Conditions - Nasopharyngeal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sintilimab, bevacizumab, gemcitabine - IMRT ### Outcomes Primary Outcomes - 3-year Event-free survival rate Secondary Outcomes - Objective Response Rate - Disease Control Rate - Progression-Free Survival - Overall survival - adverse events(AEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Co-developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals With Spinal Cord Injury - NCT ID: NCT06364813 - Study ID: H20-01461 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: University of British Columbia ### Study Description Family caregivers of individuals with spinal cord injury (SCI) provide the majority of care and are at high risk of experiencing caregiver burden, which not only impacts caregivers' own wellbeing, but also their ability to respond to patients' needs. Health education using online approaches (eHealth) has the potential to improve quality of care, enhance communication between health care users and providers, reduce costs and increase access to existing knowledge and education for family caregivers. Here, the investigators propose a research study to assess the quality of the eHealth program. The findings of this study will lead to the refinement of the eHealth program. ### Conditions - Spinal Cord Injuries - Caregiver Burden ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - COMPANION eHealth Program ### Outcomes Primary Outcomes - Family caregivers' subjective burden as assessed by the Zarit Burden Interview Secondary Outcomes - Participants' objective burden as assessed by the Dutch Objective Burden Inventory - Participants' distress as assessed by the Depression, Anxiety and Stress Scale - Participants' relationship quality satisfaction as assessed by the Dyadic Adjustment Scale - Participants' health-related quality of life as assessed by the Veterans RAND 12-item Health Survey - Caregiver competence as assessed by the Caregiving Competence Scale - Participants' opinion regarding the usability of the implementation as assessed by the System Usability Scale - Participants' health care use as assessed by a bespoke questionnaire - Participants' experience using the implementation as assessed by a qualitative interview ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial of Hepatocellular Carcinoma Resistant to PD-1 Monoclonal Antibody - NCT ID: NCT06364800 - Study ID: GDT-001-07-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2026-09-26 - Lead Sponsor: Beijing 302 Hospital ### Study Description The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in patients with hepatocellular carcinoma resistant to PD-1 monoclonal antibody.Hepatocellular Carcinoma ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - γδ T cells - PD-1 monoclonal antibody - targeted drugs ### Outcomes Primary Outcomes - Safety evaluation: Incidence of Adverse events (AEs) - Safety evaluation: Dose limited toxicity (DLTs) - Efficacy evaluation: Objective Response Rate(ORR) - Efficacy evaluation: Duration of Response(DOR) - Efficacy evaluation: Progress Free Survival(PFS) - Efficacy evaluation: Overall Survival (OS) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma - NCT ID: NCT06364787 - Study ID: GDT-001-07-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2026-09-26 - Lead Sponsor: Beijing 302 Hospital ### Study Description The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in first-line treatment of patients with hepatocellular carcinoma. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - γδ T cells - Targeted drugs - PD-1 monoclonal antibody ### Outcomes Primary Outcomes - Safety evaluation: Incidence of Adverse events (AEs) - Safety evaluation: Dose limited toxicity (DLTs) - Safety evaluation: Maximum-tolerated dose (MTD) - Efficacy evaluation: Objective Response Rate(ORR) - Efficacy evaluation: Duration of Response(DOR) - Efficacy evaluation: Progress Free Survival(PFS) - Efficacy evaluation: Overall Survival (OS) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## ALS20-101 Lentiviral Gene Therapy for Beta Thalassemia - NCT ID: NCT06364774 - Study ID: 22-020309 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Children's Hospital of Philadelphia ### Study Description The main goal of this study is to find out if the blood disorder called transfusion-dependent beta thalassemia can be safely treated by modifying blood stem cells. This is done by collecting blood stem cells from the subject, modifying those cells, adding a healthy beta globin gene, and then giving them back to the subject. It is hoped that these modified cells will decrease the need for blood transfusions. The gene modified blood stem cells are called CHOP-ALS20 ("study drug"). This experimental gene therapy has not been tried on human beings before and is not FDA approved. ### Conditions - Beta-Thalassemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ALS20 ### Outcomes Primary Outcomes - Neutrophil Engraftment - Platelet Engraftment - Overall Survival at 2 years - Incidence of transplant related mortality - Incidence of Graft Versus Host Disease - Incidence of Vector-Derived Replication Competent Lentivirus - Insertional Oncogenesis - Clonal Predominance - maintain total hemoglobin level of 9.0 g/dL or higher Secondary Outcomes ### Location - Facility: Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States @@
## Assesment of Intermediate Vision After BIL Cataract Surgery - NCT ID: NCT06364761 - Study ID: 24103_BIL_EDOF - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Universitair Ziekenhuis Brussel ### Study Description The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.Participants will:* Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)* Have to fill in 2 questionnaires about visual functioning and spectacle independanceResearchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens . ### Conditions - Cataract ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bag in the lens cataract surgery ### Outcomes Primary Outcomes - Intermediate vision Secondary Outcomes - Near vision ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer - NCT ID: NCT06364748 - Study ID: 002-2024-Shalowitz - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-09 - Lead Sponsor: West Michigan Cancer Center ### Study Description A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cellular enabled blood pressure cuff - Standard of Care Cuff ### Outcomes Primary Outcomes - To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care Secondary Outcomes - Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring - Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring - Patient satisfaction with usual care blood pressure monitoring - Patient satisfaction with remote blood pressure monitoring ### Location - Facility: West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States @@
## Entities and Variables Related to Catch-up Growth - NCT ID: NCT06364735 - Study ID: Entità e variabili - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-01 - Lead Sponsor: ASST Fatebenefratelli Sacco ### Study Description A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned. ### Conditions - Celiac Disease in Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Measure the catch-up growth degree. Secondary Outcomes - Calculate the degree of catch-up growth ### Location - Facility: ASST Fatebenefratelli Sacco, Milan, N/A, 2015, Italy @@
## Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease - NCT ID: NCT06364722 - Study ID: ZYS2024-02 - Status: COMPLETED - Start Date: 2015-05-01 - Completion Date: 2024-03-28 - Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian ### Study Description Multidisciplinary techniques such as multimodal neuroimaging, microbiology, and bioinformatics were applied to study the differences in correlation characteristics between gut microbes, functional brain networks, and peripheral inflammation among patients with active Crohn's disease (CD), CD in remission, and healthy subjects. ### Conditions - Crohn Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acupuncture treatment - Sham acupuncture ### Outcomes Primary Outcomes - Effect of Acupuncture on Crohn's Disease Activity Index (CDAI) Secondary Outcomes - Effects of Acupuncture on Anxiety and Depression - Effects of Acupuncture on Quality of Life - Effect of acupuncture on intestinal inflammation - Effects of acupuncture on gut microbiota - Effects of acupuncture on the functional activity of brain networks - Effects of acupuncture on intestinal inflammation - Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations - Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment) - Safety evaluation (number of participants with abnormal routine blood tests) - Safety evaluation (number of participants with abnormal Liver function tests) - Safety evaluation (number of participants with abnormal Renal function tests) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Criterion-learning Based Naming Treatment in Aphasia - NCT ID: NCT06364709 - Study ID: 4526 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2028-08 - Lead Sponsor: Albert Einstein Healthcare Network ### Study Description Aphasia is a disorder of spoken and written language, most commonly following a stroke. It is estimated that between 2.5 and 4 million Americans are living with aphasia today. A common problem in aphasia involves difficulty retrieving known words in the course of language production and comprehension. The overarching goal of this project is to develop and test early efficacy, efficiency, and the tolerability of a lexical treatment for aphasia in multiple-session regimens that are comprised of retrieval practice, distributed practice, and training dedicated to the elicitation of correct retrievals. The aim of this work is to add to and refine the evidence base for the implementation and optimization of these elements in the treatment of production and comprehension deficits in aphasia, and make important steps towards an ultimate goal of self-administered lexical treatment grounded in retrieval practice principles (RPP) to supplement traditional speech-language therapy that is appropriate for People with Aphasia (PWA) from a broad level of severity of lexical processing deficit in naming and/or comprehension. This project cumulatively builds on prior work to develop a theory of learning for lexical processing impairment in aphasia that aims to ultimately explain why and for whom familiar lexical treatments work, and how to maximize the benefits they confer. ### Conditions - Aphasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Criterion-learning practice ### Outcomes Primary Outcomes - Trained naming items (Experiment 1) - Trained naming items (Experiment 2) - Trained naming items (Experiment 3) - Trained comprehension items (Experiment 4) Secondary Outcomes - Trained naming items (Experiment 1) - Trained naming items (Experiment 2) - Untrained naming items (Experiment 2) - Trained naming items (Experiment 3) - Trained naming items (Experiment 4) - Trained comprehension items (Experiment 4) - Untrained comprehension items (Experiment 4) - Treatment compliance (Experiment 2) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors - NCT ID: NCT06364696 - Study ID: 4396-CL-0101 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2027-04-30 - Lead Sponsor: Astellas Pharma Inc ### Study Description Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors.ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. ASP4396 is not currently available as a treatment for the public. In this study, researchers will learn how ASP4396 is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from ASP4396.In this study, ASP4396 is being given to humans for the first time.People in this study will be adults with locally advanced (unresectable), or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies or refused to receive those treatments.The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396.This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP4396.This study will be in 2 parts.Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2.Part 2 is called Dose Expansion. Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP4396 to use in future studies.In both parts of the study, ASP4396 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will continue treatment until: they have medical problems from the treatment they can't cope with (can't tolerate); their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP4396. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished.People will visit the clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.After this, people will visit the clinic for a health check several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.After treatment has finished, people in the study will be followed up for up to 45 weeks. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ASP4396 ### Outcomes Primary Outcomes - Incidence of Dose Limiting Toxicities (DLTs) for ASP4369 - Number of Participants with Adverse Events (AEs) - Number of Participants with Serious Adverse Events (SAEs) - Number of Participants with laboratory value abnormalities and/or AEs - Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs - Number of Participants with vital sign abnormalities and/or AEs - Number of Participants with physical exam abnormalities and/or AEs - Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score Secondary Outcomes - Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Duration of Response (DOR) per RECIST v 1.1 - Disease Control Rate (DCR) per RECIST v 1.1 - Progression Free Survival (PFS) per RECIST v1.1 - Overall Survival (OS) - Pharmacokinetics (PK) of ASP4396 in plasma: area under the concentration-time curve from the time of dosing to 24 hours after dosing (AUC24h) - PK of ASP4396 metabolite in plasma: AUC24h - PK of ASP4396 in plasma: AUC168h - PK of ASP4396 metabolite in plasma: AUC168h - PK of ASP4396 in plasma: Maximum Concentration (Cmax) - PK of ASP4396 metabolite in plasma: Cmax - PK of ASP4396 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) - PK of ASP4396 metabolite in plasma: Ctrough - PK of ASP4396 in plasma: Time of maximum concentration (tmax) - PK of ASP4396 metabolite in plasma: tmax - Change from baseline of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D amino acid substitution (G12D) tumor samples ### Location - Facility: START Midwest, Grand Rapids, Michigan, 49546, United States @@
## Coronary Artery Disease and Exercise Adherence - NCT ID: NCT06364683 - Study ID: AIBU-HSF-SDEMIR-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-13 - Completion Date: 2025-05-13 - Lead Sponsor: Abant Izzet Baysal University ### Study Description This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). For this purpose, the following measurement tools will be used respectively: (1) "Patient Information Form" including sociodemographic characteristics of the patients and medical information related to the disease, (2) the Exercise Adherence Rating Scale (EARS), (3) Exercise Self-Efficacy Scale (ESE) and, (4) Turkish-Health Literacy Survey Europe-Q12 (HLS-EU-19-12Q-TR). Statistical analyses will be carried out by descriptive statistics (number, percentage, mean, standard deviation, etc.), correlation analysis and regression analysis. ### Conditions - Adherence, Treatment - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey study ### Outcomes Primary Outcomes - exercise adherence - predictors for exercise adherence Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus - NCT ID: NCT06364670 - Study ID: ZSLL-KY-2023-011-01 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12-31 - Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University ### Study Description This trial aims to use machine learning to analyze fNIRS imaging data of specific brain regions of tinnitus patients, thereby constructing a predictive model of the clinical efficacy of acupuncture for SNT. ### Conditions - Tinnitus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - acupuncture ### Outcomes Primary Outcomes - Change in resting-state functional connectivity (RSFC) - Change in hemoglobin signals - Change in Tinnitus Severity Grading Secondary Outcomes - Change in Tinnitus Handicap Inventory score - Change in average pure-tone threshold ### Location - Facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310000, China @@
## Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye - NCT ID: NCT06364657 - Study ID: IRB00439625 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-07-31 - Lead Sponsor: Johns Hopkins University ### Study Description In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals:1. To determine whether dry eye is associated with reduced corneal sensation2. To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's3. To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation. ### Conditions - Sjogren's Syndrome - Dry Eye - Neurotrophic Keratitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Eye Exam ### Outcomes Primary Outcomes - Corneal Epithelium health - Corneal Nerve health Secondary Outcomes - Correlations Between Corneal Staining Score - Correlations Between Patient Symptoms ### Location - Facility: Johns Hopkins Hospital Wilmer Eye Institute, Baltimore, Maryland, 21287, United States @@
## Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure - NCT ID: NCT06364644 - Study ID: IRB00336599 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-06-30 - Lead Sponsor: Johns Hopkins University ### Study Description This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility. ### Conditions - Type2diabetes - Heart Failure - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Community Champions - Homegrown Heroes ### Outcomes Primary Outcomes - Change in cardiorespiratory fitness Secondary Outcomes - Change in cardiac biomarker, hs-cTnT - Change in hemoglobin A1c - Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales. - Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA) - Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test - Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ) - Change in weight (kgs) - Change in BMI - Change in hip and waist circumference (centimeters) - Change in Metabolic Syndrome Severity Z score - Change in self-management as assessed by the Patient Activation Measure (PAM-13). - Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 - Change in blood pressure (systolic and diastolic (mmHg)) - Change in cardiac biomarker, gal-3 - Change in cardiac biomarkers, NT-proBNP ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CARE1 Pragmatic Clinical Trial - NCT ID: NCT06364631 - Study ID: 2023-503317-29-00 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2032-05-05 - Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris ### Study Description Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1/PDL1 axis or CTLA4. Combination therapy is SOC for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the 2 approaches and patients are treated based on physician decision without clinical /biomarker factors to guide treatment selection. PDL1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PDL1(+) and ICI-VEGFR TKI in PDL1(-) patients.Study design has been developed to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging Overall Survival (OS) for PDL1(+) patients and to demonstrate that ICI-VEGFR TKI is superior to ICI-ICI in prolonging Progression Free Survival (PFS) and OS for PDL1(-) patients. ### Conditions - Metastatic Kidney Cancer - Metastatic Kidney Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nivolumab - Ipilimumab - Pembrolizumab - Cabozantinib - Axitinib - Lenvatinib ### Outcomes Primary Outcomes - Overall Survival (OS). Secondary Outcomes - Progression-free survival according to RECIST 1.1 - Objective Response Rate (ORR) according to RECIST 1.1 - Quality of Life via questionnaire EQ-5D-5L - Quality of Life via questionnaire NNCCN/FACT Kidney Cancer Symptom Index (NFKSI) - Quality of Life via questionnaire Kidney Symptom Index (KSI) - Duration of Treatment - Time to treatment discontinuation (TTD) - Treatment-free survival (TFS) - Time to subsequent systemic anticancer therapy (TTSST) - Incidence of AE's - Health Economic evaluation: healthcare costs [France & Netherlands only] - Health Economic evaluation: cost-utility [France & Netherlands only] ### Location - Facility: Gustave Roussy, Villejuif, N/A, 94805, France @@
## Use of Wearables to Detect Infections in Kidney Transplant Recipients - NCT ID: NCT06364618 - Study ID: G-24-07 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2027-12 - Lead Sponsor: Institute for Clinical and Experimental Medicine ### Study Description The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies.The main questions it aims to answer are:1. What are the biometric data pattern changes in impending infections?2. What accuracy the machine learning algorithm can achieve?Participants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection. ### Conditions - Kidney Transplant Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Accuracy of the algorithm at detecting infections at presymptomatic stage Secondary Outcomes ### Location - Facility: Institute for Clinical and Experimental Medicine, Prague, N/A, 14021, Czechia @@
## MySpace: the Role of Vision in Representing Space - NCT ID: NCT06364605 - Study ID: IIT_UVIP_MySpace - Status: ENROLLING_BY_INVITATION - Start Date: 2021-05-03 - Completion Date: 2025-12-31 - Lead Sponsor: Istituto Italiano di Tecnologia ### Study Description My Space aims to identify the ontogenesis of spatial representation through cross-sectional and longitudinal studies in infants, children, and adolescents with typical and atypical development (visual impairments). The results will serve for the design and development of a novel multisensory device for sensorimotor rehabilitation in blind children from the early stages of life. ### Conditions - Blindness - Visual Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Rehabilitation with the iReach novel multisensory medical device ### Outcomes Primary Outcomes - Perceptual responses to multisensory stimuli - Stimuli velocity perception - Distance stimuli perception - Eye movements - Saccade Analysis - ERP evaluation and analysis - Power of the cortical activity Secondary Outcomes ### Location - Facility: Unit For Visually Impaired People, Genova, N/A, 16152, Italy @@
## Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis - NCT ID: NCT06364592 - Study ID: 2024-011-KY - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences ### Study Description The aim of this study is to preliminarily evaluate the is to assess the effects and safety of electroacupuncture for moderate to severe dysmenorrhea secondary to adenomyosis. ### Conditions - Dysmenorrhea - Adenomyosis - Electroacupuncture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Electroacupuncture - Sham Electroacupuncture ### Outcomes Primary Outcomes - The change from baseline in the numerical rating scale (NRS) score on the worst pain Secondary Outcomes - The change from baseline in the numerical rating scale (NRS) score on the average pain - The change from baseline in the numerical rating scale (NRS) score on the worst pain. - Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain. - Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain. - The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score. - The change from baseline in the the Cox Menstrual Symptom Scale (CMSS). - The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5). - The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS). ### Location - Facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, N/A, N/A, China @@
## Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT). - NCT ID: NCT06364579 - Study ID: 6533 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2031-01-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires. ### Conditions - Anal Cancer Patients ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - QOL analysis Secondary Outcomes - Overall survival (OS) - Colostomy Free Survival (CFS) - Loco-Regional Recurrence (LRR) - Disease-Free Survival (DFS) - Acute toxicity - Late toxicity ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Lazio, 00168, Italy @@
## Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma - NCT ID: NCT06364566 - Study ID: time-exploring - Status: COMPLETED - Start Date: 2010-10-15 - Completion Date: 2019-10-15 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use ### Conditions - Time ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neoadjuvant chemradiotherapy - Minimally invasive esophagectomy ### Outcomes Primary Outcomes - The overall survival of the overall population - The Disease-Free survival of the overall population - The overall survival of the non-PCR population - The Disease-Free survival of the non-PCR population - The overall survival of the PCR population - The Disease-Free survival of the PCR population Secondary Outcomes ### Location - Facility: Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, 200032, China @@
## Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study - NCT ID: NCT06364553 - Study ID: NL86416.078.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: Erasmus Medical Center ### Study Description A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia. ### Conditions - Oesophageal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Esophageal self-expandable metal stent ### Outcomes Primary Outcomes - Complication: incidence of perforation - Complication: incidence of hemorrhage - Complication: incidence of fistula formation - Complication: incidence of gastroesophageal reflux - Complication: incidence of stent migration - Efficacy: clinical outcome - Efficacy: incidence of patients receiving technical successful stent placement Secondary Outcomes - Incidence of recurrent dysphagia - Pain related to esophageal stent (placement) - Overall survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED - NCT ID: NCT06364540 - Study ID: 2023-08-14 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Antonios Likourezos ### Study Description In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled, patient-initiated delivery of analgesics in a measured and titratable fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings and for a lot of different reasons, such as to treat acute pain after surgery (like a sore throat after being intubated), as a pre-medication for general anesthesia, to treat cancer pain, and as a therapy for asthmaticus.Our research team has published two case series of 10 adult patients who were given nebulized ketamine (via BAN) for a variety of acute traumatic and non-traumatic painful conditions. The patients showed a 60% decrease in pain and a small number of side effects. Furthermore, our group published a randomized, double-blind trial of 120 adult patients evaluating the analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg), showing similar analgesic efficacy between the three different dosing regimens for short-term (up to 120 minutes) pain relief. Lastly, we recently completed a randomized, double-blind, double-dummy clinical trial comparing the analgesic efficacy and safety of nebulized ketamine and intravenous ketamine in managing acute pain in adult ED patients, with data currently being analyzed.Nebulized fentanyl given in the ED to adults with acute traumatic and non-traumatic pain syndromes at a dose range of 1.5-4 mcg/kg showed the same or even better pain-relieving effects than IV fentanyl and IV morphine alone.Our objective is to compare the analgesic efficacy and rates of side effects of a 0.75 mg/kg dose of ketamine administered via breath-actuated nebulizer (BAN) to a dose of 3 mcg/kg of fentanyl administered via breath-actuated nebulizer (BAN) in adult patients presenting to the ED with acute painful conditions. ### Conditions - Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ketamine - Fentanyl ### Outcomes Primary Outcomes - Reduction of pain scores on the numeric rating pain scale (NRS) Secondary Outcomes - Need for Rescue Analgesia - Severity of Adverse Events - Evaluation of Severity of agitation and/or sedation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma - NCT ID: NCT06364527 - Study ID: ADH-BSA-02-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: CoheroHealth ### Study Description The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes.The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines. ### Conditions - Asthma Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Aptar Digital Health respiratory disease management platform ### Outcomes Primary Outcomes - Asthma Control Questionnaire - 5 scores Secondary Outcomes - Mini-Asthma Quality of Life Questionnaire - Rescue medication usage - Inhaled corticosteroid steroid daily adherence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity - NCT ID: NCT06364514 - Study ID: IRB-P00047313 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-10-01 - Lead Sponsor: Boston Children's Hospital ### Study Description To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability. ### Conditions - Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Clinical Stability Assessment ### Outcomes Primary Outcomes - Proportion of eligible patients who consent to participate in the intervention - Rate of persistent and worsening respiratory symptoms measured by patient's clinical status; the rate of emergency department revisit or hospital readmission within 1 week of antibiotic discontinuation Secondary Outcomes - Median days of antibiotics received for patients in the intervention group as well as from historical control group ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase 1 Trial of KH801 - NCT ID: NCT06364501 - Study ID: KH801 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-05-01 - Lead Sponsor: Beijing Kanghong Biopharmaceutical Co., Ltd. ### Study Description KH801 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Or 0.9% sodium chloride Injection.This study is expected to include a total of approximately 17-42 participants. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - KH801 ### Outcomes Primary Outcomes - MTD - DLT - RP2D Secondary Outcomes - AE - Cmax - Tmax - T1/2 - AUC0-t - CL - AUC0-inf - anti-drug antibody (ADA) ### Location - Facility: Peking University Cancer Hospital, Peking, Beijing, N/A, China @@
## TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety - NCT ID: NCT06364488 - Study ID: 295721 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-31 - Lead Sponsor: BlueSkeye AI ### Study Description This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period. ### Conditions - Depression - Depression, Postpartum - Anxiety in Pregnancy - Anxiety - Anhedonia - Perinatal Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - TrueBlue App ### Outcomes Primary Outcomes - The rate of device related adverse events Secondary Outcomes - Rate of initial use (assessing feasibility and acceptability) - Rate of New Depression or Risk (Suicidality) events - Rate of referral to Perinatal Psychiatry services - Rate of acceptance of referrals to Perinatal Psychiatry - Diagnosis rate for depression, or other mental health problems, during the period of study. - Continued use (acceptability) - Loss to follow-up - Usability (quantitative measure) - Agreement between TrueBlue generated score and validated scales - Thematic results ### Location - Facility: Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom @@
## Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet? - NCT ID: NCT06364475 - Study ID: BezmialemVU-TF-AÖ-1 - Status: COMPLETED - Start Date: 2021-11-01 - Completion Date: 2022-09-01 - Lead Sponsor: Bezmialem Vakif University ### Study Description The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. This study was conceived with a view to comparing time-restricted eating, a method which can be easily conveyed and applied in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a BMI\>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their respective group were prepared. Anthropometric measurements, blood pressure, blood tests were analyzed before the study and at the end of the 8-week. ### Conditions - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 16:8 Time-Restricted Intermittent Fasting Group - Energy-Restricted Six-Meal Group ### Outcomes Primary Outcomes - Weight measured in kilogram Secondary Outcomes - Body composition - Body mass index - Waist-to-height ratio (WHtR) - Waist circumference in centimetres ### Location - Facility: İstanbul Sabri Artam Vakfi Family Medicine Center, İ̇stanbul, N/A, 34473, Turkey @@
## Precise Evaluation Criteria for Histological Regression of NASH Fibrosis - NCT ID: NCT06364462 - Study ID: ZLRK202301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04-01 - Lead Sponsor: Beijing Friendship Hospital ### Study Description It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements. ### Conditions - NASH - Liver Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lifestyle intervention ### Outcomes Primary Outcomes - Regression of NASH fibrosis Secondary Outcomes - Dynamic changes of liver stiffness measurements (LSM) - Dynamic changes of CAP - Dynamic changes of MRE - Dynamic changes of MRI-PDFF - Dynamic changes of non-invasive liver fibrosis models - Dynamic changes of non-invasive liver fibrosis models - Dynamic changes of non-invasive liver fibrosis models - Dynamic changes of non-invasive liver fibrosis models - Dynamic changes of non-invasive liver fibrosis models - Dynamic changes of metabolic markers - Dynamic changes of metabolic markers - Dynamic changes of metabolic markers - Incidence of liver-related events - Incidence of extrahepatic related events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study - NCT ID: NCT06364449 - Study ID: 202309052RIND - Status: RECRUITING - Start Date: 2023-10-13 - Completion Date: 2024-05-31 - Lead Sponsor: National Taiwan University Hospital ### Study Description Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort. ### Conditions - Decision Tree Analysis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - predicted AV access choices Secondary Outcomes - to determine factors affecting clinical use of the targeted AV access over a variable timeframe ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, N/A, Taiwan @@
## Distant Reiki Therapy on Postpartum Period Fatigue and Depression - NCT ID: NCT06364436 - Study ID: AksarayU1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-06-03 - Completion Date: 2024-04-10 - Lead Sponsor: Aksaray University ### Study Description This research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression. ### Conditions - PostPartum Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Reiki energy therapy ### Outcomes Primary Outcomes - Visual Analog Scale for Fatigue (VAS-F) - Edinburgh Postnatal Depression Scale (EPDS) Secondary Outcomes ### Location - Facility: Aksaray University, Aksaray, Merkez, N/A, Turkey @@
## Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) - NCT ID: NCT06364423 - Study ID: 10001599 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-07-01 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description Background:Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.Objective:To test anti-CD19 CAR T cell therapy in people with CLL or SLL.Eligibility:People aged 18 years and older with CLL or SLL that has not been controlled with standard drugs.Design:Participants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19.Participants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19.Participants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment.Follow-up visits will continue for 5 years. ### Conditions - B-Cell Chronic Lymphocytic Leukemia - Leukemia, Lymphocytic, Chronic, B-Cell - B-Lymphocytic Leukemia, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Autologous HuCD19 ( Anti-CD19)CAR T cells - Cyclophosphamide - Fludarabine - Rituximab ### Outcomes Primary Outcomes - Phase I: Determine the safety of administering T-cells expressing a fully-human anti-CD19 CAR to participants with advanced CLL or SLL. - Phase II: Determine the overall response rate (ORR) of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) to participants with advanced CLL Secondary Outcomes - Phase I: Assess overall response rate - Phase I+II: Assess complete response rate - Phase I+II: Assess duration of responses - Phase I+II: Determine the ORR for re treatment with rituximab, chemotherapy and CAR T cells in eligible patients - Phase II: Determine the frequency of grade 3-4 adverse events at the Optimal Dose ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors - NCT ID: NCT06364410 - Study ID: NCI-2024-02982 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-30 - Completion Date: 2026-03-31 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone. ### Conditions - Clinical Stage III Gastric Cancer AJCC v8 - Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 - Clinical Stage IV Gastric Cancer AJCC v8 - Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 - Locally Advanced Gastric Carcinoma - Locally Advanced Gastroesophageal Junction Adenocarcinoma - Locally Advanced Malignant Solid Neoplasm - Metastatic Gastric Carcinoma - Metastatic Gastroesophageal Junction Adenocarcinoma - Metastatic Malignant Solid Neoplasm - Unresectable Gastric Carcinoma - Unresectable Gastroesophageal Junction Adenocarcinoma - Unresectable Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Azenosertib - Biopsy - Biospecimen Collection - Computed Tomography - Echocardiography - Magnetic Resonance Imaging - Multigated Acquisition Scan - Trastuzumab Deruxtecan ### Outcomes Primary Outcomes - Maximum tolerated dose - Recommended phase 2 dose - Incidence of dose limiting toxicities (DLTs) - Incidence of adverse events (AEs) Secondary Outcomes - Objective response rate (ORR) - Progression free survival (PFS) - Duration of response - Pharmacodynamic effects in the tumor - Predictors of response and acquired resistance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis - NCT ID: NCT06364397 - Study ID: ESPRIT202403 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Changhai Hospital ### Study Description The goal of this clinical trial is to learn if endoscopic retrograde cholangiopancreatography (ERCP) works to treat idiopathic recurrent pancreatitis (IRAP) in adults. It also clarify the efficacy of ERCP in the diagnosis of IRAP. The main questions it aims to answer are:Does ERCP reduce the frequency of pancreatitis episodes in IRAP patients? Does ERCP contribute to identify the etiology of IRAP patients?Participants will be randomly allocated to receive ERCP (pancreatic sphincterotomy and pancreatic stent placement) or conservative treatment and be followed for 1 year. ### Conditions - Recurrent Acute Pancreatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ERCP - Health education and conservative management of clinical routines ### Outcomes Primary Outcomes - Recurrence rate of AP Secondary Outcomes - Ratio of reduced AP episodes - Proportion of patients with reduced AP episodes - Severity of AP - Evaluation of quality of life - Evaluation of psychological condition - Proportion of patients diagnosed by ERCP. ### Location - Facility: Changhai Hospital, Shanghai, Shanghai, 200433, China @@
## Radical Synchronous Chemoradiotherapy With DDP/5-FU and PD-1 for Non-metastatic Rectal Squamous Cell Carcinoma - NCT ID: NCT06364384 - Study ID: E2024074 - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2027-02-28 - Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University ### Study Description The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are:Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs.Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY. ### Conditions - Rectal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PD-1 and CRT ### Outcomes Primary Outcomes - 1-year tumor-free survival(DFS) Secondary Outcomes - 1-year overall survival (OS) - 1-year relapse-free survival (RFS) - 1-year metastasis free survival (DMFS) - Incidence of chemotherapy and immunotherapy-related adverse reactions - Complete response rate (CRR) - 1-year stoma-free survival ### Location - Facility: Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, N/A, China @@
## Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer - NCT ID: NCT06364371 - Study ID: E2023210 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-01 - Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University ### Study Description The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. The main question it aims to answer is:What is the predictive value of this model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment? Eligible patients will be prospectively enrolled, and the clinical features of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative will be collected and annotated. ### Conditions - Predictive Cancer Model - Pathologic Complete Response ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Medical examination ### Outcomes Primary Outcomes - Area under curve(AUC) Secondary Outcomes - Sensitivity - Specificity - Negative predictive value(NPV) - Positive predictive value(PPV) ### Location - Facility: The Sixth Affiliated Hospital, Sun Yatsen University, Guangzhou, Guangdong, N/A, China @@
## Interactive Computer-adaptive Chronic Kidney Disease Education Program - NCT ID: NCT06364358 - Study ID: IRB23-0385 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: University of Chicago ### Study Description The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC ### Conditions - Chronic Kidney Diseases - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Computerized CKD Education - Usual Hospital Care ### Outcomes Primary Outcomes - Change in CKD Knowledge baseline to post patient education intervention - Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention - Change in ESKD Treatment Preferences from baseline to 1 day post-intervention Secondary Outcomes - Change in Patient Activation Measure from Baseline to 30 days Post-intervention - Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up) - CKD Self-Management from baseline to 30 day post-intervention ### Location - Facility: University of Chicago Medical Center, Chicago, Illinois, 60637, United States @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06364345 - Study ID: INOVA_POCAD_1 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## #Chatsafe Netherlands: a Social Media Intervention to Improve Dutch Young People's Safe Communication About Suicide Online - NCT ID: NCT06364332 - Study ID: ChatsafeNL - Status: NOT_YET_RECRUITING - Start Date: 2024-04-04 - Completion Date: 2025-03 - Lead Sponsor: 113 Suicide Prevention ### Study Description Suicide is the leading cause of death among young people (YP) aged 10 to 25 years in the Netherlands. In addition, YP report high rates of suicidal ideation (16%). While suicidal behavior is a complex phenomenon with many factors and causes, the role of social media is becoming more prominent, especially for YP. Social media has been shown to be a source where YP can find support, but it's also a place where suicidal behavior is glorified or normalized, which can be triggering or harmful to other social media consumers.The #Chatsafe guidelines were developed by Orygen Australia to better equip young people to communicate safely about suicide on social media. These guidelines are supported by a social media campaign to make the content of the guidelines more accessible to them. The #Chatsafe intervention consists of both the guidelines and the social media campaign. A small-scale Australian feasibility study showed promising results in terms of the acceptance and safety of the campaign, and safety regarding communicating about suicide on social media platforms. Currently, in Australia it is tested to what extent these results hold up in a Randomized Controlled Trial (RCT) (Robinson et al., 2023).With funding from the Dutch National Agenda for Suicide Prevention, a contextualized replication study is conducted. The aim of this study is to determine whether the #Chatsafe intervention has an effect on the way in which Dutch YP communicate online about suicide. ### Conditions - Suicide Prevention - Communication - Social Media ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Social Media campaign ### Outcomes Primary Outcomes - Safe communication about suicide online Secondary Outcomes - Confidence when communicating about suicide online - Willingness to intervene against suicide online - Self-efficacy online - Safety of the #ChatsafeNL materials - Acceptability of the #ChatsafeNL intervention - Safety of the #ChatsafeNL intervention ### Location - Facility: 113 Suicide Prevention, Amsterdam, Noord Holland, 1105 BP, Netherlands @@
## Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD - NCT ID: NCT06364319 - Study ID: 2024PHD002-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-06-30 - Lead Sponsor: Peking University People's Hospital ### Study Description The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver. ### Conditions - cGVHD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - anti-CD25 rhMAb - Prednisone - Ruxolitinib - Cyclosporine ### Outcomes Primary Outcomes - overall response rate (ORR) Secondary Outcomes - duration of response（DOR） - patient-reported outcomes (PRO) - disease-free survival (DFS) - failure-free survival (FFS) - non-relapse mortality (NRM) - overall survival （OS） - adverse drug reactions (ADR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias - NCT ID: NCT06364306 - Study ID: 12032024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2031-12-31 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).The main questions it aims to answer are:length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.Participants will:Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes. ### Conditions - Ventral Hernia - Incisional Hernia - Abdominal Wall Defect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Robotically-assisted ventral hernia repair (RVHR) - Open ventral hernia repair (OVHR) ### Outcomes Primary Outcomes - Primary outcome: length of stay Secondary Outcomes - Comprehensive complication index (CCI) - Adverse events - pain after surgery - Functional recovery - Quality of life using SF-12 form ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Early Warning Model of Unfavorable Outcomes Following Endovascular Interventional Treatment of Intracranial Aneurysm - NCT ID: NCT06364293 - Study ID: KY2023-261-01 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description Endovascular treatment has become one of the primary treatment methods for intracranial aneurysms. The unfavorable outcomes during follow-up included aneurysm recurrence and long-term incomplete-occlusion, which would bring a high risk of rebleeding and retreatment. Previous studies have tried to predict the outcomes of aneurysms following endovascular treatment based on aneurysm characteristics including morphology, embolization packing degree, etc, but the conclusion was inconsistent. Hemodynamics of aneurysms and parent artery played a greater role in predicting outcomes following endovascular treatments. Investigators also found that the outcomes were determined by many factors, in which the demography, clinical indicators, treatment methods, and material selection can not be ignored, and the mechanism of unfavorable imaging outcomes should be explored using large samples of clinical cases and numerous variable parameters. The pre-experiment of investigators confirmed that artificial intelligence technology can meet the calculation requirements for deep mining and analysis of large sample data. This study aims to use the deep learning model to identify relevant risk factors and weights, establish a stable and accurate prediction model, then incorporate the prospective study to verify the model. The results will be very helpful in accurately predicting the adverse outcomes such as recurrence and long-term non-occlusion after endovascular treatment and help to improve the therapeutic strategy and avoid risk factors. Besides, the occurrence of ischemic or hemorrhagic complications during follow-up may affect the final follow-up outcome, so the analysis was included as one of the outcome events to evaluate the prognosis after intervention. ### Conditions - Intracranial Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational design does not include interventional behavior. ### Outcomes Primary Outcomes - Unfavorable imaging outcome Secondary Outcomes - Hemorrhagic or ischemic complication occurred during the follow-up ### Location - Facility: Beijing Tiantan hospital, Beijing, N/A, N/A, China @@
## Pediatric Prehospital Airway Resuscitation Trial - NCT ID: NCT06364280 - Study ID: 2023X0135 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-09-30 - Lead Sponsor: Ohio State University ### Study Description This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\]. ### Conditions - Heart Arrest, Out-Of-Hospital - Wounds and Injuries - Respiratory Insufficiency in Children - Child, Only - Critical Illness ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BVM - SGA - ETI ### Outcomes Primary Outcomes - 30-day ICU-free survival Secondary Outcomes - Neurologic outcome upon hospital discharge ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Babytam vs Babyexe in Post-menopausal Women at High Risk for Breast Cancer. - NCT ID: NCT06364267 - Study ID: BabyTears - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-09-01 - Lead Sponsor: Andrea DeCensi ### Study Description The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tamoxifen 10 MG - Exemestane 25 MG ### Outcomes Primary Outcomes - Quality of life MEnQol Secondary Outcomes - Other domains - PMAS questionnaire - Customer Satisfaction questionnaire - BPI - Sex hormones biomarkers - Insulin biomarker - Bone biomarker ### Location - Facility: E.O. Ospedali Galliera, Genova, N/A, 16128, Italy @@
## Effects of CBD on 2 Mile Run Time Trial Performance - NCT ID: NCT06364254 - Study ID: 2311054791 - Status: RECRUITING - Start Date: 2023-11-11 - Completion Date: 2024-05-30 - Lead Sponsor: University of Northern Colorado ### Study Description Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Cannabidiol Capsules ### Outcomes Primary Outcomes - Difference in Time Trial Times - Difference in Anxiety Measured with the State Trait Anxiety Inventory - Difference in Blood Lactate Concentrations - Difference in Gastrointestinal Distress - Different in Heart Rate Variability Secondary Outcomes ### Location - Facility: University Of Northern Colorado, Greeley, Colorado, 80639, United States @@
## Focus Groups on Cognitive Function in Psychosis - NCT ID: NCT06364241 - Study ID: 331760 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-09 - Lead Sponsor: King's College London ### Study Description Cognitive deficits are commonly observed in people with mental disorders. In psychosis, these impairments are frequently present early in the course of the disorder and have a substantial impact on functional outcomes. This project will gain insight into the cognitive deficits that people with lived experience of psychosis and their carers perceive to be the most troublesome. To achieve this, the investigators will conduct two sets of focus groups. During the first set of focus groups, the investigators will aim to identify the cognitive deficits that individuals with psychosis and their carers consider to be the most impairing.The findings of these focus groups will provide important information about what areas of cognition and functioning should be considered in future analyses of large fully anonymised datasets collected in the past from individuals with psychosis. The focus groups will not form part of those analyses, but will provide input from people with lived experience of psychosis on what problems with thinking skills are the most important for them and that should be considered by further research.The second set of focus groups will enable the investigators to determine the participants' perception of potential risks and benefits associated with the dissemination of findings on cognitive function in psychosis, to ensure this is done in a manner that is sensitive to the wishes and needs of people with lived experience of psychosis.Each participant will be asked to attend one focus group, which will last approximately one hour. Focus groups will take place at the South London and Maudsley (SLaM) Trust or at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, although provision will be made for participants to also participate online. ### Conditions - Psychosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Focus group ### Outcomes Primary Outcomes - Individual perception of impairments due to cognitive deficits associated with psychosis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia - NCT ID: NCT06364228 - Study ID: 0133-24-FB - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-04 - Lead Sponsor: University of Nebraska ### Study Description The proposed study is a double-blind, randomized, placebo-controlled study of intranasal oxytocin (OXT) to determine its efficacy in improving quality of life and reducing stress in caregivers to persons with dementia. Planned enrollment is 32 subjects over 2 years. ### Conditions - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Placebo - Oxytocin Intranasal Spray 12 International Unit (12IU) - Oxytocin Intranasal Spray 24 International Unit (24IU) - Functional MRI ### Outcomes Primary Outcomes - Participants' chronic stress levels in the past thirty days. Secondary Outcomes - Participant Quality of Life survey - Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and EmpaTom task. ### Location - Facility: University of Nebraska Medical Center, Department of Psychiatry, Omaha, Nebraska, 61898-5581, United States @@
## Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation - NCT ID: NCT06364215 - Study ID: 2024P000883 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Brigham and Women's Hospital ### Study Description Compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF). ### Conditions - Atrial Fibrillation Paroxysmal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pulmonary Vein Isolation alone - Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation ### Outcomes Primary Outcomes - Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period. - The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure. Secondary Outcomes - Freedom from atrial arrhythmias medication - Procedural time - Procedure-related Recurrencies - Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT). - Use of amiodarone - Complications. - fluoroscopy time. - Pulsed field ablation (PFA) applications during procedure. - first-pass pulmonary vein isolation (PVI). ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters - NCT ID: NCT06364202 - Study ID: 1928368 - Status: COMPLETED - Start Date: 2022-08-01 - Completion Date: 2023-11-01 - Lead Sponsor: Augusta University ### Study Description The purpose of this study is to examine the possible benefits of peanut butter consumption prior to bedtime on sleep and energy levels among fire fighters. Fire fighters require high levels of energy to perform their occupational tasks but commonly lack sleep as well as the amount of dietary protein and fat suggested for tactical athletes. By addressing this gap, we expect that if peanut butter consumption is shown to improve sleep and/or energy, this lifestyle change (peanut butter consumption) may be appealing to fire fighters because of the ease and low cost of peanut butter. Aim 1: Determine if consuming peanut butter prior to bedtime alters measures of sleep quality and quantity in fire fighters. It is hypothesized that firefighters who consume the peanut butter will have positive impacts in measure of sleep quality and energy levels.Aim 2: Examine the effects of peanut butter consumption on morning and evening energy levels ### Conditions - Sleep - Body Composition - Blood Pressure - Physical Activity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Peanut Butter ### Outcomes Primary Outcomes - Body composition - Body composition - Sleep - Blood pressure - Blood pressure Secondary Outcomes - Physical activity ### Location - Facility: Augusta University, Augusta, Georgia, 30909, United States @@
## Inspiring Seniors Toward Exercise Promotion - NCT ID: NCT06364189 - Study ID: FY22-119 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-30 - Lead Sponsor: University of North Carolina, Greensboro ### Study Description The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing \>150min/week AE and 3 days/week of ST for 30 min/day. ### Conditions - Cognitively Normal Older Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Music - Exercise ### Outcomes Primary Outcomes - Physical activity (objective) - Ecological Momentary Assessment (EMA): Affective response to PA - Ecological Momentary Assessment (EMA): Perceived autonomy - Ecological Momentary Assessment (EMA): Perceived exertion - Ecological Momentary Assessment (EMA): Behavioral intention - Ecological Momentary Assessment (EMA): Physical Activity setting - Ecological Momentary Assessment (EMA): Anticipated, remembered, and incidental affect - Ecological Momentary Assessment (EMA): Social Support for Exercise - Physical activity (self-report) Secondary Outcomes - Cognitive performance - General - Cognitive performance - Tower of London - Cognitive performance - NIH Toolbox Oral Reading Recognition Test - Cognitive performance - NIH Toolbox List Sort Working Memory Test - Cognitive performance - NIH Toolbox Picture Sequence Test - Cognitive performance - NIH Toolbox Dimensional Change Card Sort Test - Cognitive performance - NIH Toolbox Flanker Inhibitory Control and Attention Test - Cognitive performance - Mnemonic Similarity Task - Cognitive performance - Perceptual Discrimination Task - Health Related Quality of Life - Physical activity (subjective) - Music Reward Experience - Treatment Satisfaction - Body Mass Index - Waist/Hip/Leg Circumference - Sagittal Diameter - Blood Pressure - Handgrip Strength - Timed Up and Go (TUG) - 10-Meter Walk - 4-Stage Balance Test - 6-Minute Walk Test (6MWT) - 30-second Chair Stand ### Location - Facility: University of North Carolina at Greensboro, Greensboro, North Carolina, 27402-6170, United States @@
## Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis. - NCT ID: NCT06364176 - Study ID: STUDY00149479 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-10 - Lead Sponsor: University of Kansas Medical Center ### Study Description The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy.Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function. ### Conditions - Cystic Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Losartan - Placebo ### Outcomes Primary Outcomes - Sweat chloride Secondary Outcomes - Lung function - absolute - Lung function - relative - Transforming growth factor (TGF)-beta1 - airway - TGF-beta1 - systemic - Inflammatory mediators - airway - Inflammatory mediators - systemic - CFQ-R - Adverse events ### Location - Facility: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States @@
## Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults - NCT ID: NCT06364163 - Study ID: 697716 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-12 - Completion Date: 2027-12-31 - Lead Sponsor: University of Bergen ### Study Description High cholesterol concentration is a major risk factor for cardiovascular disease (CVD), and consumption of fish has been associated with a lower CVD risk in several studies. The beneficial health effects of consuming fish have traditionally been ascribed to the long-chain PUFA (LC-PUFA) EPA (C20:5n-3) and DHA (C22:6n-3), although consumption of fish oils or concentrates with high EPA and DHA contents does not affect the cholesterol concentration in humans and lowers the cholesterol concentration in rats and mice only when given in very high doses. Fish oils contain a plethora of fatty acids besides EPA and DHA, and in recent years, increased focus has been on the long-chain MUFA (LC-MUFA) cetoleic acid (C22:1n-11). Cetoleic acid is found in high amounts in oils from certain fish species such as herring, which has relatively low contents of both EPA and DHA. The investigators have recently summarised and meta-analysed the available literature that investigates the effects of diets containing fish oils or fish oil concentrates that have a high content of cetoleic acid but low or no content of EPA and DHA on cholesterol concentration in rodents, showing that cetoleic acid-rich fish oils and concentrates prevent high cholesterol concentration. ### Conditions - High Cholesterol ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Herring oil concentrate - Control ### Outcomes Primary Outcomes - Serum concentration of LDL-cholesterol Secondary Outcomes - Serum concentration of HDL-cholesterol - Serum concentration of total cholesterol - Serum concentrations of apolipoproteins - Serum concentrations of amino acids metabolites - Serum concentration of one-carbon pathway metabolites - Fatty acid composition in leukocytes - Serum concentration of glucose - Serum concentration of insulin - Urine concentrations of cystatin C - Urine concentrations of T cell immunoglobulin mucin-1 (TIM-1) - Body composition ### Location - Facility: University of Bergen, Bergen, N/A, N/A, Norway @@
## Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction - NCT ID: NCT06364150 - Study ID: MAGIC6 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-08-01 - Lead Sponsor: Seoul National Hospital ### Study Description This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction". ### Conditions - Acute Myocardial Infarction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Autologous Peripheral Blood Stem Cell injection ### Outcomes Primary Outcomes - Left ventricular systolic function Secondary Outcomes - Regional wall motion score index - B-natriuretic peptide level - 6-minute walk test - All-cause death - Target lesion Revascularization - Readmssion - Cardiovascular death - non-Target lesion Revascularization ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings - Pilot RCT - NCT ID: NCT06364137 - Study ID: 73203 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-06-30 - Lead Sponsor: Stanford University ### Study Description The research study will examine engagement in telehealth for children undergoing psychotherapy. The study in Phase I entails a pilot randomized trial with a goal to enroll 42 families, examining patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.Engagement will be assessed using well-established measures - PRIME-O (modified) video coding, MTT-Y/MTTCG and attendance data (sessions 1-4). Clinicians in the study will deliver therapy to clients for 4 sessions, providing opportunity to measure temporal sustainment of any engagement differences. ### Conditions - Anxiety Disorders - Mood Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Teleo - Standard videoconferencing ### Outcomes Primary Outcomes - PRIME-O Video Coding Score Secondary Outcomes - My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores - My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores - Attendance during Psychotherapy Sessions ### Location - Facility: Stanford University, Stanford, California, 94305, United States @@
## Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction - NCT ID: NCT06364124 - Study ID: Beijing_LH_CCU2024 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Beijing Luhe Hospital ### Study Description Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies. ### Conditions - STEMI ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - evolocumab - Atorvastatin ### Outcomes Primary Outcomes - Average percent change from baseline in LDL-C levels to discharge and day 30 Secondary Outcomes - Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30 - Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30 - Number of cardiovascular events to day 30 ### Location - Facility: Beijing luhe hospital, Beijing, N/A, N/A, China @@
## Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation - NCT ID: NCT06364111 - Study ID: Vibrabot Capsule - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2025-08-30 - Lead Sponsor: Beijing Tsinghua Chang Gung Hospital ### Study Description This is a single-center trial that enrolls 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, as well as the mechanism of action of the Vibrabot capsule. ### Conditions - Chronic Functional Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vibrabot capsule - polyethylene glycol ### Outcomes Primary Outcomes - The proportions of responders to the three therapies during the treatment period. Secondary Outcomes - Evaluation of intestinal motility - Assessment of neurotransmitters in peripheral blood - Assessment of changes in intestinal flora - Evaluation of the treatment cycle of Vibrabot Capsules ### Location - Facility: XuanJiang, Beijing, Beijing, 102218, China @@
## Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections - NCT ID: NCT06364098 - Study ID: prevention of PPH - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-02-01 - Lead Sponsor: Cairo University ### Study Description Study design:A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University.Population of study:192 pregnant women at the age range from 20 to 35 years, with BMI \< 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age \>39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level \<9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study. ### Conditions - Postpartum Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Misoprostol ### Outcomes Primary Outcomes - The amount of blood loss Secondary Outcomes - Changes in hematocrit values in both groups after delivery - Changes in Hemoglobin level measured by gm/dl in both groups after delivery ### Location - Facility: Faculty of medicine, Kasr Alainy, Cairo, Al Manyal, 11956, Egypt @@
## Enhancing Epilepsy Management With Precision Deep Brain Stimulation - NCT ID: NCT06364085 - Study ID: DBS2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Nova Scotia Health Authority ### Study Description The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study. ### Conditions - Epilepsy, Drug Resistant ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Neuromodulation programming ### Outcomes Primary Outcomes - Seizure reduction Secondary Outcomes - Change in disease score on Patient Weighted Quality Of Life In Epilepsy - Change in depression score on Neurological Disorders Depression Inventory in Epilepsy - Change in anxiety score on Anxiety General Anxiety Disorder-7 ### Location - Facility: Queen Elizabeth Health Science Centre, Halifax, Nova Scotia, B3H 3A7, Canada @@
## Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients - NCT ID: NCT06364072 - Study ID: PDC 01-0202 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-09-20 - Lead Sponsor: Cessatech A/S ### Study Description The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CT001 ### Outcomes Primary Outcomes - To assess the safety and tolerability - To evaluate the analgesic effect Secondary Outcomes - To assess medication errors ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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