data
stringlengths 358
80.8k
|
|---|
protocolSection identificationModule nctId: NCT06365359, orgStudyIdInfo id: 23_RIPH2-12, briefTitle: Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique, acronym: LUNEK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-10-15, completionDateStruct date: 2025-11-15, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University Hospital Center of Martinique, class: OTHER, collaborators name: Institut Pasteur de Guadeloupe, collaborators name: Centre de Ressources Biologiques de la Martinique (CeRBiM), descriptionModule briefSummary: 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., conditionsModule conditions: Systemic Lupus Erythematosus, conditions: Renal Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample for analysis of plasma of organochlorine pesticides concentration, interventions name: Blood sample for cell collection, outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: To compare the activity of lupus according to the level of impregnation with chlordecone., secondaryOutcomes measure: To compare the after-effects of lupus according to the level of impregnation with chlordecone., secondaryOutcomes measure: To describe the distribution of the plasma concentration of chlordecone in lupus patients followed by the internal medicine department of the Martinique University Hospital., secondaryOutcomes measure: 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., secondaryOutcomes measure: To describe the distribution of the plasma concentration of βHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital., secondaryOutcomes measure: To describe the distribution of the plasma concentration of γHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital., secondaryOutcomes measure: 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., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Center of Martinique, city: Fort-de-France, zip: 97261, country: France, hasResults: False
|
protocolSection identificationModule nctId: NCT06365346, orgStudyIdInfo id: 2024.075-T, briefTitle: Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Resilience, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Dyadic video-assisted gamified group-based music breathing therapy, interventions name: Online educational modules, outcomesModule primaryOutcomes measure: Resilience levels of children, primaryOutcomes measure: Resilience levels of parents, secondaryOutcomes measure: Children's emotional and behavioral symptoms, secondaryOutcomes measure: Parenting stress, secondaryOutcomes measure: Parents' psychological distress (i.e., depression, anxiety and stress), secondaryOutcomes measure: Feasibility outcomes - recruitment rate, secondaryOutcomes measure: Feasibility outcomes - retention rate, secondaryOutcomes measure: Feasibility outcomes - attendance, secondaryOutcomes measure: Acceptability of the intervention - level of satisfaction, secondaryOutcomes measure: Acceptability of the intervention, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Chinese University of Hong Kong, city: Hong Kong, country: Hong Kong, contacts name: Ankie Tan Cheung, PhD, role: CONTACT, phone: 852 39430515, email: ankiecheung@cuhk.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
|
protocolSection identificationModule nctId: NCT06365333, orgStudyIdInfo id: 1451_04/BVNTW-VNCSKTE, briefTitle: Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01, primaryCompletionDateStruct date: 2017-12, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: National Children's Hospital, Vietnam, class: OTHER, collaborators name: Vinmec Research Institute of Stem Cell and Gene Technology, descriptionModule briefSummary: 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., conditionsModule conditions: Intussusception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3562, type: ACTUAL, armsInterventionsModule interventions name: Fluoroscopic-guided air-enema reduction (FGAR), outcomesModule primaryOutcomes measure: Complicated intussusception, primaryOutcomes measure: ICU admission, primaryOutcomes measure: Death, primaryOutcomes measure: Failed FGAR, primaryOutcomes measure: Recurrence, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 30 Months, stdAges: CHILD, contactsLocationsModule locations facility: The National Hospital of Pediatrics, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Vinmec Research Institute of Stem Cell and Gene Technology, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, hasResults: False
|
protocolSection identificationModule nctId: NCT06365320, orgStudyIdInfo id: PROTEOMET, briefTitle: Association Between Training Load and Lactate and Other Metabolites Analyzed by Metabolomic and Proteomic Techniques, acronym: PROTEOMET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Fundació Eurecat, class: OTHER, collaborators name: University Rovira i Virgili, descriptionModule briefSummary: 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., conditionsModule conditions: Lactate, conditions: Sports Performance, conditions: Metabolomics, conditions: Proteomics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-group pretest-posttest design (quasi- experimental), primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Given the nature of the study (pretest-posttest design), masking will not be possible., enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Single basketball training, outcomesModule primaryOutcomes measure: Correlation between blood lactate levels and the subjective sensation of perceived effort, secondaryOutcomes measure: Change in saliva lactate levels, secondaryOutcomes measure: Change in blood lactate levels, secondaryOutcomes measure: Change in levels of lipid metabolic markers determined in capillary blood samples, secondaryOutcomes measure: Change in levels of other lipid metabolic markers determined in capillary blood samples, secondaryOutcomes measure: Change in levels of polar metabolites determined in capillary blood samples, secondaryOutcomes measure: Change in levels of lipid metabolic markers determined in saliva samples, secondaryOutcomes measure: Change in levels of other lipid metabolic markers determined in saliva samples, secondaryOutcomes measure: Change in levels of polar metabolites determined in saliva samples, secondaryOutcomes measure: Change in levels of proteomic markers determined in capillary blood samples, secondaryOutcomes measure: Change in levels of proteomic markers determined in saliva samples, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Heart rate variations, secondaryOutcomes measure: Sociodemographic data: age and birth date, secondaryOutcomes measure: Sociodemographic data: sex, secondaryOutcomes measure: Lifestyle data: weekly training load, secondaryOutcomes measure: Lifestyle data: playing position, secondaryOutcomes measure: Clinical data: use of supplementation, secondaryOutcomes measure: Clinical data: use of medication, secondaryOutcomes measure: Clinical data: previous muscle injuries, secondaryOutcomes measure: Physiological data, secondaryOutcomes measure: Anthropometric data: weight, secondaryOutcomes measure: Anthropometric data: height, secondaryOutcomes measure: Anthropometric data: body mass index, secondaryOutcomes measure: Anthropometric data: fat mass percentage, secondaryOutcomes measure: Anthropometric data: muscle mass percentage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fundació Eurecat, Center for Omic Sciences, city: Reus, state: Tarragona, zip: 43204, country: Spain, contacts name: Nuria Canela, PhD, role: CONTACT, phone: +34977300431, email: nuria.canela@eurecat.org, contacts name: Anna Crescenti, PhD, role: CONTACT, phone: +34977770958, phoneExt: 4832, email: anna.crescenti@eurecat.org, geoPoint lat: 41.15612, lon: 1.10687, hasResults: False
|
protocolSection identificationModule nctId: NCT06365307, orgStudyIdInfo id: Histograft-SF-2023, briefTitle: Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Histograft Co., Ltd., class: INDUSTRY, collaborators name: Petrovsky National Research Center of Surgery, descriptionModule briefSummary: 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, conditionsModule conditions: Cervical Disc Disorder With Radiculopathy, conditions: Spinal Stenosis, conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, conditions: Biomechanical Lesion, Unspecified, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: During the preliminary screening and indication for surgical treatment, patients are divided into 2 groups depending on the location of the pathological process: 1 - cervical spine, 2 - lumbar spine. During independent sequential randomization in a 1:1 ratio, patients in each of these groups are divided into clinical (A) and control (B) groups.Distribution of treatment methods by groups:1A - use of "Histograft" for spinal fusion of the cervical spine, 50 patients1. B - use of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine, 50 patients2. A - use of "Histograft" for spinal fusion of the lumbar spine, 100 patients2B - use of bone autograft for spinal fusion of the lumbar spine, 100 patients, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), interventions name: Synthetic osteoplastic material based on β-TCP or bone autograft, outcomesModule primaryOutcomes measure: Spinal fusion, primaryOutcomes measure: Adverse events and Severe Adverse Events, secondaryOutcomes measure: SF- 36 score (The Short Form-36), secondaryOutcomes measure: Unexpected Adverse Drug Reaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky", status: RECRUITING, city: Moscow, state: Moscow Oblast, zip: 117588, country: Russian Federation, contacts name: Renat Nurmukhametov, role: CONTACT, email: ethic@med.ru, contacts name: Mark Aleksanyan, role: CONTACT, contacts name: Renat Nurmukhametov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
|
protocolSection identificationModule nctId: NCT06365294, orgStudyIdInfo id: REVET Study, briefTitle: Rescue Extracranial Vertebral Stenting in Tandem Occlusions, acronym: REVET, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-31, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Dr. Cuong Tran Chi, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Acute Stroke, conditions: Ischemic Stroke, Acute, conditions: Vertebro Basilar Ischemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: Rescue extracranial stenting, outcomesModule primaryOutcomes measure: The good 3-month outcome rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Can Tho SIS Hospital, status: RECRUITING, city: Cần Thơ, zip: 900000, country: Vietnam, contacts name: Cuong Tran Chi, Doctor, role: CONTACT, phone: +84886559911, email: drcuongtran@dotquy.vn, geoPoint lat: 10.03711, lon: 105.78825, hasResults: False
|
protocolSection identificationModule nctId: NCT06365281, orgStudyIdInfo id: CARIES PREVALENCE, briefTitle: Caries Prevalence, Experience and Risk Related Factors Among Early Middle-aged Patients Attending Cairo University, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Dental Caries, conditions: Caries,Dental, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 350, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of dental caries, secondaryOutcomes measure: Caries experience, secondaryOutcomes measure: Caries risk related factors, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 44 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06365268, orgStudyIdInfo id: APHP231139, briefTitle: Perinatal Thoraco-abdomino-pelvic Tumors Study, acronym: CONTRAST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Collection of data from the patient's medical file, outcomesModule primaryOutcomes measure: Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors, primaryOutcomes measure: Description of the developmental spectrum of solid congenital truncal tumors, secondaryOutcomes measure: Characteristics and location of the tumor on pre- and post-natal imaging, secondaryOutcomes measure: Ile-de-France epidemiology of perinatal tumors, secondaryOutcomes measure: Evolution of solid congenital truncal tumors, secondaryOutcomes measure: Associated genetic abnormalities and malformations, secondaryOutcomes measure: Intercurrent obstetric events and obstetric outcomes based on the diagnoses made, secondaryOutcomes measure: Development of a management algorithm based on prenatal findings, eligibilityModule sex: ALL, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: Hôpital Necker-Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Sabine SARNACKI, MD, PhD, role: CONTACT, phone: 1 44 49 41 94, phoneExt: +33, email: sabine.sarnacki@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
|
protocolSection identificationModule nctId: NCT06365255, orgStudyIdInfo id: 2022-A01453-40, briefTitle: National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes, acronym: EPISTRESS2, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-17, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Diabetes Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 1344, type: ACTUAL, armsInterventionsModule interventions name: questionnaires, outcomesModule primaryOutcomes measure: The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps., secondaryOutcomes measure: Identify sub-populations of patients who feel stressed, secondaryOutcomes measure: Establish and categorise the different stress factors, secondaryOutcomes measure: Establishing a relationship between personality type and the impact of stress, secondaryOutcomes measure: Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Angers University Hospital, city: Angers, zip: 49100, country: France, geoPoint lat: 47.46667, lon: -0.55, locations facility: Avignon Hospital, city: Avignon, zip: 84000, country: France, geoPoint lat: 43.94834, lon: 4.80892, locations facility: St André Hospital, city: Bordeaux, zip: 33076, country: France, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Brest University Hospital, city: Brest, zip: 29200, country: France, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Dijon University Hospital, city: Dijon, zip: 21079, country: France, geoPoint lat: 47.31667, lon: 5.01667, locations facility: CERITD, city: Evry, zip: 91058, country: France, geoPoint lat: 48.63333, lon: 2.45, locations facility: Grenoble University Hospital, city: Grenoble, zip: 38043, country: France, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Lille University Hospital, city: Lille, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: APHM- La Conception Hospital, city: Marseille, zip: 13000, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Private practice in endocrinology and metabolic diseases, city: Mérignac, zip: 33700, country: France, geoPoint lat: 44.83248, lon: -0.63381, locations facility: Srasbourg University Hospital, city: Strasbourg, zip: 67091, country: France, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
|
protocolSection identificationModule nctId: NCT06365242, orgStudyIdInfo id: DOACS1_2024, briefTitle: Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study., acronym: DOACS_1, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-07-23, primaryCompletionDateStruct date: 2021-07-27, completionDateStruct date: 2022-12-23, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Pisa, class: OTHER, descriptionModule briefSummary: Evaluation of DOACs treatment on post-extraction bleeding, conditionsModule conditions: Post Operative Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 49, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Peri-operative hemorrhage, primaryOutcomes measure: Post-operative bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale, city: Pisa, zip: 56126, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
|
protocolSection identificationModule nctId: NCT06365229, orgStudyIdInfo id: 2022-P2-336-02, briefTitle: Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: Lumbar Spinal Stenosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Oswestry Disability Index (ODI), secondaryOutcomes measure: Magnetic resonance imaging (MRI), secondaryOutcomes measure: Computed tomography (CT) scans, secondaryOutcomes measure: Creatine kinase (CK), secondaryOutcomes measure: Erythrocyte sedimentation rate (ESR), secondaryOutcomes measure: Surgical complication, secondaryOutcomes measure: VAS (visual analogue scale) for leg pain, secondaryOutcomes measure: VAS (visual analogue scale) for lower back pain, secondaryOutcomes measure: Japanese Orthopaedic Association (JOA) score, secondaryOutcomes measure: Modified MacNab criteria, secondaryOutcomes measure: Operation time, secondaryOutcomes measure: Blood loss, secondaryOutcomes measure: Postoperative hospital stays, secondaryOutcomes measure: Age, secondaryOutcomes measure: Gender, secondaryOutcomes measure: Body mass index (BMI), secondaryOutcomes measure: Medical comorbidity, secondaryOutcomes measure: Smoking status, secondaryOutcomes measure: Alcohol status, secondaryOutcomes measure: Symptoms duration, secondaryOutcomes measure: Physical examination finding, secondaryOutcomes measure: Previous spinal surgery, secondaryOutcomes measure: Affected level, secondaryOutcomes measure: Stenosis grade, secondaryOutcomes measure: Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06365216, orgStudyIdInfo id: AXO-CLI-210c-03, secondaryIdInfos id: 2023-508895-13-00, type: CTIS, briefTitle: ALS Phase II Study of NX210c, acronym: SEALS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Axoltis Pharma, class: INDUSTRY, collaborators name: ACT4ALS network, descriptionModule briefSummary: 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)., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind, randomized, placebo-controlled, multicentric, phase II study in adult patients with ALS to assess efficacy, safety, tolerability and pharmacokinetics of multiple intravenous infusions of NX210c.Two doses of NX210c (5 mg/kg and 10 mg/Kg) will be investigated, along with a placebo group which will serve as a reference. Patients will be randomized to one of 3 arms in an allocation ratio of 3:3:2.Patients will participate up to approximately 20 weeks: up to 30 days for screening, 26 days of treatment and 3 months of follow-up. Lumbar punctures will assess cerebrospinal fluid (CSF) NfL and other key CSF biomarkers related to ALS and drug mechanism of action. Blood sampling will be drawn for safety, PK and biomarkers testing. Urine will equally be collected for biomarkers. A comprehensive assessment of the disease, including the ALS Functional Rating Scale (ALSFRS-R) will be performed., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: NX210c, interventions name: Placebo, outcomesModule primaryOutcomes measure: The effect of NX210c on blood neurofilament light chain (NfL) or on a blood and cerebrospinal fluid (CSF) biomarker of BBB integrity., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Lyon HCL, city: Bron, zip: 69500, country: France, contacts name: Emilien Bernard, MD, role: CONTACT, phone: 0033 (0)4 72 35 72 18, email: emilien.bernard@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, hasResults: False
|
protocolSection identificationModule nctId: NCT06365203, orgStudyIdInfo id: Through knee amputation, briefTitle: Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Amputation of Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Through knee amputation, interventions name: Above knee Amputation, outcomesModule primaryOutcomes measure: Wound healing rate, primaryOutcomes measure: Incidence of infection, secondaryOutcomes measure: Function of the limb Rehabilitation Quality of life, secondaryOutcomes measure: Mortality rate, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365190, orgStudyIdInfo id: AHMU-PD-rTMS, briefTitle: Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-04-06, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Anhui Medical University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Transcranial Magnetic Stimulation, conditions: Parkinson's Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: transcranial magnetic stimulation, interventions name: Pharmacotherapy（antiparkinsonian drugs）, outcomesModule primaryOutcomes measure: Unified Parkinson's Disease Rating Scale III scores, secondaryOutcomes measure: Hoehn-Yahr(H-Y) stage, secondaryOutcomes measure: Levodopa equivalent dose, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cognitive Neuropsychology Lab Anhui Medical University, city: Hefei, state: Anhui, zip: 230022, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
|
protocolSection identificationModule nctId: NCT06365177, orgStudyIdInfo id: 29BRC22.0243, briefTitle: Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation, acronym: TELETEST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Rehabilitation, conditions: Elderly Person, conditions: Teleconsultation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Cross-sectional interventional multicenter study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Physical consultation, interventions name: Teleconsultation, outcomesModule primaryOutcomes measure: Five Time Sit To Stand test completion time in teleconsultation, primaryOutcomes measure: Five Time Sit To Stand test completion time in face-to-face consultation, secondaryOutcomes measure: Satisfaction questionnaire, secondaryOutcomes measure: Five Time Sit To Stand test completion time in teleconsultation, secondaryOutcomes measure: Five Time Sit To Stand test completion time in face-to-face consultation, secondaryOutcomes measure: Presence or absence of falls, secondaryOutcomes measure: Number of falls, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 110 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06365164, orgStudyIdInfo id: 38RC23.0354, briefTitle: Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex, acronym: PREMATACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, collaborators name: Faculty of Psychology and Educational Sciences,University of Geneva, descriptionModule briefSummary: 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., conditionsModule conditions: Premature, conditions: Development, Child, conditions: Rooting Reflex, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 19, type: ESTIMATED, armsInterventionsModule interventions name: Tactile stimulation, outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: 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., eligibilityModule sex: ALL, minimumAge: 28 Weeks, maximumAge: 37 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: University Hospital Grenoble, city: Grenoble, state: Isere, zip: 38 000, country: France, geoPoint lat: 45.16667, lon: 5.71667, hasResults: False
|
protocolSection identificationModule nctId: NCT06365151, orgStudyIdInfo id: TMDs fibromyalgia, briefTitle: An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2025-04-05, completionDateStruct date: 2026-04-05, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universitat de Lleida, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Fibromyalgia, conditions: Temporomandibular Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Osteopathic manual therapy, interventions name: Sham osteopathic manual therapy, outcomesModule primaryOutcomes measure: catastrophizing, primaryOutcomes measure: functional limitation, primaryOutcomes measure: functional status, disability and pain, primaryOutcomes measure: pain and tinnitus, primaryOutcomes measure: myofascial trigger points, primaryOutcomes measure: Range of motion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Osteopatia i Fisioteràpia Cornellà, status: RECRUITING, city: Cornella de Llobregat, state: Barcelona, zip: 08940, country: Spain, contacts name: Llanos de la Iglesia, MsC, role: CONTACT, phone: +34679536992, email: llanos.delaiglesia@gmail.com, geoPoint lat: 41.35, lon: 2.08333, hasResults: False
|
protocolSection identificationModule nctId: NCT06365138, orgStudyIdInfo id: Aortic Rupture, briefTitle: Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2029-12-01, completionDateStruct date: 2030-12-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University Hospital Augsburg, class: OTHER, collaborators name: Epidemiology, Medical Faculty, University Augsburg, descriptionModule briefSummary: 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., conditionsModule conditions: Aortic Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Bahaviour at the time of an aortic aneurysm rupture, outcomesModule primaryOutcomes measure: Occupation at the time of the aortic aneurysm rupture, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Augsburg, status: RECRUITING, city: Augsburg, zip: 86156, country: Germany, contacts name: Tobias Warm, MD, role: CONTACT, phone: +49821400161068, email: tobias.warm@uk-augsburg.de, geoPoint lat: 48.37154, lon: 10.89851, hasResults: False
|
protocolSection identificationModule nctId: NCT06365125, orgStudyIdInfo id: 7313E, briefTitle: College Student Daily Life and Alcohol Use Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Boston University Charles River Campus, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Drinking, College, conditions: Drinking Heavy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 129, type: ESTIMATED, armsInterventionsModule interventions name: eCHECKUP TO GO, interventions name: Text messaging boosters, outcomesModule primaryOutcomes measure: Heavy drinking episodes, primaryOutcomes measure: Alcohol-related negative consequences, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Boston University Charles River Campus, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Bonnie Rowland, MA, role: CONTACT, phone: 617-906-6645, email: browland@bu.edu, contacts name: Tibor Palfai, PhD, role: CONTACT, email: palfai@bu.edu, contacts name: Bonnie Rowland, MA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06365112, orgStudyIdInfo id: R21154, briefTitle: Endoscopic Acetabulum Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Tampere University Hospital, class: OTHER, descriptionModule briefSummary: Try to develop an endoscopic surgical technique to treat acetabulum fractures, conditionsModule conditions: Acetabulum Fracture, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 13, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopy assisted, outcomesModule primaryOutcomes measure: Number of patients with major complications, primaryOutcomes measure: Number of patients with minor complications, primaryOutcomes measure: Operation time, primaryOutcomes measure: Patient satisfaction using EQ5D, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tampere University hospital, status: RECRUITING, city: Tampere, zip: 33521, country: Finland, contacts name: Piia Suomalainen, role: CONTACT, geoPoint lat: 61.49911, lon: 23.78712, hasResults: False
|
protocolSection identificationModule nctId: NCT06365099, orgStudyIdInfo id: STUDY00000896_Exp2, briefTitle: Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Texas at Austin, class: OTHER, collaborators name: Emory University, descriptionModule briefSummary: 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., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Single-pulse TMS, outcomesModule primaryOutcomes measure: Personalized classifier performance, secondaryOutcomes measure: Corticospinal tract-lesion overlap, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas at Austin, status: RECRUITING, city: Austin, state: Texas, zip: 78712, country: United States, contacts name: Sara Hussain, role: CONTACT, phone: 512-232-2686, email: sara.hussain@austin.utexas.edu, geoPoint lat: 30.26715, lon: -97.74306, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-10, uploadDate: 2024-04-05T17:22, filename: ICF_000.pdf, size: 462079, hasResults: False
|
protocolSection identificationModule nctId: NCT06365086, orgStudyIdInfo id: STUDY00000608, briefTitle: Targeting Personalized Brain States Reflecting Strong and Weak Corticospinal Tract Output in Real-time, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-27, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Texas at Austin, class: OTHER, collaborators name: Emory University, descriptionModule briefSummary: 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., conditionsModule conditions: Neurotypical Adults, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: CROSSOVER, interventionModelDescription: Participants will receive single-pulse TMS during personalized brain activity patterns reflecting either strong or weak corticospinal tract activation, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Personalized brain state-dependent single-pulse TMS, outcomesModule primaryOutcomes measure: Motor-evoked potential (MEP) amplitudes elicited from the left first dorsal interosseous muscle during personalized strong and weak CST states, secondaryOutcomes measure: State-targeting accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas at Austin, city: Austin, state: Texas, zip: 78712, country: United States, geoPoint lat: 30.26715, lon: -97.74306, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-10-04, uploadDate: 2024-04-05T16:56, filename: ICF_000.pdf, size: 305303, hasResults: False
|
protocolSection identificationModule nctId: NCT06365073, orgStudyIdInfo id: TJIRB20231276, briefTitle: A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Qin Ning, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Anthrax, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: mortality rates of severe anthrax, secondaryOutcomes measure: incidence of complications, secondaryOutcomes measure: Peripheral blood biomarkers associated with 28-day and 90-day mortality, secondaryOutcomes measure: the improvement in 28-day and 90-day mortality with treatment for severe anthrax, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, country: China, contacts name: Qin Ning, PHD,MD, role: CONTACT, phone: +8602783662391, email: qning@vip.sina.com, contacts name: Qin Ning, PHD,MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Tao Chen, PHD,MD, role: SUB_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
|
protocolSection identificationModule nctId: NCT06365060, orgStudyIdInfo id: 00003143, secondaryIdInfos id: R01CA279808, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA279808, briefTitle: Screening for AL Amyloidosis in Smoldering Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-02-27, completionDateStruct date: 2029-02-27, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Tufts Medical Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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., conditionsModule conditions: Smoldering Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: 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., primaryOutcomes measure: Validating an NGS assay that identifies IGLV genes in clonal plasma cells, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama Hospital, city: Birmingham, state: Alabama, zip: 35233, country: United States, contacts name: Susan Bal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Cedars-Sinai Medical Center, city: Los Angeles, state: California, zip: 90048, country: United States, contacts name: Robert Vescio, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: University of California, Irvine, city: Orange, state: California, zip: 92868, country: United States, contacts name: Lisa Lee, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.78779, lon: -117.85311, locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Tom Martin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Cleveland Clinic Florida, Weston Hospital, city: Weston, state: Florida, zip: 33331, country: United States, contacts name: Chakra Chaulagain, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.10037, lon: -80.39977, locations facility: Tufts Medical Center, city: Boston, state: Massachusetts, zip: 02111, country: United States, contacts name: Denis Toskic, BS, role: CONTACT, phone: 617-636-5907, email: denis.toskic@tuftsmedicine.org, contacts name: Raymond Comenzo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Giada Bianchi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Columbia University Medical Center, city: New York, state: New York, zip: 10032, country: United States, contacts name: Suzanne Lentzsch, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Cancer Center, city: New York, state: New York, zip: 10065, country: United States, contacts name: Heather Landau, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Atrium Health Levine Cancer Institute, city: Charlotte, state: North Carolina, zip: 28204, country: United States, contacts name: Cindy Varga, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.22709, lon: -80.84313, locations facility: UNC Lineberger Comprehensive Cancer Center, city: Durham, state: North Carolina, zip: 27705, country: United States, contacts name: Sascha Tuchman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, locations facility: UT Southwestern, Harold C. Simmons Comprehensive Cancer Center, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Gurbakhash Kaur, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Utah, Huntsman Cancer Hospital, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Amandeep Godara, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, locations facility: VCU Medical Center, city: Richmond, state: Virginia, zip: 23219, country: United States, contacts name: Hashim Mann, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
|
protocolSection identificationModule nctId: NCT06365047, orgStudyIdInfo id: STUDY00004926, briefTitle: Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Tufts University, class: OTHER, collaborators name: Colgate Palmolive, descriptionModule briefSummary: 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., conditionsModule conditions: Xerostomia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: double blinded, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: 8% Arginine toothpaste, interventions name: 1000 ppm F toothpaste, outcomesModule primaryOutcomes measure: Salivary pH Impact, secondaryOutcomes measure: Measuring the change in the oral microbiome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tufts University School of Dental Medicine, city: Boston, state: Massachusetts, zip: 02111, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06365034, orgStudyIdInfo id: YKLL-KY-2024（024）, briefTitle: Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Qianfoshan Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC)., conditionsModule conditions: Carcinoma, Hepatocellular, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 92, type: ESTIMATED, outcomesModule primaryOutcomes measure: Pathologic response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Qianfoshan Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Jing Liang, Dr, role: CONTACT, phone: +8618663761275, email: liangjing0531@163.com, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
|
protocolSection identificationModule nctId: NCT06365021, orgStudyIdInfo id: 88887.687583/2022-00, briefTitle: ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beny Lafer, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance and Commitment Therapy, interventions name: Bipolar Disorder Psychoeducation Therapy, outcomesModule primaryOutcomes measure: Montgomery-Asberg Depression Scale, primaryOutcomes measure: Young Mania Rating Scale, secondaryOutcomes measure: Functional Assessment Staging Tool, secondaryOutcomes measure: World Health Organization Quality of Life Brief Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Psychological Flexibility Questionnaire, otherOutcomes measure: Generalized Anxiety Disorder 7-item Scale, otherOutcomes measure: Medication Recommendation Tracking Form, otherOutcomes measure: Regulatory Satisfaction Alertness Timing Efficiency Duration, otherOutcomes measure: Adhesion and Satisfaction Questionnaire, otherOutcomes measure: Life Events Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tatiana Cohab Khafif, status: RECRUITING, city: São Paulo, state: SP, zip: 01231010, country: Brazil, contacts name: Tatiana Khafif, Master's degree, role: CONTACT, phone: +5511983389643, email: taticohab@gmail.com, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
|
protocolSection identificationModule nctId: NCT06365008, orgStudyIdInfo id: SYSKY-2024-210-01, briefTitle: Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2027-04-08, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Unresectable/Metastatic Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients 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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab+irinotecan+leucovorin folinate+fluorouracil, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qiong Yang, Doctor, role: CONTACT, phone: 13632341201, email: yangqiong05@126.com, contacts name: Yajing Liu, Doctor, role: CONTACT, phone: 13631327315, email: liuyajing1030@126.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06364995, orgStudyIdInfo id: JKEUPM-2023-1364, briefTitle: Effects of Specialised Physical Education in Volleyball on Middle School Students' Physical Fitness and Performance, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universiti Putra Malaysia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Physical Fitness, conditions: Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: In this experiment, the experimental group used the intervention of specialised physical education teaching of volleyball. However, the control group only conducted traditional physical education teaching content, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Volleyball, interventions name: Traditional Physical Education, outcomesModule primaryOutcomes measure: Effects of physical fitness of middle school students, primaryOutcomes measure: Effects on middle school students' PE entrance examination for senior high school test performance, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Yimou MAO, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610044, country: China, contacts name: Yimou MAO, PHD, role: CONTACT, email: 912327111@qq.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
|
protocolSection identificationModule nctId: NCT06364982, orgStudyIdInfo id: PER-ECL-2023-05, briefTitle: Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universitat Internacional de Catalunya, class: OTHER, descriptionModule briefSummary: The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances., conditionsModule conditions: Peri-implant Mucositis, conditions: Peri-Implantitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Two contiguous dental implants placed with less ≤ 3mm from each other., interventions name: Two contiguous dental implants placed with > 3mm from each other., outcomesModule primaryOutcomes measure: Prevalence of peri-implant diseases., secondaryOutcomes measure: FMPI, secondaryOutcomes measure: FMBI, secondaryOutcomes measure: mPI, secondaryOutcomes measure: mBI, secondaryOutcomes measure: SoP, secondaryOutcomes measure: PPD, secondaryOutcomes measure: MR, secondaryOutcomes measure: KM, secondaryOutcomes measure: Implant location, secondaryOutcomes measure: Implant position, secondaryOutcomes measure: Implant type, secondaryOutcomes measure: Implant brand, secondaryOutcomes measure: Implant roughness, secondaryOutcomes measure: Implant diameter, secondaryOutcomes measure: Implant length, secondaryOutcomes measure: Apico-coronal position of the implant, secondaryOutcomes measure: Inter-implant distances (IID), secondaryOutcomes measure: Implant placement protocol, secondaryOutcomes measure: Bone grafting procedures (BGP) at implant placement, secondaryOutcomes measure: Implant-supported restorations, secondaryOutcomes measure: Cleansability of the prosthesis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clínica Universitaria de Odontologia, city: Sant Cugat Del Vallès, state: Barcelona, zip: 08195, country: Spain, geoPoint lat: 41.47063, lon: 2.08611, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-04-10, uploadDate: 2024-04-10T16:21, filename: Prot_SAP_000.pdf, size: 82991, hasResults: False
|
protocolSection identificationModule nctId: NCT06364969, orgStudyIdInfo id: 2021-06-02, briefTitle: Investigation of the Pruritogens of Liver-related Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cholestasis, conditions: Intrahepatic Cholestasis of Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Itch intensity, secondaryOutcomes measure: Flare areas, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Guangyi Lan, role: CONTACT, phone: 13176881226, email: Guangyi_lan@stu.pku.edu.cn, contacts name: Yulong Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06364956, orgStudyIdInfo id: SYSKY-2024-124-02, briefTitle: Phase Ib/II Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab combined with two predefined dose groups of palbociclib, interventions name: RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial., outcomesModule primaryOutcomes measure: Phase I: the safety dose of the combination of Tislelizumab and palbociclib, primaryOutcomes measure: Phase II: Pathological complete response rate(pCR), secondaryOutcomes measure: Pathological Downstaging(pDS), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: Safety and AE, otherOutcomes measure: Biomarker Endpoint Analyses, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Fan Wu, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-sen Memorial Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Wenlong Zhong, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Junxin Chen, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital of Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Yun Luo, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital of Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Ebai Xu, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, country: China, contacts name: Zheng Liu, Ph.D, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Cancer Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Yu Xie, Ph.D, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Xiangya Hospital, Central South University, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Xiongbing Zu, Ph.D, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
|
protocolSection identificationModule nctId: NCT06364943, orgStudyIdInfo id: 202400020B0, briefTitle: Tear Ferning Test for Dry Eye Diagnosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2025-01-05, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Chung Shan Medical University, class: OTHER, descriptionModule briefSummary: Application of tear ferning test for clinical dry eye diagnosis, conditionsModule conditions: Dry Eye Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: with/without dry eye syndrome, outcomesModule primaryOutcomes measure: Schirmer's test, primaryOutcomes measure: Tear film breakup time, primaryOutcomes measure: Ocular surface health evaluate, secondaryOutcomes measure: Ocular surface disease index, secondaryOutcomes measure: Intraocular pressure, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jen-Ai Hospital, status: RECRUITING, city: Taichung,, zip: 412, country: Taiwan, contacts name: SHU-YAN PENG, Master, role: CONTACT, phone: 886-933-854862, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
|
protocolSection identificationModule nctId: NCT06364930, orgStudyIdInfo id: SGLT2i_HBV Study, briefTitle: SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2030-10-31, completionDateStruct date: 2031-03-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: Chronic Hepatitis B, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 412, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin 10mg Tab, interventions name: Placebo 10mg Tab, outcomesModule primaryOutcomes measure: The primary endpoint is liver complications, secondaryOutcomes measure: Cardiovascular complications, secondaryOutcomes measure: change in liver stiffness measurement, secondaryOutcomes measure: change anthropometric parameters, secondaryOutcomes measure: change anthropometric parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Wales Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Angel ML Chim, MSc, role: CONTACT, phone: 26324205, email: angelchim@cuhk.edu.hk, contacts name: Grace LH Wong, MD, role: CONTACT, phone: +85235053538, email: wonglaihung@cuhk.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
|
protocolSection identificationModule nctId: NCT06364917, orgStudyIdInfo id: IRB-300012781 (UAB2432), briefTitle: DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2027-01-30, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: Carboplatin, interventions name: Paclitaxel, interventions name: Pemetrexed, interventions name: Nivolumab, interventions name: Ipilimumab, outcomesModule primaryOutcomes measure: Rate of Molecular Response in Patients with PD-L1 Negative Advanced NSCLC Treated with Dual vs. Single ICB Plus CT Regimens, secondaryOutcomes measure: Efficacy Evaluation, secondaryOutcomes measure: Correlation Analysis, otherOutcomes measure: Progression-Free Survival (PFS), otherOutcomes measure: Median Overall Survival (OS), otherOutcomes measure: Tolerability Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Margaret Thomas, MPH, role: CONTACT, email: margaretannthomas@uabmc.edu, contacts name: Aakash Desai, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Maya Khalil, MD, role: SUB_INVESTIGATOR, contacts name: Yanish Boumber, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
|
protocolSection identificationModule nctId: NCT06364904, orgStudyIdInfo id: SYSKY-2024-123-02, briefTitle: 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., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2029-04-15, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib, interventions name: Tislelizumab, Cisplatin, Gemcitabine, outcomesModule primaryOutcomes measure: Progression-Free Survival(PFS), primaryOutcomes measure: Incidence of Grade 3/4 Neutropenia, secondaryOutcomes measure: ORR, secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: Safety and AE, secondaryOutcomes measure: Disease Control Rate(DCR), secondaryOutcomes measure: During Of Response(DOR), secondaryOutcomes measure: Biomarker Endpoint Analyses, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Fan Wu, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-sen Memorial Hospital, city: Guangzhou, state: Guangdong, country: China, contacts name: Wenlong Zhong, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Sun Yat-sen University, city: Guangzhou, state: Guangdong, country: China, contacts name: Junxin Chen, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital of Sun Yat-sen University, city: Guangzhou, state: Guangdong, country: China, contacts name: Yun Luo, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, country: China, contacts name: Ebai Xu, Ph.D, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, country: China, contacts name: Zheng Liu, Ph.D, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, country: China, contacts name: Yu Xie, Ph.D, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Xiangya Hospital, Central South University, city: Changsha, state: Hunan, country: China, contacts name: Xiongbing Zu, Ph.D, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
|
protocolSection identificationModule nctId: NCT06364891, orgStudyIdInfo id: VMMC NEXUS, briefTitle: Assessing the Impact of a Digital VMMC Platform, acronym: VMMC NEXUS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: Centre for Infectious Disease Research in Zambia, descriptionModule briefSummary: 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, conditionsModule conditions: Voluntary Medical Male Circumcision, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster randomised control study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: VMMC NEXUS Digital application, outcomesModule primaryOutcomes measure: Total number of VMMC's conducted in intervention vs control, primaryOutcomes measure: Total number of VMMC's by segment, primaryOutcomes measure: Total number of VMMC's by age, secondaryOutcomes measure: Costing, secondaryOutcomes measure: Process evaluation, secondaryOutcomes measure: Develop a workplan and handbook to allow for the intervention to be scaled up elsewhere., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ministry of Health facilities, status: RECRUITING, city: Lusaka, zip: 10101, country: Zambia, contacts name: Carolyn Moore, role: CONTACT, phone: 0966841034, email: carolyn.bolton@cidrz.org, geoPoint lat: -15.40669, lon: 28.28713, hasResults: False
|
protocolSection identificationModule nctId: NCT06364878, orgStudyIdInfo id: 813533, briefTitle: Non-invasive Diagnostics of Microbial Keratitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-23, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2028-04-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sorlandet Hospital HF, class: OTHER_GOV, descriptionModule briefSummary: 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., conditionsModule conditions: Infectious Keratitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: In vivo confocal microscopy, interventions name: Tear film sampling, outcomesModule primaryOutcomes measure: IVCM findings and cytokine profile in infectious keratitis is specific for the different microbial subtypes., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sorlandet hospital, status: RECRUITING, city: Arendal, country: Norway, contacts name: Neil Lagali, role: CONTACT, geoPoint lat: 58.46151, lon: 8.77253, hasResults: False
|
protocolSection identificationModule nctId: NCT06364865, orgStudyIdInfo id: 2022-04, briefTitle: AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study, acronym: AE05ML, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Teleflex, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Gall Bladder Disease, conditions: Bile Duct Diseases, conditions: Acute Cholecystitis, conditions: Kidney, conditions: Liver, conditions: Appendix, conditions: Spleen Disease, conditions: Prostate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 161, type: ESTIMATED, armsInterventionsModule interventions name: laparoscopic procedure, outcomesModule primaryOutcomes measure: Evaluating the safety of AE05ML, primaryOutcomes measure: Evaluating the performance of AE05ML, secondaryOutcomes measure: Evaluating device performance characteristics, secondaryOutcomes measure: Evaluating operator reported feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364852, orgStudyIdInfo id: LY007C1101, briefTitle: An Evaluation of LY007 Cell Injection for r/r B-NHL, acronym: r/r B-NHL, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-25, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, collaborators name: The First Affiliated Hospital with Nanjing Medical University, collaborators name: Shanghai Longyao Biotechnology Inc., Ltd., descriptionModule briefSummary: 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, conditionsModule conditions: B-NHL, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: LY007, outcomesModule primaryOutcomes measure: Maximum tolerated dose or clinically recommended dose;, primaryOutcomes measure: Dose limiting toxicity, primaryOutcomes measure: 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., secondaryOutcomes measure: PK aspect, secondaryOutcomes measure: PK aspect, secondaryOutcomes measure: PD aspect, secondaryOutcomes measure: therapeutic effect, secondaryOutcomes measure: Anti LY007 antibody, secondaryOutcomes measure: The titer of human anti mouse antibody, otherOutcomes measure: Exploratory study endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruijin hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Weili Zhao, MD, role: CONTACT, phone: 13512112076, phoneExt: 610707, email: zwl_trial@163.com, contacts name: Zixun Yan, MD, role: CONTACT, phone: +8613482056727, phoneExt: 610707, email: yanzixun125@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06364839, orgStudyIdInfo id: CT2024-ZJU-OBS7, briefTitle: Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-03-23, completionDateStruct date: 2024-03-25, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Xiao Xu, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Hepatocellular Carcinoma, Non-cirrhotic Liver, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions, outcomesModule primaryOutcomes measure: Postoperative complications were evaluated by postoperative imaging and serological examination, primaryOutcomes measure: The overall survival rate was evaluated by follow-up investigation and outpatient review, primaryOutcomes measure: The tumor-free survival rate was evaluated by follow-up investigation and outpatient review, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiao Xu, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
|
protocolSection identificationModule nctId: NCT06364826, orgStudyIdInfo id: NPC-202403, briefTitle: Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-04-22, completionDateStruct date: 2026-04-22, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab, bevacizumab, gemcitabine, interventions name: IMRT, outcomesModule primaryOutcomes measure: 3-year Event-free survival rate, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: adverse events(AEs), otherOutcomes measure: biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06364813, orgStudyIdInfo id: H20-01461, briefTitle: Co-developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals With Spinal Cord Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, collaborators name: The Craig H. Neilsen Foundation, descriptionModule briefSummary: 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., conditionsModule conditions: Spinal Cord Injuries, conditions: Caregiver Burden, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: COMPANION eHealth Program, outcomesModule primaryOutcomes measure: Family caregivers' subjective burden as assessed by the Zarit Burden Interview, secondaryOutcomes measure: Participants' objective burden as assessed by the Dutch Objective Burden Inventory, secondaryOutcomes measure: Participants' distress as assessed by the Depression, Anxiety and Stress Scale, secondaryOutcomes measure: Participants' relationship quality satisfaction as assessed by the Dyadic Adjustment Scale, secondaryOutcomes measure: Participants' health-related quality of life as assessed by the Veterans RAND 12-item Health Survey, secondaryOutcomes measure: Caregiver competence as assessed by the Caregiving Competence Scale, secondaryOutcomes measure: Participants' opinion regarding the usability of the implementation as assessed by the System Usability Scale, secondaryOutcomes measure: Participants' health care use as assessed by a bespoke questionnaire, secondaryOutcomes measure: Participants' experience using the implementation as assessed by a qualitative interview, otherOutcomes measure: A composite measure of recruitment rate, consent rate, retention rate, perceived benefit, and assessor masking will be evaluated as "successful" or "revise" according to expectations, otherOutcomes measure: A composite measure of treatment adherence, participant and evaluator burden during data collection, and expert burden will be evaluated as "successful" or "revise" according to expectations, otherOutcomes measure: A composite measure of internet stability, participant processing time, and treatment administration issues will be evaluated as "successful" or "revise" according to expectations, otherOutcomes measure: A measure of dose level of training time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364800, orgStudyIdInfo id: GDT-001-07-02, briefTitle: 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2026-04-26, completionDateStruct date: 2026-09-26, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing 302 Hospital, class: OTHER, collaborators name: Chinese Academy of Medical Sciences, collaborators name: Beijing GD Initiative Cell Therapy Technology Co., Ltd., descriptionModule briefSummary: 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, conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: γδ T cells, interventions name: PD-1 monoclonal antibody, interventions name: targeted drugs, outcomesModule primaryOutcomes measure: Safety evaluation: Incidence of Adverse events (AEs), primaryOutcomes measure: Safety evaluation: Dose limited toxicity (DLTs), primaryOutcomes measure: Efficacy evaluation: Objective Response Rate(ORR), primaryOutcomes measure: Efficacy evaluation: Duration of Response(DOR), primaryOutcomes measure: Efficacy evaluation: Progress Free Survival(PFS), primaryOutcomes measure: Efficacy evaluation: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364787, orgStudyIdInfo id: GDT-001-07-01, briefTitle: Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2026-04-26, completionDateStruct date: 2026-09-26, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing 302 Hospital, class: OTHER, collaborators name: Chinese Academy of Medical Sciences, collaborators name: Beijing GD Initiative Cell Therapy Technology Co., Ltd., descriptionModule briefSummary: 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., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: γδ T cells, interventions name: Targeted drugs, interventions name: PD-1 monoclonal antibody, outcomesModule primaryOutcomes measure: Safety evaluation: Incidence of Adverse events (AEs), primaryOutcomes measure: Safety evaluation: Dose limited toxicity (DLTs), primaryOutcomes measure: Safety evaluation: Maximum-tolerated dose (MTD), primaryOutcomes measure: Efficacy evaluation: Objective Response Rate(ORR), primaryOutcomes measure: Efficacy evaluation: Duration of Response(DOR), primaryOutcomes measure: Efficacy evaluation: Progress Free Survival(PFS), primaryOutcomes measure: Efficacy evaluation: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364774, orgStudyIdInfo id: 22-020309, briefTitle: ALS20-101 Lentiviral Gene Therapy for Beta Thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Philadelphia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Beta-Thalassemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm pilot, phase I/II study of 12 subjects., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: ALS20, outcomesModule primaryOutcomes measure: Neutrophil Engraftment, primaryOutcomes measure: Platelet Engraftment, primaryOutcomes measure: Overall Survival at 2 years, primaryOutcomes measure: Incidence of transplant related mortality, primaryOutcomes measure: Incidence of Graft Versus Host Disease, primaryOutcomes measure: Incidence of Vector-Derived Replication Competent Lentivirus, primaryOutcomes measure: Insertional Oncogenesis, primaryOutcomes measure: Clonal Predominance, primaryOutcomes measure: maintain total hemoglobin level of 9.0 g/dL or higher, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Janet Kwiatkowski, MD, role: CONTACT, phone: 215-590-5286, email: kwiatkowski@chop.edu, contacts name: Jaladhikumar Patel, role: CONTACT, phone: 267-426-5602, email: patelj23@chop.edu, contacts name: Janet Kwiatkowski, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
|
protocolSection identificationModule nctId: NCT06364761, orgStudyIdInfo id: 24103_BIL_EDOF, briefTitle: Assesment of Intermediate Vision After BIL Cataract Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universitair Ziekenhuis Brussel, class: OTHER, descriptionModule briefSummary: 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 ., conditionsModule conditions: Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Bag in the lens cataract surgery, outcomesModule primaryOutcomes measure: Intermediate vision, secondaryOutcomes measure: Near vision, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364748, orgStudyIdInfo id: 002-2024-Shalowitz, briefTitle: Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: West Michigan Cancer Center, class: OTHER, collaborators name: Veta Health, descriptionModule briefSummary: 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., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Cellular enabled blood pressure cuff, interventions name: Standard of Care Cuff, outcomesModule primaryOutcomes measure: To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care, secondaryOutcomes measure: Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring, secondaryOutcomes measure: Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring, secondaryOutcomes measure: Patient satisfaction with usual care blood pressure monitoring, secondaryOutcomes measure: Patient satisfaction with remote blood pressure monitoring, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West Michigan Cancer Center, status: RECRUITING, city: Kalamazoo, state: Michigan, zip: 49007, country: United States, contacts name: Wendi Mitchell, role: CONTACT, phone: 269-373-7443, email: wmitchell@wmcc.org, contacts name: Kathleen Allen, role: CONTACT, phone: 269-373-7452, email: kallen@wmcc.org, geoPoint lat: 42.29171, lon: -85.58723, hasResults: False
|
protocolSection identificationModule nctId: NCT06364735, orgStudyIdInfo id: Entità e variabili, briefTitle: Entities and Variables Related to Catch-up Growth, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: ASST Fatebenefratelli Sacco, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Celiac Disease in Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 900, type: ESTIMATED, outcomesModule primaryOutcomes measure: Measure the catch-up growth degree., secondaryOutcomes measure: Calculate the degree of catch-up growth, otherOutcomes measure: Exploratory objectives 1, otherOutcomes measure: Exploratory objectives 2, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST Fatebenefratelli Sacco, status: RECRUITING, city: Milan, zip: 2015, country: Italy, contacts name: Elena MD Groppali, role: CONTACT, email: elena.groppali@asst-fbf-sacco.it, contacts name: Elena MD Groppali, role: CONTACT, contacts name: Elena MD Groppali, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06364722, orgStudyIdInfo id: ZYS2024-02, briefTitle: Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-05-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-28, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Shanghai Institute of Acupuncture, Moxibustion and Meridian, class: OTHER, collaborators name: Fudan University, descriptionModule briefSummary: 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., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Subjects, efficacy assessors and statisticians were blinded., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: Acupuncture treatment, interventions name: Sham acupuncture, outcomesModule primaryOutcomes measure: Effect of Acupuncture on Crohn's Disease Activity Index (CDAI), secondaryOutcomes measure: Effects of Acupuncture on Anxiety and Depression, secondaryOutcomes measure: Effects of Acupuncture on Quality of Life, secondaryOutcomes measure: Effect of acupuncture on intestinal inflammation, secondaryOutcomes measure: Effects of acupuncture on gut microbiota, secondaryOutcomes measure: Effects of acupuncture on the functional activity of brain networks, secondaryOutcomes measure: Effects of acupuncture on intestinal inflammation, secondaryOutcomes measure: Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations, secondaryOutcomes measure: Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment), secondaryOutcomes measure: Safety evaluation (number of participants with abnormal routine blood tests), secondaryOutcomes measure: Safety evaluation (number of participants with abnormal Liver function tests), secondaryOutcomes measure: Safety evaluation (number of participants with abnormal Renal function tests), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364709, orgStudyIdInfo id: 4526, secondaryIdInfos id: R01DC015516, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DC015516, briefTitle: Criterion-learning Based Naming Treatment in Aphasia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2028-08, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Albert Einstein Healthcare Network, class: OTHER, collaborators name: Thomas Jefferson University, collaborators name: National Institute on Deafness and Other Communication Disorders (NIDCD), descriptionModule briefSummary: 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., conditionsModule conditions: Aphasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Criterion-learning practice, outcomesModule primaryOutcomes measure: Trained naming items (Experiment 1), primaryOutcomes measure: Trained naming items (Experiment 2), primaryOutcomes measure: Trained naming items (Experiment 3), primaryOutcomes measure: Trained comprehension items (Experiment 4), secondaryOutcomes measure: Trained naming items (Experiment 1), secondaryOutcomes measure: Trained naming items (Experiment 2), secondaryOutcomes measure: Untrained naming items (Experiment 2), secondaryOutcomes measure: Trained naming items (Experiment 3), secondaryOutcomes measure: Trained naming items (Experiment 4), secondaryOutcomes measure: Trained comprehension items (Experiment 4), secondaryOutcomes measure: Untrained comprehension items (Experiment 4), secondaryOutcomes measure: Treatment compliance (Experiment 2), otherOutcomes measure: Connected speech output performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364696, orgStudyIdInfo id: 4396-CL-0101, briefTitle: A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Astellas Pharma Inc, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 175, type: ESTIMATED, armsInterventionsModule interventions name: ASP4396, outcomesModule primaryOutcomes measure: Incidence of Dose Limiting Toxicities (DLTs) for ASP4369, primaryOutcomes measure: Number of Participants with Adverse Events (AEs), primaryOutcomes measure: Number of Participants with Serious Adverse Events (SAEs), primaryOutcomes measure: Number of Participants with laboratory value abnormalities and/or AEs, primaryOutcomes measure: Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs, primaryOutcomes measure: Number of Participants with vital sign abnormalities and/or AEs, primaryOutcomes measure: Number of Participants with physical exam abnormalities and/or AEs, primaryOutcomes measure: Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score, secondaryOutcomes measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, secondaryOutcomes measure: Duration of Response (DOR) per RECIST v 1.1, secondaryOutcomes measure: Disease Control Rate (DCR) per RECIST v 1.1, secondaryOutcomes measure: Progression Free Survival (PFS) per RECIST v1.1, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Pharmacokinetics (PK) of ASP4396 in plasma: area under the concentration-time curve from the time of dosing to 24 hours after dosing (AUC24h), secondaryOutcomes measure: PK of ASP4396 metabolite in plasma: AUC24h, secondaryOutcomes measure: PK of ASP4396 in plasma: AUC168h, secondaryOutcomes measure: PK of ASP4396 metabolite in plasma: AUC168h, secondaryOutcomes measure: PK of ASP4396 in plasma: Maximum Concentration (Cmax), secondaryOutcomes measure: PK of ASP4396 metabolite in plasma: Cmax, secondaryOutcomes measure: PK of ASP4396 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough), secondaryOutcomes measure: PK of ASP4396 metabolite in plasma: Ctrough, secondaryOutcomes measure: PK of ASP4396 in plasma: Time of maximum concentration (tmax), secondaryOutcomes measure: PK of ASP4396 metabolite in plasma: tmax, secondaryOutcomes measure: Change from baseline of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D amino acid substitution (G12D) tumor samples, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: START Midwest, status: RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: NEXT Oncology Dallas, status: RECRUITING, city: Irving, state: Texas, zip: 75039, country: United States, geoPoint lat: 32.81402, lon: -96.94889, locations facility: START Mountain Region, status: RECRUITING, city: West Valley City, state: Utah, zip: 84119, country: United States, geoPoint lat: 40.69161, lon: -112.00105, locations facility: NEXT Oncology Virginia, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False
|
protocolSection identificationModule nctId: NCT06364683, orgStudyIdInfo id: AIBU-HSF-SDEMIR-04, briefTitle: Coronary Artery Disease and Exercise Adherence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2024-11-13, completionDateStruct date: 2025-05-13, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Adherence, Treatment, conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Survey study, outcomesModule primaryOutcomes measure: exercise adherence, primaryOutcomes measure: predictors for exercise adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364670, orgStudyIdInfo id: ZSLL-KY-2023-011-01, briefTitle: Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated hospital of Zhejiang Chinese Medical University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Tinnitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: acupuncture, outcomesModule primaryOutcomes measure: Change in resting-state functional connectivity (RSFC), primaryOutcomes measure: Change in hemoglobin signals, primaryOutcomes measure: Change in Tinnitus Severity Grading, secondaryOutcomes measure: Change in Tinnitus Handicap Inventory score, secondaryOutcomes measure: Change in average pure-tone threshold, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Hantong Hu, M.D, role: CONTACT, phone: 18667103032, phoneExt: 86, email: 413351308@qq.com, contacts name: Xiaohan Huang, M.M, role: CONTACT, phone: 18334334738, phoneExt: 86, email: 1215360683@qq.com, contacts name: Hantong Hu, M.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
|
protocolSection identificationModule nctId: NCT06364657, orgStudyIdInfo id: IRB00439625, briefTitle: Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye, acronym: IIR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Sjogren's Syndrome, conditions: Dry Eye, conditions: Neurotrophic Keratitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Eye Exam, outcomesModule primaryOutcomes measure: Corneal Epithelium health, primaryOutcomes measure: Corneal Nerve health, secondaryOutcomes measure: Correlations Between Corneal Staining Score, secondaryOutcomes measure: Correlations Between Patient Symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital Wilmer Eye Institute, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Esen K Akpek, MD, role: CONTACT, phone: 410-955-5490, email: esakpek@jhmi.edu, contacts name: Lee W Guo, OD, role: SUB_INVESTIGATOR, contacts name: Michelle M Hessen, OD, role: SUB_INVESTIGATOR, contacts name: Esen K Akpek, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
|
protocolSection identificationModule nctId: NCT06364644, orgStudyIdInfo id: IRB00336599, secondaryIdInfos id: 1P50MD017348-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1P50MD017348-01, briefTitle: Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure, acronym: UNLOAD-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: 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., conditionsModule conditions: Type2diabetes, conditions: Heart Failure, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The design of the study is a randomized 2:1 parallel-arm clinical trial., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participants and interventionists will be unblinded, while those assessing outcomes will be blinded to the randomization arm ., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 402, type: ESTIMATED, armsInterventionsModule interventions name: Community Champions, interventions name: Homegrown Heroes, outcomesModule primaryOutcomes measure: Change in cardiorespiratory fitness, secondaryOutcomes measure: Change in cardiac biomarker, hs-cTnT, secondaryOutcomes measure: Change in hemoglobin A1c, secondaryOutcomes measure: Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales., secondaryOutcomes measure: Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA), secondaryOutcomes measure: Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test, secondaryOutcomes measure: Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ), secondaryOutcomes measure: Change in weight (kgs), secondaryOutcomes measure: Change in BMI, secondaryOutcomes measure: Change in hip and waist circumference (centimeters), secondaryOutcomes measure: Change in Metabolic Syndrome Severity Z score, secondaryOutcomes measure: Change in self-management as assessed by the Patient Activation Measure (PAM-13)., secondaryOutcomes measure: 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, secondaryOutcomes measure: Change in blood pressure (systolic and diastolic (mmHg)), secondaryOutcomes measure: Change in cardiac biomarker, gal-3, secondaryOutcomes measure: Change in cardiac biomarkers, NT-proBNP, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364631, orgStudyIdInfo id: 2023-503317-29-00, secondaryIdInfos id: 2023/3764, type: OTHER, domain: CSET number, briefTitle: CARE1 Pragmatic Clinical Trial, acronym: CARE1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2032-05-05, completionDateStruct date: 2032-05-05, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Gustave Roussy, Cancer Campus, Grand Paris, class: OTHER, collaborators name: European Commission, collaborators name: CRIS Cancer Foundation, collaborators name: National Cancer Institute, France, collaborators name: Rennes University Hospital, collaborators name: University Hospital, Essen, collaborators name: Fundació Privada Institut d'Investigació Oncològica de Vall d'Hebron, collaborators name: The Netherlands Cancer Institute, collaborators name: Servicio Madrileño de Salud, Madrid, Spain, collaborators name: Hospital Universitario 12 de Octubre, collaborators name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, collaborators name: Medical University of Vienna, collaborators name: FAKULTNI NEMOCNICE OLOMOUC, collaborators name: International Kidney Cancer Coalition, collaborators name: Association pour la Recherche sur les Tumeurs du Rein, collaborators name: Resilience, collaborators name: PRIMAA, collaborators name: Queen Mary University of London, descriptionModule briefSummary: 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., conditionsModule conditions: Metastatic Kidney Cancer, conditions: Metastatic Kidney Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: International, multicenter, open-label, randomized, controlled Phase 3 trial - 2 arms (A and B), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1250, type: ESTIMATED, armsInterventionsModule interventions name: Nivolumab, interventions name: Ipilimumab, interventions name: Pembrolizumab, interventions name: Cabozantinib, interventions name: Axitinib, interventions name: Lenvatinib, outcomesModule primaryOutcomes measure: Overall Survival (OS)., secondaryOutcomes measure: Progression-free survival according to RECIST 1.1, secondaryOutcomes measure: Objective Response Rate (ORR) according to RECIST 1.1, secondaryOutcomes measure: Quality of Life via questionnaire EQ-5D-5L, secondaryOutcomes measure: Quality of Life via questionnaire NNCCN/FACT Kidney Cancer Symptom Index (NFKSI), secondaryOutcomes measure: Quality of Life via questionnaire Kidney Symptom Index (KSI), secondaryOutcomes measure: Duration of Treatment, secondaryOutcomes measure: Time to treatment discontinuation (TTD), secondaryOutcomes measure: Treatment-free survival (TFS), secondaryOutcomes measure: Time to subsequent systemic anticancer therapy (TTSST), secondaryOutcomes measure: Incidence of AE's, secondaryOutcomes measure: Health Economic evaluation: healthcare costs [France & Netherlands only], secondaryOutcomes measure: Health Economic evaluation: cost-utility [France & Netherlands only], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gustave Roussy, status: RECRUITING, city: Villejuif, zip: 94805, country: France, contacts name: Laurence ALBIGES, MD, PhD, role: CONTACT, phone: +33 (0)1 42 11 66 90, email: laurence.albiges@gustaveroussy.fr, geoPoint lat: 48.7939, lon: 2.35992, hasResults: False
|
protocolSection identificationModule nctId: NCT06364618, orgStudyIdInfo id: G-24-07, briefTitle: Use of Wearables to Detect Infections in Kidney Transplant Recipients, acronym: RENALERT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Institute for Clinical and Experimental Medicine, class: OTHER_GOV, descriptionModule briefSummary: 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., conditionsModule conditions: Kidney Transplant Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Accuracy of the algorithm at detecting infections at presymptomatic stage, otherOutcomes measure: Rate of in-patient admissions, otherOutcomes measure: Incidence of decrease/increase of Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Clinical and Experimental Medicine, city: Prague, zip: 14021, country: Czechia, contacts name: Tereza Metelcova, PhD, role: CONTACT, phone: +420261262125, email: tereza.metelcova@ikem.cz, contacts name: Ivan Zahradka, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Vojtech Petr, MD, role: SUB_INVESTIGATOR, contacts name: Katarina Jakubov, MD, role: SUB_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
|
protocolSection identificationModule nctId: NCT06364605, orgStudyIdInfo id: IIT_UVIP_MySpace, briefTitle: MySpace: the Role of Vision in Representing Space, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2021-05-03, primaryCompletionDateStruct date: 2021-06-26, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Istituto Italiano di Tecnologia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Blindness, conditions: Visual Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 720, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation with the iReach novel multisensory medical device, outcomesModule primaryOutcomes measure: Perceptual responses to multisensory stimuli, primaryOutcomes measure: Stimuli velocity perception, primaryOutcomes measure: Distance stimuli perception, primaryOutcomes measure: Eye movements, primaryOutcomes measure: Saccade Analysis, primaryOutcomes measure: ERP evaluation and analysis, primaryOutcomes measure: Power of the cortical activity, eligibilityModule sex: ALL, minimumAge: 3 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unit For Visually Impaired People, city: Genova, zip: 16152, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, hasResults: False
|
protocolSection identificationModule nctId: NCT06364592, orgStudyIdInfo id: 2024-011-KY, briefTitle: Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Dysmenorrhea, conditions: Adenomyosis, conditions: Electroacupuncture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Electroacupuncture, interventions name: Sham Electroacupuncture, outcomesModule primaryOutcomes measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain, secondaryOutcomes measure: The change from baseline in the numerical rating scale (NRS) score on the average pain, secondaryOutcomes measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain., secondaryOutcomes measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain., secondaryOutcomes measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain., secondaryOutcomes measure: The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score., secondaryOutcomes measure: The change from baseline in the the Cox Menstrual Symptom Scale (CMSS)., secondaryOutcomes measure: The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5)., secondaryOutcomes measure: The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS)., otherOutcomes measure: Proportion of participants with positive expectance assessment, otherOutcomes measure: Blinding assessment, otherOutcomes measure: Adherence assessment, otherOutcomes measure: The change from baseline in the dose of rescue medicine., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, city: Beijing, country: China, contacts name: Zhishun Liu, PhD, role: CONTACT, phone: +861088002331, email: zhishunjournal@163.com, contacts name: Min Yang, role: CONTACT, phone: +8618810268077, email: yangmin2019@yeah.net, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06364579, orgStudyIdInfo id: 6533, briefTitle: Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT)., acronym: PROACT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2031-01-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Anal Cancer Patients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: QOL analysis, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Colostomy Free Survival (CFS), secondaryOutcomes measure: Loco-Regional Recurrence (LRR), secondaryOutcomes measure: Disease-Free Survival (DFS), secondaryOutcomes measure: Acute toxicity, secondaryOutcomes measure: Late toxicity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, status: RECRUITING, city: Rome, state: Lazio, zip: 00168, country: Italy, contacts name: Stefania Manfrida, MD, role: CONTACT, phone: +3900630154434, email: stefania.manfrida@policlinicogemelli.it, contacts name: Stefania Mandrida, role: CONTACT, phone: +390630155701, contacts name: Stefania Manfrida, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06364566, orgStudyIdInfo id: time-exploring, briefTitle: Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-10-15, primaryCompletionDateStruct date: 2016-10-15, completionDateStruct date: 2019-10-15, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Time, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 303, type: ACTUAL, armsInterventionsModule interventions name: Neoadjuvant chemradiotherapy, interventions name: Minimally invasive esophagectomy, outcomesModule primaryOutcomes measure: The overall survival of the overall population, primaryOutcomes measure: The Disease-Free survival of the overall population, primaryOutcomes measure: The overall survival of the non-PCR population, primaryOutcomes measure: The Disease-Free survival of the non-PCR population, primaryOutcomes measure: The overall survival of the PCR population, primaryOutcomes measure: The Disease-Free survival of the PCR population, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital Affiliated to Fudan University, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2021-10-15, uploadDate: 2024-04-10T05:47, filename: SAP_000.pdf, size: 119312, hasResults: False
|
protocolSection identificationModule nctId: NCT06364553, orgStudyIdInfo id: NL86416.078.24, briefTitle: Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study, acronym: ENTRANCE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Oesophageal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Esophageal self-expandable metal stent, outcomesModule primaryOutcomes measure: Complication: incidence of perforation, primaryOutcomes measure: Complication: incidence of hemorrhage, primaryOutcomes measure: Complication: incidence of fistula formation, primaryOutcomes measure: Complication: incidence of gastroesophageal reflux, primaryOutcomes measure: Complication: incidence of stent migration, primaryOutcomes measure: Efficacy: clinical outcome, primaryOutcomes measure: Efficacy: incidence of patients receiving technical successful stent placement, secondaryOutcomes measure: Incidence of recurrent dysphagia, secondaryOutcomes measure: Pain related to esophageal stent (placement), secondaryOutcomes measure: Overall survival, otherOutcomes measure: Patient characteristic: age, otherOutcomes measure: Patient characteristic: gender, otherOutcomes measure: Patient characteristic: tumor location, otherOutcomes measure: Patient characteristic: tumor histology, otherOutcomes measure: Stent characteristic: length of the stent, otherOutcomes measure: Stent characteristic: diameter of the stent, otherOutcomes measure: Patient characteristic: prior radiotherapy, otherOutcomes measure: Patient characteristic: prior chemotherapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06364540, orgStudyIdInfo id: 2023-08-14, briefTitle: Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED, acronym: KETAFEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Antonios Likourezos, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine, interventions name: Fentanyl, outcomesModule primaryOutcomes measure: Reduction of pain scores on the numeric rating pain scale (NRS), secondaryOutcomes measure: Need for Rescue Analgesia, secondaryOutcomes measure: Severity of Adverse Events, secondaryOutcomes measure: Evaluation of Severity of agitation and/or sedation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-18, uploadDate: 2024-04-05T12:16, filename: Prot_SAP_000.pdf, size: 208117, hasResults: False
|
protocolSection identificationModule nctId: NCT06364527, orgStudyIdInfo id: ADH-BSA-02-23, briefTitle: Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: CoheroHealth, class: INDUSTRY, collaborators name: Aptar Digital Health, collaborators name: Lindus Health, descriptionModule briefSummary: 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., conditionsModule conditions: Asthma Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 118, type: ESTIMATED, armsInterventionsModule interventions name: Aptar Digital Health respiratory disease management platform, outcomesModule primaryOutcomes measure: Asthma Control Questionnaire - 5 scores, secondaryOutcomes measure: Mini-Asthma Quality of Life Questionnaire, secondaryOutcomes measure: Rescue medication usage, secondaryOutcomes measure: Inhaled corticosteroid steroid daily adherence, otherOutcomes measure: Step-up from inhaled corticosteroids to biologics, otherOutcomes measure: Asthma related oral corticosteroids utilization and associated cost, otherOutcomes measure: Asthma related accident and emergency department visits and associated cost, otherOutcomes measure: Asthma related unscheduled outpatient clinic visits and associated cost, otherOutcomes measure: Asthma related inpatient hospitalization, associated length of stay, and associated cost, otherOutcomes measure: Computer System Usability Questionnaire, otherOutcomes measure: Semi-structured interviews using the 2019 Rudin et al study, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364514, orgStudyIdInfo id: IRB-P00047313, briefTitle: PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Boston Children's Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Clinical Stability Assessment, outcomesModule primaryOutcomes measure: Proportion of eligible patients who consent to participate in the intervention, primaryOutcomes measure: 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, secondaryOutcomes measure: Median days of antibiotics received for patients in the intervention group as well as from historical control group, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364501, orgStudyIdInfo id: KH801, briefTitle: Phase 1 Trial of KH801, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2030-05-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Beijing Kanghong Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: KH801, outcomesModule primaryOutcomes measure: MTD, primaryOutcomes measure: DLT, primaryOutcomes measure: RP2D, secondaryOutcomes measure: AE, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: T1/2, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: CL, secondaryOutcomes measure: AUC0-inf, secondaryOutcomes measure: anti-drug antibody (ADA), otherOutcomes measure: Objective Response Rate（ORR）, otherOutcomes measure: Disease Control Rate (DCR), otherOutcomes measure: Duration of Response (DOR), otherOutcomes measure: Median Progression-Free Survival (mPFS), otherOutcomes measure: Overall Survival（OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Cancer Hospital, city: Peking, state: Beijing, country: China, contacts name: Lin Shen, role: CONTACT, contacts name: Lin Shen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University, city: Guangzhou, state: Guangdong, country: China, contacts name: ErWei Song, role: CONTACT, phone: 18982182468, email: 022516@cnkh.com, contacts name: ErWei Song, role: PRINCIPAL_INVESTIGATOR, contacts name: Junyan Wu, role: PRINCIPAL_INVESTIGATOR, contacts name: Herui Yao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Central Hospital Affiliated To Shandong First Medical University, city: Jinan, state: Shandong, country: China, contacts name: Meili Sun, role: CONTACT, contacts name: Meili Sun, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: West China Second University Hospital,Sichuan University/West China Women's and Children's Hospital, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Rutie Yin, role: CONTACT, contacts name: Rutie Yin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
|
protocolSection identificationModule nctId: NCT06364488, orgStudyIdInfo id: 295721, briefTitle: TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: BlueSkeye AI, class: INDUSTRY, collaborators name: Institute of Mental Health Nottingham, collaborators name: Nottinghamshire Healthcare NHS Trust, collaborators name: Nottingham University Hospitals NHS Trust, descriptionModule briefSummary: 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., conditionsModule conditions: Depression, conditions: Depression, Postpartum, conditions: Anxiety in Pregnancy, conditions: Anxiety, conditions: Anhedonia, conditions: Perinatal Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 125 participants, of whom 12 will enter the initial 5-month within-study pilot phase aimed at understanding any device-related adverse events and usability issues., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: TrueBlue App, outcomesModule primaryOutcomes measure: The rate of device related adverse events, secondaryOutcomes measure: Rate of initial use (assessing feasibility and acceptability), secondaryOutcomes measure: Rate of New Depression or Risk (Suicidality) events, secondaryOutcomes measure: Rate of referral to Perinatal Psychiatry services, secondaryOutcomes measure: Rate of acceptance of referrals to Perinatal Psychiatry, secondaryOutcomes measure: Diagnosis rate for depression, or other mental health problems, during the period of study., secondaryOutcomes measure: Continued use (acceptability), secondaryOutcomes measure: Loss to follow-up, secondaryOutcomes measure: Usability (quantitative measure), secondaryOutcomes measure: Agreement between TrueBlue generated score and validated scales, secondaryOutcomes measure: Thematic results, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nottingham University Hospitals NHS Trust, city: Nottingham, state: Nottinghamshire, zip: NG7 2UH, country: United Kingdom, contacts name: Nia Jones, role: CONTACT, email: Nia.Jones@nottingham.ac.uk, contacts role: CONTACT, email: TrueBlue@nottingham.ac.uk, contacts name: Nia Jones, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.9536, lon: -1.15047, locations facility: Nottinghamshire Healthcare NHS Foundation Trust, city: Nottingham, zip: NG3 6AA, country: United Kingdom, contacts name: Bonnie MILLAR, role: CONTACT, email: bonnie.millar@nottingham.ac.uk, contacts role: CONTACT, email: TrueBlue@nottingham.ac.uk, contacts name: Neil Nixon, MBBS, DM, role: PRINCIPAL_INVESTIGATOR, contacts name: Deepa Bagepalli Krishnan, role: SUB_INVESTIGATOR, contacts name: Zaib un Nisa, role: SUB_INVESTIGATOR, contacts name: Amy Au-Yong, role: SUB_INVESTIGATOR, contacts name: Christina Kelly, role: SUB_INVESTIGATOR, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False
|
protocolSection identificationModule nctId: NCT06364475, orgStudyIdInfo id: BezmialemVU-TF-AÖ-1, briefTitle: Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet?, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2022-07-01, completionDateStruct date: 2022-09-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One group 16:8 time-restricted intermittent fasting and the other group energy-restricted six-meal eating. Both of groups with an eating plan suitable with their groups and 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein)., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 137, type: ACTUAL, armsInterventionsModule interventions name: 16:8 Time-Restricted Intermittent Fasting Group, interventions name: Energy-Restricted Six-Meal Group, outcomesModule primaryOutcomes measure: Weight measured in kilogram, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Waist-to-height ratio (WHtR), secondaryOutcomes measure: Waist circumference in centimetres, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İstanbul Sabri Artam Vakfi Family Medicine Center, city: İ̇stanbul, zip: 34473, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06364462, orgStudyIdInfo id: ZLRK202301, briefTitle: Precise Evaluation Criteria for Histological Regression of NASH Fibrosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-03-09, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: NASH, conditions: Liver Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: lifestyle intervention, outcomesModule primaryOutcomes measure: Regression of NASH fibrosis, secondaryOutcomes measure: Dynamic changes of liver stiffness measurements (LSM), secondaryOutcomes measure: Dynamic changes of CAP, secondaryOutcomes measure: Dynamic changes of MRE, secondaryOutcomes measure: Dynamic changes of MRI-PDFF, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of non-invasive liver fibrosis models, secondaryOutcomes measure: Dynamic changes of metabolic markers, secondaryOutcomes measure: Dynamic changes of metabolic markers, secondaryOutcomes measure: Dynamic changes of metabolic markers, secondaryOutcomes measure: Incidence of liver-related events, secondaryOutcomes measure: Incidence of extrahepatic related events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364449, orgStudyIdInfo id: 202309052RIND, briefTitle: Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-13, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Decision Tree Analysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: predicted AV access choices, secondaryOutcomes measure: to determine factors affecting clinical use of the targeted AV access over a variable timeframe, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, status: RECRUITING, city: Taipei, country: Taiwan, contacts name: Chih-Yang Chan, MD Phd, role: CONTACT, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
|
protocolSection identificationModule nctId: NCT06364436, orgStudyIdInfo id: AksarayU1, briefTitle: Distant Reiki Therapy on Postpartum Period Fatigue and Depression, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-06-03, primaryCompletionDateStruct date: 2024-03-18, completionDateStruct date: 2024-04-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Aksaray University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: PostPartum Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Reiki energy therapy, outcomesModule primaryOutcomes measure: Visual Analog Scale for Fatigue (VAS-F), primaryOutcomes measure: Edinburgh Postnatal Depression Scale (EPDS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aksaray University, city: Aksaray, state: Merkez, country: Turkey, geoPoint lat: 38.37255, lon: 34.02537, hasResults: False
|
protocolSection identificationModule nctId: NCT06364423, orgStudyIdInfo id: 10001599, secondaryIdInfos id: 001599-C, briefTitle: Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-07-01, completionDateStruct date: 2030-07-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: 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., conditionsModule conditions: B-Cell Chronic Lymphocytic Leukemia, conditions: Leukemia, Lymphocytic, Chronic, B-Cell, conditions: B-Lymphocytic Leukemia, Chronic, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Autologous HuCD19 ( Anti-CD19)CAR T cells, interventions name: Cyclophosphamide, interventions name: Fludarabine, interventions name: Rituximab, outcomesModule primaryOutcomes measure: Phase I: Determine the safety of administering T-cells expressing a fully-human anti-CD19 CAR to participants with advanced CLL or SLL., primaryOutcomes measure: 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, secondaryOutcomes measure: Phase I: Assess overall response rate, secondaryOutcomes measure: Phase I+II: Assess complete response rate, secondaryOutcomes measure: Phase I+II: Assess duration of responses, secondaryOutcomes measure: Phase I+II: Determine the ORR for re treatment with rituximab, chemotherapy and CAR T cells in eligible patients, secondaryOutcomes measure: Phase II: Determine the frequency of grade 3-4 adverse events at the Optimal Dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: NCI Medical Oncology Referral Office, role: CONTACT, phone: 240-760-6050, email: ncimo_referrals@nih.gov, contacts name: Micaela Ganaden, M.D., role: CONTACT, phone: (240) 858-3654, email: ncicar@mail.nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
|
protocolSection identificationModule nctId: NCT06364410, orgStudyIdInfo id: NCI-2024-02982, secondaryIdInfos id: NCI-2024-02982, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 10554, type: OTHER, domain: University of Texas MD Anderson Cancer Center LAO, secondaryIdInfos id: 10554, type: OTHER, domain: CTEP, secondaryIdInfos id: UM1CA186688, type: NIH, link: https://reporter.nih.gov/quickSearch/UM1CA186688, briefTitle: Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-30, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: 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., conditionsModule conditions: Clinical Stage III Gastric Cancer AJCC v8, conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, conditions: Clinical Stage IV Gastric Cancer AJCC v8, conditions: Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, conditions: Locally Advanced Gastric Carcinoma, conditions: Locally Advanced Gastroesophageal Junction Adenocarcinoma, conditions: Locally Advanced Malignant Solid Neoplasm, conditions: Metastatic Gastric Carcinoma, conditions: Metastatic Gastroesophageal Junction Adenocarcinoma, conditions: Metastatic Malignant Solid Neoplasm, conditions: Unresectable Gastric Carcinoma, conditions: Unresectable Gastroesophageal Junction Adenocarcinoma, conditions: Unresectable Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Azenosertib, interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Echocardiography, interventions name: Magnetic Resonance Imaging, interventions name: Multigated Acquisition Scan, interventions name: Trastuzumab Deruxtecan, outcomesModule primaryOutcomes measure: Maximum tolerated dose, primaryOutcomes measure: Recommended phase 2 dose, primaryOutcomes measure: Incidence of dose limiting toxicities (DLTs), primaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Pharmacodynamic effects in the tumor, secondaryOutcomes measure: Predictors of response and acquired resistance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364397, orgStudyIdInfo id: ESPRIT202403, briefTitle: Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis, acronym: ESPRIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, collaborators name: Peking Union Medical College Hospital, collaborators name: First People's Hospital of Hangzhou, descriptionModule briefSummary: 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., conditionsModule conditions: Recurrent Acute Pancreatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: ERCP, interventions name: Health education and conservative management of clinical routines, outcomesModule primaryOutcomes measure: Recurrence rate of AP, secondaryOutcomes measure: Ratio of reduced AP episodes, secondaryOutcomes measure: Proportion of patients with reduced AP episodes, secondaryOutcomes measure: Severity of AP, secondaryOutcomes measure: Evaluation of quality of life, secondaryOutcomes measure: Evaluation of psychological condition, secondaryOutcomes measure: Proportion of patients diagnosed by ERCP., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai Hospital, city: Shanghai, state: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06364384, orgStudyIdInfo id: E2024074, briefTitle: Radical Synchronous Chemoradiotherapy With DDP/5-FU and PD-1 for Non-metastatic Rectal Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Rectal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: PD-1 and CRT, outcomesModule primaryOutcomes measure: 1-year tumor-free survival(DFS), secondaryOutcomes measure: 1-year overall survival (OS), secondaryOutcomes measure: 1-year relapse-free survival (RFS), secondaryOutcomes measure: 1-year metastasis free survival (DMFS), secondaryOutcomes measure: Incidence of chemotherapy and immunotherapy-related adverse reactions, secondaryOutcomes measure: Complete response rate (CRR), secondaryOutcomes measure: 1-year stoma-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sixth Affiliated Hospital, Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Jun Huang, MD, role: CONTACT, phone: +86-13926451242, email: huangj97@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06364371, orgStudyIdInfo id: E2023210, briefTitle: Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Predictive Cancer Model, conditions: Pathologic Complete Response, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Medical examination, outcomesModule primaryOutcomes measure: Area under curve(AUC), secondaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Negative predictive value(NPV), secondaryOutcomes measure: Positive predictive value(PPV), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Sixth Affiliated Hospital, Sun Yatsen University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Jun Huang, role: CONTACT, phone: 13926451242, email: huangj97@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06364358, orgStudyIdInfo id: IRB23-0385, secondaryIdInfos id: 5R21DK121262, type: NIH, link: https://reporter.nih.gov/quickSearch/5R21DK121262, briefTitle: Interactive Computer-adaptive Chronic Kidney Disease Education Program, acronym: ICCKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: 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, conditionsModule conditions: Chronic Kidney Diseases, conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Computerized CKD Education, interventions name: Usual Hospital Care, outcomesModule primaryOutcomes measure: Change in CKD Knowledge baseline to post patient education intervention, primaryOutcomes measure: Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention, primaryOutcomes measure: Change in ESKD Treatment Preferences from baseline to 1 day post-intervention, secondaryOutcomes measure: Change in Patient Activation Measure from Baseline to 30 days Post-intervention, secondaryOutcomes measure: Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up), secondaryOutcomes measure: CKD Self-Management from baseline to 30 day post-intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago Medical Center, city: Chicago, state: Illinois, zip: 60637, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
|
protocolSection identificationModule nctId: NCT06364345, orgStudyIdInfo id: INOVA_POCAD_1, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
|
protocolSection identificationModule nctId: NCT06364332, orgStudyIdInfo id: ChatsafeNL, secondaryIdInfos id: 2023.0348, type: OTHER, domain: Medical Ethics Committee VUmc, briefTitle: #Chatsafe Netherlands: a Social Media Intervention to Improve Dutch Young People's Safe Communication About Suicide Online, acronym: CSNL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: 113 Suicide Prevention, class: OTHER, collaborators name: Orygen, collaborators name: Mind, descriptionModule briefSummary: 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., conditionsModule conditions: Suicide Prevention, conditions: Communication, conditions: Social Media, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are randomized to the intervention or the control group using block randomization with varying block sizes (block sizes vary from 2 to 16). The distribution key will be 1:1. The randomization schedule is computer generated by a researcher who will not be part of the analysing researchers., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The research team will be kept blind to randomization. A safety procedure is drawn up in which a senior researcher is appointed who will be unblinded if absolutely necessary. Principally, this will not be needed, since the study psychologists are independently alerted when a subject wants to get in touch., whoMasked: INVESTIGATOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Social Media campaign, outcomesModule primaryOutcomes measure: Safe communication about suicide online, secondaryOutcomes measure: Confidence when communicating about suicide online, secondaryOutcomes measure: Willingness to intervene against suicide online, secondaryOutcomes measure: Self-efficacy online, secondaryOutcomes measure: Safety of the #ChatsafeNL materials, secondaryOutcomes measure: Acceptability of the #ChatsafeNL intervention, secondaryOutcomes measure: Safety of the #ChatsafeNL intervention, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: 113 Suicide Prevention, city: Amsterdam, state: Noord Holland, zip: 1105 BP, country: Netherlands, contacts name: Elke Elzinga, dr, role: CONTACT, phone: 020 3113883, email: e.elzinga@113.nl, contacts name: Saskia Mérelle, dr, role: CONTACT, phone: 020 3113883, email: s.merelle@113.nl, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
|
protocolSection identificationModule nctId: NCT06364319, orgStudyIdInfo id: 2024PHD002-001, briefTitle: Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: cGVHD, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 118, type: ESTIMATED, armsInterventionsModule interventions name: anti-CD25 rhMAb, interventions name: Prednisone, interventions name: Ruxolitinib, interventions name: Cyclosporine, outcomesModule primaryOutcomes measure: overall response rate (ORR), secondaryOutcomes measure: duration of response（DOR）, secondaryOutcomes measure: patient-reported outcomes (PRO), secondaryOutcomes measure: disease-free survival (DFS), secondaryOutcomes measure: failure-free survival (FFS), secondaryOutcomes measure: non-relapse mortality (NRM), secondaryOutcomes measure: overall survival （OS）, secondaryOutcomes measure: adverse drug reactions (ADR), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06364306, orgStudyIdInfo id: 12032024, briefTitle: oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias, acronym: PRIOR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2031-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, collaborators name: St. Clara Hospital, Basel, Switzerland, collaborators name: Klinikum Kempten, Kempten, Germany, descriptionModule briefSummary: 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., conditionsModule conditions: Ventral Hernia, conditions: Incisional Hernia, conditions: Abdominal Wall Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Patients are blinded to their treatment allocation until hospital discharge criteria according to the primary endpoint are fulfilled. After discharge, blinding is difficult to be ensured because there is no control, if dressing have been removed or modified. To ensure patient blinding during hospital stay, patients from both treatment arms will receive identical dressings as if an open and minimal-invasive access had been performed. In case the dressing must be changed during the hospital stay, this will be performed while the patient is blinded using a cover.In case for any reason the patient has been unblinded to his treatment allocation (accidental or intentional dressing removal, bed-side wound opening, other) all outcome data are assessed regardless and unblinding is documented and reported in the final report., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Robotically-assisted ventral hernia repair (RVHR), interventions name: Open ventral hernia repair (OVHR), outcomesModule primaryOutcomes measure: Primary outcome: length of stay, secondaryOutcomes measure: Comprehensive complication index (CCI), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: pain after surgery, secondaryOutcomes measure: Functional recovery, secondaryOutcomes measure: Quality of life using SF-12 form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364293, orgStudyIdInfo id: KY2023-261-01, briefTitle: An Early Warning Model of Unfavorable Outcomes Following Endovascular Interventional Treatment of Intracranial Aneurysm, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, collaborators name: National Natural Science Foundation of China, descriptionModule briefSummary: 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., conditionsModule conditions: Intracranial Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: Observational design does not include interventional behavior., outcomesModule primaryOutcomes measure: Unfavorable imaging outcome, secondaryOutcomes measure: Hemorrhagic or ischemic complication occurred during the follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantan hospital, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06364280, orgStudyIdInfo id: 2023X0135, secondaryIdInfos id: UG3HL165019, type: NIH, link: https://reporter.nih.gov/quickSearch/UG3HL165019, secondaryIdInfos id: U24HL165014, type: NIH, link: https://reporter.nih.gov/quickSearch/U24HL165014, briefTitle: Pediatric Prehospital Airway Resuscitation Trial, acronym: Pedi-PART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-08-31, completionDateStruct date: 2029-09-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), collaborators name: University of Utah, descriptionModule briefSummary: 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. \[Winner of Stage I\]., conditionsModule conditions: Heart Arrest, Out-Of-Hospital, conditions: Wounds and Injuries, conditions: Respiratory Insufficiency in Children, conditions: Child, Only, conditions: Critical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The trial uses a Bayesian Adaptive Sequential Platform Trial (BASIC-PT) framework.The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\].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. \[Winner of Stage I\].The interventions will be quasi-randomized using alternate day assignment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: BVM, interventions name: SGA, interventions name: ETI, outcomesModule primaryOutcomes measure: 30-day ICU-free survival, secondaryOutcomes measure: Neurologic outcome upon hospital discharge, eligibilityModule sex: ALL, minimumAge: 24 Hours, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364267, orgStudyIdInfo id: BabyTears, briefTitle: Babytam vs Babyexe in Post-menopausal Women at High Risk for Breast Cancer., acronym: BabyTears, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Andrea DeCensi, class: OTHER, collaborators name: Dana-Farber/Brigham and Women's Cancer Center, collaborators name: Herbert Irving Comprehensive Cancer Center, collaborators name: Istituto Europeo di Oncologia, collaborators name: Breast Cancer Research Foundation, descriptionModule briefSummary: 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., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Tamoxifen 10 MG, interventions name: Exemestane 25 MG, outcomesModule primaryOutcomes measure: Quality of life MEnQol, secondaryOutcomes measure: Other domains, secondaryOutcomes measure: PMAS questionnaire, secondaryOutcomes measure: Customer Satisfaction questionnaire, secondaryOutcomes measure: BPI, secondaryOutcomes measure: Sex hormones biomarkers, secondaryOutcomes measure: Insulin biomarker, secondaryOutcomes measure: Bone biomarker, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: E.O. Ospedali Galliera, city: Genova, zip: 16128, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, hasResults: False
|
protocolSection identificationModule nctId: NCT06364254, orgStudyIdInfo id: 2311054791, briefTitle: Effects of CBD on 2 Mile Run Time Trial Performance, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Northern Colorado, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cannabidiol Capsules, outcomesModule primaryOutcomes measure: Difference in Time Trial Times, primaryOutcomes measure: Difference in Anxiety Measured with the State Trait Anxiety Inventory, primaryOutcomes measure: Difference in Blood Lactate Concentrations, primaryOutcomes measure: Difference in Gastrointestinal Distress, primaryOutcomes measure: Different in Heart Rate Variability, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Of Northern Colorado, status: RECRUITING, city: Greeley, state: Colorado, zip: 80639, country: United States, contacts name: Laura K Stewart, PhD, role: CONTACT, phone: 970-351-1891, email: laura.stewart@unco.edu, geoPoint lat: 40.42331, lon: -104.70913, hasResults: False
|
protocolSection identificationModule nctId: NCT06364241, orgStudyIdInfo id: 331760, secondaryIdInfos id: 226706/Z/22/Z, type: OTHER_GRANT, domain: Wellcome Trust, briefTitle: Focus Groups on Cognitive Function in Psychosis, acronym: PRECOGNITION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: South London and Maudsley NHS Foundation Trust, descriptionModule briefSummary: 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., conditionsModule conditions: Psychosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Focus group, outcomesModule primaryOutcomes measure: Individual perception of impairments due to cognitive deficits associated with psychosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364228, orgStudyIdInfo id: 0133-24-FB, briefTitle: Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Nebraska, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Stress, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Oxytocin Intranasal Spray 12 International Unit (12IU), interventions name: Oxytocin Intranasal Spray 24 International Unit (24IU), interventions name: Functional MRI, outcomesModule primaryOutcomes measure: Participants' chronic stress levels in the past thirty days., secondaryOutcomes measure: Participant Quality of Life survey, secondaryOutcomes measure: Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and EmpaTom task., eligibilityModule sex: FEMALE, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Nebraska Medical Center, Department of Psychiatry, city: Omaha, state: Nebraska, zip: 61898-5581, country: United States, contacts name: Minjoo Kang, MEd, role: CONTACT, phone: 402-552-6239, email: mkang@unmc.edu, contacts name: Soonjo Hwang, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Janelle N Beadle, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 41.25626, lon: -95.94043, hasResults: False
|
protocolSection identificationModule nctId: NCT06364215, orgStudyIdInfo id: 2024P000883, briefTitle: Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation, acronym: (SMILE-AF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: 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)., conditionsModule conditions: Atrial Fibrillation Paroxysmal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Pulmonary Vein Isolation alone, interventions name: Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation, outcomesModule primaryOutcomes measure: Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period., primaryOutcomes measure: 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., secondaryOutcomes measure: Freedom from atrial arrhythmias medication, secondaryOutcomes measure: Procedural time, secondaryOutcomes measure: Procedure-related Recurrencies, secondaryOutcomes measure: Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT)., secondaryOutcomes measure: Use of amiodarone, secondaryOutcomes measure: Complications., secondaryOutcomes measure: fluoroscopy time., secondaryOutcomes measure: Pulsed field ablation (PFA) applications during procedure., secondaryOutcomes measure: first-pass pulmonary vein isolation (PVI)., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Obadah Aloum, MD, role: CONTACT, phone: 617-525-7047, contacts name: Fernando Moreno, role: CONTACT, phone: 6175257047, contacts name: Jorge E Romero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06364202, orgStudyIdInfo id: 1928368, briefTitle: Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2023-11-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Augusta University, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Sleep, conditions: Body Composition, conditions: Blood Pressure, conditions: Physical Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Peanut Butter, outcomesModule primaryOutcomes measure: Body composition, primaryOutcomes measure: Body composition, primaryOutcomes measure: Sleep, primaryOutcomes measure: Blood pressure, primaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Physical activity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Augusta University, city: Augusta, state: Georgia, zip: 30909, country: United States, geoPoint lat: 33.47097, lon: -81.97484, hasResults: False
|
protocolSection identificationModule nctId: NCT06364189, orgStudyIdInfo id: FY22-119, secondaryIdInfos id: R61AG084479, type: NIH, link: https://reporter.nih.gov/quickSearch/R61AG084479, briefTitle: Inspiring Seniors Toward Exercise Promotion, acronym: iSTEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Greensboro, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: 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., conditionsModule conditions: Cognitively Normal Older Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Music, interventions name: Exercise, outcomesModule primaryOutcomes measure: Physical activity (objective), primaryOutcomes measure: Ecological Momentary Assessment (EMA): Affective response to PA, primaryOutcomes measure: Ecological Momentary Assessment (EMA): Perceived autonomy, primaryOutcomes measure: Ecological Momentary Assessment (EMA): Perceived exertion, primaryOutcomes measure: Ecological Momentary Assessment (EMA): Behavioral intention, primaryOutcomes measure: Ecological Momentary Assessment (EMA): Physical Activity setting, primaryOutcomes measure: Ecological Momentary Assessment (EMA): Anticipated, remembered, and incidental affect, primaryOutcomes measure: Ecological Momentary Assessment (EMA): Social Support for Exercise, primaryOutcomes measure: Physical activity (self-report), secondaryOutcomes measure: Cognitive performance - General, secondaryOutcomes measure: Cognitive performance - Tower of London, secondaryOutcomes measure: Cognitive performance - NIH Toolbox Oral Reading Recognition Test, secondaryOutcomes measure: Cognitive performance - NIH Toolbox List Sort Working Memory Test, secondaryOutcomes measure: Cognitive performance - NIH Toolbox Picture Sequence Test, secondaryOutcomes measure: Cognitive performance - NIH Toolbox Dimensional Change Card Sort Test, secondaryOutcomes measure: Cognitive performance - NIH Toolbox Flanker Inhibitory Control and Attention Test, secondaryOutcomes measure: Cognitive performance - Mnemonic Similarity Task, secondaryOutcomes measure: Cognitive performance - Perceptual Discrimination Task, secondaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Physical activity (subjective), secondaryOutcomes measure: Music Reward Experience, secondaryOutcomes measure: Treatment Satisfaction, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Waist/Hip/Leg Circumference, secondaryOutcomes measure: Sagittal Diameter, secondaryOutcomes measure: Blood Pressure, secondaryOutcomes measure: Handgrip Strength, secondaryOutcomes measure: Timed Up and Go (TUG), secondaryOutcomes measure: 10-Meter Walk, secondaryOutcomes measure: 4-Stage Balance Test, secondaryOutcomes measure: 6-Minute Walk Test (6MWT), secondaryOutcomes measure: 30-second Chair Stand, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Greensboro, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27402-6170, country: United States, contacts name: Project Coordinator, MS, role: CONTACT, phone: 336-334-4765, email: istep@uncg.edu, contacts name: Jennifer L Etnier, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Shin Park, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, hasResults: False
|
protocolSection identificationModule nctId: NCT06364176, orgStudyIdInfo id: STUDY00149479, briefTitle: Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Losartan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Sweat chloride, secondaryOutcomes measure: Lung function - absolute, secondaryOutcomes measure: Lung function - relative, secondaryOutcomes measure: Transforming growth factor (TGF)-beta1 - airway, secondaryOutcomes measure: TGF-beta1 - systemic, secondaryOutcomes measure: Inflammatory mediators - airway, secondaryOutcomes measure: Inflammatory mediators - systemic, secondaryOutcomes measure: CFQ-R, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, contacts name: Charles Bengtson, MD, MSc, role: CONTACT, phone: 913-588-6000, contacts name: Carolina Aguiar, role: CONTACT, phone: 9139459295, contacts name: Matthias Salathe, M.D., role: SUB_INVESTIGATOR, contacts name: Andreas Schmid, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 39.11417, lon: -94.62746, hasResults: False
|
protocolSection identificationModule nctId: NCT06364163, orgStudyIdInfo id: 697716, briefTitle: Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-12, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Bergen, class: OTHER, collaborators name: The Norwegian Seafood Research Fund, descriptionModule briefSummary: 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., conditionsModule conditions: High Cholesterol, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Herring oil concentrate, interventions name: Control, outcomesModule primaryOutcomes measure: Serum concentration of LDL-cholesterol, secondaryOutcomes measure: Serum concentration of HDL-cholesterol, secondaryOutcomes measure: Serum concentration of total cholesterol, secondaryOutcomes measure: Serum concentrations of apolipoproteins, secondaryOutcomes measure: Serum concentrations of amino acids metabolites, secondaryOutcomes measure: Serum concentration of one-carbon pathway metabolites, secondaryOutcomes measure: Fatty acid composition in leukocytes, secondaryOutcomes measure: Serum concentration of glucose, secondaryOutcomes measure: Serum concentration of insulin, secondaryOutcomes measure: Urine concentrations of cystatin C, secondaryOutcomes measure: Urine concentrations of T cell immunoglobulin mucin-1 (TIM-1), secondaryOutcomes measure: Body composition, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bergen, city: Bergen, country: Norway, contacts name: Oddrun A Gudbrandsen, PhD, role: CONTACT, phone: 55975553, phoneExt: 47, email: nkjgu@uib.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
|
protocolSection identificationModule nctId: NCT06364150, orgStudyIdInfo id: MAGIC6, briefTitle: Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction, acronym: MAGICcell6, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Seoul National Hospital, class: OTHER_GOV, descriptionModule briefSummary: 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"., conditionsModule conditions: Acute Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single arm, open label interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Autologous Peripheral Blood Stem Cell injection, outcomesModule primaryOutcomes measure: Left ventricular systolic function, secondaryOutcomes measure: Regional wall motion score index, secondaryOutcomes measure: B-natriuretic peptide level, secondaryOutcomes measure: 6-minute walk test, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Target lesion Revascularization, secondaryOutcomes measure: Readmssion, secondaryOutcomes measure: Cardiovascular death, secondaryOutcomes measure: non-Target lesion Revascularization, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06364137, orgStudyIdInfo id: 73203, briefTitle: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings - Pilot RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), collaborators name: MainSquare Co. (dba 'Teleo'), descriptionModule briefSummary: 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., conditionsModule conditions: Anxiety Disorders, conditions: Mood Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Teleo, interventions name: Standard videoconferencing, outcomesModule primaryOutcomes measure: PRIME-O Video Coding Score, secondaryOutcomes measure: My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores, secondaryOutcomes measure: My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores, secondaryOutcomes measure: Attendance during Psychotherapy Sessions, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Stanford University, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False
|
protocolSection identificationModule nctId: NCT06364124, orgStudyIdInfo id: Beijing_LH_CCU2024, briefTitle: Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing Luhe Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: STEMI, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: evolocumab, interventions name: Atorvastatin, outcomesModule primaryOutcomes measure: Average percent change from baseline in LDL-C levels to discharge and day 30, secondaryOutcomes measure: Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30, secondaryOutcomes measure: Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30, secondaryOutcomes measure: Number of cardiovascular events to day 30, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing luhe hospital, status: RECRUITING, city: Beijing, country: China, contacts name: rui yan, role: CONTACT, phone: 17746570262, email: yanrui4112@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06364111, orgStudyIdInfo id: Vibrabot Capsule, briefTitle: Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2025-06-14, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing Tsinghua Chang Gung Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Functional Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Vibrabot capsule, interventions name: polyethylene glycol, outcomesModule primaryOutcomes measure: The proportions of responders to the three therapies during the treatment period., secondaryOutcomes measure: Evaluation of intestinal motility, secondaryOutcomes measure: Assessment of neurotransmitters in peripheral blood, secondaryOutcomes measure: Assessment of changes in intestinal flora, secondaryOutcomes measure: Evaluation of the treatment cycle of Vibrabot Capsules, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: XuanJiang, status: RECRUITING, city: Beijing, state: Beijing, zip: 102218, country: China, contacts name: Xuan Jiang, professor, role: CONTACT, phone: 13671006525, email: jxa01998@btch.edu.cn, contacts name: Jinzhe Liu, physician, role: CONTACT, phone: 18810831618, email: ljza02528@btch.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06364098, orgStudyIdInfo id: prevention of PPH, briefTitle: Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-02-01, completionDateStruct date: 2023-02-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Postpartum Hemorrhage, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 192, type: ACTUAL, armsInterventionsModule interventions name: Misoprostol, outcomesModule primaryOutcomes measure: The amount of blood loss, secondaryOutcomes measure: Changes in hematocrit values in both groups after delivery, secondaryOutcomes measure: Changes in Hemoglobin level measured by gm/dl in both groups after delivery, otherOutcomes measure: Incidence of side effects of study medications, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of medicine, Kasr Alainy, city: Cairo, state: Al Manyal, zip: 11956, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06364085, orgStudyIdInfo id: DBS2024, briefTitle: Enhancing Epilepsy Management With Precision Deep Brain Stimulation, acronym: EPI-BOOST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Nova Scotia Health Authority, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Epilepsy, Drug Resistant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Neuromodulation programming, outcomesModule primaryOutcomes measure: Seizure reduction, secondaryOutcomes measure: Change in disease score on Patient Weighted Quality Of Life In Epilepsy, secondaryOutcomes measure: Change in depression score on Neurological Disorders Depression Inventory in Epilepsy, secondaryOutcomes measure: Change in anxiety score on Anxiety General Anxiety Disorder-7, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Elizabeth Health Science Centre, city: Halifax, state: Nova Scotia, zip: B3H 3A7, country: Canada, contacts name: Lutz Weise, role: CONTACT, geoPoint lat: 44.64533, lon: -63.57239, hasResults: False
|
protocolSection identificationModule nctId: NCT06364072, orgStudyIdInfo id: PDC 01-0202, secondaryIdInfos id: 2023-504023-63-00, type: CTIS, briefTitle: Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Cessatech A/S, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: CT001, outcomesModule primaryOutcomes measure: To assess the safety and tolerability, primaryOutcomes measure: To evaluate the analgesic effect, secondaryOutcomes measure: To assess medication errors, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.