data
stringlengths 358
232k
|
---|
protocolSection identificationModule nctId: NCT06356259, orgStudyIdInfo id: IMMUNRX-01, secondaryIdInfos id: 2023-503917-31, type: EUDRACT_NUMBER, briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-07, primaryCompletionDateStruct date: 2025-01-22, completionDateStruct date: 2025-01-22, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: ImmunoRx Pharma Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: IRX-010, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with Serious Adverse Events, primaryOutcomes measure: Number of participants with Treatment-Emergent Adverse Events, secondaryOutcomes measure: Pharmacokinetics(PK): Area under Curve(AUC), secondaryOutcomes measure: Pharmacokinetics(PK): Maximum Concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics(PK): Half-Life (t½), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ICON, status: RECRUITING, city: Groningen, zip: 9728, country: Netherlands, contacts name: Renger Tiessen, role: CONTACT, contacts name: Renger Tiessen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False
|
protocolSection identificationModule nctId: NCT06356246, orgStudyIdInfo id: APHP240363, briefTitle: Oral Health Status of Cystic Fibrosis Patients. An Online Survey in Collaboration With the Vaincre la Mucoviscidose Patient Association., acronym: E-MUCODENT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: Vaincre la Mucoviscidose, descriptionModule briefSummary: Cystic Fibrosis (CF) is a rare hereditary disease with autosomal recessive transmission, affecting 1 in 4700 births in France. Numerous studies have explored the links between oral health and CF, predominantly focusing on a children population. These studies reveal hyposalivation, a risk of dental erosion, an increased prevalence of enamel structural defects, but a reduced prevalence of dental caries in CF children, potentially explained by better oral hygiene. Periodontal disease does not appear to be increased in this population, while the oral quality of life of CF patients has been insufficiently studied.Today, emerging challenges arise due to the increased life expectancy of CF patients, attributed to the rise of modulators such as Kaftrio®, resulting in an adult-majority population in France. The study of periodontal diseases, associated with oral dysbiosis, becomes relevant as they represent bacterial reservoirs that could impact respiratory complications in CF patients.To deepen understanding of the links between oral health and CF, as well as to improve oral health of these patients, it is crucial to update the specific oral profile of this population. A cross-sectional survey using a questionnaire is proposed to include a large number of CF patients in France, aiming for real-life data. This questionnaire is constructed around internationally recognized tools for comparative analysis with normative data. Collaboration with the Patients Association "Vaincre la Mucoviscidose" (VLM) facilitates questionnaire creation, dissemination, and interpretation of results., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Periodontal Risk Screening Score PESS, secondaryOutcomes measure: Assess the adherence to good oral hygiene practices and dental follow-up in adult CF patients according to French Union for Oral Health (UFSBD) 2021, secondaryOutcomes measure: Evaluate the risk of dental caries and tooth wear, secondaryOutcomes measure: Assess the oral quality of life, secondaryOutcomes measure: Evaluate oral dryness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marjolaine GOSSET, city: Ivry-sur-Seine, state: Ile-de-France, zip: 94270, country: France, contacts name: Marjolaine GOSSET, MD, PhD, role: CONTACT, phone: +33 (0)1 49 59 48 20, email: marjolaine.gosset@aphp.fr, contacts name: Anne Sophie Duflos, Vaincre La Mucoviscidose, role: CONTACT, phone: +33 (0)1 40 78 91 97, email: asduflos@vaincrelamuco.org, geoPoint lat: 48.81568, lon: 2.38487, hasResults: False
|
protocolSection identificationModule nctId: NCT06356233, orgStudyIdInfo id: FIMBEX, briefTitle: Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy, acronym: FIMBEX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-10-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Fundación Iniciativa para las Neurociencias (FINCE), class: OTHER, descriptionModule briefSummary: This is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the STXBP1 gene. The study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. These patients will be followed up for 3 years. The aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (EEG, MRI and study of specific proteins and neurotransmitters in plasma, urine and CSF)., conditionsModule conditions: STXBP1 Encephalopathy With Epilepsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: No intervention will be performed, outcomesModule primaryOutcomes measure: CSF biomarkers, primaryOutcomes measure: EEG markers, primaryOutcomes measure: MRI markers, secondaryOutcomes measure: Clinical phenotype, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Ruber Internacional, city: Madrid, zip: 28034, country: Spain, contacts name: Alvaro Beltran Corbellini, MD, role: CONTACT, phone: +34913875250, email: info@neurologiaclinica.es, contacts name: Antonio Gil-Nagel, MD, PhD, role: CONTACT, contacts name: Antonio Gil-Nagel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
|
protocolSection identificationModule nctId: NCT06356220, orgStudyIdInfo id: IRB-P00046867, briefTitle: GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health), acronym: GF-NOURISH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Boston Children's Hospital, class: OTHER, descriptionModule briefSummary: We propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. We hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits, conditionsModule conditions: Celiac Disease in Children, conditions: Nutrition Disorder, Child, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1. Study Design: Prospective randomized controlled trial.2. Study population: Children (N=120) with newly diagnosed CeD3. Intervention: Gluten-Free Food Guide, a nutritional education program focused on minimizing ultra-processed foods in gluten-free die(GFFG), OR a conventional GFD nutritional education class. The nutrition educational program will be based on validated GFD education program. We will use a randomized control trial to assess improvement of overall diet quality, changes in body composition, and minimize toxic and nutrient metal exposures associated with processed gluten-free foods., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Gluten-Free Diet Education, outcomesModule primaryOutcomes measure: To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass, secondaryOutcomes measure: To compare the effect of GFFG vs conventional GFD class on diet quality, secondaryOutcomes measure: To compare the effect of GFFG versus conventional GFD on arsenic exposure, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Lauren Robertson, role: CONTACT, contacts name: Nan Du, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06356207, orgStudyIdInfo id: 113-2023, briefTitle: Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study, acronym: SALT-TILT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera di Bolzano, class: OTHER, descriptionModule briefSummary: Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. However, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. It is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. It is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ECG during Tilt Table Test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study., conditionsModule conditions: Syncope, conditions: Pacemaker, conditions: Asystole, conditions: Neurally Mediated Syncope, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Tilt Table Test, outcomesModule primaryOutcomes measure: SALT (Syncope-Asystole Latency Time), secondaryOutcomes measure: Recurrence of syncope, secondaryOutcomes measure: Recurrence of syncope, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Sanitaria di Bolzano, status: RECRUITING, city: Bolzano, zip: 39100, country: Italy, contacts name: Marco Tomaino, Dr., role: CONTACT, geoPoint lat: 46.49067, lon: 11.33982, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-06, uploadDate: 2024-04-04T15:15, filename: Prot_SAP_000.pdf, size: 334779, hasResults: False
|
protocolSection identificationModule nctId: NCT06356194, orgStudyIdInfo id: AT-01B-006, briefTitle: Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Atea Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir, conditionsModule conditions: Healthy Volunteer Study, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK, interventions name: Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered., outcomesModule primaryOutcomes measure: PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR)., primaryOutcomes measure: To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Atea Study Site, city: Québec, state: Montreal, country: Canada, contacts name: Atea Study Site, role: CONTACT, phone: 888-481-1607, email: ateaclinicaltrials@ateapharma.com, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False
|
protocolSection identificationModule nctId: NCT06356181, orgStudyIdInfo id: Pro00135143, briefTitle: Training Adaptations With and Without Ventilatory Training Device, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of South Carolina, class: OTHER, collaborators name: MAXIMUS, descriptionModule briefSummary: This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Secondary measures include sleep, affect, and mood state questionnaires. Participants will be randomized into one of two groups: with the RMT device and without the RMT device., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Respiratory Maximus Training Device, interventions name: No Respiratory Training Device, outcomesModule primaryOutcomes measure: Changes in spirometry, primaryOutcomes measure: Changes in aerobic capacity, primaryOutcomes measure: Changes in peak power, primaryOutcomes measure: Changes in ventilatory threshold, primaryOutcomes measure: Changes in countermovement jump, primaryOutcomes measure: Changes in anaerobic capacity, primaryOutcomes measure: Changes in high-intensity functional training test, primaryOutcomes measure: Changes in heart rate at ventilatory threshold, secondaryOutcomes measure: Changes in body composition, secondaryOutcomes measure: Changes in sleep quality, secondaryOutcomes measure: Changes in total mood disturbances, secondaryOutcomes measure: Changes in positive mood and emotion, secondaryOutcomes measure: Change in blood lactate responses, secondaryOutcomes measure: Changes in negative mood and emotion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of South Carolina Sport Science Lab, status: RECRUITING, city: Columbia, state: South Carolina, zip: 29208, country: United States, contacts name: Shawn M. Arent, PhD, role: CONTACT, phone: 803-576-8394, email: sarent@mailbox.sc.edu, contacts name: Sten O Stray-Gundersen, PhD, role: CONTACT, email: sten@mailbox.sc.edu, geoPoint lat: 34.00071, lon: -81.03481, hasResults: False
|
protocolSection identificationModule nctId: NCT06356168, orgStudyIdInfo id: SVR/IVR, briefTitle: Virtual Reality in End Stage Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial to compare the social virtual reality and individual virtual reality in patients with end stage kidney disease who are hemodialysis. The main aim is to determine if there are differences in symptoms between the groups. Participants will use virtual reality glasses for 30-45 minutes during dialysis sessions for 4 weeks., conditionsModule conditions: End Stage Kidney Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Social Virtual Reality, interventions name: Individual Virtual Reality, outcomesModule primaryOutcomes measure: De Jong Gierveld Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06356155, orgStudyIdInfo id: UMCC 2023.011, briefTitle: Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer, acronym: NEPTUNE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Michigan Rogel Cancer Center, class: OTHER, descriptionModule briefSummary: This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab., conditionsModule conditions: Urothelial Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Enfortumab vedotin, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in cisplatin-eligible patients based off pathological response, secondaryOutcomes measure: Assess the safety and toxicity of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in UTUC, secondaryOutcomes measure: Assess whether patients who receive the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy have increased surgical complications., secondaryOutcomes measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring RECIST v1.1 measurable disease., secondaryOutcomes measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year recurrence-free survival (RFS)., secondaryOutcomes measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year overall survival (OS)., secondaryOutcomes measure: Estimate the number of patients who are able to complete neoadjuvant combination enfortumab vedotin and pembrolizumab and safely complete definitive surgery., otherOutcomes measure: Assess comprehensive profiling of tumor and host characteristics (including genomics and assessment of tumor mutational burden) as predictors of response to treatment., otherOutcomes measure: Explore circulating biomarkers as early detectors of cancer recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan Comprehensive Cancer Center, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Irene Tsung, M.D., role: CONTACT, phone: 734-936-4385, email: itsung@umich.edu, contacts name: Irene Tsung, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
|
protocolSection identificationModule nctId: NCT06356142, orgStudyIdInfo id: UMMC-IRB-2023-317, briefTitle: The Effects of Palmar Cooling on Repeated Sprinting Ability, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Mississippi Medical Center, class: OTHER, descriptionModule briefSummary: Repeated sprinting ability is key for athletic performance in a variety of sport settings. Significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. This pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. The investigators aim to enroll 90 healthy individuals, 18-30 years of age. Participants will be randomized into two groups (Group A, and B). All groups will perform a ten-minute warm-up followed by two minutes of rest. Following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. Between sprints, participants will have 10 seconds rest. After the first series of five sprints participants will be given a 2-minute rest interval. Then participants will perform another series of five sprints followed by another 2-minute rest interval. During each rest interval, Group A will utilize a palmar cooling device. Group B will utilize a placebo version of the palmar cooling device. All sprints will be timed. Heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. Delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale., conditionsModule conditions: Exercise Induced Fatigue, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Palmar Cooling, interventions name: Placebo Palmar Cooling, outcomesModule primaryOutcomes measure: Participants Sprinting times, secondaryOutcomes measure: Participants Heart Rate Recovery, secondaryOutcomes measure: Participants Rating of Perceived exertion, secondaryOutcomes measure: Participants Reported Delayed Onset Muscle Soreness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Mississippi Medical Center, city: Jackson, state: Mississippi, zip: 39216, country: United States, contacts name: Jacob Daniels, DPT, EdD, role: CONTACT, phone: 601-815-4038, email: jbdaniels@umc.edu, geoPoint lat: 32.29876, lon: -90.18481, hasResults: False
|
protocolSection identificationModule nctId: NCT06356129, orgStudyIdInfo id: CA073-1020, secondaryIdInfos id: 2023-510178-15, type: REGISTRY, domain: EU CT Number, secondaryIdInfos id: U1111-1300-8493, type: REGISTRY, domain: UTN, briefTitle: Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma, acronym: GOLSEEK-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-24, primaryCompletionDateStruct date: 2028-08-14, completionDateStruct date: 2029-11-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Celgene, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL)., conditionsModule conditions: Large B-cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 850, type: ESTIMATED, armsInterventionsModule interventions name: Golcadomide, interventions name: Placebo, interventions name: Rituximab, interventions name: Cyclophosphamide, interventions name: Doxorubicin, interventions name: Vincristine, interventions name: Prednisone, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) assessed by the Investigator, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC), secondaryOutcomes measure: Minimal residual disease (MRD) negativity rate, secondaryOutcomes measure: Progression-free survival (PFS) assessed by the IRAC, secondaryOutcomes measure: Objective response (OR) assessed by the Investigator, secondaryOutcomes measure: Complete metabolic response (CMR) assessed by the Investigator, secondaryOutcomes measure: PFS24 assessed by the Investigator 24 months after randomization, secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Second progression-free survival (PFS2) assessed by the Investigator, secondaryOutcomes measure: Relative dose intensity (%), secondaryOutcomes measure: Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire, secondaryOutcomes measure: Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire, secondaryOutcomes measure: Mean change from baseline in the EORTC QLQ-C30, secondaryOutcomes measure: Mean change from baseline in the FACT-LymS, secondaryOutcomes measure: Number of participants with Adverse Events (AEs), secondaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Number of participants with laboratory abnormalities, secondaryOutcomes measure: Number of participants with vital sign abnormalities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Local Institution - 0014, city: Mobile, state: Alabama, zip: 36604, country: United States, contacts name: Site 0014, role: CONTACT, geoPoint lat: 30.69436, lon: -88.04305, locations facility: Local Institution - 0342, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Site 0342, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Local Institution - 0287, city: Jacksonville, state: Florida, zip: 32224, country: United States, contacts name: Site 0287, role: CONTACT, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Local Institution - 0415, city: Margate, state: Florida, zip: 33063, country: United States, contacts name: Site 0415, role: CONTACT, geoPoint lat: 26.24453, lon: -80.20644, locations facility: Local Institution - 0012, city: Pensacola, state: Florida, zip: 32504, country: United States, contacts name: Site 0012, role: CONTACT, geoPoint lat: 30.42131, lon: -87.21691, locations facility: Local Institution - 0414, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Site 0414, role: CONTACT, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Local Institution - 0303, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Site 0303, role: CONTACT, geoPoint lat: 33.749, lon: -84.38798, locations facility: Local Institution - 0182, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Site 0182, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Local Institution - 0048, city: Skokie, state: Illinois, zip: 60077, country: United States, contacts name: Site 0048, role: CONTACT, geoPoint lat: 42.03336, lon: -87.73339, locations facility: Local Institution - 0461, city: Des Moines, state: Iowa, zip: 50309, country: United States, contacts name: Site 0461, role: CONTACT, geoPoint lat: 41.60054, lon: -93.60911, locations facility: Local Institution - 0031, city: Fairway, state: Kansas, zip: 66205, country: United States, contacts name: Site 0031, role: CONTACT, geoPoint lat: 39.02223, lon: -94.6319, locations facility: Local Institution - 0436, city: Edgewood, state: Kentucky, zip: 41017, country: United States, contacts name: Site 0436, role: CONTACT, geoPoint lat: 39.01867, lon: -84.58189, locations facility: Local Institution - 0408, city: Baton Rouge, state: Louisiana, zip: 70809, country: United States, contacts name: Site 0408, role: CONTACT, geoPoint lat: 30.45075, lon: -91.15455, locations facility: Local Institution - 0067, city: Minneapolis, state: Minnesota, zip: 55407, country: United States, contacts name: Site 0067, role: CONTACT, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Local Institution - 0203, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Site 0203, role: CONTACT, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Local Institution - 0437, city: Kansas City, state: Missouri, zip: 64132, country: United States, contacts name: Site 0437, role: CONTACT, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Local Institution - 0466, city: Reno, state: Nevada, zip: 89511, country: United States, contacts name: Site 0466, role: CONTACT, geoPoint lat: 39.52963, lon: -119.8138, locations facility: Local Institution - 0049, city: Morristown, state: New Jersey, zip: 07960, country: United States, contacts name: Site 0049, role: CONTACT, geoPoint lat: 40.79677, lon: -74.48154, locations facility: Local Institution - 0190, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Site 0190, role: CONTACT, geoPoint lat: 42.88645, lon: -78.87837, locations facility: Local Institution - 0369, city: New York, state: New York, zip: 10028, country: United States, contacts name: Site 0369, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Local Institution - 0176, city: New York, state: New York, zip: 10029, country: United States, contacts name: Site 0176, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Local Institution - 0174, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Site 0174, role: CONTACT, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Local Institution - 0066, city: Massillon, state: Ohio, zip: 44646, country: United States, contacts name: Site 0066, role: CONTACT, geoPoint lat: 40.79672, lon: -81.52151, locations facility: Local Institution - 0179, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Site 0179, role: CONTACT, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Local Institution - 0009, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, contacts name: Site 0009, role: CONTACT, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Local Institution - 0419, city: York, state: Pennsylvania, zip: 17403, country: United States, contacts name: Site 0419, role: CONTACT, geoPoint lat: 39.9626, lon: -76.72774, locations facility: Local Institution - 0435, city: Fort Sam Houston, state: Texas, zip: 78234, country: United States, contacts name: Site 0435, role: CONTACT, geoPoint lat: 29.45746, lon: -98.4472, locations facility: Local Institution - 0046, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Site 0046, role: CONTACT, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Local Institution - 0424, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Site 0424, role: CONTACT, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Local Institution - 0293, city: Richmond, state: Virginia, zip: 23219, country: United States, contacts name: Site 0293, role: CONTACT, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Local Institution - 0113, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1118AAT, country: Argentina, contacts name: Site 0113, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0421, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1417DTB, country: Argentina, contacts name: Site 0421, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0112, city: Buenos Aires, zip: 1426, country: Argentina, contacts name: Site 0112, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0136, city: Buenos Aires, zip: C1431FWO, country: Argentina, contacts name: Site 0136, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0119, city: Ciudad Autónoma de Buenos Aires, zip: C1426ANZ, country: Argentina, contacts name: Site 0119, role: CONTACT, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Local Institution - 0111, city: Córdoba, zip: 5016, country: Argentina, contacts name: Site 0111, role: CONTACT, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Local Institution - 0357, city: Gosford, state: New South Wales, zip: 2250, country: Australia, contacts name: Site 0357, role: CONTACT, geoPoint lat: -33.4244, lon: 151.34399, locations facility: Local Institution - 0361, city: Sydney, state: New South Wales, zip: 2560, country: Australia, contacts name: Site 0361, role: CONTACT, geoPoint lat: -33.86785, lon: 151.20732, locations facility: Local Institution - 0358, city: Westmead, state: New South Wales, zip: 2145, country: Australia, contacts name: Site 0358, role: CONTACT, geoPoint lat: -33.80383, lon: 150.98768, locations facility: Local Institution - 0363, city: Tiwi, state: Northern Territory, zip: 0810, country: Australia, contacts name: Site 0363, role: CONTACT, geoPoint lat: -12.35876, lon: 130.878, locations facility: Local Institution - 0356, city: Birtinya, state: Queensland, zip: 4575, country: Australia, contacts name: Site 0356, role: CONTACT, geoPoint lat: -26.74322, lon: 153.11913, locations facility: Local Institution - 0360, city: Southport, state: Queensland, zip: 4215, country: Australia, contacts name: Site 0360, role: CONTACT, geoPoint lat: -27.96724, lon: 153.39796, locations facility: Local Institution - 0365, city: Frankston, state: Victoria, zip: 3195, country: Australia, contacts name: Site 0365, role: CONTACT, geoPoint lat: -38.14458, lon: 145.12291, locations facility: Local Institution - 0362, city: Heidelberg, state: Victoria, zip: 3084, country: Australia, contacts name: Site 0362, role: CONTACT, geoPoint lat: -37.75, lon: 145.06667, locations facility: Local Institution - 0359, city: St Albans, state: Victoria, zip: 3021, country: Australia, contacts name: Site 0359, role: CONTACT, geoPoint lat: -37.73901, lon: 144.80024, locations facility: Local Institution - 0364, city: Warrnambool, state: Victoria, zip: 3280, country: Australia, contacts name: Site 0364, role: CONTACT, geoPoint lat: -38.38176, lon: 142.48799, locations facility: Local Institution - 0385, city: Wels, state: Oberösterreich, zip: 4600, country: Austria, contacts name: Site 0385, role: CONTACT, geoPoint lat: 48.16667, lon: 14.03333, locations facility: Local Institution - 0387, city: Linz, zip: 4021, country: Austria, contacts name: Site 0387, role: CONTACT, geoPoint lat: 48.30639, lon: 14.28611, locations facility: Local Institution - 0386, city: Vienna, zip: 1140, country: Austria, contacts name: Site 0386, role: CONTACT, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Local Institution - 0255, city: Fortaleza, state: Ceará, zip: 60115-281, country: Brazil, contacts name: Site 0255, role: CONTACT, geoPoint lat: -3.71722, lon: -38.54306, locations facility: Local Institution - 0297, city: Lago sul, state: Distrito Federal, zip: 71635580, country: Brazil, contacts name: Site 0297, role: CONTACT, geoPoint lat: -15.90603, lon: -47.86366, locations facility: Local Institution - 0256, city: Goiania, state: Goiás, zip: 74605-020, country: Brazil, contacts name: Site 0256, role: CONTACT, geoPoint lat: -16.67861, lon: -49.25389, locations facility: Local Institution - 0302, city: Curitiba, state: Paraná, zip: 81520-060, country: Brazil, contacts name: Site 0302, role: CONTACT, geoPoint lat: -25.42778, lon: -49.27306, locations facility: Local Institution - 0296, city: Niteroi, state: Rio De Janeiro, zip: 24020-096, country: Brazil, contacts name: Site 0296, role: CONTACT, geoPoint lat: -22.88333, lon: -43.10361, locations facility: Local Institution - 0304, city: Natal, state: Rio Grande Do Norte, zip: 59075-740, country: Brazil, contacts name: Site 0304, role: CONTACT, geoPoint lat: -5.795, lon: -35.20944, locations facility: Local Institution - 0253, city: Porto Alegre, state: Rio Grande Do Sul, zip: 90110-270, country: Brazil, contacts name: Site 0253, role: CONTACT, geoPoint lat: -30.03306, lon: -51.23, locations facility: Local Institution - 0246, city: Chapecó, state: Santa Catarina, zip: 89812-211, country: Brazil, contacts name: Site 0246, role: CONTACT, geoPoint lat: -27.09639, lon: -52.61833, locations facility: Local Institution - 0247, city: Joinville, state: Santa Catarina, zip: 89201260, country: Brazil, contacts name: Site 0247, role: CONTACT, geoPoint lat: -26.30444, lon: -48.84556, locations facility: Local Institution - 0250, city: Barretos, state: São Paulo, zip: 14784400, country: Brazil, contacts name: Site 0250, role: CONTACT, geoPoint lat: -20.55722, lon: -48.56778, locations facility: Local Institution - 0249, city: Jaú, state: São Paulo, zip: 17210-120, country: Brazil, contacts name: Site 0249, role: CONTACT, geoPoint lat: -22.29639, lon: -48.55778, locations facility: Local Institution - 0248, city: Sao Paulo, state: São Paulo, zip: 01323-903, country: Brazil, contacts name: Site 0248, role: CONTACT, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Local Institution - 0316, city: Sao Paulo, state: São Paulo, zip: 01509-010, country: Brazil, contacts name: Site 0316, role: CONTACT, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Local Institution - 0252, city: Sao Paulo, state: São Paulo, zip: 04543-000, country: Brazil, contacts name: Site 0252, role: CONTACT, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Local Institution - 0301, city: São José do Rio Preto, state: São Paulo, zip: 15090000, country: Brazil, contacts name: Site 0301, role: CONTACT, geoPoint lat: -20.81972, lon: -49.37944, locations facility: Local Institution - 0298, city: Rio de Janeiro, zip: 22061-080, country: Brazil, contacts name: Site 0298, role: CONTACT, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Local Institution - 0294, city: São Paulo, zip: 01409-902, country: Brazil, contacts name: Site 0294, role: CONTACT, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Local Institution - 0251, city: São Paulo, zip: 05652-900, country: Brazil, contacts name: Site 0251, role: CONTACT, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Local Institution - 0394, city: Sofia, state: Sofia (stolitsa), zip: 1431, country: Bulgaria, contacts name: Site 0394, role: CONTACT, geoPoint lat: 42.69751, lon: 23.32415, locations facility: Local Institution - 0393, city: Plovdiv, zip: 4002, country: Bulgaria, contacts name: Site 0393, role: CONTACT, geoPoint lat: 42.15, lon: 24.75, locations facility: Local Institution - 0392, city: Sofia, zip: 1407, country: Bulgaria, contacts name: Site 0392, role: CONTACT, geoPoint lat: 42.69751, lon: 23.32415, locations facility: Local Institution - 0091, city: Victoria, state: British Columbia, zip: V8R 6V5, country: Canada, contacts name: Site 0091, role: CONTACT, geoPoint lat: 48.43294, lon: -123.3693, locations facility: Local Institution - 0153, city: Montreal, state: Quebec, zip: H3T 1M5, country: Canada, contacts name: Site 0153, role: CONTACT, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Local Institution - 0073, city: Montreal, state: Quebec, zip: H4J 1C5, country: Canada, contacts name: Site 0073, role: CONTACT, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Local Institution - 0004, city: Sherbrooke, state: Quebec, zip: J1H 5N4, country: Canada, contacts name: Site 0004, role: CONTACT, geoPoint lat: 45.40008, lon: -71.89908, locations facility: Local Institution - 0109, city: Chile, state: Región Metropolitana De Santiago, zip: 8380455, country: Chile, contacts name: Site 0109, role: CONTACT, locations facility: Local Institution - 0106, city: Santiago, state: Región Metropolitana De Santiago, zip: 7500921, country: Chile, contacts name: Site 0106, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Local Institution - 0107, city: Santiago, state: Región Metropolitana De Santiago, zip: 7580206, country: Chile, contacts name: Site 0107, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Local Institution - 0110, city: Santiago, state: Región Metropolitana De Santiago, zip: 8320325, country: Chile, contacts name: Site 0110, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Local Institution - 0108, city: Santiago, state: Región Metropolitana De Santiago, zip: 8330032, country: Chile, contacts name: Site 0108, role: CONTACT, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Local Institution - 0164, city: Viña del Mar, state: Valparaíso, zip: 0, country: Chile, contacts name: Site 0164, role: CONTACT, geoPoint lat: -33.02457, lon: -71.55183, locations facility: Local Institution - 0195, city: Beijing, state: Beijing, zip: 100091, country: China, contacts name: Site 0195, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Local Institution - 0236, city: Chongqing, state: Chongqing, zip: 400016, country: China, contacts name: Site 0236, role: CONTACT, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Local Institution - 0196, city: Chongqing, state: Chongqing, zip: 400030, country: China, contacts name: Site 0196, role: CONTACT, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Local Institution - 0274, city: Fuzhou, state: Fujian, zip: 350014, country: China, contacts name: Site 0274, role: CONTACT, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Local Institution - 0157, city: Xiamen, state: Fujian, zip: 361003, country: China, contacts name: Site 0157, role: CONTACT, geoPoint lat: 24.47979, lon: 118.08187, locations facility: Local Institution - 0133, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Site 0133, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Local Institution - 0240, city: Guangzhou, state: Guangdong, zip: 510555, country: China, contacts name: Site 0240, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Local Institution - 0338, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Site 0338, role: CONTACT, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Local Institution - 0239, city: Harbin, state: Heilongjiang, zip: 150081, country: China, contacts name: Site 0239, role: CONTACT, geoPoint lat: 45.75, lon: 126.65, locations facility: Local Institution - 0238, city: Zhengzhou, state: Henan, zip: 450008, country: China, contacts name: Site 0238, role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Local Institution - 0346, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Site 0346, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Local Institution - 0214, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Site 0214, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Local Institution - 0275, city: Changsha, state: Hunan, zip: 410013, country: China, contacts name: Site 0275, role: CONTACT, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Local Institution - 0156, city: Suzhou, state: Jiangsu, zip: 215006, country: China, contacts name: Site 0156, role: CONTACT, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Local Institution - 0237, city: Nanchang, state: Jiangxi, zip: 330006, country: China, contacts name: Site 0237, role: CONTACT, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Local Institution - 0241, city: Nanchang, state: Jiangxi, zip: 330029, country: China, contacts name: Site 0241, role: CONTACT, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Local Institution - 0291, city: Changchun, state: Jilin, zip: 130021, country: China, contacts name: Site 0291, role: CONTACT, geoPoint lat: 43.88, lon: 125.32278, locations facility: Local Institution - 0334, city: Shenyang, state: Liaoning, zip: 110004, country: China, contacts name: Site 0334, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Local Institution - 0169, city: Shenyang, state: Liaoning, zip: 110015, country: China, contacts name: Site 0169, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Local Institution - 0242, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: Site 0242, role: CONTACT, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Local Institution - 0344, city: Jinan, state: Shandong, zip: 250117, country: China, contacts name: Site 0344, role: CONTACT, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Local Institution - 0132, city: Shanghai, state: Shanghai, zip: 200025, country: China, contacts name: Site 0132, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Local Institution - 0339, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Site 0339, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Local Institution - 0234, city: Taiyuan, state: Shanxi, zip: 030032, country: China, contacts name: Site 0234, role: CONTACT, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Local Institution - 0141, city: Cheng Du, state: Sichuan, zip: 610041, country: China, contacts name: Site 0141, role: CONTACT, locations facility: Local Institution - 0289, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Site 0289, role: CONTACT, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Local Institution - 0155, city: Urumchi, state: Xinjiang, zip: 830054, country: China, contacts name: Site 0155, role: CONTACT, locations facility: Local Institution - 0197, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Site 0197, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Local Institution - 0457, city: Wenzhou, state: Zhejiang, zip: 325000, country: China, contacts name: Site 0457, role: CONTACT, geoPoint lat: 27.99942, lon: 120.66682, locations facility: Local Institution - 0130, city: Bogota, state: Cundinamarca, zip: 111151, country: Colombia, contacts name: Site 0130, role: CONTACT, geoPoint lat: 4.60971, lon: -74.08175, locations facility: Local Institution - 0129, city: Bogotá, state: Distrito Capital De Bogotá, zip: 110131, country: Colombia, contacts name: Site 0129, role: CONTACT, geoPoint lat: 4.60971, lon: -74.08175, locations facility: Local Institution - 0390, city: Zagreb, state: Grad Zagreb, zip: 10000, country: Croatia, contacts name: Site 0390, role: CONTACT, geoPoint lat: 45.81444, lon: 15.97798, locations facility: Local Institution - 0440, city: Osijek, zip: 31000, country: Croatia, contacts name: Site 0440, role: CONTACT, geoPoint lat: 45.55111, lon: 18.69389, locations facility: Local Institution - 0105, city: Brno, state: Brno-město, zip: 625 00, country: Czechia, contacts name: Site 0105, role: CONTACT, geoPoint lat: 49.19522, lon: 16.60796, locations facility: Local Institution - 0104, city: Hradec Kralove, state: Hradec Králové, zip: 500 05, country: Czechia, contacts name: Site 0104, role: CONTACT, geoPoint lat: 50.20923, lon: 15.83277, locations facility: Local Institution - 0102, city: Olomouc, state: Olomoucký Kraj, zip: 779 00, country: Czechia, contacts name: Site 0102, role: CONTACT, geoPoint lat: 49.59552, lon: 17.25175, locations facility: Local Institution - 0120, city: Pilsen, state: Plzeňský Kraj, zip: 305 99, country: Czechia, contacts name: Site 0120, role: CONTACT, geoPoint lat: 49.74747, lon: 13.37759, locations facility: Local Institution - 0103, city: PRague, state: Praha 10, zip: 100 34, country: Czechia, contacts name: Site 0103, role: CONTACT, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Local Institution - 0243, city: Praha 2, zip: 12808, country: Czechia, contacts name: Site 0243, role: CONTACT, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Local Institution - 0285, city: Aarhus, state: Midtjylland, zip: 8200, country: Denmark, contacts name: Site 0285, role: CONTACT, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Local Institution - 0284, city: Odense, state: Syddanmark, zip: 5000, country: Denmark, contacts name: Site 0284, role: CONTACT, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Local Institution - 0281, city: Oulu, state: Pohjois-Pohjanmaa, zip: 90220, country: Finland, contacts name: Site 0281, role: CONTACT, geoPoint lat: 65.01236, lon: 25.46816, locations facility: Local Institution - 0283, city: Kuopio, state: Pohjois-Savo, zip: 70210, country: Finland, contacts name: Site 0283, role: CONTACT, geoPoint lat: 62.89238, lon: 27.67703, locations facility: Local Institution - 0282, city: Turku, state: Varsinais-Suomi, zip: 20521, country: Finland, contacts name: Site 0282, role: CONTACT, geoPoint lat: 60.45148, lon: 22.26869, locations facility: Local Institution - 0280, city: Helsinki, zip: 00029, country: Finland, contacts name: Site 0280, role: CONTACT, geoPoint lat: 60.16952, lon: 24.93545, locations facility: Local Institution - 0083, city: Nice, state: Alpes-Maritimes, zip: 06202, country: France, contacts name: Site 0083, role: CONTACT, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Local Institution - 0084, city: Strasbourg, state: Alsace, zip: 67033, country: France, contacts name: Site 0084, role: CONTACT, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Local Institution - 0090, city: Bordeaux, state: Aquitaine, zip: 33076, country: France, contacts name: Site 0090, role: CONTACT, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Local Institution - 0324, city: Pessac, state: Aquitaine, zip: 33600, country: France, contacts name: Site 0324, role: CONTACT, geoPoint lat: 44.81011, lon: -0.64129, locations facility: Local Institution - 0087, city: Marseille, state: Bouches-du-Rhône, zip: 13273, country: France, contacts name: Site 0087, role: CONTACT, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Local Institution - 0292, city: Dijon, state: Côte-d'Or, zip: 21000, country: France, contacts name: Site 0292, role: CONTACT, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Local Institution - 0332, city: Brest, state: Finistère, zip: 29609, country: France, contacts name: Site 0332, role: CONTACT, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Local Institution - 0335, city: Saint-Cloud, state: Hauts-de-Seine, zip: 92210, country: France, contacts name: Site 0335, role: CONTACT, geoPoint lat: 48.84598, lon: 2.20289, locations facility: Local Institution - 0079, city: Tours, state: Indre-et-Loire, zip: 37032, country: France, contacts name: Site 0079, role: CONTACT, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Local Institution - 0321, city: Saint Priest en Jarez, state: Loire, zip: 42271, country: France, contacts name: Site 0321, role: CONTACT, geoPoint lat: 45.47501, lon: 4.37614, locations facility: Local Institution - 0081, city: Lille, state: Nord, zip: 59000, country: France, contacts name: Site 0081, role: CONTACT, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Local Institution - 0325, city: Nantes, state: Pays-de-la-Loire, zip: 44000, country: France, contacts name: Site 0325, role: CONTACT, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Local Institution - 0089, city: Pierre-Bénite, state: Rhône, zip: 69310, country: France, contacts name: Site 0089, role: CONTACT, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Local Institution - 0200, city: Creteil, state: Val-de-Marne, zip: 94010, country: France, contacts name: Site 0200, role: CONTACT, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Local Institution - 0076, city: Villejuif, state: Val-de-Marne, zip: 94805, country: France, contacts name: Site 0076, role: CONTACT, geoPoint lat: 48.7939, lon: 2.35992, locations facility: Local Institution - 0306, city: Poitiers, state: Vienne, zip: 86021, country: France, contacts name: Site 0306, role: CONTACT, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Local Institution - 0244, city: Bayonne, zip: 64109, country: France, contacts name: Site 0244, role: CONTACT, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Local Institution - 0315, city: Caen, zip: 14033, country: France, contacts name: Site 0315, role: CONTACT, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Local Institution - 0202, city: Lille, zip: 59020, country: France, contacts name: Site 0202, role: CONTACT, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Local Institution - 0077, city: Paris, zip: 75010, country: France, contacts name: Site 0077, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Local Institution - 0323, city: Saint-Pierre, zip: 97448, country: France, contacts name: Site 0323, role: CONTACT, locations facility: Local Institution - 0383, city: Augsburg, state: Bayern, zip: 86156, country: Germany, contacts name: Site 0383, role: CONTACT, geoPoint lat: 48.37154, lon: 10.89851, locations facility: Local Institution - 0384, city: Koblenz, state: Rheinland-Pfalz, zip: 56068, country: Germany, contacts name: Site 0384, role: CONTACT, geoPoint lat: 50.35357, lon: 7.57883, locations facility: Local Institution - 0370, city: Essen, zip: 45122, country: Germany, contacts name: Site 0370, role: CONTACT, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Local Institution - 0399, city: Athens, state: Attikí, zip: 106 76, country: Greece, contacts name: Site 0399, role: CONTACT, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Local Institution - 0396, city: Athens, state: Attikí, zip: 11527, country: Greece, contacts name: Site 0396, role: CONTACT, geoPoint lat: 37.97945, lon: 23.71622, locations facility: Local Institution - 0397, city: Chaidari, state: Attikí, zip: 12462, country: Greece, contacts name: Site 0397, role: CONTACT, geoPoint lat: 38.01135, lon: 23.66597, locations facility: Local Institution - 0398, city: Alexandroupolis, zip: 08100, country: Greece, contacts name: Site 0398, role: CONTACT, geoPoint lat: 40.84995, lon: 25.87644, locations facility: Local Institution - 0395, city: Ioannina, state: Ípeiros, zip: 455 00, country: Greece, contacts name: Site 0395, role: CONTACT, geoPoint lat: 39.66486, lon: 20.85189, locations facility: Local Institution - 0160, city: Budapest, state: Pest, zip: 1122, country: Hungary, contacts name: Site 0160, role: CONTACT, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Local Institution - 0162, city: Kaposvár, state: Somogy, zip: 7400, country: Hungary, contacts name: Site 0162, role: CONTACT, geoPoint lat: 46.36667, lon: 17.8, locations facility: Local Institution - 0353, city: Nyiregyhaza, state: Szabolcs-Szatmár-Bereg, zip: 4400, country: Hungary, contacts name: Site 0353, role: CONTACT, geoPoint lat: 47.95539, lon: 21.71671, locations facility: Local Institution - 0161, city: Szombathely, state: Vas, zip: 9700, country: Hungary, contacts name: Site 0161, role: CONTACT, geoPoint lat: 47.23088, lon: 16.62155, locations facility: Local Institution - 0163, city: Budapest, zip: 1088, country: Hungary, contacts name: Site 0163, role: CONTACT, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Local Institution - 0266, city: Debrecen, zip: 4032, country: Hungary, contacts name: Site 0266, role: CONTACT, geoPoint lat: 47.53333, lon: 21.63333, locations facility: Local Institution - 0276, city: Anjo, state: Aichi, zip: 446-8602, country: Japan, contacts name: Site 0276, role: CONTACT, geoPoint lat: 34.95828, lon: 137.08054, locations facility: Local Institution - 0371, city: Nagoya, state: Aichi, zip: 466-8560, country: Japan, contacts name: Site 0371, role: CONTACT, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Local Institution - 0168, city: Kashiwa, state: Chiba, zip: 277-8577, country: Japan, contacts name: Site 0168, role: CONTACT, geoPoint lat: 35.86224, lon: 139.97732, locations facility: Local Institution - 0271, city: Ogaki, state: Gifu, zip: 503-0864, country: Japan, contacts name: Site 0271, role: CONTACT, geoPoint lat: 35.35, lon: 136.61667, locations facility: Local Institution - 0368, city: Sapporo, state: Hokkaido, zip: 0608648, country: Japan, contacts name: Site 0368, role: CONTACT, geoPoint lat: 43.06667, lon: 141.35, locations facility: Local Institution - 0327, city: Sapporo, state: Hokkaido, zip: 064-0804, country: Japan, contacts name: Site 0327, role: CONTACT, geoPoint lat: 43.06667, lon: 141.35, locations facility: Local Institution - 0273, city: Amagasaki, state: Hyogo, zip: 660-8550, country: Japan, contacts name: Site 0273, role: CONTACT, geoPoint lat: 34.71667, lon: 135.41667, locations facility: Local Institution - 0328, city: Himeji, state: Hyogo, zip: 670-8540, country: Japan, contacts name: Site 0328, role: CONTACT, geoPoint lat: 34.81667, lon: 134.7, locations facility: Local Institution - 0270, city: Kanazawa, state: Ishikawa, zip: 920-8530, country: Japan, contacts name: Site 0270, role: CONTACT, geoPoint lat: 36.6, lon: 136.61667, locations facility: Local Institution - 0343, city: Morioka, state: Iwate, zip: 020-0066, country: Japan, contacts name: Site 0343, role: CONTACT, geoPoint lat: 39.7, lon: 141.15, locations facility: Local Institution - 0170, city: Isehara, state: Kanagawa, zip: 259-1193, country: Japan, contacts name: Site 0170, role: CONTACT, geoPoint lat: 35.39932, lon: 139.31019, locations facility: Local Institution - 0333, city: Yokohama, state: Kanagawa, zip: 221-0855, country: Japan, contacts name: Site 0333, role: CONTACT, geoPoint lat: 35.43333, lon: 139.65, locations facility: Local Institution - 0320, city: Sendai-shi, state: Miyagi, zip: 980-8574, country: Japan, contacts name: Site 0320, role: CONTACT, geoPoint lat: 38.26667, lon: 140.86667, locations facility: Local Institution - 0166, city: Osaka-sayama, state: Osaka, zip: 589-8511, country: Japan, contacts name: Site 0166, role: CONTACT, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Local Institution - 0269, city: Hidaka, state: Saitama, zip: 350-1298, country: Japan, contacts name: Site 0269, role: CONTACT, locations facility: Local Institution - 0288, city: Nagaizumi-cho,Sunto-gun, state: Shizuoka, zip: 411-8777, country: Japan, contacts name: Site 0288, role: CONTACT, locations facility: Local Institution - 0350, city: Bunkyo-ku, state: Tokyo, zip: 113-8431, country: Japan, contacts name: Site 0350, role: CONTACT, geoPoint lat: 35.37517, lon: 139.92991, locations facility: Local Institution - 0268, city: Itabashiku, state: Tokyo, zip: 173-8610, country: Japan, contacts name: Site 0268, role: CONTACT, locations facility: Local Institution - 0331, city: Chuo, state: Yamanashi, zip: 409-3898, country: Japan, contacts name: Site 0331, role: CONTACT, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Local Institution - 0348, city: Fukuoka, zip: 810-8563, country: Japan, contacts name: Site 0348, role: CONTACT, geoPoint lat: 33.6, lon: 130.41667, locations facility: Local Institution - 0319, city: Fukuoka, zip: 811-1395, country: Japan, contacts name: Site 0319, role: CONTACT, geoPoint lat: 33.6, lon: 130.41667, locations facility: Local Institution - 0313, city: Fukuoka, zip: 812-8582, country: Japan, contacts name: Site 0313, role: CONTACT, geoPoint lat: 33.6, lon: 130.41667, locations facility: Local Institution - 0272, city: Hiroshima, zip: 734-8551, country: Japan, contacts name: Site 0272, role: CONTACT, geoPoint lat: 34.4, lon: 132.45, locations facility: Local Institution - 0171, city: Kumamoto, zip: 860-0008, country: Japan, contacts name: Site 0171, role: CONTACT, geoPoint lat: 32.80589, lon: 130.69182, locations facility: Local Institution - 0215, city: Kyoto, zip: 602-8566, country: Japan, contacts name: Site 0215, role: CONTACT, geoPoint lat: 35.02107, lon: 135.75385, locations facility: Local Institution - 0329, city: Okayama, zip: 700-8558, country: Japan, contacts name: Site 0329, role: CONTACT, geoPoint lat: 34.65, lon: 133.93333, locations facility: Local Institution - 0322, city: Osaka, zip: 543-8555, country: Japan, contacts name: Site 0322, role: CONTACT, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Local Institution - 0347, city: Osaka, zip: 545-8586, country: Japan, contacts name: Site 0347, role: CONTACT, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Local Institution - 0167, city: Yamagata, zip: 990-9585, country: Japan, contacts name: Site 0167, role: CONTACT, geoPoint lat: 38.23333, lon: 140.36667, locations facility: Local Institution - 0149, city: Goyang-si, state: Kyǒnggi-do, zip: 10408, country: Korea, Republic of, contacts name: Site 0149, role: CONTACT, geoPoint lat: 37.65639, lon: 126.835, locations facility: Local Institution - 0117, city: Seongnam, state: Kyǒnggi-do, zip: 13620, country: Korea, Republic of, contacts name: Site 0117, role: CONTACT, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Local Institution - 0233, city: Suwon-si, state: Kyǒnggi-do, zip: 16499, country: Korea, Republic of, contacts name: Site 0233, role: CONTACT, geoPoint lat: 37.29111, lon: 127.00889, locations facility: Local Institution - 0115, city: Busan, state: Pusan-Kwangyǒkshi, zip: 49201, country: Korea, Republic of, contacts name: Site 0115, role: CONTACT, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Local Institution - 0114, city: Busan, state: Pusan-Kwangyǒkshi, zip: 49241, country: Korea, Republic of, contacts name: Site 0114, role: CONTACT, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Local Institution - 0131, city: Busan, state: Pusan-Kwangyǒkshi, zip: 49267, country: Korea, Republic of, contacts name: Site 0131, role: CONTACT, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Local Institution - 0143, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 02841, country: Korea, Republic of, contacts name: Site 0143, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Local Institution - 0069, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 03080, country: Korea, Republic of, contacts name: Site 0069, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Local Institution - 0100, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 05505, country: Korea, Republic of, contacts name: Site 0100, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Local Institution - 0068, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 06351, country: Korea, Republic of, contacts name: Site 0068, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Local Institution - 0070, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 06591, country: Korea, Republic of, contacts name: Site 0070, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Local Institution - 0118, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 07345, country: Korea, Republic of, contacts name: Site 0118, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Local Institution - 0442, city: Daegu, state: Taegu-Kwangyǒkshi, zip: 41404, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Local Institution - 0116, city: Deagu, state: Taegu-Kwangyǒkshi, zip: 41404, country: Korea, Republic of, locations facility: Local Institution - 0455, city: Seongnam, zip: 463-707, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Local Institution - 0432, city: George Town, state: Pulau Pinang, zip: 10990, country: Malaysia, contacts name: Site 0432, role: CONTACT, geoPoint lat: 5.41123, lon: 100.33543, locations facility: Local Institution - 0431, city: Kuching, state: Sarawak, zip: 93586, country: Malaysia, contacts name: Site 0431, role: CONTACT, geoPoint lat: 1.54999, lon: 110.33333, locations facility: Local Institution - 0126, city: Cdmx, state: Distrito Federal, zip: 14080, country: Mexico, contacts name: Site 0126, role: CONTACT, locations facility: Local Institution - 0122, city: Ciudad de México, state: Distrito Federal, zip: 03100, country: Mexico, contacts name: Site 0122, role: CONTACT, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Local Institution - 0121, city: Mexico City, state: Distrito Federal, zip: 14080, country: Mexico, contacts name: Site 0121, role: CONTACT, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Local Institution - 0128, city: México, state: Distrito Federal, zip: 06720, country: Mexico, contacts name: Site 0128, role: CONTACT, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Local Institution - 0127, city: Morelia, state: Michoacán, zip: 58260, country: Mexico, contacts name: Site 0127, role: CONTACT, geoPoint lat: 19.70078, lon: -101.18443, locations facility: Local Institution - 0139, city: Monterrey, state: Nuevo León, zip: 66460, country: Mexico, contacts name: Site 0139, role: CONTACT, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Local Institution - 0125, city: Oaxaca de Juarez, state: Oaxaca, zip: 68020, country: Mexico, contacts name: Site 0125, role: CONTACT, geoPoint lat: 17.06542, lon: -96.72365, locations facility: Local Institution - 0444, city: Hermosillo, state: Sonora, zip: 83106, country: Mexico, contacts name: Site 0444, role: CONTACT, geoPoint lat: 29.1026, lon: -110.97732, locations facility: Local Institution - 0463, city: Hermosillo, state: Sonora, zip: 83106, country: Mexico, geoPoint lat: 29.1026, lon: -110.97732, locations facility: Local Institution - 0123, city: Huixquilucan, zip: 52787, country: Mexico, contacts name: Site 0123, role: CONTACT, geoPoint lat: 19.35985, lon: -99.35016, locations facility: Local Institution - 0124, city: Puebla, zip: 72424, country: Mexico, contacts name: Site 0124, role: CONTACT, geoPoint lat: 19.03793, lon: -98.20346, locations facility: Local Institution - 0367, city: Dunedin, state: Otago, zip: 9016, country: New Zealand, contacts name: Site 0367, role: CONTACT, geoPoint lat: -45.87416, lon: 170.50361, locations facility: Local Institution - 0366, city: Hamilton, state: Waikato, zip: 3240, country: New Zealand, contacts name: Site 0366, role: CONTACT, geoPoint lat: -37.78333, lon: 175.28333, locations facility: Local Institution - 0391, city: Oslo, zip: 0310, country: Norway, contacts name: Site 0391, role: CONTACT, geoPoint lat: 59.91273, lon: 10.74609, locations facility: Local Institution - 0336, city: Bydgoszcz, state: Kujawsko-pomorskie, zip: 85-168, country: Poland, contacts name: Site 0336, role: CONTACT, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Local Institution - 0337, city: Lublin, state: Lubelskie, zip: 20-090, country: Poland, contacts name: Site 0337, role: CONTACT, geoPoint lat: 51.25, lon: 22.56667, locations facility: Local Institution - 0443, city: Warszawa, state: Mazowieckie, zip: 02-781, country: Poland, contacts name: Site 0443, role: CONTACT, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Local Institution - 0201, city: Kraków, state: Małopolskie, zip: 30-727, country: Poland, contacts name: Site 0201, role: CONTACT, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Local Institution - 0388, city: Poznan, state: Wielkopolskie, zip: 60-175, country: Poland, contacts name: Site 0388, role: CONTACT, geoPoint lat: 52.40692, lon: 16.92993, locations facility: Local Institution - 0330, city: Katowice, state: Śląskie, zip: 40-027, country: Poland, contacts name: Site 0330, role: CONTACT, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Local Institution - 0286, city: Lisboa, zip: 1500-650, country: Portugal, contacts name: Site 0286, role: CONTACT, geoPoint lat: 38.71667, lon: -9.13333, locations facility: Local Institution - 0098, city: Porto, zip: 4200-072, country: Portugal, contacts name: Site 0098, role: CONTACT, geoPoint lat: 41.14961, lon: -8.61099, locations facility: Local Institution - 0372, city: San Juan, zip: 00909, country: Puerto Rico, contacts name: Site 0372, role: CONTACT, geoPoint lat: 18.46633, lon: -66.10572, locations facility: Local Institution - 0375, city: Bucuresti, state: București, zip: 022328, country: Romania, contacts name: Site 0375, role: CONTACT, geoPoint lat: 44.42802, lon: 26.09665, locations facility: Local Institution - 0381, city: Bucuresti, state: București, zip: 022328, country: Romania, contacts name: Site 0381, role: CONTACT, geoPoint lat: 44.42802, lon: 26.09665, locations facility: Local Institution - 0417, city: Tg.Mures, state: Mureș, zip: 540136, country: Romania, contacts name: Site 0417, role: CONTACT, locations facility: Local Institution - 0380, city: Brasov, zip: 500052, country: Romania, contacts name: Site 0380, role: CONTACT, geoPoint lat: 45.64861, lon: 25.60613, locations facility: Local Institution - 0374, city: București, zip: 022238, country: Romania, contacts name: Site 0374, role: CONTACT, geoPoint lat: 44.42802, lon: 26.09665, locations facility: Local Institution - 0377, city: București, zip: 030171, country: Romania, contacts name: Site 0377, role: CONTACT, geoPoint lat: 44.42802, lon: 26.09665, locations facility: Local Institution - 0382, city: București, zip: 030171, country: Romania, contacts name: Site 0382, role: CONTACT, geoPoint lat: 44.42802, lon: 26.09665, locations facility: Local Institution - 0378, city: București, zip: 050098, country: Romania, contacts name: Site 0378, role: CONTACT, geoPoint lat: 44.42802, lon: 26.09665, locations facility: Local Institution - 0423, city: Cluj, zip: 400015, country: Romania, contacts name: Site 0423, role: CONTACT, geoPoint lat: 46.76667, lon: 23.6, locations facility: Local Institution - 0379, city: Iași, zip: 700483, country: Romania, contacts name: Site 0379, role: CONTACT, geoPoint lat: 47.16667, lon: 27.6, locations facility: Local Institution - 0376, city: Sibiu, zip: 550245, country: Romania, contacts name: Site 0376, role: CONTACT, geoPoint lat: 45.8, lon: 24.15, locations facility: Local Institution - 0439, city: Dammam, state: Ash Sharqīyah, zip: 31444, country: Saudi Arabia, contacts name: Site 0439, role: CONTACT, geoPoint lat: 26.43442, lon: 50.10326, locations facility: Local Institution - 0416, city: Riyadh, zip: 12713, country: Saudi Arabia, contacts name: Site 0416, role: CONTACT, geoPoint lat: 24.68773, lon: 46.72185, locations facility: Local Institution - 0427, city: Singapore, state: Central Singapore, zip: 169608, country: Singapore, contacts name: Site 0427, role: CONTACT, geoPoint lat: 1.28967, lon: 103.85007, locations facility: Local Institution - 0355, city: Banska Bystrica, state: Banskobystrický Kraj, zip: 97517, country: Slovakia, contacts name: Site 0355, role: CONTACT, geoPoint lat: 48.73946, lon: 19.15349, locations facility: Local Institution - 0204, city: Bratislava, zip: 83101, country: Slovakia, contacts name: Site 0204, role: CONTACT, geoPoint lat: 48.14816, lon: 17.10674, locations facility: Local Institution - 0412, city: A Coruña, state: A Coruña [La Coruña], zip: 15006, country: Spain, contacts name: Site 0412, role: CONTACT, geoPoint lat: 43.37135, lon: -8.396, locations facility: Local Institution - 0071, city: L'Hospitalet Del Llobregat, state: Barcelona [Barcelona], zip: 08908, country: Spain, contacts name: Site 0071, role: CONTACT, locations facility: Local Institution - 0389, city: Barakaldo, state: Bizkaia, zip: 48903, country: Spain, contacts name: Site 0389, role: CONTACT, geoPoint lat: 43.29639, lon: -2.98813, locations facility: Local Institution - 0172, city: Santa Cruz de Tenerife, state: Canarias, zip: 38010, country: Spain, contacts name: Site 0172, role: CONTACT, geoPoint lat: 28.46824, lon: -16.25462, locations facility: Local Institution - 0314, city: San Sebastian, state: Gipuzkoa, zip: 20014, country: Spain, contacts name: Site 0314, role: CONTACT, geoPoint lat: 43.31283, lon: -1.97499, locations facility: Local Institution - 0096, city: Majadahonda, state: Madrid, Comunidad De, zip: 28222, country: Spain, contacts name: Site 0096, role: CONTACT, geoPoint lat: 40.47353, lon: -3.87182, locations facility: Local Institution - 0409, city: El Palmar, Murcia, state: Murcia, Región De, zip: 30120, country: Spain, contacts name: Site 0409, role: CONTACT, locations facility: Local Institution - 0092, city: Malaga, state: Málaga, zip: 29010, country: Spain, contacts name: Site 0092, role: CONTACT, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Local Institution - 0095, city: Cáceres, zip: 10003, country: Spain, contacts name: Site 0095, role: CONTACT, geoPoint lat: 39.47649, lon: -6.37224, locations facility: Local Institution - 0072, city: Madrid, zip: 28006, country: Spain, contacts name: Site 0072, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Local Institution - 0093, city: Salamanca, zip: 37007, country: Spain, contacts name: Site 0093, role: CONTACT, geoPoint lat: 40.96882, lon: -5.66388, locations facility: Local Institution - 0277, city: Uppsala, state: Uppsala Län [se-03], zip: 751 85, country: Sweden, contacts name: Site 0277, role: CONTACT, geoPoint lat: 59.85882, lon: 17.63889, locations facility: Local Institution - 0278, city: Linköping, state: Östergötlands Län [se-05], zip: 581 85, country: Sweden, contacts name: Site 0278, role: CONTACT, geoPoint lat: 58.41086, lon: 15.62157, locations facility: Local Institution - 0142, city: Chiayi City, state: Chiayi, zip: 613, country: Taiwan, contacts name: Site 0142, role: CONTACT, geoPoint lat: 23.47917, lon: 120.44889, locations facility: Local Institution - 0146, city: Tainan City, state: Tainan, zip: 71004, country: Taiwan, contacts name: Site 0146, role: CONTACT, geoPoint lat: 22.99083, lon: 120.21333, locations facility: Local Institution - 0159, city: Kaohsiung, zip: 83301, country: Taiwan, contacts name: Site 0159, role: CONTACT, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Local Institution - 0135, city: Taichung, zip: 40447, country: Taiwan, contacts name: Site 0135, role: CONTACT, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Local Institution - 0145, city: Taichung, zip: 407, country: Taiwan, contacts name: Site 0145, role: CONTACT, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Local Institution - 0134, city: Taipei, zip: 10002, country: Taiwan, contacts name: Site 0134, role: CONTACT, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Local Institution - 0147, city: Taipei, zip: 112, country: Taiwan, contacts name: Site 0147, role: CONTACT, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Local Institution - 0158, city: Taoyuan, zip: 333, country: Taiwan, contacts name: Site 0158, role: CONTACT, geoPoint lat: 24.95233, lon: 121.20193, locations facility: Local Institution - 0434, city: Bangkok, state: Krung Thep Maha Nakhon, zip: 10330, country: Thailand, contacts name: Site 0434, role: CONTACT, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Local Institution - 0426, city: Bangkok, state: Krung Thep Maha Nakhon, zip: 10700, country: Thailand, contacts name: Site 0426, role: CONTACT, geoPoint lat: 13.75398, lon: 100.50144, locations facility: Local Institution - 0428, city: Chiang Mai, zip: 50200, country: Thailand, contacts name: Site 0428, role: CONTACT, geoPoint lat: 18.79038, lon: 98.98468, locations facility: Local Institution - 0400, city: Ankara, zip: 06100, country: Turkey, contacts name: Site 0400, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Local Institution - 0405, city: Ankara, zip: 06100, country: Turkey, contacts name: Site 0405, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Local Institution - 0422, city: Ankara, zip: 06170, country: Turkey, contacts name: Site 0422, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Local Institution - 0401, city: Ankara, zip: 06200, country: Turkey, contacts name: Site 0401, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Local Institution - 0406, city: İzmir, zip: 35100, country: Turkey, contacts name: Site 0406, role: CONTACT, geoPoint lat: 38.41273, lon: 27.13838, locations facility: Local Institution - 0403, city: Mersin, zip: 33343, country: Turkey, contacts name: Site 0403, role: CONTACT, geoPoint lat: 36.79526, lon: 34.61792, locations facility: Local Institution - 0407, city: Samsun, zip: 55270, country: Turkey, contacts name: Site 0407, role: CONTACT, geoPoint lat: 41.27976, lon: 36.3361, locations facility: Local Institution - 0402, city: Trabzon, zip: 61080, country: Turkey, contacts name: Site 0402, role: CONTACT, geoPoint lat: 41.005, lon: 39.72694, hasResults: False
|
protocolSection identificationModule nctId: NCT06356116, orgStudyIdInfo id: CMUH111-REC3-029, briefTitle: Rehabilitation After Direct Anterior Approach for Total Hip Arthroplasty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-14, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: The causes for total hip arthroplasty (THA) in Taiwan include ischemic necrosis of the femoral head and degenerative osteoarthritis. Contemporary, the surgical approach for total hip replacement mostly adopts the lateral approach. However, the direct anterior approach (DAA) has gained attention gradually due to its characteristics such as muscle preservation, small surgical incision length, and few surgical complications. Nevertheless, literature lacks detailed exploration or long-term follow-up on the recovery of physical functions related to fall occurrence after this type of surgery. It limits the establishment and design of suitable post-operative rehabilitation plans. Therefore, this study aims to explore and follow-up the functional recovery in patients who undergo the DAA for hip replacement using current usual care and new-designed accelerated rehabilitation program. The proposed method involves recruiting 30 patients who will undergo the DAA for total hip replacement, who will receive the current usual care plan; and another 30 patients will receive the accelerated rehabilitation program. The assessments will be conducted before the surgery and at 2, 4, 8, and 12 weeks after the operation, evaluating hip joint function, hip abduction and flexion muscle strength, balance function, and gait performance. The statistical analysis will utilize mixed-model two-factor ANOVA, comparing the preoperative and postoperative recovery of patients undergoing the DAA with different intervention programs and at different time points. The expected outcome of this study is to enhance the understanding of the functional recovery of patients undergoing the DAA for total hip replacement in terms of hip joint function, muscle strength, balance function, and gait performance after surgery. This information will help establish the targeted DAA postoperative treatment plans, which will be practically applied to patients and compared with the current usual care to assess its effectiveness, ultimately contributing to more efficient rehabilitation plans in the future., conditionsModule conditions: Total Hip Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Usual care, interventions name: Accelerated rehabilitation, outcomesModule primaryOutcomes measure: Functional recovery questionaire, primaryOutcomes measure: Maximum muscle strength, primaryOutcomes measure: Quality of Life questionaire, secondaryOutcomes measure: Balance function, secondaryOutcomes measure: Gait performance, secondaryOutcomes measure: Walking speed, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China Medical University Hospital, status: RECRUITING, city: Taichung, zip: 404, country: Taiwan, contacts name: Hsiu-Chen Lin, PhD, role: CONTACT, phone: +886-4-22053366, phoneExt: 7303, email: hclin@mail.cmu.edu.tw, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
|
protocolSection identificationModule nctId: NCT06356103, orgStudyIdInfo id: 0107060, briefTitle: Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula On Undernourished Neurologically Impaired Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-07-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: Purpose: Undernutrition is common in neurologically impaired children. It increases the burden of comorbidities and affects the quality of life of these children. It must be recognized and treated as early as possible. This study aimed primarily to compare the efficacy of high-caloric whey-based partially hydrolyzed formula (HC-WPHF) versus standard feeding on the nutritional status reflected by growth parameters and feeding tolerance in undernourished children with neurological impairment (NI). The secondary aim was to compare the change in these parameters after using HC-WPHF for 3 and 6 months., conditionsModule conditions: Nutrition Disorder, Child, conditions: Neurologic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized Controlled Study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: High Caloric Whey-Based Partially Hydrolyzed Formula, interventions name: nutritional feeding according to ESPGHAN guidelines, outcomesModule primaryOutcomes measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI)., primaryOutcomes measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in centimeter in undernourished children with neurological impairment (NI)., primaryOutcomes measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the body mass index (BMI) in children with neurological impairment (NI)., primaryOutcomes measure: To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in centimeter in undernourished children with neurological impairment (NI), secondaryOutcomes measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI) for 3 and 6 months, secondaryOutcomes measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months, secondaryOutcomes measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus on the body mass index in undernourished children with neurological impairment (NI) for 3 and 6 months, secondaryOutcomes measure: To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Alexandria University Children Hospital, city: Alexandria, zip: 23445, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
|
protocolSection identificationModule nctId: NCT06356090, orgStudyIdInfo id: 2023.0322 - NL84369.018.23, briefTitle: SPACE: a Parent-based Treatment for Pediatric OCD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chaim Huijser, class: OTHER, collaborators name: Levvel, descriptionModule briefSummary: This study will investigate the parent-based treatment SPACE: Supportive Parenting for Anxious Childhood Emotions. The aim of this study is to investigate whether SPACE is effective in reducing family accommodation (FA) and OCD symptoms in children with a complex obsessive-compulsive disorder (OCD), that did not or cannot benefit from first line treatment., conditionsModule conditions: Obsessive-Compulsive Disorder, conditions: Obsessive-Compulsive Disorder in Children, conditions: Obsessive-Compulsive Disorder in Adolescence, conditions: Anxiety Disorders and Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single case experimental design (SCED) with multiple baselines, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Supportive Parenting for Anxious Childhood Emotions (SPACE), outcomesModule primaryOutcomes measure: (Change in) OCD severity, primaryOutcomes measure: (Change in) family accommodation (parent report), primaryOutcomes measure: (Change in) Family accommodation (child report), primaryOutcomes measure: Daily (change in) OCD symptoms, primaryOutcomes measure: Daily (change in) family accommodation, secondaryOutcomes measure: Symptoms of child anxiety, secondaryOutcomes measure: Symptoms of child depression, secondaryOutcomes measure: Symptoms of autism, secondaryOutcomes measure: Quality of life (parent-report), secondaryOutcomes measure: Quality of life (child-report), secondaryOutcomes measure: Clinical impression of outcome, secondaryOutcomes measure: Treatment progress, secondaryOutcomes measure: Session experience, secondaryOutcomes measure: Treatment adherence, otherOutcomes measure: Demographic variables, otherOutcomes measure: Psychiatric DSM-5 diagnosis of the child, otherOutcomes measure: Parenting burden, otherOutcomes measure: Psychopathology and adaptive functioning of parents, otherOutcomes measure: Child Behavior Checklist (CBCL, parent-report), otherOutcomes measure: Youth Self-report (YSR) (child-report), otherOutcomes measure: Teacher Report Form Emotional- and behavioral problems of the child (teacher- report), otherOutcomes measure: Treatment satisfaction, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Amsterdam UMC / Levvel (Academic centre for child & adolescent psychiatry), status: RECRUITING, city: Amsterdam, country: Netherlands, contacts name: J.D.K. Veeger, role: CONTACT, contacts name: C. Huijser, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
|
protocolSection identificationModule nctId: NCT06356077, orgStudyIdInfo id: OBPM_HTN2024, briefTitle: Evaluation of the Satisfaction of a Hypertensive Population in Their Use of the Aktiia 24/7 Blood Pressure Monitor, acronym: OBPM_HTN2024, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Aktiia SA, class: INDUSTRY, descriptionModule briefSummary: OBPM_HTN2024 study was designed by AKTIIA SA to evaluate how a hypertensive population, reflective of the United States and encompassing a range of phenotypes, perceives the Aktiia 24/7 device (Aktiia G1) during their first 3 months of use., conditionsModule conditions: Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor, primaryOutcomes measure: Frequency of Aktiia app use, primaryOutcomes measure: Frequency of use of Aktiia device as compared to previously use other blood pressure monitors, secondaryOutcomes measure: Evaluation of subject's experience in using the Aktiia App, secondaryOutcomes measure: Evaluation of the most valuable data on the Aktiia Mobile App by subjects, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06356064, orgStudyIdInfo id: E2-23-3834, briefTitle: Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-15, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up., conditionsModule conditions: Spur, Heel, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 112, type: ACTUAL, armsInterventionsModule interventions name: Extracorporeal shock wave therapy, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Functional Foot Index, secondaryOutcomes measure: Radiographic assesment, epin size, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Özge TEZEN, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06356051, orgStudyIdInfo id: Gbuyukyilmaz, briefTitle: Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Epicardial fat thickness, carotid intima-media thickness, and augmentation index from arterial stiffness indicators are increased in children with T1DM compared to the healthy control group. These results support the idea that children with T1DM present significant changes in important subclinical indicators for the development of cardiovascular disease., conditionsModule conditions: Type 1 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 202, type: ACTUAL, armsInterventionsModule interventions name: Echocardiography, outcomesModule primaryOutcomes measure: Epicardial fat thickness, secondaryOutcomes measure: carotid intima-media thickness, secondaryOutcomes measure: arterial stiffness parameters such as pulse wave velocity, augmentation index, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ankara Bilkent City Hospital, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-01-04, uploadDate: 2024-03-30T05:04, filename: Prot_SAP_000.pdf, size: 347934, hasResults: False
|
protocolSection identificationModule nctId: NCT06356038, orgStudyIdInfo id: Prot. n. 76 SA/2022, briefTitle: Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-09, primaryCompletionDateStruct date: 2025-01-02, completionDateStruct date: 2025-01-02, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera "Sant'Andrea", class: OTHER, descriptionModule briefSummary: Between January 2021-2023, 65 consecutive patients at risk for PAL (defined in accordance to "2019 Society of Thoracic Surgery score-criteria of PAL") underwent lung resection (lobectomy or sublobar resection) for malignancy. 5 patients were lost. The remaining have been assigned with a 1:2 randomization into: group A (22 patients), received intra-operative phrenic nerve infiltration with Ropivacaine 10 mg/ml in the peri-neurotic fat on the pericardium and group B (38 patients), did not receive infiltration. Data on hemidiaphragm elevation, air leaks, pain at 24 and 72 hours post-surgery, shoulder pain, length of hospital stay, length of chest tube permanence, were retrospectively collected and compared.The aim of the study is to investigate the effect of intra-operative phrenic nerve infiltration with long acting anesthetic in patients at high risk for PAL, improving pulmonary expansion after surgery, and reducing air leaks, while controlling post-operative pain., conditionsModule conditions: Prolonged Air Leak, conditions: Post-operative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: intra-operative phrenic nerve infiltration, outcomesModule primaryOutcomes measure: rate of pulmonary expansion due by phrenic nerve intra-operative local anaesthetic infiltration, secondaryOutcomes measure: rate of post-operative pain control after intra-operative phrenic nerve infiltration with local anaesthetic, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera "Sant'Andrea", city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06356025, orgStudyIdInfo id: 52082, secondaryIdInfos id: 2024-512546-42, type: EUDRACT_NUMBER, briefTitle: Botulinum Toxin Injection in the UES for R-CPD, acronym: BOTUS R-CPD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: AZ Delta, class: OTHER, collaborators name: KU Leuven, descriptionModule briefSummary: The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection).This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label., conditionsModule conditions: Retrograde Cricopharyngeus Dysfunction, 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: 30, type: ESTIMATED, armsInterventionsModule interventions name: botulinum toxin type A, interventions name: Sodium Chloride 0.9% Inj, outcomesModule primaryOutcomes measure: Change of at least 50% of 'inability to belch' using the symptom questionnaire at week 12., secondaryOutcomes measure: Change in associated gastrointestinal symptoms: abdominal bloating/discomfort, secondaryOutcomes measure: Change in associated gastrointestinal symptoms: abdominal/chest pain, secondaryOutcomes measure: Change in associated gastrointestinal symptoms: flatulence, secondaryOutcomes measure: Change in associated gastrointestinal symptoms: gurgling noises from the chest/lower neck, secondaryOutcomes measure: Change of at least 50% of 'inability to belch' during long term follow-up at week 20, and at 48 weeks., secondaryOutcomes measure: Overall treatment effect (OTE), secondaryOutcomes measure: Overall symptom severity (OSS), secondaryOutcomes measure: EuroQol-5D (EQ-5D), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06356012, orgStudyIdInfo id: 71163523.1.0000.5437, briefTitle: Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated With Imiquimod, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Barretos Cancer Hospital, class: OTHER, collaborators name: Fundação de Amparo à Pesquisa do Estado de São Paulo, collaborators name: Farmoquimica S.A., collaborators name: Hospital de Cancer de Barretos - Fundacao Pio XII, descriptionModule briefSummary: The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod. Participants will be divided in 3 groups: CIN 3 who will use 16 doses of imiquimod in the uterine cervix, applied twice a week and will be treated with LEEP procedure; 2) patients with CIN 3 who will undergo standard treatment with LEEP procedure; 3) patients with negative cytology and HPV (human papillomavirus) test. Blood and cervicovaginal lavage collections will be performed at different times, for comparisons between cellular response profiles to imiquimod during treatment and baseline levels in healthy patients., conditionsModule conditions: HSIL, High-Grade Squamous Intraepithelial Lesions, conditions: Vaginal Microbiome, conditions: Biomarkers, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Imiquimod, interventions name: Loop Electrosurgical Excision Procedure, outcomesModule primaryOutcomes measure: Number of participants with histological regression of High-grade squamous intraepithelial lesion (HSIL), secondaryOutcomes measure: Identification of immune response in vaginal and plasma collection, otherOutcomes measure: Correlation between vaginal microbiome and immunological response, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06355999, orgStudyIdInfo id: 2007p000646-F, briefTitle: Levari Exp.20: 2D - Partial Feedback, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-01, primaryCompletionDateStruct date: 2021-06-01, completionDateStruct date: 2021-06-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: Suppose that observers are trying to classify a spot on the skin as normal or abnormal and suppose that the two attributes that are important are the color and shape of the spot. The investigators have found that perceptual decisions of this short are shaped by the prevalence of the target abnormality and by the feedback that observers (Os) receive. If abnormal spots are rare (low prevalence), Os will tend to become more conservative about calling spots abnormal. In this experiment, Os see items defined by color and shape. They are looking for one combination (bumpy green). Bumpy green targets can be common (50% prevalence) or rare (10%). Os in one group will get feedback about their responses based on color. The other group will receive feedback based on shape. The investigators will look for effects of prevalence and of the type of feedback. The goal is to better understand perceptual decisions in settings like clinical evaluation of skin lesions., conditionsModule conditions: Form Perception, conditions: Color Perception, conditions: Decision Making, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups, each receiving different feedback, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Observers are naive as to the purpose of the experiment until after participation, whoMasked: PARTICIPANT, enrollmentInfo count: 55, type: ACTUAL, armsInterventionsModule interventions name: Feedback, outcomesModule primaryOutcomes measure: Participant naming of visual stimuli, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Visual Attention Lab / Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06355986, orgStudyIdInfo id: 39039039AFL4016, briefTitle: Computerized Decision Support to Prevent Stroke in Atrial Fibrillation, acronym: AF-ALERT3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-07-30, completionDateStruct date: 2026-07-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Janssen, LP, descriptionModule briefSummary: Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the Mass General Brigham (MGB) health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF. To address the feasibility and impact of a computerized decision support (CDS) strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management., conditionsModule conditions: Atrial Fibrillation, conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2500-patient U.S. multicenter, community-based Quality Improvement Initiative in the form of a cluster-randomized controlled trial., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Assignment to a particular cluster (ALERT or NO ALERT) will be masked to the patient participant, investigator, and outcomes assessor. Since the intervention is a computer alert to the provider of record, he/she will be aware of whether or not a notification is provided., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Alert-based computerized decision support, outcomesModule primaryOutcomes measure: Frequency of prescription of anticoagulation at 90 days in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention at the time of study enrollment, primaryOutcomes measure: Frequency of major bleeding at 6 months from enrollment., secondaryOutcomes measure: Frequency of failure to prescribe anticoagulation because of perceived risk of bleeding in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation at the time of study enrollment and are assigned to the alert group, secondaryOutcomes measure: Frequency of a composite of major adverse cardiovascular events, defined as cerebrovascular accident, systemic embolism, any MI, symptomatic VTE, or all-cause mortality at 6 months from enrollment, otherOutcomes measure: Frequency of referral for left atrial appendage occlusion among patients with high bleeding risk at 6 months will be reported, otherOutcomes measure: Frequency of clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding at 6 months., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Elizabeth Health, city: Edgewood, state: Kentucky, zip: 41017, country: United States, contacts name: Benjamin Peterson, MD, role: CONTACT, phone: 617-987-1046, email: benjamin.peterson@stelizabeth.com, geoPoint lat: 39.01867, lon: -84.58189, locations facility: Mass General Brigham, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Gregory Piazza, MD, MS, role: CONTACT, phone: 781-956-5525, email: gregorypiazza@hotmail.com, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06355973, orgStudyIdInfo id: 2024-01-061, briefTitle: A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: MinYoung Kim, MD, PhD, class: OTHER, descriptionModule briefSummary: This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.It is for the prevention and treatment of dementia in the future. randomized, Pilot Study., conditionsModule conditions: Patients With Mild Cognitive Impairment (MCI), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Using tablets and workbooks cognitive function., interventions name: self-programming of physical function training., outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Korean-Mini Mental Status Examination (K-MMSE), secondaryOutcomes measure: Clinical Dementia Rating (CDR), secondaryOutcomes measure: Clinical Global Impressions of Change (CGIC), secondaryOutcomes measure: Instrumental Activities of Daily Living (I-ADL), secondaryOutcomes measure: Berg Balance Scale (BBS), secondaryOutcomes measure: Geriatric Quality of Life-Dementia (GQOL-D), secondaryOutcomes measure: Geriatric Depression Scale (GDSd), secondaryOutcomes measure: Global Deterioration Scale (GDS), secondaryOutcomes measure: Electroencephalography, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355960, orgStudyIdInfo id: 2024-853, briefTitle: Effect of Dexmedetomidine on Oxygenation and Lung Mechanics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals, and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation, conditionsModule conditions: Drug Use, conditions: Dexmedetomidine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 176, type: ESTIMATED, armsInterventionsModule interventions name: GROUP Dexmedetomidine, interventions name: GROUP B, interventions name: GROUP C, outcomesModule primaryOutcomes measure: Oxygenation by the end study, secondaryOutcomes measure: Intraoperative dynamic lung compliance, secondaryOutcomes measure: Intraoperative static lung compliance, secondaryOutcomes measure: Physiological dead space, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo university, city: Cairo, zip: 11562, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06355947, orgStudyIdInfo id: 103-7445B, briefTitle: Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-12-07, primaryCompletionDateStruct date: 2017-09-11, completionDateStruct date: 2018-07-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chang Gung University, class: OTHER, descriptionModule briefSummary: Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability., conditionsModule conditions: Parkinson Disease(PD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Cognitive cycling training, interventions name: Cognitive treadmill training, outcomesModule primaryOutcomes measure: Walking Speed, primaryOutcomes measure: Step Length, primaryOutcomes measure: Step Time, primaryOutcomes measure: Power Spectral Density (PSD), primaryOutcomes measure: Task Accuracy, primaryOutcomes measure: Reaction Time, primaryOutcomes measure: Balance Performance, secondaryOutcomes measure: Double Support Time, secondaryOutcomes measure: Single Support Time, secondaryOutcomes measure: Swing Time, secondaryOutcomes measure: Stance Time, secondaryOutcomes measure: Cadence, secondaryOutcomes measure: Heart rate, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung University, city: Taoyuan, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
|
protocolSection identificationModule nctId: NCT06355934, orgStudyIdInfo id: D8450R00004, briefTitle: OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis, acronym: OverTTuRe, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-21, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments) in patients with ATTR amyloidosis, and to better understand how the disease is presented., conditionsModule conditions: ATTR Amyloidosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 55000, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Outpatient visits, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Outpatient visits by specialty, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Emergency department visits, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Hospitalizations, primaryOutcomes measure: Health Care Resource Utilization (HCRU) - Health care cost, primaryOutcomes measure: Cardiac transplant, primaryOutcomes measure: All cause mortality, primaryOutcomes measure: Liver transplant, primaryOutcomes measure: Heart Failure Hospitalization, primaryOutcomes measure: New ATTR amyloidosis clinical manifestation, primaryOutcomes measure: Hospitalization (any cause), primaryOutcomes measure: Neuropathy Impairment Score (NIS), primaryOutcomes measure: Neuropathy Impairment Score Lower Limbs (NIS-LL), primaryOutcomes measure: Neuropathy Impairment Score +7 (NIS+7), primaryOutcomes measure: Neuropathy Impairment Score modified +7 (mNIS+7), primaryOutcomes measure: Neuropathy symptoms and change (NCS) score, primaryOutcomes measure: PND (Polyneuropathy Disability), primaryOutcomes measure: Other relevant clinical measurement of ATTR amyloidosis functional status, primaryOutcomes measure: Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QoL-DN) Score, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Outpatient visits, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Outpatient visits by specialty, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Emergency department visits, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Hospitalizations, secondaryOutcomes measure: Health Care Resource Utilization (HCRU) - Health care cost, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: COMPLETED, city: Eden Prairie, state: Minnesota, zip: 55344, country: United States, geoPoint lat: 44.85469, lon: -93.47079, locations facility: Research Site, status: RECRUITING, city: Horsens, country: Denmark, geoPoint lat: 55.86066, lon: 9.85034, locations facility: Research Site, status: COMPLETED, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Research Site, status: RECRUITING, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
|
protocolSection identificationModule nctId: NCT06355921, orgStudyIdInfo id: RFAdesmoid, briefTitle: A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors, acronym: RFAdesmoid, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Blokhin's Russian Cancer Research Center, class: OTHER, descriptionModule briefSummary: This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors.In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month.In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months., conditionsModule conditions: Desmoid Tumor, conditions: Desmoid Fibromatosis, conditions: Desmoid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: radiofrequency ablation, outcomesModule primaryOutcomes measure: Comparison of safety assessment., secondaryOutcomes measure: Overall Response Rate, secondaryOutcomes measure: Duration of responce, secondaryOutcomes measure: Comparison of tumor necrosis based on MRI/CT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), city: Moscow, state: MO, zip: 115522, country: Russian Federation, contacts name: Artem Galustov, role: CONTACT, phone: 9169117818, email: artem115583@mail.ru, contacts name: Aslan Valiev, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Denis Sofronov, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
|
protocolSection identificationModule nctId: NCT06355908, orgStudyIdInfo id: TT002, briefTitle: IL13Rα2 CAR-T for Patients With r/r Glioma, acronym: ENHANCING, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Yang Zhang, class: OTHER, collaborators name: TCRCure Biopharma Ltd., descriptionModule briefSummary: This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma., conditionsModule conditions: Glioma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: IL13Rα2 CAR-T, outcomesModule primaryOutcomes measure: Safety of IL13Rα2 CAR-T, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Overall Survival (OS) at 6 months (OS6), secondaryOutcomes measure: Overall Survival (OS) at 12 months (OS12), secondaryOutcomes measure: The levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood, secondaryOutcomes measure: The levels of cytokines in the CSF and peripheral blood, otherOutcomes measure: The Exploratory Indicators, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantan Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Yang Zhang, MD, phD, role: CONTACT, phone: +861059976516, email: zhangyang8025@yeah.net, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06355895, orgStudyIdInfo id: HCC 23-104, briefTitle: Liver Volume Variation Effect on SBRT Planning and Delivery for Upper Abdominal Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: American College of Radiation Oncology, descriptionModule briefSummary: Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT., conditionsModule conditions: Upper Abdominal Malignancies, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: Standardized high-carbohydrate meal, outcomesModule primaryOutcomes measure: Diurnal Difference in Liver Volumes, secondaryOutcomes measure: Difference in total liver volume, secondaryOutcomes measure: Percentage diurnal difference in liver mean dose at V5 Gy, secondaryOutcomes measure: Percentage diurnal difference in liver mean dose at V15Gy, secondaryOutcomes measure: Difference in liver mean dose at V15 Gy, secondaryOutcomes measure: Difference in liver dose at V15 Gy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC Hillman Cancer Center, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, contacts name: Samantha Demko, role: CONTACT, contacts name: Brieanna Marino, role: CONTACT, contacts name: Susannah Ellsworth, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
|
protocolSection identificationModule nctId: NCT06355882, orgStudyIdInfo id: LCOSDental, briefTitle: Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-08, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo General Hospital, class: OTHER, collaborators name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., descriptionModule briefSummary: Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed, conditionsModule conditions: Low Cardiac Output Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 29, type: ESTIMATED, armsInterventionsModule interventions name: Anesthetic infiltration, outcomesModule primaryOutcomes measure: Amount ventricular and supraventricular arrhythmia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto do Coração HCFMUSP, status: RECRUITING, city: São Paulo, zip: 05403000, country: Brazil, contacts name: Itamara LI Neves, PhD, role: CONTACT, phone: 1126615229, email: itamara@incor.usp.br, contacts name: Mariana DC Dias, role: CONTACT, phone: 19996614440, email: mariana2497@gmail.com, contacts name: Itamara LI Neves, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
|
protocolSection identificationModule nctId: NCT06355869, orgStudyIdInfo id: s65337, briefTitle: Repeatability of Gait Deviations in Children With Cerebral Palsy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-17, primaryCompletionDateStruct date: 2023-05-31, completionDateStruct date: 2023-05-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill., conditionsModule conditions: Spastic Cerebral Palsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: repeated 3D gait-analysis, outcomesModule primaryOutcomes measure: The standard error of measurement (SEM) of the continuous kinematic gait waveforms, primaryOutcomes measure: The intra-class correlation (ICC) of the gait indices, primaryOutcomes measure: The standard error of measurement (SEM) of the continuous kinetic gait waveforms, primaryOutcomes measure: The standard error of measurement (SEM) of the gait indices, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: UZ Leuven, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
|
protocolSection identificationModule nctId: NCT06355856, orgStudyIdInfo id: ACH-PNT-04(01/22), briefTitle: Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss, acronym: CAPELLI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ache Laboratorios Farmaceuticos S.A., class: INDUSTRY, descriptionModule briefSummary: Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss., conditionsModule conditions: Alopecia, 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: 196, type: ESTIMATED, armsInterventionsModule interventions name: DNN.22.17.036, interventions name: 10573048700, outcomesModule primaryOutcomes measure: Percentage variation of hairs in the hair loss phase, eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355843, orgStudyIdInfo id: SXY, briefTitle: Clinical Applications of Integrated PET/MR and PET/CT in the Diagnosis and Treatment of Prostate Cancer., statusModule overallStatus: SUSPENDED, startDateStruct date: 2022-04-28, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Anhui Medical University, class: OTHER, collaborators name: National Natural Science Foundation of China, descriptionModule briefSummary: The goal of this study type: observational study (prospective study) is to study prostate cancer occurrence and recurrence, to specifically identify and localize tumor foci at the molecular level at an early stage, to evaluate the prognosis of patients, and to accurately stage not only intermediate- and high-risk prostate cancer patients with a primary diagnosis, but also detect recurrent foci in patients with biochemical recurrence, to restage those who have developed metastases, to assess tumor load, and to ultimately assist in determining the personalized treatment plans. The main question it aims to answer is whether 68Ga-PSMA PET/CT (PET/MR) examination is beneficial for assessing the* Accurate staging of patients with intermediate- and high-risk prostate cancer at first diagnosis;* Detecting recurrent lesions in patients with recurrent tumors for re-staging;* Assessment of tumor load;* Assessment of patient prognosis. Participants will sign an informed consent form, undergo 68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy, and have regular follow-up after obtaining pathological results of surgical resection or puncture biopsy, 6 weeks after surgery or biopsy, and then every 3 months; the follow-up will include: blood PSA, whole-body bone imaging, etc., conditionsModule conditions: Prostate Cancer, conditions: Pet-ct, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-PSMA, outcomesModule primaryOutcomes measure: Measuring the value of 68Ga-PSMA PET/MRI in the diagnosis and staging of primary prostate cancer and comparing it with mp-MRI and PET/CT, primaryOutcomes measure: Exploring whether 68Ga-PSMA PET/MRI can be used as a method for diagnostic efficacy, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First affiliated hospital of anhui university, city: Hefei, state: Anhui, zip: 230032, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
|
protocolSection identificationModule nctId: NCT06355830, orgStudyIdInfo id: RETimaging4iAMD, briefTitle: Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study, acronym: Imaging4iAMD, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-01-02, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Universidade Nova de Lisboa, class: OTHER, collaborators name: iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL, collaborators name: Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal, collaborators name: Centro Hospitalar Universitário de São João, Porto, Portugal, descriptionModule briefSummary: Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD.Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC.Primary outcome: Identifying imaging predictors of iAMD progression., conditionsModule conditions: Age-Related Macular Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Orthoptic assessment (Outcome measure), outcomesModule primaryOutcomes measure: Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline, primaryOutcomes measure: Change in Drusen morphology from baseline, primaryOutcomes measure: Change in Subfoveal drusen area from baseline, primaryOutcomes measure: Change in other drusen area from baseline, primaryOutcomes measure: Change in Drusen reflectivity from baseline, primaryOutcomes measure: Change in other Drusen homogeneity from baseline, primaryOutcomes measure: Change in ellipsoid zone disruption from baseline, primaryOutcomes measure: Change in Drusen homogeneity from baseline, primaryOutcomes measure: Change in hyperreflective foci from baseline, primaryOutcomes measure: Change in hyperreflective foci location (within 500-μm disc area) from baseline, primaryOutcomes measure: Change in hyperreflective foci association to drusen from baseline, primaryOutcomes measure: Progression to Moderate Vision Loss, primaryOutcomes measure: Geographic Atrophy (GA) Growth Rate, secondaryOutcomes measure: Progression to Advanced AMD according to international classification/grading system, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE, status: RECRUITING, city: Lisbon, zip: 1150-199, country: Portugal, contacts name: Rita Flores, MD, role: CONTACT, phone: 00351218841000, phoneExt: 21355, email: ritamariaflores@gmail.com, geoPoint lat: 38.71667, lon: -9.13333, hasResults: False
|
protocolSection identificationModule nctId: NCT06355817, orgStudyIdInfo id: HS25941, briefTitle: Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-21, primaryCompletionDateStruct date: 2024-03-19, completionDateStruct date: 2024-03-19, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, collaborators name: Winnipeg Regional Health Authority, descriptionModule briefSummary: To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections., conditionsModule conditions: Anesthetics, Local, conditions: Blepharoplasty, conditions: Age-Related Ptosis, conditions: Adult, conditions: Humans, conditions: Lidocaine, conditions: Ophthalmologic Surgical Procedure, conditions: Vibration, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Each patient will receive both interventions and serve as their own comparator., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The participant and surgeon was not made aware of which intervention the participant would receive first until the time of the procedure. Randomization was made at the time of the procedure., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Vibration, interventions name: Tapping, outcomesModule primaryOutcomes measure: Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia, secondaryOutcomes measure: Difference in Pain Reduction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Misericordia Health Centre, city: Winnipeg, state: Manitoba, zip: R3C 1A2, country: Canada, geoPoint lat: 49.8844, lon: -97.14704, hasResults: False
|
protocolSection identificationModule nctId: NCT06355804, orgStudyIdInfo id: STUDY2023-1565, briefTitle: Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-04-22, completionDateStruct date: 2025-04-22, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, descriptionModule briefSummary: The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years).Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention.Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity condition, interventions name: Waitlist condition, outcomesModule primaryOutcomes measure: Physical Activity Behavior, primaryOutcomes measure: Physical Activity Behavior, primaryOutcomes measure: Physical Activity Level (Light physical activity), primaryOutcomes measure: Physical Activity Level (Moderate-to-vigorous physical activity), primaryOutcomes measure: Physical Activity Level (Daily step count), secondaryOutcomes measure: Health-related quality of Life, secondaryOutcomes measure: Health-related Quality of Life, secondaryOutcomes measure: Fatigue Severity, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355791, orgStudyIdInfo id: PDPROJ-4-TP-001-23, briefTitle: The Stability Study, acronym: STABILITY, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Spinal Simplicity LLC, class: INDUSTRY, descriptionModule briefSummary: The studied indication is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.The purpose of this study is to evaluate the effectiveness and safety of instrumented posterior arthrodesis using the Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication., conditionsModule conditions: Lumbar Spinal Stenosis, conditions: Spondylolisthesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Minuteman G5, outcomesModule primaryOutcomes measure: NRS Back and Leg, primaryOutcomes measure: ODI, primaryOutcomes measure: PROMIS 29 2.0, secondaryOutcomes measure: 12 Month Fusion Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kansas University Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, geoPoint lat: 39.11417, lon: -94.62746, hasResults: False
|
protocolSection identificationModule nctId: NCT06355778, orgStudyIdInfo id: HUM00234185, secondaryIdInfos id: 1R01DA056415, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DA056415, briefTitle: Adversity, Brain and Opioid Use Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The way people process and remember information may be related to adverse childhood experiences and Opioid Use Disorder symptoms. The purpose of this project is to examine brain function and performance during learning and memory tasks in adults. The study will compare measures of learning and memory across three groups of participants: those with an Opioid Use Disorder (OUD) that take buprenorphine for opioid replacement therapy, adults without an Opioid Use Disorder taking buprenorphine, and healthy adults that do not have an Opioid Use Disorder and are not taking buprenorphine., conditionsModule conditions: Opioid Use Disorder, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 315, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic Resonance Imaging (MRI), interventions name: Computer Tasks, outcomesModule primaryOutcomes measure: Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus, primaryOutcomes measure: Differences in Hippocampal (Hpc) volume, primaryOutcomes measure: Differences in hippocampal circuit connectivity, primaryOutcomes measure: Differences in performance, primaryOutcomes measure: Differences in performance, primaryOutcomes measure: Differences in threat reactivity measured via skin conductance response (SCR), primaryOutcomes measure: Differences in threat reactivity measured via skin conductance response (SCR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Mariya Churina, role: CONTACT, email: AdversityBrainOUD@med.umich.edu, contacts name: Elizabeth Duval, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
|
protocolSection identificationModule nctId: NCT06355765, orgStudyIdInfo id: CITIZ_001, briefTitle: Citicoline & Antioxidants in Glaucoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-10, primaryCompletionDateStruct date: 2022-12-10, completionDateStruct date: 2022-12-10, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Naples, class: OTHER, descriptionModule briefSummary: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters., conditionsModule conditions: Glaucoma, Open-Angle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Citicoline blackcurrant supplement, outcomesModule primaryOutcomes measure: Evaluation of Ganglionar cells complex (GCC), secondaryOutcomes measure: Evaluation of Retinal nerve fiber layer (RNFL), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Naples Federico II, city: NAples, zip: 80131, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
|
protocolSection identificationModule nctId: NCT06355752, orgStudyIdInfo id: 0018-N-23, briefTitle: Biomarkers of Pain and Stress Perception and Dry Needling Technique Application, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Alcala, class: OTHER, descriptionModule briefSummary: The use of the dry needling technique has become widespread in recent years for the treatment of musculoskeletal pain. Although dry needling has been shown to be effective in the treatment of shoulder pain, elbow pain, headache, etc., we do not yet have a clear understanding of the mechanisms of action that justify its beneficial effects.In this study, we propose to analyse the biochemical markers of pain generated by the application of a dry needling technique on the lumbar musculature in patients with mechanical lumbar pain of non-specific origin.The aim of this study will be to evaluate the effects of dry needling technique on the plasmatic concentration of biochemical markers.Furthermore, the test subjects will be randomly distributed into two groups.An experimental group where the subjects will receive a real dry needling technique.Another group will be treated with a sham technique., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Dry needling of lumbar iliocostalis muscle, interventions name: Sham dry needling lumbar iliocostalis muscle, outcomesModule primaryOutcomes measure: Extracting Blood Samples and Obtaining Serum/Plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro Investigación Fisioterapia y Dolor, status: RECRUITING, city: Alcalá De Henares, state: Madrid, zip: 28805, country: Spain, contacts name: Patricia Martinez-Merinero, PhD, role: CONTACT, phone: 683378391, email: info@institutofisioterapiaydolor.es, contacts name: Laura Cabellos, role: CONTACT, phone: 683378391, email: clinica.fisio@fgua.es, geoPoint lat: 40.48205, lon: -3.35996, hasResults: False
|
protocolSection identificationModule nctId: NCT06355739, orgStudyIdInfo id: BIC-19GG, BIC-2019,BIC-2219, briefTitle: CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-01-15, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Zhu Xiaofan, class: OTHER, descriptionModule briefSummary: To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children, conditionsModule conditions: B Lymphocytic Leukemia, conditions: B Lymphoblastic Lymphoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: CAR T cell injection, outcomesModule primaryOutcomes measure: Overall survival and event-free survival, secondaryOutcomes measure: Overall remission rate, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Xiaofan Zhu, MD, role: CONTACT, phone: 86-21-23909001, email: xfzhu@ihcams.ac.cn, contacts name: Jingliao Zhang, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, locations facility: InstituteHBDH, status: NOT_YET_RECRUITING, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Zhu Xiaofan, role: CONTACT, phone: 86-21-23909001, email: xfzhu@ihcams.ac.cn, contacts name: Guo Ye, role: PRINCIPAL_INVESTIGATOR, contacts name: Yang Wenyu, role: PRINCIPAL_INVESTIGATOR, contacts name: Chen Xiaojuan, role: PRINCIPAL_INVESTIGATOR, contacts name: Chen Yumei, role: PRINCIPAL_INVESTIGATOR, contacts name: Ruan Min, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
|
protocolSection identificationModule nctId: NCT06355726, orgStudyIdInfo id: ILBS-Alcoholic Hepatitis-03, briefTitle: Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Institute of Liver and Biliary Sciences, India, class: OTHER, descriptionModule briefSummary: Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.\[1\] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.\[2,8\] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation., conditionsModule conditions: Alcoholic Hepatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Plasma Exchange, interventions name: Standard Medical Treatment, outcomesModule primaryOutcomes measure: Liver transplant free survival at 28 days, 90 days and 180 days., secondaryOutcomes measure: Change in total bilirubin and INR as measured by Discriminant Functions, secondaryOutcomes measure: Number of patients with change in Model for End Stage Liver Disease (MELD), secondaryOutcomes measure: Number of patients with change in CTP, secondaryOutcomes measure: Number of patients with change in LSM,SSM, secondaryOutcomes measure: Mortality in both groups, secondaryOutcomes measure: clinical improvement in the form of jaundice as measured by total bilirubin, secondaryOutcomes measure: clinical improvement in the form of hepatic encephalopathy as measured by west haven criteria, secondaryOutcomes measure: clinical improvement in the form of ascites as measured by ICA criteria., secondaryOutcomes measure: Frequency of decompensation events on follow up period, secondaryOutcomes measure: Adverse events during plasma exchange, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Liver & Biliary Sciences (ILBS), city: New Delhi, state: Delhi, zip: 110070, country: India, geoPoint lat: 28.63576, lon: 77.22445, hasResults: False
|
protocolSection identificationModule nctId: NCT06355713, orgStudyIdInfo id: 69HCL23_0899, secondaryIdInfos id: 2023-A02010-45, type: OTHER, domain: ID-RCB, briefTitle: Improvement of Symptoms After Removal of the Essure® Contraceptive Implant, acronym: ABLES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2031-08-01, completionDateStruct date: 2036-06-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms. Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation. This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted, knowing that explantation of ESSURE® implants is recommended only in symptomatic patients. A large number of these patients, presenting symptoms, have not yet been treated for an explant.The physiopathological mechanism(s) is (are) not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory and/or allergic and/or autoimmune phenomena.Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients, determine the most appropriate surgical techniques, and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers. From a surgical point of view, there is a real risk of fracture of implants whatever the type of intervention performed: study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation. From a biological point of view, the dosage of the metallic elements constituting ESSURE® implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body. Analysis of pro-inflammatory cytokines, micro-RNAs (miRNA), quantitative analysis of inflammatory pathway messenger ribonucleic acid (mRNAs) (NanoString technology) and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms. This study responds to a significant request from patient associations., conditionsModule conditions: Implant Complication, conditions: Contraceptive Device; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 444, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination, interventions name: blood sample, interventions name: urine collection, interventions name: Collection of a lock of hair, interventions name: questionnaire, outcomesModule primaryOutcomes measure: Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms, secondaryOutcomes measure: Percentage of patients with improvement in symptoms, secondaryOutcomes measure: Short Form 12 (SF-12) score, secondaryOutcomes measure: Fibromyalgia Impact Questionnaire (FIQ) score, secondaryOutcomes measure: Hospital Anxiety and Depression scale (HADS) score, secondaryOutcomes measure: Multidimensional Fatigue Inventory (MFI)-20 score, secondaryOutcomes measure: Visual analog scale (VAS) score, secondaryOutcomes measure: Questionnaire Douleur St-Antoine (QDSA) score, secondaryOutcomes measure: Female Sexual Function Index (FSFI) score, secondaryOutcomes measure: Higham questionnaires, secondaryOutcomes measure: visual analog scale (VAS) score, secondaryOutcomes measure: Duration of the procedure, secondaryOutcomes measure: Complications, secondaryOutcomes measure: characterization of the mechanical behavior of the implant, secondaryOutcomes measure: determination of the associated mechanical stress levels determination of the associated mechanical stress levels, secondaryOutcomes measure: quantification of the factors influencing these levels of mechanical stress, secondaryOutcomes measure: thermal resistance, secondaryOutcomes measure: risk of degradation, secondaryOutcomes measure: Concentrations of titanium constituting the Essure® implant, secondaryOutcomes measure: Concentrations of nickel constituting the Essure® implant, secondaryOutcomes measure: Concentrations of chromium constituting the Essure® implant, secondaryOutcomes measure: Concentrations of tin constituting the Essure® implant, secondaryOutcomes measure: Concentrations of platinum constituting the Essure® implant, secondaryOutcomes measure: Concentrations of iridium constituting the Essure® implant, secondaryOutcomes measure: Concentrations of molybdenum constituting the Essure® implant, secondaryOutcomes measure: Concentrations of manganese constituting the Essure® implant, secondaryOutcomes measure: Concentrations of tungsten constituting the Essure® implant, secondaryOutcomes measure: Concentrations of silver constituting the Essure® implant, secondaryOutcomes measure: Concentrations of iron constituting the Essure® implant, secondaryOutcomes measure: concentration of pro-inflammatory cytokines, secondaryOutcomes measure: expression profile of miRNAs, secondaryOutcomes measure: activated T lymphocyte profile, secondaryOutcomes measure: analysis of inflammatory pathway mRNAs, secondaryOutcomes measure: Percentage of detection of Human Leukocyte Antigen, secondaryOutcomes measure: Functional brain functions, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Angers, city: Angers, zip: 49933, country: France, contacts name: Guillaume Legendre, PU,PH, role: CONTACT, phone: 0241354635, phoneExt: +33, email: guillaume.legendre@chu-angers.fr, contacts name: Guillaume Legendre, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: Hôpital Femme Mère Enfant (Hospices Civils de Lyon), city: Bron, zip: 69677, country: France, contacts name: Gautier Chene, PU,PH, role: CONTACT, phone: 0472355870, phoneExt: +33, email: gautier.chene@chu-lyon.fr, contacts name: Gautier Chene, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Hôpital Bicêtre, city: Le Kremlin-Bicêtre, zip: 94275, country: France, contacts name: Perrine CAPMAS, PU,PH, role: CONTACT, phone: 0145217714, phoneExt: +33, email: perrine.capmas@aphp.fr, contacts name: Perrine CAPMAS, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.81471, lon: 2.36073, locations facility: Hôpital Jeanne de Flandres, city: Lille, zip: 59037, country: France, contacts name: Victoire Delporte, PU,PH, role: CONTACT, phone: 0320446641, phoneExt: +33, email: victoire.delporte@chu-lille.fr, contacts name: Victoire Delporte, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Hôpital de La Conception, city: Marseille, zip: 13005, country: France, contacts name: Aubert Agostini, PU,PH, role: CONTACT, phone: 0491383702, phoneExt: +33, email: Aubert.AGOSTINI@ap-hm.fr, contacts name: Aubert Agostini, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Institut Mère Enfant Alix de Champagne, CHU Reims, city: Reims, zip: 51092, country: France, contacts name: Olivier Graesslin, PU,PH, role: CONTACT, phone: 0326783517, phoneExt: +33, email: ograesslin@chu-reims.fr, contacts name: Olivier Graesslin, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.25, lon: 4.03333, locations facility: CHU de Rouen, city: Rouen, zip: 76000, country: France, contacts name: Patrice Crochet, PU,PH, role: CONTACT, phone: 0232881054, phoneExt: +33, email: patrice.crochet@chu-rouen.fr, contacts name: Patrice Crochet, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, city: Strasbourg, zip: 67200, country: France, contacts name: Thomas Boisrame, PU,PH, role: CONTACT, phone: 0388127458, phoneExt: +33, email: thomas.boisrame@chru-strasbourg.fr, contacts name: Thomas Boisrame, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Hôpital Paule de Viguier, CHU de Toulouse, city: Toulouse, zip: 31059, country: France, contacts name: Yann Tanguy Le Gac, PU,PH, role: CONTACT, phone: 0567771105, phoneExt: +33, email: tanguylegac.y@chu-toulouse.fr, contacts name: Yann Tanguy Le Gac, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Hôpital André Mignot, Centre Hospitalier de Versailles, city: Versailles, zip: 78157, country: France, contacts name: Pierre Panel, PU,PH, role: CONTACT, phone: 0139638936, phoneExt: +33, email: ppanel@ch-versailles.fr, contacts name: Pierre Panel, PU,PH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.8, lon: 2.13333, hasResults: False
|
protocolSection identificationModule nctId: NCT06355700, orgStudyIdInfo id: 5476, briefTitle: Hepatocellular Carcinoma Liver Organoids, acronym: HELIO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to create hepatocellular carcinoma organoids from liver bioptic samples of individuals with hepatocellular carcinoma. The main questions it aims to answer are:* the feasibility of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells* the molecular pattern of the organoid tumor microenvironment* the in vitro therapeutic response of hepatocellular carcinoma organoids, conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Liver biopsy, outcomesModule primaryOutcomes measure: Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells, secondaryOutcomes measure: Analysis of hepatocellular carcinoma organoid transcriptome distribution within a reference set from The Cancer Genome Atlas, secondaryOutcomes measure: Evaluation of the concordance of somatic genetic mutations between the organoid and the original tumor, secondaryOutcomes measure: Correlation between gut microbiota community profiling and growth rate of hepatocellular carcinoma organoids, secondaryOutcomes measure: Treatment response evaluation in vitro, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: Francesca Ponziani, MD, role: CONTACT, phone: +390630156018, email: comitato.etico@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06355687, orgStudyIdInfo id: FMASU MD304/2023, briefTitle: Melatonin in Obese Patients in Laparoscopic Cholecystectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids, so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function. In this study, the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy., conditionsModule conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Melatonin, interventions name: Vitamin Supplement, outcomesModule primaryOutcomes measure: Postoperative Pain., secondaryOutcomes measure: Postoperative Pain., secondaryOutcomes measure: Analgesics usage., secondaryOutcomes measure: Postoperative nausea and vomiting., secondaryOutcomes measure: Recovery time., secondaryOutcomes measure: Number of participants with hemodynamic instability., secondaryOutcomes measure: Number of participants with hemodynamic instability., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355674, orgStudyIdInfo id: HRÜ/23.21.12, briefTitle: Adolescent Mother and Breastfeeding Education, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Adiyaman University, class: OTHER, descriptionModule briefSummary: In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives.In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements., conditionsModule conditions: Adolescent Mother, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Breastfeeding education provided with Lactation Simulation Model, outcomesModule primaryOutcomes measure: Postnatal Breastfeeding Self-Efficacy Scale-Short Form, primaryOutcomes measure: Maternal-Infant Attachment Scale, eligibilityModule sex: FEMALE, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06355661, orgStudyIdInfo id: HP/231102/PA/URTI, briefTitle: A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Vedic Lifesciences Pvt. Ltd., class: INDUSTRY, descriptionModule briefSummary: The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days, conditionsModule conditions: Upper Respiratory Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Double-blind, Randomized, Placebo-Controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule, interventions name: MCC: 400 mg (± 10%) per Capsule, outcomesModule primaryOutcomes measure: To evaluate the effect of investigational products on participant's severity of common cold like symptoms, secondaryOutcomes measure: To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms, secondaryOutcomes measure: To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms, secondaryOutcomes measure: To evaluate the effect of investigational products on Percentage of population with minimal important difference of ≥ 10.3 as per change in Wisconsin Upper Respiratory Symptom Survey-21 total score. (daily score will be analysed in study), secondaryOutcomes measure: To evaluate the effect of investigational products on Number of days taken to be afebrile (temp < 100 oF/< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline- as assessed by 10-point visual analogue scale., secondaryOutcomes measure: To evaluate the effect of investigational products on Percentage population with fever during the study., secondaryOutcomes measure: To evaluate the effect of investigational products on Quality of life as assessed by Wisconsin Upper Respiratory Symptom Survey Quality of Life, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Biswas health care & Diagnostic Centre, city: Nainital, state: Uttaranchal, country: India, contacts name: Dr Bijay Biswas, MBBS,MD, role: CONTACT, phone: 919760010003, email: biswasclinic058@gmail.com, geoPoint lat: 29.39743, lon: 79.44686, hasResults: False
|
protocolSection identificationModule nctId: NCT06355648, orgStudyIdInfo id: IRAS 337181, briefTitle: Advanced Clinical Practitioners in the ED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, descriptionModule briefSummary: No patient data is involved in the study. This study is designed to understand better how Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs). The main research question is:1) What is the EC-ACP's perception of assimilation into emergency care teams, what tensions are created due to the role, and what system adaptations are required to facilitate integration?With secondary aims :1. What are the common organisational factors that affect the implementation of the EC-ACP workforce, and what recommendations can be made to improve Trust-wide implementation?2. How are EC-ACPs deployed in two contrasting emergency departments, what differences can be identified in their Work-As-Done (WAD), and how does this compare to the Work-As-Imagined (WAI) of the role?Participants will all be staff members who work in the hospital. Patient data is not being collected or processed. This is a mixed-method study using two approaches to collect data:1. Observation of the EC-ACPs at work - noting how they interact with colleagues and how they are deployed in the ED.2. Interviews with various staff who work with the EC-ACPs clinically or in various managerial or director roles.BackgroundIn the UK, a health care role has been developed called Advanced Clinical Practitioners (ACPs). ACPs work in various clinical settings, but this study focuses on those in Emergency Care. While non-medical practitioners have worked in Emergency Departments (EDs) for over 20 years, the ACP role is relatively new. Most ACPs in ED are from a nursing or paramedical background, but they can also be from other allied health professions like physiotherapy. After the base qualification, ACPs undertake a three-year master\'s degree with clinical portfolios. Once qualified, the goal is to create clinicians who work alongside doctors, seeing, treating, and discharging patients. Unlike previous practitioner roles, EC-ACPs treat the whole spectrum of ED patients, from minor injuries and illnesses to the sickest patients needing the highest level of care.These roles were heavily supported by local and political desires to create blended workforces to meet increasing patient demands. The problem with implementing ACP roles is that initially, little consultation was held with stakeholders in EDs. This has resulted in various trade-offs. For example, trainee doctors often feel displaced by trainee ACPs seeking to learn the same or similar skills.Previous research on advanced roles in ED has focused on direct clinical comparisons between doctors and practitioners. Researchers have investigated which professional (doctors vs. nurse practitioners) triages patients quickest or who is more accurate at interpreting X-rays. There are several problems with these approaches. The first is that they can create a professional rivalry. The second problem is that these approaches oversimplify what is a more complex system of care., conditionsModule conditions: Healthy Volunteers, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Narrative data, primaryOutcomes measure: Narrative data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355635, orgStudyIdInfo id: JohannesGUVA, briefTitle: Application and Monitoring of Vasoactive and Inotrope Drugs, acronym: Vasin, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Johannes Gutenberg University Mainz, class: OTHER, descriptionModule briefSummary: The investigators aimed to establish current practice of application and monitoring of vasoactive and inotrope Drugs in non-cardiac surgery patients., conditionsModule conditions: Hemodynamic Instability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Choice and Monitoring, outcomesModule primaryOutcomes measure: current practice of correct application and monitoring of vasoactive and inotrope Drugs, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anaesthesiology;, status: RECRUITING, city: Mainz, state: Rhineland-Palatinate, zip: D55131, country: Germany, contacts name: Marc Kriege, MD, role: CONTACT, phone: 00496131170, email: MaKriege@uni-mainz.de, geoPoint lat: 49.98419, lon: 8.2791, hasResults: False
|
protocolSection identificationModule nctId: NCT06355622, orgStudyIdInfo id: 3717, briefTitle: Prevalence and Characterization of Pain in RASopathies, acronym: 3717, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-27, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: RASopathies are a group of syndromes caused by variants in genes belonging to the RAS/MAPK pathway. Pain is a neglected topic in RASopathies but it is frequently complained by affected individuals., conditionsModule conditions: RASopathy, conditions: Costello Syndrome, conditions: Cardio-Facio-Cutaneous Syndrome, conditions: Noonan Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Characterization of pain, outcomesModule primaryOutcomes measure: Prevalence of pain in verbal patients with RASopathies, primaryOutcomes measure: Prevalence of Pain in no-communitating patients with RASopathies, secondaryOutcomes measure: Characterization of pain in RASopathies, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: Chiara Leoni, MD, PhD, role: CONTACT, phone: 0039063381344, email: chiara.leoni@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06355609, orgStudyIdInfo id: DZ2023EI004-RW, briefTitle: Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW, acronym: WUKONG-32-RW, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hunan Province Tumor Hospital, class: OTHER, descriptionModule briefSummary: This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: sunvozertinib in combination with Anlotinib, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Adverse events (AEs) according to CTCAE 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan Cancer Hospital, city: Changsha, state: Hunan, zip: 410013, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
|
protocolSection identificationModule nctId: NCT06355596, orgStudyIdInfo id: 20IC6361, briefTitle: Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-11, primaryCompletionDateStruct date: 2022-04-08, completionDateStruct date: 2022-04-08, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. The main questions it aims to answer are:Can MIS skills be effectively taught to novice learners through a virtual platform using widely available technology? How do virtual and face-to-face (F2F) teaching methods compare in terms of effectiveness, measured by performance in MIS tasks and cognitive workload parameters?Participants in this study will:Be randomly allocated to either F2F or virtual teaching groups. Undergo training and evaluation using validated laparoscopic assessments, namely the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task and the European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment.Have their performance and cognitive workload parameters (SURG-TLX score, heart rate, and pupil metrics) evaluated during the tasks., conditionsModule conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants are randomly allocated to either face-to-face or virtual teaching groups, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Virtual teaching, outcomesModule primaryOutcomes measure: McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score, primaryOutcomes measure: European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score, secondaryOutcomes measure: SURG-TLX score, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Pupil metrics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Mary's Hospital, city: London, zip: W2 1NY, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
|
protocolSection identificationModule nctId: NCT06355583, orgStudyIdInfo id: C/42/2022, secondaryIdInfos id: 2022-003617-10, type: EUDRACT_NUMBER, briefTitle: Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial, acronym: MAST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant.The main questions it aims to answer are:* Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires* Changes in gut microbiome diversity across all timepoints* Markers of general health, infective/microbiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured.Participants will be asked at their routine follow up visits to,* Provide stool, urine and blood samples at the scheduled study visits* Complete questionnaires at selected visits* Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+/-3 days)Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity., conditionsModule conditions: Acute Lymphoblastic Leukaemia, conditions: Acute Leukemia of Ambiguous Lineage, conditions: Chronic Myeloid Leukemia, conditions: Chronic Myelomonocytic Leukemia, conditions: Myelodysplastic Syndrome, conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: EBX-102, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in gut microbiota diversity using Inverse Simpsons Index, secondaryOutcomes measure: Gut Microbiome Diversity - Alpha diversity, secondaryOutcomes measure: Alpha Diversity - Chao1 Index, secondaryOutcomes measure: Alpha Diversity - Shannon Index, secondaryOutcomes measure: Alpha Diversity - Faiths Phylogenetic Diversity (Faiths PD), secondaryOutcomes measure: Beta Diversity - Aitchison Distance, secondaryOutcomes measure: Gut Microbiome Taxonomic Composition, secondaryOutcomes measure: Markers of general health - ITU Admission, secondaryOutcomes measure: Quality of life EQ-5D-5L, secondaryOutcomes measure: Quality of Life EORTC-QLQ-C30, secondaryOutcomes measure: Infective Haematological Outcomes - Fever Occurrence, secondaryOutcomes measure: Infective Haematological Outcomes - Fever CTCAE Grade, secondaryOutcomes measure: Infective Haematological Outcomes - Infection, secondaryOutcomes measure: Infective Haematological Outcomes - Multi drug Resistant Bacterial Colonisation (MDROs), secondaryOutcomes measure: Infective Haematological Outcomes - Antibiotic Use, secondaryOutcomes measure: Markers of General Health - Severity of Mucositis, secondaryOutcomes measure: Markers of General Health -Occurrence of Severe Acute Kidney Injury (AKI), secondaryOutcomes measure: Markers of General Health - Occurrence of Severe liver dysfunction, secondaryOutcomes measure: Markers of general health - Use of Parenteral Nutrition, secondaryOutcomes measure: Neutrophil and platelet engraftment data, secondaryOutcomes measure: Recovery of T-cell Chimaerisms,, secondaryOutcomes measure: Haematological Outcomes - Non-relapsed mortality, secondaryOutcomes measure: Haematological Outcomes - Occurrence Graft vs Host Disease, secondaryOutcomes measure: Haematological Outcomes - Severity of graft vs Host Disease, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Graft-versus disease-free relapse-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Birmingham NHS Foundation Trust, city: Birmingham, state: England, zip: B15 2WB, country: United Kingdom, contacts name: Senior Haematology Research Sister, role: CONTACT, phone: 01213714351, email: HaematologyCancerResearch@uhb.nhs.uk, contacts name: Francesca Kinsella, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Leeds Teaching Hospital NHS Trust, city: Leeds, state: England, zip: LS9 7TF, country: United Kingdom, contacts name: Principal Investigator, role: CONTACT, phone: 01132068561, email: anjum.khan@nhs.net, geoPoint lat: 53.79648, lon: -1.54785, locations facility: University College London Hospitals NHS Trust, city: London, state: England, zip: NW1 2BU, country: United Kingdom, contacts name: BMT Trials, role: CONTACT, email: uclh.bmttrials@nhs.net, contacts name: Panagiotis Kottaridis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Kings College NHS Foundation Trust, city: London, state: England, zip: SE5 9RS, country: United Kingdom, contacts name: Principal Investigator, role: CONTACT, email: p.krishnamurthy@nhs.net, contacts name: Pramila Krishnamurthy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, city: London, state: England, zip: W12 0NN, country: United Kingdom, contacts name: Senior Research Operations Manager, role: CONTACT, phone: 02037048452, email: Eleni.Vourvou@nhs.net, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Mardsen Hostpital, city: London, zip: SW3 6JJ, country: United Kingdom, contacts name: Haemato-Oncology Department, role: CONTACT, phone: 0208915 6187, email: Emma.Nicholson@rmh.nhs.uk, contacts name: Emma Nicholson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
|
protocolSection identificationModule nctId: NCT06355570, orgStudyIdInfo id: 331314, secondaryIdInfos id: RFPR2324_29, type: OTHER_GRANT, domain: Imperial Health Charity, secondaryIdInfos id: 24/YH/0011, type: OTHER, domain: UK Health Research Authority (Research Ethics Committee), briefTitle: Delirium After Cardiac Surgery in Intensive Care Units, acronym: DaCsi-ICU, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Imperial College Healthcare NHS Trust, class: OTHER, descriptionModule briefSummary: STUDY SUMMARYSTUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit (ICU) at Hammersmith Hospital, Imperial College Healthcare NHS Trust (ICHT). This study is a mixed methods research design that includes the collection of data through qualitative interviews, quality-of-life questionnaires and patients' medical records.AIMS* Determine the incidence of ICU delirium in ICHT following cardiac surgery* Explore the compliance of outcome measures that diagnose ICU delirium* Implement a family-focused sensory stimulation programme in the ICU* Evaluate its useability and potential impact on patients, families and ICU staffSTUDY POPULATION 30 study participants (12 patients, 12 family members/friends and 6 ICU nurses)ELIGIBILITY Study eligibility criteria are specific for each care group (patients, family members/friends and ICU nurses).DURATION 12 months at Hammersmith Hospital, ICHT, conditionsModule conditions: Intensive Care Unit Delirium, conditions: Cardiac Surgery, conditions: Post Operative Delirium, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 12-patient participants will be submitted to the study intervention., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Personal Pictures, interventions name: Family Videos, interventions name: Family Videos - Intervention as required, outcomesModule primaryOutcomes measure: Feasibility of implementing the study intervention, secondaryOutcomes measure: Practicalities of introducing the study intervention, secondaryOutcomes measure: Acceptability of implementing the study intervention, secondaryOutcomes measure: Short-term delirium outcomes post-ICU discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Imperial College Healthcare NHS Trust, status: RECRUITING, city: London, zip: W12 0HS, country: United Kingdom, contacts name: Maria Reguenga, BSN, role: CONTACT, phone: +442033131703, email: maria.reguenga@nhs.net, contacts name: Sanooj Soni, PhD, role: CONTACT, phone: 07714329708, email: sanooj.soni@nhs.net, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
|
protocolSection identificationModule nctId: NCT06355557, orgStudyIdInfo id: DSRB 2023/00640, briefTitle: Human vs Machine: a RCT Comparing Traditional In-person Instruction, AI Versus VR for Learning Basic CCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Tan Tock Seng Hospital, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate if hands-on training for basic CCE with virtual reality simulators or guided by artificial intelligence is non-inferior to training by an experienced instructor., conditionsModule conditions: Ultrasound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 3-arm prospective randomised controlled trial., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: AI enabled ultrasound system for self-directed learning, interventions name: Simulator for self-directed learning, interventions name: traditional with human instructors, outcomesModule primaryOutcomes measure: Improvement in image acquisition and structure identification at the end of 3 months., eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tan Tock Seng Hospital, status: RECRUITING, city: Singapore, zip: 319581, country: Singapore, contacts name: Yie H Lau, role: CONTACT, phone: 6563577771, email: yie_hui_lau@ttsh.com.sg, contacts name: Yie H Lau, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
|
protocolSection identificationModule nctId: NCT06355544, orgStudyIdInfo id: PINEAPPL2023, secondaryIdInfos id: 2023-A02494-41, type: OTHER, domain: Agence nationale de sécurité du médicament et des produits de santé, briefTitle: Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk, acronym: PINEAPPL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Integrative Phenomics, class: INDUSTRY, collaborators name: Assistance Publique - Hôpitaux de Paris, collaborators name: Assistance Publique Hopitaux De Marseille, collaborators name: University Hospital, Bordeaux, collaborators name: Centre Hospitalier Universitaire Dijon, collaborators name: Institut Pasteur de Lille, collaborators name: Hopitaux Civils de Colmar, descriptionModule briefSummary: The goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity.The main questions it aims to answer are:* Whether it is possible to predict low-grade inflammation* What are the medical, biological, and lifestyle variables related to low-grade inflammation?Participants will be asked to:1. Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples.2. Complete questionnaires and collect a stool sample at home., conditionsModule conditions: Overweight, conditions: Obesity, conditions: Metabolic Syndrome, conditions: Healthy, conditions: Low-grade Inflammation, conditions: Normal Weight Adults, conditions: Risk Factor, Cardiovascular, conditions: Hypertension, conditions: Hypercholesterolemia, conditions: Abdominal Obesity, conditions: Metabolically Healthy Controls, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Low-grade inflammation, secondaryOutcomes measure: Gut microbiome metabolites, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Stool microbiome composition, secondaryOutcomes measure: Stool microbiome functional pathways, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Resting heart rate, secondaryOutcomes measure: Serum glycated hemoglobin (HbA1c), secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Height, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Neck circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Body fat mass, secondaryOutcomes measure: Water body mass, secondaryOutcomes measure: Lean body mass, secondaryOutcomes measure: Serum fasting low-density lipoprotein, secondaryOutcomes measure: Fasting serum high-density lipoprotein, secondaryOutcomes measure: Fasting total serum cholesterol, secondaryOutcomes measure: Consumption of dietary macronutrients, secondaryOutcomes measure: Consumption of dietary micronutrients, secondaryOutcomes measure: Consumption of dietary metabolites, secondaryOutcomes measure: Food item consumption, secondaryOutcomes measure: Food group consumption, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Serum Alanine Transaminase (ALT), secondaryOutcomes measure: Serum Aspartate Aminotransferase (ALT), secondaryOutcomes measure: Serum gamma-glutamyl transferase (GGT), secondaryOutcomes measure: Fasting serum triglycerides, secondaryOutcomes measure: Fasting serum uric acid, secondaryOutcomes measure: Fasting serum creatinine, secondaryOutcomes measure: Fasting serum insulin, secondaryOutcomes measure: Blood hemoglobin, secondaryOutcomes measure: Blood hematocrit, secondaryOutcomes measure: Red blood cells, secondaryOutcomes measure: Red blood cell volume, secondaryOutcomes measure: Hemoglobin relative red blood cell size, secondaryOutcomes measure: Mean cell hemoglobin (MCH), secondaryOutcomes measure: Blood platelets, secondaryOutcomes measure: White blood cells, secondaryOutcomes measure: Perceived quality of life, secondaryOutcomes measure: Eating behavior, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Stool consistency, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Deprivation, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Sleep apnea, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355531, orgStudyIdInfo id: FNP223-CT-2301, briefTitle: A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ferrer Internacional S.A., class: INDUSTRY, descriptionModule briefSummary: PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP., conditionsModule conditions: Progressive Supranuclear Palsy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: FNP-223, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change From Baseline to Week 52 in the PSPRS Outcome, primaryOutcomes measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), primaryOutcomes measure: Number of Participants Experiencing Serious Adverse Events (SAEs), secondaryOutcomes measure: Change From Baseline to Week 52 in Clinical Global Impression of Severity Scale (CGI-S), secondaryOutcomes measure: Change From Baseline to Week 52 Participant Global Impression of Severity Scale (PGI-S), secondaryOutcomes measure: Change From Baseline to Week 52 in Caregiver Global Impression of Severity Scale (CaGI-S), secondaryOutcomes measure: Slope of Decline in PSPRS, secondaryOutcomes measure: Change From Baseline to Week 52 in Individual Subitems of PSPRS, secondaryOutcomes measure: Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale, secondaryOutcomes measure: Change From Baseline to Week 52 in PSP Clinical Deficits Scale (PSP-CDS), secondaryOutcomes measure: Change From Baseline to Week 52 in Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Change From Baseline to Week 52 in PSP Quality of Life Scale (PSP-QoL), secondaryOutcomes measure: Pharmacokinetic characterization of FNP-223, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355518, orgStudyIdInfo id: INu-RC, briefTitle: Pre-operative Immuno-Nutrition in Radical Cystectomy, acronym: INu-RC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Policlinico San Matteo di Pavia, class: OTHER, collaborators name: IRCCS Ospedale San Raffaele, descriptionModule briefSummary: This study will evaluate the effect of preoperative oral immunonutrition on postoperative complications in patients undergoing radical cystectomy for bladder cancer. Patients receiving preoperative immunonutrition will be compared to controls receiving a standard high-calorie, high-protein oral nutritional supplement., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Immunonutrition, interventions name: Standard Oral Nutritional Supplement, outcomesModule primaryOutcomes measure: 30-day complications, secondaryOutcomes measure: 30-day severe complications, secondaryOutcomes measure: 90-day severe complications, secondaryOutcomes measure: 30-day and 90-day infectious complications, secondaryOutcomes measure: 30-day and 90-day occurrence of other medical conditions, secondaryOutcomes measure: Time to recovery of bowel function, secondaryOutcomes measure: Time to postoperative mobilization, secondaryOutcomes measure: Muscular strength modifications, secondaryOutcomes measure: Weight modifications, secondaryOutcomes measure: Biochemical nutritional indexes modifications, secondaryOutcomes measure: Need of blood transfusions, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Readmission rate, secondaryOutcomes measure: 30-day and 90-day mortality, secondaryOutcomes measure: Compliance, secondaryOutcomes measure: Tolerability (gastrointestinal symptoms related to nutritional supplement), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, city: Milan, zip: 20132, country: Italy, contacts name: Bettiga Arianna, role: CONTACT, email: bettiga.arianna@hsr.it, contacts name: Marco Moschini, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS Policlinico San Matteo, city: Pavia, zip: 27100, country: Italy, contacts name: Ferrari Alessandra, PharmD, role: CONTACT, phone: +390382503689, email: alessandra.ferrari@smatteo.pv.it, contacts name: Valentina Da Prat, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
|
protocolSection identificationModule nctId: NCT06355505, orgStudyIdInfo id: PREPS-21-0098, briefTitle: Process of Emergence and Implementation of Advanced Practice Nursing in France, acronym: PEIPA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-01-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Longitudinal, observational research with a mixed quantitative (by questionnaires) and qualitative (by interviews and observations) approach, multidisciplinary, among Advanced Practice Nurses (APNs) already graduated and 3 consecutive classes of advanced practice students who will be followed annually during their implementation as APN until the last year of the study. The questionnaires will focus on APN scope of practice evolution, economical analysis and geographical distribution of APN. The ethnographical approach will assess APN settlements and relation with healthcare colleagues and patients., conditionsModule conditions: Nurse's Role, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Factors influencing the effective implementation of advanced practice nursing in France in primary care and health facilities, secondaryOutcomes measure: Mapping of APNs in France with socio-demographic data, secondaryOutcomes measure: Definition by the APN of its role and missions, secondaryOutcomes measure: Implementation and dissemination of the APN practice in the territory according to the context of practice (community care, hospital), secondaryOutcomes measure: Identification of potential impact dimensions of Advanced Practice Nursing, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beaujon hospital, status: RECRUITING, city: Clichy, zip: 92110, country: France, contacts name: Julie Devictor, PhD, role: CONTACT, phone: 06 64 71 26 75, email: julie.devictor@aphp.fr, contacts name: Anne Leclercq, PhD, role: CONTACT, phone: 0033 7 62 70 58 05, email: anne.leclercq2@aphp.fr, geoPoint lat: 48.90018, lon: 2.30952, hasResults: False
|
protocolSection identificationModule nctId: NCT06355492, orgStudyIdInfo id: 2090/10/30, briefTitle: Virtual Reality Distraction in Pediatric Patients., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients., conditionsModule conditions: Virtual Reality, conditions: Distraction, conditions: Infiltration Anesthesia, conditions: Pediatric Patients, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality goggles (VR ), interventions name: regular screen, outcomesModule primaryOutcomes measure: Assessment of pain during virtual reality distraction, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Rokia Abdelrhman Saad Elfaramawy, city: Tanta, state: El-Gharbia, zip: 31527, country: Egypt, contacts name: Rokia A Elfaramawy, BDS, role: CONTACT, phone: 01069823221, email: Rokiaabdelrahman94@gmail.com, contacts name: Fatma A Elhendawy, Professor, role: SUB_INVESTIGATOR, contacts name: Nura I Abozena, Lecturer, role: SUB_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
|
protocolSection identificationModule nctId: NCT06355479, orgStudyIdInfo id: HY1001-2022-P3, briefTitle: A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-10, primaryCompletionDateStruct date: 2023-11-22, completionDateStruct date: 2023-12-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Healthgen Biotechnology Corp., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia.Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients.Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively., conditionsModule conditions: Hypoalbuminemia, conditions: Hepatic Cirrhosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 328, type: ACTUAL, armsInterventionsModule interventions name: OsrHSA, interventions name: Plasbumin®-20, outcomesModule primaryOutcomes measure: To evaluate the efficacy of OsrHSA on elevating the serum albumin level., secondaryOutcomes measure: To estimate the time to reach 35 g/L or more in serum albumin, secondaryOutcomes measure: To estimate the change from baseline in serum albumin, secondaryOutcomes measure: To estimate the change from baseline in colloid osmotic pressure, secondaryOutcomes measure: To estimate the change from baseline in body weight, secondaryOutcomes measure: To estimate the change from baseline in abdominal circumference, and ascites severity, secondaryOutcomes measure: To estimate the change from baseline in ascites severity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Youan Hospital, Capital Medical University, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing University Three Gorges Hospital, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The Second Affiliated Hospital of Chongqing Medical University, city: Chongqing, state: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Mengchao Hepatobiliary Hospital of Fujian Medical University, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: The First Affiliated Hospital of Fujian Medical University, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Nanfang Hospital, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Third Affiliated Hospital, Sun Yat-Sen University, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Huizhou Central People's Hospital, city: Huizhou, state: Guangdong, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Affiliated Hospital of Guilin Medical University, city: Guilin, state: Guangxi, country: China, geoPoint lat: 25.28194, lon: 110.28639, locations facility: Liuzhou Worker's Hospital, city: Liuzhou, state: Guangxi, country: China, locations facility: The First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, country: China, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Affiliated Hospital Of Zunyi Medical University, city: Zunyi, state: Guizhou, country: China, geoPoint lat: 27.68667, lon: 106.90722, locations facility: The Fourth Affiliated Hospital, Harbin Medical University, city: Harbin, state: Heilongjiang, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: Luoyang Central Hospital, city: Luoyang, state: Henan, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: The First Affiliated Hospital of Zhengzhou University, city: Zhengzhou, state: Henan, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: The Sixth People's Hospital of Zhengzhou, city: Zhengzhou, state: Henan, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Jingzhou Central Hospital, city: Jingzhou, state: Hubei, country: China, geoPoint lat: 30.35028, lon: 112.19028, locations facility: TaiHe Hospital, city: Shiyan, state: Hubei, country: China, geoPoint lat: 32.6475, lon: 110.77806, locations facility: The Central Hospital of Wuhan, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan Jinyintan Hospital, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Yichang Central People's Hospital, city: Yichang, state: Hubei, country: China, geoPoint lat: 30.71444, lon: 111.28472, locations facility: Yueyang Central Hospital, city: Yueyang, state: Hunan, country: China, geoPoint lat: 29.37455, lon: 113.09481, locations facility: The Third People's Hospital of Zhenjiang, city: Zhenjiang, state: Jiangsu, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: First Affiliated Hospital of Gannan Medical University, city: Ganzhou, state: Jiangxi, country: China, locations facility: The First Affiliated Hospital of Nanchang University, city: Nanchang, state: Jiangxi, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Pingxiang People's Hospital, city: Pingxiang, state: Jiangxi, country: China, geoPoint lat: 27.61672, lon: 113.85353, locations facility: Yichun People's Hospital, city: Yichun, state: Jiangxi, country: China, geoPoint lat: 47.72143, lon: 128.87529, locations facility: Hepatobiliary Hospital Of Jilin, city: Chang chun, state: Jilin, country: China, geoPoint lat: 42.74694, lon: 126.24667, locations facility: The First Hospital of Jilin University, city: Chang chun, state: Jilin, country: China, geoPoint lat: 42.74694, lon: 126.24667, locations facility: The Sixth People's Hospital of Shenyang, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The People's Hospital of Qinghai, city: Xining, state: Qinghai, country: China, geoPoint lat: 36.62554, lon: 101.75739, locations facility: Shandong Public Health Clinical Center, city: Jinan, state: Shandong, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: West China Hospital, Sichuan University, city: Chengdu, state: Sichuan, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Second Affiliated Hospital of Kunming Medical University, city: Kunming, state: Yunnan, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Ruian People's Hospital, city: Rui'an, state: Zhejiang, country: China, locations facility: The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University, city: Wenzhou, state: Zhejiang, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False
|
protocolSection identificationModule nctId: NCT06355466, orgStudyIdInfo id: 51-112334, briefTitle: Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-09, primaryCompletionDateStruct date: 2023-08-11, completionDateStruct date: 2023-08-28, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Golestan University of Medical sciences, class: OTHER, descriptionModule briefSummary: In this prospective cross-sectional study, patients with ESRD unfit for AVF/AVG were scheduled for a right or left trans-jugular tunneled catheter placement. All patients were asked about their catheters' function one year after its implantation and the presumed affecting factors on catheters' patency were evaluated., conditionsModule conditions: Vascular Access Devices, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 156, type: ACTUAL, outcomesModule primaryOutcomes measure: one year patency rate of hemodialysis catheters, secondaryOutcomes measure: one year patency rate of hemodialysis catheters in age subgroups, secondaryOutcomes measure: one year patency rate of hemodialysis catheters in diabetic patients, secondaryOutcomes measure: one year patency rate of hemodialysis catheters in hypertensive patients, secondaryOutcomes measure: one year patency rate of hemodialysis catheters in patients on antiplatelet drugs, secondaryOutcomes measure: one year patency rate of hemodialysis catheters in sex subgroups, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Golestan University of Medical Sciences, faculty of medicine, city: Gorgan, state: Golestan, zip: 4918936316, country: Iran, Islamic Republic of, geoPoint lat: 36.8427, lon: 54.44391, hasResults: False
|
protocolSection identificationModule nctId: NCT06355453, orgStudyIdInfo id: 2023-090-MIC-GES, briefTitle: Evaluation of the Goldcrest Patch Performance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: GE Healthcare, class: INDUSTRY, descriptionModule briefSummary: The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity., conditionsModule conditions: Fetal Monitoring, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Goldcrest Patch and Three Patch Coupons, interventions name: Goldcrest Patch and Novii Patch, outcomesModule primaryOutcomes measure: Primary Objective, primaryOutcomes measure: Primary Objective, secondaryOutcomes measure: Secondary Objective, secondaryOutcomes measure: Secondary Objective, otherOutcomes measure: Incidence of Treatment-Emergent Adverse Events Objective, eligibilityModule sex: FEMALE, minimumAge: 22 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355440, orgStudyIdInfo id: 2312288-16, briefTitle: Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The goal of this pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.The main questions it aims to answer are:* Is the intervention feasible and acceptable among participants?* Does the intervention enhance participants' cost-related health literacy?* Does the intervention reduce participants' financial toxicity?Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.Participants will receive comprehensive information support, including:* Strategies on patient-physician costs discussion* Skills for inquiring and tracking treatment-related costs* Basic knowledge about health insurance* Guidance on accessing and applying for financial assistance* Suggestions for returning to normal life and work* Strategies for holding a financial-related family meeting, conditionsModule conditions: Breast Neoplasm Female, conditions: Financial Toxicity, conditions: Financial Navigation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Financial Navigation, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Eligibility rate, primaryOutcomes measure: Consent rate, primaryOutcomes measure: Retention rate, primaryOutcomes measure: Adherence rate, primaryOutcomes measure: Patient-reported satisfaction, primaryOutcomes measure: Qualitative assessment of the intervention, secondaryOutcomes measure: Cost-related health literacy, secondaryOutcomes measure: Financial toxicity, secondaryOutcomes measure: Material domain of financial toxicity, secondaryOutcomes measure: Behavioral domain of financial toxicity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Xiaoyi Yuan, Master, role: CONTACT, phone: (+86) 18918305439, email: 22211170009@m.fudan.edu.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06355427, orgStudyIdInfo id: 2023-507938-24-00, briefTitle: The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma, acronym: FAPIChol, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Mara Veenstra, MD, class: OTHER, collaborators name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), collaborators name: UMC Utrecht, descriptionModule briefSummary: BackgroundBile duct cancer (cholangiocarcinoma) represents the second most common type of hepatobiliary cancer worldwide with an incidence of 0.35 to 2 per 100.000 annually. Currently, surgical resection is the only curative option. However, patients are not eligible for surgery if the tumor cannot be resected or the cancer has spread. For this group of patients, palliative chemotherapy is the most suited treatment option. To find out if a patient is suited for surgery, CT and MRI are performed. These imaging techniques, however, struggle to correctly identify small cancer spreads that are smaller than 1 cm. Therefore, cancer that has already spread can be found during surgery. In these cases, the tumor cannot be removed and the surgery therefore has not been of any benefit for the patient. These surgeries could be avoided by implementing a diagnostic tool with significantly higher accuracy than those currently used. Single center studies have shown that fibroblast activation protein inhibitor (FAPI) PET-CT is a very promising technique for determining metastases in tumors with prominent desmoplastic reactions, like cholangiocarcinoma. The investigators predict that implementation of preoperative FAPI PET-CT could prevent futile surgery for at least half of patients in whom intra-operative metastasized disease is found using the current work-up.Patient populationPatients ≥18 years with potentially curable proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma) who are planned to undergo surgery based on imaging using CT thorax/abdomen and MRI of the upper abdomen. Exclusion criteria are previous abdominal surgery or chemotherapy, known pregnancy or lactation and indication for FDG PET-CT.Participation in this studyParticipation would mean to undergo FAPI PET-CT prior to the scheduled surgery. This will take up about half a day of the participant's time. Afterwards, participants receive questionnaires about quality of life and use of healthcare services over a period of six months in order for the researchers to be able to calculate the cost-effectiveness of additional FAPI PET-CT.Risks and benefits of participationPatients may benefit directly from \[18F\]F-FAPI PET-CT by allowing for more targeted treatment, possibly avoiding futile surgery and receiving chemotherapy or best clinical support instead, minimizing treatment delay. Avoiding futile surgery will also prevent patients from being exposed to the risks and discomfort associated with surgery: hospital stay, possibility of intraoperative or postoperative complications, postoperative pain and recovery, and mortality.Potential risks and burdens associated with this study are an extra hospital visit and a time burden of approximately half a day. Risks associated with administering FAPI are (re)bleed and infection. Both risks have a minimal probability of onset and can usually easily be treated. As \[18F\]F-FAPI is a sub-pharmacologically micro-dosed diagnostic tracer, the risk of allergic reactions is expected to be minimal and no tissue damage is expected. The burden associated with undergoing a PET-CT may be laying still for a certain time, and possible experience of claustrophobia. Possible metastases of the cancer will have to be confirmed when suspicious findings are seen on FAPI PET-CT. This could mean that participants will have to undergo additional testing such as imaging (CT or MRI) or biopsy. Undergoing FAPI PET-CT prior to surgery will result in a surgical delay when compared with the current clinical practice. The investigators do not expect this delay to influence the patient's prognosis. Follow-up will result in a time burden for patients to answer questionnaires on a two-weekly or monthly basis., conditionsModule conditions: Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: [18F]F-FAPI PET-CT, outcomesModule primaryOutcomes measure: Diagnostic accuracy of [18F]F-FAPI PET-CT, secondaryOutcomes measure: Change of treatment, secondaryOutcomes measure: Cost-effectiveness, secondaryOutcomes measure: Number of additional significant findings using [18F]F-FAPI PET-CT, secondaryOutcomes measure: Number of times nuclear medicine specialists' [18F]F-FAPI PET-CT conclusions differed from one another, secondaryOutcomes measure: Number of lesions found on [18F]F-FAPI PET-CT, secondaryOutcomes measure: Number of days between [18F]F-FAPI PET-CT and exploratory surgery, secondaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, secondaryOutcomes measure: Number of participants in which dynamic [18F]F-FAPI PET-CT followed by conventional [18F]F-FAPI PET-CT was able to distinguish benign lesions from malignant lesions, secondaryOutcomes measure: Change in volume of interest (cm3) using dynamic [18F]F-FAPI PET-CT, secondaryOutcomes measure: Difference in SUVmax between dynamic and conventional [18F]F-FAPI PET-CT, secondaryOutcomes measure: Difference in SUVmean between dynamic and conventional [18F]F-FAPI PET-CT, secondaryOutcomes measure: Difference in transport rate (k1 to k2) on dynamic [18F]F-FAPI PET-CT between participants with malignant lesions and particpants with benign lesions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355414, orgStudyIdInfo id: IRB00385932, secondaryIdInfos id: R33AT012317, type: NIH, link: https://reporter.nih.gov/quickSearch/R33AT012317, briefTitle: Psilocybin in Chronic Low Back Pain and Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-07-30, completionDateStruct date: 2026-08-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Center for Complementary and Integrative Health (NCCIH), descriptionModule briefSummary: This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D).Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects., conditionsModule conditions: Chronic Low-back Pain, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, active control study comparing the effects of psilocybin (25mg fixed dose) and methylphenidate (40mg fixed dose), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: This is a double-blind trial, and efforts will be made to mask the study drug (psilocybin) and the active control (methylphenidate) from participants, guides, and study staff. Participants will be debriefed about their randomly assigned drug condition after the completion of the final follow-up assessment, or after discontinuation/withdrawal, whichever comes first., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, interventions name: Methylphenidate, outcomesModule primaryOutcomes measure: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA), primaryOutcomes measure: Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA), primaryOutcomes measure: Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA), primaryOutcomes measure: Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing), secondaryOutcomes measure: Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA), secondaryOutcomes measure: Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA), secondaryOutcomes measure: Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA), secondaryOutcomes measure: Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing), otherOutcomes measure: Pain as assessed by discrete pain items assessed via EMA, otherOutcomes measure: Dynamic association between affect and pain using micro-longitudinal EMA data of affective variables (positive, negative affect outcomes) and pain outcomes, otherOutcomes measure: Changes in mood as measured by a selection of discrete items derived from the Positive and Negative Affect Schedule- Expanded Form (PANAS-X)., otherOutcomes measure: Changes in self-reported Pain Impact as measured by Pain intensity (P), interference with Enjoyment of life (E), and interference with General activity (G) Scale (PEG), otherOutcomes measure: Changes in Pressure Pain Threshold (Quantitative Sensory Testing), otherOutcomes measure: Changes in Conditioned Pain Modulation (Quantitative Sensory Testing), otherOutcomes measure: Chronic Pain Exacerbation as measured by the Graded Chronic Pain Scale- Revised (GCPS-R), otherOutcomes measure: Changes in neuropathic pain features as assessed by the painDETECT questionnaire (PDQ), otherOutcomes measure: Changes in CLBP-related disability as measured by the Oswestry Disability Index (ODI), otherOutcomes measure: Change in Emotion Regulation as assessed by the Difficulties in Emotion Regulation Scale (DERS), otherOutcomes measure: Pain intensity and related dimensions of health (i.e., sleep) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.0)., otherOutcomes measure: Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale (PIPS), otherOutcomes measure: Personal values and the degree of success in following those values as measured by the Chronic Pain Values Inventory (CPVI)., otherOutcomes measure: Dispositional tendencies to feel positive emotions towards others in daily life as measured by the Dispositional Positive Emotion Scale (DPES), otherOutcomes measure: Mindfulness as measured by the Five Facet Mindfulness Questionnaire (FFMQ-15), otherOutcomes measure: Subjective experiences: Awe Experience Scale (AWE-S), otherOutcomes measure: Subjective experiences: Mystical Experience Questionnaire (MEQ30), otherOutcomes measure: Subjective experiences: Challenging Experience Questionnaire (CEQ), otherOutcomes measure: Subjective experiences: Altered States of Consciousness Questionnaire (5D-ASC), otherOutcomes measure: Subjective experiences: Psychological Insight Questionnaire (PIQ), otherOutcomes measure: Changes in basic beliefs about the world as measured by the Primals Inventory (PI-6), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins University School of Medicine, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: David Yaden, PhD, role: CONTACT, phone: 410-550-5250, phoneExt: 0-5250, email: dyaden1@jhmi.edu, contacts name: David Yaden, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Patrick Finan, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
|
protocolSection identificationModule nctId: NCT06355401, orgStudyIdInfo id: Soh-Med-24-03--06PD, briefTitle: Maintenance Hormonal Therapy and DLBCL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy and/or radiotherapy in patients with DLDCL, conditionsModule conditions: Diffuse Large B Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Tamoxifen 20mg, outcomesModule primaryOutcomes measure: disease free survival, primaryOutcomes measure: overall survival, secondaryOutcomes measure: side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06355388, orgStudyIdInfo id: TRAGUSHF, briefTitle: TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure, acronym: TRAGUS-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fondazione Toscana Gabriele Monasterio, class: OTHER, collaborators name: Azienda Ospedaliera Città della Salute e della Scienza di Torino, descriptionModule briefSummary: To verify the efficacy of transcutaneous vagus nerve stimulation (tVNS) on and autonomic balance in patients with chronic heart failure and reduced (HFrEF) or mildly reduced (HFmrEF) left ventricular ejection fraction. The study hypothesis is that tVNS increases baroreflex gain, with consequent benefits on sympathovagal balance (at short- and mid-term), and on quality of life and bio-humoral parameters (at mid-term)., conditionsModule conditions: Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, conditions: Heart Failure With Midrange Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: In order to maintain the 'double-blind,' at the end of the experimental protocol, the data acquired in each phase (baseline, active tVNS, placebo tVNS) will be saved in three different files, made unrecognizable by one of the investigators not involved in the tabulation and data analysis. A second investigator, unaware of the stimulation phases, will proceed with the tabulation of the data for each individual recording (three per patient). Only at the end of the study (or after recruiting 50% of patients for any interim analyses), will the investigators responsible for data analysis be revealed the corresponding phase for each recording., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Active tVNS, interventions name: Sham tVNS, outcomesModule primaryOutcomes measure: Mean change in baroreflex gain (ms/mmHg), primaryOutcomes measure: Mean change in baroreflex gain (ms/mmHg), otherOutcomes measure: Mean change in MSNA burst incidence (bursts/100 heartbeats), otherOutcomes measure: Mean change in peak O2 consumption (mL/Kg/min), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Michele Emdin, city: Pisa, state: Pi, zip: 56120, country: Italy, contacts name: Michele Emdin, MD, PhD, role: CONTACT, email: emdin@ftgm.it, contacts name: Francesco Gentile, MD, role: SUB_INVESTIGATOR, contacts name: Claudio Passino, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
|
protocolSection identificationModule nctId: NCT06355375, orgStudyIdInfo id: 02.24, briefTitle: Exercise in Pregnancy and Risk of Postpartum Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day, conditionsModule conditions: Depression, conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Exercise during pregnancy, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 398, type: ESTIMATED, armsInterventionsModule interventions name: exercise in pregnancy, outcomesModule primaryOutcomes measure: edinburgh depression scale, secondaryOutcomes measure: Postpartum depression, secondaryOutcomes measure: preterm birth, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gabriele Saccone, status: RECRUITING, city: Naples, zip: 80100, country: Italy, contacts name: Gabriele Saccone, role: CONTACT, phone: 0817461111, email: gabriele.saccone.1990@gmail.com, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
|
protocolSection identificationModule nctId: NCT06355362, orgStudyIdInfo id: HeCoMo, briefTitle: Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality, acronym: HeCoMo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Kliniken Essen-Mitte, class: OTHER, descriptionModule briefSummary: Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature.The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic.In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study.In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities., conditionsModule conditions: High-risk Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of postoperative complications, primaryOutcomes measure: Incidence of postoperative mortalities, secondaryOutcomes measure: Implementation rate of preoperative factors impacting postoperative outcome, secondaryOutcomes measure: Intraoperative hemodynamic characteristics, secondaryOutcomes measure: Postoperative haemodynamic characteristics, secondaryOutcomes measure: Co-morbidities of patients, secondaryOutcomes measure: Transfusion of blood components and administration of coagulation factors, secondaryOutcomes measure: Score of the physical/pathological activity status of the patients, secondaryOutcomes measure: Clinical frailty scale, secondaryOutcomes measure: Characteristics of perioperative care, time in perioperative units and the hospital, secondaryOutcomes measure: Characteristics of provision of anesthesia and type of pain therapy, secondaryOutcomes measure: Implementation rate of items perioperatively impacting outcome within an Enhanced-Recovery-After-Surgery pathway description, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355349, orgStudyIdInfo id: JW22101, briefTitle: To Evaluate the Safety and PK Characteristics in Healthy Volunteers, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-28, primaryCompletionDateStruct date: 2023-07-10, completionDateStruct date: 2023-07-17, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: JW Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: Reference Drug or Test Drug, outcomesModule primaryOutcomes measure: AUCt, primaryOutcomes measure: Cmax, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Trial Center, Jeonbuk National University Hospital, city: Jeonju, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, hasResults: False
|
protocolSection identificationModule nctId: NCT06355336, orgStudyIdInfo id: CCA/IRN-24-001, briefTitle: Real World Prostate Cancer Registry, acronym: RWPCR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2034-03-18, completionDateStruct date: 2034-03-18, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Cincinnati Cancer Advisors, class: NETWORK, descriptionModule briefSummary: Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: To determine practice patterns for prostate cancer in the region., secondaryOutcomes measure: To determine progression free survival and overall survival of patients., secondaryOutcomes measure: Prevalence of long term complications of prostate cancer treatment., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cincinnati Cancer Advisors, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45212, country: United States, contacts name: Dr. Jazieh, role: CONTACT, phone: 513-731-2273, email: a.jazieh@cincinnaticanceradvisors.org, contacts name: Amy Barber, role: CONTACT, phone: 5137312273, email: ctcoordinator@iresearchnetwork.com, contacts name: Abdul R Jazieh, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, hasResults: False
|
protocolSection identificationModule nctId: NCT06355323, orgStudyIdInfo id: PT22020, briefTitle: Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France, acronym: PREDDICHA, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-28, primaryCompletionDateStruct date: 2025-11-28, completionDateStruct date: 2025-11-28, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: CHU de Reims, class: OTHER, descriptionModule briefSummary: Primary humoral immunodeficiency (PHID), such as common variable immunodefiency, are the most common symptomatic primary immunodeficiency in adults, in France. Patients are more prone to infections (particularly bacterial upper and lower respiratory tract infections), auto-immunity and atopic manifestations. Morbidity and mortality in PHID are mainly linked to the presence of bronchiectasis, which can lead to infections and to chronic respiratory failure. However, bronchiectasis in these patients can be asymptomatic for a long time. There is no known predictive factors to identify patients more susceptible to develop bronchiectasis and notably, there was no link between the number of previous infectious episodes and bronchiectasis. A marked IgM deficiency and switched memory B cell deficiency might be associated with bronchiectasis.Thoracic CT-scan is recommended at PHID diagnosis but there is no guideline for follow-up, thus leading to bronchiectasis being under-diagnosis or leading to delayed diagnosis, conditionsModule conditions: Primary Immunodeficiency, conditions: Common Variable Immunodeficiency, conditions: Igg Subclass Deficiency, conditions: Selective IgM Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Blood test, interventions name: chest CT scan, outcomesModule primaryOutcomes measure: Thoracic CTscan, secondaryOutcomes measure: Pulmonary Function Test, secondaryOutcomes measure: Pulmonary Function Test, secondaryOutcomes measure: Pulmonary Function Test, secondaryOutcomes measure: Pulmonary Function Test, secondaryOutcomes measure: Pulmonary Function Test, secondaryOutcomes measure: Pulmonary Function Test, secondaryOutcomes measure: 6 minutes walking test, secondaryOutcomes measure: 6 minutes walking test, secondaryOutcomes measure: 6 minutes walking test, secondaryOutcomes measure: 6 minutes walking test, secondaryOutcomes measure: Quality of life questionnaires, secondaryOutcomes measure: Quality of life questionnaires, secondaryOutcomes measure: Immunophenotyping, secondaryOutcomes measure: Biochemical factors : desmosine seric concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Damien JOLLY, status: RECRUITING, city: Reims, country: France, contacts name: Amélie SERVETTAZ, role: CONTACT, phone: 03 26 83 27 68 9, phoneExt: 0033, email: aservettaz@chu-reims.fr, contacts name: Ailsa ROBBINS, role: CONTACT, phone: 03 26 83 27 68, phoneExt: 0033, email: arobbins@chu-reims.fr, geoPoint lat: 49.25, lon: 4.03333, hasResults: False
|
protocolSection identificationModule nctId: NCT06355310, orgStudyIdInfo id: IRB 2023-6429, briefTitle: Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease, acronym: SHIELD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ann & Robert H Lurie Children's Hospital of Chicago, class: OTHER, descriptionModule briefSummary: This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity., conditionsModule conditions: Non-Alcoholic Fatty Liver Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1:1 randomization, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: double blind placebo control, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Empagliflozin 10 MG, interventions name: Placebo Oral Tablet, outcomesModule primaryOutcomes measure: Hepatic Fat, secondaryOutcomes measure: Body mass index, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355297, orgStudyIdInfo id: 124CER19., briefTitle: Educational Intervention Related to Pelvic Floor Care in Females in Sport: ACTITUD, acronym: ACTITUD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-05-22, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of the Balearic Islands, class: OTHER, descriptionModule briefSummary: Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. However, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. In this situation, prevention or management of PFD is limited.New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about PFD, habits related with it, and existing gender stereotypes.To this end, all female who practice and compete in any sport in Spain will be invited to attend an educational online intervention with theoretical-practical content about PFD. As eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. Participants should have at least 16 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. Before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD self-reported diagnosis. One month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. The main outcomes will be the level of knowledge about PF, the number of habits potentially related to PFD, and score of gender stereotyped beliefs. As an additional outcome, it will be considered the PFD self-reported symptomatology., conditionsModule conditions: Pelvic Floor Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A quasiexperimental controlled trial is designed, with two arms: an experimental group and a control group., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Education about pelvic floor, outcomesModule primaryOutcomes measure: Knowledge about pelvic floor, primaryOutcomes measure: Habits related to pelvic floor dysfunctions, secondaryOutcomes measure: Gender stereotypes beliefs, secondaryOutcomes measure: Occurrence of symptoms related to pelvic floor dysfunctions, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of the Balearic Islands, city: Palma De Mallorca, state: Balearic Islands, zip: 07122, country: Spain, geoPoint lat: 39.56939, lon: 2.65024, hasResults: False
|
protocolSection identificationModule nctId: NCT06355284, orgStudyIdInfo id: D5150-P, briefTitle: Overcontrol and Suicide in PTSD, acronym: OSP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-02-27, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is frequently observed in people with obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others can strain social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support, and as a result, tend to be at greater risk of developing more severe mental health symptoms, or suicidal thoughts and behaviors, over time.New treatments are needed to improve social functioning in these vulnerable Veterans. Adding brain stimulation to psychotherapy is one method that might speed learning of social skills discussed in therapy. However, before this technology can be developed and tested more broadly, the investigators must make sure that the methods used to measure social functioning and related brain circuits are acceptable to most potential patients and can be used consistently.In this pilot project, the investigators aim to recruit trauma-exposed Veterans with overcontrolled traits and study the feasibility and acceptability of:1. Our recruitment strategy and social functioning and mental health symptom assessments2. A three-session, weekly fMRI protocol.3. A three-week online protocol for remote monitoring of social and emotional functioning., conditionsModule conditions: Compulsive Personality Disorder, conditions: Stress Disorders, Post-Traumatic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Functional MRI, outcomesModule primaryOutcomes measure: Number of potential participants screened per month meeting the overcontrol criterion., primaryOutcomes measure: Percentage of sessions completed by participants receiving MRI., primaryOutcomes measure: Percentage of remote questionnaires completed., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Providence VA Medical Center, Providence, RI, city: Providence, state: Rhode Island, zip: 02908-4734, country: United States, contacts name: Jennifer L Barredo, role: CONTACT, phone: 401-273-7100, phoneExt: 6290, email: Jennifer.Barredo@va.gov, contacts name: Jennifer L Barredo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False
|
protocolSection identificationModule nctId: NCT06355271, orgStudyIdInfo id: 2024-00019, briefTitle: Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery, acronym: MoFe, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ente Ospedaliero Cantonale, Bellinzona, class: OTHER, descriptionModule briefSummary: Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery, conditionsModule conditions: Obstetric Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single center, multiple-blind, prospective, randomized, controlled trial in 3 parallel groups, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Allocation will take place immediately before the intervention by the means of access to centralized, real-time allocation through a computer program. The identification code will be present on the data collection form (where the patient's name, surname or date of birth will not appear to ensure blinding of the study).Personnel not directly involved with patient care, present during the randomization process, will sterilely prepare anesthesia solution while maintaining a total volume of 3,1 ml. This will allow blinding of patients, care providers and data collectors. The procedure will take place as a common clinical practice in our center. When performing spinal anesthesia, sterility is of fundamental importance, so it will not be possible to have the syringe used tagged. In the kit all materials will be sterile, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Fentanyl 1, interventions name: Fentanyl2, interventions name: Fentanyl 3, outcomesModule primaryOutcomes measure: Patient Controlled Analgesia morphine consumption, primaryOutcomes measure: obstetric quality of recovery score, secondaryOutcomes measure: Visual Analogue Scale, secondaryOutcomes measure: pruritus, secondaryOutcomes measure: nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity, secondaryOutcomes measure: intraoperative hypotension, secondaryOutcomes measure: intraoperative opioids, secondaryOutcomes measure: satisfaction rate, secondaryOutcomes measure: intraoperative pain, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355258, orgStudyIdInfo id: 20230817LX001, briefTitle: A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Westlake University, class: OTHER, collaborators name: Shaoxing Central Hospital, descriptionModule briefSummary: The goal of this clinical trial is to learn if troxerutin works to prevent thrombotic events in mild or severe COVID-19 patients. It will also learn about the safety of troxerutin. The main questions it aims to answer are:* Does troxerutin lower the number of thrombotic events in participants?* What medical problems do participants have when taking troxerutin? Researchers will compare troxerutin to a placebo (a look-alike substance that contains no drug) to see if troxerutin works to prevent thrombotic events in COVID-19 patients.Participants will:* Take troxerutin or a placebo every day for 7 days.* Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests* Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia, conditionsModule conditions: COVID 19 Associated Coagulopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: According to the inclusion criteria, participants will be randomly divided into mild patients and severe patients, and then patients with severe disease were randomly assigned to placebo + low molecular weight heparin group or troxerutin + low molecular weight heparin group, and patients with mild disease were randomly assigned to placebo group or troxerutin group, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Troxerutin, interventions name: Placebo, interventions name: placebo + low molecular weight heparin, interventions name: troxerutin + low molecular weight heparin, outcomesModule primaryOutcomes measure: Overall number of thrombotic events through 28 days, primaryOutcomes measure: Tolerability of anticoagulation therapy, secondaryOutcomes measure: Time to clinical improvement in patients through 28 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shaoxing central hospital, status: RECRUITING, city: Shaoxing, state: Zhejiang, country: China, contacts name: Xu Li, Doctor, role: CONTACT, phone: 13811635032, email: lixu@westlake.edu.cn, geoPoint lat: 30.00237, lon: 120.57864, hasResults: False
|
protocolSection identificationModule nctId: NCT06355245, orgStudyIdInfo id: 2017/2160-31/1, briefTitle: MEDECA - Markers in Early Detection of Cancer, acronym: MEDECA, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-03-01, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Danderyd Hospital, class: OTHER, descriptionModule briefSummary: Early diagnosis of cancer is key for improving patient outcomes, but cancers are difficult to diagnose if patients present with unspecific symptoms. The principal objective of the MEDECA (Markers in Early Detection of Cancer) study is to identify a multi-analyte blood test that can detect and map occult cancer within a mixed population of patients presenting with serious but unspecific symptoms. The study will include 1500 patients referred to the Diagnostic Center at Danderyd Hospital (DC DS), a multidisciplinary diagnostic center referral pathway for patients with radiological findings suggestive of metastasis without known primary tumor or suspicion of serious but unspecific symptoms. Blood samples are collected prior to a standardized and extensive cancer diagnostic work-up, including an expanded panel of biochemical analyses and extensive imaging such as computed tomography or magnetic resonance investigations. In collaboration with world-leading international scientists, the blood samples will be analyzed for a panel of novel and established blood biomarkers predictive of an underlying cancer, including markers of neutrophil extracellular traps, circulating tumor DNA, platelet mRNA profiling, affinity-based proteomics and nuclear magnetic resonance metabolomics. The diagnostic accuracy of the blood biomarkers with respect to cancer detection during the diagnostic work-up will be analyzed through machine learning., conditionsModule conditions: Cancer, conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, outcomesModule primaryOutcomes measure: Cancer diagnosis, secondaryOutcomes measure: Other diagnosis, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Cancer diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Danderyd Hospital, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Charlotte Thålin, M.D., Ph.D., role: CONTACT, phone: +46709565120, email: charlotte.thalin@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
|
protocolSection identificationModule nctId: NCT06355232, orgStudyIdInfo id: Vaxine-2301, briefTitle: Covid-19 and Influenza Oral Vaccine Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-21, primaryCompletionDateStruct date: 2024-04-21, completionDateStruct date: 2025-04-21, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Vaxine Pty Ltd, class: INDUSTRY, collaborators name: Australian Respiratory and Sleep Medicine Institute Ltd, descriptionModule briefSummary: The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines., conditionsModule conditions: covid19 Infection, conditions: Influenza, Human, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomised, controlled cross-over study, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: A comparator vaccine (influenza) with an identical appearance will be used as the control., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Covid-19 vaccine, interventions name: Influenza vaccine, outcomesModule primaryOutcomes measure: SARS-CoV-2 Seroconversion, primaryOutcomes measure: Influenza Seroconversion, primaryOutcomes measure: SARS-CoV-2 Seroprotection, primaryOutcomes measure: Influenza Seroprotection, primaryOutcomes measure: SARS-CoV-2 Geometric mean titer fold change, primaryOutcomes measure: Influenza geometric mean titer fold change, primaryOutcomes measure: Safety assessment 1, primaryOutcomes measure: Safety assessment 2, primaryOutcomes measure: SARS-CoV-2 infection, primaryOutcomes measure: Influenza infection, secondaryOutcomes measure: Antibody durability, secondaryOutcomes measure: Seroconversion in participants with and without evidence of past infection, secondaryOutcomes measure: Antibody GMT in participants with and without evidence of past infection, secondaryOutcomes measure: Antibody correlates of protection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ARASMI, city: Adelaide, state: South Australia, zip: 5042, country: Australia, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
|
protocolSection identificationModule nctId: NCT06355219, orgStudyIdInfo id: IRB #19-066, briefTitle: Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines, acronym: M6, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2010-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ali Aminian, class: OTHER, descriptionModule briefSummary: The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths., conditionsModule conditions: Type 2 Diabetes Mellitus, conditions: Obesity, conditions: Microvascular Disease, conditions: Macrovascular Disease, conditions: Major Adverse Cardiovascular Events, conditions: Nephropathy, conditions: Retinopathy, conditions: Heart Failure, conditions: All Cause Mortality, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3932, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: All-cause Mortality Rate, secondaryOutcomes measure: Incidence of MACE, secondaryOutcomes measure: Incidence of Nephropathy, secondaryOutcomes measure: Incidence of Retinopathy, otherOutcomes measure: Incidence of Components of MACE Separately, otherOutcomes measure: Change in weight percentage, otherOutcomes measure: Change HBA1c percentage, otherOutcomes measure: Trends of prescription and dispenses of medications for T2DM and cardio-vascular conditions, otherOutcomes measure: Progression of Chronic Kidney Disease (CKD) in Patients with CKD stages 3 and 4 at baseline, otherOutcomes measure: Cost-effectiveness of Metabolic Surgery vs GLP-1RAs, otherOutcomes measure: Incidence of Adverse Events After Metabolic Surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06355206, orgStudyIdInfo id: NACRE20230306, briefTitle: Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis, acronym: NACRE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2034-12, completionDateStruct date: 2034-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is:Does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis?Patients will be closely followed and clinical information will be recorded., conditionsModule conditions: Cohort Study, conditions: Recurrent Acute Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: endoscopic intervention, surgery or conservative treatment, outcomesModule primaryOutcomes measure: Recurrence rate of acute pancreatitis, secondaryOutcomes measure: Proportion of patients with different treatment, secondaryOutcomes measure: Characteristics of acute pancreatitis, secondaryOutcomes measure: Proportion of patients wtih pain in RAP patients, secondaryOutcomes measure: Proportion of patients with chronic pancreatitis, secondaryOutcomes measure: Evaluation of quality of life, secondaryOutcomes measure: Evaluation of psychological condition, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355193, orgStudyIdInfo id: MZhou, briefTitle: The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2022-12-30, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Central South University, class: OTHER, descriptionModule briefSummary: This study has significant implications for research, as it provides a basis for further studies on the antiviral effects of LGLQ Oral Liquid, encouraging more extensive clinical studies in larger populations and diverse age groups to validate these findings. For medical practice, the findings suggest that LGLQ can be considered an alternative treatment option for mild cases of COVID-19, especially in managing symptoms like fatigue, potentially broadening the range of effective treatments available to healthcare practitioners. In terms of policy, the demonstrated efficacy of LGLQ could lead to its inclusion in treatment guidelines for COVID-19 and other viral infections, fostering a more integrated approach combining Western medicine and Traditional Chinese Medicine in the global fight against pandemics. The insights from this study might prompt health policymakers to reassess the potential of herbal formulations in managing and treating infectious diseases and consider them in the development of future healthcare strategies and policies., conditionsModule conditions: Treatment of Mild Cases of COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 253, type: ACTUAL, armsInterventionsModule interventions name: Langenlianqiao, interventions name: LianhuaQingWen, interventions name: placebo control group, outcomesModule primaryOutcomes measure: Treatment and symptomatic improvement effects of LGLQ, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changde Hospital, city: Changde, state: Hunan, country: China, geoPoint lat: 29.04638, lon: 111.6783, hasResults: False
|
protocolSection identificationModule nctId: NCT06355180, orgStudyIdInfo id: Shoudufazhan2024-1-2122, briefTitle: Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Capital Medical University, class: OTHER, collaborators name: Wuhu Fourth People's Hospital, collaborators name: The Second People's Hospital of Dali Bai Autonomous Prefecture, collaborators name: Inner Mongolia Autonomous Region Mental Health Center, collaborators name: Beijing Chaoyang District Third Hospital, collaborators name: Beijing Daxing District Xinkang Hospital, collaborators name: Capital's Funds for Health Improvement and Research, descriptionModule briefSummary: This study is a multicenter, non-inferiority, randomized, parallel-group, open-label clinical trial aimed at evaluating the effectiveness of esketamine versus modified electroconvulsive therapy (MECT) in treating suicidal ideation during depressive episodes of mood disorders. Additionally, it seeks to explore the potential mechanisms of esketamine's anti-suicidal effects., conditionsModule conditions: Mood Disorders, conditions: Suicidal Ideation, conditions: Depressive Episode, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients will be randomized to either the esketamine group or the MECT group, but due to the differences in treatment modalities, it will not be possible to blind the subjects and investigators. To ensure the objectivity of the measurements, independent assessors will be established. These assessors are psychiatrists trained in the consistency of the scales and will remain blinded to the group allocation of the subjects throughout the entire assessment process., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 340, type: ESTIMATED, armsInterventionsModule interventions name: Subanesthetic dose intravenous esketamine, interventions name: Modified electroconvulsive therapy, outcomesModule primaryOutcomes measure: Suicide remission rate based on the Scale for Suicidal Ideation (SSI), secondaryOutcomes measure: Quick Inventory of Depressive Symptoms Self Report (QIDS-SR), secondaryOutcomes measure: Columbia Suicide Severity Rating Scale (CSSR-S), secondaryOutcomes measure: Montgomery Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Clinical Global Impressions(CGI), secondaryOutcomes measure: Short Form 12 Health Survey(SF-12), secondaryOutcomes measure: Sheehan Disability Scale(SDS), secondaryOutcomes measure: Digital Span Test(DST), secondaryOutcomes measure: Digit Symbol Substitution Test(DSST), secondaryOutcomes measure: Perceived Deficit Questionnaire for Depression 5-item(PDQ-D-5), secondaryOutcomes measure: Young Mania Rating Scale (YMRS), secondaryOutcomes measure: Clinician Administered Dissociative States Scale(CADSS), secondaryOutcomes measure: Adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355167, orgStudyIdInfo id: Bacoxy_I, briefTitle: Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress, acronym: Bacoxy_I, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-15, primaryCompletionDateStruct date: 2022-05-25, completionDateStruct date: 2022-09-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress., conditionsModule conditions: Oxidative Stress, conditions: Cardiovascular Diseases, conditions: Bacopaside II, conditions: Bacopa Monnieri, conditions: Endothelial Dysfunction, conditions: Aquaporin 1, conditions: AQP1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group A (n=10): 400mg/d of Bacopa monnieri Broup B (n=10): 800 mg/d of Bacopa monnieri, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Bacopa monnieri, outcomesModule primaryOutcomes measure: Ex vivo DCFDA test on red blood cells (RBCs), primaryOutcomes measure: Plasma lipid peroxydes, primaryOutcomes measure: Methemoglobin in red blood cells, primaryOutcomes measure: Nitrosylated hemoglobin (HbNO) in red blood cells, secondaryOutcomes measure: haemoglobin, secondaryOutcomes measure: haematocrit, secondaryOutcomes measure: Red blood cells count, secondaryOutcomes measure: Sodium, secondaryOutcomes measure: Potassium, secondaryOutcomes measure: Bicarbonate, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: High-Density Lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Low-Density Lipoprotein (LDL) cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: aspartate aminotransferase (ASAT), (U/L), secondaryOutcomes measure: alanine aminotransferase (ALAT) (U/L), secondaryOutcomes measure: gamma-glutamyl-transferase (GGT) level, secondaryOutcomes measure: Creatinine, secondaryOutcomes measure: Glomerular filtration rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique universitaires saint luc, city: Brussels, zip: 1200, country: Belgium, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
|
protocolSection identificationModule nctId: NCT06355154, orgStudyIdInfo id: 069823- HMO-CTIL, briefTitle: Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT.Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT., conditionsModule conditions: Diabetes in Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open label, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Nutritional intervention, outcomesModule primaryOutcomes measure: Time in range, primaryOutcomes measure: Time above range, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355141, orgStudyIdInfo id: E-15189967-050.04-494458, briefTitle: Oral Structural and Functional Problems in Children With Autism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-05-13, completionDateStruct date: 2024-08-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: This study aims to examine oral structural and functional problems in children with autism., conditionsModule conditions: Autism Spectrum Disorder, conditions: Chewing Problem, conditions: Drooling, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: oral assessment, outcomesModule primaryOutcomes measure: Demographic Information Form, primaryOutcomes measure: Time to achieve Oromotor skills, primaryOutcomes measure: Oral structural assessment, secondaryOutcomes measure: Chewing evaluation, secondaryOutcomes measure: Drooling of saliva evaluation, secondaryOutcomes measure: Tongue thrust evaluation, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355128, orgStudyIdInfo id: 20240307, briefTitle: A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-02-18, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Zhongnan Hospital, class: OTHER, collaborators name: Qichun People's Hospital, descriptionModule briefSummary: To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022, conditionsModule conditions: COVID-19, conditions: Ocular Surface Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 16000, type: ACTUAL, armsInterventionsModule interventions name: NOT, outcomesModule primaryOutcomes measure: Questionnaire data were collected and statistically analyzed., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongnan Hospital of Wuhan University, city: Wuhan, state: Hubei, zip: 430071, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
|
protocolSection identificationModule nctId: NCT06355115, orgStudyIdInfo id: 400/218/K.3/302/2023, briefTitle: Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation, acronym: PACE-PRO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Brawijaya, class: OTHER, collaborators name: Saiful Anwar Hospital, descriptionModule briefSummary: The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection. Therefore, administering prophylactic antibiotics to prevent infections before they occur, is a useful strategy to lower the risk of such infections.Nonetheless, the optimal duration of prophylactic antibiotics for PPM remains uncertain. Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use. Accordingly, the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations.The main questions it aims to answer are:1. What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations?2. What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications?Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections.Participants will:* Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations.* Visit the clinic for follow-ups and tests., conditionsModule conditions: Pacemaker Complication, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Cefazolin 1000 MG Injection, outcomesModule primaryOutcomes measure: Number of participants with early pocket infection (EPI), primaryOutcomes measure: Number of participants with late pocket infection (LPI), primaryOutcomes measure: Number of participants with infective endocarditis (IE), primaryOutcomes measure: Number of participants who underwent pacemaker revision, secondaryOutcomes measure: Level of C-reactive protein (mg/dl), secondaryOutcomes measure: Level of procalcitonin (mcg/dl), secondaryOutcomes measure: Erythrocyte sedimentation rate (ESR) (mm/hour), secondaryOutcomes measure: Neutrophil-to-leukocyte ratio (NLR), secondaryOutcomes measure: Neutrophil count (cells/mm3), secondaryOutcomes measure: Leukocyte count (cells/mm3), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RSUD Dr. Saiful Anwar, status: RECRUITING, city: Malang, state: Jawa Timur, zip: 65112, country: Indonesia, contacts name: RSUD Dr. Saiful Anwar, role: CONTACT, phone: 0341-362101, email: staf-rsu-drsaifulanwar@jatimprov.go.id, geoPoint lat: -7.9797, lon: 112.6304, hasResults: False
|
protocolSection identificationModule nctId: NCT06355102, orgStudyIdInfo id: 2024-SR-116, briefTitle: The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the factors and mechanisms underlying tinnitus generation and chronification in patients with sudden sensorineural hearing loss (SSNHL) . The main questions it aims to answer are:* What are the peripheral and central influencing factors that contribute to tinnitus in patients with SSNHL?* Can serum metabolic biomarkers be identified to predict and monitor tinnitus prognosis in these patients?Participants in this study will include patients with SSNHL and tinnitus, patients with SSNHL without tinnitus, and healthy subjects. They will be asked to undergo a series of assessments, including audiological tests, vestibular function examinations, and functional magnetic resonance imaging (fMRI). Additionally, blood samples will be collected for metabolomics analysis.Investigators will compare the brain functional states and serum metabolite profiles of patients with SSNHL and tinnitus to those without tinnitus. Morever, tinnitus symptom characteristics, audiological outcomes, and brain functional states will be assessed during time., conditionsModule conditions: Sudden Sensorineural Hearing Loss, conditions: Tinnitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Brain function states, primaryOutcomes measure: Serum metabolomics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355089, orgStudyIdInfo id: VAR-MIKRO, briefTitle: Intestinal Microbiota: Immunity, Recovery and Metabolic Health, acronym: VAR-MIKRO, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-09, primaryCompletionDateStruct date: 2023-09-07, completionDateStruct date: 2023-09-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Turku, class: OTHER, collaborators name: Government Body Funding, descriptionModule briefSummary: The aim of this intervention study is to investigate the effect of a specific postbiotic (Lacticaseibacillus rhamnosus GG = LGG) and whey protein on immunity, recovery, and weight management in young adults. The objective is based on previous knowledge about the health-promoting effects of these factors. A new goal is to study the combined effect of the postbiotic and whey protein. The results of the study can be utilized to promote the health of the young adults., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ACTUAL, armsInterventionsModule interventions name: Placebo Comparator, interventions name: Whey protein hydrolysate milk product, interventions name: Postbiotic and whey protein hydrolysate milk product, outcomesModule primaryOutcomes measure: Concentrations of inflammatory markers from the blood samples, secondaryOutcomes measure: Gut microbiota composition in feces, secondaryOutcomes measure: Weight of the participant, secondaryOutcomes measure: Waist circumference of the participant, secondaryOutcomes measure: Infections during the intervention, secondaryOutcomes measure: Development of physical fitness, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Recovery, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: BMI, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 28 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Turku, city: Turku, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False
|
protocolSection identificationModule nctId: NCT06355076, orgStudyIdInfo id: CSZ03, briefTitle: New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.Participants will:The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental group received a new urethral reconstruction technique, which involves suturing the levator ani muscle with the lateral striated muscle of the urethra, the dorsal median ridge (MDR), and the Di's fascia together for continuous suturing before performing bladder urethral anastomosis. After the reconstruction is completed, the end to end anastomosis of the bladder urethra is performed, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients in the experimental or control group, as well as their family members, are unaware, whoMasked: PARTICIPANT, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: New urethral reconstruction, outcomesModule primaryOutcomes measure: Recovery of urinary incontinence, secondaryOutcomes measure: complication, secondaryOutcomes measure: PSA, secondaryOutcomes measure: recurrence, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 276600, country: China, contacts name: shouzhen chen, role: CONTACT, phone: 18560089085, email: 201900412102@mail.sdu.edu.cn, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
|
protocolSection identificationModule nctId: NCT06355063, orgStudyIdInfo id: NP-PCF-037, briefTitle: CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Pulse Biosciences, Inc., class: INDUSTRY, descriptionModule briefSummary: This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure., conditionsModule conditions: Atrial Fibrillation, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study is a prospective, multicenter, single arm, non-randomized, feasibility study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CellFX® nsPFA™ Cardiac Surgery System, outcomesModule primaryOutcomes measure: Rate of acute major adverse events (MAEs), primaryOutcomes measure: Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial free wall., secondaryOutcomes measure: Proportion of Participants with one or more SAEs, secondaryOutcomes measure: Number of Participants with Long-Term Technical Success, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Academic Medical Center, city: Amsterdam, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Maastricht University Medical Center, city: Maastricht, country: Netherlands, geoPoint lat: 50.84833, lon: 5.68889, locations facility: St. Antonius Hospital, city: Nieuwegein, country: Netherlands, geoPoint lat: 52.02917, lon: 5.08056, hasResults: False
|
protocolSection identificationModule nctId: NCT06355050, orgStudyIdInfo id: UKJ-ultraHART, briefTitle: Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer, acronym: ultraHART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2031-09-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Jena University Hospital, class: OTHER, collaborators name: University Hospital Schleswig-Holstein, collaborators name: Klinikum Stuttgart, descriptionModule briefSummary: In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered with by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively., conditionsModule conditions: Prostate Cancer, conditions: Adaptive Radiotherapy, conditions: Quality of Life, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Toxicity (CTCAE v5.0), primaryOutcomes measure: Quality of Life (EPIC 26), secondaryOutcomes measure: Planning parameters, secondaryOutcomes measure: Dose constraints, secondaryOutcomes measure: Conformity indices, secondaryOutcomes measure: Quality of adaptive planning, secondaryOutcomes measure: PSA-value, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Recurrence free survival, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Radiotherapy and Radiation Oncology, Jena University Hospital, city: Jena, country: Germany, contacts name: Klaus Pietschmann, MD, role: CONTACT, email: klaus.pietschmann@med.uni-jena.de, contacts name: Georg Wurschi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.92878, lon: 11.5899, hasResults: False
|
protocolSection identificationModule nctId: NCT06355037, orgStudyIdInfo id: B2024.1.30, briefTitle: Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of dasatinib, quercetin with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy., conditionsModule conditions: Triple-negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Quercetin, interventions name: Dasatinib, interventions name: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Safety and treatment-related AEs, secondaryOutcomes measure: Biomarker analysis1, secondaryOutcomes measure: Biomarker analysis2, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355024, orgStudyIdInfo id: A2024.1.30, briefTitle: Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of Inosine with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy., conditionsModule conditions: Triple-negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Inosine, interventions name: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Biomarker analysis1, secondaryOutcomes measure: Safety and treatment-related AEs, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06355011, orgStudyIdInfo id: 7016194, briefTitle: Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-02, completionDateStruct date: 2024-04-02, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Manchester, class: OTHER, collaborators name: The National Joint Registry, collaborators name: The Royal College of Surgeons of England, collaborators name: John Charnley Trust, collaborators name: University of Bristol, descriptionModule briefSummary: The goal of this observational registry study is to provide detailed descriptions of the patients who are receiving primary total elbow replacement surgery in England. The main questions it aims to answer are:* Who are receiving primary total elbow replacement surgery?* Where and by whom is the total elbow replacement surgery is being performed?* What the current surgical practices for total elbow replacement?Pseudonymous data from the National Joint Registry NJR of all patients with total elbow replacement will be used., conditionsModule conditions: Total Elbow Replacement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3891, type: ACTUAL, armsInterventionsModule interventions name: Total Elbow Replacement, outcomesModule primaryOutcomes measure: The incidence of total elbow replacement (TER) in England, secondaryOutcomes measure: Serious adverse events or re-admissions, secondaryOutcomes measure: Duration of elective wait, secondaryOutcomes measure: Post-operative duration of stay, secondaryOutcomes measure: Surgeon volume, secondaryOutcomes measure: Hospital volume, otherOutcomes measure: Patient characteristics (Age), otherOutcomes measure: Body mass index, otherOutcomes measure: Hand dominance, otherOutcomes measure: American Society of Anaesthesiologists (ASA) grade, otherOutcomes measure: Indication for total elbow replacement, otherOutcomes measure: Socioeconomic status, otherOutcomes measure: Ethnicity, otherOutcomes measure: Co-morbidities, otherOutcomes measure: Charlson Comorbidity Index, otherOutcomes measure: Implant classification, otherOutcomes measure: Fixation type, otherOutcomes measure: Implant type, otherOutcomes measure: If radial head replacement was used, otherOutcomes measure: Grade of primary surgeon, otherOutcomes measure: Funding, otherOutcomes measure: Elective admission type, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, city: Manchester, zip: M13 9PT, country: United Kingdom, geoPoint lat: 53.48095, lon: -2.23743, hasResults: False
|
protocolSection identificationModule nctId: NCT06354998, orgStudyIdInfo id: mRNA-1273-P401, briefTitle: A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: ModernaTX, Inc., class: INDUSTRY, descriptionModule briefSummary: To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)., conditionsModule conditions: SARS-CoV-2, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Investigational mRNA-1273.815, interventions name: Licensed Spikevax Vaccine, outcomesModule primaryOutcomes measure: Geometric Mean of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15, secondaryOutcomes measure: Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study, secondaryOutcomes measure: Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain at Day 15, secondaryOutcomes measure: Geometric Mean Ratio of nAb Against the SARS-CoV-2-specific Strain for Investigational mRNA-1273.815 Over the Licensed Spikevax Vaccine at Day 15, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Paratus Canberra, status: RECRUITING, city: Canberra, state: Australian Capital Territory, zip: 2617, country: Australia, geoPoint lat: -35.28346, lon: 149.12807, locations facility: Holdsworth House, status: RECRUITING, city: Darlinghurst, state: New South Wales, zip: 2010, country: Australia, geoPoint lat: -33.87939, lon: 151.21925, locations facility: Paratus Brisbane, status: RECRUITING, city: Brisbane, state: Queensland, zip: 2617, country: Australia, geoPoint lat: -27.46794, lon: 153.02809, locations facility: USC Morayfield, status: NOT_YET_RECRUITING, city: Morayfield, state: Queensland, zip: 4506, country: Australia, geoPoint lat: -27.10876, lon: 152.94907, locations facility: University of the Sunshine Coast, South Bank, status: RECRUITING, city: South Brisbane, state: Queensland, zip: 4101, country: Australia, geoPoint lat: -27.48034, lon: 153.02049, locations facility: Emeritus Melbourne, status: RECRUITING, city: Camberwell, state: Victoria, zip: 3124, country: Australia, geoPoint lat: -37.84205, lon: 145.0694, locations facility: AusTrials Sunshine Hospital, status: RECRUITING, city: Melbourne, state: Victoria, zip: 3021, country: Australia, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
|
protocolSection identificationModule nctId: NCT06354985, orgStudyIdInfo id: 23-5996, secondaryIdInfos id: MODEX2023, type: OTHER, domain: Clinical Trial Protocol Number, secondaryIdInfos id: FRN:183960, type: OTHER_GRANT, domain: CIHR, secondaryIdInfos id: CTO Project ID: 4701, type: OTHER, domain: Clinical Trials Ontario, briefTitle: Modafinil and Exercise for Post Stroke Fatigue, acronym: MODEX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke.Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has two main aims:1. Test if Exercise Program One is better than Exercise Program Two2. Test if Modafinil is better than a Sugar PillAs another aim, the investigators will also look at if combining Modafinil with exercise has any benefits.This study will take place at 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels.Participants will be assigned at random (like flipping a coin) to 1 of 4 groups:1. Sugar Pill plus Exercise Program One2. Sugar Pill plus Exercise Program Two3. Modafinil plus Exercise Program One4. Modafinil plus Exercise Program TwoThe treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months.The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke., conditionsModule conditions: Stroke, conditions: Fatigue, conditions: Modafinil, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All members of the research team and the participants will be blinded to medication group allocation, but cannot be blinded to exercise group allocation. Evaluators and the study statistician will be blinded to the exercise group allocation. The study statistician and the rest of the Data Safety Monitoring Board will have access to the medication assignment if needed (e.g. adverse drug reaction)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: Modafinil 200mg, interventions name: Placebo, interventions name: Exercise Program One, interventions name: Exercise Program Two, outcomesModule primaryOutcomes measure: Severity of Fatigue Symptoms, secondaryOutcomes measure: Severity of Fatigue Symptoms, secondaryOutcomes measure: Impact on Quality of Life, secondaryOutcomes measure: Walking Recovery, secondaryOutcomes measure: Leg Strength and Coordination, secondaryOutcomes measure: 3-Day Physical Activity Assessment, secondaryOutcomes measure: Mood and Anxiety, secondaryOutcomes measure: Attention, secondaryOutcomes measure: Cognition, secondaryOutcomes measure: Health Resource Utilization, secondaryOutcomes measure: Quality Adjusted Life Years, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06354972, orgStudyIdInfo id: SASP Turin, briefTitle: Impact of SASP in the GCF on the Outcomes of Periodontal Regeneration, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-02, primaryCompletionDateStruct date: 2022-11-02, completionDateStruct date: 2024-01-02, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, descriptionModule briefSummary: Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects.Methods: Sites associated with intrabony defects ≥ 3 mm requiring periodontal regeneration through minimally-invasive surgical technique were included. Pre-operatively, GCF was sampled for inflammatory biomarker analysis related to SASP \[interleukin (IL)-1β, IL-6 and IL-12; matrix-metalloproteinases (MMP)-8 and -9\]. Correlation analyses and logistic regression models were performed to assess the impact of predictors on clinical and radiographic outcomes., conditionsModule conditions: Periodontal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Minimally invasive surgical procedure, outcomesModule primaryOutcomes measure: Clinical attachment level change, primaryOutcomes measure: Achievement of composite outcome measure, secondaryOutcomes measure: Radiographic bone level change, secondaryOutcomes measure: Probing pocket depth change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CIR Dental School, city: Turin, zip: 10126, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.